ML21095A235

Shine Medical Technologies, LLC, Cover Letter for Response to Request Tor Additional Information and Supplement No. 7

ML21095A235
Person / Time
Site:	SHINE Medical Technologies
Issue date:	03/23/2021
From:	Jim Costedio SHINE Medical Technologies
To:	Document Control Desk, Office of Nuclear Reactor Regulation
Shared Package
ML21095A241	List: ML21095A214 ML21095A215 ML21095A216 ML21095A217 ML21095A218 ML21095A219 ML21095A220 ML21095A221 ML21095A222 ML21095A223 ML21095A224 ML21095A225 ML21095A226 ML21095A227 ML21095A228 ML21095A229 ML21095A230 ML21095A231 ML21095A232 ML21095A233 ML21095A234 ML21095A235 ML21095A236
References
2021-SMT-0032
Download: ML21095A235 (7)

Text

Ii SHINE Medical Technologies THIS LETTER CONTAINS PROPRJETARY AND EXPORT CONTROLLED INFORMATION IN ACCORDANCE WITH 10'CFR 2.390 March 23, 2021 2021-SMT-0032 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 Applicatlon for an Operating License," dated July 17, 2019 (ML19211C143)

(2) NRC letter to SHINE Medlcal Technologles, LLC, *issuance of Request for Additlonaf Information Related to the SHINE Medical Technologies, LLC Operating License Applicatlon (EPID No. L-2019-NEW-0004)," dated January 27, 2021 (3) SHINE Medical Technologies, LLC letter to the NRC, aSHINE Medical Technologles, LLC Operating License Application Supplement No. 5 and Response to Requa.st for Additional Information," dated December 10, 2020 (4) SHINE Medical Technologies, LLC letter to the NRC, aSHINE Medlcal Technologies, LLC Operating License Application Supplement No. 6 and Response to Request for Additional Information," dated December 15, 2020 (5) SHINE Medical Technologies, LLC letter to the NRC, *sHINE Medical Technologies, LLC Operating License Application Response to Request for Additional Information," dated January 29, 2021 (6) SHINE Medlcal Technologies, LLC letter to the NRC, aSHINE Medical Technologies, LLC Operating License Application Revision 1 of SHINE Response to Request for Additional Information 2.4-1," dated March 16, 2021 (7) SHINE Medical Technologies, LLC letter to the NRC, aSHINE Medical Technologies, LLC Operating License Application Response to Request for Additional Information and Supplement No. 3," dated August 28, 2020 SHINE Medical Technologies. LLC Operating License AppUcatton Response to Request tor Additional Information and Supplement No. Z Pursuant to 10 CFR Part 50.30, SHINE Medical Technologies, LLC (SHINE) submitted an application for an operating license for a medical Isotope production faclllty to be located in Janesville, V\11 via Reference 1. Via Reference 2, the NRC staff determined that additional information was required to enable the staff's continued review of the SHINE operating license application. SHINE has determined that a supplement to the operating license application Is necessary to address facility design changes and to provide administrative revisions. y (s--D }

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Enclosures 1, 3, 5, and 9 contain security-related information.

Withhold from public disclosure under 10 CFR 2.390.

Uoon removal of Enclosures 1. 3 5 7 and 9 this letter Is urfcontroned:

101 E. MIiwaukee Street, Sulte 600 I JanesvlBe, WI 535451 P (608) 210-1060 IF (608) 210-25041 www.shinemed.com

Document Control Desk Page2 This submittal contains information which SHINE requests to be withheld from publlc 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 optlcal storage media (OSM). provides the non-public version of the SHINE response to the NRC staffs request for addltlonal Information. 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 publlc version of the SHINE response to the NRC staff's request for addltlonal Information. provides a non-publlc version of the SHINE Final Safety Analysis Report (FSAR)

Change Summary, Including a markup of affected FSAR pages. 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 publlc version of the SHINE FSAR Change Summary. provides a non-public revision to the SHINE FSAR. In addition to incorporating the changes described in Enclosures 1 and 3, this revision Incorporates the changes described in References 3, 4, 5, and 6. 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 publlc disclosure under 10 CFR 2.390. provides a public revision to the SHINE FSAR. provides a non-publlc revision to the SHINE Technical Spectflcatlons. In addition to incorporating the changes described In Enclosure 1, this revision Incorporates the changes described in References 3, 4, and 5. 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 a non-publlc revision to the SHINE Emergency Plan. Enclosure 9 contains proprietary information, a subset of which has been determined to be ECI, as welt as SRI.

SHINE requests that the NRC withhold Enclosure 9 from public disclosure under 10 CFR 2.390.

\ 0 provides a public revision to the SHINE Emergency Plan. 1 provides an affidavit supporting the proprietary treatment of the SHINE proprietary information contained In Enclosures 1, 3, 5, 7, and 9, pursuant to 10 CFR 2.390. SHINE requests that the NRC wlthhold Enclosures 1, 3, 5, 7, and 9 from public disclosure under 10 CFR 2.390. Upon removal of Enclosures 1, 3, 5, 7, and 9, this letter is uncontrolled.

Document Control Desk Page3 The SHINE FSAR is provided in Its entirety in Enclosures 5 (Non-Public) and 6 (Public);

however, not every FSAR chapter has been revised. Revision bars within Enclosures 5 and 6 Indicate the changes incorporated into the FSAR via this supplement. The followlng table Identifies which FSAR chapter flies, submitted within the enclosed OSM, have been modified from the files previously submitted In Reference 7.

Enclosure Title Modified 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 Facilltv Descrictlon 5 FSAR Chapter 05 - Cooling Systems Yes 5 FSAR Chapter 06 - Engineered Safetv Features Yes 5 FSAR Chacter 07 - Instrumentation and Control Svstems Yes 5 FSAR Chapter 09 - Auxiliary Systems Yes 5 FSAR Chapter 11 - Radiation Protection Program and Waste Yes Management 5 FSAR Chapter 13 - Accident Analvsls Yes 5 FSAR Chacter 15 - Flnancial Quallficatlons Yes 6 FSAR Chapter 01 - The Facility Yes 6 FSAR Chapter 02 - Site Characteristics Yes 6 FSAR Chapter 03 - Design of Structures, Systems, and Yes Components 6 FSAR Chapter 04- Irradiation Unit and Radioisotope Production Yes Facilltv Description r 6 FSAR Chacter 05 - Coolina Systems Yes 6 FSAR Chacter 06 - Enaineered Safetv Features Yes 6 FSAR Chapter 07 - Instrumentation and Control Systems Yes 6 FSAR Chapter 08 - Electrical Power Svstems Yes 6 FSAR Chapter 09 - Auxiliary Systems Yes 6 FSAR Chapter 10 - Exoerlmental Fadlitles No 6 FSAR Chapter 11 - Radiation Protection Program and Waste Yes Management 6 FSAR Chacter 12 - Conduct of Operations ' Yes 6 FSAR Chapter 13 - Accident Analysis Yes 6 FSAR Chapter 14 -Technical Specifications No 6 FSAR Chacter 15 - Flnancial Qualifications Yes 6 FSAR Chapter 16 - Other License Considerations No 6 FSAR Chapter 17 - Decommissioning and Possession-Only No License Amendments 6 FSAR Chapter 18 - Highly Enriched to Low Enriched Uranium No Conversion

DocuSlgn Envelope ID: 31 A30966-8FAM 1DS-8532-7420630CD1 D7 Document Control Desk Page4 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 ~ and correct Executed on March 23, 2021.

Very truly yours, James Costedlo Vice President of Regulatory Affairs and Quality SHINE Medlcal Technologies, LLC Docket No. 50-608 Enclosures cc: Project Manager, USNRC SHINE General Counsel Supervisor, Radioactive Materials Progra.m, Wisconsin Division of Public Health (w/o Enclosures 1, 3, 5, 7, and 9)

ENCLOSURE11 SHINE MEDICAL TECHNOLOGIES, LLC SHINE MEDICAL TECHNOLOGIES, LLC OPERATING LICENSE APPLICATION RESPONSE TO REQUEST FOR ADDITIONAL INFORMATION AND SUPPLEMENT NO. 7 AFFIDAVIT OF JAMES COSTEDIO 2 pages follow

AFFIDAVIT OF JAMES COSTEDIO STATE OF WISCONSIN )

) ss.

COUNTY OF ROCK )

1 I, James Costedio, Vice President of Regulatory Affairs and Quallty of SHINE Medlcal 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 SHINE's request for proprietary treatment of certain confidential commercial and financial Information submitted in the operating license application supplement by letter 2021-SMT-0032 with enclosures. SHINE requests that the confidential Information contained in Enclosures 1, 3, 5, 7, and 9 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, 7, and 9 of 2021-SMT-0032 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 r SHINE.

b. The Information sought to be protected in Enclosures 1, 3, 5, 7, and 9 Is not available to the publlc to the best of my knowledge and belief.

\

Page 1 of 2

Docu6lgn Envelope ID: 31A3D966-BF~ 1D5-8532-742063DC01D7

c. The Information contained In Enclosures 1, 3, 5, 7, and 9 Is of the type that is customarily held in confidence by SHINE, and I/

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 aneed to know/ and 1 subject to maintaining confidentiality.

d. The proprietary Information sought to be withheld from public disclosure in Enclosures 1, 3, 5, 7, and 9 includes, but Is not llmlted to: structural configuration, primary and supporting systems of the medlcal isotope production faclllty, process and system locations, and process details. This would include information regarding the types, quantlties,,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, 7, and 9 would create substantial harm to SHINE because It would reveal trade

~ owned by SHINE, its affiliates, or third parties to whom SHINE has an obligation to maintain its confidentiality. *

e. Publlc disclosure of the information In Enclosures 1, 3, 5, 7, and 9 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, 7, and 9 of 2021-SMT-0032 Is ~nsmitted 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 property marked.

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

Executed on March 23, 2021.

James Costedlo Vice President of Regulatory .Affairs and Quality SHINE Medical Technologies, LLC Page 2 of 2