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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 ML15062A1112015-04-0202 April 2015 Issuance of Environmental Scoping Summary Report Associated with the Staff'S Review of the Application by Shine Medical Technologies, Inc., for a Construction Permit for a Medical Radioisotope Production Facility Project stage: Approval 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 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 ML15175A2132015-06-16016 June 2015 Shine Medical Technologies V. 0 - Chapter 06 - Engineered Safety Features 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 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 ML15219A1632015-08-27027 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 ML15219A2632015-08-27027 August 2015 Shine Medical Technologies Inc., Request for Withholding Information from Public Disclosure Project stage: Withholding Request Acceptance ML15219A3032015-08-27027 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 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 ML15219A3852015-08-27027 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 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 ML15267A2672016-01-0606 January 2016 July 23, 2015 Shine Technologies, Inc., - Request for Withholding Information from Public Disclosure Project stage: Withholding Request Acceptance ML15267A2912016-01-0606 January 2016 June 19, 2015 Shine Technologies, Inc., - Request for Withholding Information from Public Disclosure Project stage: Withholding Request Acceptance 2015-04-15
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MONTHYEARML23229A0202023-08-17017 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 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) ML23010A2382023-02-0303 February 2023 Shine Technologies, LLC - Individual Notice of Consideration FRN Letter 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 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 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 ML23024A1742023-02-0101 February 2023 Dr. Gregory Piefer, Chief Executive Officer - 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 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 ML22213A0492022-08-0101 August 2022 Shine Technologies, LLC Application for an Operating License Response to Request for Confirmatory Information ML22187A1342022-08-0101 August 2022 Shine Technologies, LLC - Update to Operating License Application Technical Review Schedule 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 ML22223A0662022-07-0606 July 2022 Shine Technologies, LLC, Application for an Operating License, Revision 1 of the Response to Requests for Additional Information Related to Cyber Security ML22175A0742022-07-0101 July 2022 Letter to Mary Buelow Maintenance of Reference Materials at the Hedberg Public Library for the Environmental Review of Shine Medical Technologies, LLC Operating License Application 2023-08-17
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May 20,2015 SMT-2015-020 10 CFR 50.30 U.S. Nuclear Regulatory Commission ATTN: Document Control Desk Washington, DC 20555
References:
See Below SHINE Medical Technologies. Inc. Application for Construction Permit Response to Request for Additional Information 13a2.2-5 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). The NRC staff determined that additional information was required to enable the staff's continued review of the SHINE construction permit application (Reference 3).
SHINE responded to the NRC staff's requests via References (4) and (5). Via Reference (5),
SHINE stated that a response to RAI 13a2.2-5 would be provided by June 12, 2015. provides the SHINE response to RAI 13a2.2-5.
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 May 20, 2015.
Very truly yours, R. Vann Bynum, Ph.D.
Chief Operating Officer SHINE Medical Technologies, Inc.
Docket No. 50-608 Enclosure cc: Administrator, Region Ill, USNRC Project Manager, USNRC Environmental Project Manager, USNRC Supervisor, Radioactive Materials Program, Wisconsin Division of Public Health 25551ndustrial Drive I Monona, Wl53713l P (608) 210-1060 IF (608) 210-25041 www.shinemed.com
Document Control Desk Page 2
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 (ML13172A324)
(3) NRC letter to SHINE Medical Technologies, Inc., dated March 25, 2015, SHINE Medical Technologies, Inc. - Request for Additional Information Regarding Application for Construction Permit (TAC Nos. MF2305, MF2307, and MF2308) (ML15055A116)
(4) SHINE Medical Technologies, Inc. letter to NRC, dated April 10, 2015, SHINE Medical Technologies, Inc. Application for Construction Permit, Response to Request for Additional Information (ML15120A248)
(5) SHINE Medical Technologies, Inc. letter to NRC, dated May 1, 2015, SHINE Medical Technologies, Inc. Application for Construction Permit, Response to Request for Additional Information (ML15131A464)
ENCLOSURE 1 SHINE MEDICAL TECHNOLOGIES, INC.
SHINE MEDICAL TECHNOLOGIES, INC. APPLICATION FOR CONSTRUCTION PERMIT RESPONSE TO REQUEST FOR ADDITIONAL INFORMATION 13A2.2-5 The NRC staff determined that additional information was required (Reference 1) to enable the continued review of the SHINE Medical Technologies, Inc. (SHINE) application for a construction permit to construct a medical isotope facility (References 2 and 3). The following information is provided by SHINE in response to request for additional information (RAI) 13a2.2-5.
CHAPTER 13 - ACCIDENT ANALYSIS Section 13a2.2 - Accident Analysis and Determination of Consequences (Applies to RAIs 13a2.2-5 through 7)
The ISG Augmenting NUREG-1537, Part 2, Section 13a2, Aqueous Homogeneous Reactor Accident Analyses, states that the applicant should include a systematic analysis and discussion of credible accidents for determining the limiting event in each category and that the mathematical models and analytical methods employed, including assumptions, approximations, validation, and uncertainties, should be clearly stated.
RAI 13a2.2-5 While SHINEs response to RAI 13a2.2-1 states that the basis for the internal dose conversion factors (DCFs) is International Commission on Radiological Protection Publication 30, Limits for Intakes of Radionuclides by Workers, (ICRP 30) additional information is needed on this basis, as applied to offsite DCFs for members of the public, for the NRC staff to determine the adequacy of SHINEs radiological dose consequence analysis as part of its accident analysis.
Provide information supporting the acceptability of ICRP 30, which provides DCFs for adult workers, as the basis for calculating offsite doses to members of the public, including children.
SHINE Response SHINE used International Commission on Radiation Protection (ICRP) Publication 30, Limits for Intakes of Radionuclides by Workers, (ICRP 30) to calculate dose to members of the public in the preliminary accident analysis because ICRP 30 forms part of the basis for 10 CFR 20, and there is no regulatory requirement to use any guidance other than ICRP 30. However, SHINE acknowledges that ICRP Publication 72, Age-dependent Doses to Members of the Public from Intake of Radionuclides: Part 5 Compilation of Ingestion and Inhalation Dose Coefficients, (ICRP 72) provides dose coefficients based on newer biokinetic models and data than ICRP 30. Therefore, during the detailed design process, SHINE will update the accident analysis calculations to use dose conversion factors (DCFs) from ICRP 72 and will calculate dose effects to ensure that the dose limits in 10 CFR 20.1301 are met.
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SHINE has also prepared an analysis of the total effective dose equivalent (TEDE) to individual members of the public due to normal operational emissions, to demonstrate compliance with 10 CFR 20.1301, as well as 10 CFR 20.1101(d), using DCFs based on ICRP 30. This analysis was provided in the SHINE Response to RAI 11.1-9 (Reference 4).
SHINE also acknowledges that the use of ICRP 72 will provide more representative age-dependent dose estimates for the public for normal operation.
Therefore, SHINE will also perform normal operational dose calculations for the public using ICRP 72 DCFs during final design. The calculations will include age-dependent effects and potential ingestion pathways to demonstrate compliance with the regulations. As necessary, SHINE will provide additional engineered controls (e.g., crediting the Process Vessel Vent System (PVVS) acid gas scrubber, adding local charcoal or zeolite filters, using longer holdup times in the noble gas storage tanks) and/or refined source terms (e.g., more realistic iodine release fractions) to ensure that the resulting expected doses from normal operation meet the regulatory dose limits and dose constraints.
SHINE will ensure that a consistent methodology is applied to the final dose calculations. With the Final Safety Analysis Report (FSAR), SHINE will provide a description of the following:
- methodology used to derive the site-specific atmospheric dispersion and deposition (/Q and D/Q) values
- the evaluation of input parameters related to agricultural storage times, growing periods, and intake delays appropriate for the SHINE site
- selection and use of radioiodine partitioning factors applied in the calculations.
- applied DCFs for the appropriate iodine species
- dry and wet deposition effects
- source term assumptions and methodology
- final dose calculation results
- credited engineered controls An Issues Management Report (IMR) has been issued to track the inclusion of this information in the FSAR.
Based on the above, it is acceptable to use ICRP 30 for calculating off-site doses to members of the public for purposes of obtaining the construction permit because the calculation results meet regulatory requirements, use codified methodologies, and SHINE will calculate doses to the public for normal operation and design basis accidents using ICRP 72 DCFs during final design.
References (1) NRC letter to SHINE Medical Technologies, Inc., dated March 25, 2015, SHINE Medical Technologies, Inc. - Request for Additional Information Regarding Application for Construction Permit (TAC Nos. MF2305, MF2307, and MF2308) (ML15055A116)
(2) SHINE Medical Technologies, Inc. letter to NRC, dated March 26, 2013, Part One of the SHINE Medical Technologies, Inc. Application for Construction Permit (ML130880226)
(3) SHINE Medical Technologies, Inc. letter to NRC, dated May 31, 2013, Part Two of the SHINE Medical Technologies, Inc. Application for Construction Permit (ML13172A324)
(4) SHINE Medical Technologies, Inc. letter to NRC, dated March 23, 2015, SHINE Medical Technologies, Inc. Application for Construction Permit, Response to Request for Additional Information 11.1-9 (ML15092A397)
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