ML19053A278

Shine Medical Technologies - Periodic Report Required by the License Conditions in Section 3.0.(1) of CPMIF-001

ML19053A278
Person / Time
Site:	SHINE Medical Technologies
Issue date:	02/22/2019
From:	Jim Costedio SHINE Medical Technologies
To:	Document Control Desk, Office of Nuclear Reactor Regulation
References
2019-SMT-0010
Download: ML19053A278 (5)

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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