Letter Sequence Request |
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EPID:L-2018-LLM-0154, Shine Medical Technologies, Inc., Submittal of Periodic Report Required by the License Conditions in Section 3.D.(1) of CPMIF-001 (Approved, Closed) |
Initiation
- Request, Request, Request, Request, Request, Request, Request, Request, Request, Request, Request, Request, Request, Request
- Acceptance...
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MONTHYEARML16238A0342016-08-25025 August 2016 Shine Medical Technologies, Inc., Submittal of Periodic Report Required by the License Conditions in Section 3.D.(1) of CPMIF-001 Project stage: Request ML17055A5732017-02-24024 February 2017 Shine Medical Technologies, Inc. - Periodic Report Required by the License Conditions in Section 3.D.(1) of CPMIF-001 Project stage: Request ML17235A1102017-08-23023 August 2017 Shine Medical Technologies, Inc. - Periodic Report Required by the License Conditions in Section 3.D.(1) of CPMIF-001 Project stage: Request ML18054A0022018-02-23023 February 2018 Shine Medical Technologies - Periodic Report Required by the License Conditions in Section 3.D.(1) of CPMIF-001 Project stage: Request ML18166A1782018-06-13013 June 2018 Shine Medical Technologies, Inc., Submittal of Annual Financial Report Project stage: Request ML18234A0202018-08-22022 August 2018 Shine Medical Technologies, Inc. - Periodic Report Required by the License Conditions in Section 3.D.(1) of CPMIF-001 Project stage: Request ML18347A2152018-12-11011 December 2018 Shine Medical Technologies - Application for Order Approving Indirect Transfer of Control of Construction Permit and Conforming Administrative Construction Permit Amendment Project stage: Request ML19024A5302019-02-13013 February 2019 Shine Medical Technologies, Inc. - Request for Additional Information Regarding the Application for Indirect License Transfer and Conforming Amendment Project stage: RAI ML19010A1722019-02-13013 February 2019 Shine Medical Technologies, Inc. - Request for Withholding Information from Public Disclosure Project stage: Withholding Request Acceptance ML19010A0952019-02-13013 February 2019, 14 February 2019 Shine Medical Technologies, Inc. Application for Indirect License Transfer Project stage: Request ML19010A0962019-02-13013 February 2019 Shine Medical Technologies, Inc. - Notice of Consideration of Approval of Indirect License Transfer and Conforming Amendment and Opportunity for a Hearing and Petition for Leave to Intervene Project stage: Other ML19010A0972019-02-14014 February 2019 Shine Medical Technologies, Inc. - Federal Register Notice Related to Consideration of Approval of Transfer of License and Conforming Amendment Project stage: Other ML19053A2782019-02-22022 February 2019 Shine Medical Technologies - Periodic Report Required by the License Conditions in Section 3.0.(1) of CPMIF-001 Project stage: Request ML19071A0562019-03-0808 March 2019 Shine Medical Technologies, Inc., Affidavit & Response to Request for Additional Information to Application for Order Approving Indirect Transfer of Control of Construction Permit Response to Request for Additional Information Project stage: Response to RAI ML19071A0552019-03-0808 March 2019 Shine Medical Technologies, Inc., Application for Order Approving Indirect Transfer of Control of Construction Permit Response to Request for Additional Information Project stage: Response to RAI ML19102A3482019-05-0202 May 2019 Shine Medical Technologies, Inc. - Response to Withholding Request Related to Indirect Transfer of and Conforming Amendment to Construction Permit No. CPMIF-001 Project stage: Other ML19102A3212019-05-0202 May 2019, 20 May 2019, 30 May 2019 Shine Medical Technologies, Inc. - Indirect Transfer of and Conforming Amendment to Construction Permit No. CPMIF-001 Project stage: Request ML19102A3242019-05-20020 May 2019 Shine Medical Technologies, Inc. - Order Approving Indirect Transfer of and Conforming Amendment to Construction Permit No. CPMIF-001 Project stage: Request ML19102A3232019-05-20020 May 2019 Shine Medical Technologies, Inc. - Cover Letter for Indirect Transfer of and Conforming Amendment to Construction Permit No. CPMIF-001 Project stage: Other ML19162A0262019-07-0101 July 2019 Shine Medical Technologies, LLC - Amendment No. 1 to Shine Medical Isotope Production Facility Construction Permit No. CPMIF-001 Project stage: Other ML19162A0242019-07-0101 July 2019 Shine Medical Technologies, LLC - Issuance of Amendment Reflecting Indirect Transfer of Construction Permit No. CPMIF-001 Project stage: Request ML19162A0252019-07-0101 July 2019 Shine Medical Technologies, LLC - Issuance of Amendment Reflecting Indirect Transfer of Construction Permit No. CPMIF-001 Project stage: Approval ML19234A0472019-08-22022 August 2019 Shine Medical Technologies - Periodic Report Required by the License Conditions in Section 3.0.(1) of CPMIF-001 Project stage: Request ML19331A8322019-11-14014 November 2019 Shine Medical Technologies, LLC Supplement 1 to Final Safety Analysis Report Project stage: Request ML20052C7942020-02-21021 February 2020 Shine Medical Technologies, Inc., Periodic Report Required by the License Conditions in Section 3.D.(1) of CPMIF-001 Project stage: Other 2019-02-13
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Category:Letter
MONTHYEARML24128A2162024-05-0707 May 2024 Shine Technologies, LLC, Submittal of Annual Financial Report 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) 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 2024-05-07
[Table view] Category:Periodic Monitoring Report (Radiological/Environmental)
MONTHYEARML19053A2782019-02-22022 February 2019 Shine Medical Technologies - Periodic Report Required by the License Conditions in Section 3.0.(1) of CPMIF-001 ML17235A1102017-08-23023 August 2017 Shine Medical Technologies, Inc. - Periodic Report Required by the License Conditions in Section 3.D.(1) of CPMIF-001 ML17055A5732017-02-24024 February 2017 Shine Medical Technologies, Inc. - Periodic Report Required by the License Conditions in Section 3.D.(1) of CPMIF-001 2019-02-22
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Text
February 22, 2019 2019-SMT-0010 10 CFR 50.4 U.S. Nuclear Regulatory Commission ATTN : Document Control Desk Washington, DC 20555
References:
(1) NRC letter to SHINE Medical Technologies, Inc., "SHINE Medical Technologies, Inc. - Issuance of Construction Permit for Medical Isotope Facility," dated February 26, 2016(ML16041A473)
(2) SHINE Medical Technologies , Inc. letter to NRC, "Periodic Report Required by the License Conditions in Section 3.D.(1) of CPMIF-001," dated August 22, 2018 (ML18234A020)
Periodic Report Required by the License Conditions in Section 3.0.(1) of CPMIF-001 Pursuant to the License Conditions described in Section 3.D.(1) of the SHINE Medical Technologies, Inc. (SHINE) Construction Permit (Reference 1), SHINE is submitting the enclosed periodic report, updating the NRC staff on progress related to nuclear criticality safety and radiation protection since SHINE's previous periodic report (Reference 2).
If you have any questions, please contact Mr. Jeff Bartelme, Licensing Manager, at 608/210-1735.
I declare under the penalty of perjury that the foregoing is true and correct.
Executed on February 22, 2019.
Very truly yours, 4~
Vice President of Regulatory Affairs and Quality SHINE Medical Technologies, Inc.
Docket No. 50-608 Enclosure cc: Project Manager, USNRC Supervisor, Radioactive Materials Program, Wisconsin Division of Public Health 101 E. Milwaukee St., Suite 600 I Janesville, WI 53545 IP (608) 210-1060 IF (608) 210-2504 I www.shinemed.com
ENCLOSURE SHINE MEDICAL TECHNOLOGIES, INC.
PERIODIC REPORT REQUIRED BY THE LICENSE CONDITIONS IN SECTION 3.D.(1) OF CPMIF-001 Pursuant to the License Conditions described in Section 3.D.(1) of the SHINE Medical Technologies, Inc. (SHINE) Construction Permit (Reference 1), SHINE is providing the following periodic report, updating the NRC staff on progress related to nuclear criticality safety and radiation protection.
License Condition 3.D.(1)(a)
The technical basis for the design of the criticality accident alarm system (CAAS), including a description of the methodology for determining detector placement. The technical basis shall demonstrate that the CAAS will meet the requirements of 10 CFR 70.24(a) and the commitments listed on page 6b-19 of the Preliminary Safety Analysis Report, Revision 0.
SHINE Update Since the submittal of SHINEs previous periodic report updating the NRC staff on progress related to the criticality accident alarm system (CAAS) (Reference 2), SHINE has completed a preliminary analysis to determine appropriate placement of detectors associated with the CAAS in order to meet the requirements of 10 CFR 70.24(a). The preliminary analysis uses detector response functions typical of neutron detectors installed in similar facilities. Work is continuing to ensure that the use of neutron detectors in the Radioisotope Production Facility (RPF) provides adequate coverage of areas in which special nuclear material (SNM) is used, handled, or stored.
Future work includes a final analysis of detector placement within the RPF using final construction drawings, structural material compositions, and specific detector response functions associated with the detectors selected for use in the facility.
Documentation associated with development of the technical basis will be produced as needed to demonstrate that the CAAS meets 10 CFR 70.24(a) and the commitments listed on Page 6b-19 of the SHINE Preliminary Safety Analysis Report (PSAR).
License Condition 3.D.(1)(b)
The basis for determining that criticality events are not credible for radioisotope production facility (RPF) processes even though fissile materials may be present. The basis shall demonstrate that the each such event satisfies the definition of not credible, as described in the SHINE integrated safety analysis Summary.
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SHINE Update Since the submittal of SHINEs previous periodic report updating the NRC staff on progress related to nuclear criticality safety and radiation protection (Reference 2), SHINE has used the following criteria for determining that criticality events are not credible for RPF processes even though fissile materials may be present:
Not Credible x Event is not physically possible, or x Event is caused by a sequence of events involving many unlikely human actions or errors for which there is no reason or motive.
The determination that a criticality event is not credible is made as part of the criticality safety evaluation process.
Future SHINE work includes continued evaluation of criticality events for RPF processes. For any criticality event SHINE determines to be not credible even though fissile material may be present, SHINE will provide the basis for the determination, demonstrating that each such event satisfies the above definition of not credible, as described in the SHINE Integrated Safety Analysis (ISA) Summary.
License Condition 3.D.(1)(c)
Summaries of the criticality safety analysis for the affected processes that include the following:
(1) a list of identified criticality hazards, (2) a list of controlled parameters, (3) a description of evaluated normal and abnormal conditions, (4) a description of the licensees approach to meeting the double contingency principle, and (5) a list of anticipated passive and active engineered controls, including any assumptions, to ensure the process(es) will remain subcritical under normal and credible abnormal conditions. The criticality safety analysis summaries shall demonstrate that all RPF processes will remain subcritical under all normal and credible abnormal conditions and will satisfy the double contingency principle.
SHINE Update Since the submittal of SHINEs previous periodic report updating the NRC staff on progress related to nuclear criticality safety and radiation protection (Reference 2), SHINE has completed preliminary nuclear criticality safety evaluations (NCSEs) for the following systems:
x Target solution preparation system (TSPS) x Radioactive liquid waste system (RLWS) x Molybdenum extraction and purification system (MEPS) x Uranium receipt and storage system (URSS) x Target solution staging system (TSSS) x Vacuum transfer system (VTS) x Process vessel vent system (PVVS) x Radioactive drain system (RDS) x Radioactive liquid waste immobilization system (RLWI) x Analytical laboratory (LABS)
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Future SHINE work includes finalizing NCSEs for RPF processes, completing NCSEs for the remaining systems in the facility, and integrating the results of the NCSEs into the ISA Summary.
Once the NCSEs have been finalized, SHINE will summarize the NCSEs of the affected processes in the ISA Summary, including a list of identified criticality hazards; a list of controlled parameters; a description of evaluated normal and abnormal conditions; a description of SHINEs approach to meeting the double contingency principle; and a list of anticipated passive and active engineered controls, including any assumptions, to ensure the processes will remain subcritical under normal and credible abnormal conditions. The ISA Summary will be provided to the NRC staff as part of the operating license application and will demonstrate that all RPF processes will remain subcritical under all normal and credible abnormal conditions and will satisfy the double contingency principle.
License Condition 3.D.(1)(d)
The relevant nuclear criticality safety evaluations (NCSEs) shall address the reactivity contributions from all fissile isotopes or SHINE shall apply an additional subcritical margin to account for neglecting these nuclides. The treatment of fissile nuclides other than U-235, whether through the NCSEs or the addition of subcritical margin, shall demonstrate that all RPF processes will remain subcritical under all normal and credible abnormal conditions.
SHINE Update Since the submittal of SHINEs previous periodic report updating the NRC staff on progress related to nuclear criticality safety and radiation protection (Reference 2), there have been no changes in methodology related to the evaluation of reactivity contributions from all fissile isotopes. SHINE continues to perform NCSEs for RPF processes using 21% enriched fresh target solution in all calculations as a conservative estimate of system multiplication. The use of 21% enriched fresh target solution in the NCSEs will demonstrate that all RPF processes will remain subcritical under all normal and credible abnormal conditions.
License Condition 3.D.(1)(e)
The design information on the RPF supercells, tank vaults containing the liquid waste storage tanks, evaporation hot cells, and 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 10 CFR Part 20.
SHINE Update Since the submittal of SHINEs previous periodic report updating the NRC staff on progress related to nuclear criticality safety and radiation protection (Reference 2), work on the development of additional design information on RPF supercells, tank vaults containing liquid waste storage tanks, evaporation hot cells, and liquid waste solidification hot cells has continued to analyze expected dose rates and to demonstrate the adequacy of shielding within the RPF.
Expected direct dose rates throughout the SHINE facility have been determined. Dose rate calculations determined the dose rate from individual sources, including those stored in the RPF supercells, tank vaults containing the liquid waste storage tanks, evaporation hot cells, and liquid waste solidification hot cells, and combined these sources to create dose maps for the SHINE facility. The RPF was modeled according to current design, with conservative assumptions made as to shielding materials and the density of processing equipment. Several scenarios were Page 3 of 4
analyzed to ensure that operational factors that affect occupational dose rates were considered.
The scenarios include:
- 1. Operation of all irradiation units (IUs),
- 2. Solution in all hold tanks,
- 3. Operation of every other IU with non-operating IU hold tanks full of solution,
- 4. Processing two batches of irradiated target solution, and
- 5. In the process of filling two IUs.
Monte Carlo N-Particle 5 (MCNP5) was used to calculate dose rates and Python was used for analyzing the plotting data. A dose rate map was created for each scenario. The ALARA goal for the normal operations dose rate for normally occupied locations in the facility is 0.25 mrem/hour at 30 centimeters from the surface of the shielding. Radiation levels in normally occupied areas of the RPF may rise above the 0.25 mrem/hour level during some operations, but remain below 5 mrem/hour, except in small sections above the pipe trench during solution transfers. However, administrative controls, such as occupancy times, established in the Radiation Protection Program and radiation work permits will ensure that doses to workers remain ALARA. These dose rates were calculated using the maximum specified gap sizes, minimum density shielding materials, and the nominal source terms for full power operation. Additional design information related to the RPF supercells, tank vaults containing liquid waste storage tanks, evaporation hot cells, and liquid waste solidification hot cells will be provided as part of the operating license application.
Future SHINE work includes using the design information on RPF supercells, tank vaults containing liquid waste storage tanks, evaporation hot cells, and liquid waste solidification hot cells to update or perform occupancy time analyses demonstrating shielding and occupancy times within the RPF are consistent with as low as is reasonably achievable practices and the dose requirements of 10 CFR Part 20.
REFERENCES (1) NRC letter to SHINE Medical Technologies, Inc., SHINE Medical Technologies, Inc. -
Issuance of Construction Permit for Medical Isotope Facility, dated February 26, 2016 (ML16041A473)
(2) SHINE Medical Technologies, Inc. letter to NRC, Periodic Report Required by the License Conditions in Section 3.D.(1) of CPMIF-001, dated August 22, 2018 (ML18234A020)
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