ML13269A378

Shine Medical Technologies, Inc., Submittal of Preliminary Emergency Plan

ML13269A378
Person / Time
Site:	SHINE Medical Technologies
Issue date:	09/25/2013
From:	Bynum R V SHINE Medical Technologies
To:	Document Control Desk, Office of Nuclear Reactor Regulation
References
SMT-2013-033, TAC MF2307
Download: ML13269A378 (6)

Text

• SHINEMedical TechnologiesTHIS LETTER CONTAINS PROPRIETARY INFORMATIONIN ACCORDANCE WITH 10 CFR 2.390September 25, 2013SMT-2013-03310 CFR 50.30U.S. Nuclear Regulatory CommissionATTN: Document Control DeskWashington, DC 20555References: (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 August 28, 2013,SHINE Medical Technologies, Inc. -Status of the Acceptance Review ofPart Two of the Application for Construction Permit (TAC No. MF2307)(ML13233A356)Submittal of the SHINE Medical Technologies, Inc. Preliminary Emergency PlanPursuant to 10 CFR 50.30, SHINE Medical Technologies, Inc. (SHINE) submitted an applicationfor a construction permit to construct a medical isotope facility to be located in Janesville, WI(References 1 and 2). Via Reference (3), the NRC requested that SHINE provide a preliminaryplan for coping with emergencies.Enclosure 1 provides the proprietary version of the SHINE Preliminary Emergency Plan. Inaddition to proprietary information, Enclosure 1 contains security-related information identifiedutilizing the guidance contained in Regulatory Information Summary (RIS) 2005-31,Attachment 2, Section 2.C, Emergency Planning/Fire Protection Information. SHINE requeststhat the NRC withhold Enclosure 1, in its entirety, from public disclosure in accordance with10 CFR 2.390(d)(1).Enclosure 2 provides an affidavit supporting the proprietary treatment of the SHINE proprietaryinformation contained in Enclosure 1, pursuant to 10 CFR 2.390. SHINE requests that the NRCwithhold Enclosure 1 from public disclosure under 10 CFR 2.390. Upon removal of Enclosure 1,this letter is uncontrolled.If you have any questions, please contact Mr. Jim Costedio, Licensing Manager,at 608/210-1730.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.ýj %5, D2555 Industrial Drive I Monona, WI 53713 1 P (608) 210-1060 1 F (608) 210-2504 1 www.shinemed.com Document Control DeskPage 2THIS LETTER CONTAINS PROPRIETARY INFORMATIONIN ACCORDANCE WITH 10 CFR 2.390I declare under the penalty of perjury that the foregoing is true and correct.Executed on September 25, 2013.Very truly yours,R. Vann Bynum, Ph.D.Chief Operating OfficerSHINE Medical Technologies, Inc.Docket No. 50-608Enclosurescc: Administrator, Region Ill, USNRCProject Manager, USNRCSupervisor, Radioactive Materials Program, Wisconsin Division of Public Health(w/o Enclosure 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.

ENCLOSURE 1 CONTAINS PROPRIETARY INFORMATIONIN ACCORDANCE WITH 10 CFR 2.390ENCLOSURE 1SHINE MEDICAL TECHNOLOGIES, INC.SUBMITTAL OF THE SHINE MEDICAL TECHNOLOGIES, INC.PRELIMINARY EMERGENCY PLANPRELIMINARY EMERGENCY PLANEnclosure 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.48 pages follow ENCLOSURE 2SHINE MEDICAL TECHNOLOGIES, INC.SUBMITTAL OF THE SHINE MEDICAL TECHNOLOGIES, INC.PRELIMINARY EMERGENCY PLANAFFIDAVIT OF RICHARD VANN BYNUM2 pages follow

• SHINEMedical TechnologiesAFFIDAVIT OF RICHARD VANN BYNUMSTATE OF WISCONSIN) ss.COUNTY OF DANEI, 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 RegulatoryCommission (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 preliminaryemergency plan for the SHINE medical isotope facility transmitted by letterSMT-2013-033 with enclosures. SHINE requests that the confidentialinformation contained in Enclosure 1 be withheld from public disclosure in theirentirety.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 informationsought to be withheld from public disclosure should be withheld.a. The information sought to be withheld from public disclosure contained inEnclosure 1 of SMT-2013-033 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.1

c. The information contained in Enclosure 1 is of the type that is customarilyheld in confidence by SHINE, and there is a rational basis for doing so. Theinformation that SHINE is requesting to be withheld from public disclosureincludes 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 substantialharm 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-2013-033 istransmitted to the NRC in confidence and under the provisions of10 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 September 25, 2013.Richard VanE Thn.D.COO -SHINE Medical Technologies, Inc.2