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Category:Letter
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 - 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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 24, 2017 Gregory Piefer, Ph.D.
Chief Executive Officer SHINE Medical Technologies, Inc.
101 E. Milwaukee Street, Suite 600 Janesville, WI 53545
SUBJECT:
SHINE MEDICAL TECHNOLOGIES, INC. - ACKNOWLEDGMENT OF RECEIPT OF PERIODIC REPORTS ON CONSTRUCTION PERMIT CONDITIONS
Dear Dr. Piefer:
In order to verify certain design developments related to nuclear criticality safety and radiation protection in the SHINE Medical Technologies, Inc. (SHINE) Radioisotope Production Facility (RPF), the U.S. Nuclear Regulatory Commission (NRC) collects periodic reports containing the information set forth in Section 3.D.(1) of SHINE Construction Permit No. CPMIF-001.
By letter dated February 24, 2017 (Agencywide Documents Access and Management System
[ADAMS] Accession No. ML17055A573), SHINE submitted to the NRC its second periodic report on nuclear criticality safety and radiation protection consistent with Section 3.D.(1) of its construction permit, CPMIF-001. SHINE submitted to the NRC its first periodic report on August 25, 2016 (ADAMS Accession No. ML16238A034).
As described in its two periodic reports, SHINE has performed limited work on four of the five license conditions described in Section 3.D.(1) of its construction permit. In support of developing the technical basis for the design of the criticality accident alarm system in License Condition 3.D.(1)(a), SHINE has worked with criticality accident alarm system equipment vendors on the development of an initial estimate of equipment quantities. With respect to the criticality safety considerations described in License Conditions 3.D.(1)(b) - (d), SHINE has indicated that it has begun to prepare programmatic nuclear criticality safety documentation to be used for the development of nuclear criticality safety evaluations for the SHINE RPF. At this time, SHINE has not developed any additional design information on the RPF supercells, tank vaults containing the liquid waste storage tanks, evaporation hot cells, or liquid waste solidification hot cells, demonstrating shielding and occupancy times within the RPF are consistent with as low as is reasonably achievable practices and dose requirements of Title 10 of the Code of Federal Regulations Part 20, Standards for Protection against Radiation, as described in License Condition 3.D.(1)(e).
As of the writing of this letter, SHINE has neither initiated construction of its proposed facility nor submitted any additional design information as part of an operating license application for NRC review under Docket No. 50-608.
G. Piefer Based upon the information provided in SHINEs periodic reports, the status of activities authorized under Construction Permit No. CPMIF-001, and the status of applications submitted under Docket No. 50-608, no NRC action is necessary on SHINEs periodic reports at this time.
The NRC may request that SHINE provide clarifying or more detailed information in order to verify certain design developments as set forth in Section 3.D.(1) of SHINEs construction permit if the NRC considers this information necessary prior to the completion of construction. This may include requests that SHINE make reference material available via electronic reading room or meet with NRC staff to support the planning and conducting of NRC inspections during construction.
If you have any questions, please contact Steven Lynch at 301-415-1524, or by electronic mail at Steven.Lynch@nrc.gov.
Sincerely,
/RA/
Steven T. Lynch, Project Manager Research and Test Reactors Licensing Branch Division of Policy and Rulemaking Office of Nuclear Reactor Regulation Docket No. 50-608 cc: See next page
SHINE External Stakeholder Mailing List Jeff Bartelme Licensing Manager SHINE Medical Technologies, Inc.
101 E. Milwaukee Street, Suite 600 Janesville, WI 53545 Jeff Chamberlin National Nuclear Security Administration, NA-231 U.S. Department of Energy 1000 Independence Ave SW Washington, DC 20585 Mark Paulson Supervisor Radiation Protection Section Wisconsin Department of Health Services P.O. Box 2659 Madison, WI 53701-2659 TRTR Newsletter University of Florida Department of Nuclear Engineering Sciences 202 Nuclear Sciences Center Gainesville, FL 32611 Mark Freitag City Manager P.O. Box 5005 Janesville, WI 53547-5005 Bill McCoy 1326 Putnam Avenue Janesville, WI 53546 Alfred Lembrich 541 Miller Avenue Janesville, WI 53548 Gerald and Muriel Bumgarner 1735 S Osborne Ave Janesville, WI 53546
ML17102B287; *concurred via email NRR-088 OFFICE NRR/DPR/PRLB/PM* NRR/DPR/PROB/LA* NMSS/FCSE/ECB NAME SLynch NParker YFaraz*
DATE 4/13/17 4/13/17 4/27/17 OFFICE OGC* NRR/DPR/PRLB NAME JWachutka AAdams (LTran for)
DATE 5/23/17 5/24/17