ML22304A126

Shine Technologies, LLC Application for an Operating License Response to Request for Confirmatory Information

ML22304A126
Person / Time
Site:	SHINE Medical Technologies
Issue date:	10/31/2022
From:	Jim Costedio SHINE Medical Technologies
To:	Office of Nuclear Reactor Regulation, Document Control Desk
References
2022-SMT-0114
Download: ML22304A126 (1)

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October 31, 2022 2022-SMT-0114 10 CFR 50.30 U.S. Nuclear Regulatory Commission ATTN: Document Control Desk Washington, DC 20555

References:

(1) SHINE Medical Technologies, LLC letter to the NRC, SHINE Medical Technologies, LLC Application for an Operating License, dated July 17, 2019 (ML19211C143)

(2) NRC electronic mail to SHINE Technologies, LLC, Request to Confirm Information FSAR Chapter 13, Accident Analysis, dated October 28, 2022 SHINE Technologies, LLC Application for an Operating License Response to Request for Confirmatory Information Pursuant to 10 CFR Part 50.30, SHINE Technologies, LLC (SHINE) submitted an application for an operating license for a medical isotope production facility to be located in Janesville, Wisconsin (Reference 1). The NRC staff determined that confirmatory information was required to enable the staffs continued review of the SHINE operating license application (Reference 2).

Enclosure 1 provides the SHINE responses to the NRC staffs request for confirmatory information.

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 October 31, 2022.

Very truly yours, James Costedio Vice President of Regulatory Affairs and Quality SHINE Technologies, LLC Docket No. 50-608 Enclosure cc: Project Manager, USNRC SHINE General Counsel Supervisor, Radioactive Materials Program, Wisconsin Division of Public Health 3400 Innovation Ct

• Janesville, WI 53546

• 877.512.6554

• info@shinemed.com

• www.SHINEtechnologies.com

ENCLOSURE 1 SHINE TECHNOLOGIES, LLC SHINE TECHNOLOGIES, LLC APPLICATION FOR AN OPERATING LICENSE RESPONSE TO REQUEST FOR CONFIRMATORY INFORMATION The U.S. Nuclear Regulatory Commission (NRC) staff determined that confirmatory information was required (Reference 1) to enable the continued review of the SHINE Technologies, LLC (SHINE) operating license application (Reference 2). The following information is provided by SHINE in response to the NRC staffs request.

RCI 13-1 For the accident-specific materials-at-risk described in SHINE FSAR Section 13a2.2, Accident Analysis and Determination of Consequences, confirm the following the following information:

For the accident specific material-at-risk (MAR) for the maximum hypothetical accident, the analysis deterministically assumes that 25 percent of iodine in the TSV solution in initially within the TSV offgas system (TOGS). It is assumed that the iodine in solution is predominantly volatile and that aqueous to gas partitioning occurs rapidly, causing 100% of the iodine inventory to be released to TOGS post shutdown. SHINE conservatively assumes that 100% of the safety-basis MAR is released.

SHINE Response SHINE confirms the information related to the accident-specific materials-at-risk described in Section 13a2.2 of the FSAR is accurate.

RCI 13-2 For the identification of control volumes and leakage paths in SHINE FSAR Section 13a2.2, confirm the following information:

SHINE identified the control volumes, leakage paths, and heat sinks that define the model geometry. The control volumes used in the analysis include the source volume, the building volume, and the environment. Leakage paths are treated as junctions between the control volumes.

The analysis considers each part of the facility as a fixed volume that the material is free to disperse into. Dispersion within these volumes is assumed to be instantaneous. Each volume is connected by one or more junctions which allows flow in one direction at a volumetric flow rate, either pressure-driven or constant. Counter-current flow, or flow back into the previous control volume, is not considered in this calculation.

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The SHINE-identified scenarios can be organized into four leak-path combinations which include: release location, initial confinement, secondary confinement, and release to environment. These leak-path combinations are:

1. Confinement by IU Cell or concrete cell -> IF building -> environment;

2. Confinement by glovebox -> IF building -> environment;

3. Confinement by hot cell -> RPF building -> environment; and

4. Confinement by concrete vault -> RPF building -> environment.

SHINE Response SHINE confirms the information related to the identification of control volumes and leakage paths in Section 13a2.2 of the FSAR is accurate, with one clarification. For the release from a tritium purification system (TPS) glovebox (Scenario 7 of CALC-2018-0048, Radiological Dose Consequences), the release scenario also considers the volume of the TPS room in the leak path, such that the appropriate leak-path combination for item 2 of the list is: confinement by glovebox -> TPS room -> IF building -> environment.

RCI 13-3 For the derivation of iodine reduction factors in SHINE FSAR Section 13a2.2, confirm the following the following information:

SHINE utilized the following model and guidance to perform this analysis:

• Iodine partitioning was calculated using equations based on the definitions found in NUREG/CR-5950, Iodine Evolution and pH Control.

• Bursting bubble aerosols are treated using a linear relationship between entrainment coefficients and the volumetric flow rate with entrainment coefficients consistent with the small amount of dissolved materials present in the target solution.

• Spray and free-fall aerosols use a constant airborne release fraction found in NUREG/CR-6410.

• Radiolysis was treated as either an instantaneous release of hydrogen or as entrainment with source generation based on decay power inputs for long-term problems.

All scenarios containing iodine use isotope reduction factors that account for TOGS running during normal operations. Scenarios that are downstream from the IU cell take an additional removal factor of iodine due to the operation of the TOGS during the post-irradiation dump tank hold time.

SHINE calculation, CALC-2018-0048, Appendix B, Justification for Treatment of Iodine, contains the justification for the removal factors that are utilized in this calculation as well as the isotope-specific reduction factors. The table below provides a list for each DBA scenarios which assumes iodine removal factors for the IU, the dump tank, or both.

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Design-Basis Accident Scenarios Utilizing Iodine Removal Factors Irradiation Dump Tank Scenario Reduction Reduction Number Factor Factor 1a x 1b x 3 x 9a x x 9b x x 10 x 11 x x 12 x x 14 x x SHINE Response SHINE confirms the information related to the models, guidance, and assumptions made in examined scenarios used to derive the iodine reduction factors in Section 13a2.2 of the FSAR is accurate.

RCI 13-4 For the quantification of leak rates between volumes in SHINE FSAR Section 13a2.2, confirm the following information:

SHINE defined leakage rates between volumes driven by pressure, gas density differences, and barometric breathing. The outcome of this sub-step as expressions for removal rates. The gas pressure in each volume is determined using a combination of conservation laws for mass and energy, temperature-dependent specific heats, and the ideal gas law. Pressure-driven flow through each junction was calculated using the standard compressible flow equation for pressure-driven flow. Pressure-driven flow through shielding cover plug gaps was calculated using the equation for plane Poiseuille flow. In the absence of pressure-driven flow, counter-current flow was assumed to be induced and was calculated based on the difference in pressure from one side of the cover plug to the other. There is no assumed flow from the IF to the RPF or vice versa; all material in the IF or RPF control volumes exits the SHINE facility to the environment.

SHINE Response SHINE confirms the information related to the quantification of leak rates between volumes identified in Section 13a2.2 of the FSAR is accurate.

RCI 13-5 For the quantification of removal mechanisms in SHINE FSAR 13a2.2, confirm the following information:

SHINE established expressions for removal rates of radionuclides. Specifically, iodine adsorption, non-volatile aerosol deposition, and removal by filters along flow paths. Removal by Page 3 of 6

aerosol settling was evaluated using Stokes law and the calculated equilibrium particle size for a hygroscopic particle. Consideration of removal by filters in the accident flow paths was done by assigning decontamination factors for noble gases, iodine, and aerosols to each filter.

Removal due to barometric breathing was based on an analysis of the peak-to-peak magnitude of environmental pressure fluctuations. Eight years of pressure data were collected and analyzed to provide a bounding estimate of the barometric breathing flow rate for the facility.

SHINE Response SHINE confirms the information related to the established expressions for the removal rates of radionuclides in Section 13a2.2 of the FSAR is accurate.

RCI 13-6 For assessing meteorological conditions in SHINE FSAR Section 13a2.2, confirm the following:

The x/Q values are calculated for periods of 0-2 hours, 0-8 hours, 8-24 hours, 1-4 days, and 4-30 days following the effluent release.

The control room atmospheric dispersion x/Q values utilized in the SHINE accident analysis are reported in CALC-2018-0048 Rev. 6, Table 3-1, 95th Percentile Site Boundary x/Q values, are as follows:

Time Bin (hours)

Locations 0-2 2-8 8-24 24-96 96-720 Control Room Public 1.40E-2 1.09E-2 4.61E-3 2.99E-3 2.33E-3 x/Q Values (s/m3)

SHINE Response SHINE confirms the control room atmospheric dispersion x/Q values utilized in the SHINE accident analysis are accurate.

RCI 13-7 For operator radiological consequences assumptions in SHINE FSAR Section 13a.2.2, confirm the following:

The volume of the control room is conservatively estimated to be 350 m3 based on the dimensions of the control room minus estimated sizes of the equipment in the control room.

SHINE assumes no cross contamination from IF and RPF as the control room is not part of the radiologically control area. Therefore, the radionuclide flow path from the material at risk source to the control room is accident-dependent but generally flows to the environment to the facility ventilation system intake (FVZ4) using the control room atmospheric c/Q values. The facility ventilation zone four system is responsible for delivering air to the control room and many other rooms in the non-radiologically controlled area of the SHINE facility where approximately 20% of the FVZ4 inlet flow is delivered to the control room. The FVZ4 is assumed to continue running after all initiating events as it is not safety-related. Material that reaches the control room are assumed to instantaneously diffuses within the control room volume. The ventilation system is Page 4 of 6

assumed to continue running after all initiating events for a period of 30 days. The breathing rate for control room operators is 3.50E-04 m3/s based on those stated in RG 1.195 for the duration of the scenario. Control room occupancy factors are sourced from RG 1.195 item 4.2.6 as described below:

Control Room Occupancy Factors 0-24 hours 24-96 hours96-720 hours Occupancy Factor 1.0 0.6 0.4 SHINE Response SHINE confirms the identified estimates and assumptions used to calculate radiological dose consequences to operators in the control room are accurate.

RCI-13-8 For public radiological consequences assumptions in SHINE FSAR Section 13a.2.2, confirm the following:

The public radiological consequences are computed by modeling the radionuclide flow path from the material at risk source to the environment in combination with the siting public atmospheric c/Q values over a 30-day period. The breathing rate for control room operators is 3.50E-04 m3/s based on those stated in RG 1.195 for the duration of the scenario.

SHINE Response SHINE confirms the identified modeling approach and assumed breathing rate used to calculate the radiological dose consequences to the public are accurate.

RCI 13-9 TS 5.5.1, Nuclear Safety Program, states, in part, the following:

The safety program accomplishes these goals through development and maintenance of the accident analysis, identification of safety-related controls credited for the prevention or mitigation of accidents, and establishment of programmatic administrative controls to ensure reliability of the credited controls.

Confirm that TS 5.5.1 will ensure that the SHINE Safety Analysis and its supporting documentation remain accurate and current, including prompt updates of the SHINE Safety Analysis and its supporting documentation when a change is made to the facility, operations, or FSAR descriptions.

SHINE Response SHINE confirms that Section 5.5.1 of the Technical Specifications ensures the SHINE Safety Analysis and its supporting documentation will remain accurate and current, including prompt updates when changes are made to the facility, operations, or FSAR descriptions.

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References

1. NRC electronic mail to SHINE Technologies, LLC, Request to Confirm Information FSAR Chapter 13, Accident Analysis, dated October 28, 2022

2. SHINE Medical Technologies, LLC letter to the NRC, SHINE Medical Technologies, LLC Application for an Operating License, dated July 17, 2019 (ML19211C143)

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