ML20052C794

Shine Medical Technologies, Inc., Periodic Report Required by the License Conditions in Section 3.D.(1) of CPMIF-001

ML20052C794
Person / Time
Site:	SHINE Medical Technologies
Issue date:	02/21/2020
From:	Jim Costedio SHINE Medical Technologies
To:	Document Control Desk, Office of Nuclear Reactor Regulation
References
2020-SMT-0015, EPID L-2018-LLM-0154
Download: ML20052C794 (5)

Text

February 21, 2020 2020-SMT-0015 10 CFR 50.4 U.S. Nuclear Regulatory Commission ATTN: Document Control Desk Washington, DC 20555

References:

(1) NRC letter to SHINE Medical Technologies, LLC, "SHINE Medical Technologies, LLC - Issuance of Amendment Reflecting Indirect Transfer of Construction Permit No. CPMIF-001 (EPID NO. L-2018-LLM-0154)," dated July 1, 2019 (ML19162A024)

(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, 2019 (ML19234A047)

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, LLC (SHINE) Construction Permit as amended (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, Director of Licensing, at 608/210-1735.

I declare under the penalty of perjury that the foregoing is true and correct.

Executed on February 21, 2020.

Very truly yours, James Costedio Vice President of Regulatory Affairs and Quality SHINE Medical Technologies, LLC 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, LLC 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, LLC (SHINE) Construction Permit as amended (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 nuclear criticality safety and radiation protection (Reference 2), SHINE has submitted an operating license application supplement (Reference 3). As described in previous periodic reports (Reference 2 et al.), the design of the criticality accident alarm system (CAAS) has developed over time. The preliminary CAAS design, as described in the Preliminary Safety Analysis Report (PSAR) including the commitments listed on page 6b-19 of the PSAR, has been updated. The CAAS design description, including the information required by the license condition described in Section 3.D.(1)(a) of the SHINE Construction Permit (Reference 1), is provided in the Final Safety Analysis Report (FSAR) (Reference 3).

FSAR Sections 6b.3.3 and 7.7.6 provide the technical basis for the design of the CAAS, including a description of the methodology for determining detector placement provided in FSAR Section 6b.3.3. The CAAS design, as described in the FSAR, demonstrates that the CAAS meets the requirements of 10 CFR 70.24(a) and conforms to the requirements in ANSI/ANS-8.3-1997, as endorsed by Regulatory Guide 3.71, Revision 3 (Reference 4).

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.

Page 1 of 4

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 submitted an operating license application supplement (Reference 3). The information required by the license condition described in Section 3.D.(1)(b) of the SHINE Construction Permit (Reference 1), is provided in the Integrated Safety Analysis (ISA) Summary and the FSAR (Reference 3).

ISA Summary Section 4.4.1 and FSAR Section 6b.3.2 provide the criticality safety basis, for each RPF process, which describes the bases for determining that processes will remain subcritical under normal and credible abnormal conditions even though fissile materials may be present. ISA Summary Section 9 provides the definitions of credible and not credible events.

ISA Summary Appendix F contains a list of evaluated criticality safety accident sequences, evaluation results, and criticality safety controls applicable to RPF processes. The bases for determining that RPF processes will remain subcritical under normal and credible abnormal conditions, provided in the ISA Summary and the FSAR, are consistent with the definitions described in the 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 submitted an operating license application supplement (Reference 3). The information required by the license condition described in Section 3.D.(1)(c) of the SHINE Construction Permit (Reference 1), is provided in the ISA Summary and the FSAR (Reference 3).

ISA Summary Section 4.4.1 and FSAR Section 6b.3.2 provide descriptions of the criticality safety basis for each process system, which includes summaries of the criticality safety analyses for the affected processes to ensure the processes will remain subcritical under normal and credible abnormal conditions. The ISA Summary and FSAR includes descriptions of assumptions for the analyses described, as well as the following:

• A list of identified criticality hazards for each process is provided in ISA Summary Appendix F.

• Controlled parameters are described in FSAR Section 6b.3.2, and the parameters used for each process are described in ISA Summary Section 4.4.1 and FSAR Section 6b.3.2.

Additionally, a list of criticality controls for each process is provided in ISA Summary Appendix F, Table F-2.

Page 2 of 4

• A description of evaluated normal and abnormal conditions is provided in ISA Summary Appendix F.

• A description of SHINEs approach to meeting the double contingency principle is provided in FSAR Section 6b.3.2.

• A list of passive and active engineered controls is provided in ISA Summary Appendix F, Table F-2.

The criticality safety analysis summaries provided in the ISA Summary and the FSAR 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 demonstrates 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), SHINE has submitted an operating license application supplement (Reference 3). The information required by the license condition described in Section 3.D.(1)(e) of the SHINE Construction Permit (Reference 1), is provided in the FSAR (Reference 3).

FSAR Section 4b.2 provides a description and analysis of shielding designs for the areas in the RPF where radioactive materials are transferred, stored, and processed, including:

• Supercell, including the following cells:

o Extraction (3 cells) o Purification (3 cells)

Page 3 of 4

o Packaging (2 cells) o Process vessel vent system (PVVS) o Iodine and xenon purification and packaging (IXP)

• Process tank vaults

• Process valve pits

• Pipe trenches

• Carbon delay bed vault

• Solid waste drum storage bore holes

• Radioactive liquid waste immobilization (RLWI) shielded enclosure FSAR Section 11.1 describes the Radiation Protection Program and the As Low As Reasonably Achievable (ALARA) Program, which discuss, among other radiation protection principles, facility design considerations that minimize personnel occupancy times spent in radiation areas.

FSAR Section 11.1.1 provides a description of radiation source locations and source term characterizations. FSAR Table 11.1-4 provides a table of normally-occupied and transient-occupied areas, projected dose rates, and area radiological designations. FSAR Figure 11.1-1 provides the facility radiologically controlled area (RCA) layout and projected radiation area designations within the RCA. The analyses presented in FSAR Section 11.1 demonstrates that the shielding designs described in FSAR Section 4b.2, along with the Radiation Protection Program and ALARA Program requirements described in FSAR Section 11.1, are consistent with ALARA practices and dose requirements of 10 CFR Part 20.

REFERENCES (1) NRC letter to SHINE Medical Technologies, LLC, SHINE Medical Technologies, LLC -

Issuance of Amendment Reflecting Indirect Transfer of Construction Permit No.

CPMIF-001 (EPID NO. L-2018-LLM-0154), dated July 1, 2019 (ML19162A024)

(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, 2019 (ML19234A047)

(3) SHINE Medical Technologies, LLC letter to NRC, SHINE Medical Technologies, LLC Operating License Application Supplement No. 1, dated November 14, 2019 (ML19331A832)

(4) Nuclear Criticality Safety Standards for Nuclear Materials Outside Reactor Cores, Regulatory Guide 3.71, Revision 3, October 2018 (ML18169A258)

Page 4 of 4