ML22249A125

Shine Technologies, LLC Final Safety Analysis Report - Application for an Operating License Supplement No. 30, Cover Letter

ML22249A125
Person / Time
Site:	SHINE Medical Technologies
Issue date:	08/31/2022
From:	Jim Costedio SHINE Technologies, SHINE Health. Illuminated
To:	Office of Nuclear Reactor Regulation
Shared Package
ML22249A148	List: ML22249A125 ML22249A126 ML22249A127 ML22249A128 ML22249A129 ML22249A130 ML22249A131 ML22249A132 ML22249A133 ML22249A134 ML22249A135 ML22249A136 ML22249A137 ML22249A138 ML22249A139 ML22249A140 ML22249A141 ML22249A142 ML22249A143 ML22249A144 ML22249A145 ML22249A146
References
2022-SMT-0077
Download: ML22249A125 (6)

Text

THIS LETTER CONTAINS PROPRIETARY AND EXPORT CONTROLLED INFORMATION IN ACCORDANCE WITH 10 CFR 2.390 August 31, 2022 2022-SMT-0077 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 14,"

dated January 26, 2022 (ML22034A612)

SHINE Technologies, LLC Application for an Operating License Supplement No. 30 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 via Reference 1. SHINE has determined that a supplement to the operating license application is necessary to address facility design changes and to incorporate changes associated with SHINE responses to NRC requests for additional information.

This submittal contains information which SHINE requests to be withheld from public disclosure, including proprietary information in accordance with 10 CFR 2.390(a)(4), export controlled information (ECI) in accordance with 10 CFR 2.390(a)(3), and security-related information (SRI) in accordance with 10 CFR 2.390(d). SRI was identified utilizing the guidance contained in Regulatory Issue Summary (RIS) 2005-31, Revision 1. The revised application documents are provided via optical storage media (OSM). provides the non-public version of the SHINE Final Safety Analysis Report (FSAR)

Change Summary, including a markup of affected FSAR pages not previously submitted. contains proprietary information, a subset of which has been determined to be ECI, as well as SRI. SHINE requests that the NRC withhold Enclosure 1 from public disclosure under 10 CFR 2.390. provides the public version of the SHINE FSAR Change Summary. provides a non-public revision to the SHINE FSAR. Enclosure 3 contains proprietary information, a subset of which has been determined to be ECI, as well as SRI.

SHINE requests that the NRC withhold Enclosure 3 from public disclosure under 10 CFR 2.390. provides a public revision to the SHINE FSAR.

Enclosures 1, 3, and 5 contain security-related information.

Withhold from public disclosure under 10 CFR 2.390.

Upon removal of Enclosures 1, 3, 5, and 7 this letter is uncontrolled.

3400 Innovation Ct.* Janesville, WI 53546

• 877.512.6554

• info@shinemed.com

• www.SHINEtechnologies.com

Document Control Desk Page 2 provides a non-public revision to the SHINE Phased Startup Operations Application Supplement. Enclosure 5 contains proprietary information, a subset of which has been determined to be ECI, as well as SRI. SHINE requests that the NRC withhold Enclosure 5 from public disclosure under 10 CFR 2.390. provides a public revision to the SHINE Phased Startup Operations Application Supplement. provides a non-public revision to the SHINE Technical Specifications. Enclosure 7 contains proprietary information, a subset of which has been determined to be ECI. SHINE requests that the NRC withhold Enclosure 7 from public disclosure under 10 CFR 2.390. provides a public revision to the SHINE Technical Specifications. provides an affidavit supporting the proprietary treatment of the SHINE proprietary information contained in Enclosures 1, 3, 5, and 7, pursuant to 10 CFR 2.390. SHINE requests that the NRC withhold Enclosures 1, 3, 5, and 7 from public disclosure under 10 CFR 2.390.

Upon removal of Enclosures 1, 3, 5, and 7, this letter is uncontrolled.

The SHINE FSAR is provided in its entirety in Enclosures 3 (Non-Public) and 4 (Public);

however, not every FSAR chapter has been revised. Revision bars within Enclosures 3 and 4 indicate the changes incorporated into the FSAR via this supplement. The following table identifies which FSAR chapter files, submitted within the enclosed OSM, have been modified from the files previously submitted in Reference 2.

Enclosure Title Modified 3 FSAR Chapter 01 - The Facility No 3 FSAR Chapter 02 - Site Characteristics No 3 FSAR Chapter 03 - Design of Structures, Systems, and No Components 3 FSAR Chapter 04 - Irradiation Unit and Radioisotope Production Yes Facility Description 3 FSAR Chapter 05 - Coolinq Systems No 3 FSAR Chapter 06 - Engineered Safety Features Yes 3 FSAR Chapter 07 - Instrumentation and Control Systems Yes 3 FSAR Chapter 09 - Auxiliary Systems Yes 3 FSAR Chapter 11 - Radiation Protection Program and Waste Yes Management 3 FSAR Chapter 13 - Accident Analysis Yes 3 FSAR Chapter 15 - Financial Qualifications No 4 FSAR Chapter 01 - The Facility No 4 FSAR Chapter 02 - Site Characteristics No 4 FSAR Chapter 03 - Design of Structures, Systems, and No Components 4 FSAR Chapter 04 - Irradiation Unit and Radioisotope Production Yes Facility Description 4 FSAR Chapter 05 - Cooling Systems No 4 FSAR Chapter 06 - Enqineered Safety Features Yes

Document Control Desk Page 3 Enclosure Title Modified 4 FSAR Chapter 07 - Instrumentation and Control Systems Yes 4 FSAR Chapter 08 - Electrical Power Systems Yes 4 FSAR Chapter 09 - Auxiliary Systems Yes 4 FSAR Chapter 10 - Experimental Facilities No 4 FSAR Chapter 11 - Radiation Protection Program and Waste Yes Management 4 FSAR Chapter 12 - Conduct of Operations Yes 4 FSAR Chapter 13 - Accident Analysis Yes 4 FSAR Chapter 14 - Technical Specifications No 4 FSAR Chapter 15 - Financial Qualifications No 4 FSAR Chapter 16 - Other License Considerations No 4 FSAR Chapter 17 - Decommissioning and Possession-Only No License Amendments 4 FSAR Chapter 18 - Highly Enriched to Low Enriched Uranium No Conversion 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 31, 2022.

Very truly yours, James Costedio Vice President of Regulatory Affairs and Quality SHINE Technologies, LLC Docket No. 50-608 Enclosures cc: Project Manager, USNRC SHINE General Counsel Supervisor, Radioactive Materials Program, Wisconsin Division of Public Health (w/o Enclosures 1, 3, 5, and 7)

ENCLOSURE 9 SHINE TECHNOLOGIES, LLC SHINE TECHNOLOGIES, LLC APPLICATION FOR AN OPERATING LICENSE SUPPLEMENT NO. 30 AFFIDAVIT OF JAMES COSTEDIO

AFFIDAVIT OF JAMES COSTEDIO STATE OF WISCONSIN )

) ss.

COUNTY OF ROCK )

I, James Costedio, Vice President of Regulatory Affairs and Quality of SHINE Technologies, LLC (SHINE), do hereby affirm and state:

1. I am authorized to execute this affidavit on behalf of SHINE . I am authorized to review information submitted to or discussed with the Nuclear Regulatory Commission (NRC) and apply for the withholding of information from public disclosure . The purpose of this affidavit is to provide the information required by 10 CFR 2.390(b) in support of SHIN E's request for proprietary treatment of certain confidential commercial and financial information submitted in the operating license application supplement by letter 2022-SMT-0077 with enclosures. SHINE requests that the confidential information contained in Enclosures 1, 3, 5, and 7 be withheld from public disclosure in their entirety.

2. I have knowledge of the criteria used by SHINE in designating information as sensitive, proprietary, or confidential.

3. Pursuant to the provisions of paragraph (a)(4) of 10 CFR 2.390, the following is furnished for consideration by the NRC in determining whether the information sought to be withheld from public disclosure should be withheld .

a. The information sought to be withheld from public disclosure contained in Enclosures 1, 3, 5, and 7 of 2022-SMT-0077 is owned by SHINE, its affiliates, or third parties to whom SHINE has an obligation to maintain its confidentiality. This information is and has been held in confidence by SHINE.

b. The information sought to be protected in Enclosures 1, 3, 5, and 7 is not available to the public to the best of my knowledge and belief.

Page 1 of 2

c. The information contained in Enclosures 1, 3, 5, and 7 is of the type that is customarily held in confidence by SHINE, and there is a rational basis for doing so. The information that SHINE is requesting to be withheld from public disclosure includes trade secret, commercial financial information, commercial information, or information that is subject to export controls.

SHINE limits access to these elements to those with a "need to know," and subject to maintaining confidentiality.

d. The proprietary information sought to be withheld from public disclosure in Enclosures 1, 3, 5, and 7 includes, but is not limited to: structural configuration, primary and supporting systems of the medical isotope production facility, process and system locations, and process details. This would include information regarding the types, quantities, and locations of materials stored on site as would be referenced in facility configuration drawings. Public disclosure of the information in Enclosures 1, 3, 5, and 7 would create substantial harm to SHINE because it would reveal trade secrets owned by SHINE, its affiliates, or third parties to whom SHINE has an obligation to maintain its confidentiality.

e. Public disclosure of the information in Enclosures 1, 3, 5, and 7 would create substantial harm to SHINE because it would reveal valuable business information regarding SHINE's competitive expectations, assumptions, processes, and current position. Its use by a competitor could substantially improve their competitive position in the design, manufacture, shipment, installation, assurance of quality, or licensing of a similar product.

f. The information contained in Enclosures 1, 3, 5, and 7 of 2022-SMT-0077 is transmitted to the NRC in confidence and under the provisions of 10 CFR 2.390; it is to be received in confidence by the NRC. The information is properly marked.

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

Executed on August 31, 2022.

es Costedio ice President of Regulatory Affairs and Quality SHINE Technologies, LLC Page 2 of 2