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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 Shines Cybersecurity Program for Its 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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UNITED STATES NUCLEAR REGULATORY COMMISSION WASHINGTON, D.C. 20555-0001 Reid Nelson, Director Office of Federal Agency Programs Advisory Council on Historic Preservation 401 F Street NW, Suite 308 Washington, DC 20001-2637
SUBJECT:
NOTICE OF AVAILABILITY AND REQUEST FOR COMMENTS ON DRAFT ENVIRONMENTAL IMPACT STATEMENT SUPPLEMENT RELATED TO THE OPERATING LICENSE FOR THE SHINE MEDICAL ISOTOPE PRODUCTION FACILITY (DOCKET NO. 50-608)
Dear Reid Nelson:
The U.S. Nuclear Regulatory Commission (NRC) is conducting an environmental review of an application for an operating license from SHINE Medical Technologies, LLC (SHINE) for a medical isotope production facility (the SHINE facility). The operating license application was submitted pursuant to Title 10 of the Code of Federal Regulations (10 CFR) part 50.
The SHINE facility is being constructed approximately 4 miles south of Janesville, Rock County, Wisconsin and if licensed, would produce radioisotopes for use in diagnostic medical procedures.
As stated in our letter dated November 27, 2019, a review was conducted for the construction permit application for the SHINE facility from 2013-2015. At the conclusion of the safety and environmental reviews, the NRC issued Construction Permit No. CPMIF-001 for the SHINE facility to SHINE on February 29, 2016 (Agencywide Documents Access and Management System (ADAMS) Accession No. ML16041A473). The safety review was supported by NUREG-2189, Safety Evaluation Report Related to SHINE Medical Technologies, Inc. Construction Permit Application for a Medical Radioisotope Production Facility, dated August 2016 (ML16229A140), and the environmental review was supported by NUREG-2183, Environmental Impact Statement for the Construction Permit for the SHINE Medical Radioisotope Production Facility, dated October 2015 (ML15288A046).
In connection with the issuance of an operating license for a production or utilization facility, the NRC is required to supplement its final Environmental Impact Statement (EIS) on the construction permit for that facility in accordance with 10 CFR 51.95(b). This supplement updates the prior environmental review and will only cover matters that differ from those or that reflect significant new information relative to that discussed in the final EIS. Therefore, the NRC has prepared a draft Supplement 1 to NUREG-2183 (the draft supplement) under 10 CFR Part 51, the NRCs regulations implementing the National Environmental Policy Act of 1969, as amended (NEPA). July 8, 2022 R. Nelson 2
As discussed in our November 2019 letter, the NRC is complying with section 106 of the National Historic Preservation Act of 1966, as amended (NHPA), through the NEPA process in accordance with 36 CFR 800.8(c). Consistent with the area of potential effects (APE) previously considered for the construction permit application, the APE for this undertaking is the same (i.e., the area of the site and its immediate environs). In the context of NEPA, the NRC staffs preliminary determination is that the impacts on historic and cultural resources from the operation of the SHINE facility would remain small. Under the provisions of the NHPA, the NRC staffs preliminary determination is that no historic properties would be affected by this undertaking. This recommendation is based on: (1) the analysis and findings in the draft supplement; (2) consultation with Federal, State, Tribal, and local agencies; (3) the environmental report submitted by SHINE; (4) the NRC staffs independent environmental review; and (5) the consideration of public comments.
A copy of the draft supplement is available via the following link:
https://www.nrc.gov/docs/ML2217/ML22179A346.pdf. The draft supplement is also available through the web-based version of the NRCs ADAMS at https://www.nrc.gov/readingrm/adams.html under Accession No. ML22179A346.
Pursuant to 36 CFR 800.8(c), we are requesting your comments on the draft supplement and preliminary conclusions. Electronic comments may be submitted to the NRC by accessing https://www.regulations.gov and searching for Docket ID NRC-2022-0135 or by emailing SHINEEnvironmental@nrc.gov. Written comments should be submitted by mail to:
Program Management, Announcements and Editing Staff Office of Administration Mail Stop: TWFN-7A60M U.S. Nuclear Regulatory Commission Washington, DC 20555-0001
Please note that the public comment period for the draft supplement ends on August 22, 2022.
The NRC will hold a public meeting as an online webinar and teleconference to discuss the findings of the draft supplement on July 27, 2022, from 6:00 p.m. to 8:00 p.m. central time.
Webinar and teleconference details are available in the following NRC public meeting notice: https://www.nrc.gov/pmns/mtg?do=details&Code=20220659.
If you have any questions concerning the NRC staff's review of this operating license application, please contact Lance Rakovan, Senior Environmental Project Manager, at 301-415-2589 or via email at Lance.Rakovan@nrc.gov.
Sincerely, Theodore B. Smith, Chief Environmental Review License Renewal Branch Division of Rulemaking, Environmental, and Financial Support Office of Nuclear Material Safety and Safeguards Docket No. 50-608 Signed by Smith, Theodore on 07/08/22
ML22175A039 OFFICE NMSS/REFS/ELRBNMSS/REFS:LA NMSS/REFS/ELRB NAME LRakovan AWalker-Smith TSmith DATE 6/13/2022 6/13/2022 7/8/2022