ML22032A342

Shine Technologies, LLC, Application for an Operating License Revision 1 of the Shine Response to Request for Additional Information 11-2

ML22032A342
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Site:	SHINE Medical Technologies
Issue date:	02/01/2022
From:	SHINE Technologies
To:	Office of Nuclear Reactor Regulation
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ENCLOSURE 2 SHINE TECHNOLOGIES, LLC SHINE TECHNOLOGIES, LLC APPLICATION FOR AN OPERATING LICENSE REVISION 1 OF THE SHINE RESPONSE TO REQUEST FOR ADDITIONAL INFORMATION 11-2 PUBLIC VERSION The NRC staff determined that additional information was required to enable the staffs continued review of the SHINE Technologies, LLC (SHINE) operating license application (Reference 1). SHINE provided the response to the NRC staffs request for additional information (RAI) via Reference 2. SHINE has determined that the SHINE Response to RAI 11-2, provided via Reference 2, requires revision to account for design progression (e.g.,

including updates to potential leakage from the irradiation unit [IU] cells and radioisotope production facility [RPF] hot cells, removal of the process vessel vent system [PVVS] guard beds from the PVVS hot cell, incorporation of iodine and xenon purification and packaging [IXP]

system hot cell, and incorporation of the PVVS carbon monoxide [CO] monitor cabinet).

Revision 1 of the SHINE Response to RAI 11-2 is provided below.

Chapter 11- Radiation Protection Program and Waste Management RAI 11-2 10 CFR 50.34(b)(3) states that the FSAR shall include the kinds and quantities of radioactive material expected to be produced in the operation of the facility as it relates to tracking the amount of radioactive material contained in the various facility components as well as the anticipated radionuclides inside and outside the plant environment. In addition, NUREG-1537 Part 2, Section 11.1.1, Radiation Sources, states that applicant should identify the quantities and concentrations expected to be released. 10 CFR 20.1101(b) states that the applicant shall use, to the extent practical, procedures and engineering controls based upon sound radiation protection principles to achieve occupational doses and doses to members of the public that are as low as is reasonably achievable (ALARA).

Section 11.1.1, Radiation Sources, of the SHINE FSAR, page 11.1-2 states that the normal operation internal facility radiation dose rates are consistent with ALARA principles and that the dose rates were calculated using the maximum specified shield plug gap sizes, minimum density shielding materials, and the nominal inventories for full power operation.

a. In order for NRC staff to determine whether SHINEs dose rate estimates are appropriate for meeting 10 CFR 20.1101(b) and consistent with ALARA principles, provide a summary of the calculations/evaluations, assumptions, methodology, and input parameters that resulted in the estimated dose rates. The current information provided in FSAR section 11.1 tables generically provides a total curie content for components but does not provide enough details for the staff to perform an independent evaluation. Provide FSAR tables that provide the expected activities by isotope, in the components located in the SHINE facility to demonstrate compliance with 10 CFR 50.34(b)(3). The tables that staff are referring to Page 1 of 14

include: Tables 11.1-5, 11.1-9, and 11.1-10. In addition, the staff requests the applicant provide a table that summarizes the volumes in components such as tanks and systems assumed for dose calculations and provide thickness for tanks and pipes to allow staff to verify the stated radiation zoning in FSAR section 11.1. If other assumptions were necessary for the dose calculations provide that information within the response to this question.

Section 11.1.1.1, Airborne Radioactive Sources, of the SHINE FSAR, page 11.1-4 states that SHINE maintains airborne radioactive material at very low concentrations in normally occupied areas and that systems are designed to protect workers in keeping with the ALARA principles of 10 CFR Part 20.

b. In order for NRC staff to determine whether SHINE airborne doses to occupational workers are consistent with the ALARA principles, provide a summary of the calculations/evaluations, assumptions, methodology, and input parameters for the calculated expected doses rates, include DAC estimates, from gaseous radioactive sources presented in Section 11.1.1.1.

Section 11.1.1.1., Airborne Radioactive Sources, of the SHINE FSAR, page 11.1-5 states only nuclides with greater than 1 Ci/year released are included in Table 11.1-8.

c. Describe why SHINE limited the nuclides in Table 11.1-8 to only nuclides with greater than 1 Ci/year, which appears contrary to 10 CFR 50.34 and the guidance in NUREG-1537.

Update the FSAR and Table 11.1-8 to include the quantities expected to be released, as necessary.

Consistent with the evaluation findings in Section 11.1.1 of NUREG-1537, Part 2, the information requested in parts a., b., and c. of this RAI is necessary for the NRC staff to confirm that the FSAR identifies potential radiation safety hazards associated with the SHINE facility and conduct an independent review of the SHINE radiation protection program.

SHINE Response

a. SHINE has revised Tables 11.1-5, 11.1-9, and 11.1-10 of the FSAR to provide the conservative best estimate activities by isotope within the components located in the SHINE facility. These changes have been incorporated into the FSAR via Reference 3.

The information provided in Sheet 1 of Tables 11.1-5, 11.1-9, and 11.1-10 of the FSAR includes the estimated maximum activity for specified components based on the safety basis operating conditions described in Table 11.1-1 of the FSAR. As discussed in Subsection 11.1.1 of the FSAR, isotope inventories based on the safety basis operating conditions are unsuitable for use in analyzing normal operations. As such, the exterior dose rate estimates provided in Sheet 1 of Tables 11.1-5, 11.1-9, and 11.1-10 of the FSAR are based on conservative best estimate activities within the specified components, consistent with Part 2 of NUREG-1537 (Reference 4). The conservative best estimate activities by isotope provided in subsequent sheets of Tables 11.1-5, 11.1-9, and 11.1-10 of the FSAR are based on nominal operating conditions as described in Table 11.1-1 of the FSAR.

A summary of the methodology used for shielding calculations in the IF and the RPF are provided in Subsections 4a2.5.3.1 and 4b.2.3.1 of the FSAR, respectively. Additional information regarding calculation assumptions and input parameters, which resulted in the Page 2 of 14

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Export Controlled Information - Withheld from public disclosure under 10 CFR 2.390(a)(3) estimated dose rates provided in Tables 11.1-5, 11.1-9, and 11.1-10 of the FSAR, is described below for each of the SHINE facility locations listed in the tables.

Table 11.1-5, Airborne Radioactive Sources TPS; tritium purification system; TPS gloveboxes The estimated maximum activity for the tritium purification system (TPS) is 300,000 Ci of tritium (including tritium within the neutron driver assembly system [NDAS] units) as listed in Table 11.1-5 of the FSAR. There is no direct dose contribution from tritium because tritium beta decays with low energy. The beta radiation is shielded by the process piping and tanks that contain the tritium. The dose rate estimate provided in Table 11.1-5 of the FSAR includes contributions from the derived air concentration (DAC) as stated in the table footnotes. The SHINE Response to RAI 11-2b discusses DAC estimates.

NDAS; driver vacuum hardware; IU cell The estimated maximum activity for a single NDAS unit is [ ]PROP/ECI Ci of tritium as listed in Table 11.1-5 of the FSAR. There is no direct dose contribution from tritium because tritium beta decays with low energy. The beta radiation is shielded by the process piping and tanks that contain the tritium. The dose rate estimate provided in Table 11.1-5 of the FSAR includes contributions from the DAC as stated in the table footnotes. The SHINE Response to RAI 11-2b discusses DAC estimates.

TOGS; off-gas piping, zeolite beds; TOGS shielded cell The TOGS isotopic activity inventory is provided in Sheet 2 of Table 11.1-5 of the FSAR.

The isotopic activity inventory accounts for greater than 99 percent of the expected activity.

The inventory of airborne nuclides in the TOGS skid, within the TOGS shielded cell, is based on the nominal operating conditions as described in Table 11.1-1 of the FSAR, accounting for continuous gas removal from the target solution during operation and the fractional amount of gas in the TOGS cell compared to the rest of the airspace in the primary system boundary (PSB). Tanks and piping are not credited in the shielding analysis. The geometry and configuration of the TOGS cell shielding credited in the shielding analysis is described in Subsection 4a2.5.2.2 of the FSAR.

RVZ1; IU cell atmosphere and PCLS; IU cell The estimated maximum activity in each IU cell atmosphere and PCLS is 1E-05 Ci of Ar-41 and 10 Ci of N-16 as listed in Table 11.1-5 of the FSAR. The inventory of airborne nuclides in the IU cell airspace and PCLS in the IU cell is based on the nominal operating conditions as described in Table 11.1-1 of the FSAR, accounting for all generated N-16 in the PCLS and light water pool system (LWPS) and all activated Ar-41 in the IU cell air. The direct dose contribution in normally occupied areas from these radionuclides is not evaluated because the Ar-41 and the N-16 in the IU cell airspace and light water pool are shielded by the IU cell and the N-16 in PCLS piping and tanks is primarily under water which provides additional shielding. The geometry and configuration of the IU cell shielding credited in the shielding analysis is described in Subsection 4a2.5.2.2 of the FSAR.

RVZ1; supercell atmosphere; supercell gloveboxes The activity inventory of airborne nuclides in the supercell atmosphere due to process leakage is provided in Sheet 3 of Table 11.1-5 of the FSAR. The inventory of airborne nuclides in the supercell atmosphere is based on the nominal operating conditions accounting for decay as described in Table 11.1-1 of the FSAR and accounting for production material extraction. The isotope inventory within the extraction, purification, and Page 3 of 14

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PVVS cells of the supercell accounts for one batch worth of release to the respective cell.

The isotope inventory in Sheet 3 of Table 11.1-5 of the FSAR accounts for greater than 99 percent of the estimated activity in the supercell atmosphere. The airborne nuclides in the extraction and purification atmosphere do not significantly add to the estimated dose rates in normally occupied areas from the liquid and solid sources in the supercell described in Tables 11.1-9 and 11.1-10 of the FSAR, respectively. The geometry and configuration of the supercell shielding is described in Subsection 4b.2.2.2 of the FSAR.

PVVS and VTS; PVVS and VTS piping; pipe trenches, valve pits, PVVS carbon monoxide (CO) cabinet, and PVVS hot cell The isotopic activity inventory of the PVVS and VTS in the pipe trenches, valve pits, and PVVS hot cell, and PVVS CO monitor cabinet is provided in Sheet 4 of Table 11.1-5 of the FSAR. The isotopic activity inventory accounts for greater than 99 percent of the expected activity. The activity inventory is for the entire PVVS and VTS systems. The inventory of airborne nuclides in the PVVS and VTS is based on the nominal operating conditions as described in Table 11.1-1 of the FSAR, accounting for additional decay period and loading of carbon delay beds and iodine guard beds. Loading of the carbon delay beds is based on the filling of the TSV; decay periods are applied which account for expected bed loading periods. The vessels housing the isotopes are not credited in the shielding analysis. All the krypton and xenon is assumed to be in the carbon delay beds in the carbon delay bed vault, and all the iodine is assumed to be in the iodine guard beds. Dose estimates which account for the entire PVVS and VTS inventory within the carbon delay beds and iodine guard beds is bounding for the PVVS and VTS piping, pipe trenches, valve pits, PVVS hot cell, and PVVS CO monitor cabinet.

Table 11.1-9, Liquid Radioactive Sources TSPS; target solution, unirradiated; target solution preparation area Sources in the target solution preparation system (TSPS) include uranium from unirradiated target solution. Because the main radiation from the unirradiated target solution is alpha radiation, there is no direct dose contribution. Therefore, an isotopic activity inventory is not included.

SCAS; target solution in TSV (operating); IU cell The isotopic activity inventory for the subcritical assembly system (SCAS) target solution in the TSV, while operating, is listed in Sheet 3 of Table 11.1-9 of the FSAR. The isotopic activity inventory accounts for greater than 99 percent of the expected activity per IU cell, and is based on the nominal operating conditions as described in Table 11.1-1 of the FSAR.

The target solution is modeled in a tank approximately [ ]PROP/ECI in length with an outer diameter of approximately [ ]PROP/ECI and an inner diameter of approximately

[ ]PROP/ECI . The thickness of the tank is not relied on for shielding. The top of the tank is modeled under approximately 5.9 feet of water inside the IU cell. In addition to the estimated dose from the target solution isotope inventory, the NDAS is driving the subcritical multiplication in the TSV; therefore, there is a significant dose impact from the NDAS and SCAS neutrons as well as photons generated during fission. Dose rates on the IU cell walls from these sources of radiation are provided in Subsection 4a2.5.3.1 of the FSAR.

SCAS; Target solution in TSV, TSV dump tank (shutdown); IU cell The isotopic activity inventory for the SCAS target solution in the TSV or dump tank at shutdown is listed in Sheet 3 of Table 11.1-9 of the FSAR. The isotope inventory accounts for greater than 99 percent of the expected activity per IU cell, and is based on the nominal Page 4 of 14

operating conditions as described in Table 11.1-1 of the FSAR. The thickness of the tank is not relied on for shielding. The target solution is modeled in the dump tank approximately 12.5 feet underwater. IU cell shielding is described in Subsection 4a2.5.2.2 of the FSAR.

LWPS; water in the light water pool; IU cell The estimated maximum activity in the light water pool is listed in Table 11.1-9 of the FSAR as 30 Ci of tritium per IU cell. There is no direct dose contribution from tritium because tritium beta decays. The beta radiation is shielded by the process piping and tanks that contain the tritium.

NDAS; oil in NDAS pumps; IU cell The estimated maximum activity for the NDAS pump oil is listed in Table 11.1-9 of the FSAR as 2000 Ci of tritium per IU cell. There is no direct dose contribution from tritium because tritium beta decays. The beta radiation is shielded by the process piping and tanks that contain the tritium.

PCLS; primary cooling water in pump and piping; IU cell and primary cooling room The isotopic activity inventory in the PCLS skid in the primary cooling room is listed in Sheet 4 of Table 11.1-9 of the FSAR. The inventory accounts for greater than 99 percent of the expected activity per IU cell. The inventory of nuclides in the PCLS skid is based on the nominal operating conditions as described in Table 11.1-1 of the FSAR, accounting for additional decay period in the N-16 delay tank and in the PCLS skid. The shielding properties of the PCLS skid and piping are not considered in the shielding analysis. The nuclide inventory is not identified for the PCLS components in the IU cell because they are shielded by the IU cell and light water pool and do not significantly contribute to the dose in normally occupied areas.

MEPS; target solution in pump, extraction column, and lift tanks; supercell The isotopic activity inventory of target solution is listed for select radionuclides pre-extraction in Table 11.1-3 of the FSAR, which accounts for greater than 95.8 percent of the expected activity. The isotopic activities listed in this table are based on the nominal operating conditions as described in Table 11.1-1 of the FSAR for one batch of target solution. The isotopic activity inventories in the molybdenum extraction and purification system (MEPS) pump, extraction column, and lift tanks is approximately 10 percent of the isotopic inventory activities identified in Table 11.1-3 of the FSAR based on MEPS process volumes. The shielding properties of the MEPS pump, extraction column, and lift tanks are not considered in the shielding analysis. The supercell shielding is discussed in Subsection 4b.2.2.2 of the FSAR.

MEPS; Mo eluate in Mo eluate hold tank; supercell The isotopic activity inventory for the molybdenum (Mo) eluate in the Mo eluate hold tank is listed in Sheet 5 of Table 11.1-9 of the FSAR, which accounts for greater than 99 percent of the expected activity per batch. The inventory of nuclides in the Mo eluate hold tank is based on the nominal operating conditions and decay as described in Table 11.1-1 of the FSAR, accounting for production material extraction. The shielding properties of the Mo eluate tank are not considered in the shielding analysis. The Mo eluate tank shape and placement has negligible contribution to external dose rates outside the supercell shielding.

The supercell shielding is discussed in Subsection 4b.2.2.2 of the FSAR.

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MEPS; Mo-99 product; supercell The isotopic activity inventory for a single batch of molybdenum product is

[ ]PROP/ECI Ci of molybdenum-99, which accounts for greater than 99 percent of the total activity of the product. The inventory of nuclides in the molybdenum product is based on the nominal operating conditions and decay as described in Table 11.1-1 of the FSAR, accounting for additional decay period associated with processing times, and accounting for production material extraction. The shielding properties of the product bottle are not considered in the shielding analysis. The supercell shielding is discussed in Subsection 4b.2.2.2 of the FSAR.

TSSS; target solution in target solution hold tank; tank vault The isotopic activity inventory for the target solution hold tank is listed in Sheet 6 of Table 11.1-9 of the FSAR. The isotopic activity inventory accounts for greater than 99 percent of the expected activity. The inventory of nuclides in the target solution hold tank is based on the nominal operating conditions as described in Table 11.1-1 of the FSAR, accounting for additional decay period and production material extraction. The target solution is modeled in an annular tank with an inner solution diameter of approximately

[ ]PROP/ECI and an outer solution diameter of [ ]PROP/ECI. The thickness of the tank is approximately [ ]PROP/ECI. The tank is modeled in a vault with the top of the tank approximately [ ]PROP/ECI from the floor of the RPF. The vault shield plug considered in the shielding analysis is discussed in Subsection 4b.2.2.2 of the FSAR.

RLWS; liquid waste in annular waste tank; tank vault The isotopic activity inventory for the annular waste tank is listed in Sheet 7 of Table 11.1-9 of the FSAR. The isotopic activity inventory accounts for greater than 99 percent of the expected activity. The RLWS annular waste tanks are described in Subsection 9b.7.4.2 of the FSAR. The inventory of nuclides in the annular waste tank is based on the nominal operating conditions as described in Table 11.1-1 of the FSAR, accounting for additional decay period and production material extraction. The annular waste tank is modeled with the same dimensions as the target solution hold tank. The tank is modeled in a vault with the top of the tank approximately [ ]PROP/ECI from the floor of the RPF. The vault shield plug considered in the shielding analysis is discussed in Subsection 4b.2.2.2 of the FSAR.

RLWS; liquid waste in RLWS collection tank; tank vault The isotopic activity inventory for the collection waste tank is listed in Sheet 8 of Table 11.1-9 of the FSAR. The isotopic activity inventory accounts for greater than 99 percent of the expected activity. The RLWS collection tanks are described in Subsection 9b.7.4.2 of the FSAR. The inventory of nuclides in the collection tank is based on the nominal operating conditions as described in Table 11.1-1 of the FSAR, accounting for additional decay period and production material extraction. Extraction column washes are considered in the shielding analysis to be bounding of the liquid waste that would normally be in the tank. The RLWS collection tank is modeled as approximately [

]PROP/ECI. The top of the tanks are approximately

[ ]PROP/ECI from the floor of the RPF. The vault shield plug considered in the shielding analysis is discussed in Subsection 4b.2.2.2 of the FSAR.

Table 11.1-10, Solid Radioactive Sources NDAS; neutron driver; IU cell The isotopic activity inventory for the activated neutron driver equipment is not provided.

The neutron driver is not a significant source of radiation for the normally occupied area Page 6 of 14

because of low activity and the neutron driver is shielded by multiple feet of concrete inside the IU cell. IU cell shielding is described in Subsection 4a2.5.2.2 of the FSAR.

TOGS; TOGS components; IU cell and TOGS cell The isotopic activity inventory for the TOGS solid sources is listed in Sheet 2 of Table 11.1-10 of the FSAR. The isotopic activity inventory accounts for greater than 99 percent of the expected activity. The inventory of solid nuclides in the IU cell and the TOGS cell is based on the nominal operating conditions as described in Table 11.1-1 of the FSAR, accounting for continuous gas removal from the target solution during operation. The distribution of daughter products is assumed to be 30 percent in the TOGS cell and 70 percent in the IU cell. The shielding properties of the tanks and piping in the TOGS cell are not considered in the shielding analysis. The geometry and configuration of the TOGS cell shielding credited in the shielding analysis is described in Subsection 4a2.5.2.2 of the FSAR.

SCAS; neutron multiplier, SASS; IU cell The isotopic activity for the neutron multiplier and the SASS are not provided. The neutron multiplier and SASS are not a significant source of radiation for the normally occupied area because they are located inside the light water pool in the IU cell. IU cell shielding is described in Subsection 4a2.5.2.2 of the FSAR.

MEPS, spent columns, supercell The isotopic activity inventory for the spent columns is listed in Sheet 3 of Table 11.1-10 of the FSAR. The inventory of nuclides in the molybdenum product is based on the nominal operating conditions as described in Table 11.1-1 of the FSAR, accounting for additional decay period and production material extraction. The shielding properties of the MEPS columns are not credited in the shielding analysis. The supercell shielding is discussed in Subsection 4b.2.2.2 of the FSAR.

MEPS; glassware; supercell and solid waste drum storage The isotopic activity for the MEPS glassware is not provided. The MEPS glassware does not significantly contribute to the dose rates in normally occupied areas in comparison to other source terms inside of the supercell and solid waste drum storage.

TSPS and URSS; uranium metal and uranium oxide; target solution preparation and storage areas The isotopic activity for the fresh uranium metal and uranium oxides is not provided. The uranium metal and uranium oxides emit alpha radiation and do not significantly contribute to the direct dose rate in normally occupied areas.

RLWI; solidified waste drum; liquid waste solidification cell The isotopic activity inventory for the solidified waste drum is listed in Sheet 4 of Table 11.1-10 of the FSAR. The isotopic activity inventory accounts for greater than 99 percent of the expected activity. The inventory of nuclides in the solidified waste drum is based on the nominal operating conditions as described in Table 11.1-1 of the FSAR, accounting for additional decay period and production material extraction. Two grouted barrels of 0.85 m length and 0.57 m diameter are modeled in the shielding analysis. The RLWI shielded enclosure (i.e., liquid waste solidification cell) is discussed in Subsection 4b.2.2.2 of the FSAR.

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Solid radwaste; spent filters; supercell The isotopic activity inventory for the spent supercell filters is listed in Sheet 5 of Table 11.1-10 of the FSAR. The isotopic activity inventory accounts for greater than 99 percent of the expected activity. The inventory of nuclides in the supercell filters is based on the nominal operating conditions as described in Table 11.1-1 of the FSAR, accounting for additional decay period and production material extraction. The shielding properties of the filters are not credited in the shielding analysis. Lead shielding with a thickness of 3 inches is placed around the filters.

SCAS; subcritical multiplication source; IU cell The isotopic activity inventory of the subcritical multiplication source is not provided. The subcritical multiplication source is not a significant contributor to the dose rates in normally occupied areas. The subcritical multiplication source is below multiple feet of water in the light water pool inside the IU cell. IU cell shielding is described in Subsection 4a2.5.2.2 of the FSAR.

b. A summary of the assumptions, methodology, and input parameters for the exterior dose rate estimates from gaseous radioactive sources, identified in Table 11.1-5 of the FSAR, is provided in the SHINE Response to RAI 11-2a. A summary of the assumptions, methodology, and input parameters, for the DAC estimates from gaseous radioactive sources, identified in Table 11.1-6 of the FSAR, is described below for each of the facility locations listed in Table 11.1-6 of the FSAR.

Radioactive sources that could become airborne at the SHINE facility are primarily tritium and radioactive gas produced as a byproduct of the production process. The systems handling gaseous radioactive materials include the TPS, the NDAS, the TOGS, the radiologically controlled area ventilation zone 1 (RVZ1), the PVVS, and the VTS. DAC calculations consider leakage from systems containing radioactive gases in the facility. A conservative best estimate of airborne release, due to normal operation and maintenance, is performed to estimate DACs for the facility.

The estimated DACs are provided in Table 11.1-6 of the FSAR as a percentage of the DAC limits specified in 10 CFR Part 20, Appendix B. The overall DAC is calculated using the summation over all nuclides (i.e., summation of the concentration of nuclide i [Ci/mL] over the DAC limit for nuclide i [Ci/mL]). The following assumptions and input parameters are applied to the DAC estimate calculations:

IF maintenance activities that breach the PSB are not regular maintenance activities and are preceded by flushing and decontamination efforts.

In the RPF, solution transfer is done using vacuum lifts rather than pumps, and valves are hermetically sealed and designed for maintenance without breaching the process boundary. As a result, leakage from regular maintenance activities is expected to be minimal compared to the normal system leakage.

Unoccupied areas connected by the RVZ1r are assumed to be above 1 DAC during operation for conservatism.

The dilution volume used to calculate the concentration for a source term in the IF is 1.29E+07 cubic meters per year based on the following:

o Square footage of the IF general area: 8,875 square feet o Minimum outdoor airflow rate: 7.5 cfm per person o Estimated maximum occupant load: 13 persons per 1,000 square feet Page 8 of 14

The dilution volume used to calculate the concentration for a source term in the RPF is 1.81E+07 cubic meters per year based on the following:

o Square footage of the RPF general area: 12,505 square feet o Minimum outdoor airflow rate: 7.5 cfm per person o Estimated maximum occupant load: 13 persons per 1,000 square feet Primary System Boundary, IF General Area The PSB consists of the TSV, TOGS, TSV dump tank, and interconnecting piping. Most of the leakage from this system is the krypton, xenon, and iodine that are being circulated through TOGS. The mass of each isotope time averaged over an irradiation cycle is provided in Table 11-2-1. The fractional leak rates (fraction/second) for krypton, xenon, and iodine from the PSB to the primary confinement boundary are 8.35E-11, 6.68E-11, and 4.80E-11, respectively. Leak path factors (fraction/second) to the IF from the primary confinement boundary for noble gases and iodine is 8.68E-08.

The mass of each nuclide in the primary confinement boundary is tracked with an iterative timestep calculation accounting for the amounts leaked into and out of the primary confinement boundary and accounting for decay at each timestep. The timesteps continue until no isotope shows greater than a 1 percent change in mass. The leakage out of the primary confinement boundary for the final timestep is used as the steady state leakage out of the primary confinement boundary. This is converted to annual leakage and applied to all 8 operating units to get the total leakage per year into the general area. The annual leakage values are then converted from grams per year to curies per year and divided by the dilution volume to get the concentration.

Tritium Systems, TPS Room Tritium within the TPS glove box permeates to the TPS room at a yearly release rate of 0.5 Ci/yr. The dilution volume used to calculate the concentration for the TPS room is 1.81E+06 cubic meters per year based on a 1,248 square feet TPS room, 7.5 cfm per person minimum outdoor airflow rate, and 13 persons per 1,000 square feet maximum occupant load. The concentration is the quotient of the yearly release rate due to TPS glovebox permeation and the dilution volume in the TPS room.

Tritium Systems, IF General Area, Normal Operation No leak path factor is used for tritium from the IU cell to the IF. It is assumed that any material released into the cell will be released to the IF general area through leakage or when the cell is opened for maintenance. NDAS component permeation in the IF general area is assumed at a yearly release rate of 2 Ci/yr of tritium. The concentration is the quotient of the yearly release rate due to permeation and the dilution volume in the IF.

Tritium Systems, IF General Area, Maintenance No leak path factor is used for tritium from the IU cell to the IF. It is assumed that any material released into the cell will be released to the IF general area through leakage or when the cell is opened for maintenance. The directed airflow and flexible exhaust ducts in the NDAS service cell (NSC) are assumed to reduce tritium released through NDAS maintenance operations by 90 percent. The NDAS maintenance releases are assumed to occur during the one-week per year scheduled driver maintenance period for each driver, for a total of an 8-week duration for this release. NDAS maintenance releases to the IF general area occur at a yearly release rate of 4.22 Ci/yr of tritium. The concentration is the quotient of the yearly release rate due to maintenance and the eight-week dilution volume in the IF.

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Below-Grade Vaults, PVVS Carbon Monoxide (CO) Monitor Cabinet, RPF General Area Out-leakage from the PVVS carbon delay beds is negligible due to most of the material being adsorbed onto the carbon and unavailable for release. The PVVS leak rate from the below grade vaults and CO monitor cabinet is calculated based on an assumption of 5,000 components and fittings with a maximum leak rate of 1E-4 standard cubic centimeters per second helium leakage equivalent at one atmosphere pressure differential (accounting for the partial pressure and molecular mass of the elements leaking out). TOGS purges are not taken into account for the DAC contribution from PVVS; the PSB leakage accounts for all TOGS gas that would be purged to PVVS.

The PVVS airborne isotopic activity inventory rate leaking to the RPF is provided in Table 11-2-2 on a per batch basis. The same isotopic inventory is used for the available leakage from the PVVS equipment in the hot cell or in the below-grade vaults and CO monitor cabinet. The fractional leak rates out of the PVVS equipment for iodine, krypton, and xenon are 6.70E-05, 1.17E-04, and 9.33E-05, respectively. Leak path factors are used to calculate fractional leak rates from the below-grade vaults and CO monitor cabinet; the fractional leak rate for noble gases and iodine is 8.68E-08. The concentration inside the system is calculated using a PVVS flowrate of 12 scfm.

The isotopic inventory for the PVVS represents the cumulative material in PVVS from a single batch-cycle and is calculated for various timesteps after transfer to the RPF. The timestep calculation accounts for decay, release rate to the PVVS equipment, the flowrate of PVVS, and the leak rate into the below-grade vaults to provide the total leakage per batch-cycle. The leakage per batch-cycle into the RPF is multiplied by 8 batches per cycle and 50 cycles per year to calculate the annual release. The concentration is the quotient of the annual release and the RPF dilution factor.

PVVS Hot Cell, PVVS Hot Cell and RPF General Area The isotopic activity inventory released per batch for the PVVS hot cell is provided in Sheet 3 of Table 11.1-5 of the FSAR. The PVVS hot cell leakage estimate uses the same method as the below-grade vaults description, and rather than using the leak rate from the below-grade vault, the leak rate of the hot cells is used. The free volume of the PVVS hot cell is modelled as approximately 264 cubic feet. The leak rates (L/s) for krypton, xenon, and iodine from the PVVS equipment are 1.17E-04, 9.33E-05, and 6.70E-05, respectively. The fractional leak rates (fraction/second) for krypton, xenon, and iodine from the PVVS hot cell to the RPF are 1.17E-04, 9.33E-05, and 6.70E-05, respectively. The concentration is the quotient of the release rate per year and the dilution volume.

Extraction Hot Cell and Iodine and Xenon Purification and Packaging (IXP) Hot Cell, Hot Cells and RPF General Area Liquid releases are only considered for the processes where connections are regularly broken to install new separation columns. Three batches are assumed to be processed through the extraction cells for calculation of the DAC within the hot cells. Eight batches are used to calculate the release to the RPF general area. The release to the IXP hot cell is bounded by the release to the extraction hot cell.

The extraction cell airborne isotopic activity inventory per batch is provided in Sheet 3 of Table 11.1-5 of the FSAR. An airborne release fraction for particulates of 2E-4 is used to determine the fraction of material that would be airborne. The free volume of the extraction hot cell is modelled as approximately 135 cubic feet. The fractional leak rates (fraction/second) for krypton, xenon, and iodine from the extraction hot cell to the RPF are Page 10 of 14

1.17E-04, 9.33E-05, and 6.70E-05, respectively. The yearly release rate to the RPF is based on the release rate per batch times 8 batches per cycle and 50 cycles per year. The yearly release rate into one extraction cell is based on the release per batch times 3 batches per extraction cell and 50 cycles per year. The concentration is the quotient of the release rate per year and the dilution volume.

Purification Hot Cell, Purification Hot Cell and RPF General Area The purification cell airborne isotopic activity inventory per batch is provided in Sheet 3 of Table 11.1-5 of the FSAR. Three batches are assumed to be processed through the purification cells for calculation of the DAC within the hot cells. Eight batches are used to calculate the release to the RPF general area.

An airborne release fraction for particulates of 2E-4 is used to determine the fraction of material that would be airborne. The free volume of the purification hot cell is modelled as approximately 93 cubic feet. The fractional leak rates (fraction/second) for krypton, xenon, and iodine from the PVVS hot cell to the RPF are 1.17E-04, 9.33E-05, and 6.70E-05, respectively. The yearly release rate to the RPF is based on the release rate per batch times 8 batches per cycle and 50 cycles per year. The yearly release rate into one purification cell is based on the release per batch times 3 batches per purification cell and 50 cycles per year. The concentration is the quotient of the release rate per year and the dilution volume.

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Table 11-2 Isotope Mass, Primary System Boundary During Irradiation Cycle Nuclide Mass (g)

I-123 [ ]PROP/ECI I-124 [ ]PROP/ECI I-125 [ ]PROP/ECI I-126 [ ]PROP/ECI I-129 [ ]PROP/ECI I-130 [ ]PROP/ECI I-131 [ ]PROP/ECI I-132 [ ]PROP/ECI I-132m [ ]PROP/ECI I-133 [ ]PROP/ECI I-134 [ ]PROP/ECI I-135 [ ]PROP/ECI Kr-81 [ ]PROP/ECI Kr-83m [ ]PROP/ECI Kr-85 [ ]PROP/ECI Kr-85m [ ]PROP/ECI Kr-87 [ ]PROP/ECI Kr-88 [ ]PROP/ECI Xe-127 [ ]PROP/ECI Xe-131m [ ]PROP/ECI Xe-133 [ ]PROP/ECI Xe-133m [ ]PROP/ECI Xe-135 [ ]PROP/ECI Xe-135m [ ]PROP/ECI Xe-138 [ ]PROP/ECI Page 12 of 14

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Table 11-2 Isotope Mass Flow Rate Leaked from PVVS Below-Grade and CO Monitor Cabinet per Batch Nuclide Mass Flow Rate (g/hr)

I-123 [ ]PROP/ECI I-124 [ ]PROP/ECI I-125 [ ]PROP/ECI I-126 [ ]PROP/ECI I-129 [ ]PROP/ECI I-130 [ ]PROP/ECI I-131 [ ]PROP/ECI I-132 [ ]PROP/ECI I-132m [ ]PROP/ECI I-133 [ ]PROP/ECI I-134 [ ]PROP/ECI I-135 [ ]PROP/ECI Kr-81 [ ]PROP/ECI Kr-83m [ ]PROP/ECI Kr-85 [ ]PROP/ECI Kr-85m [ ]PROP/ECI Kr-87 [ ]PROP/ECI Kr-88 [ ]PROP/ECI Xe-127 [ ]PROP/ECI Xe-131m [ ]PROP/ECI Xe-133 [ ]PROP/ECI Xe-133m [ ]PROP/ECI Xe-135 [ ]PROP/ECI Xe-135m [ ]PROP/ECI Xe-138 [ ]PROP/ECI Page 13 of 14

c. Table 11.1-8 of the FSAR provides the estimated annual release from normal and maintenance operations of the SHINE facility. SHINE limited the nuclides in Table 11.1-8 of the FSAR to only nuclides with greater than 1 Ci/yr estimated release because the nuclides identified in Table 11.1-8 of the FSAR account for greater than 99.9 percent of the total annual estimated release activity. The SHINE Response to RAI 11-3a provides the estimated annual release from normal and maintenance operations for all nuclides.

References

1. NRC letter to SHINE Medical Technologies, LLC, Issuance of Request for Additional Information Related to the SHINE Medical Technologies, LLC Operating License Application (EPID No. L-2019-NEW-0004), dated January 27, 2021 (ML21309A044)

2. SHINE Medical Technologies, LLC letter to the NRC, SHINE Medical Technologies, LLC Operating License Application Response to Request for Additional Information and Supplement No. 7, dated March 23, 2021 (ML21095A241)

3. SHINE Technologies, LLC letter to the NRC, SHINE Technologies, LLC Operating License Application Supplement No. 14, dated January 26, 2022

4. U.S. Nuclear Regulatory Commission, "Guidelines for Preparing and Reviewing Applications for the Licensing of Non-Power Reactors: Standard Review Plan and Acceptance Criteria,"

NUREG-1537, Part 2, February 1996 (ML042430048)

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