ML19337A275

Shine Medical Technologies, LLC Supplement 1 to Final Safety Analysis Report

ML19337A275
Person / Time
Site:	SHINE Medical Technologies, 99902034
Issue date:	11/14/2019
From:	Jim Costedio SHINE Medical Technologies
To:	Document Control Desk, Office of Nuclear Reactor Regulation
Shared Package
ML19331A832	List: ML19331A647 ML19331A648 ML19331A649 ML19331A652 ML19331A654 ML19331A657 ML19331A659 ML19331A660 ML19331A661 ML19331A662 ML19331A663 ML19331A664 ML19331A665 ML19331A667 ML19331A669 ML19331A672 ML19331A674 ML19331A676 ML19331A679 ML19331A681 ML19331A682 ML19337A275
References
2019-SMT-0119
Download: ML19337A275 (6)

Text

THIS LETTER CONTAINS PROPRIETARY AND EXPORT CONTROLLED INFORMATION IN ACCORDANCE WITH 10 CFR 2.390 November 14, 2019 2019-SMT-0119 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 SHINE Medical Technologies, LLC Operating License Application Supplement No. 1 Pursuant to 10 CFR Part 50.30, SHINE Medical Technologies, LLC (SHINE) submitted an application for an operating license for a medical isotope production facility to be located in Janesville, WI via Reference 1. SHINE has determined that a supplement to the application is necessary to address facility design changes and administrative errors identified in application documents.

This application supplement 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 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 a non-public version of the SHINE Final Safety Analysis Report (FSAR)

Change Summary, including a markup of affected FSAR pages. Enclosure 1 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 a public version of the SHINE FSAR Change Summary. provides a non-public revision to the SHINE FSAR, incorporating the changes described in Enclosure 1. 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. provides a non-public revision to the SHINE Integrated Safety Analysis (ISA)

Summary. Revision 3 of the SHINE ISA Summary incorporates conforming changes associated 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 6, this letter is uncontrolled.

101 E. Milwaukee Street, Suite 600 I Janesville, WI 53545 I P (608) 210-1060 I F (608) 210-2504 I www.shinemed.com

Document Control Desk Page 2 with the FSAR changes described in Enclosure 1, as well as additional updates described in the revision log of the ISA Summary. 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 , in its entirety, from public disclosure under 10 CFR 2.390. provides a non-public revision to the SHINE Technical Specifications. Revision 1 of the SHINE Technical Specifications incorporates conforming changes associated with the FSAR changes described in Enclosure 1, as well as administrative updates. Enclosure 6 contains proprietary information, a subset of which has been determined to be ECI. SHINE requests that the NRC withhold Enclosure 6 from public disclosure under 10 CFR 2.390. provides a public revision to the SHINE Technical Specifications. provides a revision to the SHINE Quality Assurance Program Description (QAPD).

Revision 14 of the SHINE QAPD incorporates organizational changes as well as administrative updates. provides an affidavit supporting the proprietary treatment of the SHINE proprietary information contained in Enclosures 1, 3, 5, and 6, pursuant to 10 CFR 2.390. SHINE requests that the NRC withhold Enclosures 1, 3, 5, and 6 from public disclosure under 10 CFR 2.390.

Upon removal of Enclosures 1, 3, 5, and 6, 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. The following table identifies which FSAR chapter files, submitted within the enclosed OSM, have been modified from the files previously submitted in Reference 1.

Enclosure Title Modified 3 FSAR Chapter 01 - The Facility Yes 3 FSAR Chapter 02 - Site Characteristics No 3 FSAR Chapter 03 - Design of Structures, Systems, and Yes Components 3 FSAR Chapter 04 - Irradiation Unit and Radioisotope Production Yes Facility Description 3 FSAR Chapter 05 - Coolinq Systems Yes 3 FSAR Chapter 06 - Enqineered 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 No Manaqement 3 FSAR Chapter 13 - Accident Analysis Yes 3 FSAR Chapter 15 - Financial Qualifications No 4 FSAR Chapter 01 - The Facility Yes 4 FSAR Chapter 02 - Site Characteristics No 4 FSAR Chapter 03 - Design of Structures, Systems, and Yes Components 4 FSAR Chapter 04 - Irradiation Unit and Radioisotope Production Yes Facility Description

Document Control Desk Page 3 Enclosure Title Modified 4 FSAR Chapter 05 - Cooling Systems Yes 4 FSAR Chapter 06 - Enqineered Safety Features Yes 4 FSAR Chapter 07 - Instrumentation and Control Systems Yes 4 FSAR Chapter 08 - Electrical Power Systems No 4 FSAR Chapter 09 - Auxiliary Systems Yes 4 FSAR Chapter 10 - Experimental Facilities No 4 FSAR Chapter 11 - Radiation Protection Program and Waste No Manaqement 4 FSAR Chapter 12 - Conduct of Operations No 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 November 14, 2019.

Very truly yours, cl~

~ : President of Regulatory Affairs and Quality SHINE Medical Technologies, LLC Docket No. 50-608 Enclosures cc: Project Manager, USNRC Supervisor, Radioactive Materials Program, Wisconsin Division of Public Health (w/o Enclosures 1, 3, 5, and 6)

ENCLOSURE 9 SHINE MEDICAL TECHNOLOGIES, LLC SHINE MEDICAL TECHNOLOGIES, LLC OPERATING LICENSE APPLICATION SUPPLEMENT N0.1 AFFIDAVIT OF JAMES COSTEDIO 2 pages follow

AFFIDAVIT OF JAMES COSTEDIO STATE OF WISCONSIN )

) ss.

COUNTY OF ROCK )

I, James Costedio, Vice President of Regulatory Affairs and Qual ity of SHINE Medical 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 by letter 2019-SMT-0119 with enclosures. SHINE requests that the confidential information contained in Enclosures 1, 3, 5, and 6 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 6 of 2019-SMT-0119 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 6 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 6 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 6 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 6 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 6 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 6 of 2019-SMT-0119 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 November 14, 2019.

)/.~ mes Costedio Vice President of Regulatory Affairs and Quality SHINE Medical Technologies, LLC Page 2 of 2