ML20255A027

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Shine Medical Technologies, LLC Operating License Application Response to Request for Additional Information and Supplement No. 3
ML20255A027
Person / Time
Site: SHINE Medical Technologies
Issue date: 08/28/2020
From: Jim Costedio
SHINE Medical Technologies
To:
Document Control Desk, Office of Nuclear Reactor Regulation
Shared Package
ML20255A026 List:
References
2020-SMT-0081
Download: ML20255A027 (6)
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Text

{{#Wiki_filter:SHINE Medical Technologies THIS LETTER CONTAINS PROPRIETARY AND EXPORT CONTROLLED INFORMATION IN ACCORDANCE WITH 10 CFR 2.390 August 28, 2020 2020-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) NRC letter to SHINE Medical Technologies, LLC, "Issuance of Request for Additional Information Related to the SHINE Medical Technologies, LLC Operating License Application (EPID No. L-2019-NEW-0004)," dated May 26, 2020 (ML20148M278) (3) SHINE Medical Technologies, LLC letter to the NRC, "SHINE Medical Technologies, LLC Operating License Application Response to Request for '------~-----~---dditionaLLnfor:mation,.'.'._datedJuAe-1-1-,~202u------~----------- 

                            - (4) SHINE Medical Technologies, LLC letter to the NRC, "SHINE Medical Technologies, LLC Application for an Operating License SHINE Response to Request for Additional lnfo[mation 4a-4," dated July 30, 2020 (ML20220A339)

(5) SHINE Medical Technologies, LLC letter to the NRG, "SHINE Medical Technologies, LLC Operating License Application Supplement No. 2," dated March 27, 2020 (ML20105A294) SHINE Medical Technologies, LLC Operating License Application Response to Request for Additional Information and Supplement No. 3 Pursuant to 10 CFR Part 50.30, SHINE Medical Technologies, LLC (SHl['JE) submitted an application for an operating license for a medical isotope production facility to be located in Janesville, WI via Reference 1. Via Reference 2, the NRC staff determineq that additional information was required to enable the staff's continued review of the SHINE operating license application. SHINE responded to a portion of the NRC staffs requests via References 3 and 4. SHINE has determined that a supplement to the operating license application is necessary to address facility design changes and to provide administrative revisions. 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 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). 

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            ~ - - - - - -Enclosures  -----              ---------------------~

2 and 4 contain security-related information. Withhold from public disclosure under 10 CFR 2.390. ('JfZ{( Upon removal of Enclosures 2, 4, and 6, this letter is uncontrolled. 101 E. Milwaukee Street, Suite 600 I Janesville, WI 535451 P (608) 210-1060 IF (608) 210-2504 J www.shinemed.com

Document Control Desk Page 2 Enclosure 1 provides the SHINE response to the NRC staff's request for additional information associated with Chapter 7 of the Final Safety Analysis Report (FSAR). Enclosure 2 provides a non-public version of the SHINE FSAR Change Summary, including a markup of affected FSAR pages. Enclosure 2 contains proprietary information, a subset of which has been determined to be ECI, as well as SRI. SHINE requests that the NRC withhold Enclosure 2 from public disclosure under 10 CFR 2.390. Enclosure 3 provides a public version of the SHINE FSAR Change Summary. Enclosure 4 provides a non-public revision to the SHINE FSAR, incorporating the changes described in Enclosures 1 and 2. Enclosure 4 contains proprietary information, a subset of which has been determined to be ECI, as well as SRI. SHINE requests that the NRC withhold Enclosure 4 from public disclosure under 10 CFR 2.390. Enclosure 5 provides a public revision to the SHINE FSAR. Enclosure 6 provides a non-public revision to the SHINE Technical Specifications incorporating the changes identified in Enclosure 1, as well as conforming changes associated with the FSAR changes described in Enclosure 2. The revision also incorporates markups to the SHINE Technical Specifications provided in Reference 4. Enclosure 6 contains proprietary information, >-------~a~s=u=b=se=t~o-f~w~h-ich has_be_e.o_deJermine~dJo_be.ECLSHlb!E_[equests__thaUbeJ'JRC_witbbol._.__ _ _ _ _ _ _ _ , Enclosure 6 from public disclosure under 10 CFR 2.390. Enclosure 7 provides a public revision to the SHINE Technical Specifications. Enclosure 8 provides an affidavit supporting the proprietary treatment of the SHINE proprietary information contained in Enclosures 2, 4, and 6, pursuant to 10 CFR 2.390. SHINE requests that the NRC withhold Enclosures 2, 4, and 6 from public disclosure under 10 CFR 2.390. Upon removal of Enclosures 2, 4, and 6, this letter is uncontrolled. The SHINE FSAR is provided in its entirety in Enclosures 4 (Non-Public) and 5 (Public); however, not every FSAR chapter has been revised. Revision bars within Enclosures 4 and 5 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 5. Enclosure Title Modified 4 FSAR Chapter 01 - The Facility Yes 4 FSAR Chapter 02 - Site Characteristics Yes 4 FSAR Chapter 03 - Design of Structures, Systems, and Yes Coml)onents 4 FSAR Chapter 04 - Irradiation Unit and Radioisotope Production Yes Facilitv Descriotion 4 FSAR Chaoter 05 - Coolina Systems Yes 4 FSAR Chaoter 06 - Enaineered Safety Features Yes 4 FSAR Chaoter 07 - Instrumentation and Control Systems Yes 4 FSAR Chaoter 09 - Auxiliary Systems Yes

Document Control Desk Page 3 Enclosure Title Modified 4 FSAR Chapter 11 - Radiation Protection Program and Waste Yes ManaQement 4 FSAR Chapter 13 - Accident Analysis Yes 4 FSAR Chapter 15 - Financial Qualifications Yes 5 FSAR Chapter 01 -The Facility Yes 5 FSAR Chapter 02 - Site Characteristics Yes 5 FSAR Chapter 03 - Design of Structures, Systems, and Yes Components 5 FSAR Chapter 04- Irradiation Unit and Radioisotope Production Yes Facility Description 5 FSAR Chapter 05 - Cooling Systems Yes 5 FSAR Chapter 06 - Engineered Safety Features Yes 5 FSAR Chapter 07 - Instrumentation and Control Systems Yes 5 FSAR Chapter 08 - Electrical Power Systems Yes 5 FSAR Chapter 09 - Auxiliary Systems Yes 5 FSAR Chapter 1O - Experimental Facilities No 5 FSAR Chapter 11 - Radiation Protection Program and Waste Yes ManaQement 5 FSAR Chapter 12 - Conduct of Operations Yes 5 FSAR Chapter 13 - Accident Analysis Yes 5 FSAR Chapter 14- Technical Specifications No 5 FSAR Chapter 15 - Financial Qualifications Yes 5 FSAR Chapter 16 - Other License Considerations No 5 FSAR Chapter 17 - Decommissioning and Possession-Only No License Amendments 5 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 28, 2020. Very truly yours, G=-C:-~ J F52D89e892~4F(f ames os e 10 Vice President of Regulatory Affairs and Quality SHINE Medical 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 2, 4, and 6) 

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ENCLOSURE 8 SHINE MEDICAL TECHNOLOGIES, LLC SHINE MEDICAL TECHNOLOGIES, LLC OPERATING LICENSE APPLICATION RESPONSE TO REQUEST FOR ADDITIONAL INFORMATION AND SUPPLEMENT NO. 3 AFFIDAVIT OF JAMES COSTEDIO 2 pages follow

SHINE Medical Technologies AFFIDAVIT OF JAMES COSTEDIO STATE OF WISCONSIN ) 

                             ) SS.

COUNTY OF ROCK ) I, James Costedio, Vice President of Regulatory Affairs and Quality 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~lhe-purpose-of-this-affidavit-is-t0-provide-the-inf0rmati0n-re(luired-by*-------

10 CFR 2.390(b) in support of SHINE's request for proprietary treatment of certain confidential commercial and financial information submitted in the operating license application supplement by letter 2020-SMT-0081 with enclosures. SHINE requests that the confidential information contained in Enclosures 2, 4, 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 2, 4, and 6 of 2020-SMT-0081 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 2, 4, 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 2, 4, and 6 is of the type that is customarily held in confidence by SHINE, and there is a rational basi~ 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 2, 4, 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 2, 4, 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 2, 4, 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 b~ a competitor c{)uld sullstantialJy_ _ _ _ _ __ 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 2, 4, and 6 of 2020-SMT-0081 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 28, 2020. James Costedio Vice President of Regulatory Affairs and Quality SHINE Medical Technologies, LLC Page 2 of 2}}

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