ML13302C044

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Shine Medical Technologies, Inc. Application for Construction Permit Response to Environmental Requests for Additional Information
ML13302C044
Person / Time
Site: SHINE Medical Technologies
Issue date: 10/04/2013
From: Bynum R V
SHINE Medical Technologies
To:
Document Control Desk, Office of Nuclear Reactor Regulation
Shared Package
ML13303A887 List:
References
SMT-2013-034
Download: ML13302C044 (7)
v • d • e


Text

  • SHINEMedical Technologies THIS LETTER CONTAINS PROPRIETARY INFORMATION IN ACCORDANCE WITH 10 CFR 2.390October 4, 2013SMT-2013-034 10 CFR 50.30U.S. Nuclear Regulatory Commission ATTN: Document Control DeskWashington, DC 20555

References:

(1) SHINE Medical Technologies, Inc. letter to NRC, dated March 26, 2013,Part One of the SHINE Medical Technologies, Inc. Application forConstruction Permit (ML130880226)

(2) SHINE Medical Technologies, Inc. letter to NRC, dated May 31, 2013,Part Two of the SHINE Medical Technologies, Inc. Application forConstruction Permit (ML13172A361)

(3) NRC letter to SHINE Medical Technologies, Inc., dated July 3, 2013,Environmental Site Audit Regarding SHINE Medical, Inc. ProposedRadioisotope Production Facility (ML13168A562)

(4) NRC letter to SHINE Medical Technologies, Inc., dated September 11, 2013,Requests for Additional Information for the Environmental Review of theSHINE Radioisotope Production Facility Construction Permit Application (ML13231A041)

SHINE Medical Technologqies, Inc. Application for Construction PermitResponse to Environmental Requests for Additional Information Pursuant to 10 CFR 50.30, SHINE Medical Technologies, Inc. (SHINE) submitted an application for a construction permit to construct a medical isotope facility to be located in Janesville, WI(References 1 and 2). To develop the environmental impact statement, the NRC stafftransmitted an environmental site audit needs list for SHINE to discuss with the NRC during theenvironment site audit (Reference 3).An environmental site audit was held during the week of July 29, 2013. On July 31, 2013,SHINE discussed the Reference (3) requested needs list with the NRC. Subsequently, the NRCstaff determined additional information was required to complete the environmental review(Reference 4).Enclosure 1 provides the non-public (proprietary) version of the SHINE response to the NRCstaff's request for additional information.

Enclosure 1 is being provided via optical storagemedia (OSM) as OSM#1. In additional to proprietary information, Enclosure 1 containssecurity-related information which was identified utilizing the guidance contained in Regulatory Information Summary (RIS) 2005-31.

SHINE requests that the NRC withhold Enclosure 1 frompublic disclosure under 10 CFR 2.390.Enclosure 1 contains both proprietary and security-related information.

Withhold from public disclosure under 10 CFR 2.390.Upon removal of Enclosure 1, this letter is uncontrolled.

2555 Industrial Drive I Monona, W1 53713 1 P (608) 210-10601 F (608) 210-2504 1 www.shinemed.com ADD)

Document Control DeskPage 2THIS LETTER CONTAINS PROPRIETARY INFORMATION IN ACCORDANCE WITH 10 CFR 2.390Enclosure 2 provides the public (non-proprietary) version of the SHINE response to the NRCstaff's request for additional information.

Enclosure 2 is provided via OSM as OSM#2.Enclosure 3 provides an affidavit supporting the proprietary treatment of the SHINE proprietary information pursuant to 10 CFR 2.390. Enclosure 1 contains proprietary information.

SHINErequests that the NRC withhold Enclosure 1 from public disclosure under 10 CFR 2.390. Uponremoval of Enclosure 1, this letter is uncontrolled.

If you have any questions, please contact Mr. Jim Costedio, Licensing Manager,at 608/210-1730.

I declare under the penalty of perjury that the foregoing is true and correct.Executed on October 4, 2013.Very truly yours,R. Vann Bynum, Ph.D.Chief Operating OfficerSHINE Medical Technologies, Inc.Docket No. 50-608Enclosures cc: Administrator, Region III, USNRCProject Manager, USNRCEnvironmental Project Manager, USNRCSupervisor, Radioactive Materials

Program, Wisconsin Division of Public HealthEnclosure 1 contains both proprietary and security-related information.

Withhold from public disclosure under 10 CFR 2.390.Upon removal of Enclosure 1, this letter is uncontrolled.

ENCLOSURE 1 CONTAINS PROPRIETARY INFORMATION IN ACCORDANCE WITH 10 CFR 2.390ENCLOSURE 1SHINE MEDICAL TECHNOLOGIES, INC.SHINE MEDICAL TECHNOLOGIES, INC. APPLICATION FOR CONSTRUCTION PERMITRESPONSE TO ENVIRONMENTAL REQUESTS FOR ADDITIONAL INFORMATION NON-PUBLIC VERSION(OSM#1),,NI.HINE MMdcal Technologies SMT-201 3-034SHINE Medical Technologies, Inc.Application for Construction PermitResponse to Environmental Requests forAdditional Information Non-Public Version(OS M#1)Enclosure 1 contains both proprietary and security-related information.

Withhold from public disclosure under 10 CFR 2.390.Upon removal of Enclosure 1, this letter is uncontrolled.

ENCLOSURE2 SHINE MEDICAL TECHNOLOGIES, INC.SHINE MEDICAL TECHNOLOGIES, INC. APPLICATION FOR CONSTRUCTION PERMITRESPONSE TO ENVIRONMENTAL REQUESTS FOR ADDITIONAL INFORMATION PUBLIC VERSION(OSM#2)mINHINEMMecca Technologies SMT-201 3-034 4SHINE Medical Technologies, Inc.Application for Construction PermitResponse to Environmental Requests forAdditional Information Public Version(OSM#2)

ENCLOSURE 3SHINE MEDICAL TECHNOLOGIES, INC.SHINE MEDICAL TECHNOLOGIES, INC. APPLICATION FOR CONSTRUCTION PERMITRESPONSE TO ENVIRONMENTAL REQUESTS FOR ADDITIONAL INFORMATION AFFIDAVIT OF RICHARD VANN BYNUM2 pages follow

)) ss.COUNTY OF DANE )I, Richard Vann Bynum, Chief Operating Officer of SHINE Medical Technologies, Inc. (SHINE),do hereby affirm and state:1 .I am authorized to execute this affidavit on behalf of SHINE. I am authorized toreview information submitted to or discussed with the Nuclear Regulatory Commission (NRC) and apply for the withholding of information from publicdisclosure.

The purpose of this affidavit is to provide the information required by10 CFR 2.390(b) in support of SHINE's request for proprietary treatment ofcertain confidential commercial information submitted in the SHINE response tothe NRC staff's environmental requests for additional information.

SHINErequests that the confidential information contained in Enclosure 1 be withheldfrom public disclosure in their entirety.

2. I have knowledge of the criteria used by SHINE in designating information assensitive, proprietary, or confidential.
3. Pursuant to the provisions of paragraph (a)(4) of 10 CFR 2.390, the following isfurnished 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 inEnclosure 1 of SMT-2013-034 is owned by SHINE, its affiliates or thirdparties to whom SHINE has an obligation to maintain its confidentiality.

Thisinformation is and has been held in confidence by SHINE.b. The information sought to be protected in Enclosure 1 is not available to thepublic to the best of my knowledge and belief.I

c. The information contained in Enclosure 1 is of the type that is customarily held in confidence by SHINE, and there is a rational basis for doing so. Theinformation that SHINE is requesting to be withheld from public disclosure includes trade secret, commercial information or information that is subject toexport 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 inEnclosure 1 includes, but is not limited to: primary and supporting systems ofthe medical isotope facility and process details.

This would includeinformation regarding the types and quantities of materials stored on site.Public disclosure of the information in Enclosure 1 would create substantial

  • harm to SHINE because it would reveal trade secrets owned by SHINE, itsaffiliates or third parties to whom SHINE has an obligation to maintain itsconfidentiality.
e. The information contained in Enclosure 1 of letter SMT-2013-034 istransmitted to the NRC in confidence and under the provisions of*10. CFR 2.390; it is to be received in confidence by the NRC. Theinformation is properly marked.I declare under the penalty of perjury that the foregoing is true and correct.Executed on October 4, 2013.Richard Vann BCOO -SHINE Medical Technologies, Inc.2
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