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| | issue date = 09/25/2013 | | | issue date = 09/25/2013 |
| | title = Shine Medical Technologies, Inc., Submittal of Preliminary Emergency Plan | | | title = Shine Medical Technologies, Inc., Submittal of Preliminary Emergency Plan |
| | author name = Bynum R V | | | author name = Bynum R |
| | author affiliation = SHINE Medical Technologies, Inc | | | author affiliation = SHINE Medical Technologies, Inc |
| | addressee name = | | | addressee name = |
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| {{#Wiki_filter:*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. | | {{#Wiki_filter:*SHINE Medical Technologies THIS LETTER CONTAINS PROPRIETARY INFORMATION IN ACCORDANCE WITH 10 CFR 2.390 September 25, 2013 SMT-2013-033 10 CFR 50.30 U.S. Nuclear Regulatory Commission ATTN: Document Control Desk Washington, DC 20555 |
| 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 | | ==References:== |
| : 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 | | (1) SHINE Medical Technologies, Inc. letter to NRC, dated March 26, 2013, Part One of the SHINE Medical Technologies, Inc. Application for Construction Permit (ML130880226) |
| }} | | (2) SHINE Medical Technologies, Inc. letter to NRC, dated May 31, 2013, Part Two of the SHINE Medical Technologies, Inc. Application for Construction Permit (ML13172A361) |
| | (3) NRC letter to SHINE Medical Technologies, Inc., dated August 28, 2013, SHINE Medical Technologies, Inc. - Status of the Acceptance Review of Part Two of the Application for Construction Permit (TAC No. MF2307) |
| | (ML13233A356) |
| | Submittal of the SHINE Medical Technologies, Inc. Preliminary Emergency Plan 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). Via Reference (3), the NRC requested that SHINE provide a preliminary plan for coping with emergencies. provides the proprietary version of the SHINE Preliminary Emergency Plan. In addition to proprietary information, Enclosure 1 contains security-related information identified utilizing the guidance contained in Regulatory Information Summary (RIS) 2005-31, , Section 2.C, Emergency Planning/Fire Protection Information. SHINE requests that the NRC withhold Enclosure 1, in its entirety, from public disclosure in accordance with 10 CFR 2.390(d)(1). provides an affidavit supporting the proprietary treatment of the SHINE proprietary information contained in Enclosure 1, pursuant to 10 CFR 2.390. SHINE requests that the NRC withhold 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. ýj %5 Upon removal of Enclosure 1, this letter is uncontrolled. , D 2555 Industrial Drive I Monona, WI 53713 1P (608) 210-1060 1F (608) 210-2504 1www.shinemed.com |
| | |
| | Document Control Desk Page 2 THIS LETTER CONTAINS PROPRIETARY INFORMATION IN ACCORDANCE WITH 10 CFR 2.390 I 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 Officer SHINE Medical Technologies, Inc. |
| | Docket No. 50-608 Enclosures cc: Administrator, Region Ill, USNRC Project Manager, USNRC Supervisor, 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 INFORMATION IN ACCORDANCE WITH 10 CFR 2.390 ENCLOSURE 1 SHINE MEDICAL TECHNOLOGIES, INC. |
| | SUBMITTAL OF THE SHINE MEDICAL TECHNOLOGIES, INC. |
| | PRELIMINARY EMERGENCY PLAN PRELIMINARY EMERGENCY PLAN 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 2 SHINE MEDICAL TECHNOLOGIES, INC. |
| | SUBMITTAL OF THE SHINE MEDICAL TECHNOLOGIES, INC. |
| | PRELIMINARY EMERGENCY PLAN AFFIDAVIT OF RICHARD VANN BYNUM 2 pages follow |
| | * SHINE Medical Technologies AFFIDAVIT OF RICHARD VANN BYNUM STATE OF WISCONSIN |
| | ) 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 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 information submitted in the preliminary emergency plan for the SHINE medical isotope facility transmitted by letter SMT-2013-033 with enclosures. SHINE requests that the confidential information contained in Enclosure 1 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 Enclosure 1 of SMT-2013-033 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 Enclosure 1 is not available to the public to the best of my knowledge and belief. |
| | 1 |
| | : 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. The information that SHINE is requesting to be withheld from public disclosure includes trade secret, 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 Enclosure 1 includes, but is not limited to: primary and supporting systems of the medical isotope facility and process details. This would include information 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, its affiliates or third parties to whom SHINE has an obligation to maintain its confidentiality. |
| | : e. The information contained in Enclosure 1 of letter SMT-2013-033 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 September 25, 2013. |
| | Richard VanE Thn.D. |
| | COO - SHINE Medical Technologies, Inc. |
| | 2}} |
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Administration
- Withholding Request Acceptance, Withholding Request Acceptance, Withholding Request Acceptance, Withholding Request Acceptance, Withholding Request Acceptance, Withholding Request Acceptance, Withholding Request Acceptance, Withholding Request Acceptance, Withholding Request Acceptance, Withholding Request Acceptance, Withholding Request Acceptance, Withholding Request Acceptance, Withholding Request Acceptance, Withholding Request Acceptance, Withholding Request Acceptance, Withholding Request Acceptance
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MONTHYEARML13172A3612013-05-31031 May 2013 Part Two of the Shine Medical Technologies, Inc. Application for Construction Permit Project stage: Request ML13269A3782013-09-25025 September 2013 Shine Medical Technologies, Inc., Submittal of Preliminary Emergency Plan Project stage: Other ML14119A0432014-03-17017 March 2014 Affidavit for Shine Medical Technologies, Inc. Discussion Notes Associated with March 20, 2014 Meeting Project stage: Request ML14121A5342014-05-0808 May 2014 Shine Medical Technologies, Inc., Request for Withholding Information from Public Disclosure Project stage: Withholding Request Acceptance ML14195A1592014-09-19019 September 2014 Shine Medical Technologies, Inc. - Request for Additional Information Regarding Application for Construction Permit Project stage: RAI ML14356A5282014-12-0303 December 2014 Shine Medical Technologies, Inc. Application for Construction Permit Response to Request for Additional Information Project stage: Response to RAI ML15005A4072015-01-0606 January 2015 Shine Medical Technologies, Inc., Request for Additional Information Regarding Application for Construction Permit Project stage: RAI ML15043A3952015-02-0606 February 2015 Shine Medical Technologies, Inc. - Application for Construction Permit - Response to Request for Additional Information Project stage: Response to RAI ML15037A2492015-03-0303 March 2015 Shine Medical Technologies, Inc., - Proposed Review Schedule, Notice of Hearing, Opportunity to Petition for Leave to Intervene, and Order Imposing Procedures Project stage: Other ML15037A1082015-03-0404 March 2015 Federal Register Notice - Notice of Hearing, Opportunity to Petition for Leave to Intervene, and Order Imposing Procedures for Access to Sensitive Unclassified Non-Safeguards Information for Contention Preparation on a Construction Permit f Project stage: Request ML15092A4072015-03-23023 March 2015 Shine Medical Technologies, Inc., Application for Construction Permit, Response to Request for Additional Information 11.1-9 Project stage: Response to RAI ML15055A1162015-03-25025 March 2015 Shine Medical Technologies, Inc., - Request for Additional Information Regarding Application for Construction Permit Project stage: RAI ML15120A2412015-04-10010 April 2015 Shine Medical Technologies, Inc., Application for Construction Permit, Response to Request for Additional Information Project stage: Response to RAI ML15099A6072015-04-15015 April 2015 Shine Medical Technologies, Inc., - Request for Additional Information Regarding Application for Construction Permit(Tac Nos. MF2305, MF2307, and MF2308) Project stage: RAI ML15131A4622015-05-0101 May 2015 Shine Medical Technologies, Inc. Application for Construction Permit, Response to Request for Additional Information Project stage: Response to RAI ML15147A2032015-05-14014 May 2015 Shine Medical Technologies, Inc., Application for Construction Permit, Response to Request for Additional Information Project stage: Response to RAI ML15140A7342015-05-20020 May 2015 Shine Medical Technologies, Inc. Application for Construction Permit, Response to Request for Additional Information 13a2.2-5 Project stage: Response to RAI ML15140A7222015-05-21021 May 2015 Shine Medical Technologies, Inc., Request for Withholding Information from Public Disclosure Project stage: Withholding Request Acceptance ML15140A7232015-05-21021 May 2015 Shine Medical Technologies, Inc. - Request for Withholding Information from Public Disclosure Project stage: Withholding Request Acceptance ML15140A7242015-05-21021 May 2015 Shine Technologies, Inc. - Request for Withholding Information from Public Disclosure Project stage: Withholding Request Acceptance ML15140A7252015-05-21021 May 2015 Shine Technologies, Inc. - Request for Withholding Information from Public Disclosure Project stage: Withholding Request Acceptance ML15140A7262015-05-21021 May 2015 Shine Technologies, Inc. - Request for Withholding Information from Public Disclosure Project stage: Withholding Request Acceptance ML15140A7312015-05-21021 May 2015 Shine Technologies, Inc. - Request for Withholding Information from Public Disclosure Project stage: Withholding Request Acceptance ML15161A3432015-05-21021 May 2015 Shine Medical Technologies, Inc. Preliminary Safety Analysis Report Revisions Resulting from Request for Additional Information Responses Project stage: Request ML15175A2132015-06-16016 June 2015 Shine Medical Technologies V. 0 - Chapter 06 - Engineered Safety Features Project stage: Request ML15175A1312015-06-16016 June 2015 Shine Medical Technologies, Inc. Application for Construction Permit Revision to Sections 13b.3 and 19.4 of the Preliminary Safety Analysis Report Project stage: Request ML15183A2902015-06-19019 June 2015 Shine Medical Technologies, Inc. Application for Construction Permit - Response to Request for Additional Information Project stage: Response to RAI ML15222A2012015-07-23023 July 2015 Shine Medical Technologies, Inc. Application for Construction Permit Response to Request for Additional Information 6b.3-30 Project stage: Response to RAI ML15236A1272015-08-0707 August 2015 Shine Medical Technologies, Inc. Application for Construction Permit Submittal of Atkins-NS-TR-SHN-15-06, Revision 1 Project stage: Request ML15219A3032015-08-27027 August 2015 Shine Medical Technologies Inc., Request for Withholding Information from Public Disclosure Project stage: Withholding Request Acceptance ML15219A2632015-08-27027 August 2015 Shine Medical Technologies Inc., Request for Withholding Information from Public Disclosure Project stage: Withholding Request Acceptance ML15219A3352015-08-27027 August 2015 Shine Medical Technologies Inc., Request for Withholding Information from Public Disclosure Project stage: Withholding Request Acceptance ML15219A1822015-08-27027 August 2015 Shine Medical Technologies Inc., Request for Withholding Information from Public Disclosure Project stage: Withholding Request Acceptance ML15219A3852015-08-27027 August 2015 Shine Medical Technologies Inc., Request for Withholding Information from Public Disclosure Project stage: Withholding Request Acceptance ML15219A1632015-08-27027 August 2015 Shine Medical Technologies Inc., Request for Withholding Information from Public Disclosure Project stage: Withholding Request Acceptance ML15219A4252015-08-27027 August 2015 Shine Medical Technologies Inc. - Request for Withholding Information from Public Disclosure Project stage: Withholding Request Acceptance ML15244A7712015-08-27027 August 2015 Draft Request for Additional Information Shine Medical Technologies, Inc. Preliminary Safety Analysis Report Supporting a Construction Permit Application Project stage: Draft RAI ML15244A5062015-08-27027 August 2015 E-mail from Steven Lynch to Jim Costedio Transmitting Draft Request for Additional Information Supporting Shine PSAR Project stage: Draft RAI ML15247A0672015-09-0202 September 2015 Shine Medical Technologies, Inc. Application for Construction Permit Response to Request for Additional Information Project stage: Response to RAI ML15259A0242015-09-15015 September 2015 Shine Medical Technologies, Inc. - Application for Construction Permit, Revision 1 of Shine Response to Request for Additional Information 6b.3-34 Project stage: Response to RAI ML15259A1642015-09-24024 September 2015 Shine Medical Technologies, Inc., - Request for Additional Information Regarding Application for Construction Permit Project stage: RAI ML15267A2912016-01-0606 January 2016 June 19, 2015 Shine Technologies, Inc., - Request for Withholding Information from Public Disclosure Project stage: Withholding Request Acceptance ML15267A2672016-01-0606 January 2016 July 23, 2015 Shine Technologies, Inc., - Request for Withholding Information from Public Disclosure Project stage: Withholding Request Acceptance 2015-04-15
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Category:Emergency Preparedness-Emergency Plan
MONTHYEARML22202A4512022-07-21021 July 2022 Enclosure 2: Shine Technologies, LLC Emergency Plan ML22027A6672022-01-27027 January 2022 Shine Technologies, LLC, Operating License Application Supplement No. 16 Submittal of a Revision to the Shine Emergency Plan ML21095A2342021-03-23023 March 2021 Shine Medical Technologies, LLC, Revisions to Final Safety Analysis Report, Enclosure 10, Emergency Plan ML19211C1382019-07-17017 July 2019 Shine Medical Technologies, LLC, Emergency Plan ML13269A3782013-09-25025 September 2013 Shine Medical Technologies, Inc., Submittal of Preliminary Emergency Plan 2022-07-21
[Table view] Category:Letter
MONTHYEARML24128A2162024-05-0707 May 2024 Shine Technologies, LLC, Submittal of Annual Financial Report ML24047A0392024-02-16016 February 2024 Shine Technologies, LLC - Periodic Report Required by the License Conditions in Section 3.D.(1) of CPMIF-001 ML23229A0202023-08-17017 August 2023 Periodic Report Required by the License Conditions in Section 3.D.(1) of CPMIF-001 ML23087A2272023-05-0505 May 2023 Shine Technologies, LLC - Issuance of Amendment No. 4 to Construction Permit No. CPMIF-001 for the Receipt and Possession of Contained Special Nuclear Material ML23086C0502023-04-27027 April 2023 Shine Technologies, LLC - Letter, Environmental Assessment and Finding of No Significant Impact ML23088A3382023-04-0505 April 2023 Shine Technologies, LLC - Review of the Physical Security Plan in Support of an Operating License for a Medical Radioisotope Production Facility ML23010A1982023-02-24024 February 2023 Shine Technologies, LLC - Letter: Safety Evaluation Report for the Shine Medical Radioisotope Production Facility Operating License Application ML23048A2442023-02-17017 February 2023 Shine Technologies, LLC Request to Amend Construction Permit No. CPMIF-001 Response to Request for Additional Information ML23010A2382023-02-0303 February 2023 Shine Technologies, LLC - Individual Notice of Consideration FRN Letter ML23034A1872023-02-0303 February 2023 Shine Medical Technologies, LLC Notice of Availability of Environmental Impact Statement Supplement Related to the Operating License for the Shine Medical Isotope Production Facility (Docket Number: 50-608) ML23023A0922023-02-0202 February 2023 Notice of Availability of the Environmental Impact Statement Supplement Related to the Operating License for the Shine Medical Isotope Production Facility ML23023A0942023-02-0202 February 2023 Notice of Availability of the Environmental Impact Statement Supplement Related to the Operating License for the Shine Medical Isotope Production Facility ML23023A0862023-02-0202 February 2023 Notice of Availability of the Environmental Impact Statement Supplement Related to the Operating License for the Shine Medical Isotope Production Facility ML23024A1682023-02-0101 February 2023 Letter to Ken Westlake, EPA Region 5 - Issuance of Final EIS Supplement Related to the Operating License ML22287A1852023-02-0101 February 2023 Shine Technologies, LLC Regulatory Report on the Audit of Phased Startup Operations Application Supplement ML23024A1742023-02-0101 February 2023 Dr. Gregory Piefer, Chief Executive Officer - Issuance of Final EIS Supplement Related to the Operating License ML22308A2332023-01-0909 January 2023 Shine Technologies LLC - Regulatory Audit Report for Chapter 8 - Irradiation Facility and Radioisotope Production Facility Electrical Power Systems ML22347A2142023-01-0404 January 2023 Shine Technologies LLC - Regulatory Audit Report for I&C Combined Sessions ML22356A1932022-12-22022 December 2022 Shine Technologies, LLC Application for an Operating License - Response to Request for Confirmatory Information ML22347A1772022-12-14014 December 2022 Shine Technologies LLC - Regulatory Audit Report for Programmable Logic Lifecycle ML22301A1492022-12-0707 December 2022 Shine Technologies, LLC - Regulatory Audit Report for Chapter 13 - Accident Analysis and Criticality Safety ML22322A2122022-12-0202 December 2022 Shine Medical Technologies - Cybersecurity Audit Summary Report ML22322A2232022-12-0202 December 2022 Shine Medical Technologies - Fire Protection Audit Summary Report ML22348A0672022-12-0101 December 2022 Shine Technologies, LLC - Request for Confirmatory Information Related to Instrumentation and Control Systems ML22335A5722022-12-0101 December 2022 Shine Technologies, LLC Application for an Operating License Response to Request for Confirmatory Information ML22292A3192022-11-30030 November 2022 Shine Medical Technologies, LLC Issuance of Order and Amendment No. 3 to Construction Permit No. CPMIF-001 ML22318A1782022-11-14014 November 2022 Shine Technologies, LLC Application for an Operating License Response to Request for Confirmatory Information ML22304A1262022-10-31031 October 2022 Shine Technologies, LLC Application for an Operating License Response to Request for Confirmatory Information ML22279A9512022-10-0606 October 2022 Shine Technologies, LLC Request to Amend Construction Permit No. CPMIF-001 ML22271A9632022-09-28028 September 2022 Shine Technologies, LLC Application for an Operating License Supplement No. 31 Revision to the Phased Startup Operations Application Supplement ML22263A3442022-09-20020 September 2022 Shine Technologies, LLC Application for an Operating License - Response to Request for Additional Information ML22263A0272022-09-19019 September 2022 Shine Technologies, LLC - Application for an Operating License - Response to Request for Confirmatory Information ML22220A2612022-09-12012 September 2022 Shine Technologies LLC - Regulatory Report on the Audit Chapter 14, Technical Specifications ML22251A3272022-09-0808 September 2022 Shine Technologies, LLC Application for an Operating License Revision 1 of Shine Response to Requests for Additional Information 7-38, 7-40, and 7-48 ML22249A1252022-08-31031 August 2022 Shine Technologies, LLC Final Safety Analysis Report - Application for an Operating License Supplement No. 30, Cover Letter ML22105A1102022-08-26026 August 2022 Shine Medical Technologies LLC - Request for Additional Information Related to the OGC Review of Phrase Approach ML22061A2122022-08-24024 August 2022 Shine Medical Technologies LLC - Regulatory Audit Plan for Phased Approach - Session 1 ML22187A1342022-08-0101 August 2022 Shine Technologies, LLC - Update to Operating License Application Technical Review Schedule ML22213A0492022-08-0101 August 2022 Shine Technologies, LLC Application for an Operating License Response to Request for Confirmatory Information ML22206A2082022-07-27027 July 2022 Shine Medical Technologies, LLC - Request for Confirmatory Information Related to Radiation Protection Program and Waste Management ML22207A0062022-07-26026 July 2022 Shine Technologies, LLC Application for an Operating License Supplement No. 29 ML22202A4492022-07-21021 July 2022 Shine Technologies, LLC Operating License Application Supplement No. 28 - Submittal of a Revision to the Shine Emergency Plan ML22188A2412022-07-14014 July 2022 Meeting with Shine Medical Technologies, LLC (EPID No. L-2019-NEW-0004), to Discuss Development of Shine'S Cybersecurity Program for It'S Medical Isotope Production Facility ML22175A0392022-07-11011 July 2022 Letter to Reid Nelson, Achp Notice of Availability and Request for Comments on the Draft EIS Supplement Related to the Operating License for the Shine Facility ML22175A0542022-07-0808 July 2022 Letter to Gregory Piefer - Notice of Availability of the Draft EIS Supplement Related to the Operating License for the Shine Medical Isotope Production Facility ML22175A0912022-07-0808 July 2022 Notice of Availability and Request for Comments on the Draft Environmental Impact Statement Supplement Related to the Operating License for the Shine (Multiple Tribal Letters) ML22175A0772022-07-0808 July 2022 Letter to Daina Penkiunas - Notice of Availability and Request for Comments on the Draft EIS Supplement Related to the Operating License for the Shine Facility ML22175A0632022-07-0808 July 2022 Letter to Ken Westlake, EPA Region 5 - Notice of Availability and Request for Comments on the Draft EIS Supplement Related to the Operating License for the Shine Facility ML22188A1942022-07-0707 July 2022 Shine Technologies, LLC, Application for an Operating License Supplement No. 27 ML22188A0562022-07-0707 July 2022 Shine Technologies, LLC Operating License Application Supplement No. 26 Submittal of a Revision to the Shine Material Control and Accounting Plan 2024-05-07
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Text
- SHINE Medical Technologies THIS LETTER CONTAINS PROPRIETARY INFORMATION IN ACCORDANCE WITH 10 CFR 2.390 September 25, 2013 SMT-2013-033 10 CFR 50.30 U.S. Nuclear Regulatory Commission ATTN: Document Control Desk Washington, DC 20555
References:
(1) SHINE Medical Technologies, Inc. letter to NRC, dated March 26, 2013, Part One of the SHINE Medical Technologies, Inc. Application for Construction Permit (ML130880226)
(2) SHINE Medical Technologies, Inc. letter to NRC, dated May 31, 2013, Part Two of the SHINE Medical Technologies, Inc. Application for Construction Permit (ML13172A361)
(3) NRC letter to SHINE Medical Technologies, Inc., dated August 28, 2013, SHINE Medical Technologies, Inc. - Status of the Acceptance Review of Part Two of the Application for Construction Permit (TAC No. MF2307)
(ML13233A356)
Submittal of the SHINE Medical Technologies, Inc. Preliminary Emergency Plan 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). Via Reference (3), the NRC requested that SHINE provide a preliminary plan for coping with emergencies. provides the proprietary version of the SHINE Preliminary Emergency Plan. In addition to proprietary information, Enclosure 1 contains security-related information identified utilizing the guidance contained in Regulatory Information Summary (RIS) 2005-31, , Section 2.C, Emergency Planning/Fire Protection Information. SHINE requests that the NRC withhold Enclosure 1, in its entirety, from public disclosure in accordance with 10 CFR 2.390(d)(1). provides an affidavit supporting the proprietary treatment of the SHINE proprietary information contained in Enclosure 1, pursuant to 10 CFR 2.390. SHINE requests that the NRC withhold 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. ýj %5 Upon removal of Enclosure 1, this letter is uncontrolled. , D 2555 Industrial Drive I Monona, WI 53713 1P (608) 210-1060 1F (608) 210-2504 1www.shinemed.com
Document Control Desk Page 2 THIS LETTER CONTAINS PROPRIETARY INFORMATION IN ACCORDANCE WITH 10 CFR 2.390 I 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 Officer SHINE Medical Technologies, Inc.
Docket No. 50-608 Enclosures cc: Administrator, Region Ill, USNRC Project Manager, USNRC Supervisor, 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 INFORMATION IN ACCORDANCE WITH 10 CFR 2.390 ENCLOSURE 1 SHINE MEDICAL TECHNOLOGIES, INC.
SUBMITTAL OF THE SHINE MEDICAL TECHNOLOGIES, INC.
PRELIMINARY EMERGENCY PLAN PRELIMINARY EMERGENCY PLAN 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 2 SHINE MEDICAL TECHNOLOGIES, INC.
SUBMITTAL OF THE SHINE MEDICAL TECHNOLOGIES, INC.
PRELIMINARY EMERGENCY PLAN AFFIDAVIT OF RICHARD VANN BYNUM 2 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 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 information submitted in the preliminary emergency plan for the SHINE medical isotope facility transmitted by letter SMT-2013-033 with enclosures. SHINE requests that the confidential information contained in Enclosure 1 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 Enclosure 1 of SMT-2013-033 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 Enclosure 1 is not available to the public to the best of my knowledge and belief.
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- 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. The information that SHINE is requesting to be withheld from public disclosure includes trade secret, 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 Enclosure 1 includes, but is not limited to: primary and supporting systems of the medical isotope facility and process details. This would include information 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, its affiliates or third parties to whom SHINE has an obligation to maintain its confidentiality.
- e. The information contained in Enclosure 1 of letter SMT-2013-033 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 September 25, 2013.
Richard VanE Thn.D.
COO - SHINE Medical Technologies, Inc.
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