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{{#Wiki_filter:RADIATION PROTECTION PROGRAM AND WASTE MANAGEMENT TABLE OF CONTENTS tion                                          Title                                                                 Page 1     RADIATION PROTECTION ............................................................................... 11.1-1 11.1.1     RADIATION SOURCES ................................................................... 11.1-1 11.1.2     RADIATION PROTECTION PROGRAM .......................................... 11.1-6 11.1.3     ALARA PROGRAM ........................................................................ 11.1-13 11.1.4     RADIATION MONITORING AND SURVEYING ............................. 11.1-18 11.1.5     RADIATION EXPOSURE CONTROL AND DOSIMETRY ............. 11.1-21 11.1.6     CONTAMINATION CONTROL EQUIPMENT AND FACILITY LAYOUT GENERAL DESIGN CONSIDERATIONS FOR 10 CFR 20.1406 ............................................................................. 11.1-26 11.1.7     ENVIRONMENTAL MONITORING ................................................ 11.1-27 2     RADIOACTIVE WASTE MANAGEMENT .......................................................... 11.2-1 11.2.1     RADIOACTIVE WASTE MANAGEMENT PROGRAM ..................... 11.2-1 11.2.2     RADIOACTIVE WASTE CONTROLS .............................................. 11.2-4 11.2.3     RELEASE OF RADIOACTIVE WASTE ............................................ 11.2-8 3     RESPIRATORY PROTECTION PROGRAM ..................................................... 11.3-1 4    REFERENCES ................................................................................................... 11.4-1 NE Medical Technologies                      11-i                                                                  Rev. 0
{{#Wiki_filter:Chapter 11 - Radiation Protection Program and Waste Management Table of Contents CHAPTER 11 RADIATION PROTECTION PROGRAM AND WASTE MANAGEMENT TABLE OF CONTENTS Section Title Page SHINE Medical Technologies 11-i Rev. 0 11.1 RADIATION PROTECTION............................................................................... 11.1-1 11.1.1 RADIATION SOURCES................................................................... 11.1-1 11.1.2 RADIATION PROTECTION PROGRAM.......................................... 11.1-6 11.1.3 ALARA PROGRAM........................................................................ 11.1-13 11.1.4 RADIATION MONITORING AND SURVEYING............................. 11.1-18 11.1.5 RADIATION EXPOSURE CONTROL AND DOSIMETRY............. 11.1-21 11.1.6 CONTAMINATION CONTROL EQUIPMENT AND FACILITY LAYOUT GENERAL DESIGN CONSIDERATIONS FOR 10 CFR 20.1406............................................................................. 11.1-26 11.1.7 ENVIRONMENTAL MONITORING................................................ 11.1-27 11.2 RADIOACTIVE WASTE MANAGEMENT.......................................................... 11.2-1 11.2.1 RADIOACTIVE WASTE MANAGEMENT PROGRAM..................... 11.2-1 11.2.2 RADIOACTIVE WASTE CONTROLS.............................................. 11.2-4 11.2.3 RELEASE OF RADIOACTIVE WASTE............................................ 11.2-8 11.3 RESPIRATORY PROTECTION PROGRAM..................................................... 11.3-1


mber                                    Title 1-1  Parameters Applicable to Target Solution Radionuclide Inventories 1-2  Nominal Versus Safety Basis Radionuclide Inventories in Target Solution 1-3  Irradiated Target Solution Activity for Select Radionuclides Pre-Extraction 1-4   Radiation Areas at the SHINE Facility 1-5  Airborne Radioactive Sources 1-6  Estimated Derived Air Concentrations 1-7  Key Parameters for Normal Yearly Release Calculation 1-8  Estimated Annual Releases from Normal and Maintenance Operations (Nuclides with Greater than 1 Ci Annual Release) 1-9  Liquid Radioactive Sources 1-10  Solid Radioactive Sources 1-11 Administrative Radiation Exposure Limits 1-12  Radiation Monitoring Equipment 1-13  Radiological Postings 1-14  Environmental Monitoring Locations 2-1  Estimated Annual Waste Stream Summary 2-2  Waste Methodology for Accelerator 2-3  Waste Methodology for Spent Columns 2-4  Waste Methodology for Process Glassware 2-5  Waste Methodology for Consolidated Liquids 2-6  Chemical Composition and Radiological Properties of Liquid Waste Streams NE Medical Technologies                  11-ii                                  Rev. 0
==11.4 REFERENCES==
................................................................................................... 11.4-1


mber                                  Title 1-1   Probable Radiation Area Designations Within the SHINE RCA, Ground Floor Level 1-Estimated Derived Air Concentrations, Ground Floor Level 1-Radiation Protection Organization 1-Environmental Dosimeter Locations NE Medical Technologies                11-iii                                Rev. 0
Chapter 11 - Radiation Protection Program and Waste Management List of Tables LIST OF TABLES Number Title SHINE Medical Technologies 11-ii Rev. 0 11.1-1 Parameters Applicable to Target Solution Radionuclide Inventories 11.1-2 Nominal Versus Safety Basis Radionuclide Inventories in Target Solution 11.1-3 Irradiated Target Solution Activity for Select Radionuclides Pre-Extraction 11.1-4 Radiation Areas at the SHINE Facility 11.1-5 Airborne Radioactive Sources 11.1-6 Estimated Derived Air Concentrations 11.1-7 Key Parameters for Normal Yearly Release Calculation 11.1-8 Estimated Annual Releases from Normal and Maintenance Operations (Nuclides with Greater than 1 Ci Annual Release) 11.1-9 Liquid Radioactive Sources 11.1-10 Solid Radioactive Sources 11.1-11 Administrative Radiation Exposure Limits 11.1-12 Radiation Monitoring Equipment 11.1-13 Radiological Postings 11.1-14 Environmental Monitoring Locations 11.2-1 Estimated Annual Waste Stream Summary 11.2-2 Waste Methodology for Accelerator 11.2-3 Waste Methodology for Spent Columns 11.2-4 Waste Methodology for Process Glassware 11.2-5 Waste Methodology for Consolidated Liquids 11.2-6 Chemical Composition and Radiological Properties of Liquid Waste Streams


onym/Abbreviation      Definition RA                      as low as reasonably achievable SI                        American National Standards Institute AS                        criticality accident alarm system M                        continuous air monitor S                        continuous air sampler BEM                      carbon delay bed effluent monitor DE                        committed effective dose equivalent MP                        Community Environmental Monitoring Program O                        Chief Executive Officer curies r                        curies per year centimeter O                        Chief Operating Officer ground level deposition factor C                        derived air concentration T                        U.S. Department of Transportation NE Medical Technologies 11-iv                                  Rev. 0
Chapter 11 - Radiation Protection Program and Waste Management List of Figures LIST OF FIGURES Number Title SHINE Medical Technologies 11-iii Rev. 0 11.1-1 Probable Radiation Area Designations Within the SHINE RCA, Ground Floor Level 11.1-2 Estimated Derived Air Concentrations, Ground Floor Level 11.1-3 Radiation Protection Organization 11.1-4 Environmental Dosimeter Locations


onym/Abbreviation       Definition
Chapter 11 - Radiation Protection Program and Waste Management Acronyms and Abbreviations ACRONYMS AND ABBREVIATIONS Acronym/Abbreviation Definition SHINE Medical Technologies 11-iv Rev. 0 ALARA as low as reasonably achievable ANSI American National Standards Institute CAAS criticality accident alarm system CAM continuous air monitor CAS continuous air sampler CDBEM carbon delay bed effluent monitor CEDE committed effective dose equivalent CEMP Community Environmental Monitoring Program CEO Chief Executive Officer Ci curies Ci/yr curies per year cm centimeter COO Chief Operating Officer D/Q ground level deposition factor DAC derived air concentration DOT U.S. Department of Transportation
/100 cm2                  disintegrations per minute per 100 square centimeters O                          data quality objectives A                          U.S. Environmental Protection Agency r                        cubic feet per year PA                        high efficiency particulate air hour A                          high radiation area 1                        iodine-131 irradiation facility irradiation unit iodine and xenon purification and packaging kilometers krypton kilowatt low-enriched uranium lower level of detection NE Medical Technologies 11-v                                      Rev. 0


onym/Abbreviation       Definition low level waste low specific activity liquid scintillation counter PS                        light water pool system RLAP                      Multi-Agency Radiological Laboratory Analytical Protocols Manual I                          maximum exposed individual PS                        molybdenum extraction and purification system LW                        mixed low level waste molybdenum 99                        molybdenum-99 m                        millirem m/hr                      millirem per hour m/yr                     millirem per year v                          millisievert 6                          nitrogen-16 AS                        neutron driver assembly system NE Medical Technologies 11-vi                                    Rev. 0
Chapter 11 - Radiation Protection Program and Waste Management Acronyms and Abbreviations ACRONYMS AND ABBREVIATIONS Acronym/Abbreviation Definition SHINE Medical Technologies 11-v Rev. 0 dpm/100 cm2 disintegrations per minute per 100 square centimeters DQO data quality objectives EPA U.S. Environmental Protection Agency ft3/yr cubic feet per year HEPA high efficiency particulate air hr hour HRA high radiation area I-131 iodine-131 IF irradiation facility IU irradiation unit IXP iodine and xenon purification and packaging km kilometers Kr krypton kW kilowatt LEU low-enriched uranium LLD lower level of detection


onym/Abbreviation       Definition DS                        neutron flux detection system LS                        primary closed loop cooling system NL                        Pacific Northwest National Laboratory E                          personal protective equipment B                          primary system boundary VS                        process vessel vent system radiation area M                          radiation area monitor A                          radiologically controlled area RA                        Resource Conservation and Recovery Act MP                        radiological environmental monitoring program WI                        radioactive liquid waste immobilization WS                        radioactive liquid waste storage F                          radioisotope production facility C                          Radiation Safety Committee CC                        Radiation Safety Information Computational Center NE Medical Technologies 11-vii                                    Rev. 0
Chapter 11 - Radiation Protection Program and Waste Management Acronyms and Abbreviations ACRONYMS AND ABBREVIATIONS Acronym/Abbreviation Definition SHINE Medical Technologies 11-vi Rev. 0 LLW low level waste LSA low specific activity LSC liquid scintillation counter LWPS light water pool system MARLAP Multi-Agency Radiological Laboratory Analytical Protocols Manual MEI maximum exposed individual MEPS molybdenum extraction and purification system MLLW mixed low level waste Mo molybdenum Mo-99 molybdenum-99 mrem millirem mrem/hr millirem per hour mrem/yr millirem per year mSv millisievert N-16 nitrogen-16 NDAS neutron driver assembly system


onym/Abbreviation         Definition Z1                          radiological ventilation zone 1 Z2                          radiological ventilation zone 2 P                          radiation work permit SS                          subcritical assembly support structure AS                          subcritical assembly system M                          stack release monitor C                          system, structure, and component sievert P                          toxicity characteristic leaching procedure DE                          total effective dose equivalent GS                          TSV off-gas system tritium purification system S                          target solution preparation system S                          target solution storage system target solution vessel 35                          uranium-235 NE Medical Technologies 11-viii                                      Rev. 0
Chapter 11 - Radiation Protection Program and Waste Management Acronyms and Abbreviations ACRONYMS AND ABBREVIATIONS Acronym/Abbreviation Definition SHINE Medical Technologies 11-vii Rev. 0 NFDS neutron flux detection system PCLS primary closed loop cooling system PNNL Pacific Northwest National Laboratory PPE personal protective equipment PSB primary system boundary PVVS process vessel vent system RA radiation area RAM radiation area monitor RCA radiologically controlled area RCRA Resource Conservation and Recovery Act REMP radiological environmental monitoring program RLWI radioactive liquid waste immobilization RLWS radioactive liquid waste storage RPF radioisotope production facility RSC Radiation Safety Committee RSICC Radiation Safety Information Computational Center


onym/Abbreviation       Definition SS                        uranium receipt and storage system RA                        very high radiation area vacuum transfer system C                        waste acceptance criteria S                        Waste Control Specialists annual average relative atmospheric concentration xenon NE Medical Technologies 11-ix                                Rev. 0
Chapter 11 - Radiation Protection Program and Waste Management Acronyms and Abbreviations ACRONYMS AND ABBREVIATIONS Acronym/Abbreviation Definition SHINE Medical Technologies 11-viii Rev. 0 RVZ1 radiological ventilation zone 1 RVZ2 radiological ventilation zone 2 RWP radiation work permit SASS subcritical assembly support structure SCAS subcritical assembly system SRM stack release monitor SSC system, structure, and component Sv sievert TCLP toxicity characteristic leaching procedure TEDE total effective dose equivalent TOGS TSV off-gas system TPS tritium purification system TSPS target solution preparation system TSSS target solution storage system TSV target solution vessel U-235 uranium-235


RADIATION PROTECTION
Chapter 11 - Radiation Protection Program and Waste Management Acronyms and Abbreviations ACRONYMS AND ABBREVIATIONS Acronym/Abbreviation Definition SHINE Medical Technologies 11-ix Rev. 0 URSS uranium receipt and storage system VHRA very high radiation area VTS vacuum transfer system WAC waste acceptance criteria WCS Waste Control Specialists
  .1      RADIATION SOURCES SHINE facility is designed to generate molybdenum-99 (Mo-99) for use as a medical ope. The process of producing Mo-99 involves irradiating a uranyl sulfate target solution with eutron source in a subcritical assembly to cause fission. Irradiation of the target solution ates Mo-99 along with other radioactive fission and activation products. When the irradiation e is complete, the radioactive materials are transferred to various locations in the facility to plete the separation and purification processes. This section identifies sources of radiation radioactive materials received, used, or generated in the facility; sources and the nature of orne, liquid or solid radioactive materials; and the type of radiation emitted (alpha, beta, ma, and neutron).
/Q annual average relative atmospheric concentration Xe xenon
lysis has been performed that quantifies the radionuclide inventory for normal operations in SHINE facility. The highest radionuclide inventory for one target solution batch exists in the et solution vessel (TSV) at the end of the irradiation cycle. As the target solution is processed e facility for Mo-99 and other medical isotope extraction, solution adjustments, and waste dling, radiation sources are transferred within the facility by means of pipes in shielded ches.
re are two scenarios with assumptions listed in Table 11.1-1: nominal and safety basis. The inal parameter values or ranges are the best estimate operating conditions for full power ration of the facility. The safety basis parameter values define the bounding radionuclide ntory relative to the TSV, TSV dump tank, and supercell.
safety basis inventories throughout the facility are generated by using the limiting values for h parameter to maximize the individual inventories. This includes using bounding values for ment partitioning during the extraction process. This approach of maximizing inventories at h location results in an overall facility fission product inventory that is greater than originally erated in the irradiation process. This ensures that the individual safety basis inventories are nding when being used to calculate releases for the safety analysis but makes them uitable for use in analyzing normal operations.
ration of the TSV results in the production of radioactive fission products and actinides dominantly through neutron capture in uranium. Table 11.1-2 provides a summary of the ults for total activity in curies (Ci) from actinides and fission products contained within each batch of target solution after [                    ]PROP/ECI of irradiation, [  ]PROP/ECI inal cycles or [ ]  PROP/ECI safety basis cycles. The at shutdown values represent the vity contained within the target solution immediately after shutdown of the neutron driver. The
-extraction values are the target solution activity when it is ready to be transferred from the dump tank in the irradiation unit (IU) cell to one of the supercells in the radioisotope duction facility (RPF) to begin the molybdenum extraction process. This represents the ximum expected activity for a target solution batch as it is processed through the RPF. For the inal inventory, the post extraction values are the activity remaining in the target solution wing extraction of Mo and other elements according to best estimate partitioning fractions.
the safety basis inventory, only noble gases were removed during extraction, at bounding
  ) element partitioning fractions.
NE Medical Technologies                       11.1-1                                        Rev. 0


ease Fractions (USNRC, 1986) for the nominal and safety basis radionuclide inventories after
Proprietary Information - Withheld from public disclosure under 10 CFR 2.390(a)(4)
                  ]PROP/ECI of irradiation and the subsequent decay time in the TSV dump tank.
Export Controlled Information - Withheld from public disclosure under 10 CFR 2.390(a)(3)
his time, it is ready to be pumped into the supercell to begin the molybdenum extraction and on product removal processes. The cycle and decay times used for the radionuclide ntory generation are listed in Table 11.1-1.
Chapter 11 - Radiation Protection Program and Waste Management Radiation Protection SHINE Medical Technologies 11.1-1 Rev. 0 CHAPTER 11 - RADIATION PROTECTION PROGRAM AND WASTE MANAGEMENT 11.1 RADIATION PROTECTION 11.1.1 RADIATION SOURCES The SHINE facility is designed to generate molybdenum-99 (Mo-99) for use as a medical isotope. The process of producing Mo-99 involves irradiating a uranyl sulfate target solution with a neutron source in a subcritical assembly to cause fission. Irradiation of the target solution creates Mo-99 along with other radioactive fission and activation products. When the irradiation cycle is complete, the radioactive materials are transferred to various locations in the facility to complete the separation and purification processes. This section identifies sources of radiation and radioactive materials received, used, or generated in the facility; sources and the nature of airborne, liquid or solid radioactive materials; and the type of radiation emitted (alpha, beta, gamma, and neutron).
NE uses the following radiation area designations, as defined in 10 CFR 20, including sideration for neutron and gamma dose rates:
Analysis has been performed that quantifies the radionuclide inventory for normal operations in the SHINE facility. The highest radionuclide inventory for one target solution batch exists in the target solution vessel (TSV) at the end of the irradiation cycle. As the target solution is processed in the facility for Mo-99 and other medical isotope extraction, solution adjustments, and waste handling, radiation sources are transferred within the facility by means of pipes in shielded trenches.
* Unrestricted Area means an area to which access is neither limited nor controlled by SHINE. This would be the area beyond the site boundary.
There are two scenarios with assumptions listed in Table 11.1-1: nominal and safety basis. The nominal parameter values or ranges are the best estimate operating conditions for full power operation of the facility. The safety basis parameter values define the bounding radionuclide inventory relative to the TSV, TSV dump tank, and supercell.
* Radiation Areas (RAs) are those accessible areas in which radiation levels could result in an individual receiving a dose equivalent in excess of 5 millirem (mrem) in 1 hour (hr) at 30 centimeters from the radiation source or from any surface that the radiation penetrates.
The safety basis inventories throughout the facility are generated by using the limiting values for each parameter to maximize the individual inventories. This includes using bounding values for element partitioning during the extraction process. This approach of maximizing inventories at each location results in an overall facility fission product inventory that is greater than originally generated in the irradiation process. This ensures that the individual safety basis inventories are bounding when being used to calculate releases for the safety analysis but makes them unsuitable for use in analyzing normal operations.
* High Radiation Areas (HRAs) are those accessible areas in which radiation levels from radiation sources external to the body could result in an individual receiving a dose equivalent in excess of 100 mrem in 1 hour at 30 centimeters from the radiation source or from any surface that the radiation penetrates.
Operation of the TSV results in the production of radioactive fission products and actinides predominantly through neutron capture in uranium. Table 11.1-2 provides a summary of the results for total activity in curies (Ci) from actinides and fission products contained within each TSV batch of target solution after [ ]PROP/ECI of irradiation, [ ]PROP/ECI nominal cycles or [ ]PROP/ECI safety basis cycles. The at shutdown values represent the activity contained within the target solution immediately after shutdown of the neutron driver. The pre-extraction values are the target solution activity when it is ready to be transferred from the TSV dump tank in the irradiation unit (IU) cell to one of the supercells in the radioisotope production facility (RPF) to begin the molybdenum extraction process. This represents the maximum expected activity for a target solution batch as it is processed through the RPF. For the nominal inventory, the post extraction values are the activity remaining in the target solution following extraction of Mo and other elements according to best estimate partitioning fractions.
* Very High Radiation Areas (VHRAs) are those accessible areas in which radiation levels from radiation sources external to the body could result in an individual receiving an absorbed dose in excess of 500 rads in 1 hour at 1 meter from the radiation source or 1 meter from any surface that the radiation penetrates.
For the safety basis inventory, only noble gases were removed during extraction, at bounding (low) element partitioning fractions.
SHINE facility is designed and constructed so that the measurable dose rate in the estricted area due to activities at the plant are less than the limits of 10 CFR 20.1301(a)(2).
 
radiation shielding is designed to ensure that during normal operation internal facility ation dose rates are consistent with as low as reasonably achievable (ALARA) radiological ctices required by 10 CFR 20. The goal for the normal operations dose rate for normally upied locations in the facility is 0.25 mrem/hr at 30 centimeters from the surface of the lding. Radiation levels may rise above the 0.25 mrem/hr level during some operations such ank transfers. At full-power operation of the eight units, portions of the normally occupied a in IF and RPF exceed the 0.25 mrem/hr goal but remain below 5 mrem/hr, except in small tions above the pipe trench during solution transfers. These dose rates were calculated using maximum specified shield plug gap sizes, minimum density shielding materials, and the inal inventories for full power operation.
Proprietary Information - Withheld from public disclosure under 10 CFR 2.390(a)(4)
bulation of normally and transient-occupied areas, dose rates, and designations is provided able 11.1-4. Figure 11.1-1 provides the probable radiation area designations, above grade, in the radiologically controlled area (RCA) at the SHINE facility.
Export Controlled Information - Withheld from public disclosure under 10 CFR 2.390(a)(3)
cedures for transient access to shielded vaults, cells, and rooms ensure doses are ntained ALARA by addressing the following:
Chapter 11 - Radiation Protection Program and Waste Management Radiation Protection SHINE Medical Technologies 11.1-2 Rev. 0 Table 11.1-3 lists the activity associated with the radionuclides listed in NUREG/CR-4467, Relative Importance of Individual Elements to Reactor Accident Consequences Assuming Equal Release Fractions (USNRC, 1986) for the nominal and safety basis radionuclide inventories after
* job planning,
[ ]PROP/ECI of irradiation and the subsequent decay time in the TSV dump tank.
* radiation protection coverage,
At this time, it is ready to be pumped into the supercell to begin the molybdenum extraction and fission product removal processes. The cycle and decay times used for the radionuclide inventory generation are listed in Table 11.1-1.
* survey techniques and frequencies, NE Medical Technologies                      11.1-2                                      Rev. 0
SHINE uses the following radiation area designations, as defined in 10 CFR 20, including consideration for neutron and gamma dose rates:
* frequency for updating radiation work permits or their equivalent, and
Unrestricted Area means an area to which access is neither limited nor controlled by SHINE. This would be the area beyond the site boundary.
* placement of measuring and alarming dosimeters.
Radiation Areas (RAs) are those accessible areas in which radiation levels could result in an individual receiving a dose equivalent in excess of 5 millirem (mrem) in 1 hour (hr) at 30 centimeters from the radiation source or from any surface that the radiation penetrates.
elded vaults, cells, and rooms designated as high radiation areas or very high radiation areas enoted in Figure 11.1-1 are not normally occupied when those conditions exist.
High Radiation Areas (HRAs) are those accessible areas in which radiation levels from radiation sources external to the body could result in an individual receiving a dose equivalent in excess of 100 mrem in 1 hour at 30 centimeters from the radiation source or from any surface that the radiation penetrates.
ministrative procedures address the management oversight and specific control measures ded for entry into high radiation areas and very high radiation areas, if it is ever necessary to
Very High Radiation Areas (VHRAs) are those accessible areas in which radiation levels from radiation sources external to the body could result in an individual receiving an absorbed dose in excess of 500 rads in 1 hour at 1 meter from the radiation source or 1 meter from any surface that the radiation penetrates.
: o. The procedures include the process for gaining entry to these areas, such as the control distribution of keys.
The SHINE facility is designed and constructed so that the measurable dose rate in the unrestricted area due to activities at the plant are less than the limits of 10 CFR 20.1301(a)(2).
ical transient access for maintenance or other necessary work to the shielded vaults, cells, rooms that are usually high radiation areas or very high radiation areas is normally ormed after dose rates have been reduced to at least the level of a radiation area. This is e by removing the radioactive materials or changing the conditions (such as shutting down accelerator in an IU cell), using temporary shielding, and waiting for sufficient decay.
The radiation shielding is designed to ensure that during normal operation internal facility radiation dose rates are consistent with as low as reasonably achievable (ALARA) radiological practices required by 10 CFR 20. The goal for the normal operations dose rate for normally occupied locations in the facility is 0.25 mrem/hr at 30 centimeters from the surface of the shielding. Radiation levels may rise above the 0.25 mrem/hr level during some operations such as tank transfers. At full-power operation of the eight units, portions of the normally occupied area in IF and RPF exceed the 0.25 mrem/hr goal but remain below 5 mrem/hr, except in small sections above the pipe trench during solution transfers. These dose rates were calculated using the maximum specified shield plug gap sizes, minimum density shielding materials, and the nominal inventories for full power operation.
or radiation sources in the facility originate in the target solution. At the end of the TSV diation cycle, irradiated target solution is transferred to one of the three extraction cells for cessing. Off-gas that is purged from the primary system boundary (PSB) is sent to the cess vessel vent system (PVVS), where it travels through carbon guard beds and a series of bon delay beds to allow for capture of iodine and decay of short-lived noble gas nuclides ore being released through the facility exhaust stack. Facility special nuclear material (SNM) ntories are tabulated in Table 4b.4-1.
A tabulation of normally and transient-occupied areas, dose rates, and designations is provided in Table 11.1-4. Figure 11.1-1 provides the probable radiation area designations, above grade, within the radiologically controlled area (RCA) at the SHINE facility.
three sections below describe the major radiation sources in the facility. Other radiological rces in the facility are bounded by the fission product source coming from the TSV described ubsection 11.1.1.2.
Procedures for transient access to shielded vaults, cells, and rooms ensure doses are maintained ALARA by addressing the following:
  .1.1        Airborne Radioactive Sources ioactive sources that could become airborne at the SHINE facility are primarily tritium and oactive gases produced as a byproduct of the Mo-99 production process. The systems dling gaseous radioactive materials include the tritium purification system (TPS) and the TSV gas system (TOGS), both located in the irradiation facility (IF) area; and the PVVS and uum transfer system (VTS) located in the RPF. These airborne radioactive materials are tained within closed systems consisting of piping components and tanks. Table 11.1-5 vides information on the various locations, types, and expected dose rates from gaseous oactive sources.
job planning, radiation protection coverage, survey techniques and frequencies,
on-41 is produced in the IU cells during irradiation. Due to the low flow rate out of the primary finement boundary to radiological ventilation zone 1 (RVZ1), most argon-41 decays prior to g released. Approximately 0.02 curies per year (Ci/yr) of argon-41 are released to the ironment through the facility stack.
 
ogen-16 is produced within the primary cooling loop and the light water pool. Dose rates from e sources are mitigated by delay tanks and biological shielding that limits radiation dose to upied areas adjacent to the shielding.
Chapter 11 - Radiation Protection Program and Waste Management Radiation Protection SHINE Medical Technologies 11.1-3 Rev. 0 training of workers, pre-work briefing, frequency for updating radiation work permits or their equivalent, and placement of measuring and alarming dosimeters.
NE Medical Technologies                      11.1-3                                        Rev. 0
Shielded vaults, cells, and rooms designated as high radiation areas or very high radiation areas as denoted in Figure 11.1-1 are not normally occupied when those conditions exist.
Administrative procedures address the management oversight and specific control measures needed for entry into high radiation areas and very high radiation areas, if it is ever necessary to do so. The procedures include the process for gaining entry to these areas, such as the control and distribution of keys.
Typical transient access for maintenance or other necessary work to the shielded vaults, cells, and rooms that are usually high radiation areas or very high radiation areas is normally performed after dose rates have been reduced to at least the level of a radiation area. This is done by removing the radioactive materials or changing the conditions (such as shutting down the accelerator in an IU cell), using temporary shielding, and waiting for sufficient decay.
Major radiation sources in the facility originate in the target solution. At the end of the TSV irradiation cycle, irradiated target solution is transferred to one of the three extraction cells for processing. Off-gas that is purged from the primary system boundary (PSB) is sent to the process vessel vent system (PVVS), where it travels through carbon guard beds and a series of carbon delay beds to allow for capture of iodine and decay of short-lived noble gas nuclides before being released through the facility exhaust stack. Facility special nuclear material (SNM) inventories are tabulated in Table 4b.4-1.
The three sections below describe the major radiation sources in the facility. Other radiological sources in the facility are bounded by the fission product source coming from the TSV described in Subsection 11.1.1.2.
11.1.1.1 Airborne Radioactive Sources Radioactive sources that could become airborne at the SHINE facility are primarily tritium and radioactive gases produced as a byproduct of the Mo-99 production process. The systems handling gaseous radioactive materials include the tritium purification system (TPS) and the TSV off-gas system (TOGS), both located in the irradiation facility (IF) area; and the PVVS and vacuum transfer system (VTS) located in the RPF. These airborne radioactive materials are contained within closed systems consisting of piping components and tanks. Table 11.1-5 provides information on the various locations, types, and expected dose rates from gaseous radioactive sources.
Argon-41 is produced in the IU cells during irradiation. Due to the low flow rate out of the primary confinement boundary to radiological ventilation zone 1 (RVZ1), most argon-41 decays prior to being released. Approximately 0.02 curies per year (Ci/yr) of argon-41 are released to the environment through the facility stack.
Nitrogen-16 is produced within the primary cooling loop and the light water pool. Dose rates from these sources are mitigated by delay tanks and biological shielding that limits radiation dose to occupied areas adjacent to the shielding.
 
Chapter 11 - Radiation Protection Program and Waste Management Radiation Protection SHINE Medical Technologies 11.1-4 Rev. 0 The design of the SHINE facility maintains airborne radioactive material at very low concentrations in normally occupied areas. Confinement and ventilation systems are designed to protect workers from sources of airborne radioactivity during normal operation and minimize worker exposure during maintenance activities, keeping with the ALARA principles outlined in 10 CFR 20.
Although most process gas systems within the facility are maintained below atmospheric pressure, some leakage of process gases is expected due to the difference in partial pressure between the system and the surrounding environment. A conservative best estimate of airborne releases due to normal operation and maintenance was performed to estimate derived air concentrations (DACs) for the facility.
Leakage from process systems was estimated based on the number of components and fittings, achievable leak tightness per fitting, permeation through equipment, and partial pressures of airborne radionuclides. For processes in hot cells that require routine disconnection of components (e.g., extraction columns) special fittings are used to minimize process leakage.
The effects of the confinement systems are incorporated into the analysis. The results of the evaluation, broken down into particulates, halogens, noble gases, and tritium, are provided in Table 11.1-6. These values provide a conservative best estimate of the facility DACs.
Figure 11.1-2 provides the DAC zoning map for the facility, using the following definitions:
Zone 1 (< 1.0 DAC);
Zone 2 (1.0 - 10 DAC); and Zone 3 (> 10 DAC).
Gaseous activity from the TSV and process operations is routed through the PVVS which includes carbon delay beds to allow for airborne radionuclides to decay to low enough levels such that normal releases are below the 10 CFR 20 limits. Additional airborne release pathways are RVZ1 ventilation of the facility hot cells, flow out of the primary confinement boundary to RVZ1, and radiological ventilation zone 2 (RVZ2) ventilation of any leakage to the general area (material evaluated for the DAC). These additional pathways do not pass through the carbon delay beds but do contain filters as described in Subsection 9a2.1.1. Table 11.1-7 lists key parameters used in the normal release calculation. Releases from the TPS that are treated by the glovebox stripper system (GBSS) are negligible in comparison to tritium releases to the general area due to maintenance and leakage and are not included in Table 11.1-7 or Table 11.1-8.
Annual off-site doses due to the normal operation of the SHINE facility have been calculated using the computer code GENII2 (PNNL, 2012). The GENII2 computer code was developed for the Environmental Protection Agency (EPA) by Pacific Northwest National Laboratory (PNNL) and is distributed by the Radiation Safety Information Computational Center (RSICC). Annual average relative atmospheric concentration (/Q) values were determined using the methodology in Regulatory Guide 1.111, Methods for Estimating Atmospheric Transport and Dispersion of Gaseous Effluents in Routine Releases from Light-Water-Cooled Reactors (USNRC, 1977) with the meteorological data in Section 2.3. The /Q values for the maximally exposed individual (MEI), which is the nearest point on the site boundary, and the nearest full-time resident are 7.1E-5 sec/m3 and 5.3E-6 sec/m3, respectively.


ect workers from sources of airborne radioactivity during normal operation and minimize ker exposure during maintenance activities, keeping with the ALARA principles outlined in CFR 20.
Chapter 11 - Radiation Protection Program and Waste Management Radiation Protection SHINE Medical Technologies 11.1-5 Rev. 0 Table 11.1-8 contains the estimated annual release from maintenance and normal operation of eight irradiation units. The release is comprised of release inventories from the four airborne release pathways described above: PVVS, hot cells, primary confinement boundary, and material leaked to the general area. The dominant source term is the process gases released through PVVS. Only nuclides with greater than 1 Ci/yr released are included in the table.
ough most process gas systems within the facility are maintained below atmospheric ssure, some leakage of process gases is expected due to the difference in partial pressure ween the system and the surrounding environment. A conservative best estimate of airborne ases due to normal operation and maintenance was performed to estimate derived air centrations (DACs) for the facility.
The dose analysis considered the release of airborne radionuclides and exposure to off-site individuals through direct exposure and potential environmental pathways, such as leafy vegetable ingestion, meat ingestion, and milk ingestion. The analysis considered variations in consumption and other parameters by age group. The estimated annual doses at the MEI and the nearest resident are 3.9 mrem and 0.3 mrem, respectively, which are less than the limit in 10 CFR 20.
kage from process systems was estimated based on the number of components and fittings, ievable leak tightness per fitting, permeation through equipment, and partial pressures of orne radionuclides. For processes in hot cells that require routine disconnection of ponents (e.g., extraction columns) special fittings are used to minimize process leakage.
Calculational methodologies related to accidental releases of airborne radioactive sources are discussed in Chapter 13.
effects of the confinement systems are incorporated into the analysis. The results of the luation, broken down into particulates, halogens, noble gases, and tritium, are provided in le 11.1-6. These values provide a conservative best estimate of the facility DACs.
11.1.1.2 Liquid Radioactive Sources There are numerous locations within the SHINE facility where the presence of radioactive liquids results in a source of radiation. These sources (except for as noted below) are derived from the irradiated uranyl sulfate target solution as it is being processed through the facility. The first exception is the primary cooling water, which carries nitrogen-16 and other activation products as it is pumped through the primary closed loop cooling system (PCLS). The second exception is the production of low-activity fresh uranyl sulfate target solution. These radioactive materials are contained within closed systems consisting of piping components and tanks.
ure 11.1-2 provides the DAC zoning map for the facility, using the following definitions:
In addition, there are two locations where tritium is expected to collect due to operation of the neutron driver assembly system (NDAS). These are the light water pool and the oil used in the NDAS pumps. The small quantities of tritium released into the IU cell by permeation through and leakage from the NDAS components is expected to be converted to tritiated water and slowly increase the tritium concentration in the pool water. The oil used in the NDAS pumps is in direct contact with the tritium in the accelerator, causing it to become contaminated with tritium over time. Table 11.1-9 provides information on the various locations, types, and expected doses from liquid radioactive sources.
* Zone 1 (< 1.0 DAC);
Liquid radioactive wastes generated at the facility are generally solidified and shipped to a disposal facility. Table 11.2-1 contains a list of liquid radioactive waste generated at the facility including the annual quantities and disposal destinations. Radioactive liquid discharges from the SHINE facility to the sanitary sewer are made in accordance with 10 CFR 20.2003 and 10 CFR 20.2007. See Section 11.2 for additional information on liquid discharges from the RCA.
* Zone 2 (1.0 - 10 DAC); and
11.1.1.3 Solid Radioactive Sources Solid radioactive sources exist in several locations in the SHINE facility. Fresh, low enriched uranium is received at the facility in the form of uranium metal or uranium oxide that has been enriched to a nominal 19.75 percent by weight in uranium-235 (U-235). If uranium metal is received, it is converted to uranium oxide and then to a liquid uranyl sulfate solution. Other solid radioactive sources are listed in Table 11.2-1 and include spent extraction columns from the molybdenum extraction process, glassware, spent filters, and solidified liquid waste.  
* Zone 3 (> 10 DAC).
eous activity from the TSV and process operations is routed through the PVVS which udes carbon delay beds to allow for airborne radionuclides to decay to low enough levels h that normal releases are below the 10 CFR 20 limits. Additional airborne release pathways RVZ1 ventilation of the facility hot cells, flow out of the primary confinement boundary to Z1, and radiological ventilation zone 2 (RVZ2) ventilation of any leakage to the general area terial evaluated for the DAC). These additional pathways do not pass through the carbon y beds but do contain filters as described in Subsection 9a2.1.1. Table 11.1-7 lists key ameters used in the normal release calculation. Releases from the TPS that are treated by glovebox stripper system (GBSS) are negligible in comparison to tritium releases to the eral area due to maintenance and leakage and are not included in Table 11.1-7 or le 11.1-8.
ual off-site doses due to the normal operation of the SHINE facility have been calculated g the computer code GENII2 (PNNL, 2012). The GENII2 computer code was developed for Environmental Protection Agency (EPA) by Pacific Northwest National Laboratory (PNNL) is distributed by the Radiation Safety Information Computational Center (RSICC). Annual rage relative atmospheric concentration (/Q) values were determined using the methodology egulatory Guide 1.111, Methods for Estimating Atmospheric Transport and Dispersion of eous Effluents in Routine Releases from Light-Water-Cooled Reactors (USNRC, 1977) with meteorological data in Section 2.3. The /Q values for the maximally exposed individual I), which is the nearest point on the site boundary, and the nearest full-time resident are E-5 sec/m3 and 5.3E-6 sec/m3, respectively.
NE Medical Technologies                      11.1-4                                      Rev. 0


ase pathways described above: PVVS, hot cells, primary confinement boundary, and erial leaked to the general area. The dominant source term is the process gases released ugh PVVS. Only nuclides with greater than 1 Ci/yr released are included in the table.
Chapter 11 - Radiation Protection Program and Waste Management Radiation Protection SHINE Medical Technologies 11.1-6 Rev. 0 The natural uranium neutron multiplier is located in the subcritical assembly. The uranium interacts with the neutron flux producing both activation products and fission products that are retained within the metal structure.
dose analysis considered the release of airborne radionuclides and exposure to off-site viduals through direct exposure and potential environmental pathways, such as leafy etable ingestion, meat ingestion, and milk ingestion. The analysis considered variations in sumption and other parameters by age group. The estimated annual doses at the MEI and nearest resident are 3.9 mrem and 0.3 mrem, respectively, which are less than the limit in CFR 20.
In addition, metal components in the IU cell are activated and components of the TOGS contain radioactive material. The subcritical multiplication sources for the subcritical assemblies are also located in the IU cell.
culational methodologies related to accidental releases of airborne radioactive sources are ussed in Chapter 13.
These solid radioactive sources are contained within IU cells, shielded cells, hot cells, or preparation areas within the RCA of the facility. Table 11.1-10 provides information on the major solid radioactive sources including their location and activity. The radionuclide inventory in the solid waste system is a function of the TSV system operation.
  .1.2        Liquid Radioactive Sources re are numerous locations within the SHINE facility where the presence of radioactive liquids ults in a source of radiation. These sources (except for as noted below) are derived from the diated uranyl sulfate target solution as it is being processed through the facility. The first eption is the primary cooling water, which carries nitrogen-16 and other activation products as pumped through the primary closed loop cooling system (PCLS). The second exception is production of low-activity fresh uranyl sulfate target solution. These radioactive materials are tained within closed systems consisting of piping components and tanks.
A list of solid radioactive wastes including annual quantities and disposal destinations is provided in Table 11.2-1.
ddition, there are two locations where tritium is expected to collect due to operation of the tron driver assembly system (NDAS). These are the light water pool and the oil used in the AS pumps. The small quantities of tritium released into the IU cell by permeation through and age from the NDAS components is expected to be converted to tritiated water and slowly ease the tritium concentration in the pool water. The oil used in the NDAS pumps is in direct tact with the tritium in the accelerator, causing it to become contaminated with tritium over
Disposal of solid radioactive waste with respect to storage, monitoring, and management is discussed in Section 11.2.
  . Table 11.1-9 provides information on the various locations, types, and expected doses from id radioactive sources.
11.1.1.4 Technical Specifications Certain material in this section provides information that is used in the technical specifications.
id radioactive wastes generated at the facility are generally solidified and shipped to a osal facility. Table 11.2-1 contains a list of liquid radioactive waste generated at the facility uding the annual quantities and disposal destinations. Radioactive liquid discharges from the NE facility to the sanitary sewer are made in accordance with 10 CFR 20.2003 and CFR 20.2007. See Section 11.2 for additional information on liquid discharges from the RCA.
This includes limiting conditions for operation, setpoints, design features, and means for accomplishing surveillances. In addition, significant material is also applicable to, and may be referenced by, the bases that are described in the technical specifications.
  .1.3        Solid Radioactive Sources d radioactive sources exist in several locations in the SHINE facility. Fresh, low enriched nium is received at the facility in the form of uranium metal or uranium oxide that has been ched to a nominal 19.75 percent by weight in uranium-235 (U-235). If uranium metal is eived, it is converted to uranium oxide and then to a liquid uranyl sulfate solution. Other solid oactive sources are listed in Table 11.2-1 and include spent extraction columns from the ybdenum extraction process, glassware, spent filters, and solidified liquid waste.
11.1.2 RADIATION PROTECTION PROGRAM The radiation protection program protects the radiological health and safety of workers and members of the public and complies with the regulatory requirements in 10 CFR 19, 20, and 70.
NE Medical Technologies                      11.1-5                                        Rev. 0
11.1.2.1 Commitment to Radiation Protection Program Implementation SHINE has established a radiation protection program with the specific purpose of protecting the radiological health and safety of workers and members of the public. The objectives of the program are to prevent acute radiation injuries (non-stochastic or deterministic effects) and to limit the potential risks of probabilistic (stochastic) effects (which may result from chronic exposure) to acceptable levels. The SHINE radiation protection program was developed and is implemented commensurate with the risks posed by a medical isotope facility. The program contains the SHINE management policy statement to maintain occupational and public radiation exposures ALARA.
The radiation protection program meets the requirements of 10 CFR 20, Subpart B, Radiation Protection Programs, and is consistent with the guidance provided in Regulatory Guide 8.2, Revision 1, Administrative Practices in Radiation Surveys and Monitoring (USNRC, 2011), and ANSI/ANS 15.11-2016, Radiation Protection at Research Reactor Facilities (ANSI/ANS, 2016).
Procedures and engineering controls are based upon sound radiation protection principles to achieve occupational doses to on-site personnel and doses to members of the public that are ALARA. The radiation protection program content and implementation are reviewed at least annually as required by 10 CFR 20.1101(c).


ined within the metal structure.
Chapter 11 - Radiation Protection Program and Waste Management Radiation Protection SHINE Medical Technologies 11.1-7 Rev. 0 The radiation protection program includes written procedures, periodic assessments of work practices and internal/external doses received, work plans, and the personnel and equipment required to implement the ALARA goal. Protection of plant personnel requires (a) surveillance of and control over the radiation exposure of personnel and (b) maintaining the exposure of personnel not only within permissible limits, but also within ALARA philosophy and exposure goals.
ddition, metal components in the IU cell are activated and components of the TOGS contain oactive material. The subcritical multiplication sources for the subcritical assemblies are also ted in the IU cell.
SHINEs administrative personnel exposure limits for radiation workers are set below the limits specified in 10 CFR 20. This provides assurance that regulatory radiation exposure limits are not exceeded and that the ALARA principle is emphasized. Administrative exposure limits are provided in Table 11.1-11.
se solid radioactive sources are contained within IU cells, shielded cells, hot cells, or paration areas within the RCA of the facility. Table 11.1-10 provides information on the major d radioactive sources including their location and activity. The radionuclide inventory in the d waste system is a function of the TSV system operation.
The radiation exposure policy and control measures for personnel are established in accordance with requirements of 10 CFR 20 and the guidance in the following regulatory guides:
t of solid radioactive wastes including annual quantities and disposal destinations is provided able 11.2-1.
Regulatory Guide 8.10, Revision 2, Operating Philosophy for Maintaining Occupational Radiation Exposures as Low as Is Reasonably Achievable (USNRC, 2016)
posal of solid radioactive waste with respect to storage, monitoring, and management is ussed in Section 11.2.
Regulatory Guide 8.13, Revision 3, Instruction Concerning Prenatal Radiation Exposure (USNRC, 1999)
  .1.4        Technical Specifications tain material in this section provides information that is used in the technical specifications.
Regulatory Guide 8.29, Revision 1, Instruction Concerning Risks from Occupational Radiation Exposure (USNRC, 1996)
includes limiting conditions for operation, setpoints, design features, and means for omplishing surveillances. In addition, significant material is also applicable to, and may be renced by, the bases that are described in the technical specifications.
The SHINE corrective action process is implemented if (1) personnel dose monitoring results or personnel contamination levels exceed the administrative personnel limits; (2) if an incident results in airborne occupational exposures exceeding the administrative limits; or (3) the dose limits in 10 CFR 20 are exceeded.
  .2      RADIATION PROTECTION PROGRAM radiation protection program protects the radiological health and safety of workers and mbers of the public and complies with the regulatory requirements in 10 CFR 19, 20, and 70.
Information developed from reportable occurrences is tracked in the corrective action program and is used to improve radiation protection practices, decreasing the probability of similar incidents.
  .2.1        Commitment to Radiation Protection Program Implementation NE has established a radiation protection program with the specific purpose of protecting the ological health and safety of workers and members of the public. The objectives of the gram are to prevent acute radiation injuries (non-stochastic or deterministic effects) and to t the potential risks of probabilistic (stochastic) effects (which may result from chronic osure) to acceptable levels. The SHINE radiation protection program was developed and is lemented commensurate with the risks posed by a medical isotope facility. The program tains the SHINE management policy statement to maintain occupational and public radiation osures ALARA.
11.1.2.1.1 Responsibilities of Key Program Personnel The key personnel responsible for implementing the radiation protection program are shown in Figure 11.1-3 and are discussed below. Chapter 12 discusses the SHINE organization and responsibilities of key management personnel in further detail.
radiation protection program meets the requirements of 10 CFR 20, Subpart B, Radiation tection Programs, and is consistent with the guidance provided in Regulatory Guide 8.2, ision 1, Administrative Practices in Radiation Surveys and Monitoring (USNRC, 2011), and SI/ANS 15.11-2016, Radiation Protection at Research Reactor Facilities (ANSI/ANS, 2016).
Chief Executive Officer The Chief Executive Officer (CEO) is responsible for the overall management and leadership of the company.
cedures and engineering controls are based upon sound radiation protection principles to ieve occupational doses to on-site personnel and doses to members of the public that are RA. The radiation protection program content and implementation are reviewed at least ually as required by 10 CFR 20.1101(c).
Chief Operating Officer The Chief Operating Officer (COO) reports to the CEO and is responsible for overall company operations.
NE Medical Technologies                      11.1-6                                        Rev. 0


uired to implement the ALARA goal. Protection of plant personnel requires (a) surveillance of control over the radiation exposure of personnel and (b) maintaining the exposure of sonnel not only within permissible limits, but also within ALARA philosophy and exposure ls.
Chapter 11 - Radiation Protection Program and Waste Management Radiation Protection SHINE Medical Technologies 11.1-8 Rev. 0 Vice President Regulatory Affairs & Quality The Vice President Regulatory Affairs & Quality reports to the CEO and is responsible for licensing and quality activities.
NEs administrative personnel exposure limits for radiation workers are set below the limits cified in 10 CFR 20. This provides assurance that regulatory radiation exposure limits are not eeded and that the ALARA principle is emphasized. Administrative exposure limits are vided in Table 11.1-11.
Quality Manager The Quality Manager reports to the Vice President Regulatory Affairs & Quality and is responsible for assuring compliance with regulatory requirements and procedures.
radiation exposure policy and control measures for personnel are established in accordance requirements of 10 CFR 20 and the guidance in the following regulatory guides:
Plant Manager The Plant Manager is responsible for operation of the facility, including the protection of personnel from radiation exposure resulting from facility operations and materials, and for compliance with applicable NRC regulations and the facility license. The Plant Manager designates the authority to approve procedures related to personnel radiation protection to the Radiation Protection Manager in accordance with the guidance provided in ANSI/ANS-15.1-2007 (ANSI/ANS, 2007). The Plant Manager reports to the COO.
* Regulatory Guide 8.10, Revision 2, Operating Philosophy for Maintaining Occupational Radiation Exposures as Low as Is Reasonably Achievable (USNRC, 2016)
Radiation Protection Manager The Radiation Protection Manager is responsible for implementing the radiation protection program. The Radiation Protection Manager reports directly to the Plant Manager, independent from facility operations. The Radiation Protection Manager has direct access to executive management for matters involving radiation protection. The Radiation Protection Manager and radiation protection personnel are responsible for:
* Regulatory Guide 8.13, Revision 3, Instruction Concerning Prenatal Radiation Exposure (USNRC, 1999)
Establishing the radiation protection program.
* Regulatory Guide 8.29, Revision 1, Instruction Concerning Risks from Occupational Radiation Exposure (USNRC, 1996)
Generating and maintaining procedures associated with the program.
SHINE corrective action process is implemented if (1) personnel dose monitoring results or sonnel contamination levels exceed the administrative personnel limits; (2) if an incident ults in airborne occupational exposures exceeding the administrative limits; or (3) the dose ts in 10 CFR 20 are exceeded.
Ensuring that ALARA is incorporated into procedures and practiced by personnel, including stopping work when unsafe practices are identified.
rmation developed from reportable occurrences is tracked in the corrective action program is used to improve radiation protection practices, decreasing the probability of similar dents.
Ensuring the efficacy of the program is reviewed and audited for compliance with NRC and other governmental regulations and applicable regulatory guides.
  .2.1.1    Responsibilities of Key Program Personnel key personnel responsible for implementing the radiation protection program are shown in ure 11.1-3 and are discussed below. Chapter 12 discusses the SHINE organization and ponsibilities of key management personnel in further detail.
Modifying the program based upon experience, facility history, regulatory updates, and changes to guidance documents.
ef Executive Officer Chief Executive Officer (CEO) is responsible for the overall management and leadership of company.
Adequately staffing the Radiation Protection Department to implement the radiation protection program.
ef Operating Officer Chief Operating Officer (COO) reports to the CEO and is responsible for overall company rations.
Ensuring that the occupational radiation exposure dose limits of 10 CFR 20 are not exceeded under normal operations.
NE Medical Technologies                    11.1-7                                        Rev. 0
Ensuring administrative radiation dose limits are not exceeded without prior approval from the Radiation Safety Committee.
Establishing and maintaining an ALARA program.
Demonstrating, where practical, familiarity and reasoning associated with improvements in ALARA principles and practices, including modifications that were considered and implemented.
Establishing and maintaining a Respiratory Protection Program.
Establishing and maintaining the Radiological Environmental Monitoring Program.
Establishing and maintaining a Radioactive Waste Management Program.
Monitoring worker doses, both internal and external.


Vice President Regulatory Affairs & Quality reports to the CEO and is responsible for nsing and quality activities.
Chapter 11 - Radiation Protection Program and Waste Management Radiation Protection SHINE Medical Technologies 11.1-9 Rev. 0 Assuring that the proper radiation protection instrumentation, equipment, and supplies are available at workplaces, in good working order, and are used properly.
lity Manager Quality Manager reports to the Vice President Regulatory Affairs & Quality and is ponsible for assuring compliance with regulatory requirements and procedures.
Ensuring calibration and quality assurance of health physics associated radiological instrumentation.
nt Manager Plant Manager is responsible for operation of the facility, including the protection of sonnel from radiation exposure resulting from facility operations and materials, and for pliance with applicable NRC regulations and the facility license. The Plant Manager ignates the authority to approve procedures related to personnel radiation protection to the iation Protection Manager in accordance with the guidance provided in ANSI/ANS-15.1-2007 SI/ANS, 2007). The Plant Manager reports to the COO.
Establishing and maintaining a radiation safety training program for personnel working in radiologically controlled areas.
iation Protection Manager Radiation Protection Manager is responsible for implementing the radiation protection gram. The Radiation Protection Manager reports directly to the Plant Manager, independent facility operations. The Radiation Protection Manager has direct access to executive nagement for matters involving radiation protection. The Radiation Protection Manager and ation protection personnel are responsible for:
Posting restricted areas and, within these areas, posting radiological areas, as required by the radiation protection program (e.g., airborne radioactivity area, high radiation area, contamination area).
* Establishing the radiation protection program.
Informing management of any radiation protection concerns.
* Generating and maintaining procedures associated with the program.
Operations Manager The Operations Manager is responsible for operating the facility safely and in accordance with facility procedures so that effluents released to the environment and exposures to the public and on-site personnel meet the limits specified in applicable regulations, procedures and guidance documents.
* Ensuring that ALARA is incorporated into procedures and practiced by personnel, including stopping work when unsafe practices are identified.
On-site Personnel On-site personnel are responsible for performing their work activities in a safe manner. SHINE has established policies, procedures and practices to ensure that personnel can work safely in the facility. The policies, procedures and practices implement rules and regulations intended to ensure workers and the public are protected from specific hazards encountered at the facility.
* Ensuring the efficacy of the program is reviewed and audited for compliance with NRC and other governmental regulations and applicable regulatory guides.
Personnel whose duties require (1) working with radioactive material, (2) entering restricted areas, (3) controlling facility operations that could affect effluent releases, or (4) directing the activities of others, are trained such that they understand and effectively carry out their responsibilities.
* Modifying the program based upon experience, facility history, regulatory updates, and changes to guidance documents.
11.1.2.1.2 Radiation Protection Program Staffing and Qualifications The radiation protection program staff is assigned responsibility for implementation of the radiation protection program functions; therefore, only suitably trained radiation protection personnel are employed at the facility. The radiation protection staff includes, at a minimum, a Radiation Protection Manager and radiation control technicians.
* Adequately staffing the Radiation Protection Department to implement the radiation protection program.
Staff selection and qualification are addressed in Chapter 12. The Radiation Protection Manager selection and qualification is consistent with the requirements for a Level 2 position. Radiation control technicians are considered Other Technical Personnel, as described in Subsection 12.1.4.
* Ensuring that the occupational radiation exposure dose limits of 10 CFR 20 are not exceeded under normal operations.
Sufficient resources in terms of staffing and equipment are provided to implement an effective radiation protection program.
* Ensuring administrative radiation dose limits are not exceeded without prior approval from the Radiation Safety Committee.
11.1.2.1.3 Independence of the Radiation Protection Program The radiation protection program is independent of facility operations. This independence ensures that the radiation protection program maintains its objectivity and is focused only on implementing sound radiation protection principles necessary to achieve occupational doses and doses to members of the public that are ALARA.
* Establishing and maintaining an ALARA program.
* Demonstrating, where practical, familiarity and reasoning associated with improvements in ALARA principles and practices, including modifications that were considered and implemented.
* Establishing and maintaining a Respiratory Protection Program.
* Establishing and maintaining the Radiological Environmental Monitoring Program.
* Establishing and maintaining a Radioactive Waste Management Program.
* Monitoring worker doses, both internal and external.
NE Medical Technologies                      11.1-8                                      Rev. 0
* Ensuring calibration and quality assurance of health physics associated radiological instrumentation.
* Establishing and maintaining a radiation safety training program for personnel working in radiologically controlled areas.
* Posting restricted areas and, within these areas, posting radiological areas, as required by the radiation protection program (e.g., airborne radioactivity area, high radiation area, contamination area).
* Informing management of any radiation protection concerns.
rations Manager Operations Manager is responsible for operating the facility safely and in accordance with lity procedures so that effluents released to the environment and exposures to the public and site personnel meet the limits specified in applicable regulations, procedures and guidance uments.
site Personnel site personnel are responsible for performing their work activities in a safe manner. SHINE established policies, procedures and practices to ensure that personnel can work safely in facility. The policies, procedures and practices implement rules and regulations intended to ure workers and the public are protected from specific hazards encountered at the facility.
sonnel whose duties require (1) working with radioactive material, (2) entering restricted as, (3) controlling facility operations that could affect effluent releases, or (4) directing the vities of others, are trained such that they understand and effectively carry out their ponsibilities.
  .2.1.2     Radiation Protection Program Staffing and Qualifications radiation protection program staff is assigned responsibility for implementation of the ation protection program functions; therefore, only suitably trained radiation protection sonnel are employed at the facility. The radiation protection staff includes, at a minimum, a iation Protection Manager and radiation control technicians.
ff selection and qualification are addressed in Chapter 12. The Radiation Protection Manager ction and qualification is consistent with the requirements for a Level 2 position. Radiation trol technicians are considered Other Technical Personnel, as described in section 12.1.4.
ficient resources in terms of staffing and equipment are provided to implement an effective ation protection program.
  .2.1.3     Independence of the Radiation Protection Program radiation protection program is independent of facility operations. This independence ures that the radiation protection program maintains its objectivity and is focused only on lementing sound radiation protection principles necessary to achieve occupational doses and es to members of the public that are ALARA.
NE Medical Technologies                      11.1-9                                          Rev. 0


adiation Safety Committee (RSC) is established to maintain a high standard of radiation ection during facility operations. The RSC oversees activities at the SHINE facility to protect sonnel from unnecessary radiation exposure, prevent contamination of natural resources, and nsure compliance with state and federal regulations governing the possession, use, and osal of radioactive materials. The RSC meets periodically, but at least annually, to monitor lity radiological performance and ALARA implementation, review proposed changes to the ation protection program, identify trends, and set ALARA policy and goals for the facility. The C reviews the results of audits and regulatory inspections, worker suggestions, reportable urrences, and exposure incidents. The RSC assesses changes to the facility for the effect on radiation protection program and the license.
Chapter 11 - Radiation Protection Program and Waste Management Radiation Protection SHINE Medical Technologies 11.1-10 Rev. 0 11.1.2.1.4 Radiation Safety Committee A Radiation Safety Committee (RSC) is established to maintain a high standard of radiation protection during facility operations. The RSC oversees activities at the SHINE facility to protect personnel from unnecessary radiation exposure, prevent contamination of natural resources, and to ensure compliance with state and federal regulations governing the possession, use, and disposal of radioactive materials. The RSC meets periodically, but at least annually, to monitor facility radiological performance and ALARA implementation, review proposed changes to the radiation protection program, identify trends, and set ALARA policy and goals for the facility. The RSC reviews the results of audits and regulatory inspections, worker suggestions, reportable occurrences, and exposure incidents. The RSC assesses changes to the facility for the effect on the radiation protection program and the license.
Radiation Protection Manager chairs the RSC. The RSC Charter defines the purposes, tions, responsibility, composition, qualifications, quorum, meeting frequency, and reporting uirements of the RSC.
The Radiation Protection Manager chairs the RSC. The RSC Charter defines the purposes, functions, responsibility, composition, qualifications, quorum, meeting frequency, and reporting requirements of the RSC.
  .2.1.5       Commitment to Written Radiation Protection Procedures iation protection procedures are prepared, reviewed and approved to carry out activities ted to the radiation protection program. Procedures are used to control radiation protection vities in order to ensure that the activities are carried out in a safe, effective and consistent nner. Radiation protection procedures are reviewed and revised as necessary by the iation Protection Manager or designee to incorporate facility or operational changes.
11.1.2.1.5 Commitment to Written Radiation Protection Procedures Radiation protection procedures are prepared, reviewed and approved to carry out activities related to the radiation protection program. Procedures are used to control radiation protection activities in order to ensure that the activities are carried out in a safe, effective and consistent manner. Radiation protection procedures are reviewed and revised as necessary by the Radiation Protection Manager or designee to incorporate facility or operational changes.
iation protection procedures provide direction for the following activities:
Radiation protection procedures provide direction for the following activities:
* Facility radiation monitoring, including surveys, personnel monitoring, and sampling and analysis of solid, liquid and gaseous wastes processed or released from the facility
Facility radiation monitoring, including surveys, personnel monitoring, and sampling and analysis of solid, liquid and gaseous wastes processed or released from the facility Calibration of area radiation monitors, facility air monitors, laboratory radiation detection systems, personnel radiation monitors and portable instruments Access control, radiological posting, and monitoring of radiological work activities Radioactive materials handling and shipment Contamination control Control of exposures and ALARA implementation Control of instrument alarm setpoints Administration of the radiation work permit (RWP) process Radiation protection procedures undergo technical verification and review to ensure compliance with regulatory requirements, applicable license conditions and the radiation protection program, as well as conformance with industry standard practices, as applicable. Radiation protection procedures are reviewed at least once every three years in accordance with the guidance in Regulatory Guide 8.10. Radiation protection procedures related to personnel radiation protection are reviewed by the SHINE Review and Audit Committee.
* Calibration of area radiation monitors, facility air monitors, laboratory radiation detection systems, personnel radiation monitors and portable instruments
Work performed in radiologically controlled areas is performed in accordance with the RWP process. The RWP specifies radiological controls for intended work activities and provides written authorization for entry into and work within Radiation Areas, High Radiation Areas, Very High Radiation Areas, Contamination Areas and Airborne Radioactivity Areas. The RWP informs workers of area radiological conditions and entry requirements and provides a mechanism to  
* Access control, radiological posting, and monitoring of radiological work activities
* Radioactive materials handling and shipment
* Contamination control
* Control of exposures and ALARA implementation
* Control of instrument alarm setpoints
* Administration of the radiation work permit (RWP) process iation protection procedures undergo technical verification and review to ensure compliance regulatory requirements, applicable license conditions and the radiation protection program, well as conformance with industry standard practices, as applicable. Radiation protection cedures are reviewed at least once every three years in accordance with the guidance in ulatory Guide 8.10. Radiation protection procedures related to personnel radiation protection reviewed by the SHINE Review and Audit Committee.
rk performed in radiologically controlled areas is performed in accordance with the RWP cess. The RWP specifies radiological controls for intended work activities and provides ten authorization for entry into and work within Radiation Areas, High Radiation Areas, Very h Radiation Areas, Contamination Areas and Airborne Radioactivity Areas. The RWP informs kers of area radiological conditions and entry requirements and provides a mechanism to NE Medical Technologies                    11.1-10                                          Rev. 0


.2.1.6     Commitment to Radiation Protection Training design and implementation of the radiation protection training program complies with the uirements of 10 CFR 19.12. Records are maintained in accordance with 10 CFR 20, part L.
Chapter 11 - Radiation Protection Program and Waste Management Radiation Protection SHINE Medical Technologies 11.1-11 Rev. 0 relate worker exposure to specific work activities. The procedures controlling RWPs are consistent with the guidance provided in Regulatory Guide 8.10 (USNRC, 2016).
development and implementation of the radiation protection training program is consistent the guidance provided in the following regulatory guidance documents:
11.1.2.1.6 Commitment to Radiation Protection Training The design and implementation of the radiation protection training program complies with the requirements of 10 CFR 19.12. Records are maintained in accordance with 10 CFR 20, Subpart L.
* Regulatory Guide 8.10 - Operating Philosophy for Maintaining Occupational Radiation Exposures As Low As Reasonably Achievable (USNRC, 2016)
The development and implementation of the radiation protection training program is consistent with the guidance provided in the following regulatory guidance documents:
* Regulatory Guide 8.13 - Instructions Concerning Prenatal Radiation Exposure (USNRC, 1999)
Regulatory Guide 8.10 - Operating Philosophy for Maintaining Occupational Radiation Exposures As Low As Reasonably Achievable (USNRC, 2016)
* Regulatory Guide 8.29 - Instructions Concerning Risks from Occupational Radiation (USNRC, 1996)
Regulatory Guide 8.13 - Instructions Concerning Prenatal Radiation Exposure (USNRC, 1999)
* ASTM E1168 Radiological Protection Training for Nuclear Facility Workers (ASTM, 2013).
Regulatory Guide 8.29 - Instructions Concerning Risks from Occupational Radiation (USNRC, 1996)
viduals who require unescorted access into restricted areas (as defined in section 11.1.5.1.1) receive training that is commensurate with the radiological hazard to ch they may be exposed. Non-facility visitors and fire or emergency responders requiring ess to restricted areas are provided with trained escorts who have received radiation ection training.
ASTM E1168 Radiological Protection Training for Nuclear Facility Workers (ASTM, 2013).
level of radiation protection training provided is based on the potential radiological health s associated with an employee's work responsibilities and incorporates the provisions of CFR 19.12. In accordance with 10 CFR 19.12, any individual working at the facility who is y to receive in a year a dose in excess of 100 mrem (1 millisievert [mSv]) is:
Individuals who require unescorted access into restricted areas (as defined in Subsection 11.1.5.1.1) receive training that is commensurate with the radiological hazard to which they may be exposed. Non-facility visitors and fire or emergency responders requiring access to restricted areas are provided with trained escorts who have received radiation protection training.
* Kept informed of the storage, transfer, or use of radioactive material.
The level of radiation protection training provided is based on the potential radiological health risks associated with an employee's work responsibilities and incorporates the provisions of 10 CFR 19.12. In accordance with 10 CFR 19.12, any individual working at the facility who is likely to receive in a year a dose in excess of 100 mrem (1 millisievert [mSv]) is:
* Instructed in the health protection problems associated with exposure to radiation and radioactive material, in precautions or procedures to minimize exposure, and in the purposes and functions of protective devices employed.
Kept informed of the storage, transfer, or use of radioactive material.
* Provided with access to and training on the use of personal protective equipment (PPE).
Instructed in the health protection problems associated with exposure to radiation and radioactive material, in precautions or procedures to minimize exposure, and in the purposes and functions of protective devices employed.
* Required to observe, to the extent within the worker's control, the applicable provisions of the NRC regulations and licenses for the protection of personnel from exposure to radiation and radioactive material.
Provided with access to and training on the use of personal protective equipment (PPE).
* Instructed of their responsibility to report promptly to the facility management any condition which may cause a violation of NRC regulations and licenses or unnecessary exposure to radiation and radioactive material.
Required to observe, to the extent within the worker's control, the applicable provisions of the NRC regulations and licenses for the protection of personnel from exposure to radiation and radioactive material.
* Instructed in the appropriate response to warnings made in the event of any unusual occurrence or malfunction that may involve exposure to radiation and radioactive material.
Instructed of their responsibility to report promptly to the facility management any condition which may cause a violation of NRC regulations and licenses or unnecessary exposure to radiation and radioactive material.
* Advised of the various notifications and reports to individuals that a worker may request in accordance with 10 CFR 19.13.
Instructed in the appropriate response to warnings made in the event of any unusual occurrence or malfunction that may involve exposure to radiation and radioactive material.
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Advised of the various notifications and reports to individuals that a worker may request in accordance with 10 CFR 19.13.


radiation protection training program takes into consideration a worker's normally assigned k activities. Abnormal situations involving exposure to radiation and radioactive material, that reasonably be expected to occur during the life of the facility, are also evaluated and factored the training. The extent of these instructions is commensurate with the potential radiological lth protection problems present in the workplace.
Chapter 11 - Radiation Protection Program and Waste Management Radiation Protection SHINE Medical Technologies 11.1-12 Rev. 0 Workers who perform or supervise the shipment of radioactive materials are trained and qualified in accordance with 49 CFR 172, Subpart H, in accordance with 10 CFR 71.5.
raining of personnel previously trained is performed for radiological, chemical, industrial, and cality safety at least annually. The retraining program also includes procedure changes and ating and changes in required skills. Changes to training are implemented, when required, to incidents potentially compromising safety or if changes are made to the facility or cesses.
The radiation protection training program takes into consideration a worker's normally assigned work activities. Abnormal situations involving exposure to radiation and radioactive material, that can reasonably be expected to occur during the life of the facility, are also evaluated and factored into the training. The extent of these instructions is commensurate with the potential radiological health protection problems present in the workplace.
ords of training are maintained in accordance with the SHINE records management system.
Retraining of personnel previously trained is performed for radiological, chemical, industrial, and criticality safety at least annually. The retraining program also includes procedure changes and updating and changes in required skills. Changes to training are implemented, when required, due to incidents potentially compromising safety or if changes are made to the facility or processes.
ility training programs are established in accordance with Subsection 12.1.4. The radiation ection sections of the training program are evaluated at least annually. The program content viewed to ensure it remains current and adequate to ensure worker safety.
Records of training are maintained in accordance with the SHINE records management system.
  .2.1.7       Radiation Safety Audits iation safety audits are conducted, at a minimum, on an annual basis for the purpose of ewing all functional elements of the radiation protection program to meet the requirement of CFR 20.1101(c). The audit activity is led by a member of the Review and Audit Committee, or er designated independent individual, with the knowledge and experience to perform the vity. The audits provide sufficient information to assess:
Facility training programs are established in accordance with Subsection 12.1.4. The radiation protection sections of the training program are evaluated at least annually. The program content is reviewed to ensure it remains current and adequate to ensure worker safety.
* Compliance with NRC regulations
11.1.2.1.7 Radiation Safety Audits Radiation safety audits are conducted, at a minimum, on an annual basis for the purpose of reviewing all functional elements of the radiation protection program to meet the requirement of 10 CFR 20.1101(c). The audit activity is led by a member of the Review and Audit Committee, or other designated independent individual, with the knowledge and experience to perform the activity. The audits provide sufficient information to assess:
* Compliance with the terms and conditions of the license
Compliance with NRC regulations Compliance with the terms and conditions of the license Occupational doses and doses to members of the public for ALARA compliance Maintenance of radiation protection program required records Deficiencies identified during the audit are addressed through the corrective action program. The results of the radiation safety audits are provided to the Radiation Safety Committee, the COO and the CEO for review. Section 12.2 provides additional details of audit activities.
* Occupational doses and doses to members of the public for ALARA compliance
11.1.2.1.8 Record Keeping Radiation protection records are used for developing trend analysis, for keeping staff and management informed regarding radiation protection matters, and for reporting to regulatory agencies. In addition, the records are used to formulate action based on data obtained (such as survey or sample results), including historical trends.
* Maintenance of radiation protection program required records iciencies identified during the audit are addressed through the corrective action program. The ults of the radiation safety audits are provided to the Radiation Safety Committee, the COO the CEO for review. Section 12.2 provides additional details of audit activities.
In accordance with 10 CFR 20, Subpart L, the following records are retained until termination of the facility operating license:
  .2.1.8       Record Keeping iation protection records are used for developing trend analysis, for keeping staff and nagement informed regarding radiation protection matters, and for reporting to regulatory ncies. In addition, the records are used to formulate action based on data obtained (such as vey or sample results), including historical trends.
Records documenting provisions of the radiation protection program
ccordance with 10 CFR 20, Subpart L, the following records are retained until termination of facility operating license:
* Records documenting provisions of the radiation protection program
[10 CFR 20.2102(b)].
[10 CFR 20.2102(b)].
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* Results of measurements and calculations used to determine individual intakes of radioactive material used in the assessment of internal dose [10 CFR 20.2103(b)(2)].
Chapter 11 - Radiation Protection Program and Waste Management Radiation Protection SHINE Medical Technologies 11.1-13 Rev. 0 Results of surveys to determine individual dose from external sources
* Results of air sampling, surveys and bioassays required pursuant to 10 CFR 20.1703(c)(1) and (2) for the Respiratory Protection Program
[10 CFR 20.2103(b)(1)].
Results of measurements and calculations used to determine individual intakes of radioactive material used in the assessment of internal dose [10 CFR 20.2103(b)(2)].
Results of air sampling, surveys and bioassays required pursuant to 10 CFR 20.1703(c)(1) and (2) for the Respiratory Protection Program
[10 CFR 20.2103(b)(3)].
[10 CFR 20.2103(b)(3)].
* Results of measurements and calculations used to evaluate release of radioactive effluents to the environment [10 CFR 20.2103(b)(4)].
Results of measurements and calculations used to evaluate release of radioactive effluents to the environment [10 CFR 20.2103(b)(4)].
* NRC Form 4, Cumulative Occupational Dose History [10 CFR 20.2104(f)].
NRC Form 4, Cumulative Occupational Dose History [10 CFR 20.2104(f)].
* Planned Special Exposure documentation [10 CFR 20.2105(b)].
Planned Special Exposure documentation [10 CFR 20.2105(b)].
* Dose received by all individuals for whom monitoring was required pursuant to 10 CFR 20.1502, and records of doses received during planned special exposures, accidents and emergency conditions. Dose to an embryo/fetus are maintained with record of dose to the declared pregnant woman. [10 CFR 20.2106(a) through (f)].
Dose received by all individuals for whom monitoring was required pursuant to 10 CFR 20.1502, and records of doses received during planned special exposures, accidents and emergency conditions. Dose to an embryo/fetus are maintained with record of dose to the declared pregnant woman. [10 CFR 20.2106(a) through (f)].
* Declaration of pregnancy [10 CFR 20.2106(e)].
Declaration of pregnancy [10 CFR 20.2106(e)].
* Compliance with dose limit for individual members of the public [10 CFR 20.2107(b)].
Compliance with dose limit for individual members of the public [10 CFR 20.2107(b)].
* Disposal of licensed materials and disposal by burial in soil [10 CFR 20.2108(b)].
Disposal of licensed materials and disposal by burial in soil [10 CFR 20.2108(b)].
ccordance with 10 CFR 20, Subpart L, the following records are retained for three years:
In accordance with 10 CFR 20, Subpart L, the following records are retained for three years:
* Records of audits and reviews of the radiation protection program [10 CFR 20.2102(b)].
Records of audits and reviews of the radiation protection program [10 CFR 20.2102(b)].
* Records of surveys and calibrations required by 10 CFR 20.1501, Surveys and Monitoring, and 20.1906(b), Receiving and Opening Packages [10 CFR 20.2103(a)].
Records of surveys and calibrations required by 10 CFR 20.1501, Surveys and Monitoring, and 20.1906(b), Receiving and Opening Packages [10 CFR 20.2103(a)].
* Records used in preparing NRC Form 4 [10 CFR 20.2104(f)].
Records used in preparing NRC Form 4 [10 CFR 20.2104(f)].
ccordance with 10 CFR 20.2110, records will be legible throughout the retention period. The ord may be an original, or reproduced copy or microform provided it is authenticated by horized personnel and the microform is capable of producing a clear copy throughout the ntion period. Records may be stored in electronic media with the capability for producing ble, accurate and complete records during the required retention period. Records, such as rs, drawings and specifications, include all pertinent information, such as stamps, initials and atures.
In accordance with 10 CFR 20.2110, records will be legible throughout the retention period. The record may be an original, or reproduced copy or microform provided it is authenticated by authorized personnel and the microform is capable of producing a clear copy throughout the retention period. Records may be stored in electronic media with the capability for producing legible, accurate and complete records during the required retention period. Records, such as letters, drawings and specifications, include all pertinent information, such as stamps, initials and signatures.
  .2.1.9     Technical Specifications vities related to the administration and audit of the radiation protection are contained in the lity technical specifications.
11.1.2.1.9 Technical Specifications Activities related to the administration and audit of the radiation protection are contained in the facility technical specifications.
  .3       ALARA PROGRAM section 11.1.2.1 states the facility's commitment to the implementation of an ALARA gram. The objective of the program is to make every reasonable effort to maintain exposure adiation as far below the dose limits of 10 CFR 20.1201 and 10 CFR 20.1301 as is practical.
11.1.3 ALARA PROGRAM Subsection 11.1.2.1 states the facility's commitment to the implementation of an ALARA program. The objective of the program is to make every reasonable effort to maintain exposure to radiation as far below the dose limits of 10 CFR 20.1201 and 10 CFR 20.1301 as is practical.
design and implementation of the ALARA program is consistent with the guidance provided egulatory Guides 8.2 (USNRC, 2011), 8.13 (USNRC, 1999), and 8.29 (USNRC, 1996). The ration of the facility is consistent with the guidance provided in Regulatory Guide 8.10 NRC, 2016).
The design and implementation of the ALARA program is consistent with the guidance provided in Regulatory Guides 8.2 (USNRC, 2011), 8.13 (USNRC, 1999), and 8.29 (USNRC, 1996). The operation of the facility is consistent with the guidance provided in Regulatory Guide 8.10 (USNRC, 2016).
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son-rem) is maintained ALARA. The dose equivalent to an embryo/fetus of a declared gnant worker is maintained at or below the limit in 10 CFR 20.1208.
Chapter 11 - Radiation Protection Program and Waste Management Radiation Protection SHINE Medical Technologies 11.1-14 Rev. 0 Annual doses to individual personnel are maintained ALARA. In addition, the annual collective dose to personnel (i.e., the sum of annual individual doses, expressed in person-sievert [Sv] or person-rem) is maintained ALARA. The dose equivalent to an embryo/fetus of a declared pregnant worker is maintained at or below the limit in 10 CFR 20.1208.
radiation protection program is written and implemented to ensure that it is comprehensive effective. The written program documents policies that are implemented to ensure the RA goal is met. Procedures are written so that they incorporate the ALARA philosophy into routine operations and ensure that exposures are consistent with administrative dose limits.
The radiation protection program is written and implemented to ensure that it is comprehensive and effective. The written program documents policies that are implemented to ensure the ALARA goal is met. Procedures are written so that they incorporate the ALARA philosophy into the routine operations and ensure that exposures are consistent with administrative dose limits.
discussed in Subsection 11.1.5, radiological zones/areas are established within the facility.
As discussed in Subsection 11.1.5, radiological zones/areas are established within the facility.
establishment of these zones supports the ALARA commitment by minimizing the spread of tamination and reducing exposure of personnel to radiation.
The establishment of these zones supports the ALARA commitment by minimizing the spread of contamination and reducing exposure of personnel to radiation.
cific goals of the ALARA program include maintaining occupational exposures and ironmental releases as far below regulatory limits as is reasonably achievable. The ALARA cept is also incorporated into the design of the facility. The plant is divided into radiation es with radiation levels that are consistent with the access requirements for those areas.
Specific goals of the ALARA program include maintaining occupational exposures and environmental releases as far below regulatory limits as is reasonably achievable. The ALARA concept is also incorporated into the design of the facility. The plant is divided into radiation zones with radiation levels that are consistent with the access requirements for those areas.
as where on-site personnel spend significant amounts of time are designed to maintain the est dose rates reasonably achievable.
Areas where on-site personnel spend significant amounts of time are designed to maintain the lowest dose rates reasonably achievable.
Radiation Protection Manager is responsible for implementing the ALARA program and uring that adequate resources are committed to make the program effective. The Radiation tection Manager prepares an annual ALARA program evaluation report. The report reviews radiological exposure and effluent release data for trends, including ALARA dose goals, results of audits and inspections, (3) use, maintenance, and surveillance of equipment used exposure and effluent control, and (4) other issues that may influence the effectiveness of the ation protection/ALARA programs. The effectiveness of the ALARA program is reviewed by RSC. The RSC sets the ALARA goals for the facility and reviews new activities to ensure RA principles are considered. Efforts for improving the effectiveness of equipment used for ent and exposure control are also evaluated by the RSC. Any resulting recommendations the committee reviews and evaluations are documented in RSC meeting minutes. The mittee's recommendations are dispositioned in the facilitys corrective action process.
The Radiation Protection Manager is responsible for implementing the ALARA program and ensuring that adequate resources are committed to make the program effective. The Radiation Protection Manager prepares an annual ALARA program evaluation report. The report reviews (1) radiological exposure and effluent release data for trends, including ALARA dose goals, (2) results of audits and inspections, (3) use, maintenance, and surveillance of equipment used for exposure and effluent control, and (4) other issues that may influence the effectiveness of the radiation protection/ALARA programs. The effectiveness of the ALARA program is reviewed by the RSC. The RSC sets the ALARA goals for the facility and reviews new activities to ensure ALARA principles are considered. Efforts for improving the effectiveness of equipment used for effluent and exposure control are also evaluated by the RSC. Any resulting recommendations from the committee reviews and evaluations are documented in RSC meeting minutes. The committee's recommendations are dispositioned in the facilitys corrective action process.
  .3.1       ALARA Program Considerations SHINE facility is designed to maximize the incorporation of good engineering practices and ons learned to accomplish ALARA objectives.
11.1.3.1 ALARA Program Considerations The SHINE facility is designed to maximize the incorporation of good engineering practices and lessons learned to accomplish ALARA objectives.
  .3.1.1     Design and Construction Policies RA principles were applied during the design of the SHINE facility, consistent with the ommendations in Regulatory Guide 8.8, Information Relevant to Ensuring that Occupational iation Exposures at Nuclear Power Stations Will be As Low As Is Reasonably Achievable NRC, 1978).
11.1.3.1.1 Design and Construction Policies ALARA principles were applied during the design of the SHINE facility, consistent with the recommendations in Regulatory Guide 8.8, Information Relevant to Ensuring that Occupational Radiation Exposures at Nuclear Power Stations Will be As Low As Is Reasonably Achievable (USNRC, 1978).
ign considerations for maintaining personnel external doses ALARA include the following:
Design considerations for maintaining personnel external doses ALARA include the following:
* Materials of construction
Materials of construction Radioactive material processing, storage, and disposal facilities Radiation monitoring systems
* Radioactive material processing, storage, and disposal facilities
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Areas
Chapter 11 - Radiation Protection Program and Waste Management Radiation Protection SHINE Medical Technologies 11.1-15 Rev. 0 Facility layout for personnel traffic and equipment maintainability and accessibility Systems and devices to control access to High Radiation Areas and Very High Radiation Areas Utilizing the ALARA concepts of time, distance and shielding. For example:
* Utilizing the ALARA concepts of time, distance and shielding. For example:
Design work stations to minimize time operators need to be in radiation fields to perform work Locate equipment that require access at a maximum distance from radiation sources or provide remote equipment operation, where practicable Incorporate shielding, where appropriate, to achieve the design condition of 0.25 mrem/hr at 12 inches [30 cm] from the shielding surface Design considerations for preventing personnel contamination and minimizing the spread of contamination within the facility include the following:
      - Design work stations to minimize time operators need to be in radiation fields to perform work
Ventilation and filter systems Confinement to keep contamination ALARA Enclosures to prevent the spread of contamination Materials of construction to facilitate decontamination Facility layout, with emphasis on personnel and material movement patterns The following design considerations are used to control radioactive effluent releases:
      - Locate equipment that require access at a maximum distance from radiation sources or provide remote equipment operation, where practicable
Control of airborne effluents by incorporating confinement, radioactive gaseous waste system disposal capabilities, and exhaust system features Control of liquid effluents to ensure radioactive materials in excess of the limits are not released Use of radioactivity monitoring systems to monitor radioactive effluents The original facility design concepts to maintain exposures ALARA are presented in Subsection 11.1.3.2.
      - Incorporate shielding, where appropriate, to achieve the design condition of 0.25 mrem/hr at 12 inches [30 cm] from the shielding surface ign considerations for preventing personnel contamination and minimizing the spread of tamination within the facility include the following:
11.1.3.1.2 Operation Policies The activities conducted by management personnel who have plant operational responsibility for radiation protection are addressed in Subsection 11.1.2. These activities are consistent with the recommendations of Regulatory Guide 8.10 (USNRC, 2016).
Ventilation and filter systems
11.1.3.2 ALARA Facility Design Considerations Facility design considerations for maintaining personnel exposures ALARA are presented in the following paragraphs. The basic management philosophy guiding the SHINE facility design to maintain radiation exposures ALARA includes:
* Confinement to keep contamination ALARA
Designing structures, systems and components such that radioactive material, to the greatest extent practical, is remotely handled and isolated from on-site personnel by shielded compartments and hot cells.
* Enclosures to prevent the spread of contamination
Designing structures, systems and components for reliability and maintainability, thereby reducing the maintenance requirements on radioactive components.
* Materials of construction to facilitate decontamination
* Facility layout, with emphasis on personnel and material movement patterns following design considerations are used to control radioactive effluent releases:
* Control of airborne effluents by incorporating confinement, radioactive gaseous waste system disposal capabilities, and exhaust system features
* Control of liquid effluents to ensure radioactive materials in excess of the limits are not released
* Use of radioactivity monitoring systems to monitor radioactive effluents original facility design concepts to maintain exposures ALARA are presented in section 11.1.3.2.
  .3.1.2       Operation Policies activities conducted by management personnel who have plant operational responsibility for ation protection are addressed in Subsection 11.1.2. These activities are consistent with the ommendations of Regulatory Guide 8.10 (USNRC, 2016).
  .3.2         ALARA Facility Design Considerations ility design considerations for maintaining personnel exposures ALARA are presented in the wing paragraphs. The basic management philosophy guiding the SHINE facility design to ntain radiation exposures ALARA includes:
* Designing structures, systems and components such that radioactive material, to the greatest extent practical, is remotely handled and isolated from on-site personnel by shielded compartments and hot cells.
* Designing structures, systems and components for reliability and maintainability, thereby reducing the maintenance requirements on radioactive components.
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inspection activities.
Chapter 11 - Radiation Protection Program and Waste Management Radiation Protection SHINE Medical Technologies 11.1-16 Rev. 0 Designing structures, systems and components to reduce the radiation fields and control streaming, thereby reducing radiation exposure during operation, maintenance, and inspection activities.
* Designing structures, systems and components to reduce access, repair and removal times, thereby reducing the time spent in radiation fields during operation, maintenance, and inspection.
Designing structures, systems and components to reduce access, repair and removal times, thereby reducing the time spent in radiation fields during operation, maintenance, and inspection.
* Designing structures, systems and components to accommodate remote and semi-remote operation, maintenance and inspection, thereby reducing the time spent in radiation fields.
Designing structures, systems and components to accommodate remote and semi-remote operation, maintenance and inspection, thereby reducing the time spent in radiation fields.
.3.2.1     General Design Considerations for ALARA Exposures eral design considerations and methods to maintain in-plant radiation exposures ALARA sistent with the recommendations of Regulatory Guide 8.8 (USNRC, 1978) have two ctives:
11.1.3.2.1 General Design Considerations for ALARA Exposures General design considerations and methods to maintain in-plant radiation exposures ALARA consistent with the recommendations of Regulatory Guide 8.8 (USNRC, 1978) have two objectives:
* Minimizing the necessity for access to and personnel time spent in radiation areas.
Minimizing the necessity for access to and personnel time spent in radiation areas.
* Minimizing radiation levels in routinely occupied plant areas in the vicinity of plant equipment expected to require personnel attention.
Minimizing radiation levels in routinely occupied plant areas in the vicinity of plant equipment expected to require personnel attention.
following operations are considered during the equipment and facility design to maintain osures ALARA:
The following operations are considered during the equipment and facility design to maintain exposures ALARA:
* Normal operation.
Normal operation.
* Maintenance and repairs.
Maintenance and repairs.
* In-service inspection and calibrations.
In-service inspection and calibrations.
* Other anticipated operational occurrences.
Other anticipated operational occurrences.
* Decommissioning.
Decommissioning.
mples of features that assist in maintaining exposures ALARA include:
Examples of features that assist in maintaining exposures ALARA include:
* Design provisions for maintenance of the PCLS and light water pool chemistry conditions, such that corrosion and resulting activation product source terms are minimized.
Design provisions for maintenance of the PCLS and light water pool chemistry conditions, such that corrosion and resulting activation product source terms are minimized.
* Features to allow draining, flushing, and decontamination of equipment and piping.
Features to allow draining, flushing, and decontamination of equipment and piping.
* Shielding for personnel protection during maintenance or repairs and during decommissioning.
Shielding for personnel protection during maintenance or repairs and during decommissioning.
* Means and adequate space for the use of movable shielding.
Means and adequate space for the use of movable shielding.
* Separation of more highly radioactive equipment from less radioactive equipment and separate shielded compartments for adjacent items of radioactive equipment.
Separation of more highly radioactive equipment from less radioactive equipment and separate shielded compartments for adjacent items of radioactive equipment.
* Shielded access openings for installation and removal of plant components.
Shielded access openings for installation and removal of plant components.
* Design features, such as the means to provide surface decontamination within hot cells.
Design features, such as the means to provide surface decontamination within hot cells.
* Means and adequate space for the use of remote operations, maintenance, and inspection equipment.
Means and adequate space for the use of remote operations, maintenance, and inspection equipment.
* Separating clean areas from potentially contaminated ones.
Separating clean areas from potentially contaminated ones.
.3.2.2     Equipment Design Considerations for ALARA Exposures ipment design considerations to minimize the necessity for, and amount of, time spent in a ation area include:
11.1.3.2.2 Equipment Design Considerations for ALARA Exposures Equipment design considerations to minimize the necessity for, and amount of, time spent in a radiation area include:
NE Medical Technologies                    11.1-16                                        Rev. 0


repair or preventive maintenance.
Chapter 11 - Radiation Protection Program and Waste Management Radiation Protection SHINE Medical Technologies 11.1-17 Rev. 0 Reliability, availability, maintainability, inspectability, constructability, and other design features of equipment, components, and materials to reduce or eliminate the need for repair or preventive maintenance.
* Design features to facilitate ease of maintenance or repair, including ease of disassembly and modularization of components for replacement or removal to a lower radiation area for repair or disposal.
Design features to facilitate ease of maintenance or repair, including ease of disassembly and modularization of components for replacement or removal to a lower radiation area for repair or disposal.
* Capabilities to remotely or mechanically operate, repair, service, monitor, or inspect equipment.
Capabilities to remotely or mechanically operate, repair, service, monitor, or inspect equipment.
* Consideration of redundancy of equipment or components to reduce the need for immediate repair when radiation levels may be high and when there is no feasible method available to reduce radiation levels.
Consideration of redundancy of equipment or components to reduce the need for immediate repair when radiation levels may be high and when there is no feasible method available to reduce radiation levels.
* Capabilities for equipment to be operated from accessible areas both during normal and abnormal operating conditions.
Capabilities for equipment to be operated from accessible areas both during normal and abnormal operating conditions.
ipment design considerations directed toward minimizing radiation levels near equipment or ponents requiring personnel access include:
Equipment design considerations directed toward minimizing radiation levels near equipment or components requiring personnel access include:
* Selection of materials that minimize the creation of radioactive contamination.
Selection of materials that minimize the creation of radioactive contamination.
* Equipment and piping designs that minimize the accumulation of radioactive materials (e.g., the use of buttwelding fittings and minimizing the number of fittings reduces radiation accumulation at the seams and welds).
Equipment and piping designs that minimize the accumulation of radioactive materials (e.g., the use of buttwelding fittings and minimizing the number of fittings reduces radiation accumulation at the seams and welds).
* Provisions for draining, flushing, or, if necessary, remote cleaning or decontamination of equipment containing radioactive materials.
Provisions for draining, flushing, or, if necessary, remote cleaning or decontamination of equipment containing radioactive materials.
* Design to limit leaks or control the fluid that does leak. This includes the use of hermetically sealed valves and directing leakage via drip pans and piping.
Design to limit leaks or control the fluid that does leak. This includes the use of hermetically sealed valves and directing leakage via drip pans and piping.
* Provisions for isolating equipment from radioactive process fluids.
Provisions for isolating equipment from radioactive process fluids.
.3.2.3       Facility Layout Design Considerations for ALARA Exposures ility layout design considerations to minimize the amount of personnel time spent in a ation area include the following:
11.1.3.2.3 Facility Layout Design Considerations for ALARA Exposures Facility layout design considerations to minimize the amount of personnel time spent in a radiation area include the following:
* Locating equipment, instruments, and sampling stations that require routine maintenance, calibration, operation, or inspection, to promote ease of access and minimize occupancy time in radiation areas.
Locating equipment, instruments, and sampling stations that require routine maintenance, calibration, operation, or inspection, to promote ease of access and minimize occupancy time in radiation areas.
* Laying out plant areas to allow remote or mechanical operation, service, monitoring, or inspection of contaminated equipment.
Laying out plant areas to allow remote or mechanical operation, service, monitoring, or inspection of contaminated equipment.
* Providing, where practicable, for movement of equipment or components requiring service to a lower radiation area.
Providing, where practicable, for movement of equipment or components requiring service to a lower radiation area.
ign considerations directed toward minimizing radiation levels in occupied areas and in the nity of equipment requiring personnel access include the following:
Design considerations directed toward minimizing radiation levels in occupied areas and in the vicinity of equipment requiring personnel access include the following:
* Separating radiation sources and occupied areas, where practicable.
Separating radiation sources and occupied areas, where practicable.
* Redundant components requiring periodic maintenance that are a source of radiation are located in separate compartments, where practicable, to allow maintenance of one component while the other component is in operation.
Redundant components requiring periodic maintenance that are a source of radiation are located in separate compartments, where practicable, to allow maintenance of one component while the other component is in operation.
* Highly radioactive passive components with minimal maintenance requirements are located in shielded enclosures and are provided with access via shielded openings or removable blocks.
Highly radioactive passive components with minimal maintenance requirements are located in shielded enclosures and are provided with access via shielded openings or removable blocks.
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passing through a higher radiation zone.
Chapter 11 - Radiation Protection Program and Waste Management Radiation Protection SHINE Medical Technologies 11.1-18 Rev. 0 Providing means and adequate space for using movable shielding when required.
* Locating equipment, instruments, and sampling sites in the lowest practicable radiation zone.
Designing of the plant layout so that access to a given radiation zone does not require passing through a higher radiation zone.
* Providing control panels to permit remote operation of essential instrumentation and controls from the lowest radiation zone practicable.
Locating equipment, instruments, and sampling sites in the lowest practicable radiation zone.
* Providing means to control contamination by maintaining ventilation air flow patterns from areas of lower radioactivity to areas of higher radioactivity.
Providing control panels to permit remote operation of essential instrumentation and controls from the lowest radiation zone practicable.
* Providing means to facilitate decontamination of potentially contaminated areas.
Providing means to control contamination by maintaining ventilation air flow patterns from areas of lower radioactivity to areas of higher radioactivity.
  .4       RADIATION MONITORING AND SURVEYING
Providing means to facilitate decontamination of potentially contaminated areas.
  .4.1       Radiation Monitoring nventory of calibrated radiation detection and measurement instruments is maintained to orm functions such as radiation surveys, contamination surveys, package surveys, sealed rce leak tests, air sampling measurements, effluent release measurements, and dose rate asurements. Radiation monitoring equipment, their function and location is shown in le 11.1-12 and is discussed below.
11.1.4 RADIATION MONITORING AND SURVEYING 11.1.4.1 Radiation Monitoring An inventory of calibrated radiation detection and measurement instruments is maintained to perform functions such as radiation surveys, contamination surveys, package surveys, sealed source leak tests, air sampling measurements, effluent release measurements, and dose rate measurements. Radiation monitoring equipment, their function and location is shown in Table 11.1-12 and is discussed below.
: a. Personnel Monitors Personnel who enter radiologically restricted areas (as defined in Subsection 11.1.5.1) are required to wear personnel monitoring devices. In addition, personnel are required to monitor themselves prior to exiting restricted areas which may have the potential for contamination.
a.
: b. Continuous Air Monitors Continuous air monitors (CAMs) provide indication of the airborne activity levels in the restricted areas of the facility. Alarms are used to provide early warning of unanticipated increases in airborne radioactivity levels. Procedures provide detailed instructions for using and determining CAM alarm setpoints. When deemed necessary, portable air samplers may be used to collect a sample on filter paper for subsequent analysis in the laboratory.
Personnel Monitors Personnel who enter radiologically restricted areas (as defined in Subsection 11.1.5.1) are required to wear personnel monitoring devices. In addition, personnel are required to monitor themselves prior to exiting restricted areas which may have the potential for contamination.
: c. Continuous Tritium Detectors Tritium is monitored at specific locations where airborne tritium may be present and present a potential hazard to individuals. Tritium monitoring is accomplished using fixed continuous instruments for room air sampling and ventilation duct sampling.
b.
: d. Gaseous Effluent Monitoring The stack release monitor (SRM) on the facility effluent stack and the carbon delay bed effluent monitor (CDBEM) must be capable of:
Continuous Air Monitors Continuous air monitors (CAMs) provide indication of the airborne activity levels in the restricted areas of the facility. Alarms are used to provide early warning of unanticipated increases in airborne radioactivity levels. Procedures provide detailed instructions for using and determining CAM alarm setpoints. When deemed necessary, portable air samplers may be used to collect a sample on filter paper for subsequent analysis in the laboratory.
* Continuous monitoring of radioactive stack releases for noble gases.
c.
* Generating real time data for control room display and recording.
Continuous Tritium Detectors Tritium is monitored at specific locations where airborne tritium may be present and present a potential hazard to individuals. Tritium monitoring is accomplished using fixed continuous instruments for room air sampling and ventilation duct sampling.
NE Medical Technologies                      11.1-18                                      Rev. 0
d.
Gaseous Effluent Monitoring The stack release monitor (SRM) on the facility effluent stack and the carbon delay bed effluent monitor (CDBEM) must be capable of:
Continuous monitoring of radioactive stack releases for noble gases.
Generating real time data for control room display and recording.


Chapter 11 - Radiation Protection Program and Waste Management Radiation Protection SHINE Medical Technologies 11.1-19 Rev. 0 Allowing periodic collection of filters to allow for laboratory analysis for particulate and iodine.
The SRM provides continuous on-line sampling of releases of gaseous effluents from the facility to demonstrate that releases are within the regulatory limits. The CDBEM is provided to monitor the safety-related alternate release path.
The SRM provides continuous on-line sampling of releases of gaseous effluents from the facility to demonstrate that releases are within the regulatory limits. The CDBEM is provided to monitor the safety-related alternate release path.
: e. Detection and Monitoring of Radioactivity in Liquid Systems and Liquid Effluents There are no piped radioactive liquid effluent discharges from the facility; therefore, there are no installed liquid effluent monitors. However, liquid effluent releases are collected and sampled prior to release.
e.
Detection and Monitoring of Radioactivity in Liquid Systems and Liquid Effluents There are no piped radioactive liquid effluent discharges from the facility; therefore, there are no installed liquid effluent monitors. However, liquid effluent releases are collected and sampled prior to release.
Closed loop process cooling water systems are monitored (through sampling or installed instrumentation) to detect leakage between process fluids and cooling water due to failure in a heat exchanger or other system boundary component.
Closed loop process cooling water systems are monitored (through sampling or installed instrumentation) to detect leakage between process fluids and cooling water due to failure in a heat exchanger or other system boundary component.
: f. Radiation Area Monitors Radiation area monitors (RAMs) provide radiation monitoring and alarms to alert personnel and the control room of radiation levels that are in excess of normal background levels. RAMs are located in areas to monitor the environment for radioactivity during normal operations, operational occurrences and postulated accidents. Procedures provide detailed instructions for determining and employing alarm set points for RAMs.
f.
Radiation Area Monitors Radiation area monitors (RAMs) provide radiation monitoring and alarms to alert personnel and the control room of radiation levels that are in excess of normal background levels. RAMs are located in areas to monitor the environment for radioactivity during normal operations, operational occurrences and postulated accidents. Procedures provide detailed instructions for determining and employing alarm set points for RAMs.
RAMs may be provided in High Radiation Areas in order to provide a remote readout. If a RAM is not provided in a particular High Radiation Area, then portable instruments are required by the RWP to measure dose rates when personnel access the area.
RAMs may be provided in High Radiation Areas in order to provide a remote readout. If a RAM is not provided in a particular High Radiation Area, then portable instruments are required by the RWP to measure dose rates when personnel access the area.
: g. Control Point Monitoring Monitor stations are located at the access points for restricted areas. Monitors are provided to detect radioactive contamination of personnel. Monitoring station locations are evaluated and moved as necessary in response to changes in the facility radiological conditions.
g.
Control Point Monitoring Monitor stations are located at the access points for restricted areas. Monitors are provided to detect radioactive contamination of personnel. Monitoring station locations are evaluated and moved as necessary in response to changes in the facility radiological conditions.
Monitoring equipment used at the facility access points are shown in Table 11.1-12.
Monitoring equipment used at the facility access points are shown in Table 11.1-12.
: h. Criticality Monitoring Criticality monitoring in the RPF is provided by the criticality accident alarm system (CAAS). This system is described in Section 7.7.
h.
iation monitoring systems, their functions, and their interfaces with the engineered safety ures in the facility are described in Section 7.7.
Criticality Monitoring Criticality monitoring in the RPF is provided by the criticality accident alarm system (CAAS). This system is described in Section 7.7.
NE Medical Technologies                    11.1-19                                        Rev. 0
Radiation monitoring systems, their functions, and their interfaces with the engineered safety features in the facility are described in Section 7.7.


cedures are prepared for each of the radiation monitoring instruments used and specify the uency and method of calibration. Radiation monitoring equipment is calibrated before being into use and after any maintenance or repair that may affect instrument performance.
Chapter 11 - Radiation Protection Program and Waste Management Radiation Protection SHINE Medical Technologies 11.1-20 Rev. 0 11.1.4.1.1 Calibration and Maintenance of Radiation Monitoring Equipment Procedures are prepared for each of the radiation monitoring instruments used and specify the frequency and method of calibration. Radiation monitoring equipment is calibrated before being put into use and after any maintenance or repair that may affect instrument performance.
bration of portable radiological monitoring equipment used to document radiological survey ults is performed in accordance with ANSI N323AB-2013, American National Standard for iation Protection Instrumentation Test and Calibration, Portable Survey Instruments SI/ANS, 2014).
Calibration of portable radiological monitoring equipment used to document radiological survey results is performed in accordance with ANSI N323AB-2013, American National Standard for Radiation Protection Instrumentation Test and Calibration, Portable Survey Instruments (ANSI/ANS, 2014).
iation monitoring equipment is calibrated in accordance with manufacturer ommendations.
Radiation monitoring equipment is calibrated in accordance with manufacturer recommendations.
ntenance and repair of radiation protection instrumentation is performed in accordance with roved procedures and instrument manufacturer recommendations.
Maintenance and repair of radiation protection instrumentation is performed in accordance with approved procedures and instrument manufacturer recommendations.
  .4.1.2       Operational Tests of Radiation Monitoring Equipment ration and response tests of radiation monitoring, counting, and air sampling instruments are ormed by personnel trained in the use of the instrument and following approved procedures.
11.1.4.1.2 Operational Tests of Radiation Monitoring Equipment Operation and response tests of radiation monitoring, counting, and air sampling instruments are performed by personnel trained in the use of the instrument and following approved procedures.
se tests are consistent with the manufacturers recommendations and applicable regulatory uirements. Operation and response tests are conducted at a frequency consistent with stry practices and is addressed in detailed instructions.
These tests are consistent with the manufacturers recommendations and applicable regulatory requirements. Operation and response tests are conducted at a frequency consistent with industry practices and is addressed in detailed instructions.
  .4.2         Radiation Surveys iation surveys are conducted for two purposes: (1) to ascertain radiation levels, centrations of radioactive materials, and potential radiological hazards that could be present e facility; and (2) to detect releases of radioactive material from facility equipment and rations.
11.1.4.2 Radiation Surveys Radiation surveys are conducted for two purposes: (1) to ascertain radiation levels, concentrations of radioactive materials, and potential radiological hazards that could be present in the facility; and (2) to detect releases of radioactive material from facility equipment and operations.
assure compliance with the requirements of 10 CFR 20, Subpart C, there are written cedures for the radiation survey and monitoring programs. The radiation survey and nitoring programs assure compliance with the requirements of 10 CFR 20, Subpart F, part C, Subpart L, and Subpart M.
To assure compliance with the requirements of 10 CFR 20, Subpart C, there are written procedures for the radiation survey and monitoring programs. The radiation survey and monitoring programs assure compliance with the requirements of 10 CFR 20, Subpart F, Subpart C, Subpart L, and Subpart M.
radiation survey and monitoring practices are consistent with the guidance provided in the wing references:
The radiation survey and monitoring practices are consistent with the guidance provided in the following references:
* Regulatory Guide 8.2, Guide for Administrative Practice in Radiation Monitoring (USNRC, 2011)
Regulatory Guide 8.2, Guide for Administrative Practice in Radiation Monitoring (USNRC, 2011)
* Regulatory Guide 8.7, Instructions for Recording and Reporting Occupational Radiation Exposure Data (USNRC, 2018)
Regulatory Guide 8.7, Instructions for Recording and Reporting Occupational Radiation Exposure Data (USNRC, 2018)
* Regulatory Guide 8.9, Acceptable Concepts, Models, Equations, and Assumptions for a Bioassay Program (USNRC, 1993)
Regulatory Guide 8.9, Acceptable Concepts, Models, Equations, and Assumptions for a Bioassay Program (USNRC, 1993)
* Regulatory Guide 8.24, Health Physics Surveys During Enriched Uranium-235 Processing and Fuel Fabrication (USNRC, 2012) (applicable to target solution preparation processes)
Regulatory Guide 8.24, Health Physics Surveys During Enriched Uranium-235 Processing and Fuel Fabrication (USNRC, 2012) (applicable to target solution preparation processes)
NE Medical Technologies                       11.1-20                                        Rev. 0
 
* ANSI N323AB-2013, American National Standard for Radiation Protection Instrumentation Test and Calibration, Portable Survey Instruments (ANSI/ANS, 2014) cedures include sampling protocol and data analysis methods. Equipment selection is based he type of radiation being monitored.
Chapter 11 - Radiation Protection Program and Waste Management Radiation Protection SHINE Medical Technologies 11.1-21 Rev. 0 Regulatory Guide 8.34, Monitoring Criteria and Methods to Calculate Occupational Radiation Doses (USNRC, 1992)
vey procedures also specify the frequency of measurements and record keeping and orting requirements. Survey records include:
ANSI N323AB-2013, American National Standard for Radiation Protection Instrumentation Test and Calibration, Portable Survey Instruments (ANSI/ANS, 2014)
* Radiation dose rate survey results
Procedures include sampling protocol and data analysis methods. Equipment selection is based on the type of radiation being monitored.
* Surface contamination survey results
Survey procedures also specify the frequency of measurements and record keeping and reporting requirements. Survey records include:
* Airborne radioactivity survey results
Radiation dose rate survey results Surface contamination survey results Airborne radioactivity survey results 11.1.4.3 Technical Specifications Certain material in this section provides information that is used in the technical specifications.
  .4.3         Technical Specifications tain material in this section provides information that is used in the technical specifications.
This includes limiting conditions for operation, setpoints, design features, and means for accomplishing surveillances. In addition, significant material is also applicable to, and may be referenced by, the bases that are described in the technical specifications.
includes limiting conditions for operation, setpoints, design features, and means for omplishing surveillances. In addition, significant material is also applicable to, and may be renced by, the bases that are described in the technical specifications.
11.1.5 RADIATION EXPOSURE CONTROL AND DOSIMETRY 11.1.5.1 Controlled Access Area The area of the SHINE site within the security fence, including within the main production facility physical structure beyond the main reception area, but outside any restricted area is part of the controlled access area. Due to the presence of administrative and physical barriers, members of the public do not have direct access to this controlled access area of the site and must be processed by security and authorized to enter the facility. Training for access to a controlled access area is provided commensurate with the radiological hazard.
  .5       RADIATION EXPOSURE CONTROL AND DOSIMETRY
Facility visitors include delivery people, tour guests, and service personnel who are transient occupants of the controlled area. Area monitoring demonstrates compliance with public dose limits for such visitors. Exposure to SHINE employees or contractors who work only in the controlled access area, but do not enter restricted areas, is limited such that the exposures do not exceed 100 mrem per year.
  .5.1         Controlled Access Area area of the SHINE site within the security fence, including within the main production facility sical structure beyond the main reception area, but outside any restricted area is part of the trolled access area. Due to the presence of administrative and physical barriers, members of public do not have direct access to this controlled access area of the site and must be cessed by security and authorized to enter the facility. Training for access to a controlled ess area is provided commensurate with the radiological hazard.
11.1.5.1.1 Radiological Zones Radiological zones with varied definitions and span of control have been designated for the facility site and areas surrounding the facility site. The purpose of these zones is to (1) control the spread of contamination, (2) control personnel access to avoid unnecessary exposure of personnel to radiation, and (3) control access to radioactive sources present in the facility. Public access to radiological areas is restricted as detailed in this section and as directed by facility management. Areas where personnel spend substantial amounts of time are designed to minimize the exposure received when routine tasks are performed, in accordance with the ALARA principle.
ility visitors include delivery people, tour guests, and service personnel who are transient upants of the controlled area. Area monitoring demonstrates compliance with public dose ts for such visitors. Exposure to SHINE employees or contractors who work only in the trolled access area, but do not enter restricted areas, is limited such that the exposures do exceed 100 mrem per year.
 
  .5.1.1       Radiological Zones iological zones with varied definitions and span of control have been designated for the lity site and areas surrounding the facility site. The purpose of these zones is to (1) control the ead of contamination, (2) control personnel access to avoid unnecessary exposure of sonnel to radiation, and (3) control access to radioactive sources present in the facility. Public ess to radiological areas is restricted as detailed in this section and as directed by facility nagement. Areas where personnel spend substantial amounts of time are designed to imize the exposure received when routine tasks are performed, in accordance with the RA principle.
Chapter 11 - Radiation Protection Program and Waste Management Radiation Protection SHINE Medical Technologies 11.1-22 Rev. 0 The following definitions are provided to describe how the radiation protection program is implemented to protect workers and the general public on the site:
NE Medical Technologies                     11.1-21                                      Rev. 0
a.
: a. Unrestricted Area NRC regulation 10 CFR 20.1003 defines an unrestricted area as an area for which access is neither limited nor controlled by the licensee. The area adjacent to the facility site is an unrestricted area. This area can be accessed by members of the public or by facility personnel. The unrestricted area is governed by the limits in 10 CFR 20.1301. The total effective dose equivalent (TEDE) to individual members of the public from the licensed operation may not exceed 1 mSv (100 mrem) in a year (exclusive of background radiation). The dose in any unrestricted area from external sources may not exceed 0.02 mSv (2 mrem) in any one hour.
Unrestricted Area NRC regulation 10 CFR 20.1003 defines an unrestricted area as an area for which access is neither limited nor controlled by the licensee. The area adjacent to the facility site is an unrestricted area. This area can be accessed by members of the public or by facility personnel. The unrestricted area is governed by the limits in 10 CFR 20.1301. The total effective dose equivalent (TEDE) to individual members of the public from the licensed operation may not exceed 1 mSv (100 mrem) in a year (exclusive of background radiation). The dose in any unrestricted area from external sources may not exceed 0.02 mSv (2 mrem) in any one hour.
: b. Restricted Area 10 CFR 20.1003 defines a restricted area as an area where access is limited by the licensee for the purpose of protecting individuals against undue risks from exposure to radiation and radioactive materials. Access to and egress from a restricted area at the facility site is through a radiation protection control point. Monitoring equipment is located at these control points.
b.
Restricted Area 10 CFR 20.1003 defines a restricted area as an area where access is limited by the licensee for the purpose of protecting individuals against undue risks from exposure to radiation and radioactive materials. Access to and egress from a restricted area at the facility site is through a radiation protection control point. Monitoring equipment is located at these control points.
Most restricted areas are located within the physical structure of the main production facility and locations in the material staging building where radioactive material is normally stored. Radioactive material may be temporarily stored in outdoor areas during transfer between areas. These temporary areas may require that a restricted area be established with the controls described in this section.
Most restricted areas are located within the physical structure of the main production facility and locations in the material staging building where radioactive material is normally stored. Radioactive material may be temporarily stored in outdoor areas during transfer between areas. These temporary areas may require that a restricted area be established with the controls described in this section.
: c. Radiologically Controlled Area The RCA is a restricted area. The RCA is an area within the restricted area posted for the purpose of protecting individuals against undue risks from exposure to radiation and radioactive materials. Only individuals who have successfully completed training in radiation protection procedures are permitted to access this area without escort by trained personnel.
c.
itional radiological areas may exist within the restricted area. The areas may be temporary or manent. The areas are posted to inform workers of the potential hazard in the area and to prevent the spread of contamination. The areas are conspicuously posted in accordance the requirements of 10 CFR 20 as shown on Table 11.1-13.
Radiologically Controlled Area The RCA is a restricted area. The RCA is an area within the restricted area posted for the purpose of protecting individuals against undue risks from exposure to radiation and radioactive materials. Only individuals who have successfully completed training in radiation protection procedures are permitted to access this area without escort by trained personnel.
iation areas and expected dose rates are shown in Table 11.1-4.
Additional radiological areas may exist within the restricted area. The areas may be temporary or permanent. The areas are posted to inform workers of the potential hazard in the area and to help prevent the spread of contamination. The areas are conspicuously posted in accordance with the requirements of 10 CFR 20 as shown on Table 11.1-13.
.5.2         Access and Egress Control NE establishes and implements an access control program that ensures that (a) signs, ls, and other access controls are properly posted and operative, (b) restricted areas are blished to prevent the spread of contamination and are identified with appropriate signs, and step-off pads, change facilities, protective clothing facilities, and personnel monitoring ruments are provided in sufficient quantities and locations, as necessary.
Radiation areas and expected dose rates are shown in Table 11.1-4.
NE Medical Technologies                        11.1-22                                        Rev. 0
11.1.5.2 Access and Egress Control SHINE establishes and implements an access control program that ensures that (a) signs, labels, and other access controls are properly posted and operative, (b) restricted areas are established to prevent the spread of contamination and are identified with appropriate signs, and (c) step-off pads, change facilities, protective clothing facilities, and personnel monitoring instruments are provided in sufficient quantities and locations, as necessary.


ve and passive safety features are provided to control access to high radiation areas in ordance with 10 CFR 20.1601. These safety features include:
Chapter 11 - Radiation Protection Program and Waste Management Radiation Protection SHINE Medical Technologies 11.1-23 Rev. 0 Personnel access to high radiation areas is controlled to prevent unplanned radiation exposures.
* Neutron driver service cell personnel access door interlocks de-energize the accelerator to reduce the level of radiation upon personnel entry (defense-in-depth design attribute),
Personnel access is controlled through administrative methods, including procedures and RWPs.
Active and passive safety features are provided to control access to high radiation areas in accordance with 10 CFR 20.1601. These safety features include:
Neutron driver service cell personnel access door interlocks de-energize the accelerator to reduce the level of radiation upon personnel entry (defense-in-depth design attribute),
and accelerator key switches prevent activation of the accelerator while personnel are present.
and accelerator key switches prevent activation of the accelerator while personnel are present.
* Hot cells requiring periodic/routine entry where there is potential for excessive personnel exposures are equipped with door interlocks to prevent the hot cell door from being opened when the evaluated hazard exists (e.g., excessive radiation field, target solution transfer occurring in cell).
Hot cells requiring periodic/routine entry where there is potential for excessive personnel exposures are equipped with door interlocks to prevent the hot cell door from being opened when the evaluated hazard exists (e.g., excessive radiation field, target solution transfer occurring in cell).
* The neutron driver service cell and hot cells are equipped with audible and visual warnings so that an individual attempting to enter the High Radiation Area and the supervisor of the activity are made aware of the entry or are controlled by locked entry with positive access controls over each individual entry, consistent with 10 CFR 20.1601(a).
The neutron driver service cell and hot cells are equipped with audible and visual warnings so that an individual attempting to enter the High Radiation Area and the supervisor of the activity are made aware of the entry or are controlled by locked entry with positive access controls over each individual entry, consistent with 10 CFR 20.1601(a).
* High radiation areas are radiologically shielded and isolated from access to individuals by the use of engineered physical barriers. These include structural shield blocks and/or locked shield doors, consistent with 10 CFR 20.1601(a)(3).
High radiation areas are radiologically shielded and isolated from access to individuals by the use of engineered physical barriers. These include structural shield blocks and/or locked shield doors, consistent with 10 CFR 20.1601(a)(3).
ess to and egress from the restricted area is through one of the monitor stations at the ricted area boundary. Access to and egress from each Radiation Area, High Radiation Area, taminated Area or Airborne Radioactivity Area within the restricted area may also be vidually controlled. A monitor (frisker), step-off pad, and container for any discarded ective clothing may be provided at the egress point from certain of these areas to prevent the ead of contamination.
Access to and egress from the restricted area is through one of the monitor stations at the restricted area boundary. Access to and egress from each Radiation Area, High Radiation Area, Contaminated Area or Airborne Radioactivity Area within the restricted area may also be individually controlled. A monitor (frisker), step-off pad, and container for any discarded protective clothing may be provided at the egress point from certain of these areas to prevent the spread of contamination.
  .5.3       Posting for Radiation Protection Awareness iological postings are clearly identified by physical means such as placarding or boundary king in accordance with 10 CFR 20.1902.
11.1.5.3 Posting for Radiation Protection Awareness Radiological postings are clearly identified by physical means such as placarding or boundary marking in accordance with 10 CFR 20.1902.
  .5.4       Protective Clothing and Equipment sonnel working in areas that are classified as airborne radioactivity areas or contaminated as must wear appropriate PPE. If the areas containing the surface contamination can be ated from adjacent work areas via a barrier such that dispersible material is not likely to be sferred beyond the area of contamination, personnel working in the adjacent area are not uired to wear PPE. Areas requiring PPE are posted at each of their entry points. The radiation ker training program provides instruction to personnel on the proper use of PPE.
11.1.5.4 Protective Clothing and Equipment Personnel working in areas that are classified as airborne radioactivity areas or contaminated areas must wear appropriate PPE. If the areas containing the surface contamination can be isolated from adjacent work areas via a barrier such that dispersible material is not likely to be transferred beyond the area of contamination, personnel working in the adjacent area are not required to wear PPE. Areas requiring PPE are posted at each of their entry points. The radiation worker training program provides instruction to personnel on the proper use of PPE.
iation protection management and associated technical staff are responsible for determining need for PPE in each work area and documenting the PPE requirements on the applicable P. For areas with removable contamination from beta/gamma emitters or uranium above 00 disintegrations per minute per 100 square centimeters (dpm/100 cm2) or from alpha tters other than uranium above 20 dpm/cm2 PPE is required. PPE includes coveralls, gloves, NE Medical Technologies                    11.1-23                                        Rev. 0
Radiation protection management and associated technical staff are responsible for determining the need for PPE in each work area and documenting the PPE requirements on the applicable RWP. For areas with removable contamination from beta/gamma emitters or uranium above 1,000 disintegrations per minute per 100 square centimeters (dpm/100 cm2) or from alpha emitters other than uranium above 20 dpm/cm2 PPE is required. PPE includes coveralls, gloves,  


respiratory protection program is described in Section 11.3.
Chapter 11 - Radiation Protection Program and Waste Management Radiation Protection SHINE Medical Technologies 11.1-24 Rev. 0 shoe covers, and rubber boots. Guidance for selecting and using PPE is provided in the facility radiation protection program.
  .5.5       Personnel Monitoring for External Exposures ernal exposures are received primarily from the fission products produced in the target tion. Other potential sources of exposure include neutrons (e.g., from operational neutron ers), activation products, and tritium gas. The nuclides of radiological significance are tified above in Section 11.1.
The respiratory protection program is described in Section 11.3.
sonnel whose duties require them to enter restricted areas wear individual external dosimetry ices that are sensitive to beta, gamma and neutron radiation. Personnel handling licensed rces and working around radioactive materials outside restricted areas (e.g.,
11.1.5.5 Personnel Monitoring for External Exposures External exposures are received primarily from the fission products produced in the target solution. Other potential sources of exposure include neutrons (e.g., from operational neutron drivers), activation products, and tritium gas. The nuclides of radiological significance are identified above in Section 11.1.
sportation-related surveys) wear individual external dosimetry devices that are sensitive to a, gamma and neutron radiation. Any individual entering a High Radiation Area or Very High iation Area wears personal dosimetry, and supplemental dosimetry with dose and dose rate m capability.
Personnel whose duties require them to enter restricted areas wear individual external dosimetry devices that are sensitive to beta, gamma and neutron radiation. Personnel handling licensed sources and working around radioactive materials outside restricted areas (e.g.,
sonal dosimetry shall be worn in a manner consistent with the manufacturers directions.
transportation-related surveys) wear individual external dosimetry devices that are sensitive to beta, gamma and neutron radiation. Any individual entering a High Radiation Area or Very High Radiation Area wears personal dosimetry, and supplemental dosimetry with dose and dose rate alarm capability.
ernal dosimetry devices are evaluated at least quarterly, or soon after participation in high-e evolutions, to ascertain external exposures. Administrative limits on radiation exposure are d in Table 11.1-11. The administrative limits are reflective of ALARA principles.
Personal dosimetry shall be worn in a manner consistent with the manufacturers directions.
stigation levels are set at 25 percent of the annual administrative limit for any workers upational dose received during a calendar quarter. An investigation is performed and umented to determine what types of activities may have contributed to the worker's external osure. The investigation may include, but is not limited to, procedural reviews, efficiency ies of the ventilation system, uranium storage protocol, and work practices.
External dosimetry devices are evaluated at least quarterly, or soon after participation in high-dose evolutions, to ascertain external exposures. Administrative limits on radiation exposure are listed in Table 11.1-11. The administrative limits are reflective of ALARA principles.
time an administrative limit is exceeded, the Radiation Protection Manager is informed. The iation Protection Manager is responsible for determining the need for and recommending stigations or corrective actions to the responsible manager(s). Copies of the Radiation tection Manager's recommendations are provided to the RSC.
Investigation levels are set at 25 percent of the annual administrative limit for any workers occupational dose received during a calendar quarter. An investigation is performed and documented to determine what types of activities may have contributed to the worker's external exposure. The investigation may include, but is not limited to, procedural reviews, efficiency studies of the ventilation system, uranium storage protocol, and work practices.
osure limits for volunteer emergency responders are controlled and administered by the lity Emergency Plan.
Any time an administrative limit is exceeded, the Radiation Protection Manager is informed. The Radiation Protection Manager is responsible for determining the need for and recommending investigations or corrective actions to the responsible manager(s). Copies of the Radiation Protection Manager's recommendations are provided to the RSC.
  .5.6       Determination of Internal Exposures purposes of assessing dose used to determine compliance with occupational dose ivalent limits, SHINE shall, when required under 10 CFR 20.1502, take suitable and timely asurements of one of the following:
Exposure limits for volunteer emergency responders are controlled and administered by the facility Emergency Plan.
: 1. Concentrations of radioactive materials in air in work areas.
11.1.5.6 Determination of Internal Exposures For purposes of assessing dose used to determine compliance with occupational dose equivalent limits, SHINE shall, when required under 10 CFR 20.1502, take suitable and timely measurements of one of the following:
: 2. Quantities of radionuclides in the body.
1.
: 3. Quantities of radionuclides excreted from the body.
Concentrations of radioactive materials in air in work areas.
: 4. Combinations of these measurements.
2.
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Quantities of radionuclides in the body.
3.
Quantities of radionuclides excreted from the body.
4.
Combinations of these measurements.


oactive material at the airborne concentration in which the individual is present.
Chapter 11 - Radiation Protection Program and Waste Management Radiation Protection SHINE Medical Technologies 11.1-25 Rev. 0 Unless respiratory protective equipment is used, as provided in 10 CFR 20.1703, or the assessment of intake is based on bioassays, SHINE shall assume that an individual inhales radioactive material at the airborne concentration in which the individual is present.
radiation protection program includes detailed methodology for determination of internal osures.
The radiation protection program includes detailed methodology for determination of internal exposures.
.5.7       Evaluation and Record of Doses vidual worker occupational dose is assessed on a quarterly basis and is performed more uently when reasonable suspicion exists regarding an abnormal exposure. External imetry devices are processed and evaluated by a provider accredited by the National untary Laboratory Accreditation Program.
11.1.5.7 Evaluation and Record of Doses Individual worker occupational dose is assessed on a quarterly basis and is performed more frequently when reasonable suspicion exists regarding an abnormal exposure. External dosimetry devices are processed and evaluated by a provider accredited by the National Voluntary Laboratory Accreditation Program.
* Procedures for the evaluation and summation of doses are based on guidance contained in Regulatory Guides 8.7 (USNRC, 2018) and 8.34 (USNRC, 1992).
Procedures for the evaluation and summation of doses are based on guidance contained in Regulatory Guides 8.7 (USNRC, 2018) and 8.34 (USNRC, 1992).
ords are maintained of doses received by all individuals for whom monitoring is required er 10 CFR 20.1502, in accordance with 10 CFR 20.2106. The records include the following, pplicable:
Records are maintained of doses received by all individuals for whom monitoring is required under 10 CFR 20.1502, in accordance with 10 CFR 20.2106. The records include the following, as applicable:
* The deep-dose equivalent to the whole body, lens dose equivalent, shallow-dose equivalent to the skin and shallow-dose equivalent to the extremities;
The deep-dose equivalent to the whole body, lens dose equivalent, shallow-dose equivalent to the skin and shallow-dose equivalent to the extremities; The estimated intake of radionuclides; The committed effective dose equivalent (CEDE) assigned to the intake of radionuclides; The specific information used to calculate the CEDE under 10 CFR 20.1204(a) and (c),
* The estimated intake of radionuclides;
when required by 10 CFR 20.1502; The TEDE, when required by 10 CFR 20.1202; and The total of the deep-dose equivalent and the committed dose to the organ receiving the highest total dose.
* The committed effective dose equivalent (CEDE) assigned to the intake of radionuclides;
See also Subsection 11.1.2.1.8 for retained individual dose evaluation records.
* The specific information used to calculate the CEDE under 10 CFR 20.1204(a) and (c),
11.1.5.8 Planned Special Exposures SHINE may authorize an adult worker to receive (non-emergency) doses, in addition to and accounted for separately, from the doses received under the limits specified in 10 CFR 20.1206(e), provided that each of the requirements of 10 CFR 20.1206(a), (b), (c),
when required by 10 CFR 20.1502;
and (d) are met.
* The TEDE, when required by 10 CFR 20.1202; and
SHINE maintains records of the conduct of a planned special exposure and submit a written report as required by 10 CFR 20.1206(f). In accordance with 10 CFR 20.2105, the record of a planned special exposure includes:
* The total of the deep-dose equivalent and the committed dose to the organ receiving the highest total dose.
The exceptional circumstances requiring the use of a planned special exposure.
also Subsection 11.1.2.1.8 for retained individual dose evaluation records.
The name of the management official who authorized the planned special exposure and a copy of the signed authorization.
.5.8       Planned Special Exposures NE may authorize an adult worker to receive (non-emergency) doses, in addition to and ounted for separately, from the doses received under the limits specified in CFR 20.1206(e), provided that each of the requirements of 10 CFR 20.1206(a), (b), (c),
What actions were necessary.
(d) are met.
Why the actions were necessary.
NE maintains records of the conduct of a planned special exposure and submit a written ort as required by 10 CFR 20.1206(f). In accordance with 10 CFR 20.2105, the record of a ned special exposure includes:
How doses were maintained ALARA.
* The exceptional circumstances requiring the use of a planned special exposure.
* The name of the management official who authorized the planned special exposure and a copy of the signed authorization.
* What actions were necessary.
* Why the actions were necessary.
* How doses were maintained ALARA.
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  .6     CONTAMINATION CONTROL EQUIPMENT AND FACILITY LAYOUT GENERAL DESIGN CONSIDERATIONS FOR 10 CFR 20.1406 tamination control is part of the radiation protection program described in Subsection 11.1.2.
Chapter 11 - Radiation Protection Program and Waste Management Radiation Protection SHINE Medical Technologies 11.1-26 Rev. 0 What individual and collective doses were expected to result, and the doses actually received in the planned special exposure.
sonnel receiving Radiation Worker Training are instructed on the sources, detection and trol of radioactive contamination. Procedures provide instruction for identifying and controlling tamination. Records of contamination events are entered into the corrective action process, ewed by the RSC, and maintained as records, as applicable, in accordance with the radiation ection program requirements described in Subsection 11.1.2.
11.1.6 CONTAMINATION CONTROL EQUIPMENT AND FACILITY LAYOUT GENERAL DESIGN CONSIDERATIONS FOR 10 CFR 20.1406 Contamination control is part of the radiation protection program described in Subsection 11.1.2.
eral equipment and facility layout design considerations to prevent the spread of tamination in the facility and to the environment and to facilitate eventual decommissioning in ordance with 10 CFR 20.1406 include the features discussed in the following subsections.
Personnel receiving Radiation Worker Training are instructed on the sources, detection and control of radioactive contamination. Procedures provide instruction for identifying and controlling contamination. Records of contamination events are entered into the corrective action process, reviewed by the RSC, and maintained as records, as applicable, in accordance with the radiation protection program requirements described in Subsection 11.1.2.
  .6.1       Shielded Compartments and Hot Cells cess equipment containing significant radioactive material is located within shielded partments or hot cells.
General equipment and facility layout design considerations to prevent the spread of contamination in the facility and to the environment and to facilitate eventual decommissioning in accordance with 10 CFR 20.1406 include the features discussed in the following subsections.
cess equipment which does not require local operator interaction during production, such as neutron driver assembly and the subcritical assembly, is located in shielded compartments cess is provided via shielded openings as required). Where operator intervention is required ng processing activities, for example molybdenum extraction and purification, the equipment cated in shielded hot cells and the operator is provided with a means for remote viewing and nipulation of components.
11.1.6.1 Shielded Compartments and Hot Cells Process equipment containing significant radioactive material is located within shielded compartments or hot cells.
se shielded compartments and shielded hot cells are provided to facilitate confinement, ation, and collection of potential liquid spills to minimize the spread of contamination to the lity and the environment. With the exception of the below grade confinement, these shielded partments and shielded hot cells are provided with ventilation systems which are operated at ative pressures with respect to the surrounding environment (see Section 9a2.1).
Process equipment which does not require local operator interaction during production, such as the neutron driver assembly and the subcritical assembly, is located in shielded compartments (access is provided via shielded openings as required). Where operator intervention is required during processing activities, for example molybdenum extraction and purification, the equipment is located in shielded hot cells and the operator is provided with a means for remote viewing and manipulation of components.
  .6.2       Piping ere shielding is required, radioactive piping is located inside shielded compartments or hot
These shielded compartments and shielded hot cells are provided to facilitate confinement, isolation, and collection of potential liquid spills to minimize the spread of contamination to the facility and the environment. With the exception of the below grade confinement, these shielded compartments and shielded hot cells are provided with ventilation systems which are operated at negative pressures with respect to the surrounding environment (see Section 9a2.1).
: s. For transfers between hot cells the piping is located in shielded pipe trenches which vide for liquid and airborne confinement and detection of leakage. Inspection ports are vided to allow for visual inspection of piping. Use of embedded piping is minimized to facilitate ection and detect leakage.
11.1.6.2 Piping Where shielding is required, radioactive piping is located inside shielded compartments or hot cells. For transfers between hot cells the piping is located in shielded pipe trenches which provide for liquid and airborne confinement and detection of leakage. Inspection ports are provided to allow for visual inspection of piping. Use of embedded piping is minimized to facilitate inspection and detect leakage.
  .6.3       Light Water Pool light water pool which provides shielding and cooling for the subcritical assembly system AS) is designed with leak detection to prevent unidentified leakage to the facility and the ironment.
11.1.6.3 Light Water Pool The light water pool which provides shielding and cooling for the subcritical assembly system (SCAS) is designed with leak detection to prevent unidentified leakage to the facility and the environment.
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cess tanks are seismically supported and are located in seismically designed concrete vaults are designed to prevent unidentified leakage to the facility and the environment.
Chapter 11 - Radiation Protection Program and Waste Management Radiation Protection SHINE Medical Technologies 11.1-27 Rev. 0 11.1.6.4 Process Tanks Process tanks are seismically supported and are located in seismically designed concrete vaults that are designed to prevent unidentified leakage to the facility and the environment.
  .6.5       Monitoring and Controlled Entry and Egress to Restricted Area ess to and egress from these areas is strictly controlled via administrative procedures and sive confinement structure design.
11.1.6.5 Monitoring and Controlled Entry and Egress to Restricted Area Access to and egress from these areas is strictly controlled via administrative procedures and passive confinement structure design.
sonnel access and egress is controlled by Radiation Protection personnel, equipment and cedures. Prior to entry, personnel must don appropriate PPE to minimize the potential for sical contamination of the worker and the subsequent spread of contamination beyond the ricted area. This PPE is either removed and disposed of or monitored for contamination prior elease from the restricted area. Personnel must then pass through appropriate portal nitoring equipment prior to egress from the restricted area.
Personnel access and egress is controlled by Radiation Protection personnel, equipment and procedures. Prior to entry, personnel must don appropriate PPE to minimize the potential for physical contamination of the worker and the subsequent spread of contamination beyond the restricted area. This PPE is either removed and disposed of or monitored for contamination prior to release from the restricted area. Personnel must then pass through appropriate portal monitoring equipment prior to egress from the restricted area.
entially contaminated materials removed from the restricted area (for example, production erial, tools, disposed equipment, various process and maintenance consumables) are veyed and released, when appropriate, following radiation protection program implementing cedures. Disposal of contaminated materials is performed in accordance with radioactive te management program implementing procedures (see Section 11.2).
Potentially contaminated materials removed from the restricted area (for example, production material, tools, disposed equipment, various process and maintenance consumables) are surveyed and released, when appropriate, following radiation protection program implementing procedures. Disposal of contaminated materials is performed in accordance with radioactive waste management program implementing procedures (see Section 11.2).
tricted areas in the main production facility are provided with fixed CAMs to detect the ential spread of airborne contamination within the restricted area. Additionally, RAMs are in e to detect potential increases in background radiation levels.
Restricted areas in the main production facility are provided with fixed CAMs to detect the potential spread of airborne contamination within the restricted area. Additionally, RAMs are in place to detect potential increases in background radiation levels.
iation protection personnel routinely perform radiation and contamination assessments of essible areas within restricted areas. Special surveys are performed, prior to entry, if access quired to normally unoccupied areas.
Radiation protection personnel routinely perform radiation and contamination assessments of accessible areas within restricted areas. Special surveys are performed, prior to entry, if access is required to normally unoccupied areas.
  .7     ENVIRONMENTAL MONITORING
11.1.7 ENVIRONMENTAL MONITORING 11.1.7.1 Environmental Monitoring Program SHINE maintains a radiological environmental monitoring program (REMP) as required by 10 CFR 20.1302. The REMP is used to verify the effectiveness of facility measures which are used to control the release of radioactive material and to verify that measurable concentrations of radioactive materials and levels of radiation are not higher than expected based on effluent measurements and modeling of the environmental exposure pathways.
  .7.1       Environmental Monitoring Program NE maintains a radiological environmental monitoring program (REMP) as required by CFR 20.1302. The REMP is used to verify the effectiveness of facility measures which are d to control the release of radioactive material and to verify that measurable concentrations of oactive materials and levels of radiation are not higher than expected based on effluent asurements and modeling of the environmental exposure pathways.
Guidance provided in Regulatory Guide 4.1, Radiological Environmental Monitoring for Nuclear Power Plants (USNRC, 2009) and Table 3.12-1 of NUREG-1301, Offsite Dose Calculation Manual Guidance: Standard Radiological Effluent Controls for Pressurized Water Reactors (USNRC, 1991), was considered when developing the REMP for the SHINE facility. In addition, the REMP was developed using the data quality objectives (DQO) process which is a scientific systematic planning method. The DQOs were developed according to the U.S. Environmental Protection Agency (EPA) Guidance on Systematic Planning Using the Data Quality Objectives Process (EPA, 2006).
dance provided in Regulatory Guide 4.1, Radiological Environmental Monitoring for Nuclear er Plants (USNRC, 2009) and Table 3.12-1 of NUREG-1301, Offsite Dose Calculation nual Guidance: Standard Radiological Effluent Controls for Pressurized Water Reactors NRC, 1991), was considered when developing the REMP for the SHINE facility. In addition, REMP was developed using the data quality objectives (DQO) process which is a scientific tematic planning method. The DQOs were developed according to the U.S. Environmental tection Agency (EPA) Guidance on Systematic Planning Using the Data Quality Objectives cess (EPA, 2006).
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  .7.2       Effluent Release Pathways orne effluents from the facility include noble gases, iodine and other halogens, particulates, tritium. The following pathways represent plausible public exposure scenarios from airborne ents:
Chapter 11 - Radiation Protection Program and Waste Management Radiation Protection SHINE Medical Technologies 11.1-28 Rev. 0 Environmental monitoring is conducted at potential receptor locations. Details of the REMP are presented in the following sections.
* Direct radiation exposure pathway monitored using dosimeters.
11.1.7.2 Effluent Release Pathways Airborne effluents from the facility include noble gases, iodine and other halogens, particulates, and tritium. The following pathways represent plausible public exposure scenarios from airborne effluents:
* Inhalation pathway monitored using continuous air samples.
Direct radiation exposure pathway monitored using dosimeters.
* Ingestion exposure pathway.
Inhalation pathway monitored using continuous air samples.
re are no routine radioactive liquid effluent discharges from the RCA. Radioactive liquid harges from the SHINE facility to the sanitary sewer are infrequent and made in accordance 10 CFR 20.2003 and 10 CFR 20.2007. There are no piped liquid effluent pathways from the A to the sanitary sewer. Sampling is used to determine suitability for release. See tion 11.2 for additional information on liquid discharges from the RCA.
Ingestion exposure pathway.
  .7.2.1     Direct Radiation Monitoring ct exposure to gamma and beta emitting radionuclides released through the stack of the NE production facility is monitored and measured at receptor locations using environmental imeters. The dosimeters measure direct radiation from radiation sources contained within the NE main production facility, from sources within the material staging building, from oactivity in the airborne effluent, and from deposition of airborne radioactivity onto the und.
There are no routine radioactive liquid effluent discharges from the RCA. Radioactive liquid discharges from the SHINE facility to the sanitary sewer are infrequent and made in accordance with 10 CFR 20.2003 and 10 CFR 20.2007. There are no piped liquid effluent pathways from the RCA to the sanitary sewer. Sampling is used to determine suitability for release. See Section 11.2 for additional information on liquid discharges from the RCA.
escription of dosimeter locations and the rationale for locations are provided in Table 11.1-14.
11.1.7.2.1 Direct Radiation Monitoring Direct exposure to gamma and beta emitting radionuclides released through the stack of the SHINE production facility is monitored and measured at receptor locations using environmental dosimeters. The dosimeters measure direct radiation from radiation sources contained within the SHINE main production facility, from sources within the material staging building, from radioactivity in the airborne effluent, and from deposition of airborne radioactivity onto the ground.
imeter locations are shown on Figure 11.1-4. Table 3.12-1 of NUREG-1301 (USNRC, 1991) ommends 40 dosimeter locations (i.e., an inner ring and an outer ring of dosimeters with one imeter in each ring at each of the 16 meteorological sectors and the balance of dosimeters to ocated at special interest areas). At least one dosimeter is to serve as a control, i.e., located gnificant distance from the facility such that it represents a background dose. Considering the of the SHINE facility and the low power level of the SHINE subcritical IUs, 24 dosimeter tions are specified. These dosimeters are located in order to provide annual direct dose rmation at on-site locations which are expected to have occupancy and at property line tions which ensure all directions are monitored. The property line locations include the ction of the theoretical MEI and the direction of the nearest occupied structure. At least one tion includes a paired dosimeter so that data quality can be determined. Three of the imeters are stationed off site at special interest areas and one dosimeter is located a ificant distance from the facility to represent background dose.
A description of dosimeter locations and the rationale for locations are provided in Table 11.1-14.
imeter values are calculated using the reports from the laboratory providing results.
Dosimeter locations are shown on Figure 11.1-4. Table 3.12-1 of NUREG-1301 (USNRC, 1991) recommends 40 dosimeter locations (i.e., an inner ring and an outer ring of dosimeters with one dosimeter in each ring at each of the 16 meteorological sectors and the balance of dosimeters to be located at special interest areas). At least one dosimeter is to serve as a control, i.e., located a significant distance from the facility such that it represents a background dose. Considering the size of the SHINE facility and the low power level of the SHINE subcritical IUs, 24 dosimeter locations are specified. These dosimeters are located in order to provide annual direct dose information at on-site locations which are expected to have occupancy and at property line locations which ensure all directions are monitored. The property line locations include the direction of the theoretical MEI and the direction of the nearest occupied structure. At least one location includes a paired dosimeter so that data quality can be determined. Three of the dosimeters are stationed off site at special interest areas and one dosimeter is located a significant distance from the facility to represent background dose.
kground radiation is subtracted from the dosimeter results. The background radiation values those established during the baseline environmental survey which obtained baseline imeter readings at each dosimeter location.
Dosimeter values are calculated using the reports from the laboratory providing results.
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Background radiation is subtracted from the dosimeter results. The background radiation values are those established during the baseline environmental survey which obtained baseline dosimeter readings at each dosimeter location.


orne effluent releases from the SHINE facility contribute to off-site doses. Air monitoring ects iodine or particulate releases from the SHINE facility. Noble gas and tritium asurements are not included in the REMP. Noble gas and tritium measurements are ormed by the radiation protection program.
Chapter 11 - Radiation Protection Program and Waste Management Radiation Protection SHINE Medical Technologies 11.1-29 Rev. 0 11.1.7.2.2 Iodine and Particulate Monitoring for Releases via Airborne Pathway Airborne effluent releases from the SHINE facility contribute to off-site doses. Air monitoring detects iodine or particulate releases from the SHINE facility. Noble gas and tritium measurements are not included in the REMP. Noble gas and tritium measurements are performed by the radiation protection program.
ironmental airborne sampling is performed to identify and quantify particulates and oiodine in airborne effluents. Regulatory Position C.3.b of Regulatory Guide 4.1 (USNRC,
Environmental airborne sampling is performed to identify and quantify particulates and radioiodine in airborne effluents. Regulatory Position C.3.b of Regulatory Guide 4.1 (USNRC, 2009) indicates that airborne sampling should always be included in the environmental monitoring programs for nuclear power plants since the airborne effluent pathway exists at all sites. Since the SHINE facility includes airborne effluent releases and radioactivity in the airborne effluent can result in measurable off-site doses and since there is a potential for a portion of the dose to be attributable to radioactive iodine and airborne particulate radioactivity releases, the REMP includes airborne sampling.
: 9) indicates that airborne sampling should always be included in the environmental nitoring programs for nuclear power plants since the airborne effluent pathway exists at all
11.1.7.2.2.1 Air Sampling Locations The DQO process and the guidance provided in Table 3.12-1 of NUREG-1301 (USNRC, 1991) were used to establish locations for airborne sample acquisition, sampling frequency, and type of sample analysis. Continuous air sample locations are specified in accordance with guidance provided in Table 3.12-1 of NUREG-1301 (USNRC, 1991). The continuous air sampling is performed using continuous air samplers (CAS) which include a radioiodine canister for iodine-131 (I-131) analysis and a particulate sampler which is analyzed for gross beta radioactivity.
: s. Since the SHINE facility includes airborne effluent releases and radioactivity in the airborne ent can result in measurable off-site doses and since there is a potential for a portion of the e to be attributable to radioactive iodine and airborne particulate radioactivity releases, the MP includes airborne sampling.
Four CAS locations (CAS 2 - CAS 5) are near the facility property line in the north, south, east and west direction sectors co-located with ED1, ED9, ED5, and ED13 (refer to Figure 11.1-4),
  .7.2.2.1       Air Sampling Locations DQO process and the guidance provided in Table 3.12-1 of NUREG-1301 (USNRC, 1991) e used to establish locations for airborne sample acquisition, sampling frequency, and type of ple analysis. Continuous air sample locations are specified in accordance with guidance vided in Table 3.12-1 of NUREG-1301 (USNRC, 1991). The continuous air sampling is ormed using continuous air samplers (CAS) which include a radioiodine canister for ne-131 (I-131) analysis and a particulate sampler which is analyzed for gross beta oactivity.
respectively, to ensure all directions are monitored. The north and east direction sectors (with respect to the SHINE facility vent stack) have the highest calculated annual ground level deposition factor (D/Q) values (CAS 2 and CAS 4). There is also a control CAS (CAS 1) located a sufficient distance from the SHINE medical isotope production facility to provide background information for airborne activity. Table 3.12-1 of NUREG-1301 (USNRC, 1991) suggests an additional air sample location in the vicinity of a community having the highest calculated annual average ground level deposition factor, D/Q. This CAS requirement is combined with the air sample location at the site boundary location in the north direction (refer to Table 11.1-14). A description of air sample locations and the rationale for air sample locations are provided in Table 11.1-14.
r CAS locations (CAS 2 - CAS 5) are near the facility property line in the north, south, east west direction sectors co-located with ED1, ED9, ED5, and ED13 (refer to Figure 11.1-4),
The air sampling data is used to validate the effluent monitoring and dose compliance data sets.
pectively, to ensure all directions are monitored. The north and east direction sectors (with pect to the SHINE facility vent stack) have the highest calculated annual ground level osition factor (D/Q) values (CAS 2 and CAS 4). There is also a control CAS (CAS 1) located fficient distance from the SHINE medical isotope production facility to provide background rmation for airborne activity. Table 3.12-1 of NUREG-1301 (USNRC, 1991) suggests an itional air sample location in the vicinity of a community having the highest calculated annual rage ground level deposition factor, D/Q. This CAS requirement is combined with the air ple location at the site boundary location in the north direction (refer to Table 11.1-14). A cription of air sample locations and the rationale for air sample locations are provided in le 11.1-14.
Results are compared to the radionuclide-specific values provided in 10 CFR 20, Appendix B. A sum-of-the fractions approach is used wherein the isotopic values measured are compared with their associated limits in 10 CFR 20, Appendix B. This allows the calculation of dose due to iodine and particulate activities and includes both inhalation dose and cloud immersion dose.
air sampling data is used to validate the effluent monitoring and dose compliance data sets.
Background subtraction is based on results of the baseline environmental survey, thus providing a location-specific and statistically valid means to subtract background.
ults are compared to the radionuclide-specific values provided in 10 CFR 20, Appendix B. A
  -of-the fractions approach is used wherein the isotopic values measured are compared with r associated limits in 10 CFR 20, Appendix B. This allows the calculation of dose due to ne and particulate activities and includes both inhalation dose and cloud immersion dose.
kground subtraction is based on results of the baseline environmental survey, thus providing cation-specific and statistically valid means to subtract background.
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REG-1301 (USNRC, 1991) suggests sampling of various biological media as a means to rectly assess doses due to particulate and iodine ingestion. This type of monitoring may ude sampling of soils, broad leafed plants, fish, meat, or milk. Nuclear power plants have long nitored this pathway and have seen neither appreciable dose nor upward trending of osition. Since the SHINE source term is expected to be several orders of magnitude lower n that of a nuclear power plant and particulate and iodine radionuclides are not normally ected to be present in measurable quantities within airborne effluent releases from the NE facility, biota monitoring is not routinely included in the REMP.
Chapter 11 - Radiation Protection Program and Waste Management Radiation Protection SHINE Medical Technologies 11.1-30 Rev. 0 11.1.7.2.3 Ingestion Pathway (Biota Monitoring)
  .7.2.4     Groundwater Monitoring face waters of the rivers in the vicinity of the plant (e.g., the Rock River and its tributaries) are expected to accumulate detectable levels of radioactivity. As such, surface water sampling is included in the REMP. Similarly, marine life in the rivers is not expected to accumulate ectable levels of radioactivity and thus sampling of fish or other marine creatures for the stion pathway is not included in the REMP.
NUREG-1301 (USNRC, 1991) suggests sampling of various biological media as a means to indirectly assess doses due to particulate and iodine ingestion. This type of monitoring may include sampling of soils, broad leafed plants, fish, meat, or milk. Nuclear power plants have long monitored this pathway and have seen neither appreciable dose nor upward trending of deposition. Since the SHINE source term is expected to be several orders of magnitude lower than that of a nuclear power plant and particulate and iodine radionuclides are not normally expected to be present in measurable quantities within airborne effluent releases from the SHINE facility, biota monitoring is not routinely included in the REMP.
asured local water table elevations for the site identify the groundwater gradient and indicate the groundwater flow is to the west and to the south. The nearest drinking water source is a located approximately a third of a mile (0.54 km) to the northwest of the facility.
11.1.7.2.4 Groundwater Monitoring Surface waters of the rivers in the vicinity of the plant (e.g., the Rock River and its tributaries) are not expected to accumulate detectable levels of radioactivity. As such, surface water sampling is not included in the REMP. Similarly, marine life in the rivers is not expected to accumulate detectable levels of radioactivity and thus sampling of fish or other marine creatures for the ingestion pathway is not included in the REMP.
re are four test wells within the property boundary for the SHINE facility that were used for nitoring groundwater in support of a hydrological assessment of the site. One test well is ted north, one south, one east, and one west of the SHINE main production facility. Although e are no defined liquid effluent release pathways and the groundwater is not expected to be taminated due to operation of the SHINE facility, the test wells to the west and the south are pled for the presence of radionuclide contaminants. Sampling is in accordance with the ommendations in Table 3.12-1 of NUREG-1301 (USNRC, 1991) (i.e., quarterly with gamma opic and tritium analysis). The rationale for sampling the test wells to the west and south of SHINE facility is provided in Table 11.1-14.
Measured local water table elevations for the site identify the groundwater gradient and indicate that the groundwater flow is to the west and to the south. The nearest drinking water source is a well located approximately a third of a mile (0.54 km) to the northwest of the facility.
  .7.3       Community Environmental Monitoring Program ddition to the monitoring that is performed by the REMP to meet regulatory requirements, NE has a Community Environmental Monitoring Program (CEMP). The CEMP includes ntary environmental monitoring based on public or SHINE interests that are not regulatory in ure.
There are four test wells within the property boundary for the SHINE facility that were used for monitoring groundwater in support of a hydrological assessment of the site. One test well is located north, one south, one east, and one west of the SHINE main production facility. Although there are no defined liquid effluent release pathways and the groundwater is not expected to be contaminated due to operation of the SHINE facility, the test wells to the west and the south are sampled for the presence of radionuclide contaminants. Sampling is in accordance with the recommendations in Table 3.12-1 of NUREG-1301 (USNRC, 1991) (i.e., quarterly with gamma isotopic and tritium analysis). The rationale for sampling the test wells to the west and south of the SHINE facility is provided in Table 11.1-14.
  .7.4       Preoperational Baseline Monitoring operational monitoring, beginning approximately two years prior to anticipated licensed vity, serves to provide baseline data for evaluating the impact of operation of the SHINE lity. The collection of samples and analysis of data follow the sampling and analyses edule specified in Subsection 11.1.7.5 and continue into the operational phase of facility ration. The preoperational monitoring is conducted so that the preoperational radiological ditions are understood in sufficient detail to allow future reasonable, direct comparison with a collected after licensed operation of the facility.
11.1.7.3 Community Environmental Monitoring Program In addition to the monitoring that is performed by the REMP to meet regulatory requirements, SHINE has a Community Environmental Monitoring Program (CEMP). The CEMP includes voluntary environmental monitoring based on public or SHINE interests that are not regulatory in nature.
NE Medical Technologies                      11.1-30                                          Rev. 0
11.1.7.4 Preoperational Baseline Monitoring Preoperational monitoring, beginning approximately two years prior to anticipated licensed activity, serves to provide baseline data for evaluating the impact of operation of the SHINE facility. The collection of samples and analysis of data follow the sampling and analyses schedule specified in Subsection 11.1.7.5 and continue into the operational phase of facility operation. The preoperational monitoring is conducted so that the preoperational radiological conditions are understood in sufficient detail to allow future reasonable, direct comparison with data collected after licensed operation of the facility.  


following frequencies are used; however, alterations may be made based upon data and ds, and the justification of any such alterations are described in the Annual Report. If sample nalysis frequencies are reduced, the changes are not to reduce the overall effectiveness of REMP.
Chapter 11 - Radiation Protection Program and Waste Management Radiation Protection SHINE Medical Technologies 11.1-31 Rev. 0 11.1.7.5 Sampling and Analysis The following frequencies are used; however, alterations may be made based upon data and trends, and the justification of any such alterations are described in the Annual Report. If sample or analysis frequencies are reduced, the changes are not to reduce the overall effectiveness of the REMP.
* Air sample filters - monthly, or more frequently if required by dust loading on media
Air sample filters - monthly, or more frequently if required by dust loading on media Environmental dosimeters - quarterly Groundwater test wells - quarterly Sample analysis employs analytical techniques so that an appropriate analytical sensitivity (e.g.,
* Environmental dosimeters - quarterly
a priori Lower Level of Detection [LLD]) is achieved. SHINE may also use the analytical detection sensitivities as determined based on the Multi-Agency Radiological Laboratory Analytical Protocols Manual (MARLAP). Deviations from the a priori analytical sensitivity levels due to interference from other radionuclides or other factors are evaluated and documented. SHINE reports analytical sensitivity capabilities of the REMP in the Annual Report.
* Groundwater test wells - quarterly mple analysis employs analytical techniques so that an appropriate analytical sensitivity (e.g.,
In accordance with Regulatory Guide 4.1 (USNRC, 2009), Revision 2, analyses for carbon-14 in environmental media are not required since the facility produced component is a small fraction of the naturally occurring carbon-14.
iori Lower Level of Detection [LLD]) is achieved. SHINE may also use the analytical detection sitivities as determined based on the Multi-Agency Radiological Laboratory Analytical tocols Manual (MARLAP). Deviations from the a priori analytical sensitivity levels due to rference from other radionuclides or other factors are evaluated and documented. SHINE orts analytical sensitivity capabilities of the REMP in the Annual Report.
11.1.7.6 Environmental Monitoring Program Procedures Environmental surveys conducted in support of the REMP are performed in accordance with facility implementing procedures. Document control measures are employed to ensure that changes to the REMP or implementing procedures are reviewed for adequacy, approved by authorized personnel and are distributed to and used at the appropriate locations throughout the facility.
ccordance with Regulatory Guide 4.1 (USNRC, 2009), Revision 2, analyses for carbon-14 in ironmental media are not required since the facility produced component is a small fraction of naturally occurring carbon-14.
11.1.7.7 REMP Reports An Annual Report is provided to the NRC in accordance with ANSI/ANS 15.1-2007 (ANSI/ANS, 2007). The Annual Report provides summarized results of environmental surveys performed outside the facility.
  .7.6       Environmental Monitoring Program Procedures ironmental surveys conducted in support of the REMP are performed in accordance with lity implementing procedures. Document control measures are employed to ensure that nges to the REMP or implementing procedures are reviewed for adequacy, approved by horized personnel and are distributed to and used at the appropriate locations throughout the lity.
11.1.7.8 Records, Periodic Review and Corrective Actions Records of off-site environmental surveys are retained in accordance with the SHINE records management program for the lifetime of the facility.
  .7.7       REMP Reports Annual Report is provided to the NRC in accordance with ANSI/ANS 15.1-2007 (ANSI/ANS, 7). The Annual Report provides summarized results of environmental surveys performed ide the facility.
An annual environmental monitoring program review is conducted to examine the adequacy and effectiveness of the REMP to achieve its objectives. The program review evaluates the need to expand (or reduce) the environmental monitoring program given the results of the environmental data and trends in environmental radioactivity. Any reductions shall be thoroughly evaluated and justified, given that environmental data indicating the absence of facility-related radioactivity are important. The review confirms exposure pathways and sampling media and validates that the principal radionuclides being discharged are the same nuclides being analyzed in the environmental program.  
  .7.8       Records, Periodic Review and Corrective Actions ords of off-site environmental surveys are retained in accordance with the SHINE records nagement program for the lifetime of the facility.
annual environmental monitoring program review is conducted to examine the adequacy and ctiveness of the REMP to achieve its objectives. The program review evaluates the need to and (or reduce) the environmental monitoring program given the results of the environmental a and trends in environmental radioactivity. Any reductions shall be thoroughly evaluated and ified, given that environmental data indicating the absence of facility-related radioactivity are ortant. The review confirms exposure pathways and sampling media and validates that the cipal radionuclides being discharged are the same nuclides being analyzed in the ironmental program.
NE Medical Technologies                      11.1-31                                      Rev. 0


gram for disposition.
Chapter 11 - Radiation Protection Program and Waste Management Radiation Protection SHINE Medical Technologies 11.1-32 Rev. 0 Any adverse trends or anomalies identified during the conduct of the program, during Annual Report preparation, or during periodic reviews, are entered into the facility corrective action program for disposition.
NE Medical Technologies 11.1-32 Rev. 0


Table 11.1 Parameters Applicable to Target Solution Radionuclide Inventories Parameter                 Nominal Values         Safety Basis Values wer                                        125 kW                   137.5 kW diation Time                               5.5 days                 30 days al Time Between Irradiations           [         ]PROP       [         ]PROP/ECI mber of Cycles                           [   ]PROP/ECI           [   ]PROP/ECI ment Partitioning (Extraction)             Nominal                     None ween Cycles ment Partitioning (Extraction) on           Nominal       Bounding (noble gases only) al Cycle V Dump Tank Decay Time               [         ]PROP/ECI     [         ]PROP/ECI percell Extraction Time             [         ]PROP/ECI       [       ]PROP/ECI NE Medical Technologies                11.1-33                                    Rev. 0
Proprietary Information - Withheld from public disclosure under 10 CFR 2.390(a)(4)
Export Controlled Information - Withheld from public disclosure under 10 CFR 2.390(a)(3)
Chapter 11 - Radiation Protection Program and Waste Management Radiation Protection SHINE Medical Technologies 11.1-33 Rev. 0 Table 11.1 Parameters Applicable to Target Solution Radionuclide Inventories Parameter Nominal Values Safety Basis Values Power 125 kW 137.5 kW Irradiation Time 5.5 days 30 days Total Time Between Irradiations
[ ]PROP
[ ]PROP/ECI Number of Cycles
[ ]PROP/ECI
[ ]PROP/ECI Element Partitioning (Extraction)
Between Cycles Nominal None Element Partitioning (Extraction) on Final Cycle Nominal Bounding (noble gases only)
TSV Dump Tank Decay Time
[ ]PROP/ECI
[ ]PROP/ECI Supercell Extraction Time
[ ]PROP/ECI
[ ]PROP/ECI


Table 11.1 Nominal Versus Safety Basis Radionuclide Inventories in Target Solution Actinide Activity (Ci)                                     Fission Product Activity (Ci)
Proprietary Information - Withheld from public disclosure under 10 CFR 2.390(a)(4)
Case             At Shutdown         Pre-Extraction     Post-Extraction       At Shutdown         Pre-Extraction     Post-Extraction minal Values(a) [           ]PROP/ECI [         ]PROP/ECI [           ]PROP/ECI [         ]PROP/ECI [         ]PROP/ECI [         ]PROP/ECI Safety Basis    [           ]PROP/ECI [         ]PROP/ECI [          ]PROP/ECI [          ]PROP/ECI [        ]PROP/ECI [        ]PROP/ECI Values(b)
Export Controlled Information - Withheld from public disclosure under 10 CFR 2.390(a)(3)
Difference          13 percent          20 percent          28 percent            20 percent          70 percent          170 percent
Chapter 11 - Radiation Protection Program and Waste Management Radiation Protection SHINE Medical Technologies 11.1-34 Rev. 0 Table 11.1 Nominal Versus Safety Basis Radionuclide Inventories in Target Solution Actinide Activity (Ci)
: a. Pre-Extraction: [       ]PROP/ECI post-shutdown; Post-Extraction: [       ]PROP/ECI post-shutdown
Fission Product Activity (Ci)
: b. Pre-Extraction: [       ]PROP/ECI post-shutdown; Post-Extraction: [       ]PROP/ECI post-shutdown NE Medical Technologies                                          11.1-34                                                              Rev. 0
Case At Shutdown Pre-Extraction Post-Extraction At Shutdown Pre-Extraction Post-Extraction Nominal Values(a)
: a. Pre-Extraction: [ ]PROP/ECI post-shutdown; Post-Extraction: [ ]PROP/ECI post-shutdown
[ ]PROP/ECI
[ ]PROP/ECI
[ ]PROP/ECI [ ]PROP/ECI [ ]PROP/ECI [ ]PROP/ECI Safety Basis Values(b)
: b. Pre-Extraction: [ ]PROP/ECI post-shutdown; Post-Extraction: [ ]PROP/ECI post-shutdown
[ ]PROP/ECI
[ ]PROP/ECI
[ ]PROP/ECI [ ]PROP/ECI [ ]PROP/ECI [ ]PROP/ECI Difference 13 percent 20 percent 28 percent 20 percent 70 percent 170 percent


ble 11.1 Irradiated Target Solution Activity for Select Radionuclides Pre-Extraction (Sheet 1 of 3)
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Radionuclide           Nominal Activity (Curies)     Safety Basis Activity (Curies)
Export Controlled Information - Withheld from public disclosure under 10 CFR 2.390(a)(3)
PROP/ECI             [       ]PROP/ECI Kr-85                  [        ]
Chapter 11 - Radiation Protection Program and Waste Management Radiation Protection SHINE Medical Technologies 11.1-35 Rev. 0 Table 11.1 Irradiated Target Solution Activity for Select Radionuclides Pre-Extraction (Sheet 1 of 3)
Kr-85m                  [         ]PROP/ECI             [       ]PROP/ECI Kr-87                   [         ]PROP/ECI             [       ]PROP/ECI Kr-88                   [         ]PROP/ECI             [       ]PROP/ECI Rb-86                   [         ]PROP/ECI             [       ]PROP/ECI Sr-89                   [         ]PROP/ECI             [       ]PROP/ECI Sr-90                   [         ]PROP/ECI             [       ]PROP/ECI Sr-91                   [         ]PROP/ECI             [       ]PROP/ECI Sr-92                   [         ]PROP/ECI             [       ]PROP/ECI Y-90                   [         ]PROP/ECI             [       ]PROP/ECI Y-91                   [         ]PROP/ECI             [       ]PROP/ECI Y-92                   [         ]PROP/ECI             [       ]PROP/ECI Y-93                   [         ]PROP/ECI             [       ]PROP/ECI Zr-95                   [         ]PROP/ECI             [       ]PROP/ECI Zr-97                   [         ]PROP/ECI             [       ]PROP/ECI Nb-95                   [         ]PROP/ECI             [       ]PROP/ECI Mo-99                   [         ]PROP/ECI             [       ]PROP/ECI Tc-99m                   [         ]PROP/ECI             [       ]PROP/ECI Ru-103                   [         ]PROP/ECI             [       ]PROP/ECI Ru-105                   [         ]PROP/ECI             [       ]PROP/ECI Ru-106                   [         ]PROP/ECI             [       ]PROP/ECI Rh-105                   [         ]PROP/ECI             [       ]PROP/ECI Sb-127                   [         ]PROP/ECI             [       ]PROP/ECI Sb-129                   [         ]PROP/ECI             [       ]PROP/ECI Te-127                   [         ]PROP/ECI             [       ]PROP/ECI Te-127m                   [         ]PROP/ECI             [       ]PROP/ECI Te-129                   [         ]PROP/ECI             [       ]PROP/ECI Te-129m                   [         ]PROP/ECI             [       ]PROP/ECI NE Medical Technologies                11.1-35                                    Rev. 0
Radionuclide Nominal Activity (Curies)
Safety Basis Activity (Curies)
Kr-85
[ ]PROP/ECI
[ ]PROP/ECI Kr-85m
[ ]PROP/ECI
[ ]PROP/ECI Kr-87
[ ]PROP/ECI
[ ]PROP/ECI Kr-88
[ ]PROP/ECI
[ ]PROP/ECI Rb-86
[ ]PROP/ECI
[ ]PROP/ECI Sr-89
[ ]PROP/ECI
[ ]PROP/ECI Sr-90
[ ]PROP/ECI
[ ]PROP/ECI Sr-91
[ ]PROP/ECI
[ ]PROP/ECI Sr-92
[ ]PROP/ECI
[ ]PROP/ECI Y-90
[ ]PROP/ECI
[ ]PROP/ECI Y-91
[ ]PROP/ECI
[ ]PROP/ECI Y-92
[ ]PROP/ECI
[ ]PROP/ECI Y-93
[ ]PROP/ECI
[ ]PROP/ECI Zr-95
[ ]PROP/ECI
[ ]PROP/ECI Zr-97
[ ]PROP/ECI
[ ]PROP/ECI Nb-95
[ ]PROP/ECI
[ ]PROP/ECI Mo-99
[ ]PROP/ECI
[ ]PROP/ECI Tc-99m
[ ]PROP/ECI
[ ]PROP/ECI Ru-103
[ ]PROP/ECI
[ ]PROP/ECI Ru-105
[ ]PROP/ECI
[ ]PROP/ECI Ru-106
[ ]PROP/ECI
[ ]PROP/ECI Rh-105
[ ]PROP/ECI
[ ]PROP/ECI Sb-127
[ ]PROP/ECI
[ ]PROP/ECI Sb-129
[ ]PROP/ECI
[ ]PROP/ECI Te-127
[ ]PROP/ECI
[ ]PROP/ECI Te-127m
[ ]PROP/ECI
[ ]PROP/ECI Te-129
[ ]PROP/ECI
[ ]PROP/ECI Te-129m
[ ]PROP/ECI
[ ]PROP/ECI


Radionuclide        Nominal Activity (Curies) Safety Basis Activity (Curies)
Proprietary Information - Withheld from public disclosure under 10 CFR 2.390(a)(4)
Te-131m             [         ]PROP/ECI         [       ]PROP/ECI Te-132             [         ]PROP/ECI         [       ]PROP/ECI I-131             [         ]PROP/ECI         [       ]PROP/ECI I-132             [         ]PROP/ECI         [       ]PROP/ECI I-133             [         ]PROP/ECI         [       ]PROP/ECI I-134             [         ]PROP/ECI         [       ]PROP/ECI I-135             [         ]PROP/ECI         [       ]PROP/ECI Xe-131m             [         ]PROP/ECI         [       ]PROP/ECI Xe-133             [         ]PROP/ECI         [       ]PROP/ECI Xe-133m             [         ]PROP/ECI         [       ]PROP/ECI Xe-135             [         ]PROP/ECI         [       ]PROP/ECI Xe-135m             [         ]PROP/ECI         [       ]PROP/ECI Xe-138             [         ]PROP/ECI         [       ]PROP/ECI Cs-134             [         ]PROP/ECI         [       ]PROP/ECI Cs-136             [         ]PROP/ECI         [       ]PROP/ECI Cs-137             [         ]PROP/ECI         [       ]PROP/ECI Ba-139             [         ]PROP/ECI         [       ]PROP/ECI Ba-140             [         ]PROP/ECI         [       ]PROP/ECI La-140             [         ]PROP/ECI         [       ]PROP/ECI La-141             [         ]PROP/ECI         [       ]PROP/ECI La-142             [         ]PROP/ECI         [       ]PROP/ECI Ce-141             [         ]PROP/ECI         [       ]PROP/ECI Ce-143             [         ]PROP/ECI         [       ]PROP/ECI Ce-144             [         ]PROP/ECI         [       ]PROP/ECI Pr-143             [         ]PROP/ECI         [       ]PROP/ECI Nd-147             [         ]PROP/ECI         [       ]PROP/ECI Np-239             [         ]PROP/ECI         [       ]PROP/ECI Pu-238             [         ]PROP/ECI         [       ]PROP/ECI Pu-239             [         ]PROP/ECI         [       ]PROP/ECI Pu-240             [         ]PROP/ECI         [       ]PROP/ECI Pu-241             [         ]PROP/ECI         [       ]PROP/ECI NE Medical Technologies          11.1-36                                  Rev. 0
Export Controlled Information - Withheld from public disclosure under 10 CFR 2.390(a)(3)
Chapter 11 - Radiation Protection Program and Waste Management Radiation Protection SHINE Medical Technologies 11.1-36 Rev. 0 Te-131m
[ ]PROP/ECI
[ ]PROP/ECI Te-132
[ ]PROP/ECI
[ ]PROP/ECI I-131
[ ]PROP/ECI
[ ]PROP/ECI I-132
[ ]PROP/ECI
[ ]PROP/ECI I-133
[ ]PROP/ECI
[ ]PROP/ECI I-134
[ ]PROP/ECI
[ ]PROP/ECI I-135
[ ]PROP/ECI
[ ]PROP/ECI Xe-131m
[ ]PROP/ECI
[ ]PROP/ECI Xe-133
[ ]PROP/ECI
[ ]PROP/ECI Xe-133m
[ ]PROP/ECI
[ ]PROP/ECI Xe-135
[ ]PROP/ECI
[ ]PROP/ECI Xe-135m
[ ]PROP/ECI
[ ]PROP/ECI Xe-138
[ ]PROP/ECI
[ ]PROP/ECI Cs-134
[ ]PROP/ECI
[ ]PROP/ECI Cs-136
[ ]PROP/ECI
[ ]PROP/ECI Cs-137
[ ]PROP/ECI
[ ]PROP/ECI Ba-139
[ ]PROP/ECI
[ ]PROP/ECI Ba-140
[ ]PROP/ECI
[ ]PROP/ECI La-140
[ ]PROP/ECI
[ ]PROP/ECI La-141
[ ]PROP/ECI
[ ]PROP/ECI La-142
[ ]PROP/ECI
[ ]PROP/ECI Ce-141
[ ]PROP/ECI
[ ]PROP/ECI Ce-143
[ ]PROP/ECI
[ ]PROP/ECI Ce-144
[ ]PROP/ECI
[ ]PROP/ECI Pr-143
[ ]PROP/ECI
[ ]PROP/ECI Nd-147
[ ]PROP/ECI
[ ]PROP/ECI Np-239
[ ]PROP/ECI
[ ]PROP/ECI Pu-238
[ ]PROP/ECI
[ ]PROP/ECI Pu-239
[ ]PROP/ECI
[ ]PROP/ECI Pu-240
[ ]PROP/ECI
[ ]PROP/ECI Pu-241
[ ]PROP/ECI
[ ]PROP/ECI Table 11.1 Irradiated Target Solution Activity for Select Radionuclides Pre-Extraction (Sheet 2 of 3)
Radionuclide Nominal Activity (Curies)
Safety Basis Activity (Curies)


Radionuclide        Nominal Activity (Curies) Safety Basis Activity (Curies)
Proprietary Information - Withheld from public disclosure under 10 CFR 2.390(a)(4)
Am-241               [         ]PROP/ECI         [       ]PROP/ECI Cm-242               [         ]PROP/ECI         [       ]PROP/ECI Cm-244               [         ]PROP/ECI         [       ]PROP/ECI Rb-88               [         ]PROP/ECI         [       ]PROP/ECI Y-91m               [         ]PROP/ECI         [       ]PROP/ECI Nb-97m               [         ]PROP/ECI         [       ]PROP/ECI Nb-97               [         ]PROP/ECI         [       ]PROP/ECI Rh-103m             [         ]PROP/ECI         [       ]PROP/ECI Rh-105m             [         ]PROP/ECI         [       ]PROP/ECI Rh-106             [         ]PROP/ECI         [       ]PROP/ECI Ba-136m             [         ]PROP/ECI         [       ]PROP/ECI Ba-137m             [         ]PROP/ECI         [       ]PROP/ECI Pr-144             [         ]PROP/ECI         [       ]PROP/ECI Pr-144m             [         ]PROP/ECI         [       ]PROP/ECI NE Medical Technologies          11.1-37                                  Rev. 0
Export Controlled Information - Withheld from public disclosure under 10 CFR 2.390(a)(3)
Chapter 11 - Radiation Protection Program and Waste Management Radiation Protection SHINE Medical Technologies 11.1-37 Rev. 0 Am-241
[ ]PROP/ECI
[ ]PROP/ECI Cm-242
[ ]PROP/ECI
[ ]PROP/ECI Cm-244
[ ]PROP/ECI
[ ]PROP/ECI Rb-88
[ ]PROP/ECI
[ ]PROP/ECI Y-91m
[ ]PROP/ECI
[ ]PROP/ECI Nb-97m
[ ]PROP/ECI
[ ]PROP/ECI Nb-97
[ ]PROP/ECI
[ ]PROP/ECI Rh-103m
[ ]PROP/ECI
[ ]PROP/ECI Rh-105m
[ ]PROP/ECI
[ ]PROP/ECI Rh-106
[ ]PROP/ECI
[ ]PROP/ECI Ba-136m
[ ]PROP/ECI
[ ]PROP/ECI Ba-137m
[ ]PROP/ECI
[ ]PROP/ECI Pr-144
[ ]PROP/ECI
[ ]PROP/ECI Pr-144m
[ ]PROP/ECI
[ ]PROP/ECI Table 11.1 Irradiated Target Solution Activity for Select Radionuclides Pre-Extraction (Sheet 3 of 3)
Radionuclide Nominal Activity (Curies)
Safety Basis Activity (Curies)


Table 11.1 Radiation Areas at the SHINE Facility Area                             Dose Rate                       Designation mally occupied areas within RCA room                                       5 mrem/hr               Normally occupied area S service cell without elerator operation ells, hot cells, and other lded vaults; cells; and rooms -
Chapter 11 - Radiation Protection Program and Waste Management Radiation Protection SHINE Medical Technologies 11.1-38 Rev. 0 Table 11.1 Radiation Areas at the SHINE Facility Area Dose Rate Designation Normally occupied areas within the RCA TPS room NDAS service cell without accelerator operation 5 mrem/hr Normally occupied area IU cells, hot cells, and other shielded vaults; cells; and rooms -
erial not present or accelerator n operation, after sufficient ay period ve RPF trench during solution             > 5 mrem/hr but                   Radiation Area sfers                                      100 mrem/hr                 (transient occupation) ary cooling rooms during ration eneral area during accelerator ration in NDAS service cell ells, hot cells, and other lded vaults; cells; and rooms -
material not present or accelerator not in operation, after sufficient decay period Above RPF trench during solution transfers Primary cooling rooms during operation IF general area during accelerator operation in NDAS service cell
erial present or accelerator in   > 100 mrem/hr (High Radiation High Radiation Area or Very High ration or shutdown without                    Area) or Radiation Area (rarely occupied, cient decay period              > 500 rad/hr (Very High Radiation per ALARA controls)
> 5 mrem/hr but 100 mrem/hr Radiation Area (transient occupation)
Area)
IU cells, hot cells, and other shielded vaults; cells; and rooms -
S service cell with accelerator ration NE Medical Technologies                      11.1-38                                        Rev. 0
material present or accelerator in operation or shutdown without sufficient decay period NDAS service cell with accelerator operation
> 100 mrem/hr (High Radiation Area) or
> 500 rad/hr (Very High Radiation Area)
High Radiation Area or Very High Radiation Area (rarely occupied, per ALARA controls)


Table 11.1 Airborne Radioactive Sources Estimated                Exterior Major            Maximum                Dose Rate System                     Component                 Location                 Sources           Activity (Ci)           (mrem/hr)(a)
Proprietary Information - Withheld from public disclosure under 10 CFR 2.390(a)(4)
Tritium purification S                                                    TPS glovebox                        H-3              300,000(b)                < 0.25 system Driver vacuum AS                                                  IU cell                            H-3          [    ]PROP/ECI(c)          < 0.25 hardware Off-gas piping, zeolite GS                                                  TOGS shielded cell              I, Kr, Xe          120,000(d)                < 0.25 beds IU cell atmosphere and                                                      Ar-41: 1E-05 Z1                                                  IU cell                    Ar-41 and N-16                                      N/A PCLS                                                                          N-16: 10(d)
Export Controlled Information - Withheld from public disclosure under 10 CFR 2.390(a)(3)
I, Kr, Xe, and Z1                          Supercell atmosphere    Supercell gloveboxes                                      3                    < 0.2 particulates Pipe trenches, valve pits, VS and VTS                  PVVS and VTS piping                                      I, Kr, Xe            25,000(d)                  <1 and PVVS hot cell
Chapter 11 - Radiation Protection Program and Waste Management Radiation Protection SHINE Medical Technologies 11.1-39 Rev. 0 Table 11.1 Airborne Radioactive Sources System Component Location Major Sources Estimated Maximum Activity (Ci)
Exterior Dose Rate (mrem/hr)(a)
: a. Dose contribution from listed source in normally occupied area, includes direct dose at 30 cm from the exterior of the shielding surface and contributions from the derived air concentration.
: a. Dose contribution from listed source in normally occupied area, includes direct dose at 30 cm from the exterior of the shielding surface and contributions from the derived air concentration.
TPS Tritium purification system TPS glovebox H-3 300,000(b)
: b. Includes inventory in NDAS units.
: b. Includes inventory in NDAS units.
< 0.25 NDAS Driver vacuum hardware IU cell H-3
[ ]PROP/ECI(c)
: c. H-3 activity is per NDAS unit.
: c. H-3 activity is per NDAS unit.
< 0.25 TOGS Off-gas piping, zeolite beds TOGS shielded cell I, Kr, Xe 120,000(d)
: d. Value is per irradiation unit (IU).
: d. Value is per irradiation unit (IU).
NE Medical Technologies                                          11.1-39                                                                Rev. 0
< 0.25 RVZ1 IU cell atmosphere and PCLS IU cell Ar-41 and N-16 Ar-41: 1E-05 N-16: 10(d)
N/A RVZ1 Supercell atmosphere Supercell gloveboxes I, Kr, Xe, and particulates 3
< 0.2 PVVS and VTS PVVS and VTS piping Pipe trenches, valve pits, and PVVS hot cell I, Kr, Xe 25,000(d)
< 1


Table 11.1 Estimated Derived Air Concentrations Source Description           Location           Particulate   Halogen       Noble Gas Tritium   Total mary System Boundary IF General Area                 -          0.1%           0.4%       -    0.5%
Chapter 11 - Radiation Protection Program and Waste Management Radiation Protection SHINE Medical Technologies 11.1-40 Rev. 0 Table 11.1 Estimated Derived Air Concentrations Source Description Location Particulate Halogen Noble Gas Tritium Total Primary System Boundary IF General Area 0.1%
TPS Room                       -              -            -    7.0%     7.0%
0.4%
IF General Area,
0.5%
                                                      -              -            -    3.2%     3.2%
Tritium Systems TPS Room 7.0%
ium Systems          Normal Operation IF General Area,
7.0%
                                                      -              -            -    5.2%     5.2%
IF General Area, Normal Operation 3.2%
Maintenance ow-Grade Vaults       RPF General Area               -          0.8%           0.0%       -    0.8%
3.2%
PVVS Hot Cell                   -            12%           1.9%       -      14%
IF General Area, Maintenance 5.2%
VS Hot Cell RPF General Area               -          0.0%           0.0%       -    0.0%
5.2%
Extraction Hot Cell           13%         > 10 DAC         76%   0.0%   > 10 DAC raction Hot Cell RPF General Area             0.0%         2.1%           0.0%   0.0%     2.1%
Below-Grade Vaults RPF General Area 0.8%
Purification Hot Cell         38%         > 10 DAC         220%   0.0%   > 10 DAC ification Hot Cell RPF General Area             0.0%         4.2%           0.0%   0.0%     4.2%
0.0%
General Area Total                                   -          0.1%           0.4%   8.3%     8.9%
0.8%
F General Area Total                               0.0%         7.1%           0.0%       -    7.1%
PVVS Hot Cell PVVS Hot Cell 12%
NE Medical Technologies                                11.1-40                                      Rev. 0
1.9%
14%
RPF General Area 0.0%
0.0%
0.0%
Extraction Hot Cell Extraction Hot Cell 13%
> 10 DAC 76%
0.0%
> 10 DAC RPF General Area 0.0%
2.1%
0.0%
0.0%
2.1%
Purification Hot Cell Purification Hot Cell 38%
> 10 DAC 220%
0.0%
> 10 DAC RPF General Area 0.0%
4.2%
0.0%
0.0%
4.2%
IF General Area Total 0.1%
0.4%
8.3%
8.9%
RPF General Area Total 0.0%
7.1%
0.0%
7.1%


Table 11.1 Key Parameters for Normal Yearly Release Calculation Primary Confinement Parameter       PVVS Pathway       Hot Cells       Boundary       General Area mary Nuclide Kr, Xe, I,    Kr, Xe, Ar 41, ntory              Kr, Xe, I                                        Kr, Xe, I, H-3 particulates        N-16 stituents e of Radiation Beta and Gamma Beta and Gamma Beta and Gamma Beta and Gamma tted al Curies           9.0E+05             320             430               32 ary stituents            Kr, Xe           Kr, Xe           Kr, Xe         Kr, Xe, H-3 eased e of Radiation Beta and Gamma Beta and Gamma Beta and Gamma Beta and Gamma tted al Curies           9.3E+03             16               9.5                 32 ay Time 1.7 days (Kr) dited for                              None          1 minute          None 40 days (Xe) ay Carbon Filter on Carbon Guard Hot Cell RVZ1 Bed                        Carbon Filter on Carbon Filter on ne Removal                            Exhaust Facility RVZ1     Facility RVZ1 hanisms                        Carbon Filter on Carbon Delay                        Exhaust          Exhaust Facility RVZ1 Beds Exhaust NE Medical Technologies              11.1-41                                  Rev. 0
Chapter 11 - Radiation Protection Program and Waste Management Radiation Protection SHINE Medical Technologies 11.1-41 Rev. 0 Table 11.1 Key Parameters for Normal Yearly Release Calculation Parameter PVVS Pathway Hot Cells Primary Confinement Boundary General Area Primary Nuclide Inventory Constituents Kr, Xe, I Kr, Xe, I, particulates Kr, Xe, Ar 41, N-16 Kr, Xe, I, H-3 Type of Radiation Emitted Beta and Gamma Beta and Gamma Beta and Gamma Beta and Gamma Total Curies 9.0E+05 320 430 32 Primary Constituents Released Kr, Xe Kr, Xe Kr, Xe Kr, Xe, H-3 Type of Radiation Emitted Beta and Gamma Beta and Gamma Beta and Gamma Beta and Gamma Total Curies 9.3E+03 16 9.5 32 Delay Time Credited for Decay 1.7 days (Kr) 40 days (Xe)
None 1 minute None Iodine Removal Mechanisms Carbon Guard Bed Carbon Filter on Hot Cell RVZ1 Exhaust Carbon Filter on Facility RVZ1 Exhaust Carbon Filter on Facility RVZ1 Exhaust Carbon Delay Beds Carbon Filter on Facility RVZ1 Exhaust


able 11.1 Estimated Annual Releases from Normal and Maintenance Operations (Nuclides with Greater than 1 Ci Annual Release)
Chapter 11 - Radiation Protection Program and Waste Management Radiation Protection SHINE Medical Technologies 11.1-42 Rev. 0 Table 11.1 Estimated Annual Releases from Normal and Maintenance Operations (Nuclides with Greater than 1 Ci Annual Release)
Radionuclide                             Annual Release (Ci)
Radionuclide Annual Release (Ci)
Kr-83m                                     5.9E+00 Kr-85                                     1.2E+02 Kr-85m                                     5.0E+01 Kr-88                                     2.2E+00 Xe-131m                                     1.3E+03 Xe-133                                     7.8E+03 Xe-133m                                     1.1E+00 Xe-135                                     6.2E+00 Xe-135m                                     1.0E+01 H-3                                       7.3E+01 NE Medical Technologies                11.1-42                            Rev. 0
Kr-83m 5.9E+00 Kr-85 1.2E+02 Kr-85m 5.0E+01 Kr-88 2.2E+00 Xe-131m 1.3E+03 Xe-133 7.8E+03 Xe-133m 1.1E+00 Xe-135 6.2E+00 Xe-135m 1.0E+01 H-3 7.3E+01


Table 11.1 Liquid Radioactive Sources (Sheet 1 of 2)
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Exterior Major        Estimated Maximum      Dose Rate System(a)           Component(a)               Location(a)             Sources           Activity (Ci)     (mrem/hr)(d)
Export Controlled Information - Withheld from public disclosure under 10 CFR 2.390(a)(3)
Target solution,         Target Solution PS                                                                    U-234, U-235, U-238         3               N/A unirradiated          Preparation Area U-235 Fission Target solution in TSV AS                                                    IU cell           (Neutrons and   [       ]PROP/ECI(b)   < 0.25 (operating)
Chapter 11 - Radiation Protection Program and Waste Management Radiation Protection SHINE Medical Technologies 11.1-43 Rev. 0 Table 11.1 Liquid Radioactive Sources (Sheet 1 of 2)
Photons)
System(a)
Target solution in TSV, AS                      TSV dump tank                 IU cell         (see Table 11.1-3) [       ]PROP/ECI(b)   < 0.03 (shutdown)
Component(a)
Water in the light water PS                                                    IU cell                 H-3               30(b)             N/A pool AS                    Oil in NDAS pumps               IU cell                 H-3               2000(b)             N/A Primary cooling water       IU cell and primary LS                                                                            N-16               7.5(b)             <2 in pump and piping          cooling room Target solution in PS                      pump, extraction             Supercell         (see Table 11.1-3) [       ]PROP/ECI(c)     <5 column, and lift tanks Mo eluate in Mo eluate PS                                                  Supercell         Mo, [   ]PROP/ECI [       ]PROP/ECI(c)     <3 hold tank PS                      Mo-99 product               Supercell             Mo-99, Tc-99   [       ]PROP/ECI(c)   < 0.2 Target solution in target SS                                                  Tank vault         (see Table 11.1-3) [       ]PROP/ECI(b)   < 0.25 solution hold tank NE Medical Technologies                                      11.1-43                                                    Rev. 0
Location(a)
Major Sources Estimated Maximum Activity (Ci)
Exterior Dose Rate (mrem/hr)(d)
TSPS Target solution, unirradiated Target Solution Preparation Area U-234, U-235, U-238 3
N/A SCAS Target solution in TSV (operating)
IU cell U-235 Fission (Neutrons and Photons)
[ ]PROP/ECI(b)
< 0.25 SCAS Target solution in TSV, TSV dump tank (shutdown)
IU cell (see Table 11.1-3)
[ ]PROP/ECI(b)
< 0.03 LWPS Water in the light water pool IU cell H-3 30(b)
N/A NDAS Oil in NDAS pumps IU cell H-3 2000(b)
N/A PCLS Primary cooling water in pump and piping IU cell and primary cooling room N-16 7.5(b)
< 2 MEPS Target solution in pump, extraction column, and lift tanks Supercell (see Table 11.1-3)
[ ]PROP/ECI(c)
< 5 MEPS Mo eluate in Mo eluate hold tank Supercell Mo, [ ]PROP/ECI
[ ]PROP/ECI(c)
< 3 MEPS Mo-99 product Supercell Mo-99, Tc-99
[ ]PROP/ECI(c)
< 0.2 TSSS Target solution in target solution hold tank Tank vault (see Table 11.1-3)
[ ]PROP/ECI(b)
< 0.25


Exterior Major          Estimated Maximum            Dose Rate System(a)               Component(a)             Location(a)                  Sources              Activity (Ci)          (mrem/hr)(d)
Proprietary Information - Withheld from public disclosure under 10 CFR 2.390(a)(4)
Export Controlled Information - Withheld from public disclosure under 10 CFR 2.390(a)(3)
Chapter 11 - Radiation Protection Program and Waste Management Radiation Protection SHINE Medical Technologies 11.1-44 Rev. 0 RLWS Liquid waste in annular waste tank Tank vault
[
[
Liquid waste in annular WS                                                      Tank vault                ]PROP/ECI and             3.8E+04               < 0.1 waste tank other fission products
]PROP/ECI and other fission products 3.8E+04
< 0.1 RLWS Liquid waste in RLWS collection tank Tank vault
[
[
Liquid waste in RLWS WS                                                      Tank vault              ]PROP/ECI and               5.7E+04               < 0.1 collection tank other fission products
]PROP/ECI and other fission products 5.7E+04
< 0.1
: a. Physical and chemical properties of process solutions, special nuclear material inventories, and descriptions of the systems can be found in Chapter 4.
: a. Physical and chemical properties of process solutions, special nuclear material inventories, and descriptions of the systems can be found in Chapter 4.
: b. Value is per irradiation unit (IU).
: b. Value is per irradiation unit (IU).
: c. Value is per cycle.
: c. Value is per cycle.
: d. For normally-occupied areas.
: d. For normally-occupied areas.
NE Medical Technologies                                          11.1-44                                                                Rev. 0
Table 11.1 Liquid Radioactive Sources (Sheet 2 of 2)
System(a)
Component(a)
Location(a)
Major Sources Estimated Maximum Activity (Ci)
Exterior Dose Rate (mrem/hr)(d)


Table 11.1 Solid Radioactive Sources Estimated    Exterior Major            Maximum      Dose Rate System(a)                Component(a)                  Location                    Sources          Activity (Ci) (mrem/hr)
Proprietary Information - Withheld from public disclosure under 10 CFR 2.390(a)(4)
AS                            Neutron Driver                IU Cell              Activation Products        300(b)      N/A Rb, Cs, Ba, Sr, Y, La, and GS                        TOGS Components          IU Cell and TOGS Cell                                  5.6E+04(b)     < 0.25 Ce Neutron Multiplier,                                  Activation and Fission AS                                                          IU Cell                                        1.5E+05(b)     N/A SASS                                                  Products Spent Extraction [
Export Controlled Information - Withheld from public disclosure under 10 CFR 2.390(a)(3)
PS                                                          Supercell        [                  ]PROP/ECI  2.6E+04(c)     <5 PROP/ECI
Security-Related - Withheld under 10 CFR 2.390(d)
                                      ]
Chapter 11 - Radiation Protection Program and Waste Management Radiation Protection SHINE Medical Technologies 11.1-45 Rev. 0 Table 11.1 Solid Radioactive Sources System(a)
Supercell and Solid PS                              Glassware                                      [              ]PROP/ECI      100(c)      N/A Waste Drum Storage Target Solution Fresh Uranium Metal PS and URSS                                        Preparation and Storage      U-234, U-235, U-238            3          N/A and Uranium Oxide Areas Liquid Waste            Activation and Fission WI                        Solidified Waste Drum                                                                125(d)      < 0.25 Solidification Cell              Products d Radwaste                    Spent Filters                Supercell                    Iodine                400        <1 Subcritical                                      Alpha-neutron Source AS                                                          IU Cell                                        [    ]SRI      N/A Multiplication Source                                    (PuBe or AmBe)
: a. Descriptions of the systems and their physical characteristics can be found in Chapter 4.
: a. Descriptions of the systems and their physical characteristics can be found in Chapter 4.
Component(a)
Location Major Sources Estimated Maximum Activity (Ci)
Exterior Dose Rate (mrem/hr)
NDAS Neutron Driver IU Cell Activation Products 300(b)
: b. Value is per irradiation unit (IU).
: b. Value is per irradiation unit (IU).
N/A TOGS TOGS Components IU Cell and TOGS Cell Rb, Cs, Ba, Sr, Y, La, and Ce 5.6E+04(b)
< 0.25 SCAS Neutron Multiplier, SASS IU Cell Activation and Fission Products 1.5E+05(b)
N/A MEPS Spent Extraction [
]PROP/ECI Supercell
[ ]PROP/ECI 2.6E+04(c)
: c. Value is per cycle.
: c. Value is per cycle.
< 5 MEPS Glassware Supercell and Solid Waste Drum Storage
[ ]PROP/ECI 100(c)
N/A TSPS and URSS Fresh Uranium Metal and Uranium Oxide Target Solution Preparation and Storage Areas U-234, U-235, U-238 3
N/A RLWI Solidified Waste Drum Liquid Waste Solidification Cell Activation and Fission Products 125(d)
: d. Value is per drum.
: d. Value is per drum.
NE Medical Technologies                                              11.1-45                                                    Rev. 0
< 0.25 Solid Radwaste Spent Filters Supercell Iodine 400
< 1 SCAS Subcritical Multiplication Source IU Cell Alpha-neutron Source (PuBe or AmBe)
[ ]SRI N/A


Table 11.1 Administrative Radiation Exposure Limits SHINE 10 CFR 20 Limit Administrative Type of Dose                          (rem/year)   Limit (rem/year) more limiting of:
Chapter 11 - Radiation Protection Program and Waste Management Radiation Protection SHINE Medical Technologies 11.1-46 Rev. 0 Table 11.1 Administrative Radiation Exposure Limits Type of Dose 10 CFR 20 Limit (rem/year)
Total effective dose equivalent to whole body, or               5               2 Sum of deep-dose equivalent and committed dose 50              20 equivalent to any organ or tissue other than lens of eye dose equivalent to lens of eye                                 15               6 llow-dose equivalent to skin of the whole body or any 50               20 emity lared Pregnant Worker e to embryo/fetus during the entire pregnancy: taken as sum of the deep-dose equivalent to the woman and the       0.5 rem per      0.5 rem per e to the embryo/fetus from radionuclides in the embryo/ gestation period gestation period s and the woman vidual Members of the Public l effective dose equivalent                                   0.1             0.1 NE Medical Technologies                      11.1-46                                Rev. 0
SHINE Administrative Limit (rem/year)
The more limiting of:
Total effective dose equivalent to whole body, or 5
2 Sum of deep-dose equivalent and committed dose equivalent to any organ or tissue other than lens of eye 50 20 Eye dose equivalent to lens of eye 15 6
Shallow-dose equivalent to skin of the whole body or any extremity 50 20 Declared Pregnant Worker Dose to embryo/fetus during the entire pregnancy: taken as the sum of the deep-dose equivalent to the woman and the dose to the embryo/fetus from radionuclides in the embryo/
fetus and the woman 0.5 rem per gestation period 0.5 rem per gestation period Individual Members of the Public Total effective dose equivalent 0.1 0.1


Table 11.1 Radiation Monitoring Equipment Radiation Monitoring Instrument Type(a)(b)                               Location                                          Function Radiation Survey Instruments able dose rate - neutron                          Various                                            Routine and job coverage surveys able dose rate - beta/gamma                      Various                                            Routine and job coverage surveys kers                                              Various egress points within the RCA              Ensure effective control of the spread of contamination sonnel contamination monitors                      Egress points from RCA                            Verify effectiveness of contamination controls Laboratory/Benchtop Instruments id Scintillation Counter (LSC)                    Counting room                                      Tritium and low energy beta-emitting radionuclide sample analysis Background Sample Counter - alpha/beta          Counting room                                      Count smears and air samples ma Spectroscopy                                  Counting room                                      Various gamma-emitting radionuclide sample analyses Air Sampling and Monitoring sonnel Lapel Sampler                              Various as specified by procedure or RWP          Representative air monitoring during work; internal dose assignment Samplers                                          Various as specified by procedure or RWP          Airborne radioactivity concentration measurement tinuous Alpha / Beta Air Monitor (CAM)            Areas where airborne contamination may be present, Early detection of unanticipated increases in airborne as specified by procedure                          radioactivity concentration tinuous Tritium Air Monitor                      See Table 7.7-3                                    See Table 7.7-3 Radiation Area Monitors iation Area Monitors (RAM)                        See Table 7.7-2                                    See Table 7.7-2 Radiological Effluent Monitor k Release Monitor                                Located in the main production facility stack      Direct exposure to gamma and beta emitting radionuclides released through the stack of the SHINE main production facility is monitored and measured rcoal Delay Bed Effluent Monitor                  Located at the outlet of the process vessel vent  Monitor to trend the performance of the charcoal system (PVVS) charcoal delay beds                  delay beds. Ensure the PVVS effluent stream is monitored if the safety-related effluent release point is in use.
Chapter 11 - Radiation Protection Program and Waste Management Radiation Protection SHINE Medical Technologies 11.1-47 Rev. 0 Table 11.1 Radiation Monitoring Equipment Radiation Monitoring Instrument Type(a)(b)
: a. See Table 7.7-1 for safety-related process radiation monitors.
: a. See Table 7.7-1 for safety-related process radiation monitors.
: b. See Table 11.1-14 for Environmental Monitoring equipment and locations.
: b. See Table 11.1-14 for Environmental Monitoring equipment and locations.
NE Medical Technologies                                                  11.1-47                                                                      Rev. 0
Location Function Radiation Survey Instruments Portable dose rate - neutron Various Routine and job coverage surveys Portable dose rate - beta/gamma Various Routine and job coverage surveys Friskers Various egress points within the RCA Ensure effective control of the spread of contamination Personnel contamination monitors Egress points from RCA Verify effectiveness of contamination controls Laboratory/Benchtop Instruments Liquid Scintillation Counter (LSC)
Counting room Tritium and low energy beta-emitting radionuclide sample analysis Low Background Sample Counter - alpha/beta Counting room Count smears and air samples Gamma Spectroscopy Counting room Various gamma-emitting radionuclide sample analyses Air Sampling and Monitoring Personnel Lapel Sampler Various as specified by procedure or RWP Representative air monitoring during work; internal dose assignment Air Samplers Various as specified by procedure or RWP Airborne radioactivity concentration measurement Continuous Alpha / Beta Air Monitor (CAM)
Areas where airborne contamination may be present, as specified by procedure Early detection of unanticipated increases in airborne radioactivity concentration Continuous Tritium Air Monitor See Table 7.7-3 See Table 7.7-3 Radiation Area Monitors Radiation Area Monitors (RAM)
See Table 7.7-2 See Table 7.7-2 Radiological Effluent Monitor Stack Release Monitor Located in the main production facility stack Direct exposure to gamma and beta emitting radionuclides released through the stack of the SHINE main production facility is monitored and measured Charcoal Delay Bed Effluent Monitor Located at the outlet of the process vessel vent system (PVVS) charcoal delay beds Monitor to trend the performance of the charcoal delay beds. Ensure the PVVS effluent stream is monitored if the safety-related effluent release point is in use.


Table 11.1 Radiological Postings Posting                                         Requirement Accessible area in which radiation levels could result in an CAUTION                individual receiving in excess of 5 mrem in one hour 30 cm RADIATION AREA              from the radiation source or surface that the radiation penetrates.
Chapter 11 - Radiation Protection Program and Waste Management Radiation Protection SHINE Medical Technologies 11.1-48 Rev. 0 Table 11.1 Radiological Postings Posting Requirement CAUTION RADIATION AREA Accessible area in which radiation levels could result in an individual receiving in excess of 5 mrem in one hour 30 cm from the radiation source or surface that the radiation penetrates.
CAUTION HIGH RADIATION AREA Accessible area in which radiation levels could result in an individual receiving in excess of 100 mrem in one hour 30 cm or from the radiation source or surface that the radiation penetrates.
CAUTION HIGH RADIATION AREA or DANGER HIGH RADIATION AREA Accessible area in which radiation levels could result in an individual receiving in excess of 100 mrem in one hour 30 cm from the radiation source or surface that the radiation penetrates.
DANGER HIGH RADIATION AREA Accessible area in which radiation levels could result in an GRAVE DANGER              individual receiving an absorbed dose in excess of 500 rads VERY HIGH RADIATION AREA        in one hour at one meter from a radiation source or from any surface that the radiation penetrates.
GRAVE DANGER VERY HIGH RADIATION AREA Accessible area in which radiation levels could result in an individual receiving an absorbed dose in excess of 500 rads in one hour at one meter from a radiation source or from any surface that the radiation penetrates.
CAUTION AIRBORNE             Licensed airborne radioactive materials in a room, enclosure, RADIOACTIVITY AREA            or area exists in concentrations exceeding the derived air concentrations specified in 10 CFR 20, Appendix B, Table I, or                  or when an individual present in the area without respiratory protective equipment could exceed, during the hours an DANGER AIRBORNE              individual is present in a week, an intake of 0.6% of the RADIOACTIVITY AREA            annual limit on intake or 12 DAC-hours.
CAUTION AIRBORNE RADIOACTIVITY AREA or DANGER AIRBORNE RADIOACTIVITY AREA Licensed airborne radioactive materials in a room, enclosure, or area exists in concentrations exceeding the derived air concentrations specified in 10 CFR 20, Appendix B, Table I, or when an individual present in the area without respiratory protective equipment could exceed, during the hours an individual is present in a week, an intake of 0.6% of the annual limit on intake or 12 DAC-hours.
An area where removable contamination levels are above CAUTION 20 dpm/100 cm2 of alpha activity or 1,000 dpm/100 cm2 CONTAMINATION AREA beta/gamma activity.
CAUTION CONTAMINATION AREA An area where removable contamination levels are above 20 dpm/100 cm2 of alpha activity or 1,000 dpm/100 cm2 beta/gamma activity.
CAUTION RADIOACTIVE MATERIAL(S)
CAUTION RADIOACTIVE MATERIAL(S) or DANGER RADIOACTIVE MATERIAL(S)
Areas or rooms in which there is use of, or stored, an amount or                  of licensed radioactive material exceeding 10 times the quantity of material in Appendix C to 10 CFR 20.
Areas or rooms in which there is use of, or stored, an amount of licensed radioactive material exceeding 10 times the quantity of material in Appendix C to 10 CFR 20.
DANGER RADIOACTIVE MATERIAL(S)
NE Medical Technologies                11.1-48                                            Rev. 0


Table 11.1 Environmental Monitoring Locations nitoring Type                     Location                                         Rationale Groundwater Sampling st Well                                         The groundwater gradient is to the west and the south Test well located directly west of
Chapter 11 - Radiation Protection Program and Waste Management Radiation Protection SHINE Medical Technologies 11.1-49 Rev. 0 Table 11.1 Environmental Monitoring Locations Monitoring Type Location Rationale Groundwater Sampling Test Well SM-GW4A Sampling Test well located directly west of the SHINE facility The groundwater gradient is to the west and the south and thus any groundwater contamination is likely to flow to the west and to the south.
-GW4A                                          and thus any groundwater contamination is likely to flow the SHINE facility mpling                                        to the west and to the south.
Test Well SM-GW2A Sampling Test well located directly south of the SHINE facility The groundwater gradient is to the west and the south and thus any groundwater contamination is likely to flow to the west and to the south.
st Well                                         The groundwater gradient is to the west and the south Test well located directly south of
Environmental Dosimeters ED 1 - 16 Site Boundary One in each of the 16 compass directions from the site center.
-GW2A                                          and thus any groundwater contamination is likely to flow the SHINE facility mpling                                        to the west and to the south.
ED 17 - 20 Outside the main production facility but within the site boundary (ED 17 north, ED 18 east, ED 19 south, ED 20 west)
Environmental Dosimeters One in each of the 16 compass directions from the site 1 - 16 Site Boundary center.
One in each of the four cardinal directions surrounding the main production facility.
Outside the main production facility but within the site boundary One in each of the four cardinal directions surrounding 17 - 20 (ED 17 north, ED 18 east, ED 19 the main production facility.
ED 21 - 23 Rock County Christian Elementary School (ED 21)
south, ED 20 west)
Jackson Elementary School (ED 22)
Rock County Christian Elementary School (ED 21)
Jackson Elementary School             Special interest areas (e.g., population centers, nearby 21 - 23 (ED 22)                               residences or schools).
University of Wisconsin - Rock County (ED 23)
University of Wisconsin - Rock County (ED 23)
To serve as a control (i.e., located a significant distance ED 24    Kennedy Elementary School              from the facility such that is represents a background dose).
Special interest areas (e.g., population centers, nearby residences or schools).
Air Samplers Control air sampler located a sufficient distance from the Sampler Off-site location, co-located with SHINE facility such that airborne samples are AS 1)  ED 24 unaffected by airborne effluent releases from the facility.
ED 24 Kennedy Elementary School To serve as a control (i.e., located a significant distance from the facility such that is represents a background dose).
This direction has high ground level deposition factor (D/Q) and is in the direction of Janesville. Since the Close to property line, north of the Sampler                                          community of Janesville is relatively close to the site main production facility, AS 2)                                          boundary, this air sampler location is credited with co-located with ED 1 satisfying two of the conditions for air sample location recommendations in Table 3.12-1 of NUREG-1301.
Air Samplers Air Sampler (CAS 1)
Close to property line, east of the Sampler                                          This direction has high D/Q and is in the direction of main production facility, AS 3)                                          dairy production and the horse pasture.
Off-site location, co-located with ED 24 Control air sampler located a sufficient distance from the SHINE facility such that airborne samples are unaffected by airborne effluent releases from the facility.
co-located with ED 5 Close to property line, west of the Sampler main production facility,             This location ensures all directions are monitored.
Air Sampler (CAS 2)
AS 4) co-located with ED 9 Close to property line, south of the Sampler                                          This location is in the direction of the nearest occupied main production facility, AS 5)                                         structure.
Close to property line, north of the main production facility, co-located with ED 1 This direction has high ground level deposition factor (D/Q) and is in the direction of Janesville. Since the community of Janesville is relatively close to the site boundary, this air sampler location is credited with satisfying two of the conditions for air sample location recommendations in Table 3.12-1 of NUREG-1301.
co-located with ED 13 NE Medical Technologies                       11.1-49                                                Rev. 0
Air Sampler (CAS 3)
Close to property line, east of the main production facility, co-located with ED 5 This direction has high D/Q and is in the direction of dairy production and the horse pasture.
Air Sampler (CAS 4)
Close to property line, west of the main production facility, co-located with ED 9 This location ensures all directions are monitored.
Air Sampler (CAS 5)
Close to property line, south of the main production facility, co-located with ED 13 This location is in the direction of the nearest occupied structure.
 
Security-Related Information - Withheld under 10 CFR 2.390(d)
Chapter 11 - Radiation Protection Program and Waste Management Radiation Protection SHINE Medical Technologies 11.1-50 Rev. 0 Figure 11.1 Probable Radiation Area Designations Within the SHINE RCA, Ground Floor Level
 
Security-Related Information - Withheld under 10 CFR 2.390(d)
Chapter 11 - Radiation Protection Program and Waste Management Radiation Protection SHINE Medical Technologies 11.1-51 Rev. 0 Figure 11.1 Estimated Derived Air Concentrations, Ground Floor Level
 
Chapter 11 - Radiation Protection Program and Waste Management Radiation Protection SHINE Medical Technologies 11.1-52 Rev. 0 Figure 11.1 Radiation Protection Organization
 
Chapter 11 - Radiation Protection Program and Waste Management Radiation Protection SHINE Medical Technologies 11.1-53 Rev. 0 Figure 11.1 Environmental Dosimeter Locations
 
Chapter 11 - Radiation Protection Program and Waste Management Radioactive Waste Management SHINE Medical Technologies 11.2-1 Rev. 0 11.2 RADIOACTIVE WASTE MANAGEMENT SHINE produces medical isotopes by the fission of low enriched uranium (LEU) driven by accelerator-produced neutrons. Several irradiation and processing steps create liquid, gaseous, or solid radioactive waste materials. This section describes the management program, controls, and disposal pathways established to ensure proper identification, classification, control, processing (as required), and packaging, for each anticipated radioactive waste stream generated by the SHINE facility. SHINE is committed to comply with all applicable local and national regulations for managing radioactive wastes.
SHINE will comply with the following federal regulations related to radioactive wastes:
10 CFR 20, Standards for Protection Against Radiation 10 CFR 61, Licensing Requirements for Land Disposal of Radioactive Waste 10 CFR 71, Packaging and Transportation of Radioactive Material 40 CFR, Chapter I, Subchapter F, Radiation Protection Programs 40 CFR, Chapter I, Subchapter I, Solid Wastes 49 CFR, Chapter I, Subchapter C, Hazardous Materials Regulations SHINE is regulated by the NRC. The State of Wisconsin regulates radioactive waste once it leaves the SHINE facility and is transported. SHINE complies with Wisconsin regulations relating to the transportation and disposal of hazardous waste per Wisconsin Administrative Code Chapter NR 662. The State of Wisconsin implements the U.S. Department of Transportation (DOT) radioactive waste transportation regulations.
Radioactive wastes are prepared for shipment in approved shipping containers and shipped off-site using common or contract carriers in compliance with DOT regulations (49 CFR) and 10 CFR 20, 10 CFR 61 and 10 CFR 71, as applicable.
SHINE complies with the waste acceptance criteria (WAC) of the selected licensed disposal facilities, including any local or state regulations specified in those criteria. The State of Wisconsin is in the Midwest Interstate Low-Level Radioactive Waste Compact. Waste disposal sites available for this compact include:
EnergySolutions in Clive, UT Waste Control Specialists (WCS) in Andrews, TX Section 11.1 describes the program and procedures for controlling and assessing radioactive exposures associated with radioactive sources, including radioactive waste streams.
11.2.1 RADIOACTIVE WASTE MANAGEMENT PROGRAM The Radioactive Waste Management Program is coordinated with the Radiation Protection Program under the Plant Manager. The goal of the Radioactive Waste Management Program is to minimize waste generation, minimize exposure of personnel, and to protect the general public and environment. The authority, duties, and responsibilities of personnel in the waste management organization are prescribed in the Radioactive Waste Management Program document.


NE Medical Technologies 11.1-50 Rev. 0 NE Medical Technologies 11.1-51 Rev. 0 NE Medical Technologies 11.1-52 Rev. 0 NE Medical Technologies 11.1-53 Rev. 0 NE produces medical isotopes by the fission of low enriched uranium (LEU) driven by elerator-produced neutrons. Several irradiation and processing steps create liquid, gaseous, olid radioactive waste materials. This section describes the management program, controls, disposal pathways established to ensure proper identification, classification, control, cessing (as required), and packaging, for each anticipated radioactive waste stream erated by the SHINE facility. SHINE is committed to comply with all applicable local and onal regulations for managing radioactive wastes.
Chapter 11 - Radiation Protection Program and Waste Management Radioactive Waste Management SHINE Medical Technologies 11.2-2 Rev. 0 11.2.1.1 Plant Manager The Plant Manager reports to the Chief Operating Officer. The Plant Manager has overall responsibility for the safe operation of the SHINE facility and is responsible for ensuring the protection of personnel from radiation exposure resulting from processing, handling and storing radioactive material and waste. The Plant Managers responsibilities are to:
NE will comply with the following federal regulations related to radioactive wastes:
Assign responsibility and delegates commensurate authority to implement the Radioactive Waste Management Program.
* 10 CFR 20, Standards for Protection Against Radiation
Provide waste management staff appropriate to the scope of operations and experienced in waste management operations.
* 10 CFR 61, Licensing Requirements for Land Disposal of Radioactive Waste
Ensure that the waste management self-assessment program is implemented.
* 10 CFR 71, Packaging and Transportation of Radioactive Material
Ensure compliance with applicable federal and state regulations, and facility license conditions.
* 40 CFR, Chapter I, Subchapter F, Radiation Protection Programs
Approve changes to the facility Process Control Program.
* 40 CFR, Chapter I, Subchapter I, Solid Wastes
11.2.1.2 Radiation Protection Manager The Radiation Protection Manager reports to the Plant Manager. The Radiation Protection Manager is responsible for establishing and maintaining the Radioactive Waste Management Program. The Radiation Protection Department maintains organizational independence from the Operations Department. The Radiation Protection Manager and Radiation Protection staff responsibilities are to:
* 49 CFR, Chapter I, Subchapter C, Hazardous Materials Regulations NE is regulated by the NRC. The State of Wisconsin regulates radioactive waste once it es the SHINE facility and is transported. SHINE complies with Wisconsin regulations relating he transportation and disposal of hazardous waste per Wisconsin Administrative Code pter NR 662. The State of Wisconsin implements the U.S. Department of Transportation T) radioactive waste transportation regulations.
Develop waste management procedures for the processing, packaging and shipment of radioactive waste from the facility.
ioactive wastes are prepared for shipment in approved shipping containers and shipped site using common or contract carriers in compliance with DOT regulations (49 CFR) and CFR 20, 10 CFR 61 and 10 CFR 71, as applicable.
Ensure that the concept of ALARA is incorporated into the Radioactive Waste Management Program procedures and is practiced by personnel.
NE complies with the waste acceptance criteria (WAC) of the selected licensed disposal lities, including any local or state regulations specified in those criteria. The State of consin is in the Midwest Interstate Low-Level Radioactive Waste Compact. Waste disposal s available for this compact include:
Process radioactive waste generated at the facility.
* EnergySolutions in Clive, UT
Provide technical input to the design of equipment and processes.
* Waste Control Specialists (WCS) in Andrews, TX tion 11.1 describes the program and procedures for controlling and assessing radioactive osures associated with radioactive sources, including radioactive waste streams.
Perform radiological analysis tasks supporting the Radioactive Waste Management Program.
  .1      RADIOACTIVE WASTE MANAGEMENT PROGRAM Radioactive Waste Management Program is coordinated with the Radiation Protection gram under the Plant Manager. The goal of the Radioactive Waste Management Program is inimize waste generation, minimize exposure of personnel, and to protect the general public environment. The authority, duties, and responsibilities of personnel in the waste nagement organization are prescribed in the Radioactive Waste Management Program ument.
Provide technical input to the Radioactive Waste Management Program training program.
NE Medical Technologies                      11.2-1                                      Rev. 0
Maintain contractual relationships with waste disposal sites, waste processing facilities, and radioactive waste carriers.
Maintain working knowledge of waste disposal acceptance criteria, regulations, standards and guides.
Conduct self-assessments of radioactive waste management practices and compliance with procedures.
11.2.1.3 Training Manager The Training Manager reports to the Plant Manager and is responsible for implementation of the Radioactive Waste Management Program training as described in the Radiation Protection Program. The Training Manager has the following responsibilities:
Develops the waste management training and qualification program in accordance with facility procedures and ensuring compliance with 49 CFR 172, Subpart H, Training.
Provides training to personnel commensurate with the radiological waste hazard to which they may be exposed.


Plant Manager reports to the Chief Operating Officer. The Plant Manager has overall ponsibility for the safe operation of the SHINE facility and is responsible for ensuring the ection of personnel from radiation exposure resulting from processing, handling and storing oactive material and waste. The Plant Managers responsibilities are to:
Chapter 11 - Radiation Protection Program and Waste Management Radioactive Waste Management SHINE Medical Technologies 11.2-3 Rev. 0 Provides re-training of previously-trained waste management personnel at least once every three years. Includes training on procedure changes and changes in required skills.
* Assign responsibility and delegates commensurate authority to implement the Radioactive Waste Management Program.
Evaluates the waste management and qualification training program periodically.
* Provide waste management staff appropriate to the scope of operations and experienced in waste management operations.
* Ensure that the waste management self-assessment program is implemented.
* Ensure compliance with applicable federal and state regulations, and facility license conditions.
* Approve changes to the facility Process Control Program.
  .1.2        Radiation Protection Manager Radiation Protection Manager reports to the Plant Manager. The Radiation Protection nager is responsible for establishing and maintaining the Radioactive Waste Management gram. The Radiation Protection Department maintains organizational independence from the rations Department. The Radiation Protection Manager and Radiation Protection staff ponsibilities are to:
* Develop waste management procedures for the processing, packaging and shipment of radioactive waste from the facility.
* Ensure that the concept of ALARA is incorporated into the Radioactive Waste Management Program procedures and is practiced by personnel.
* Process radioactive waste generated at the facility.
* Provide technical input to the design of equipment and processes.
* Perform radiological analysis tasks supporting the Radioactive Waste Management Program.
* Provide technical input to the Radioactive Waste Management Program training program.
* Maintain contractual relationships with waste disposal sites, waste processing facilities, and radioactive waste carriers.
* Maintain working knowledge of waste disposal acceptance criteria, regulations, standards and guides.
* Conduct self-assessments of radioactive waste management practices and compliance with procedures.
  .1.3        Training Manager Training Manager reports to the Plant Manager and is responsible for implementation of the ioactive Waste Management Program training as described in the Radiation Protection gram. The Training Manager has the following responsibilities:
* Develops the waste management training and qualification program in accordance with facility procedures and ensuring compliance with 49 CFR 172, Subpart H, Training.
* Provides training to personnel commensurate with the radiological waste hazard to which they may be exposed.
NE Medical Technologies                    11.2-2                                        Rev. 0
* Evaluates the waste management and qualification training program periodically.
Reviews program content to ensure it remains current and adequate to ensure worker safety.
Reviews program content to ensure it remains current and adequate to ensure worker safety.
  .1.4         Quality Manager Quality Manager reports to the Vice President Regulatory Affairs & Quality. The Quality nager has the following responsibilities:
11.2.1.4 Quality Manager The Quality Manager reports to the Vice President Regulatory Affairs & Quality. The Quality Manager has the following responsibilities:
* Review and audit facility radioactive waste handing, storing and shipping activities in accordance with the Quality Assurance Program Description to verify compliance with facility procedures, applicable federal and state regulations and applicable regulatory guides.
Review and audit facility radioactive waste handing, storing and shipping activities in accordance with the Quality Assurance Program Description to verify compliance with facility procedures, applicable federal and state regulations and applicable regulatory guides.
  .1.5         Shipping Personnel viduals who perform the duties of shipping radioactive waste, are trained in accordance with CFR 172, Subpart H, Training.
11.2.1.5 Shipping Personnel Individuals who perform the duties of shipping radioactive waste, are trained in accordance with 49 CFR 172, Subpart H, Training.
  .1.6         Radioactive Waste Management Procedures ioactive Waste Management Program implementing procedures are developed to provide ction for efficient and safe conduct of waste operations. The procedures include applicable trols and limits significant to the waste management operation. The procedures include:
11.2.1.6 Radioactive Waste Management Procedures Radioactive Waste Management Program implementing procedures are developed to provide direction for efficient and safe conduct of waste operations. The procedures include applicable controls and limits significant to the waste management operation. The procedures include:
* Waste minimization and pollution prevention, including process controls to minimize generation of waste and separation of radioactive waste and nonradioactive waste to reduce volumes of radioactive wastes.
Waste minimization and pollution prevention, including process controls to minimize generation of waste and separation of radioactive waste and nonradioactive waste to reduce volumes of radioactive wastes.
Radiological characterization and waste classification.
Radiological characterization and waste classification.
Operating and process controls with parameters for processing wastes.
Operating and process controls with parameters for processing wastes.
Line 651: Line 890:
Waste disposal recordkeeping.
Waste disposal recordkeeping.
Interim waste storage controls and recordkeeping.
Interim waste storage controls and recordkeeping.
Radiological Waste Management Program and implementing procedures are developed and trolled in accordance with SHINEs document control requirements.
The Radiological Waste Management Program and implementing procedures are developed and controlled in accordance with SHINEs document control requirements.
  .1.7         Record Keeping and Document Controls ords are developed and retained in accordance with the requirements specified in the iation Protection Program (see Subsection 11.1.2.1.8), the SHINE Document Control NE Medical Technologies                      11.2-3                                      Rev. 0
11.2.1.7 Record Keeping and Document Controls Records are developed and retained in accordance with the requirements specified in the Radiation Protection Program (see Subsection 11.1.2.1.8), the SHINE Document Control  


  .1.8       Waste Management Audits ility radioactive waste management audits are conducted, at a minimum, on an annual basis ccordance with 10 CFR 20.1101(c) for the purpose of reviewing the functional and safety ments of the radioactive waste management program. The audits also evaluate programmatic rts to minimize production of radioactive wastes. The audit activity is led by the Review and it Committee (see Section 12.2) as a subset of the Radiation Protection Program audit and results are sent to executive management. Any deficiencies identified by the audit are ressed by the corrective action process.
Chapter 11 - Radiation Protection Program and Waste Management Radioactive Waste Management SHINE Medical Technologies 11.2-4 Rev. 0 Program, and as specified in federal and state regulations applicable to the Radioactive Waste Management Program.
  .1.9       Technical Specifications iables, conditions, or other items that may be subjects of a technical specification associated radioactive waste management are contained in the facility Technical Specifications.
11.2.1.8 Waste Management Audits Facility radioactive waste management audits are conducted, at a minimum, on an annual basis in accordance with 10 CFR 20.1101(c) for the purpose of reviewing the functional and safety elements of the radioactive waste management program. The audits also evaluate programmatic efforts to minimize production of radioactive wastes. The audit activity is led by the Review and Audit Committee (see Section 12.2) as a subset of the Radiation Protection Program audit and the results are sent to executive management. Any deficiencies identified by the audit are addressed by the corrective action process.
  .2     RADIOACTIVE WASTE CONTROLS ioactive waste is generally considered to be any item or substance which is no longer of use he facility and which contains radioactivity above the established natural background oactivity. The wastes generated by the SHINE facility are not spent nuclear fuel, high-level te, or byproduct material as defined in paragraphs (2), (3) and (4) of the definition of roduct Material set forth in 10 CFR 20.1003. Therefore, the radioactive wastes generated by SHINE facility are all classified as low level waste (LLW). The LLW generated by the SHINE lity during operation is expected to be classified as Class A, Class B or Class C waste. The tron multipliers are designed for the life of the facility and will be disposed of as greater-than ss C (GTCC) waste during decommissioning.
11.2.1.9 Technical Specifications Variables, conditions, or other items that may be subjects of a technical specification associated with radioactive waste management are contained in the facility Technical Specifications.
the purposes of transportation, packaged wastes may be categorized as low specific activity A), requiring Type A packaging, or requiring Type B packaging.
11.2.2 RADIOACTIVE WASTE CONTROLS Radioactive waste is generally considered to be any item or substance which is no longer of use to the facility and which contains radioactivity above the established natural background radioactivity. The wastes generated by the SHINE facility are not spent nuclear fuel, high-level waste, or byproduct material as defined in paragraphs (2), (3) and (4) of the definition of Byproduct Material set forth in 10 CFR 20.1003. Therefore, the radioactive wastes generated by the SHINE facility are all classified as low level waste (LLW). The LLW generated by the SHINE facility during operation is expected to be classified as Class A, Class B or Class C waste. The neutron multipliers are designed for the life of the facility and will be disposed of as greater-than Class C (GTCC) waste during decommissioning.
the purposes of both transportation and operational ALARA, wastes may be categorized as er contact handled or remote handled. The upper limit for remote handled waste dose rates is ned based on payload limits for the specific shielded transportation casks used and on WAC he intended disposal site.
For the purposes of transportation, packaged wastes may be categorized as low specific activity (LSA), requiring Type A packaging, or requiring Type B packaging.
iation Protection Program requirements and the ALARA Program (see Section 11.1) apply to oactive waste management, including, but not limited to, control of materials, monitoring and eys, radiologically controlled area (RCA) access control, contamination control and personnel itoring. ALARA goals and implementation are detailed in Subsection 11.1.3.
For the purposes of both transportation and operational ALARA, wastes may be categorized as either contact handled or remote handled. The upper limit for remote handled waste dose rates is defined based on payload limits for the specific shielded transportation casks used and on WAC for the intended disposal site.
material staging building is used for interim storage of wastes for decay and for preparation for ment. Wastes are not stored for more than five years. The material staging building design luated the shielding provided by the building to ensure 10 CFR 20 site dose limits are met and RA principles are followed.
Radiation Protection Program requirements and the ALARA Program (see Section 11.1) apply to radioactive waste management, including, but not limited to, control of materials, monitoring and surveys, radiologically controlled area (RCA) access control, contamination control and personnel monitoring. ALARA goals and implementation are detailed in Subsection 11.1.3.
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The material staging building is used for interim storage of wastes for decay and for preparation for shipment. Wastes are not stored for more than five years. The material staging building design evaluated the shielding provided by the building to ensure 10 CFR 20 site dose limits are met and ALARA principles are followed.  


oactive wastes.
Chapter 11 - Radiation Protection Program and Waste Management Radioactive Waste Management SHINE Medical Technologies 11.2-5 Rev. 0 Radioactive waste management operating procedures are discussed in Subsection 11.2.1.6.
  .2.1       Radioactive Waste Minimization ste minimization and pollution prevention are key elements of the Radiological Waste nagement Program. Implementing procedures (see Subsection 11.2.1.6) address:
These procedures ensure proper identification, characterization, and separate treatment of radioactive wastes.
: a. Responsibilities for waste minimization and pollution prevention.
11.2.2.1 Radioactive Waste Minimization Waste minimization and pollution prevention are key elements of the Radiological Waste Management Program. Implementing procedures (see Subsection 11.2.1.6) address:
: b. Employee training and education on general environmental activities and hazards regarding the facility, operations, pollution prevention, waste minimization requirements, goals and accomplishments.
a.
: c. Setting goals for reducing the volume or radioactivity in each waste stream.
Responsibilities for waste minimization and pollution prevention.
: d. Sorting and compaction to reduce the volume of solid waste.
b.
: e. Segregation of nonradiological and radiological wastes to reduce the volume of radiological waste due to contamination.
Employee training and education on general environmental activities and hazards regarding the facility, operations, pollution prevention, waste minimization requirements, goals and accomplishments.
: f. Process controls that minimize generation of wastes.
c.
: g. Periodic assessments to identify opportunities to reduce or eliminate the generation of wastes.
Setting goals for reducing the volume or radioactivity in each waste stream.
: h. Recognition of employees for efforts to improve waste minimization and environmental conditions.
d.
  .2.2       Waste Stream Sources ste management operations occur in the main production facility and the material staging ding (see Figure 1.3-1 and Figure 1.3-3). At least 5,600 square feet (ft2) of the material ing building is for temporary storage to allow for decay. As allowed by the waste drum ign, building design, and programmatic controls (e.g., inspection requirements), drums may tored in multiple layers. Equipment and associated features for containment and/or kaging, storage, and disposal of solid, liquid, and gaseous radioactive waste are discussed in section 9b.7.3, Subsection 9b.7.4, and Subsection 9b.7.5.
Sorting and compaction to reduce the volume of solid waste.
nges to the facility will be performed in accordance with 10 CFR 50.59, Changes, Tests and eriments, and will be assessed for their impact on radioactive waste sources or nagement, as applicable.
e.
le 11.2-1 summarizes the facility waste streams, characteristics, generation rates, and ment categories. The waste streams and typical waste classifications are described in the wing subsections.
Segregation of nonradiological and radiological wastes to reduce the volume of radiological waste due to contamination.
  .2.2.1     Uranium Receipt and Storage System ste generated by uranium receipt and storage includes used cannisters in which new uranium al and uranium oxide are received. The used cannisters are processed as Class A waste, if returned to the supplier. The uranium receipt and storage system (URSS) utilizes gloveboxes high efficiency particulate air (HEPA) filters in the air supply and return lines. The spent PA filters are Class A waste.
f.
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Process controls that minimize generation of wastes.
g.
Periodic assessments to identify opportunities to reduce or eliminate the generation of wastes.
h.
Recognition of employees for efforts to improve waste minimization and environmental conditions.
11.2.2.2 Waste Stream Sources Waste management operations occur in the main production facility and the material staging building (see Figure 1.3-1 and Figure 1.3-3). At least 5,600 square feet (ft2) of the material staging building is for temporary storage to allow for decay. As allowed by the waste drum design, building design, and programmatic controls (e.g., inspection requirements), drums may be stored in multiple layers. Equipment and associated features for containment and/or packaging, storage, and disposal of solid, liquid, and gaseous radioactive waste are discussed in Subsection 9b.7.3, Subsection 9b.7.4, and Subsection 9b.7.5.
Changes to the facility will be performed in accordance with 10 CFR 50.59, Changes, Tests and Experiments, and will be assessed for their impact on radioactive waste sources or management, as applicable.
Table 11.2-1 summarizes the facility waste streams, characteristics, generation rates, and shipment categories. The waste streams and typical waste classifications are described in the following subsections.
11.2.2.2.1 Uranium Receipt and Storage System Waste generated by uranium receipt and storage includes used cannisters in which new uranium metal and uranium oxide are received. The used cannisters are processed as Class A waste, if not returned to the supplier. The uranium receipt and storage system (URSS) utilizes gloveboxes with high efficiency particulate air (HEPA) filters in the air supply and return lines. The spent HEPA filters are Class A waste.


target solution preparation process may generate waste in the form of spent filters from uranyl sulfate dissolution tanks, if not cleaned and reused, and spent HEPA filters from vebox air supply and return lines. The spent filters are Class A waste.
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  .2.2.3     Irradiation Unit rradiation unit (IU) consists of a subcritical assembly system (SCAS) coupled with a neutron er assembly system (NDAS). The IU components become activated during their service life.
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AS major components are designed for the life of the facility and are not anticipated waste ams. Spent NDAS components are Class A waste. Contaminated oil from the NDAS vacuum ps is Class B waste.
Chapter 11 - Radiation Protection Program and Waste Management Radioactive Waste Management SHINE Medical Technologies 11.2-6 Rev. 0 11.2.2.2.2 Target Solution Preparation System The target solution preparation process may generate waste in the form of spent filters from the uranyl sulfate dissolution tanks, if not cleaned and reused, and spent HEPA filters from glovebox air supply and return lines. The spent filters are Class A waste.
  .2.2.4     TSV Off-Gas System target solution vessel (TSV) off-gas system (TOGS) removes radiolysis and fission duct gases from the TSV during irradiation operation and from the TSV dump tank during l down operation. There are a total of eight independent TOGS, one for each IU.
11.2.2.2.3 Irradiation Unit An irradiation unit (IU) consists of a subcritical assembly system (SCAS) coupled with a neutron driver assembly system (NDAS). The IU components become activated during their service life.
TOGS contains skid-mounted equipment that includes recombiner beds, demisters, and lite beds. Skid replacement occurs infrequently. Skids containing recombiner beds and misters are treated with an acid flush and processed as Class A or B waste. Zeolite beds are igned for the life of the facility, however, if replaced more frequently and processed arately from the remainder of the skid components, the zeolite beds are expected to be ss B or Class C waste.
SCAS major components are designed for the life of the facility and are not anticipated waste streams. Spent NDAS components are Class A waste. Contaminated oil from the NDAS vacuum pumps is Class B waste.
  .2.2.5     Molybdenum Extraction and Purification System molybdenum extraction and purification system (MEPS) separates molybdenum from an diated uranyl sulfate target solution. The molybdenum is then concentrated and purified into a ium molybdate solution. The MEPS is located within a series of hot cells. Waste generated the MEPS includes spent molybdenum extraction columns, [
11.2.2.2.4 TSV Off-Gas System The target solution vessel (TSV) off-gas system (TOGS) removes radiolysis and fission product gases from the TSV during irradiation operation and from the TSV dump tank during cool down operation. There are a total of eight independent TOGS, one for each IU.
      ]PROP/ECI, and purification glassware. MEPS liquid wastes are processed by the oactive liquid waste immobilization (RLWI) system.
The TOGS contains skid-mounted equipment that includes recombiner beds, demisters, and zeolite beds. Skid replacement occurs infrequently. Skids containing recombiner beds and demisters are treated with an acid flush and processed as Class A or B waste. Zeolite beds are designed for the life of the facility, however, if replaced more frequently and processed separately from the remainder of the skid components, the zeolite beds are expected to be Class B or Class C waste.
nt extraction columns [                               ]PROP/ECI are stored in a hot cell, then sferred to the drum storage bore holes for decay, and ultimately disposed as Class B or C te.
11.2.2.2.5 Molybdenum Extraction and Purification System The molybdenum extraction and purification system (MEPS) separates molybdenum from an irradiated uranyl sulfate target solution. The molybdenum is then concentrated and purified into a sodium molybdate solution. The MEPS is located within a series of hot cells. Waste generated from the MEPS includes spent molybdenum extraction columns, [  
glassware used in this process is not expected to contain significant quantities of long-lived onuclides and is Class A waste.
]PROP/ECI, and purification glassware. MEPS liquid wastes are processed by the radioactive liquid waste immobilization (RLWI) system.
                      ]PROP/ECI associated with MEPS column washes occurs in the RLWI tem. The [                                           ]PROP/ECI are disposed as Class B or Class C te.
Spent extraction columns [ ]PROP/ECI are stored in a hot cell, then transferred to the drum storage bore holes for decay, and ultimately disposed as Class B or C waste.
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The glassware used in this process is not expected to contain significant quantities of long-lived radionuclides and is Class A waste.
[ ]PROP/ECI associated with MEPS column washes occurs in the RLWI system. The [ ]PROP/ECI are disposed as Class B or Class C waste.


process vessel vent system (PVVS) removes radioactive particulates, iodine, and noble es that are generated within the radioisotope production facility (RPF) and primary system ndary (PSB) prior to being discharged to the atmosphere. PVVS waste consists of spent PA filters and spent carbon guard beds. The spent HEPA filters are Class A waste and the nt carbon guard beds are Class A or Class B waste. Condensate from PVVS can be blended other waste streams and processed by RLWI.
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  .2.2.7     Iodine and Xenon Purification and Packaging System iodine and xenon purification and packaging (IXP) system separates the iodine fission ducts from the uranyl sulfate target solution or from [                           ]PROP/ECI. The system generates spent iodine recovery, [
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    ]PROP/ECI.
Chapter 11 - Radiation Protection Program and Waste Management Radioactive Waste Management SHINE Medical Technologies 11.2-7 Rev. 0 11.2.2.2.6 Process Vessel Vent System The process vessel vent system (PVVS) removes radioactive particulates, iodine, and noble gases that are generated within the radioisotope production facility (RPF) and primary system boundary (PSB) prior to being discharged to the atmosphere. PVVS waste consists of spent HEPA filters and spent carbon guard beds. The spent HEPA filters are Class A waste and the spent carbon guard beds are Class A or Class B waste. Condensate from PVVS can be blended with other waste streams and processed by RLWI.
ne recovery, [                                     ]PROP/ECI will be regularly changed out and Class B or Class C waste.
11.2.2.2.7 Iodine and Xenon Purification and Packaging System The iodine and xenon purification and packaging (IXP) system separates the iodine fission products from the uranyl sulfate target solution or from [ ]PROP/ECI. The IXP system generates spent iodine recovery, [
  .2.2.8     Hot Cells cells contain HEPA and carbon filter combinations on the air supply and return lines. Spent PA and carbon filters are Class A waste.
]PROP/ECI.
  .2.2.9     Primary Closed Loop Cooling System primary closed loop cooling system (PCLS) has potential for radioactive contamination due inor leakage from the PSB and activation products. Contamination would collect on the LS filters and deionizer resins. PCLS filters could become contaminated with radionuclides to activation of corrosion particles as the water passes through the TSV, however, corrosion e stainless steel components is expected to be small. The spent PCLS filters are expected to Class A waste. PCLS deionizer resins are contained in disposable deionizer units. The tanks designed for complete replacement without removal of the ion exchange resins in the tanks.
Iodine recovery, [ ]PROP/ECI will be regularly changed out and are Class B or Class C waste.
disposable tanks are Class A waste.
11.2.2.2.8 Hot Cells Hot cells contain HEPA and carbon filter combinations on the air supply and return lines. Spent HEPA and carbon filters are Class A waste.
  .2.2.10   Light Water Pool System light water pool has potential for radioactive contamination due to minor leakage from the B and activation products. Any contamination would collect on the filters and deionizer resins d to cleanup the light water pool. Similar to the PCLS, the deionizer resins are contained in osable deionizer units and are expected to be Class A waste. Spent filters are expected to be ss A waste.
11.2.2.2.9 Primary Closed Loop Cooling System The primary closed loop cooling system (PCLS) has potential for radioactive contamination due to minor leakage from the PSB and activation products. Contamination would collect on the PCLS filters and deionizer resins. PCLS filters could become contaminated with radionuclides due to activation of corrosion particles as the water passes through the TSV, however, corrosion of the stainless steel components is expected to be small. The spent PCLS filters are expected to be Class A waste. PCLS deionizer resins are contained in disposable deionizer units. The tanks are designed for complete replacement without removal of the ion exchange resins in the tanks.
  .2.2.11   Radioactive Liquid Waste ioactive liquid waste streams include waste liquids from:
The disposable tanks are Class A waste.
* MEPS
11.2.2.2.10 Light Water Pool System The light water pool has potential for radioactive contamination due to minor leakage from the PSB and activation products. Any contamination would collect on the filters and deionizer resins used to cleanup the light water pool. Similar to the PCLS, the deionizer resins are contained in disposable deionizer units and are expected to be Class A waste. Spent filters are expected to be Class A waste.
* IXP system
11.2.2.2.11 Radioactive Liquid Waste Radioactive liquid waste streams include waste liquids from:
* PVVS NE Medical Technologies                    11.2-7                                      Rev. 0
MEPS IXP system PVVS
* Laboratory liquid waste liquid waste streams are shown in Table 11.2-1.
id waste streams are collected in uranium liquid waste and radioactive liquid waste collection s, consolidated in liquid waste blending tanks and treated for disposal using the RLWI tem. The quantity and size of the tanks are managed to maximize decay time and provide a er for upset conditions. Each uranium liquid waste tank has at least [          ]PROP/ECI acity and the liquid waste collection and blending tanks each have at least 600 gallons acity. Hold times for decay are based on minimizing dose rates to workers during the obilization process. Solidified liquid waste is expected to be Class A.
chemical composition and relative radiological inventory of liquid waste streams is presented able 11.2-6.
  .2.2.12    Radioactive Gaseous Waste orne radioactive sources are present in the tritium purification system (TPS), PVVS, TOGS, uum transfer system (VTS), and the NDAS. Airborne radioactive sources and release are ressed in Subsection 11.1.1.1 and Table 11.1-5.
RCA ventilation systems generate spent prefilters, HEPA filters and carbon filters that are ss A generated solid waste.
  .2.3        Technical Specifications iables, conditions, or other items that may be subjects of a technical specification associated radioactive waste controls are contained in the facility Technical Specifications.
  .3      RELEASE OF RADIOACTIVE WASTE ease, for the purposes of this subsection, means that wastes are processed and packaged as uired to meet the WAC of an established, licensed LLW disposal facility. Processing may be prised of one or more of several operations, including compaction, solidification with an ropriate solidification agent, adsorption onto a solid medium (e.g., elemental iodine onto vated carbon filters), interim storage for decay of radionuclides, consolidated handling and cessing, extraction and consolidation of radionuclides by segregation, and mixing (possibly more than one waste stream) so that the bulk volume of waste is readily disposable.
iation monitoring of effluent waste streams is described in Section 7.7. Radiation monitoring uirements are also described in the Radiation Protection Program. The Radiation Protection gram is described in detail in Subsection 11.1.2.
id effluent is not routinely discharged from the RCA. Radioactive liquid discharges from the NE facility to the sanitary sewer are infrequent and made in accordance with CFR 20.2003 and 10 CFR 20.2007. There are no piped liquid effluent pathways from the RCA he sanitary sewer. Sampling is used to determine suitability for release.
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sification and management will be made in accordance with the Radioactive Waste nagement Program implementing procedures.
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  .3.1       Solid Wastes subsections below discuss the methodology for the eventual release of the major solid tes generated by the SHINE facility. Processing requirements are in accordance with the eiving facilitys WAC and will be modified as needed to reflect any change in the disposal site WAC.
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  .3.1.1      Irradiation Units d waste streams associated with the IUs are the NDAS activated components. The NDAS is prised of an accelerator section, pumping section, roots stack, and target chamber embly. The target chamber assembly is expected to be Class A waste and the WAC specified EnergySolutions will apply. The accelerator stage, pumping stage and roots stack are sidered oversize and must meet specific WAC applicable to oversize components.
Chapter 11 - Radiation Protection Program and Waste Management Radioactive Waste Management SHINE Medical Technologies 11.2-8 Rev. 0 Decontamination liquid waste from decontamination of structures, systems, and components (SSCs) during normal operation Laboratory liquid waste The liquid waste streams are shown in Table 11.2-1.
le 11.2-2 displays the typical methodology associated with disassembly and processing of waste stream.
Liquid waste streams are collected in uranium liquid waste and radioactive liquid waste collection tanks, consolidated in liquid waste blending tanks and treated for disposal using the RLWI system. The quantity and size of the tanks are managed to maximize decay time and provide a buffer for upset conditions. Each uranium liquid waste tank has at least [ ]PROP/ECI capacity and the liquid waste collection and blending tanks each have at least 600 gallons capacity. Hold times for decay are based on minimizing dose rates to workers during the immobilization process. Solidified liquid waste is expected to be Class A.
  .3.1.2      Spent Columns nt molybdenum extraction columns, [                              ]PROP/ECI, and IXP recovery,
The chemical composition and relative radiological inventory of liquid waste streams is presented in Table 11.2-6.
                                  ]PROP/ECI will be held in hot cells for decay, then consolidated supercell export waste drums prior to disposal.
11.2.2.2.12 Radioactive Gaseous Waste Airborne radioactive sources are present in the tritium purification system (TPS), PVVS, TOGS, vacuum transfer system (VTS), and the NDAS. Airborne radioactive sources and release are addressed in Subsection 11.1.1.1 and Table 11.1-5.
columns are removed from the process lines using quick-disconnect style inlet and outlet nectors specifically designed for use with remote manipulators in hot cell environments.
The RCA ventilation systems generate spent prefilters, HEPA filters and carbon filters that are Class A generated solid waste.
iation and wear-resistant seals and automatically closing valves built into the connectors vide leak tightness to minimize or prevent leakage.
11.2.2.3 Technical Specifications Variables, conditions, or other items that may be subjects of a technical specification associated with radioactive waste controls are contained in the facility Technical Specifications.
r removing a spent column from the originating process, it is stored in a hot cell for sufficient to allow short-lived fission products to decay. After several columns have decayed, they are sported out of the cell in one transfer to reduce personnel exposure and the number of sfer operations. The number of columns transferred is limited based on export waste drum acity. The export waste drum is shielded to ensure personnel doses are maintained ALARA within procedure limits during the transfer. The estimated dose rate for an extraction column, he time of process removal is approximately 9500 rem/hr at 3 feet unshielded. The peak dose drops to approximately 580 rem/hr at 3 feet unshielded after storage in the hot cell.
11.2.3 RELEASE OF RADIOACTIVE WASTE Release, for the purposes of this subsection, means that wastes are processed and packaged as required to meet the WAC of an established, licensed LLW disposal facility. Processing may be comprised of one or more of several operations, including compaction, solidification with an appropriate solidification agent, adsorption onto a solid medium (e.g., elemental iodine onto activated carbon filters), interim storage for decay of radionuclides, consolidated handling and processing, extraction and consolidation of radionuclides by segregation, and mixing (possibly from more than one waste stream) so that the bulk volume of waste is readily disposable.
en a set of columns are to be transferred out of the hot cell, they are remotely loaded into an ort waste drum within a shielded cask. Dose rates from the cask and contamination levels are firmed to be within limits, then the cask is remotely transported to a bore hole for interim w-grade storage. The shielded cask is surveyed and decontaminated, if needed, prior to se.
Radiation monitoring of effluent waste streams is described in Section 7.7. Radiation monitoring requirements are also described in the Radiation Protection Program. The Radiation Protection Program is described in detail in Subsection 11.1.2.
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Liquid effluent is not routinely discharged from the RCA. Radioactive liquid discharges from the SHINE facility to the sanitary sewer are infrequent and made in accordance with 10 CFR 20.2003 and 10 CFR 20.2007. There are no piped liquid effluent pathways from the RCA to the sanitary sewer. Sampling is used to determine suitability for release.


a for loading into a Type B shipping container.
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spent columns are expected to be Type B or C generated waste and have no specified time uirement in storage. The spent columns are stored in order to consolidate shipments to imize handling for ALARA and to consolidate the columns to reduce disposal volumes.
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uirements for this waste stream are presented in Table 11.2-3.
Chapter 11 - Radiation Protection Program and Waste Management Radioactive Waste Management SHINE Medical Technologies 11.2-9 Rev. 0 Table 11.2-1 shows the anticipated waste generation, classifications, shipment types, and expected disposal sites for the identified waste streams. Final determinations of waste classification and management will be made in accordance with the Radioactive Waste Management Program implementing procedures.
                                                                                  ]PROP/ECI
11.2.3.1 Solid Wastes The subsections below discuss the methodology for the eventual release of the major solid wastes generated by the SHINE facility. Processing requirements are in accordance with the receiving facilitys WAC and will be modified as needed to reflect any change in the disposal site or WAC.
  .3.1.3    Process Glassware nt molybdenum purification glassware is remotely handled to move the glassware from the cell to an export waste drum. The glassware may be crushed in the waste drum using a otely controlled compactor and transported to the material staging building in a shielded sport cask. Requirements for this waste stream are presented in Table 11.2-4.
11.2.3.1.1 Irradiation Units Solid waste streams associated with the IUs are the NDAS activated components. The NDAS is comprised of an accelerator section, pumping section, roots stack, and target chamber assembly. The target chamber assembly is expected to be Class A waste and the WAC specified by EnergySolutions will apply. The accelerator stage, pumping stage and roots stack are considered oversize and must meet specific WAC applicable to oversize components.
  .3.1.4    Zeolite Beds silver coated zeolite beds are a component of the TOGS and are provided to remove iodine the sweep gas. Toxicity characteristic leaching procedure (TCLP) would result in the sification of this waste as Resource Conservation and Recovery Act (RCRA) waste; ever, the waste is also radioactive and as such may be a mixed low level waste (MLLW). The te classification for this material is a function of both the efficiency of the zeolite beds and the nge out frequency of the beds. The design goal is for the beds to last the lifetime of the lity; however, this waste stream is assumed to be replaced every five years. The zeolite bed the potential to be Class B or Class C waste.
Table 11.2-2 displays the typical methodology associated with disassembly and processing of this waste stream.
  .3.1.5    Recombiner Beds, Demister and Component Replacement waste stream is associated with the TOGS. This waste stream is based on infrequent acement of the TOGS skids. Acid flushing of the skid components (excluding the zeolite s) will be performed prior to disposal. Cs-137 and Sr-90 are expected to dominate the waste sification. Remote handling and packaging may be required due to considerable dose rates ected should replacement be required. This waste stream is Class A or Class B waste.
11.2.3.1.2 Spent Columns Spent molybdenum extraction columns, [ ]PROP/ECI, and IXP recovery,
  .3.1.6    PCLS and LWPS Deionizer Units PCLS and LWPS deionizer resins are contained in disposable deionizer units. The spent s are dewatered and disposed as Class A generated waste.
[ ]PROP/ECI will be held in hot cells for decay, then consolidated into supercell export waste drums prior to disposal.
  .3.2      Liquid Waste Streams eral waste streams are solidified on site to meet DOT criteria and disposal site WAC, as cribed in Subsection 11.2.2. The consolidated liquid waste stream (post-treatment) is enable for disposal as Class A waste at EnergySolutions.
The columns are removed from the process lines using quick-disconnect style inlet and outlet connectors specifically designed for use with remote manipulators in hot cell environments.
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Radiation and wear-resistant seals and automatically closing valves built into the connectors provide leak tightness to minimize or prevent leakage.
After removing a spent column from the originating process, it is stored in a hot cell for sufficient time to allow short-lived fission products to decay. After several columns have decayed, they are transported out of the cell in one transfer to reduce personnel exposure and the number of transfer operations. The number of columns transferred is limited based on export waste drum capacity. The export waste drum is shielded to ensure personnel doses are maintained ALARA and within procedure limits during the transfer. The estimated dose rate for an extraction column, at the time of process removal is approximately 9500 rem/hr at 3 feet unshielded. The peak dose rate drops to approximately 580 rem/hr at 3 feet unshielded after storage in the hot cell.
When a set of columns are to be transferred out of the hot cell, they are remotely loaded into an export waste drum within a shielded cask. Dose rates from the cask and contamination levels are confirmed to be within limits, then the cask is remotely transported to a bore hole for interim below-grade storage. The shielded cask is surveyed and decontaminated, if needed, prior to reuse.  


ioactive liquid waste and estimated generated volumes are provided in Table 11.2-1.
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nium liquid wastes and other radioactive liquid wastes are collected and processed arately, then blended prior to solidification. Uranium liquid wastes may consist of ybdenum extraction column acid wash, extraction column water wash, iodine recovery mn [              ]PROP/ECI, VTS knockout pot contents, spent target solution, or ontamination waste. Radioactive liquid waste may consist of [
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                                                                          ]PROP/ECI, purification te, [                                                                ]PROP/ECI, or PVVS densate. Blending of wastes is performed without exceeding the maximum uranium centration applicable to the receiving disposal site. Certain fissile material may be exempted er 10 CFR 71.15.
Chapter 11 - Radiation Protection Program and Waste Management Radioactive Waste Management SHINE Medical Technologies 11.2-10 Rev. 0 When a shipment of columns is to be prepared, the export waste drum is retracted using the remote-controlled grappler and placed into a shielded cask and the cask is transported to an area for loading into a Type B shipping container.
waste stream process includes removal of radionuclides, radioactive decay, pH adjustment, ding of uranium and radioactive liquid wastes, and solidification in 55-gallon drums using a dification agent.
The spent columns are expected to be Type B or C generated waste and have no specified time requirement in storage. The spent columns are stored in order to consolidate shipments to minimize handling for ALARA and to consolidate the columns to reduce disposal volumes.
anticipated disposal site for the solidified liquid waste is EnergySolutions.
Requirements for this waste stream are presented in Table 11.2-3.
uirements for this waste stream are presented in Table 11.2-5.
[
  .3.3       Gaseous Waste Streams orne radioactive sources are identified in Subsection 11.1.1 and Table 11.1-5. The RCA tilation system filtering and exhaust stack discharge is described in Subsection 9a2.1.1. The aust stack location is shown on Figure 1.3-2. The stack release monitor provides continuous nitoring of radioactive noble gas stack releases and a means to sample and measure the k air for particulate, iodine, and tritium concentration to ensure compliance with gaseous ent regulatory limits. The estimate of annual release of radionuclides is provided in le 11.1-8. The effect of releases on the surrounding environment is addressed by the ironmental Monitoring Program described in Subsection 11.1.7.
]PROP/ECI 11.2.3.1.3 Process Glassware Spent molybdenum purification glassware is remotely handled to move the glassware from the hot cell to an export waste drum. The glassware may be crushed in the waste drum using a remotely controlled compactor and transported to the material staging building in a shielded transport cask. Requirements for this waste stream are presented in Table 11.2-4.
NE Medical Technologies                      11.2-11                                      Rev. 0
11.2.3.1.4 Zeolite Beds The silver coated zeolite beds are a component of the TOGS and are provided to remove iodine from the sweep gas. Toxicity characteristic leaching procedure (TCLP) would result in the classification of this waste as Resource Conservation and Recovery Act (RCRA) waste; however, the waste is also radioactive and as such may be a mixed low level waste (MLLW). The waste classification for this material is a function of both the efficiency of the zeolite beds and the change out frequency of the beds. The design goal is for the beds to last the lifetime of the facility; however, this waste stream is assumed to be replaced every five years. The zeolite bed has the potential to be Class B or Class C waste.
11.2.3.1.5 Recombiner Beds, Demister and Component Replacement This waste stream is associated with the TOGS. This waste stream is based on infrequent replacement of the TOGS skids. Acid flushing of the skid components (excluding the zeolite beds) will be performed prior to disposal. Cs-137 and Sr-90 are expected to dominate the waste classification. Remote handling and packaging may be required due to considerable dose rates expected should replacement be required. This waste stream is Class A or Class B waste.
11.2.3.1.6 PCLS and LWPS Deionizer Units The PCLS and LWPS deionizer resins are contained in disposable deionizer units. The spent units are dewatered and disposed as Class A generated waste.
11.2.3.2 Liquid Waste Streams Several waste streams are solidified on site to meet DOT criteria and disposal site WAC, as described in Subsection 11.2.2. The consolidated liquid waste stream (post-treatment) is amenable for disposal as Class A waste at EnergySolutions.


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Chapter 11 - Radiation Protection Program and Waste Management                                                       Radioactive Waste Management Table 11.2 Estimated Annual Waste Stream Summary (Sheet 1 of 2)
Chapter 11 - Radiation Protection Program and Waste Management Radioactive Waste Management SHINE Medical Technologies 11.2-11 Rev. 0 11.2.3.2.1 Consolidated Liquids Radioactive liquid waste and estimated generated volumes are provided in Table 11.2-1.
As            As        As Class as        Generated    Generated Disposed    Shipment Description                        Matrix      Generated          Amount        Units      (ft3)      Type        Destination(a)
Uranium liquid wastes and other radioactive liquid wastes are collected and processed separately, then blended prior to solidification. Uranium liquid wastes may consist of molybdenum extraction column acid wash, extraction column water wash, iodine recovery column [ ]PROP/ECI, VTS knockout pot contents, spent target solution, or decontamination waste. Radioactive liquid waste may consist of [
MEPS Extraction Columns [                                [
]PROP/ECI, purification waste, [ ]PROP/ECI, or PVVS condensate.Blending of wastes is performed without exceeding the maximum uranium concentration applicable to the receiving disposal site. Certain fissile material may be exempted under 10 CFR 71.15.
B or C        [ ]PROP/ECI     ft3/yr    270        Type B            WCS
This waste stream process includes removal of radionuclides, radioactive decay, pH adjustment, blending of uranium and radioactive liquid wastes, and solidification in 55-gallon drums using a solidification agent.
          ]PROP/ECI                                      ]PROP/ECI
The anticipated disposal site for the solidified liquid waste is EnergySolutions.
[                              ]PROP/ECI        [    ]PROP/ECI    B or C              72        ft3/yr      72        Type B            WCS IXP Separation Columns                            [     ]PROP/ECI   B or C      [   ]PROP/ECI       3 ft /yr      35        Type B            WCS Type A or LWPS Deionizer Units                                  Resin            A                48          ft3/yr      80                    EnergySolutions LSA Type A or PCLS Deionizer Units                                  Resin            A                  48        ft3/yr      80                    EnergySolutions LSA Type A or Uranium Canisters                                      Solid          A                2.0(b)      ft3/yr      3.3                   EnergySolutions LSA Type A or NDAS Accelerator Subassembly                          Solid          A        [        ]PROP/ECI  ft3/yr  13,600                    EnergySolutions LSA Type A or NDAS Target Chamber Subassembly                        Solid          A          [    ]PROP/ECI    ft3/yr    1330                    EnergySolutions LSA Type A, B, or EnergySolutions or TOGS Skids                                            Solid        A or B              922        ft3/yr    1540 LSA            WCS TOGS Zeolite Beds                                      Solid        B or C            0.64        ft3/yr      1       Type B            WCS Type A or LWPS Filters                                          Solid          A                1.6        ft3/yr      2.7                    EnergySolutions LSA Type A or PCLS Filters                                          Solid          A                1.6        ft3/yr      2.7                    EnergySolutions LSA TSPS, URSS, PVVS, Hot Cell, RVZ1, RVZ2, RLWI                                                                              Type A or Solid          A                182        ft3/yr    142                    EnergySolutions HEPA Filters                                                                                                                LSA Type A or Hot Cell, RVZ1, RVZ2 Charcoal Filters                  Solid          A                  32        ft3/yr      54                    EnergySolutions LSA Type A or TSPS Uranyl Sulfate Solution Filters                  Solid          A              0.35(c)      ft3/yr    0.58                    EnergySolutions LSA SHINE Medical Technologies                                                11.2-12                                                                Rev. 0
Requirements for this waste stream are presented in Table 11.2-5.
11.2.3.3 Gaseous Waste Streams Airborne radioactive sources are identified in Subsection11.1.1 and Table11.1-5. The RCA ventilation system filtering and exhaust stack discharge is described in Subsection 9a2.1.1. The exhaust stack location is shown on Figure1.3-2. Thestack release monitor provides continuous monitoring of radioactive noble gas stack releases and a means to sample and measure the stack air for particulate, iodine, and tritium concentration to ensure compliance with gaseous effluent regulatory limits. The estimate of annual release of radionuclides is provided in Table11.1-8. The effect of releases on the surrounding environment is addressed by the Environmental Monitoring Program described in Subsection11.1.7.


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Chapter 11 - Radiation Protection Program and Waste Management                                                                               Radioactive Waste Management Table 11.2 Estimated Annual Waste Stream Summary (Sheet 2 of 2)
Chapter 11 - Radiation Protection Program and Waste Management Radioactive Waste Management SHINE Medical Technologies 11.2-12 Rev. 0 Table 11.2 Estimated Annual Waste Stream Summary (Sheet 1 of 2)
As                As          As Class as         Generated         Generated     Disposed    Shipment Description                                Matrix          Generated           Amount            Units         (ft3)       Type     Destination(a)
Description Matrix Class as Generated As Generated Amount As Generated Units As Disposed (ft3)
EnergySolutions or PVVS Carbon Guard Bed                                             Solid             A or B             0.48             ft3/yr       0.81       Type B WCS Type A or MEPS Glassware                                                   Solid               A                 208             ft3/yr       347                 EnergySolutions LSA Type A or Class A Trash                                                     Solid               A               400(d)             ft3/yr       677                 EnergySolutions LSA Type A or Contaminated Oil                                                   Oil               B                   2               ft3/yr         3.3                     WCS LSA Extraction Column Acid Wash                                     Liquid(e)             A         [       ]PROP/ECI   [     ]PROP/ECI Extraction Column Water Wash                                   Liquid(e)             A         [       ]PROP/ECI   [     ]PROP/ECI
Shipment Type Destination(a)
[                               ]PROP/ECI                     Liquid(e)             A         [       ]PROP/ECI   [     ]PROP/ECI
MEPS Extraction Columns [
[                                         ]PROP/ECI           Liquid(e)             A             [ ]PROP/ECI     [     ]PROP/ECI
]PROP/ECI
[                                     ]PROP/ECI                 Liquid(e)             A             [ ]PROP/ECI     [     ]PROP/ECI Iodine Recovery Column [                 ]PROP/ECI             Liquid(e)             A           [     ]PROP/ECI   [     ]PROP/ECI Spent Target Solution                                           Liquid(e)             A           [     ]PROP/ECI   [     ]PROP/ECI             Type A or 2,599(f)(g)            EnergySolutions LSA Vacuum Transfer System Knockout Pot                             Liquid(e)             A                   14             gal/yr Radiological Laboratory Waste                                   Liquid(e)             A                 275             gal/yr (e)
[
Decontamination Waste                                          Liquid                A               2,768             gal/yr Cintichem Purification Waste & Rotary Evaporator Liquid(e)             A                   82             gal/yr Condensate
]PROP/ECI B or C
[                                       ]PROP/ECI               Liquid(e)             A           [     ]PROP/ECI   [     ]PROP/ECI PVVS Condenser Condensate                                       Liquid(e)             A                 701             gal/yr
[ ]PROP/ECI ft3/yr 270 Type B WCS
[ ]PROP/ECI
[ ]PROP/ECI B or C 72 ft3/yr 72 Type B WCS IXP Separation Columns
[ ]PROP/ECI B or C
[ ]PROP/ECI ft3/yr 35 Type B WCS LWPS Deionizer Units Resin A
48 ft3/yr 80 Type A or LSA EnergySolutions PCLS Deionizer Units Resin A
48 ft3/yr 80 Type A or LSA EnergySolutions Uranium Canisters Solid A
2.0(b) ft3/yr 3.3 Type A or LSA EnergySolutions NDAS Accelerator Subassembly Solid A
[ ]PROP/ECI ft3/yr 13,600 Type A or LSA EnergySolutions NDAS Target Chamber Subassembly Solid A
[ ]PROP/ECI ft3/yr 1330 Type A or LSA EnergySolutions TOGS Skids Solid A or B 922 ft3/yr 1540 Type A, B, or LSA EnergySolutions or WCS TOGS Zeolite Beds Solid B or C 0.64 ft3/yr 1
Type B WCS LWPS Filters Solid A
1.6 ft3/yr 2.7 Type A or LSA EnergySolutions PCLS Filters Solid A
1.6 ft3/yr 2.7 Type A or LSA EnergySolutions TSPS, URSS, PVVS, Hot Cell, RVZ1, RVZ2, RLWI HEPA Filters Solid A
182 ft3/yr 142 Type A or LSA EnergySolutions Hot Cell, RVZ1, RVZ2 Charcoal Filters Solid A
32 ft3/yr 54 Type A or LSA EnergySolutions TSPS Uranyl Sulfate Solution Filters Solid A
0.35(c) ft3/yr 0.58 Type A or LSA EnergySolutions
 
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Chapter 11 - Radiation Protection Program and Waste Management Radioactive Waste Management SHINE Medical Technologies 11.2-13 Rev. 0 PVVS Carbon Guard Bed Solid A or B 0.48 ft3/yr 0.81 Type B EnergySolutions or WCS MEPS Glassware Solid A
208 ft3/yr 347 Type A or LSA EnergySolutions Class A Trash Solid A
400(d) ft3/yr 677 Type A or LSA EnergySolutions Contaminated Oil Oil B
2 ft3/yr 3.3 Type A or LSA WCS Extraction Column Acid Wash Liquid(e)
A
[ ]PROP/ECI
[ ]PROP/ECI 2,599(f)(g)
Type A or LSA EnergySolutions Extraction Column Water Wash Liquid(e)
A
[ ]PROP/ECI
[ ]PROP/ECI
[ ]PROP/ECI Liquid(e)
A
[ ]PROP/ECI
[ ]PROP/ECI
[ ]PROP/ECI Liquid(e)
A
[ ]PROP/ECI
[ ]PROP/ECI
[ ]PROP/ECI Liquid(e)
A
[ ]PROP/ECI
[ ]PROP/ECI Iodine Recovery Column [ ]PROP/ECI Liquid(e)
A
[ ]PROP/ECI
[ ]PROP/ECI Spent Target Solution Liquid(e)
A
[ ]PROP/ECI
[ ]PROP/ECI Vacuum Transfer System Knockout Pot Liquid(e)
A 14 gal/yr Radiological Laboratory Waste Liquid(e)
A 275 gal/yr Decontamination Waste Liquid(e)
A 2,768 gal/yr Cintichem Purification Waste & Rotary Evaporator Condensate Liquid(e)
A 82 gal/yr
[ ]PROP/ECI Liquid(e)
A
[ ]PROP/ECI
[ ]PROP/ECI PVVS Condenser Condensate Liquid(e)
A 701 gal/yr
: a. Waste destination may be subject to change.
: a. Waste destination may be subject to change.
: b. Uranium metal and/or uranium oxide cannisters may be returned to the supplier in lieu of disposition as solid waste.
: b. Uranium metal and/or uranium oxide cannisters may be returned to the supplier in lieu of disposition as solid waste.
Line 770: Line 1,070:
: d. Class A trash is exclusive of other solid wastes identified in the table.
: d. Class A trash is exclusive of other solid wastes identified in the table.
: e. Liquid waste streams may be reused or may be combined and treated as a homogenous influent waste stream and solidified together.
: e. Liquid waste streams may be reused or may be combined and treated as a homogenous influent waste stream and solidified together.
: f. As shipped volume of liquid waste streams is in the form of a uniform solidified matrix using a solidification agent.
f.
As shipped volume of liquid waste streams is in the form of a uniform solidified matrix using a solidification agent.
: g. 25 percent margin has been added to volume of solidified liquid shipped waste.
: g. 25 percent margin has been added to volume of solidified liquid shipped waste.
SHINE Medical Technologies                                                                11.2-13                                                                      Rev. 0
Table 11.2 Estimated Annual Waste Stream Summary (Sheet 2 of 2)
Description Matrix Class as Generated As Generated Amount As Generated Units As Disposed (ft3)
Shipment Type Destination(a)


Table 11.2 Waste Methodology for Accelerator Requirement                                           Basis assemble irradiation unit           Operational requirement.
Chapter 11 - Radiation Protection Program and Waste Management Radioactive Waste Management SHINE Medical Technologies 11.2-14 Rev. 0 Table 11.2 Waste Methodology for Accelerator Requirement Basis Disassemble irradiation unit (separate accelerator section, pumping section, and roots stack from the target chamber assembly).
parate accelerator section, mping section, and roots stack m the target chamber embly).
Operational requirement.
ermine if free liquid is present   Required to meet WAC maximum free liquids requirement absorb liquids, if present.      of 1 percent. This is particularly applicable to drift tubes and target chamber section waste.
Determine if free liquid is present and absorb liquids, if present.
ke waste characterization           Waste must be characterized in the manner appropriate asurements.                        and in conformance with the procedures of the destination to which it will be sent.
Required to meet WAC maximum free liquids requirement of 1 percent. This is particularly applicable to drift tubes and target chamber section waste.
vide capability to load oversized Ensure capability to maneuver radioactive oversize debris.
Make waste characterization measurements.
ris into cargo container.
Waste must be characterized in the manner appropriate and in conformance with the procedures of the destination to which it will be sent.
vide storage, waste               Items meeting the "standard debris" definition are shipped regation, consolidation and        in a roll-off. One roll-off may be continuously stored in the kaging capacity.                  material staging building. Oversized items (non-standard debris) are shipped in a cargo container. One cargo container may be continuously on-site.
Provide capability to load oversized debris into cargo container.
void space (if required) in       Required to meet WAC requirement to minimize void ordance with the WAC.              space.
Ensure capability to maneuver radioactive oversize debris.
NE Medical Technologies                      11.2-14                                          Rev. 0
Provide storage, waste segregation, consolidation and packaging capacity.
Items meeting the "standard debris" definition are shipped in a roll-off. One roll-off may be continuously stored in the material staging building. Oversized items (non-standard debris) are shipped in a cargo container. One cargo container may be continuously on-site.
Fill void space (if required) in accordance with the WAC.
Required to meet WAC requirement to minimize void space.  


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Export Controlled Information - Withheld from public disclosure under 10 CFR 2.390(a)(3)
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Chapter 11 - Radiation Protection Program and Waste Management                                                         Radioactive Waste Management Table 11.2 Waste Methodology for Spent Columns(a)
Chapter 11 - Radiation Protection Program and Waste Management Radioactive Waste Management SHINE Medical Technologies 11.2-15 Rev. 0 Table 11.2 Waste Methodology for Spent Columns(a) a.
Requirement                                                     Basis Hold spent columns in hot cell for a period of           Spent columns are highly radioactive when decay sufficient to allow short-lived fission             removed from active service. Hold time is for products to decay.                                        decay and consolidated processing.
Applicable to spent molybdenum extraction columns [ ]PROP/ECI and IXP recovery, [ ]PROP/ECI.
Remote transfer from hot cell to export waste             Maintain worker dose ALARA.
Requirement Basis Hold spent columns in hot cell for a period of decay sufficient to allow short-lived fission products to decay.
drum.
Spent columns are highly radioactive when removed from active service. Hold time is for decay and consolidated processing.
Provide safe, shielded storage outside of hot             Protected on-site storage until a full shipment cell.                                                    of spent columns is prepared for disposal.
Remote transfer from hot cell to export waste drum.
Provide management controls to ensure proper             Since multiple columns can be held in each hot hold time is applied to spent columns.                    cell post service, it is necessary to ensure each column has been held for a sufficient time to meet radiological dose requirements during handling prior to being transferred.
Maintain worker dose ALARA.
Determine if free liquid is present and absorb           Required to meet WAC maximum free liquids liquids, if present.                                      requirement of 1 percent.
Provide safe, shielded storage outside of hot cell.
Fill void space (if required) in accordance with         Required to meet WAC requirement to the WAC.                                                  minimize void space.
Protected on-site storage until a full shipment of spent columns is prepared for disposal.
: a. Applicable to spent molybdenum extraction columns [                                              ]PROP/ECI and IXP recovery, [                                              ]PROP/ECI.
Provide management controls to ensure proper hold time is applied to spent columns.
SHINE Medical Technologies                            11.2-15                                            Rev. 0
Since multiple columns can be held in each hot cell post service, it is necessary to ensure each column has been held for a sufficient time to meet radiological dose requirements during handling prior to being transferred.
Determine if free liquid is present and absorb liquids, if present.
Required to meet WAC maximum free liquids requirement of 1 percent.
Fill void space (if required) in accordance with the WAC.
Required to meet WAC requirement to minimize void space.


Table 11.2 Waste Methodology for Process Glassware Requirement                                         Basis mote transfer from hot cell to export waste   Maintain worker dose ALARA.
Chapter 11 - Radiation Protection Program and Waste Management Radioactive Waste Management SHINE Medical Technologies 11.2-16 Rev. 0 Table 11.2 Waste Methodology for Process Glassware Requirement Basis Remote transfer from hot cell to export waste drum.
m.
Maintain worker dose ALARA.
ear sample glassware.                         Waste characterization to confirm disposal site and applicable WAC.
Smear sample glassware.
ssware is compacted.                         Glassware can be compacted for efficient packaging and transportation.
Waste characterization to confirm disposal site and applicable WAC.
ermine if free liquid is present and absorb   Required to meet WAC maximum free liquids ids, if present.                              requirement of 1 percent.
Glassware is compacted.
void space (if required) in accordance with   Required to meet WAC requirement to WAC.                                          minimize void space.
Glassware can be compacted for efficient packaging and transportation.
NE Medical Technologies                    11.2-16                                      Rev. 0
Determine if free liquid is present and absorb liquids, if present.
Required to meet WAC maximum free liquids requirement of 1 percent.
Fill void space (if required) in accordance with the WAC.
Required to meet WAC requirement to minimize void space.


Table 11.2 Waste Methodology for Consolidated Liquids Requirement                                         Basis lect uranium liquid waste and non-uranium   Process separately prior to blending.
Chapter 11 - Radiation Protection Program and Waste Management Radioactive Waste Management SHINE Medical Technologies 11.2-17 Rev. 0 Table 11.2 Waste Methodology for Consolidated Liquids Requirement Basis Collect uranium liquid waste and non-uranium liquid wastes separately.
id wastes separately.
Process separately prior to blending.
ply hold time to uranium liquid waste.       Radioactive decay to achieve solidification product suitable for LSA or Type A packaging.
Apply hold time to uranium liquid waste.
nsolidate uranium and non-uranium liquid     Liquid waste consolidation and processing.
Radioactive decay to achieve solidification product suitable for LSA or Type A packaging.
stes into blending tanks.
Consolidate uranium and non-uranium liquid wastes into blending tanks.
mple blended wastes after mixing.           A representative sample is required to verify maximum uranium concentration is not exceeded and for accurate waste characterization prior to solidification.
Liquid waste consolidation and processing.
idify waste.                                 Use of a solidification agent to ensure final waste form meets requirements. Required to meet WAC maximum free liquids requirement for solidified waste forms (0.5 percent by volume).
Sample blended wastes after mixing.
it void space.                             WAC requirement to minimize void space.
A representative sample is required to verify maximum uranium concentration is not exceeded and for accurate waste characterization prior to solidification.
ablish dedicated area in the material       Solidified waste may require decay post-ging building for decay or shipment          processing to meet DOT limits.
Solidify waste.
solidation.
Use of a solidification agent to ensure final waste form meets requirements. Required to meet WAC maximum free liquids requirement for solidified waste forms (0.5 percent by volume).
intain records relative to drums in the     Drums may be held to decay to DOT limits.
Limit void space.
rage area.
WAC requirement to minimize void space.
NE Medical Technologies                 11.2-17                                        Rev. 0
Establish dedicated area in the material staging building for decay or shipment consolidation.
Solidified waste may require decay post-processing to meet DOT limits.
Maintain records relative to drums in the storage area.
Drums may be held to decay to DOT limits.
 
Proprietary Information - Withheld from public disclosure under 10 CFR 2.390(a)(4)
Export Controlled Information - Withheld from public disclosure under 10 CFR 2.390(a)(3)
Chapter 11 - Radiation Protection Program and Waste Management Radioactive Waste Management SHINE Medical Technologies 11.2-18 Rev. 0 Table 11.2 Chemical Composition and Radiological Properties of Liquid Waste Streams (Sheet 1 of 2)
Description Chemical Composition (wt/wt)
Estimated Annual Volume Radiological Inventory(1)
Qualitative Radiological Properties Extraction Column Acid Wash
[ ]PROP/ECI
[ ]PROP/ECI
[ ]PROP/ECI
[ ]PROP/ECI
[ ]PROP/ECI Medium Most fission products pass through separation columns, though some are expected to be retained on the columns and then be removed with column washes.
Extraction Column Water Wash
>99% H2O trace H2SO4 trace UO2SO4
[ ]PROP/ECI
[ ]PROP/ECI
[
]PROP/ECI
[ ]PROP/ECI
[ ]PROP/ECI
[ ]PROP/ECI
[ ]PROP/ECI
[
]PROP/ECI
[ ]PROP/ECI
[ ]PROP/ECI
[ ]PROP/ECI
[ ]PROP/ECI
[
]PROP/ECI
[ ]PROP/ECI
[ ]PROP/ECI
[ ]PROP/ECI Iodine Recovery Column Washes
[ ]PROP/ECI
[ ]PROP/ECI
[ ]PROP/ECI
[ ]PROP/ECI
[ ]PROP/ECI
[
]PROP/ECI
[ ]PROP/ECI
[ ]PROP/ECI
[ ]PROP/ECI
[ ]PROP/ECI
[
]PROP/ECI
[ ]PROP/ECI
[ ]PROP/ECI
[ ]PROP/ECI
[ ]PROP/ECI Spent Target Solution
[ ]PROP/ECI
[ ]PROP/ECI
[ ]PROP/ECI
[ ]PROP/ECI
[ ]PROP/ECI High Fission products remaining in the target solution after useful lifetime contribute to a relatively high radiological inventory.


Table 11.2 Chemical Composition and Radiological Properties of Liquid Waste Streams (Sheet 1 of 2)
Proprietary Information - Withheld from public disclosure under 10 CFR 2.390(a)(4)
Qualitative Chemical Composition            Estimated Annual      Radiological    Radiological Description              (wt/wt)                     Volume          Inventory(1)     Properties
Export Controlled Information - Withheld from public disclosure under 10 CFR 2.390(a)(3)
[          ]PROP/ECI raction Column [                    ]PROP/ECI
Chapter 11 - Radiation Protection Program and Waste Management Radioactive Waste Management SHINE Medical Technologies 11.2-19 Rev. 0 Vacuum Transfer System Knockout Pot 100% H2O 14 gal.
[            ]PROP/ECI d Wash          [                    ]PROP/ECI PROP/ECI
Low Liquid collected in the Knockout pot generally consists of condensed water vapor.
[                  ]
Radiological Laboratory Waste 99% H2O 1.0% H2SO4 trace UO2SO4
                >99% H2O raction Column trace H2SO4
[ ]PROP/ECI 280 gal.
[            ]PROP/ECI ter Wash        trace UO2SO4
Low Laboratory waste is expected to consist of small sample volumes of highly-diluted process fluids.
[               ]PROP/ECI
Decontamination Waste 98% H2O 1.0% H2SO4 1.0% UO2SO4
[          ]PROP/ECI
[ ]PROP/ECI 2,800 gal.
[                  ]PROP/ECI  [            ]PROP/ECI PROP/ECI                PROP/ECI                                            Most fission
Varies Dependent on decontamination needs.
      ]        [             ]
Cintichem Purification Liquid Waste including Rotary Evaporator Condensate 98% H2O 1.1% NH4OH 0.88% HNO3 trace HCl trace K3RuCl6 trace KMnO4 trace -benzoin oxime (ABO) trace MoO2(ABO)2 trace MoO2 trace NaNO3 trace RhCl3 82 gal.
products pass
Low Fission products remaining after majority removed in prior MEPS processing steps.
[            ]PROP/ECI                                             through separation
Process Vessel Vent System Condenser Condensate 100% H2O 700 gal.
[                    ]PROP/ECI    [      ]PROP/ECI                  columns, though PROP/ECI                  PROP/ECI                                            some are
Low Process vessel vent system condensate generally consists of condensed water vapor.
  ]            [              ]                                        Medium expected to be
(1) Radiological inventory relative to other liquid waste streams.
[            ]PROP/ECI                                            retained on the
Table 11.2 Chemical Composition and Radiological Properties of Liquid Waste Streams (Sheet 2 of 2)
[      ]PROP/ECI                  columns and then
Description Chemical Composition (wt/wt)
[              ]PROP/ECI
Estimated Annual Volume Radiological Inventory(1)
  ]PROP/ECI                                                                        be removed with column washes.
Qualitative Radiological Properties
[            ]PROP/ECI ne Recovery    [                  ]PROP/ECI
[        ]PROP/ECI umn Washes      [                    ]PROP/ECI PROP/ECI
[                ]
[          ]PROP/ECI
[              ]PROP/ECI        [        ]PROP/ECI
  ]PROP/ECI    [                    ]PROP/ECI
[          ]PROP/ECI
[                ]PROP/ECI          [  ]PROP/ECI PROP/ECI
  ]            [                    ]PROP/ECI Fission products remaining in the
[          ]PROP/ECI                                                target solution nt Target      [                    ]PROP/ECI                                      after useful lifetime
[      ]PROP/ECI      High ution          [                    ]PROP/ECI                                      contribute to a PROP/ECI
[                ]                                                  relatively high radiological inventory.
NE Medical Technologies                        11.2-18                                          Rev. 0


(Sheet 2 of 2)
Chapter 11 - Radiation Protection Program and Waste Management Respiratory Protection Program SHINE Medical Technologies 11.3-1 Rev. 0 11.3 RESPIRATORY PROTECTION PROGRAM In accordance with 10 CFR 20, Subpart H, the respiratory protection program:
Qualitative Chemical Composition          Estimated Annual Radiological    Radiological Description              (wt/wt)                  Volume      Inventory(1)    Properties Liquid collected in uum Transfer                                                                the Knockout pot tem Knockout    100% H2O                            14 gal.       Low      generally consists of condensed water vapor.
Incorporates process and engineering controls, pursuant to 10 CFR 20.1701, to control the concentration of radioactive material in the air. The design of heating, ventilation, and air conditioning systems is described in Section 9a2.1.
Laboratory waste 99% H2O                                                    is expected to iological      1.0% H2SO4                                                  consist of small 280 gal.       Low oratory Waste  trace UO2SO4                                                sample volumes of
Implements other controls, pursuant to 10 CFR 20.1702, when it is not practical to apply process or engineering controls to control the concentrations of radioactive material in the air to values below those that define an airborne radioactivity area. Consistent with the as low as reasonably achievable (ALARA) program described in Section 11.1, the respiratory protection program implements increased monitoring and limiting intakes by controlling access, limiting exposure times, and using respiratory protection equipment.
[            ]PROP/ECI                                    highly-diluted process fluids.
Implements controls, pursuant to 10 CFR 20.1703, for the use of individual respiratory protection equipment to limit the intake of radioactive material. The respiratory protection program includes evaluation of potential hazards and estimated doses by performing surveys, bioassays, air sampling, or other means as necessary. The program provides protection of personnel from airborne concentrations exceeding the limits of Appendix B to 10 CFR 20 and ensures that respiratory equipment is tested and certified, including testing of respirators for operability before usage. The program ensures that written procedures specify the selection, fitting, issuance, maintenance, testing, training of personnel, monitoring, medical evaluations, and recordkeeping for individual respiratory protection equipment and for specifying when such equipment is to be used. Procedures for the use of individual respiratory protection equipment are revised as applicable when making changes to processes, facility, or equipment. Records are maintained for the respiratory protection program, including training in respirator use and maintenance.
98% H2O Dependent on ontamination    1.0% H2SO4 2,800 gal.     Varies    decontamination ste              1.0% UO2SO4 needs.
[            ]PROP/ECI 98% H2O 1.1% NH4OH 0.88% HNO3 trace HCl tichem                                                                      Fission products trace K3RuCl6 ification Liquid                                                            remaining after trace KMnO4 ste including                                        82 gal.       Low      majority removed trace -benzoin oxime ary Evaporator                                                              in prior MEPS (ABO) densate                                                                    processing steps.
trace MoO2(ABO)2 trace MoO2 trace NaNO3 trace RhCl3 Process vessel cess Vessel                                                                  vent system t System                                                                    condensate 100% H2O                          700 gal.       Low denser                                                                    generally consists densate                                                                    of condensed water vapor.
Radiological inventory relative to other liquid waste streams.
NE Medical Technologies                        11.2-19                                    Rev. 0


ccordance with 10 CFR 20, Subpart H, the respiratory protection program:
Chapter 11 - Radiation Protection Program and Waste Management References SHINE Medical Technologies 11.4-1 Rev. 0
* Incorporates process and engineering controls, pursuant to 10 CFR 20.1701, to control the concentration of radioactive material in the air. The design of heating, ventilation, and air conditioning systems is described in Section 9a2.1.
* Implements other controls, pursuant to 10 CFR 20.1702, when it is not practical to apply process or engineering controls to control the concentrations of radioactive material in the air to values below those that define an airborne radioactivity area. Consistent with the as low as reasonably achievable (ALARA) program described in Section 11.1, the respiratory protection program implements increased monitoring and limiting intakes by controlling access, limiting exposure times, and using respiratory protection equipment.
* Implements controls, pursuant to 10 CFR 20.1703, for the use of individual respiratory protection equipment to limit the intake of radioactive material. The respiratory protection program includes evaluation of potential hazards and estimated doses by performing surveys, bioassays, air sampling, or other means as necessary. The program provides protection of personnel from airborne concentrations exceeding the limits of Appendix B to 10 CFR 20 and ensures that respiratory equipment is tested and certified, including testing of respirators for operability before usage. The program ensures that written procedures specify the selection, fitting, issuance, maintenance, testing, training of personnel, monitoring, medical evaluations, and recordkeeping for individual respiratory protection equipment and for specifying when such equipment is to be used. Procedures for the use of individual respiratory protection equipment are revised as applicable when making changes to processes, facility, or equipment. Records are maintained for the respiratory protection program, including training in respirator use and maintenance.
NE Medical Technologies                     11.3-1                                       Rev. 0


SI/ANS, 2007. The Development of Technical Specifications for Research Reactors, SI/ANS-15.1-2007, American National Standards Institute/American Nuclear Society, 2007.
==11.4 REFERENCES==
SI/ANS, 2014. American National Standard for Radiation Protection Instrumentation Test and bration, Portable Survey Instruments, ANSI N323AB-2013, American National Standards itute/American Nuclear Society, 2014.
ANSI/ANS, 2007. The Development of Technical Specifications for Research Reactors, ANSI/ANS-15.1-2007, American National Standards Institute/American Nuclear Society, 2007.
SI/ANS, 2016. Radiation Protection at Research Reactor Facilities, ANSI/ANS 15.11-2016, erican National Standards Institute/American Nuclear Society, 2016.
ANSI/ANS, 2014. American National Standard for Radiation Protection Instrumentation Test and Calibration, Portable Survey Instruments, ANSI N323AB-2013, American National Standards Institute/American Nuclear Society, 2014.
TM, 2013. Radiological Protection Training for Nuclear Facility Workers, ASTM E1168-95, erican Society for Testing and Materials, 2013.
ANSI/ANS, 2016. Radiation Protection at Research Reactor Facilities, ANSI/ANS 15.11-2016, American National Standards Institute/American Nuclear Society, 2016.
A, 2006. Guidance on Systematic Planning Using the Data Quality Objectives Process, A QA/G-4, Environmental Protection Agency, February 2006.
ASTM, 2013. Radiological Protection Training for Nuclear Facility Workers, ASTM E1168-95, American Society for Testing and Materials, 2013.
NL, 2012. GENII Version 2 Users Guide, PNNL-14583, Revision 4, Pacific Northwest ional Laboratory, September 2012.
EPA, 2006. Guidance on Systematic Planning Using the Data Quality Objectives Process, EPA QA/G-4, Environmental Protection Agency, February 2006.
NRC, 1977. Methods for Estimating Atmospheric Transport and Dispersion of Gaseous uents in Routine Releases from Light-Water-Cooled Reactors, Regulatory Guide 1.111, ision 1, U.S. Nuclear Regulatory Commission, July 1977.
PNNL, 2012. GENII Version 2 Users Guide, PNNL-14583, Revision 4, Pacific Northwest National Laboratory, September 2012.
NRC, 1978. Information Relevant to Ensuring that Occupational Radiation Exposures at lear Power Stations Will be As Low As Is Reasonably Achievable, Regulatory Guide 8.8, ision 3, U.S. Nuclear Regulatory Commission, June 1978.
USNRC, 1977. Methods for Estimating Atmospheric Transport and Dispersion of Gaseous Effluents in Routine Releases from Light-Water-Cooled Reactors, Regulatory Guide 1.111, Revision 1, U.S. Nuclear Regulatory Commission, July 1977.
NRC, 1986. Relative Importance of Individual Elements to Reactor Accident Consequences uming Equal Release Fractions, NUREG/CR-4467, U.S. Nuclear Regulatory Commission, ch 1986.
USNRC, 1978. Information Relevant to Ensuring that Occupational Radiation Exposures at Nuclear Power Stations Will be As Low As Is Reasonably Achievable, Regulatory Guide 8.8, Revision 3, U.S. Nuclear Regulatory Commission, June 1978.
NRC, 1991. Offsite Dose Calculation Manual Guidance: Standard Radiological Effluent trols for Pressurized Water Reactors, Generic Letter 89-01, Supplement No. 1, REG-1301, U.S. Nuclear Regulatory Commission, April 1991.
USNRC, 1986. Relative Importance of Individual Elements to Reactor Accident Consequences Assuming Equal Release Fractions, NUREG/CR-4467, U.S. Nuclear Regulatory Commission, March 1986.
NRC, 1992. Monitoring Criteria and Methods to Calculate Occupational Radiation Doses, ulatory Guide 8.34, Revision 0, U.S. Nuclear Regulatory Commission, July 1992.
USNRC, 1991. Offsite Dose Calculation Manual Guidance: Standard Radiological Effluent Controls for Pressurized Water Reactors, Generic Letter 89-01, Supplement No. 1, NUREG-1301, U.S. Nuclear Regulatory Commission, April 1991.
NRC, 1993. Acceptable Concepts, Models, Equations and Assumptions for a Bioassay gram, Regulatory Guide 8.9, Revision 1, U.S. Nuclear Regulatory Commission, July 1993.
USNRC, 1992. Monitoring Criteria and Methods to Calculate Occupational Radiation Doses, Regulatory Guide 8.34, Revision 0, U.S. Nuclear Regulatory Commission, July 1992.
NRC, 1996. Instruction Concerning Risks from Occupational Radiation Exposure, Regulatory de 8.29, Revision 1, U.S. Nuclear Regulatory Commission, February 1996.
USNRC, 1993. Acceptable Concepts, Models, Equations and Assumptions for a Bioassay Program, Regulatory Guide 8.9, Revision 1, U.S. Nuclear Regulatory Commission, July 1993.
NRC, 1999. Instruction Concerning Prenatal Radiation Exposure, Regulatory Guide 8.13, ision 3, U.S. Nuclear Regulatory Commission, June 1999.
USNRC, 1996. Instruction Concerning Risks from Occupational Radiation Exposure, Regulatory Guide 8.29, Revision 1, U.S. Nuclear Regulatory Commission, February 1996.
NE Medical Technologies                  11.4-1                                    Rev. 0
USNRC, 1999. Instruction Concerning Prenatal Radiation Exposure, Regulatory Guide 8.13, Revision 3, U.S. Nuclear Regulatory Commission, June 1999.


NRC, 2011. Administrative Practices in Radiation Surveys and Monitoring, Regulatory de 8.2, Revision 1, U.S. Nuclear Regulatory Commission, May 2011.
Chapter 11 - Radiation Protection Program and Waste Management References SHINE Medical Technologies 11.4-2 Rev. 0 USNRC, 2009. Radiological Environmental Monitoring for Nuclear Power Plants, Regulatory Guide 4.1, Revision 2, U.S. Nuclear Regulatory Commission, June 2009.
NRC, 2012. Health Physics Surveys During Enriched Uranium-235 Processing and Fuel rication, Regulatory Guide 8.24, Revision 2, U.S. Nuclear Regulatory Commission, June 2.
USNRC, 2011. Administrative Practices in Radiation Surveys and Monitoring, Regulatory Guide 8.2, Revision 1, U.S. Nuclear Regulatory Commission, May 2011.
NRC, 2016. Operating Philosophy for Maintaining Occupational Radiation Exposures As Low s Reasonably Achievable, Regulatory Guide 8.10, Revision 2, U.S. Nuclear Regulatory mmission, August 2016.
USNRC, 2012. Health Physics Surveys During Enriched Uranium-235 Processing and Fuel Fabrication, Regulatory Guide 8.24, Revision 2, U.S. Nuclear Regulatory Commission, June 2012.
NRC, 2018. Instructions for Recording and Reporting Occupational Radiation Exposure Data, ulatory Guide 8.7, Revision 4, U.S. Nuclear Regulatory Commission, April 2018.
USNRC, 2016. Operating Philosophy for Maintaining Occupational Radiation Exposures As Low As Is Reasonably Achievable, Regulatory Guide 8.10, Revision 2, U.S. Nuclear Regulatory Commission, August 2016.
NE Medical Technologies                  11.4-2                                    Rev. 0}}
USNRC, 2018. Instructions for Recording and Reporting Occupational Radiation Exposure Data, Regulatory Guide 8.7, Revision 4, U.S. Nuclear Regulatory Commission, April 2018.}}

Latest revision as of 04:28, 31 December 2024

Shine Medical Technologies, LLC Supplement 1 to Final Safety Analysis Report, Chapter 11, Radiation Protection Program and Waste Management
ML19331A667
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Site: SHINE Medical Technologies, 99902034
Issue date: 11/14/2019
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Text

Chapter 11 - Radiation Protection Program and Waste Management Table of Contents CHAPTER 11 RADIATION PROTECTION PROGRAM AND WASTE MANAGEMENT TABLE OF CONTENTS Section Title Page SHINE Medical Technologies 11-i Rev. 0 11.1 RADIATION PROTECTION............................................................................... 11.1-1 11.1.1 RADIATION SOURCES................................................................... 11.1-1 11.1.2 RADIATION PROTECTION PROGRAM.......................................... 11.1-6 11.1.3 ALARA PROGRAM........................................................................ 11.1-13 11.1.4 RADIATION MONITORING AND SURVEYING............................. 11.1-18 11.1.5 RADIATION EXPOSURE CONTROL AND DOSIMETRY............. 11.1-21 11.1.6 CONTAMINATION CONTROL EQUIPMENT AND FACILITY LAYOUT GENERAL DESIGN CONSIDERATIONS FOR 10 CFR 20.1406............................................................................. 11.1-26 11.1.7 ENVIRONMENTAL MONITORING................................................ 11.1-27 11.2 RADIOACTIVE WASTE MANAGEMENT.......................................................... 11.2-1 11.2.1 RADIOACTIVE WASTE MANAGEMENT PROGRAM..................... 11.2-1 11.2.2 RADIOACTIVE WASTE CONTROLS.............................................. 11.2-4 11.2.3 RELEASE OF RADIOACTIVE WASTE............................................ 11.2-8 11.3 RESPIRATORY PROTECTION PROGRAM..................................................... 11.3-1

11.4 REFERENCES

................................................................................................... 11.4-1

Chapter 11 - Radiation Protection Program and Waste Management List of Tables LIST OF TABLES Number Title SHINE Medical Technologies 11-ii Rev. 0 11.1-1 Parameters Applicable to Target Solution Radionuclide Inventories 11.1-2 Nominal Versus Safety Basis Radionuclide Inventories in Target Solution 11.1-3 Irradiated Target Solution Activity for Select Radionuclides Pre-Extraction 11.1-4 Radiation Areas at the SHINE Facility 11.1-5 Airborne Radioactive Sources 11.1-6 Estimated Derived Air Concentrations 11.1-7 Key Parameters for Normal Yearly Release Calculation 11.1-8 Estimated Annual Releases from Normal and Maintenance Operations (Nuclides with Greater than 1 Ci Annual Release) 11.1-9 Liquid Radioactive Sources 11.1-10 Solid Radioactive Sources 11.1-11 Administrative Radiation Exposure Limits 11.1-12 Radiation Monitoring Equipment 11.1-13 Radiological Postings 11.1-14 Environmental Monitoring Locations 11.2-1 Estimated Annual Waste Stream Summary 11.2-2 Waste Methodology for Accelerator 11.2-3 Waste Methodology for Spent Columns 11.2-4 Waste Methodology for Process Glassware 11.2-5 Waste Methodology for Consolidated Liquids 11.2-6 Chemical Composition and Radiological Properties of Liquid Waste Streams

Chapter 11 - Radiation Protection Program and Waste Management List of Figures LIST OF FIGURES Number Title SHINE Medical Technologies 11-iii Rev. 0 11.1-1 Probable Radiation Area Designations Within the SHINE RCA, Ground Floor Level 11.1-2 Estimated Derived Air Concentrations, Ground Floor Level 11.1-3 Radiation Protection Organization 11.1-4 Environmental Dosimeter Locations

Chapter 11 - Radiation Protection Program and Waste Management Acronyms and Abbreviations ACRONYMS AND ABBREVIATIONS Acronym/Abbreviation Definition SHINE Medical Technologies 11-iv Rev. 0 ALARA as low as reasonably achievable ANSI American National Standards Institute CAAS criticality accident alarm system CAM continuous air monitor CAS continuous air sampler CDBEM carbon delay bed effluent monitor CEDE committed effective dose equivalent CEMP Community Environmental Monitoring Program CEO Chief Executive Officer Ci curies Ci/yr curies per year cm centimeter COO Chief Operating Officer D/Q ground level deposition factor DAC derived air concentration DOT U.S. Department of Transportation

Chapter 11 - Radiation Protection Program and Waste Management Acronyms and Abbreviations ACRONYMS AND ABBREVIATIONS Acronym/Abbreviation Definition SHINE Medical Technologies 11-v Rev. 0 dpm/100 cm2 disintegrations per minute per 100 square centimeters DQO data quality objectives EPA U.S. Environmental Protection Agency ft3/yr cubic feet per year HEPA high efficiency particulate air hr hour HRA high radiation area I-131 iodine-131 IF irradiation facility IU irradiation unit IXP iodine and xenon purification and packaging km kilometers Kr krypton kW kilowatt LEU low-enriched uranium LLD lower level of detection

Chapter 11 - Radiation Protection Program and Waste Management Acronyms and Abbreviations ACRONYMS AND ABBREVIATIONS Acronym/Abbreviation Definition SHINE Medical Technologies 11-vi Rev. 0 LLW low level waste LSA low specific activity LSC liquid scintillation counter LWPS light water pool system MARLAP Multi-Agency Radiological Laboratory Analytical Protocols Manual MEI maximum exposed individual MEPS molybdenum extraction and purification system MLLW mixed low level waste Mo molybdenum Mo-99 molybdenum-99 mrem millirem mrem/hr millirem per hour mrem/yr millirem per year mSv millisievert N-16 nitrogen-16 NDAS neutron driver assembly system

Chapter 11 - Radiation Protection Program and Waste Management Acronyms and Abbreviations ACRONYMS AND ABBREVIATIONS Acronym/Abbreviation Definition SHINE Medical Technologies 11-vii Rev. 0 NFDS neutron flux detection system PCLS primary closed loop cooling system PNNL Pacific Northwest National Laboratory PPE personal protective equipment PSB primary system boundary PVVS process vessel vent system RA radiation area RAM radiation area monitor RCA radiologically controlled area RCRA Resource Conservation and Recovery Act REMP radiological environmental monitoring program RLWI radioactive liquid waste immobilization RLWS radioactive liquid waste storage RPF radioisotope production facility RSC Radiation Safety Committee RSICC Radiation Safety Information Computational Center

Chapter 11 - Radiation Protection Program and Waste Management Acronyms and Abbreviations ACRONYMS AND ABBREVIATIONS Acronym/Abbreviation Definition SHINE Medical Technologies 11-viii Rev. 0 RVZ1 radiological ventilation zone 1 RVZ2 radiological ventilation zone 2 RWP radiation work permit SASS subcritical assembly support structure SCAS subcritical assembly system SRM stack release monitor SSC system, structure, and component Sv sievert TCLP toxicity characteristic leaching procedure TEDE total effective dose equivalent TOGS TSV off-gas system TPS tritium purification system TSPS target solution preparation system TSSS target solution storage system TSV target solution vessel U-235 uranium-235

Chapter 11 - Radiation Protection Program and Waste Management Acronyms and Abbreviations ACRONYMS AND ABBREVIATIONS Acronym/Abbreviation Definition SHINE Medical Technologies 11-ix Rev. 0 URSS uranium receipt and storage system VHRA very high radiation area VTS vacuum transfer system WAC waste acceptance criteria WCS Waste Control Specialists

/Q annual average relative atmospheric concentration Xe xenon

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Export Controlled Information - Withheld from public disclosure under 10 CFR 2.390(a)(3)

Chapter 11 - Radiation Protection Program and Waste Management Radiation Protection SHINE Medical Technologies 11.1-1 Rev. 0 CHAPTER 11 - RADIATION PROTECTION PROGRAM AND WASTE MANAGEMENT 11.1 RADIATION PROTECTION 11.1.1 RADIATION SOURCES The SHINE facility is designed to generate molybdenum-99 (Mo-99) for use as a medical isotope. The process of producing Mo-99 involves irradiating a uranyl sulfate target solution with a neutron source in a subcritical assembly to cause fission. Irradiation of the target solution creates Mo-99 along with other radioactive fission and activation products. When the irradiation cycle is complete, the radioactive materials are transferred to various locations in the facility to complete the separation and purification processes. This section identifies sources of radiation and radioactive materials received, used, or generated in the facility; sources and the nature of airborne, liquid or solid radioactive materials; and the type of radiation emitted (alpha, beta, gamma, and neutron).

Analysis has been performed that quantifies the radionuclide inventory for normal operations in the SHINE facility. The highest radionuclide inventory for one target solution batch exists in the target solution vessel (TSV) at the end of the irradiation cycle. As the target solution is processed in the facility for Mo-99 and other medical isotope extraction, solution adjustments, and waste handling, radiation sources are transferred within the facility by means of pipes in shielded trenches.

There are two scenarios with assumptions listed in Table 11.1-1: nominal and safety basis. The nominal parameter values or ranges are the best estimate operating conditions for full power operation of the facility. The safety basis parameter values define the bounding radionuclide inventory relative to the TSV, TSV dump tank, and supercell.

The safety basis inventories throughout the facility are generated by using the limiting values for each parameter to maximize the individual inventories. This includes using bounding values for element partitioning during the extraction process. This approach of maximizing inventories at each location results in an overall facility fission product inventory that is greater than originally generated in the irradiation process. This ensures that the individual safety basis inventories are bounding when being used to calculate releases for the safety analysis but makes them unsuitable for use in analyzing normal operations.

Operation of the TSV results in the production of radioactive fission products and actinides predominantly through neutron capture in uranium. Table 11.1-2 provides a summary of the results for total activity in curies (Ci) from actinides and fission products contained within each TSV batch of target solution after [ ]PROP/ECI of irradiation, [ ]PROP/ECI nominal cycles or [ ]PROP/ECI safety basis cycles. The at shutdown values represent the activity contained within the target solution immediately after shutdown of the neutron driver. The pre-extraction values are the target solution activity when it is ready to be transferred from the TSV dump tank in the irradiation unit (IU) cell to one of the supercells in the radioisotope production facility (RPF) to begin the molybdenum extraction process. This represents the maximum expected activity for a target solution batch as it is processed through the RPF. For the nominal inventory, the post extraction values are the activity remaining in the target solution following extraction of Mo and other elements according to best estimate partitioning fractions.

For the safety basis inventory, only noble gases were removed during extraction, at bounding (low) element partitioning fractions.

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Chapter 11 - Radiation Protection Program and Waste Management Radiation Protection SHINE Medical Technologies 11.1-2 Rev. 0 Table 11.1-3 lists the activity associated with the radionuclides listed in NUREG/CR-4467, Relative Importance of Individual Elements to Reactor Accident Consequences Assuming Equal Release Fractions (USNRC, 1986) for the nominal and safety basis radionuclide inventories after

[ ]PROP/ECI of irradiation and the subsequent decay time in the TSV dump tank.

At this time, it is ready to be pumped into the supercell to begin the molybdenum extraction and fission product removal processes. The cycle and decay times used for the radionuclide inventory generation are listed in Table 11.1-1.

SHINE uses the following radiation area designations, as defined in 10 CFR 20, including consideration for neutron and gamma dose rates:

Unrestricted Area means an area to which access is neither limited nor controlled by SHINE. This would be the area beyond the site boundary.

Radiation Areas (RAs) are those accessible areas in which radiation levels could result in an individual receiving a dose equivalent in excess of 5 millirem (mrem) in 1 hour1.157407e-5 days <br />2.777778e-4 hours <br />1.653439e-6 weeks <br />3.805e-7 months <br /> (hr) at 30 centimeters from the radiation source or from any surface that the radiation penetrates.

High Radiation Areas (HRAs) are those accessible areas in which radiation levels from radiation sources external to the body could result in an individual receiving a dose equivalent in excess of 100 mrem in 1 hour1.157407e-5 days <br />2.777778e-4 hours <br />1.653439e-6 weeks <br />3.805e-7 months <br /> at 30 centimeters from the radiation source or from any surface that the radiation penetrates.

Very High Radiation Areas (VHRAs) are those accessible areas in which radiation levels from radiation sources external to the body could result in an individual receiving an absorbed dose in excess of 500 rads in 1 hour1.157407e-5 days <br />2.777778e-4 hours <br />1.653439e-6 weeks <br />3.805e-7 months <br /> at 1 meter from the radiation source or 1 meter from any surface that the radiation penetrates.

The SHINE facility is designed and constructed so that the measurable dose rate in the unrestricted area due to activities at the plant are less than the limits of 10 CFR 20.1301(a)(2).

The radiation shielding is designed to ensure that during normal operation internal facility radiation dose rates are consistent with as low as reasonably achievable (ALARA) radiological practices required by 10 CFR 20. The goal for the normal operations dose rate for normally occupied locations in the facility is 0.25 mrem/hr at 30 centimeters from the surface of the shielding. Radiation levels may rise above the 0.25 mrem/hr level during some operations such as tank transfers. At full-power operation of the eight units, portions of the normally occupied area in IF and RPF exceed the 0.25 mrem/hr goal but remain below 5 mrem/hr, except in small sections above the pipe trench during solution transfers. These 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 tabulation of normally and transient-occupied areas, dose rates, and designations is provided in Table 11.1-4. Figure 11.1-1 provides the probable radiation area designations, above grade, within the radiologically controlled area (RCA) at the SHINE facility.

Procedures for transient access to shielded vaults, cells, and rooms ensure doses are maintained ALARA by addressing the following:

job planning, radiation protection coverage, survey techniques and frequencies,

Chapter 11 - Radiation Protection Program and Waste Management Radiation Protection SHINE Medical Technologies 11.1-3 Rev. 0 training of workers, pre-work briefing, frequency for updating radiation work permits or their equivalent, and placement of measuring and alarming dosimeters.

Shielded vaults, cells, and rooms designated as high radiation areas or very high radiation areas as denoted in Figure 11.1-1 are not normally occupied when those conditions exist.

Administrative procedures address the management oversight and specific control measures needed for entry into high radiation areas and very high radiation areas, if it is ever necessary to do so. The procedures include the process for gaining entry to these areas, such as the control and distribution of keys.

Typical transient access for maintenance or other necessary work to the shielded vaults, cells, and rooms that are usually high radiation areas or very high radiation areas is normally performed after dose rates have been reduced to at least the level of a radiation area. This is done by removing the radioactive materials or changing the conditions (such as shutting down the accelerator in an IU cell), using temporary shielding, and waiting for sufficient decay.

Major radiation sources in the facility originate in the target solution. At the end of the TSV irradiation cycle, irradiated target solution is transferred to one of the three extraction cells for processing. Off-gas that is purged from the primary system boundary (PSB) is sent to the process vessel vent system (PVVS), where it travels through carbon guard beds and a series of carbon delay beds to allow for capture of iodine and decay of short-lived noble gas nuclides before being released through the facility exhaust stack. Facility special nuclear material (SNM) inventories are tabulated in Table 4b.4-1.

The three sections below describe the major radiation sources in the facility. Other radiological sources in the facility are bounded by the fission product source coming from the TSV described in Subsection 11.1.1.2.

11.1.1.1 Airborne Radioactive Sources Radioactive sources that could become airborne at the SHINE facility are primarily tritium and radioactive gases produced as a byproduct of the Mo-99 production process. The systems handling gaseous radioactive materials include the tritium purification system (TPS) and the TSV off-gas system (TOGS), both located in the irradiation facility (IF) area; and the PVVS and vacuum transfer system (VTS) located in the RPF. These airborne radioactive materials are contained within closed systems consisting of piping components and tanks. Table 11.1-5 provides information on the various locations, types, and expected dose rates from gaseous radioactive sources.

Argon-41 is produced in the IU cells during irradiation. Due to the low flow rate out of the primary confinement boundary to radiological ventilation zone 1 (RVZ1), most argon-41 decays prior to being released. Approximately 0.02 curies per year (Ci/yr) of argon-41 are released to the environment through the facility stack.

Nitrogen-16 is produced within the primary cooling loop and the light water pool. Dose rates from these sources are mitigated by delay tanks and biological shielding that limits radiation dose to occupied areas adjacent to the shielding.

Chapter 11 - Radiation Protection Program and Waste Management Radiation Protection SHINE Medical Technologies 11.1-4 Rev. 0 The design of the SHINE facility maintains airborne radioactive material at very low concentrations in normally occupied areas. Confinement and ventilation systems are designed to protect workers from sources of airborne radioactivity during normal operation and minimize worker exposure during maintenance activities, keeping with the ALARA principles outlined in 10 CFR 20.

Although most process gas systems within the facility are maintained below atmospheric pressure, some leakage of process gases is expected due to the difference in partial pressure between the system and the surrounding environment. A conservative best estimate of airborne releases due to normal operation and maintenance was performed to estimate derived air concentrations (DACs) for the facility.

Leakage from process systems was estimated based on the number of components and fittings, achievable leak tightness per fitting, permeation through equipment, and partial pressures of airborne radionuclides. For processes in hot cells that require routine disconnection of components (e.g., extraction columns) special fittings are used to minimize process leakage.

The effects of the confinement systems are incorporated into the analysis. The results of the evaluation, broken down into particulates, halogens, noble gases, and tritium, are provided in Table 11.1-6. These values provide a conservative best estimate of the facility DACs.

Figure 11.1-2 provides the DAC zoning map for the facility, using the following definitions:

Zone 1 (< 1.0 DAC);

Zone 2 (1.0 - 10 DAC); and Zone 3 (> 10 DAC).

Gaseous activity from the TSV and process operations is routed through the PVVS which includes carbon delay beds to allow for airborne radionuclides to decay to low enough levels such that normal releases are below the 10 CFR 20 limits. Additional airborne release pathways are RVZ1 ventilation of the facility hot cells, flow out of the primary confinement boundary to RVZ1, and radiological ventilation zone 2 (RVZ2) ventilation of any leakage to the general area (material evaluated for the DAC). These additional pathways do not pass through the carbon delay beds but do contain filters as described in Subsection 9a2.1.1. Table 11.1-7 lists key parameters used in the normal release calculation. Releases from the TPS that are treated by the glovebox stripper system (GBSS) are negligible in comparison to tritium releases to the general area due to maintenance and leakage and are not included in Table 11.1-7 or Table 11.1-8.

Annual off-site doses due to the normal operation of the SHINE facility have been calculated using the computer code GENII2 (PNNL, 2012). The GENII2 computer code was developed for the Environmental Protection Agency (EPA) by Pacific Northwest National Laboratory (PNNL) and is distributed by the Radiation Safety Information Computational Center (RSICC). Annual average relative atmospheric concentration (/Q) values were determined using the methodology in Regulatory Guide 1.111, Methods for Estimating Atmospheric Transport and Dispersion of Gaseous Effluents in Routine Releases from Light-Water-Cooled Reactors (USNRC, 1977) with the meteorological data in Section 2.3. The /Q values for the maximally exposed individual (MEI), which is the nearest point on the site boundary, and the nearest full-time resident are 7.1E-5 sec/m3 and 5.3E-6 sec/m3, respectively.

Chapter 11 - Radiation Protection Program and Waste Management Radiation Protection SHINE Medical Technologies 11.1-5 Rev. 0 Table 11.1-8 contains the estimated annual release from maintenance and normal operation of eight irradiation units. The release is comprised of release inventories from the four airborne release pathways described above: PVVS, hot cells, primary confinement boundary, and material leaked to the general area. The dominant source term is the process gases released through PVVS. Only nuclides with greater than 1 Ci/yr released are included in the table.

The dose analysis considered the release of airborne radionuclides and exposure to off-site individuals through direct exposure and potential environmental pathways, such as leafy vegetable ingestion, meat ingestion, and milk ingestion. The analysis considered variations in consumption and other parameters by age group. The estimated annual doses at the MEI and the nearest resident are 3.9 mrem and 0.3 mrem, respectively, which are less than the limit in 10 CFR 20.

Calculational methodologies related to accidental releases of airborne radioactive sources are discussed in Chapter 13.

11.1.1.2 Liquid Radioactive Sources There are numerous locations within the SHINE facility where the presence of radioactive liquids results in a source of radiation. These sources (except for as noted below) are derived from the irradiated uranyl sulfate target solution as it is being processed through the facility. The first exception is the primary cooling water, which carries nitrogen-16 and other activation products as it is pumped through the primary closed loop cooling system (PCLS). The second exception is the production of low-activity fresh uranyl sulfate target solution. These radioactive materials are contained within closed systems consisting of piping components and tanks.

In addition, there are two locations where tritium is expected to collect due to operation of the neutron driver assembly system (NDAS). These are the light water pool and the oil used in the NDAS pumps. The small quantities of tritium released into the IU cell by permeation through and leakage from the NDAS components is expected to be converted to tritiated water and slowly increase the tritium concentration in the pool water. The oil used in the NDAS pumps is in direct contact with the tritium in the accelerator, causing it to become contaminated with tritium over time. Table 11.1-9 provides information on the various locations, types, and expected doses from liquid radioactive sources.

Liquid radioactive wastes generated at the facility are generally solidified and shipped to a disposal facility. Table 11.2-1 contains a list of liquid radioactive waste generated at the facility including the annual quantities and disposal destinations. Radioactive liquid discharges from the SHINE facility to the sanitary sewer are made in accordance with 10 CFR 20.2003 and 10 CFR 20.2007. See Section 11.2 for additional information on liquid discharges from the RCA.

11.1.1.3 Solid Radioactive Sources Solid radioactive sources exist in several locations in the SHINE facility. Fresh, low enriched uranium is received at the facility in the form of uranium metal or uranium oxide that has been enriched to a nominal 19.75 percent by weight in uranium-235 (U-235). If uranium metal is received, it is converted to uranium oxide and then to a liquid uranyl sulfate solution. Other solid radioactive sources are listed in Table 11.2-1 and include spent extraction columns from the molybdenum extraction process, glassware, spent filters, and solidified liquid waste.

Chapter 11 - Radiation Protection Program and Waste Management Radiation Protection SHINE Medical Technologies 11.1-6 Rev. 0 The natural uranium neutron multiplier is located in the subcritical assembly. The uranium interacts with the neutron flux producing both activation products and fission products that are retained within the metal structure.

In addition, metal components in the IU cell are activated and components of the TOGS contain radioactive material. The subcritical multiplication sources for the subcritical assemblies are also located in the IU cell.

These solid radioactive sources are contained within IU cells, shielded cells, hot cells, or preparation areas within the RCA of the facility. Table 11.1-10 provides information on the major solid radioactive sources including their location and activity. The radionuclide inventory in the solid waste system is a function of the TSV system operation.

A list of solid radioactive wastes including annual quantities and disposal destinations is provided in Table 11.2-1.

Disposal of solid radioactive waste with respect to storage, monitoring, and management is discussed in Section 11.2.

11.1.1.4 Technical Specifications Certain material in this section provides information that is used in the technical specifications.

This includes limiting conditions for operation, setpoints, design features, and means for accomplishing surveillances. In addition, significant material is also applicable to, and may be referenced by, the bases that are described in the technical specifications.

11.1.2 RADIATION PROTECTION PROGRAM The radiation protection program protects the radiological health and safety of workers and members of the public and complies with the regulatory requirements in 10 CFR 19, 20, and 70.

11.1.2.1 Commitment to Radiation Protection Program Implementation SHINE has established a radiation protection program with the specific purpose of protecting the radiological health and safety of workers and members of the public. The objectives of the program are to prevent acute radiation injuries (non-stochastic or deterministic effects) and to limit the potential risks of probabilistic (stochastic) effects (which may result from chronic exposure) to acceptable levels. The SHINE radiation protection program was developed and is implemented commensurate with the risks posed by a medical isotope facility. The program contains the SHINE management policy statement to maintain occupational and public radiation exposures ALARA.

The radiation protection program meets the requirements of 10 CFR 20, Subpart B, Radiation Protection Programs, and is consistent with the guidance provided in Regulatory Guide 8.2, Revision 1, Administrative Practices in Radiation Surveys and Monitoring (USNRC, 2011), and ANSI/ANS 15.11-2016, Radiation Protection at Research Reactor Facilities (ANSI/ANS, 2016).

Procedures and engineering controls are based upon sound radiation protection principles to achieve occupational doses to on-site personnel and doses to members of the public that are ALARA. The radiation protection program content and implementation are reviewed at least annually as required by 10 CFR 20.1101(c).

Chapter 11 - Radiation Protection Program and Waste Management Radiation Protection SHINE Medical Technologies 11.1-7 Rev. 0 The radiation protection program includes written procedures, periodic assessments of work practices and internal/external doses received, work plans, and the personnel and equipment required to implement the ALARA goal. Protection of plant personnel requires (a) surveillance of and control over the radiation exposure of personnel and (b) maintaining the exposure of personnel not only within permissible limits, but also within ALARA philosophy and exposure goals.

SHINEs administrative personnel exposure limits for radiation workers are set below the limits specified in 10 CFR 20. This provides assurance that regulatory radiation exposure limits are not exceeded and that the ALARA principle is emphasized. Administrative exposure limits are provided in Table 11.1-11.

The radiation exposure policy and control measures for personnel are established in accordance with requirements of 10 CFR 20 and the guidance in the following regulatory guides:

Regulatory Guide 8.10, Revision 2, Operating Philosophy for Maintaining Occupational Radiation Exposures as Low as Is Reasonably Achievable (USNRC, 2016)

Regulatory Guide 8.13, Revision 3, Instruction Concerning Prenatal Radiation Exposure (USNRC, 1999)

Regulatory Guide 8.29, Revision 1, Instruction Concerning Risks from Occupational Radiation Exposure (USNRC, 1996)

The SHINE corrective action process is implemented if (1) personnel dose monitoring results or personnel contamination levels exceed the administrative personnel limits; (2) if an incident results in airborne occupational exposures exceeding the administrative limits; or (3) the dose limits in 10 CFR 20 are exceeded.

Information developed from reportable occurrences is tracked in the corrective action program and is used to improve radiation protection practices, decreasing the probability of similar incidents.

11.1.2.1.1 Responsibilities of Key Program Personnel The key personnel responsible for implementing the radiation protection program are shown in Figure 11.1-3 and are discussed below. Chapter 12 discusses the SHINE organization and responsibilities of key management personnel in further detail.

Chief Executive Officer The Chief Executive Officer (CEO) is responsible for the overall management and leadership of the company.

Chief Operating Officer The Chief Operating Officer (COO) reports to the CEO and is responsible for overall company operations.

Chapter 11 - Radiation Protection Program and Waste Management Radiation Protection SHINE Medical Technologies 11.1-8 Rev. 0 Vice President Regulatory Affairs & Quality The Vice President Regulatory Affairs & Quality reports to the CEO and is responsible for licensing and quality activities.

Quality Manager The Quality Manager reports to the Vice President Regulatory Affairs & Quality and is responsible for assuring compliance with regulatory requirements and procedures.

Plant Manager The Plant Manager is responsible for operation of the facility, including the protection of personnel from radiation exposure resulting from facility operations and materials, and for compliance with applicable NRC regulations and the facility license. The Plant Manager designates the authority to approve procedures related to personnel radiation protection to the Radiation Protection Manager in accordance with the guidance provided in ANSI/ANS-15.1-2007 (ANSI/ANS, 2007). The Plant Manager reports to the COO.

Radiation Protection Manager The Radiation Protection Manager is responsible for implementing the radiation protection program. The Radiation Protection Manager reports directly to the Plant Manager, independent from facility operations. The Radiation Protection Manager has direct access to executive management for matters involving radiation protection. The Radiation Protection Manager and radiation protection personnel are responsible for:

Establishing the radiation protection program.

Generating and maintaining procedures associated with the program.

Ensuring that ALARA is incorporated into procedures and practiced by personnel, including stopping work when unsafe practices are identified.

Ensuring the efficacy of the program is reviewed and audited for compliance with NRC and other governmental regulations and applicable regulatory guides.

Modifying the program based upon experience, facility history, regulatory updates, and changes to guidance documents.

Adequately staffing the Radiation Protection Department to implement the radiation protection program.

Ensuring that the occupational radiation exposure dose limits of 10 CFR 20 are not exceeded under normal operations.

Ensuring administrative radiation dose limits are not exceeded without prior approval from the Radiation Safety Committee.

Establishing and maintaining an ALARA program.

Demonstrating, where practical, familiarity and reasoning associated with improvements in ALARA principles and practices, including modifications that were considered and implemented.

Establishing and maintaining a Respiratory Protection Program.

Establishing and maintaining the Radiological Environmental Monitoring Program.

Establishing and maintaining a Radioactive Waste Management Program.

Monitoring worker doses, both internal and external.

Chapter 11 - Radiation Protection Program and Waste Management Radiation Protection SHINE Medical Technologies 11.1-9 Rev. 0 Assuring that the proper radiation protection instrumentation, equipment, and supplies are available at workplaces, in good working order, and are used properly.

Ensuring calibration and quality assurance of health physics associated radiological instrumentation.

Establishing and maintaining a radiation safety training program for personnel working in radiologically controlled areas.

Posting restricted areas and, within these areas, posting radiological areas, as required by the radiation protection program (e.g., airborne radioactivity area, high radiation area, contamination area).

Informing management of any radiation protection concerns.

Operations Manager The Operations Manager is responsible for operating the facility safely and in accordance with facility procedures so that effluents released to the environment and exposures to the public and on-site personnel meet the limits specified in applicable regulations, procedures and guidance documents.

On-site Personnel On-site personnel are responsible for performing their work activities in a safe manner. SHINE has established policies, procedures and practices to ensure that personnel can work safely in the facility. The policies, procedures and practices implement rules and regulations intended to ensure workers and the public are protected from specific hazards encountered at the facility.

Personnel whose duties require (1) working with radioactive material, (2) entering restricted areas, (3) controlling facility operations that could affect effluent releases, or (4) directing the activities of others, are trained such that they understand and effectively carry out their responsibilities.

11.1.2.1.2 Radiation Protection Program Staffing and Qualifications The radiation protection program staff is assigned responsibility for implementation of the radiation protection program functions; therefore, only suitably trained radiation protection personnel are employed at the facility. The radiation protection staff includes, at a minimum, a Radiation Protection Manager and radiation control technicians.

Staff selection and qualification are addressed in Chapter 12. The Radiation Protection Manager selection and qualification is consistent with the requirements for a Level 2 position. Radiation control technicians are considered Other Technical Personnel, as described in Subsection 12.1.4.

Sufficient resources in terms of staffing and equipment are provided to implement an effective radiation protection program.

11.1.2.1.3 Independence of the Radiation Protection Program The radiation protection program is independent of facility operations. This independence ensures that the radiation protection program maintains its objectivity and is focused only on implementing sound radiation protection principles necessary to achieve occupational doses and doses to members of the public that are ALARA.

Chapter 11 - Radiation Protection Program and Waste Management Radiation Protection SHINE Medical Technologies 11.1-10 Rev. 0 11.1.2.1.4 Radiation Safety Committee A Radiation Safety Committee (RSC) is established to maintain a high standard of radiation protection during facility operations. The RSC oversees activities at the SHINE facility to protect personnel from unnecessary radiation exposure, prevent contamination of natural resources, and to ensure compliance with state and federal regulations governing the possession, use, and disposal of radioactive materials. The RSC meets periodically, but at least annually, to monitor facility radiological performance and ALARA implementation, review proposed changes to the radiation protection program, identify trends, and set ALARA policy and goals for the facility. The RSC reviews the results of audits and regulatory inspections, worker suggestions, reportable occurrences, and exposure incidents. The RSC assesses changes to the facility for the effect on the radiation protection program and the license.

The Radiation Protection Manager chairs the RSC. The RSC Charter defines the purposes, functions, responsibility, composition, qualifications, quorum, meeting frequency, and reporting requirements of the RSC.

11.1.2.1.5 Commitment to Written Radiation Protection Procedures Radiation protection procedures are prepared, reviewed and approved to carry out activities related to the radiation protection program. Procedures are used to control radiation protection activities in order to ensure that the activities are carried out in a safe, effective and consistent manner. Radiation protection procedures are reviewed and revised as necessary by the Radiation Protection Manager or designee to incorporate facility or operational changes.

Radiation protection procedures provide direction for the following activities:

Facility radiation monitoring, including surveys, personnel monitoring, and sampling and analysis of solid, liquid and gaseous wastes processed or released from the facility Calibration of area radiation monitors, facility air monitors, laboratory radiation detection systems, personnel radiation monitors and portable instruments Access control, radiological posting, and monitoring of radiological work activities Radioactive materials handling and shipment Contamination control Control of exposures and ALARA implementation Control of instrument alarm setpoints Administration of the radiation work permit (RWP) process Radiation protection procedures undergo technical verification and review to ensure compliance with regulatory requirements, applicable license conditions and the radiation protection program, as well as conformance with industry standard practices, as applicable. Radiation protection procedures are reviewed at least once every three years in accordance with the guidance in Regulatory Guide 8.10. Radiation protection procedures related to personnel radiation protection are reviewed by the SHINE Review and Audit Committee.

Work performed in radiologically controlled areas is performed in accordance with the RWP process. The RWP specifies radiological controls for intended work activities and provides written authorization for entry into and work within Radiation Areas, High Radiation Areas, Very High Radiation Areas, Contamination Areas and Airborne Radioactivity Areas. The RWP informs workers of area radiological conditions and entry requirements and provides a mechanism to

Chapter 11 - Radiation Protection Program and Waste Management Radiation Protection SHINE Medical Technologies 11.1-11 Rev. 0 relate worker exposure to specific work activities. The procedures controlling RWPs are consistent with the guidance provided in Regulatory Guide 8.10 (USNRC, 2016).

11.1.2.1.6 Commitment to Radiation Protection Training The design and implementation of the radiation protection training program complies with the requirements of 10 CFR 19.12. Records are maintained in accordance with 10 CFR 20, Subpart L.

The development and implementation of the radiation protection training program is consistent with the guidance provided in the following regulatory guidance documents:

Regulatory Guide 8.10 - Operating Philosophy for Maintaining Occupational Radiation Exposures As Low As Reasonably Achievable (USNRC, 2016)

Regulatory Guide 8.13 - Instructions Concerning Prenatal Radiation Exposure (USNRC, 1999)

Regulatory Guide 8.29 - Instructions Concerning Risks from Occupational Radiation (USNRC, 1996)

ASTM E1168 Radiological Protection Training for Nuclear Facility Workers (ASTM, 2013).

Individuals who require unescorted access into restricted areas (as defined in Subsection 11.1.5.1.1) receive training that is commensurate with the radiological hazard to which they may be exposed. Non-facility visitors and fire or emergency responders requiring access to restricted areas are provided with trained escorts who have received radiation protection training.

The level of radiation protection training provided is based on the potential radiological health risks associated with an employee's work responsibilities and incorporates the provisions of 10 CFR 19.12. In accordance with 10 CFR 19.12, any individual working at the facility who is likely to receive in a year a dose in excess of 100 mrem (1 millisievert [mSv]) is:

Kept informed of the storage, transfer, or use of radioactive material.

Instructed in the health protection problems associated with exposure to radiation and radioactive material, in precautions or procedures to minimize exposure, and in the purposes and functions of protective devices employed.

Provided with access to and training on the use of personal protective equipment (PPE).

Required to observe, to the extent within the worker's control, the applicable provisions of the NRC regulations and licenses for the protection of personnel from exposure to radiation and radioactive material.

Instructed of their responsibility to report promptly to the facility management any condition which may cause a violation of NRC regulations and licenses or unnecessary exposure to radiation and radioactive material.

Instructed in the appropriate response to warnings made in the event of any unusual occurrence or malfunction that may involve exposure to radiation and radioactive material.

Advised of the various notifications and reports to individuals that a worker may request in accordance with 10 CFR 19.13.

Chapter 11 - Radiation Protection Program and Waste Management Radiation Protection SHINE Medical Technologies 11.1-12 Rev. 0 Workers who perform or supervise the shipment of radioactive materials are trained and qualified in accordance with 49 CFR 172, Subpart H, in accordance with 10 CFR 71.5.

The radiation protection training program takes into consideration a worker's normally assigned work activities. Abnormal situations involving exposure to radiation and radioactive material, that can reasonably be expected to occur during the life of the facility, are also evaluated and factored into the training. The extent of these instructions is commensurate with the potential radiological health protection problems present in the workplace.

Retraining of personnel previously trained is performed for radiological, chemical, industrial, and criticality safety at least annually. The retraining program also includes procedure changes and updating and changes in required skills. Changes to training are implemented, when required, due to incidents potentially compromising safety or if changes are made to the facility or processes.

Records of training are maintained in accordance with the SHINE records management system.

Facility training programs are established in accordance with Subsection 12.1.4. The radiation protection sections of the training program are evaluated at least annually. The program content is reviewed to ensure it remains current and adequate to ensure worker safety.

11.1.2.1.7 Radiation Safety Audits Radiation safety audits are conducted, at a minimum, on an annual basis for the purpose of reviewing all functional elements of the radiation protection program to meet the requirement of 10 CFR 20.1101(c). The audit activity is led by a member of the Review and Audit Committee, or other designated independent individual, with the knowledge and experience to perform the activity. The audits provide sufficient information to assess:

Compliance with NRC regulations Compliance with the terms and conditions of the license Occupational doses and doses to members of the public for ALARA compliance Maintenance of radiation protection program required records Deficiencies identified during the audit are addressed through the corrective action program. The results of the radiation safety audits are provided to the Radiation Safety Committee, the COO and the CEO for review. Section 12.2 provides additional details of audit activities.

11.1.2.1.8 Record Keeping Radiation protection records are used for developing trend analysis, for keeping staff and management informed regarding radiation protection matters, and for reporting to regulatory agencies. In addition, the records are used to formulate action based on data obtained (such as survey or sample results), including historical trends.

In accordance with 10 CFR 20, Subpart L, the following records are retained until termination of the facility operating license:

Records documenting provisions of the radiation protection program

[10 CFR 20.2102(b)].

Chapter 11 - Radiation Protection Program and Waste Management Radiation Protection SHINE Medical Technologies 11.1-13 Rev. 0 Results of surveys to determine individual dose from external sources

[10 CFR 20.2103(b)(1)].

Results of measurements and calculations used to determine individual intakes of radioactive material used in the assessment of internal dose [10 CFR 20.2103(b)(2)].

Results of air sampling, surveys and bioassays required pursuant to 10 CFR 20.1703(c)(1) and (2) for the Respiratory Protection Program

[10 CFR 20.2103(b)(3)].

Results of measurements and calculations used to evaluate release of radioactive effluents to the environment [10 CFR 20.2103(b)(4)].

NRC Form 4, Cumulative Occupational Dose History [10 CFR 20.2104(f)].

Planned Special Exposure documentation [10 CFR 20.2105(b)].

Dose received by all individuals for whom monitoring was required pursuant to 10 CFR 20.1502, and records of doses received during planned special exposures, accidents and emergency conditions. Dose to an embryo/fetus are maintained with record of dose to the declared pregnant woman. [10 CFR 20.2106(a) through (f)].

Declaration of pregnancy [10 CFR 20.2106(e)].

Compliance with dose limit for individual members of the public [10 CFR 20.2107(b)].

Disposal of licensed materials and disposal by burial in soil [10 CFR 20.2108(b)].

In accordance with 10 CFR 20, Subpart L, the following records are retained for three years:

Records of audits and reviews of the radiation protection program [10 CFR 20.2102(b)].

Records of surveys and calibrations required by 10 CFR 20.1501, Surveys and Monitoring, and 20.1906(b), Receiving and Opening Packages [10 CFR 20.2103(a)].

Records used in preparing NRC Form 4 [10 CFR 20.2104(f)].

In accordance with 10 CFR 20.2110, records will be legible throughout the retention period. The record may be an original, or reproduced copy or microform provided it is authenticated by authorized personnel and the microform is capable of producing a clear copy throughout the retention period. Records may be stored in electronic media with the capability for producing legible, accurate and complete records during the required retention period. Records, such as letters, drawings and specifications, include all pertinent information, such as stamps, initials and signatures.

11.1.2.1.9 Technical Specifications Activities related to the administration and audit of the radiation protection are contained in the facility technical specifications.

11.1.3 ALARA PROGRAM Subsection 11.1.2.1 states the facility's commitment to the implementation of an ALARA program. The objective of the program is to make every reasonable effort to maintain exposure to radiation as far below the dose limits of 10 CFR 20.1201 and 10 CFR 20.1301 as is practical.

The design and implementation of the ALARA program is consistent with the guidance provided in Regulatory Guides 8.2 (USNRC, 2011), 8.13 (USNRC, 1999), and 8.29 (USNRC, 1996). The operation of the facility is consistent with the guidance provided in Regulatory Guide 8.10 (USNRC, 2016).

Chapter 11 - Radiation Protection Program and Waste Management Radiation Protection SHINE Medical Technologies 11.1-14 Rev. 0 Annual doses to individual personnel are maintained ALARA. In addition, the annual collective dose to personnel (i.e., the sum of annual individual doses, expressed in person-sievert [Sv] or person-rem) is maintained ALARA. The dose equivalent to an embryo/fetus of a declared pregnant worker is maintained at or below the limit in 10 CFR 20.1208.

The radiation protection program is written and implemented to ensure that it is comprehensive and effective. The written program documents policies that are implemented to ensure the ALARA goal is met. Procedures are written so that they incorporate the ALARA philosophy into the routine operations and ensure that exposures are consistent with administrative dose limits.

As discussed in Subsection 11.1.5, radiological zones/areas are established within the facility.

The establishment of these zones supports the ALARA commitment by minimizing the spread of contamination and reducing exposure of personnel to radiation.

Specific goals of the ALARA program include maintaining occupational exposures and environmental releases as far below regulatory limits as is reasonably achievable. The ALARA concept is also incorporated into the design of the facility. The plant is divided into radiation zones with radiation levels that are consistent with the access requirements for those areas.

Areas where on-site personnel spend significant amounts of time are designed to maintain the lowest dose rates reasonably achievable.

The Radiation Protection Manager is responsible for implementing the ALARA program and ensuring that adequate resources are committed to make the program effective. The Radiation Protection Manager prepares an annual ALARA program evaluation report. The report reviews (1) radiological exposure and effluent release data for trends, including ALARA dose goals, (2) results of audits and inspections, (3) use, maintenance, and surveillance of equipment used for exposure and effluent control, and (4) other issues that may influence the effectiveness of the radiation protection/ALARA programs. The effectiveness of the ALARA program is reviewed by the RSC. The RSC sets the ALARA goals for the facility and reviews new activities to ensure ALARA principles are considered. Efforts for improving the effectiveness of equipment used for effluent and exposure control are also evaluated by the RSC. Any resulting recommendations from the committee reviews and evaluations are documented in RSC meeting minutes. The committee's recommendations are dispositioned in the facilitys corrective action process.

11.1.3.1 ALARA Program Considerations The SHINE facility is designed to maximize the incorporation of good engineering practices and lessons learned to accomplish ALARA objectives.

11.1.3.1.1 Design and Construction Policies ALARA principles were applied during the design of the SHINE facility, consistent with the recommendations in Regulatory Guide 8.8, Information Relevant to Ensuring that Occupational Radiation Exposures at Nuclear Power Stations Will be As Low As Is Reasonably Achievable (USNRC, 1978).

Design considerations for maintaining personnel external doses ALARA include the following:

Materials of construction Radioactive material processing, storage, and disposal facilities Radiation monitoring systems

Chapter 11 - Radiation Protection Program and Waste Management Radiation Protection SHINE Medical Technologies 11.1-15 Rev. 0 Facility layout for personnel traffic and equipment maintainability and accessibility Systems and devices to control access to High Radiation Areas and Very High Radiation Areas Utilizing the ALARA concepts of time, distance and shielding. For example:

Design work stations to minimize time operators need to be in radiation fields to perform work Locate equipment that require access at a maximum distance from radiation sources or provide remote equipment operation, where practicable Incorporate shielding, where appropriate, to achieve the design condition of 0.25 mrem/hr at 12 inches [30 cm] from the shielding surface Design considerations for preventing personnel contamination and minimizing the spread of contamination within the facility include the following:

Ventilation and filter systems Confinement to keep contamination ALARA Enclosures to prevent the spread of contamination Materials of construction to facilitate decontamination Facility layout, with emphasis on personnel and material movement patterns The following design considerations are used to control radioactive effluent releases:

Control of airborne effluents by incorporating confinement, radioactive gaseous waste system disposal capabilities, and exhaust system features Control of liquid effluents to ensure radioactive materials in excess of the limits are not released Use of radioactivity monitoring systems to monitor radioactive effluents The original facility design concepts to maintain exposures ALARA are presented in Subsection 11.1.3.2.

11.1.3.1.2 Operation Policies The activities conducted by management personnel who have plant operational responsibility for radiation protection are addressed in Subsection 11.1.2. These activities are consistent with the recommendations of Regulatory Guide 8.10 (USNRC, 2016).

11.1.3.2 ALARA Facility Design Considerations Facility design considerations for maintaining personnel exposures ALARA are presented in the following paragraphs. The basic management philosophy guiding the SHINE facility design to maintain radiation exposures ALARA includes:

Designing structures, systems and components such that radioactive material, to the greatest extent practical, is remotely handled and isolated from on-site personnel by shielded compartments and hot cells.

Designing structures, systems and components for reliability and maintainability, thereby reducing the maintenance requirements on radioactive components.

Chapter 11 - Radiation Protection Program and Waste Management Radiation Protection SHINE Medical Technologies 11.1-16 Rev. 0 Designing structures, systems and components to reduce the radiation fields and control streaming, thereby reducing radiation exposure during operation, maintenance, and inspection activities.

Designing structures, systems and components to reduce access, repair and removal times, thereby reducing the time spent in radiation fields during operation, maintenance, and inspection.

Designing structures, systems and components to accommodate remote and semi-remote operation, maintenance and inspection, thereby reducing the time spent in radiation fields.

11.1.3.2.1 General Design Considerations for ALARA Exposures General design considerations and methods to maintain in-plant radiation exposures ALARA consistent with the recommendations of Regulatory Guide 8.8 (USNRC, 1978) have two objectives:

Minimizing the necessity for access to and personnel time spent in radiation areas.

Minimizing radiation levels in routinely occupied plant areas in the vicinity of plant equipment expected to require personnel attention.

The following operations are considered during the equipment and facility design to maintain exposures ALARA:

Normal operation.

Maintenance and repairs.

In-service inspection and calibrations.

Other anticipated operational occurrences.

Decommissioning.

Examples of features that assist in maintaining exposures ALARA include:

Design provisions for maintenance of the PCLS and light water pool chemistry conditions, such that corrosion and resulting activation product source terms are minimized.

Features to allow draining, flushing, and decontamination of equipment and piping.

Shielding for personnel protection during maintenance or repairs and during decommissioning.

Means and adequate space for the use of movable shielding.

Separation of more highly radioactive equipment from less radioactive equipment and separate shielded compartments for adjacent items of radioactive equipment.

Shielded access openings for installation and removal of plant components.

Design features, such as the means to provide surface decontamination within hot cells.

Means and adequate space for the use of remote operations, maintenance, and inspection equipment.

Separating clean areas from potentially contaminated ones.

11.1.3.2.2 Equipment Design Considerations for ALARA Exposures Equipment design considerations to minimize the necessity for, and amount of, time spent in a radiation area include:

Chapter 11 - Radiation Protection Program and Waste Management Radiation Protection SHINE Medical Technologies 11.1-17 Rev. 0 Reliability, availability, maintainability, inspectability, constructability, and other design features of equipment, components, and materials to reduce or eliminate the need for repair or preventive maintenance.

Design features to facilitate ease of maintenance or repair, including ease of disassembly and modularization of components for replacement or removal to a lower radiation area for repair or disposal.

Capabilities to remotely or mechanically operate, repair, service, monitor, or inspect equipment.

Consideration of redundancy of equipment or components to reduce the need for immediate repair when radiation levels may be high and when there is no feasible method available to reduce radiation levels.

Capabilities for equipment to be operated from accessible areas both during normal and abnormal operating conditions.

Equipment design considerations directed toward minimizing radiation levels near equipment or components requiring personnel access include:

Selection of materials that minimize the creation of radioactive contamination.

Equipment and piping designs that minimize the accumulation of radioactive materials (e.g., the use of buttwelding fittings and minimizing the number of fittings reduces radiation accumulation at the seams and welds).

Provisions for draining, flushing, or, if necessary, remote cleaning or decontamination of equipment containing radioactive materials.

Design to limit leaks or control the fluid that does leak. This includes the use of hermetically sealed valves and directing leakage via drip pans and piping.

Provisions for isolating equipment from radioactive process fluids.

11.1.3.2.3 Facility Layout Design Considerations for ALARA Exposures Facility layout design considerations to minimize the amount of personnel time spent in a radiation area include the following:

Locating equipment, instruments, and sampling stations that require routine maintenance, calibration, operation, or inspection, to promote ease of access and minimize occupancy time in radiation areas.

Laying out plant areas to allow remote or mechanical operation, service, monitoring, or inspection of contaminated equipment.

Providing, where practicable, for movement of equipment or components requiring service to a lower radiation area.

Design considerations directed toward minimizing radiation levels in occupied areas and in the vicinity of equipment requiring personnel access include the following:

Separating radiation sources and occupied areas, where practicable.

Redundant components requiring periodic maintenance that are a source of radiation are located in separate compartments, where practicable, to allow maintenance of one component while the other component is in operation.

Highly radioactive passive components with minimal maintenance requirements are located in shielded enclosures and are provided with access via shielded openings or removable blocks.

Chapter 11 - Radiation Protection Program and Waste Management Radiation Protection SHINE Medical Technologies 11.1-18 Rev. 0 Providing means and adequate space for using movable shielding when required.

Designing of the plant layout so that access to a given radiation zone does not require passing through a higher radiation zone.

Locating equipment, instruments, and sampling sites in the lowest practicable radiation zone.

Providing control panels to permit remote operation of essential instrumentation and controls from the lowest radiation zone practicable.

Providing means to control contamination by maintaining ventilation air flow patterns from areas of lower radioactivity to areas of higher radioactivity.

Providing means to facilitate decontamination of potentially contaminated areas.

11.1.4 RADIATION MONITORING AND SURVEYING 11.1.4.1 Radiation Monitoring An inventory of calibrated radiation detection and measurement instruments is maintained to perform functions such as radiation surveys, contamination surveys, package surveys, sealed source leak tests, air sampling measurements, effluent release measurements, and dose rate measurements. Radiation monitoring equipment, their function and location is shown in Table 11.1-12 and is discussed below.

a.

Personnel Monitors Personnel who enter radiologically restricted areas (as defined in Subsection 11.1.5.1) are required to wear personnel monitoring devices. In addition, personnel are required to monitor themselves prior to exiting restricted areas which may have the potential for contamination.

b.

Continuous Air Monitors Continuous air monitors (CAMs) provide indication of the airborne activity levels in the restricted areas of the facility. Alarms are used to provide early warning of unanticipated increases in airborne radioactivity levels. Procedures provide detailed instructions for using and determining CAM alarm setpoints. When deemed necessary, portable air samplers may be used to collect a sample on filter paper for subsequent analysis in the laboratory.

c.

Continuous Tritium Detectors Tritium is monitored at specific locations where airborne tritium may be present and present a potential hazard to individuals. Tritium monitoring is accomplished using fixed continuous instruments for room air sampling and ventilation duct sampling.

d.

Gaseous Effluent Monitoring The stack release monitor (SRM) on the facility effluent stack and the carbon delay bed effluent monitor (CDBEM) must be capable of:

Continuous monitoring of radioactive stack releases for noble gases.

Generating real time data for control room display and recording.

Chapter 11 - Radiation Protection Program and Waste Management Radiation Protection SHINE Medical Technologies 11.1-19 Rev. 0 Allowing periodic collection of filters to allow for laboratory analysis for particulate and iodine.

The SRM provides continuous on-line sampling of releases of gaseous effluents from the facility to demonstrate that releases are within the regulatory limits. The CDBEM is provided to monitor the safety-related alternate release path.

e.

Detection and Monitoring of Radioactivity in Liquid Systems and Liquid Effluents There are no piped radioactive liquid effluent discharges from the facility; therefore, there are no installed liquid effluent monitors. However, liquid effluent releases are collected and sampled prior to release.

Closed loop process cooling water systems are monitored (through sampling or installed instrumentation) to detect leakage between process fluids and cooling water due to failure in a heat exchanger or other system boundary component.

f.

Radiation Area Monitors Radiation area monitors (RAMs) provide radiation monitoring and alarms to alert personnel and the control room of radiation levels that are in excess of normal background levels. RAMs are located in areas to monitor the environment for radioactivity during normal operations, operational occurrences and postulated accidents. Procedures provide detailed instructions for determining and employing alarm set points for RAMs.

RAMs may be provided in High Radiation Areas in order to provide a remote readout. If a RAM is not provided in a particular High Radiation Area, then portable instruments are required by the RWP to measure dose rates when personnel access the area.

g.

Control Point Monitoring Monitor stations are located at the access points for restricted areas. Monitors are provided to detect radioactive contamination of personnel. Monitoring station locations are evaluated and moved as necessary in response to changes in the facility radiological conditions.

Monitoring equipment used at the facility access points are shown in Table 11.1-12.

h.

Criticality Monitoring Criticality monitoring in the RPF is provided by the criticality accident alarm system (CAAS). This system is described in Section 7.7.

Radiation monitoring systems, their functions, and their interfaces with the engineered safety features in the facility are described in Section 7.7.

Chapter 11 - Radiation Protection Program and Waste Management Radiation Protection SHINE Medical Technologies 11.1-20 Rev. 0 11.1.4.1.1 Calibration and Maintenance of Radiation Monitoring Equipment Procedures are prepared for each of the radiation monitoring instruments used and specify the frequency and method of calibration. Radiation monitoring equipment is calibrated before being put into use and after any maintenance or repair that may affect instrument performance.

Calibration of portable radiological monitoring equipment used to document radiological survey results is performed in accordance with ANSI N323AB-2013, American National Standard for Radiation Protection Instrumentation Test and Calibration, Portable Survey Instruments (ANSI/ANS, 2014).

Radiation monitoring equipment is calibrated in accordance with manufacturer recommendations.

Maintenance and repair of radiation protection instrumentation is performed in accordance with approved procedures and instrument manufacturer recommendations.

11.1.4.1.2 Operational Tests of Radiation Monitoring Equipment Operation and response tests of radiation monitoring, counting, and air sampling instruments are performed by personnel trained in the use of the instrument and following approved procedures.

These tests are consistent with the manufacturers recommendations and applicable regulatory requirements. Operation and response tests are conducted at a frequency consistent with industry practices and is addressed in detailed instructions.

11.1.4.2 Radiation Surveys Radiation surveys are conducted for two purposes: (1) to ascertain radiation levels, concentrations of radioactive materials, and potential radiological hazards that could be present in the facility; and (2) to detect releases of radioactive material from facility equipment and operations.

To assure compliance with the requirements of 10 CFR 20, Subpart C, there are written procedures for the radiation survey and monitoring programs. The radiation survey and monitoring programs assure compliance with the requirements of 10 CFR 20, Subpart F, Subpart C, Subpart L, and Subpart M.

The radiation survey and monitoring practices are consistent with the guidance provided in the following references:

Regulatory Guide 8.2, Guide for Administrative Practice in Radiation Monitoring (USNRC, 2011)

Regulatory Guide 8.7, Instructions for Recording and Reporting Occupational Radiation Exposure Data (USNRC, 2018)

Regulatory Guide 8.9, Acceptable Concepts, Models, Equations, and Assumptions for a Bioassay Program (USNRC, 1993)

Regulatory Guide 8.24, Health Physics Surveys During Enriched Uranium-235 Processing and Fuel Fabrication (USNRC, 2012) (applicable to target solution preparation processes)

Chapter 11 - Radiation Protection Program and Waste Management Radiation Protection SHINE Medical Technologies 11.1-21 Rev. 0 Regulatory Guide 8.34, Monitoring Criteria and Methods to Calculate Occupational Radiation Doses (USNRC, 1992)

ANSI N323AB-2013, American National Standard for Radiation Protection Instrumentation Test and Calibration, Portable Survey Instruments (ANSI/ANS, 2014)

Procedures include sampling protocol and data analysis methods. Equipment selection is based on the type of radiation being monitored.

Survey procedures also specify the frequency of measurements and record keeping and reporting requirements. Survey records include:

Radiation dose rate survey results Surface contamination survey results Airborne radioactivity survey results 11.1.4.3 Technical Specifications Certain material in this section provides information that is used in the technical specifications.

This includes limiting conditions for operation, setpoints, design features, and means for accomplishing surveillances. In addition, significant material is also applicable to, and may be referenced by, the bases that are described in the technical specifications.

11.1.5 RADIATION EXPOSURE CONTROL AND DOSIMETRY 11.1.5.1 Controlled Access Area The area of the SHINE site within the security fence, including within the main production facility physical structure beyond the main reception area, but outside any restricted area is part of the controlled access area. Due to the presence of administrative and physical barriers, members of the public do not have direct access to this controlled access area of the site and must be processed by security and authorized to enter the facility. Training for access to a controlled access area is provided commensurate with the radiological hazard.

Facility visitors include delivery people, tour guests, and service personnel who are transient occupants of the controlled area. Area monitoring demonstrates compliance with public dose limits for such visitors. Exposure to SHINE employees or contractors who work only in the controlled access area, but do not enter restricted areas, is limited such that the exposures do not exceed 100 mrem per year.

11.1.5.1.1 Radiological Zones Radiological zones with varied definitions and span of control have been designated for the facility site and areas surrounding the facility site. The purpose of these zones is to (1) control the spread of contamination, (2) control personnel access to avoid unnecessary exposure of personnel to radiation, and (3) control access to radioactive sources present in the facility. Public access to radiological areas is restricted as detailed in this section and as directed by facility management. Areas where personnel spend substantial amounts of time are designed to minimize the exposure received when routine tasks are performed, in accordance with the ALARA principle.

Chapter 11 - Radiation Protection Program and Waste Management Radiation Protection SHINE Medical Technologies 11.1-22 Rev. 0 The following definitions are provided to describe how the radiation protection program is implemented to protect workers and the general public on the site:

a.

Unrestricted Area NRC regulation 10 CFR 20.1003 defines an unrestricted area as an area for which access is neither limited nor controlled by the licensee. The area adjacent to the facility site is an unrestricted area. This area can be accessed by members of the public or by facility personnel. The unrestricted area is governed by the limits in 10 CFR 20.1301. The total effective dose equivalent (TEDE) to individual members of the public from the licensed operation may not exceed 1 mSv (100 mrem) in a year (exclusive of background radiation). The dose in any unrestricted area from external sources may not exceed 0.02 mSv (2 mrem) in any one hour.

b.

Restricted Area 10 CFR 20.1003 defines a restricted area as an area where access is limited by the licensee for the purpose of protecting individuals against undue risks from exposure to radiation and radioactive materials. Access to and egress from a restricted area at the facility site is through a radiation protection control point. Monitoring equipment is located at these control points.

Most restricted areas are located within the physical structure of the main production facility and locations in the material staging building where radioactive material is normally stored. Radioactive material may be temporarily stored in outdoor areas during transfer between areas. These temporary areas may require that a restricted area be established with the controls described in this section.

c.

Radiologically Controlled Area The RCA is a restricted area. The RCA is an area within the restricted area posted for the purpose of protecting individuals against undue risks from exposure to radiation and radioactive materials. Only individuals who have successfully completed training in radiation protection procedures are permitted to access this area without escort by trained personnel.

Additional radiological areas may exist within the restricted area. The areas may be temporary or permanent. The areas are posted to inform workers of the potential hazard in the area and to help prevent the spread of contamination. The areas are conspicuously posted in accordance with the requirements of 10 CFR 20 as shown on Table 11.1-13.

Radiation areas and expected dose rates are shown in Table 11.1-4.

11.1.5.2 Access and Egress Control SHINE establishes and implements an access control program that ensures that (a) signs, labels, and other access controls are properly posted and operative, (b) restricted areas are established to prevent the spread of contamination and are identified with appropriate signs, and (c) step-off pads, change facilities, protective clothing facilities, and personnel monitoring instruments are provided in sufficient quantities and locations, as necessary.

Chapter 11 - Radiation Protection Program and Waste Management Radiation Protection SHINE Medical Technologies 11.1-23 Rev. 0 Personnel access to high radiation areas is controlled to prevent unplanned radiation exposures.

Personnel access is controlled through administrative methods, including procedures and RWPs.

Active and passive safety features are provided to control access to high radiation areas in accordance with 10 CFR 20.1601. These safety features include:

Neutron driver service cell personnel access door interlocks de-energize the accelerator to reduce the level of radiation upon personnel entry (defense-in-depth design attribute),

and accelerator key switches prevent activation of the accelerator while personnel are present.

Hot cells requiring periodic/routine entry where there is potential for excessive personnel exposures are equipped with door interlocks to prevent the hot cell door from being opened when the evaluated hazard exists (e.g., excessive radiation field, target solution transfer occurring in cell).

The neutron driver service cell and hot cells are equipped with audible and visual warnings so that an individual attempting to enter the High Radiation Area and the supervisor of the activity are made aware of the entry or are controlled by locked entry with positive access controls over each individual entry, consistent with 10 CFR 20.1601(a).

High radiation areas are radiologically shielded and isolated from access to individuals by the use of engineered physical barriers. These include structural shield blocks and/or locked shield doors, consistent with 10 CFR 20.1601(a)(3).

Access to and egress from the restricted area is through one of the monitor stations at the restricted area boundary. Access to and egress from each Radiation Area, High Radiation Area, Contaminated Area or Airborne Radioactivity Area within the restricted area may also be individually controlled. A monitor (frisker), step-off pad, and container for any discarded protective clothing may be provided at the egress point from certain of these areas to prevent the spread of contamination.

11.1.5.3 Posting for Radiation Protection Awareness Radiological postings are clearly identified by physical means such as placarding or boundary marking in accordance with 10 CFR 20.1902.

11.1.5.4 Protective Clothing and Equipment Personnel working in areas that are classified as airborne radioactivity areas or contaminated areas must wear appropriate PPE. If the areas containing the surface contamination can be isolated from adjacent work areas via a barrier such that dispersible material is not likely to be transferred beyond the area of contamination, personnel working in the adjacent area are not required to wear PPE. Areas requiring PPE are posted at each of their entry points. The radiation worker training program provides instruction to personnel on the proper use of PPE.

Radiation protection management and associated technical staff are responsible for determining the need for PPE in each work area and documenting the PPE requirements on the applicable RWP. For areas with removable contamination from beta/gamma emitters or uranium above 1,000 disintegrations per minute per 100 square centimeters (dpm/100 cm2) or from alpha emitters other than uranium above 20 dpm/cm2 PPE is required. PPE includes coveralls, gloves,

Chapter 11 - Radiation Protection Program and Waste Management Radiation Protection SHINE Medical Technologies 11.1-24 Rev. 0 shoe covers, and rubber boots. Guidance for selecting and using PPE is provided in the facility radiation protection program.

The respiratory protection program is described in Section 11.3.

11.1.5.5 Personnel Monitoring for External Exposures External exposures are received primarily from the fission products produced in the target solution. Other potential sources of exposure include neutrons (e.g., from operational neutron drivers), activation products, and tritium gas. The nuclides of radiological significance are identified above in Section 11.1.

Personnel whose duties require them to enter restricted areas wear individual external dosimetry devices that are sensitive to beta, gamma and neutron radiation. Personnel handling licensed sources and working around radioactive materials outside restricted areas (e.g.,

transportation-related surveys) wear individual external dosimetry devices that are sensitive to beta, gamma and neutron radiation. Any individual entering a High Radiation Area or Very High Radiation Area wears personal dosimetry, and supplemental dosimetry with dose and dose rate alarm capability.

Personal dosimetry shall be worn in a manner consistent with the manufacturers directions.

External dosimetry devices are evaluated at least quarterly, or soon after participation in high-dose evolutions, to ascertain external exposures. Administrative limits on radiation exposure are listed in Table 11.1-11. The administrative limits are reflective of ALARA principles.

Investigation levels are set at 25 percent of the annual administrative limit for any workers occupational dose received during a calendar quarter. An investigation is performed and documented to determine what types of activities may have contributed to the worker's external exposure. The investigation may include, but is not limited to, procedural reviews, efficiency studies of the ventilation system, uranium storage protocol, and work practices.

Any time an administrative limit is exceeded, the Radiation Protection Manager is informed. The Radiation Protection Manager is responsible for determining the need for and recommending investigations or corrective actions to the responsible manager(s). Copies of the Radiation Protection Manager's recommendations are provided to the RSC.

Exposure limits for volunteer emergency responders are controlled and administered by the facility Emergency Plan.

11.1.5.6 Determination of Internal Exposures For purposes of assessing dose used to determine compliance with occupational dose equivalent limits, SHINE shall, when required under 10 CFR 20.1502, take suitable and timely measurements of one of the following:

1.

Concentrations of radioactive materials in air in work areas.

2.

Quantities of radionuclides in the body.

3.

Quantities of radionuclides excreted from the body.

4.

Combinations of these measurements.

Chapter 11 - Radiation Protection Program and Waste Management Radiation Protection SHINE Medical Technologies 11.1-25 Rev. 0 Unless respiratory protective equipment is used, as provided in 10 CFR 20.1703, or the assessment of intake is based on bioassays, SHINE shall assume that an individual inhales radioactive material at the airborne concentration in which the individual is present.

The radiation protection program includes detailed methodology for determination of internal exposures.

11.1.5.7 Evaluation and Record of Doses Individual worker occupational dose is assessed on a quarterly basis and is performed more frequently when reasonable suspicion exists regarding an abnormal exposure. External dosimetry devices are processed and evaluated by a provider accredited by the National Voluntary Laboratory Accreditation Program.

Procedures for the evaluation and summation of doses are based on guidance contained in Regulatory Guides 8.7 (USNRC, 2018) and 8.34 (USNRC, 1992).

Records are maintained of doses received by all individuals for whom monitoring is required under 10 CFR 20.1502, in accordance with 10 CFR 20.2106. The records include the following, as applicable:

The deep-dose equivalent to the whole body, lens dose equivalent, shallow-dose equivalent to the skin and shallow-dose equivalent to the extremities; The estimated intake of radionuclides; The committed effective dose equivalent (CEDE) assigned to the intake of radionuclides; The specific information used to calculate the CEDE under 10 CFR 20.1204(a) and (c),

when required by 10 CFR 20.1502; The TEDE, when required by 10 CFR 20.1202; and The total of the deep-dose equivalent and the committed dose to the organ receiving the highest total dose.

See also Subsection 11.1.2.1.8 for retained individual dose evaluation records.

11.1.5.8 Planned Special Exposures SHINE may authorize an adult worker to receive (non-emergency) doses, in addition to and accounted for separately, from the doses received under the limits specified in 10 CFR 20.1206(e), provided that each of the requirements of 10 CFR 20.1206(a), (b), (c),

and (d) are met.

SHINE maintains records of the conduct of a planned special exposure and submit a written report as required by 10 CFR 20.1206(f). In accordance with 10 CFR 20.2105, the record of a planned special exposure includes:

The exceptional circumstances requiring the use of a planned special exposure.

The name of the management official who authorized the planned special exposure and a copy of the signed authorization.

What actions were necessary.

Why the actions were necessary.

How doses were maintained ALARA.

Chapter 11 - Radiation Protection Program and Waste Management Radiation Protection SHINE Medical Technologies 11.1-26 Rev. 0 What individual and collective doses were expected to result, and the doses actually received in the planned special exposure.

11.1.6 CONTAMINATION CONTROL EQUIPMENT AND FACILITY LAYOUT GENERAL DESIGN CONSIDERATIONS FOR 10 CFR 20.1406 Contamination control is part of the radiation protection program described in Subsection 11.1.2.

Personnel receiving Radiation Worker Training are instructed on the sources, detection and control of radioactive contamination. Procedures provide instruction for identifying and controlling contamination. Records of contamination events are entered into the corrective action process, reviewed by the RSC, and maintained as records, as applicable, in accordance with the radiation protection program requirements described in Subsection 11.1.2.

General equipment and facility layout design considerations to prevent the spread of contamination in the facility and to the environment and to facilitate eventual decommissioning in accordance with 10 CFR 20.1406 include the features discussed in the following subsections.

11.1.6.1 Shielded Compartments and Hot Cells Process equipment containing significant radioactive material is located within shielded compartments or hot cells.

Process equipment which does not require local operator interaction during production, such as the neutron driver assembly and the subcritical assembly, is located in shielded compartments (access is provided via shielded openings as required). Where operator intervention is required during processing activities, for example molybdenum extraction and purification, the equipment is located in shielded hot cells and the operator is provided with a means for remote viewing and manipulation of components.

These shielded compartments and shielded hot cells are provided to facilitate confinement, isolation, and collection of potential liquid spills to minimize the spread of contamination to the facility and the environment. With the exception of the below grade confinement, these shielded compartments and shielded hot cells are provided with ventilation systems which are operated at negative pressures with respect to the surrounding environment (see Section 9a2.1).

11.1.6.2 Piping Where shielding is required, radioactive piping is located inside shielded compartments or hot cells. For transfers between hot cells the piping is located in shielded pipe trenches which provide for liquid and airborne confinement and detection of leakage. Inspection ports are provided to allow for visual inspection of piping. Use of embedded piping is minimized to facilitate inspection and detect leakage.

11.1.6.3 Light Water Pool The light water pool which provides shielding and cooling for the subcritical assembly system (SCAS) is designed with leak detection to prevent unidentified leakage to the facility and the environment.

Chapter 11 - Radiation Protection Program and Waste Management Radiation Protection SHINE Medical Technologies 11.1-27 Rev. 0 11.1.6.4 Process Tanks Process tanks are seismically supported and are located in seismically designed concrete vaults that are designed to prevent unidentified leakage to the facility and the environment.

11.1.6.5 Monitoring and Controlled Entry and Egress to Restricted Area Access to and egress from these areas is strictly controlled via administrative procedures and passive confinement structure design.

Personnel access and egress is controlled by Radiation Protection personnel, equipment and procedures. Prior to entry, personnel must don appropriate PPE to minimize the potential for physical contamination of the worker and the subsequent spread of contamination beyond the restricted area. This PPE is either removed and disposed of or monitored for contamination prior to release from the restricted area. Personnel must then pass through appropriate portal monitoring equipment prior to egress from the restricted area.

Potentially contaminated materials removed from the restricted area (for example, production material, tools, disposed equipment, various process and maintenance consumables) are surveyed and released, when appropriate, following radiation protection program implementing procedures. Disposal of contaminated materials is performed in accordance with radioactive waste management program implementing procedures (see Section 11.2).

Restricted areas in the main production facility are provided with fixed CAMs to detect the potential spread of airborne contamination within the restricted area. Additionally, RAMs are in place to detect potential increases in background radiation levels.

Radiation protection personnel routinely perform radiation and contamination assessments of accessible areas within restricted areas. Special surveys are performed, prior to entry, if access is required to normally unoccupied areas.

11.1.7 ENVIRONMENTAL MONITORING 11.1.7.1 Environmental Monitoring Program SHINE maintains a radiological environmental monitoring program (REMP) as required by 10 CFR 20.1302. The REMP is used to verify the effectiveness of facility measures which are used to control the release of radioactive material and to verify that measurable concentrations of radioactive materials and levels of radiation are not higher than expected based on effluent measurements and modeling of the environmental exposure pathways.

Guidance provided in Regulatory Guide 4.1, Radiological Environmental Monitoring for Nuclear Power Plants (USNRC, 2009) and Table 3.12-1 of NUREG-1301, Offsite Dose Calculation Manual Guidance: Standard Radiological Effluent Controls for Pressurized Water Reactors (USNRC, 1991), was considered when developing the REMP for the SHINE facility. In addition, the REMP was developed using the data quality objectives (DQO) process which is a scientific systematic planning method. The DQOs were developed according to the U.S. Environmental Protection Agency (EPA) Guidance on Systematic Planning Using the Data Quality Objectives Process (EPA, 2006).

Chapter 11 - Radiation Protection Program and Waste Management Radiation Protection SHINE Medical Technologies 11.1-28 Rev. 0 Environmental monitoring is conducted at potential receptor locations. Details of the REMP are presented in the following sections.

11.1.7.2 Effluent Release Pathways Airborne effluents from the facility include noble gases, iodine and other halogens, particulates, and tritium. The following pathways represent plausible public exposure scenarios from airborne effluents:

Direct radiation exposure pathway monitored using dosimeters.

Inhalation pathway monitored using continuous air samples.

Ingestion exposure pathway.

There are no routine radioactive liquid effluent discharges from the RCA. Radioactive liquid discharges from the SHINE facility to the sanitary sewer are infrequent and made in accordance with 10 CFR 20.2003 and 10 CFR 20.2007. There are no piped liquid effluent pathways from the RCA to the sanitary sewer. Sampling is used to determine suitability for release. See Section 11.2 for additional information on liquid discharges from the RCA.

11.1.7.2.1 Direct Radiation Monitoring Direct exposure to gamma and beta emitting radionuclides released through the stack of the SHINE production facility is monitored and measured at receptor locations using environmental dosimeters. The dosimeters measure direct radiation from radiation sources contained within the SHINE main production facility, from sources within the material staging building, from radioactivity in the airborne effluent, and from deposition of airborne radioactivity onto the ground.

A description of dosimeter locations and the rationale for locations are provided in Table 11.1-14.

Dosimeter locations are shown on Figure 11.1-4. Table 3.12-1 of NUREG-1301 (USNRC, 1991) recommends 40 dosimeter locations (i.e., an inner ring and an outer ring of dosimeters with one dosimeter in each ring at each of the 16 meteorological sectors and the balance of dosimeters to be located at special interest areas). At least one dosimeter is to serve as a control, i.e., located a significant distance from the facility such that it represents a background dose. Considering the size of the SHINE facility and the low power level of the SHINE subcritical IUs, 24 dosimeter locations are specified. These dosimeters are located in order to provide annual direct dose information at on-site locations which are expected to have occupancy and at property line locations which ensure all directions are monitored. The property line locations include the direction of the theoretical MEI and the direction of the nearest occupied structure. At least one location includes a paired dosimeter so that data quality can be determined. Three of the dosimeters are stationed off site at special interest areas and one dosimeter is located a significant distance from the facility to represent background dose.

Dosimeter values are calculated using the reports from the laboratory providing results.

Background radiation is subtracted from the dosimeter results. The background radiation values are those established during the baseline environmental survey which obtained baseline dosimeter readings at each dosimeter location.

Chapter 11 - Radiation Protection Program and Waste Management Radiation Protection SHINE Medical Technologies 11.1-29 Rev. 0 11.1.7.2.2 Iodine and Particulate Monitoring for Releases via Airborne Pathway Airborne effluent releases from the SHINE facility contribute to off-site doses. Air monitoring detects iodine or particulate releases from the SHINE facility. Noble gas and tritium measurements are not included in the REMP. Noble gas and tritium measurements are performed by the radiation protection program.

Environmental airborne sampling is performed to identify and quantify particulates and radioiodine in airborne effluents. Regulatory Position C.3.b of Regulatory Guide 4.1 (USNRC, 2009) indicates that airborne sampling should always be included in the environmental monitoring programs for nuclear power plants since the airborne effluent pathway exists at all sites. Since the SHINE facility includes airborne effluent releases and radioactivity in the airborne effluent can result in measurable off-site doses and since there is a potential for a portion of the dose to be attributable to radioactive iodine and airborne particulate radioactivity releases, the REMP includes airborne sampling.

11.1.7.2.2.1 Air Sampling Locations The DQO process and the guidance provided in Table 3.12-1 of NUREG-1301 (USNRC, 1991) were used to establish locations for airborne sample acquisition, sampling frequency, and type of sample analysis. Continuous air sample locations are specified in accordance with guidance provided in Table 3.12-1 of NUREG-1301 (USNRC, 1991). The continuous air sampling is performed using continuous air samplers (CAS) which include a radioiodine canister for iodine-131 (I-131) analysis and a particulate sampler which is analyzed for gross beta radioactivity.

Four CAS locations (CAS 2 - CAS 5) are near the facility property line in the north, south, east and west direction sectors co-located with ED1, ED9, ED5, and ED13 (refer to Figure 11.1-4),

respectively, to ensure all directions are monitored. The north and east direction sectors (with respect to the SHINE facility vent stack) have the highest calculated annual ground level deposition factor (D/Q) values (CAS 2 and CAS 4). There is also a control CAS (CAS 1) located a sufficient distance from the SHINE medical isotope production facility to provide background information for airborne activity. Table 3.12-1 of NUREG-1301 (USNRC, 1991) suggests an additional air sample location in the vicinity of a community having the highest calculated annual average ground level deposition factor, D/Q. This CAS requirement is combined with the air sample location at the site boundary location in the north direction (refer to Table 11.1-14). A description of air sample locations and the rationale for air sample locations are provided in Table 11.1-14.

The air sampling data is used to validate the effluent monitoring and dose compliance data sets.

Results are compared to the radionuclide-specific values provided in 10 CFR 20, Appendix B. A sum-of-the fractions approach is used wherein the isotopic values measured are compared with their associated limits in 10 CFR 20, Appendix B. This allows the calculation of dose due to iodine and particulate activities and includes both inhalation dose and cloud immersion dose.

Background subtraction is based on results of the baseline environmental survey, thus providing a location-specific and statistically valid means to subtract background.

Chapter 11 - Radiation Protection Program and Waste Management Radiation Protection SHINE Medical Technologies 11.1-30 Rev. 0 11.1.7.2.3 Ingestion Pathway (Biota Monitoring)

NUREG-1301 (USNRC, 1991) suggests sampling of various biological media as a means to indirectly assess doses due to particulate and iodine ingestion. This type of monitoring may include sampling of soils, broad leafed plants, fish, meat, or milk. Nuclear power plants have long monitored this pathway and have seen neither appreciable dose nor upward trending of deposition. Since the SHINE source term is expected to be several orders of magnitude lower than that of a nuclear power plant and particulate and iodine radionuclides are not normally expected to be present in measurable quantities within airborne effluent releases from the SHINE facility, biota monitoring is not routinely included in the REMP.

11.1.7.2.4 Groundwater Monitoring Surface waters of the rivers in the vicinity of the plant (e.g., the Rock River and its tributaries) are not expected to accumulate detectable levels of radioactivity. As such, surface water sampling is not included in the REMP. Similarly, marine life in the rivers is not expected to accumulate detectable levels of radioactivity and thus sampling of fish or other marine creatures for the ingestion pathway is not included in the REMP.

Measured local water table elevations for the site identify the groundwater gradient and indicate that the groundwater flow is to the west and to the south. The nearest drinking water source is a well located approximately a third of a mile (0.54 km) to the northwest of the facility.

There are four test wells within the property boundary for the SHINE facility that were used for monitoring groundwater in support of a hydrological assessment of the site. One test well is located north, one south, one east, and one west of the SHINE main production facility. Although there are no defined liquid effluent release pathways and the groundwater is not expected to be contaminated due to operation of the SHINE facility, the test wells to the west and the south are sampled for the presence of radionuclide contaminants. Sampling is in accordance with the recommendations in Table 3.12-1 of NUREG-1301 (USNRC, 1991) (i.e., quarterly with gamma isotopic and tritium analysis). The rationale for sampling the test wells to the west and south of the SHINE facility is provided in Table 11.1-14.

11.1.7.3 Community Environmental Monitoring Program In addition to the monitoring that is performed by the REMP to meet regulatory requirements, SHINE has a Community Environmental Monitoring Program (CEMP). The CEMP includes voluntary environmental monitoring based on public or SHINE interests that are not regulatory in nature.

11.1.7.4 Preoperational Baseline Monitoring Preoperational monitoring, beginning approximately two years prior to anticipated licensed activity, serves to provide baseline data for evaluating the impact of operation of the SHINE facility. The collection of samples and analysis of data follow the sampling and analyses schedule specified in Subsection 11.1.7.5 and continue into the operational phase of facility operation. The preoperational monitoring is conducted so that the preoperational radiological conditions are understood in sufficient detail to allow future reasonable, direct comparison with data collected after licensed operation of the facility.

Chapter 11 - Radiation Protection Program and Waste Management Radiation Protection SHINE Medical Technologies 11.1-31 Rev. 0 11.1.7.5 Sampling and Analysis The following frequencies are used; however, alterations may be made based upon data and trends, and the justification of any such alterations are described in the Annual Report. If sample or analysis frequencies are reduced, the changes are not to reduce the overall effectiveness of the REMP.

Air sample filters - monthly, or more frequently if required by dust loading on media Environmental dosimeters - quarterly Groundwater test wells - quarterly Sample analysis employs analytical techniques so that an appropriate analytical sensitivity (e.g.,

a priori Lower Level of Detection [LLD]) is achieved. SHINE may also use the analytical detection sensitivities as determined based on the Multi-Agency Radiological Laboratory Analytical Protocols Manual (MARLAP). Deviations from the a priori analytical sensitivity levels due to interference from other radionuclides or other factors are evaluated and documented. SHINE reports analytical sensitivity capabilities of the REMP in the Annual Report.

In accordance with Regulatory Guide 4.1 (USNRC, 2009), Revision 2, analyses for carbon-14 in environmental media are not required since the facility produced component is a small fraction of the naturally occurring carbon-14.

11.1.7.6 Environmental Monitoring Program Procedures Environmental surveys conducted in support of the REMP are performed in accordance with facility implementing procedures. Document control measures are employed to ensure that changes to the REMP or implementing procedures are reviewed for adequacy, approved by authorized personnel and are distributed to and used at the appropriate locations throughout the facility.

11.1.7.7 REMP Reports An Annual Report is provided to the NRC in accordance with ANSI/ANS 15.1-2007 (ANSI/ANS, 2007). The Annual Report provides summarized results of environmental surveys performed outside the facility.

11.1.7.8 Records, Periodic Review and Corrective Actions Records of off-site environmental surveys are retained in accordance with the SHINE records management program for the lifetime of the facility.

An annual environmental monitoring program review is conducted to examine the adequacy and effectiveness of the REMP to achieve its objectives. The program review evaluates the need to expand (or reduce) the environmental monitoring program given the results of the environmental data and trends in environmental radioactivity. Any reductions shall be thoroughly evaluated and justified, given that environmental data indicating the absence of facility-related radioactivity are important. The review confirms exposure pathways and sampling media and validates that the principal radionuclides being discharged are the same nuclides being analyzed in the environmental program.

Chapter 11 - Radiation Protection Program and Waste Management Radiation Protection SHINE Medical Technologies 11.1-32 Rev. 0 Any adverse trends or anomalies identified during the conduct of the program, during Annual Report preparation, or during periodic reviews, are entered into the facility corrective action program for disposition.

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Chapter 11 - Radiation Protection Program and Waste Management Radiation Protection SHINE Medical Technologies 11.1-33 Rev. 0 Table 11.1 Parameters Applicable to Target Solution Radionuclide Inventories Parameter Nominal Values Safety Basis Values Power 125 kW 137.5 kW Irradiation Time 5.5 days 30 days Total Time Between Irradiations

[ ]PROP

[ ]PROP/ECI Number of Cycles

[ ]PROP/ECI

[ ]PROP/ECI Element Partitioning (Extraction)

Between Cycles Nominal None Element Partitioning (Extraction) on Final Cycle Nominal Bounding (noble gases only)

TSV Dump Tank Decay Time

[ ]PROP/ECI

[ ]PROP/ECI Supercell Extraction Time

[ ]PROP/ECI

[ ]PROP/ECI

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Chapter 11 - Radiation Protection Program and Waste Management Radiation Protection SHINE Medical Technologies 11.1-34 Rev. 0 Table 11.1 Nominal Versus Safety Basis Radionuclide Inventories in Target Solution Actinide Activity (Ci)

Fission Product Activity (Ci)

Case At Shutdown Pre-Extraction Post-Extraction At Shutdown Pre-Extraction Post-Extraction Nominal Values(a)

a. Pre-Extraction: [ ]PROP/ECI post-shutdown; Post-Extraction: [ ]PROP/ECI post-shutdown

[ ]PROP/ECI

[ ]PROP/ECI

[ ]PROP/ECI [ ]PROP/ECI [ ]PROP/ECI [ ]PROP/ECI Safety Basis Values(b)

b. Pre-Extraction: [ ]PROP/ECI post-shutdown; Post-Extraction: [ ]PROP/ECI post-shutdown

[ ]PROP/ECI

[ ]PROP/ECI

[ ]PROP/ECI [ ]PROP/ECI [ ]PROP/ECI [ ]PROP/ECI Difference 13 percent 20 percent 28 percent 20 percent 70 percent 170 percent

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Chapter 11 - Radiation Protection Program and Waste Management Radiation Protection SHINE Medical Technologies 11.1-35 Rev. 0 Table 11.1 Irradiated Target Solution Activity for Select Radionuclides Pre-Extraction (Sheet 1 of 3)

Radionuclide Nominal Activity (Curies)

Safety Basis Activity (Curies)

Kr-85

[ ]PROP/ECI

[ ]PROP/ECI Kr-85m

[ ]PROP/ECI

[ ]PROP/ECI Kr-87

[ ]PROP/ECI

[ ]PROP/ECI Kr-88

[ ]PROP/ECI

[ ]PROP/ECI Rb-86

[ ]PROP/ECI

[ ]PROP/ECI Sr-89

[ ]PROP/ECI

[ ]PROP/ECI Sr-90

[ ]PROP/ECI

[ ]PROP/ECI Sr-91

[ ]PROP/ECI

[ ]PROP/ECI Sr-92

[ ]PROP/ECI

[ ]PROP/ECI Y-90

[ ]PROP/ECI

[ ]PROP/ECI Y-91

[ ]PROP/ECI

[ ]PROP/ECI Y-92

[ ]PROP/ECI

[ ]PROP/ECI Y-93

[ ]PROP/ECI

[ ]PROP/ECI Zr-95

[ ]PROP/ECI

[ ]PROP/ECI Zr-97

[ ]PROP/ECI

[ ]PROP/ECI Nb-95

[ ]PROP/ECI

[ ]PROP/ECI Mo-99

[ ]PROP/ECI

[ ]PROP/ECI Tc-99m

[ ]PROP/ECI

[ ]PROP/ECI Ru-103

[ ]PROP/ECI

[ ]PROP/ECI Ru-105

[ ]PROP/ECI

[ ]PROP/ECI Ru-106

[ ]PROP/ECI

[ ]PROP/ECI Rh-105

[ ]PROP/ECI

[ ]PROP/ECI Sb-127

[ ]PROP/ECI

[ ]PROP/ECI Sb-129

[ ]PROP/ECI

[ ]PROP/ECI Te-127

[ ]PROP/ECI

[ ]PROP/ECI Te-127m

[ ]PROP/ECI

[ ]PROP/ECI Te-129

[ ]PROP/ECI

[ ]PROP/ECI Te-129m

[ ]PROP/ECI

[ ]PROP/ECI

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Chapter 11 - Radiation Protection Program and Waste Management Radiation Protection SHINE Medical Technologies 11.1-36 Rev. 0 Te-131m

[ ]PROP/ECI

[ ]PROP/ECI Te-132

[ ]PROP/ECI

[ ]PROP/ECI I-131

[ ]PROP/ECI

[ ]PROP/ECI I-132

[ ]PROP/ECI

[ ]PROP/ECI I-133

[ ]PROP/ECI

[ ]PROP/ECI I-134

[ ]PROP/ECI

[ ]PROP/ECI I-135

[ ]PROP/ECI

[ ]PROP/ECI Xe-131m

[ ]PROP/ECI

[ ]PROP/ECI Xe-133

[ ]PROP/ECI

[ ]PROP/ECI Xe-133m

[ ]PROP/ECI

[ ]PROP/ECI Xe-135

[ ]PROP/ECI

[ ]PROP/ECI Xe-135m

[ ]PROP/ECI

[ ]PROP/ECI Xe-138

[ ]PROP/ECI

[ ]PROP/ECI Cs-134

[ ]PROP/ECI

[ ]PROP/ECI Cs-136

[ ]PROP/ECI

[ ]PROP/ECI Cs-137

[ ]PROP/ECI

[ ]PROP/ECI Ba-139

[ ]PROP/ECI

[ ]PROP/ECI Ba-140

[ ]PROP/ECI

[ ]PROP/ECI La-140

[ ]PROP/ECI

[ ]PROP/ECI La-141

[ ]PROP/ECI

[ ]PROP/ECI La-142

[ ]PROP/ECI

[ ]PROP/ECI Ce-141

[ ]PROP/ECI

[ ]PROP/ECI Ce-143

[ ]PROP/ECI

[ ]PROP/ECI Ce-144

[ ]PROP/ECI

[ ]PROP/ECI Pr-143

[ ]PROP/ECI

[ ]PROP/ECI Nd-147

[ ]PROP/ECI

[ ]PROP/ECI Np-239

[ ]PROP/ECI

[ ]PROP/ECI Pu-238

[ ]PROP/ECI

[ ]PROP/ECI Pu-239

[ ]PROP/ECI

[ ]PROP/ECI Pu-240

[ ]PROP/ECI

[ ]PROP/ECI Pu-241

[ ]PROP/ECI

[ ]PROP/ECI Table 11.1 Irradiated Target Solution Activity for Select Radionuclides Pre-Extraction (Sheet 2 of 3)

Radionuclide Nominal Activity (Curies)

Safety Basis Activity (Curies)

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Chapter 11 - Radiation Protection Program and Waste Management Radiation Protection SHINE Medical Technologies 11.1-37 Rev. 0 Am-241

[ ]PROP/ECI

[ ]PROP/ECI Cm-242

[ ]PROP/ECI

[ ]PROP/ECI Cm-244

[ ]PROP/ECI

[ ]PROP/ECI Rb-88

[ ]PROP/ECI

[ ]PROP/ECI Y-91m

[ ]PROP/ECI

[ ]PROP/ECI Nb-97m

[ ]PROP/ECI

[ ]PROP/ECI Nb-97

[ ]PROP/ECI

[ ]PROP/ECI Rh-103m

[ ]PROP/ECI

[ ]PROP/ECI Rh-105m

[ ]PROP/ECI

[ ]PROP/ECI Rh-106

[ ]PROP/ECI

[ ]PROP/ECI Ba-136m

[ ]PROP/ECI

[ ]PROP/ECI Ba-137m

[ ]PROP/ECI

[ ]PROP/ECI Pr-144

[ ]PROP/ECI

[ ]PROP/ECI Pr-144m

[ ]PROP/ECI

[ ]PROP/ECI Table 11.1 Irradiated Target Solution Activity for Select Radionuclides Pre-Extraction (Sheet 3 of 3)

Radionuclide Nominal Activity (Curies)

Safety Basis Activity (Curies)

Chapter 11 - Radiation Protection Program and Waste Management Radiation Protection SHINE Medical Technologies 11.1-38 Rev. 0 Table 11.1 Radiation Areas at the SHINE Facility Area Dose Rate Designation Normally occupied areas within the RCA TPS room NDAS service cell without accelerator operation 5 mrem/hr Normally occupied area IU cells, hot cells, and other shielded vaults; cells; and rooms -

material not present or accelerator not in operation, after sufficient decay period Above RPF trench during solution transfers Primary cooling rooms during operation IF general area during accelerator operation in NDAS service cell

> 5 mrem/hr but 100 mrem/hr Radiation Area (transient occupation)

IU cells, hot cells, and other shielded vaults; cells; and rooms -

material present or accelerator in operation or shutdown without sufficient decay period NDAS service cell with accelerator operation

> 100 mrem/hr (High Radiation Area) or

> 500 rad/hr (Very High Radiation Area)

High Radiation Area or Very High Radiation Area (rarely occupied, per ALARA controls)

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Chapter 11 - Radiation Protection Program and Waste Management Radiation Protection SHINE Medical Technologies 11.1-39 Rev. 0 Table 11.1 Airborne Radioactive Sources System Component Location Major Sources Estimated Maximum Activity (Ci)

Exterior Dose Rate (mrem/hr)(a)

a. Dose contribution from listed source in normally occupied area, includes direct dose at 30 cm from the exterior of the shielding surface and contributions from the derived air concentration.

TPS Tritium purification system TPS glovebox H-3 300,000(b)

b. Includes inventory in NDAS units.

< 0.25 NDAS Driver vacuum hardware IU cell H-3

[ ]PROP/ECI(c)

c. H-3 activity is per NDAS unit.

< 0.25 TOGS Off-gas piping, zeolite beds TOGS shielded cell I, Kr, Xe 120,000(d)

d. Value is per irradiation unit (IU).

< 0.25 RVZ1 IU cell atmosphere and PCLS IU cell Ar-41 and N-16 Ar-41: 1E-05 N-16: 10(d)

N/A RVZ1 Supercell atmosphere Supercell gloveboxes I, Kr, Xe, and particulates 3

< 0.2 PVVS and VTS PVVS and VTS piping Pipe trenches, valve pits, and PVVS hot cell I, Kr, Xe 25,000(d)

< 1

Chapter 11 - Radiation Protection Program and Waste Management Radiation Protection SHINE Medical Technologies 11.1-40 Rev. 0 Table 11.1 Estimated Derived Air Concentrations Source Description Location Particulate Halogen Noble Gas Tritium Total Primary System Boundary IF General Area 0.1%

0.4%

0.5%

Tritium Systems TPS Room 7.0%

7.0%

IF General Area, Normal Operation 3.2%

3.2%

IF General Area, Maintenance 5.2%

5.2%

Below-Grade Vaults RPF General Area 0.8%

0.0%

0.8%

PVVS Hot Cell PVVS Hot Cell 12%

1.9%

14%

RPF General Area 0.0%

0.0%

0.0%

Extraction Hot Cell Extraction Hot Cell 13%

> 10 DAC 76%

0.0%

> 10 DAC RPF General Area 0.0%

2.1%

0.0%

0.0%

2.1%

Purification Hot Cell Purification Hot Cell 38%

> 10 DAC 220%

0.0%

> 10 DAC RPF General Area 0.0%

4.2%

0.0%

0.0%

4.2%

IF General Area Total 0.1%

0.4%

8.3%

8.9%

RPF General Area Total 0.0%

7.1%

0.0%

7.1%

Chapter 11 - Radiation Protection Program and Waste Management Radiation Protection SHINE Medical Technologies 11.1-41 Rev. 0 Table 11.1 Key Parameters for Normal Yearly Release Calculation Parameter PVVS Pathway Hot Cells Primary Confinement Boundary General Area Primary Nuclide Inventory Constituents Kr, Xe, I Kr, Xe, I, particulates Kr, Xe, Ar 41, N-16 Kr, Xe, I, H-3 Type of Radiation Emitted Beta and Gamma Beta and Gamma Beta and Gamma Beta and Gamma Total Curies 9.0E+05 320 430 32 Primary Constituents Released Kr, Xe Kr, Xe Kr, Xe Kr, Xe, H-3 Type of Radiation Emitted Beta and Gamma Beta and Gamma Beta and Gamma Beta and Gamma Total Curies 9.3E+03 16 9.5 32 Delay Time Credited for Decay 1.7 days (Kr) 40 days (Xe)

None 1 minute None Iodine Removal Mechanisms Carbon Guard Bed Carbon Filter on Hot Cell RVZ1 Exhaust Carbon Filter on Facility RVZ1 Exhaust Carbon Filter on Facility RVZ1 Exhaust Carbon Delay Beds Carbon Filter on Facility RVZ1 Exhaust

Chapter 11 - Radiation Protection Program and Waste Management Radiation Protection SHINE Medical Technologies 11.1-42 Rev. 0 Table 11.1 Estimated Annual Releases from Normal and Maintenance Operations (Nuclides with Greater than 1 Ci Annual Release)

Radionuclide Annual Release (Ci)

Kr-83m 5.9E+00 Kr-85 1.2E+02 Kr-85m 5.0E+01 Kr-88 2.2E+00 Xe-131m 1.3E+03 Xe-133 7.8E+03 Xe-133m 1.1E+00 Xe-135 6.2E+00 Xe-135m 1.0E+01 H-3 7.3E+01

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Chapter 11 - Radiation Protection Program and Waste Management Radiation Protection SHINE Medical Technologies 11.1-43 Rev. 0 Table 11.1 Liquid Radioactive Sources (Sheet 1 of 2)

System(a)

Component(a)

Location(a)

Major Sources Estimated Maximum Activity (Ci)

Exterior Dose Rate (mrem/hr)(d)

TSPS Target solution, unirradiated Target Solution Preparation Area U-234, U-235, U-238 3

N/A SCAS Target solution in TSV (operating)

IU cell U-235 Fission (Neutrons and Photons)

[ ]PROP/ECI(b)

< 0.25 SCAS Target solution in TSV, TSV dump tank (shutdown)

IU cell (see Table 11.1-3)

[ ]PROP/ECI(b)

< 0.03 LWPS Water in the light water pool IU cell H-3 30(b)

N/A NDAS Oil in NDAS pumps IU cell H-3 2000(b)

N/A PCLS Primary cooling water in pump and piping IU cell and primary cooling room N-16 7.5(b)

< 2 MEPS Target solution in pump, extraction column, and lift tanks Supercell (see Table 11.1-3)

[ ]PROP/ECI(c)

< 5 MEPS Mo eluate in Mo eluate hold tank Supercell Mo, [ ]PROP/ECI

[ ]PROP/ECI(c)

< 3 MEPS Mo-99 product Supercell Mo-99, Tc-99

[ ]PROP/ECI(c)

< 0.2 TSSS Target solution in target solution hold tank Tank vault (see Table 11.1-3)

[ ]PROP/ECI(b)

< 0.25

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Chapter 11 - Radiation Protection Program and Waste Management Radiation Protection SHINE Medical Technologies 11.1-44 Rev. 0 RLWS Liquid waste in annular waste tank Tank vault

[

]PROP/ECI and other fission products 3.8E+04

< 0.1 RLWS Liquid waste in RLWS collection tank Tank vault

[

]PROP/ECI and other fission products 5.7E+04

< 0.1

a. Physical and chemical properties of process solutions, special nuclear material inventories, and descriptions of the systems can be found in Chapter 4.
b. Value is per irradiation unit (IU).
c. Value is per cycle.
d. For normally-occupied areas.

Table 11.1 Liquid Radioactive Sources (Sheet 2 of 2)

System(a)

Component(a)

Location(a)

Major Sources Estimated Maximum Activity (Ci)

Exterior Dose Rate (mrem/hr)(d)

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Chapter 11 - Radiation Protection Program and Waste Management Radiation Protection SHINE Medical Technologies 11.1-45 Rev. 0 Table 11.1 Solid Radioactive Sources System(a)

a. Descriptions of the systems and their physical characteristics can be found in Chapter 4.

Component(a)

Location Major Sources Estimated Maximum Activity (Ci)

Exterior Dose Rate (mrem/hr)

NDAS Neutron Driver IU Cell Activation Products 300(b)

b. Value is per irradiation unit (IU).

N/A TOGS TOGS Components IU Cell and TOGS Cell Rb, Cs, Ba, Sr, Y, La, and Ce 5.6E+04(b)

< 0.25 SCAS Neutron Multiplier, SASS IU Cell Activation and Fission Products 1.5E+05(b)

N/A MEPS Spent Extraction [

]PROP/ECI Supercell

[ ]PROP/ECI 2.6E+04(c)

c. Value is per cycle.

< 5 MEPS Glassware Supercell and Solid Waste Drum Storage

[ ]PROP/ECI 100(c)

N/A TSPS and URSS Fresh Uranium Metal and Uranium Oxide Target Solution Preparation and Storage Areas U-234, U-235, U-238 3

N/A RLWI Solidified Waste Drum Liquid Waste Solidification Cell Activation and Fission Products 125(d)

d. Value is per drum.

< 0.25 Solid Radwaste Spent Filters Supercell Iodine 400

< 1 SCAS Subcritical Multiplication Source IU Cell Alpha-neutron Source (PuBe or AmBe)

[ ]SRI N/A

Chapter 11 - Radiation Protection Program and Waste Management Radiation Protection SHINE Medical Technologies 11.1-46 Rev. 0 Table 11.1 Administrative Radiation Exposure Limits Type of Dose 10 CFR 20 Limit (rem/year)

SHINE Administrative Limit (rem/year)

The more limiting of:

Total effective dose equivalent to whole body, or 5

2 Sum of deep-dose equivalent and committed dose equivalent to any organ or tissue other than lens of eye 50 20 Eye dose equivalent to lens of eye 15 6

Shallow-dose equivalent to skin of the whole body or any extremity 50 20 Declared Pregnant Worker Dose to embryo/fetus during the entire pregnancy: taken as the sum of the deep-dose equivalent to the woman and the dose to the embryo/fetus from radionuclides in the embryo/

fetus and the woman 0.5 rem per gestation period 0.5 rem per gestation period Individual Members of the Public Total effective dose equivalent 0.1 0.1

Chapter 11 - Radiation Protection Program and Waste Management Radiation Protection SHINE Medical Technologies 11.1-47 Rev. 0 Table 11.1 Radiation Monitoring Equipment Radiation Monitoring Instrument Type(a)(b)

a. See Table 7.7-1 for safety-related process radiation monitors.
b. See Table 11.1-14 for Environmental Monitoring equipment and locations.

Location Function Radiation Survey Instruments Portable dose rate - neutron Various Routine and job coverage surveys Portable dose rate - beta/gamma Various Routine and job coverage surveys Friskers Various egress points within the RCA Ensure effective control of the spread of contamination Personnel contamination monitors Egress points from RCA Verify effectiveness of contamination controls Laboratory/Benchtop Instruments Liquid Scintillation Counter (LSC)

Counting room Tritium and low energy beta-emitting radionuclide sample analysis Low Background Sample Counter - alpha/beta Counting room Count smears and air samples Gamma Spectroscopy Counting room Various gamma-emitting radionuclide sample analyses Air Sampling and Monitoring Personnel Lapel Sampler Various as specified by procedure or RWP Representative air monitoring during work; internal dose assignment Air Samplers Various as specified by procedure or RWP Airborne radioactivity concentration measurement Continuous Alpha / Beta Air Monitor (CAM)

Areas where airborne contamination may be present, as specified by procedure Early detection of unanticipated increases in airborne radioactivity concentration Continuous Tritium Air Monitor See Table 7.7-3 See Table 7.7-3 Radiation Area Monitors Radiation Area Monitors (RAM)

See Table 7.7-2 See Table 7.7-2 Radiological Effluent Monitor Stack Release Monitor Located in the main production facility stack Direct exposure to gamma and beta emitting radionuclides released through the stack of the SHINE main production facility is monitored and measured Charcoal Delay Bed Effluent Monitor Located at the outlet of the process vessel vent system (PVVS) charcoal delay beds Monitor to trend the performance of the charcoal delay beds. Ensure the PVVS effluent stream is monitored if the safety-related effluent release point is in use.

Chapter 11 - Radiation Protection Program and Waste Management Radiation Protection SHINE Medical Technologies 11.1-48 Rev. 0 Table 11.1 Radiological Postings Posting Requirement CAUTION RADIATION AREA Accessible area in which radiation levels could result in an individual receiving in excess of 5 mrem in one hour 30 cm from the radiation source or surface that the radiation penetrates.

CAUTION HIGH RADIATION AREA or DANGER HIGH RADIATION AREA Accessible area in which radiation levels could result in an individual receiving in excess of 100 mrem in one hour 30 cm from the radiation source or surface that the radiation penetrates.

GRAVE DANGER VERY HIGH RADIATION AREA Accessible area in which radiation levels could result in an individual receiving an absorbed dose in excess of 500 rads in one hour at one meter from a radiation source or from any surface that the radiation penetrates.

CAUTION AIRBORNE RADIOACTIVITY AREA or DANGER AIRBORNE RADIOACTIVITY AREA Licensed airborne radioactive materials in a room, enclosure, or area exists in concentrations exceeding the derived air concentrations specified in 10 CFR 20, Appendix B, Table I, or when an individual present in the area without respiratory protective equipment could exceed, during the hours an individual is present in a week, an intake of 0.6% of the annual limit on intake or 12 DAC-hours.

CAUTION CONTAMINATION AREA An area where removable contamination levels are above 20 dpm/100 cm2 of alpha activity or 1,000 dpm/100 cm2 beta/gamma activity.

CAUTION RADIOACTIVE MATERIAL(S) or DANGER RADIOACTIVE MATERIAL(S)

Areas or rooms in which there is use of, or stored, an amount of licensed radioactive material exceeding 10 times the quantity of material in Appendix C to 10 CFR 20.

Chapter 11 - Radiation Protection Program and Waste Management Radiation Protection SHINE Medical Technologies 11.1-49 Rev. 0 Table 11.1 Environmental Monitoring Locations Monitoring Type Location Rationale Groundwater Sampling Test Well SM-GW4A Sampling Test well located directly west of the SHINE facility The groundwater gradient is to the west and the south and thus any groundwater contamination is likely to flow to the west and to the south.

Test Well SM-GW2A Sampling Test well located directly south of the SHINE facility The groundwater gradient is to the west and the south and thus any groundwater contamination is likely to flow to the west and to the south.

Environmental Dosimeters ED 1 - 16 Site Boundary One in each of the 16 compass directions from the site center.

ED 17 - 20 Outside the main production facility but within the site boundary (ED 17 north, ED 18 east, ED 19 south, ED 20 west)

One in each of the four cardinal directions surrounding the main production facility.

ED 21 - 23 Rock County Christian Elementary School (ED 21)

Jackson Elementary School (ED 22)

University of Wisconsin - Rock County (ED 23)

Special interest areas (e.g., population centers, nearby residences or schools).

ED 24 Kennedy Elementary School To serve as a control (i.e., located a significant distance from the facility such that is represents a background dose).

Air Samplers Air Sampler (CAS 1)

Off-site location, co-located with ED 24 Control air sampler located a sufficient distance from the SHINE facility such that airborne samples are unaffected by airborne effluent releases from the facility.

Air Sampler (CAS 2)

Close to property line, north of the main production facility, co-located with ED 1 This direction has high ground level deposition factor (D/Q) and is in the direction of Janesville. Since the community of Janesville is relatively close to the site boundary, this air sampler location is credited with satisfying two of the conditions for air sample location recommendations in Table 3.12-1 of NUREG-1301.

Air Sampler (CAS 3)

Close to property line, east of the main production facility, co-located with ED 5 This direction has high D/Q and is in the direction of dairy production and the horse pasture.

Air Sampler (CAS 4)

Close to property line, west of the main production facility, co-located with ED 9 This location ensures all directions are monitored.

Air Sampler (CAS 5)

Close to property line, south of the main production facility, co-located with ED 13 This location is in the direction of the nearest occupied structure.

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Chapter 11 - Radiation Protection Program and Waste Management Radiation Protection SHINE Medical Technologies 11.1-50 Rev. 0 Figure 11.1 Probable Radiation Area Designations Within the SHINE RCA, Ground Floor Level

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Chapter 11 - Radiation Protection Program and Waste Management Radiation Protection SHINE Medical Technologies 11.1-51 Rev. 0 Figure 11.1 Estimated Derived Air Concentrations, Ground Floor Level

Chapter 11 - Radiation Protection Program and Waste Management Radiation Protection SHINE Medical Technologies 11.1-52 Rev. 0 Figure 11.1 Radiation Protection Organization

Chapter 11 - Radiation Protection Program and Waste Management Radiation Protection SHINE Medical Technologies 11.1-53 Rev. 0 Figure 11.1 Environmental Dosimeter Locations

Chapter 11 - Radiation Protection Program and Waste Management Radioactive Waste Management SHINE Medical Technologies 11.2-1 Rev. 0 11.2 RADIOACTIVE WASTE MANAGEMENT SHINE produces medical isotopes by the fission of low enriched uranium (LEU) driven by accelerator-produced neutrons. Several irradiation and processing steps create liquid, gaseous, or solid radioactive waste materials. This section describes the management program, controls, and disposal pathways established to ensure proper identification, classification, control, processing (as required), and packaging, for each anticipated radioactive waste stream generated by the SHINE facility. SHINE is committed to comply with all applicable local and national regulations for managing radioactive wastes.

SHINE will comply with the following federal regulations related to radioactive wastes:

10 CFR 20, Standards for Protection Against Radiation 10 CFR 61, Licensing Requirements for Land Disposal of Radioactive Waste 10 CFR 71, Packaging and Transportation of Radioactive Material 40 CFR, Chapter I, Subchapter F, Radiation Protection Programs 40 CFR, Chapter I, Subchapter I, Solid Wastes 49 CFR, Chapter I, Subchapter C, Hazardous Materials Regulations SHINE is regulated by the NRC. The State of Wisconsin regulates radioactive waste once it leaves the SHINE facility and is transported. SHINE complies with Wisconsin regulations relating to the transportation and disposal of hazardous waste per Wisconsin Administrative Code Chapter NR 662. The State of Wisconsin implements the U.S. Department of Transportation (DOT) radioactive waste transportation regulations.

Radioactive wastes are prepared for shipment in approved shipping containers and shipped off-site using common or contract carriers in compliance with DOT regulations (49 CFR) and 10 CFR 20, 10 CFR 61 and 10 CFR 71, as applicable.

SHINE complies with the waste acceptance criteria (WAC) of the selected licensed disposal facilities, including any local or state regulations specified in those criteria. The State of Wisconsin is in the Midwest Interstate Low-Level Radioactive Waste Compact. Waste disposal sites available for this compact include:

EnergySolutions in Clive, UT Waste Control Specialists (WCS) in Andrews, TX Section 11.1 describes the program and procedures for controlling and assessing radioactive exposures associated with radioactive sources, including radioactive waste streams.

11.2.1 RADIOACTIVE WASTE MANAGEMENT PROGRAM The Radioactive Waste Management Program is coordinated with the Radiation Protection Program under the Plant Manager. The goal of the Radioactive Waste Management Program is to minimize waste generation, minimize exposure of personnel, and to protect the general public and environment. The authority, duties, and responsibilities of personnel in the waste management organization are prescribed in the Radioactive Waste Management Program document.

Chapter 11 - Radiation Protection Program and Waste Management Radioactive Waste Management SHINE Medical Technologies 11.2-2 Rev. 0 11.2.1.1 Plant Manager The Plant Manager reports to the Chief Operating Officer. The Plant Manager has overall responsibility for the safe operation of the SHINE facility and is responsible for ensuring the protection of personnel from radiation exposure resulting from processing, handling and storing radioactive material and waste. The Plant Managers responsibilities are to:

Assign responsibility and delegates commensurate authority to implement the Radioactive Waste Management Program.

Provide waste management staff appropriate to the scope of operations and experienced in waste management operations.

Ensure that the waste management self-assessment program is implemented.

Ensure compliance with applicable federal and state regulations, and facility license conditions.

Approve changes to the facility Process Control Program.

11.2.1.2 Radiation Protection Manager The Radiation Protection Manager reports to the Plant Manager. The Radiation Protection Manager is responsible for establishing and maintaining the Radioactive Waste Management Program. The Radiation Protection Department maintains organizational independence from the Operations Department. The Radiation Protection Manager and Radiation Protection staff responsibilities are to:

Develop waste management procedures for the processing, packaging and shipment of radioactive waste from the facility.

Ensure that the concept of ALARA is incorporated into the Radioactive Waste Management Program procedures and is practiced by personnel.

Process radioactive waste generated at the facility.

Provide technical input to the design of equipment and processes.

Perform radiological analysis tasks supporting the Radioactive Waste Management Program.

Provide technical input to the Radioactive Waste Management Program training program.

Maintain contractual relationships with waste disposal sites, waste processing facilities, and radioactive waste carriers.

Maintain working knowledge of waste disposal acceptance criteria, regulations, standards and guides.

Conduct self-assessments of radioactive waste management practices and compliance with procedures.

11.2.1.3 Training Manager The Training Manager reports to the Plant Manager and is responsible for implementation of the Radioactive Waste Management Program training as described in the Radiation Protection Program. The Training Manager has the following responsibilities:

Develops the waste management training and qualification program in accordance with facility procedures and ensuring compliance with 49 CFR 172, Subpart H, Training.

Provides training to personnel commensurate with the radiological waste hazard to which they may be exposed.

Chapter 11 - Radiation Protection Program and Waste Management Radioactive Waste Management SHINE Medical Technologies 11.2-3 Rev. 0 Provides re-training of previously-trained waste management personnel at least once every three years. Includes training on procedure changes and changes in required skills.

Evaluates the waste management and qualification training program periodically.

Reviews program content to ensure it remains current and adequate to ensure worker safety.

11.2.1.4 Quality Manager The Quality Manager reports to the Vice President Regulatory Affairs & Quality. The Quality Manager has the following responsibilities:

Review and audit facility radioactive waste handing, storing and shipping activities in accordance with the Quality Assurance Program Description to verify compliance with facility procedures, applicable federal and state regulations and applicable regulatory guides.

11.2.1.5 Shipping Personnel Individuals who perform the duties of shipping radioactive waste, are trained in accordance with 49 CFR 172, Subpart H, Training.

11.2.1.6 Radioactive Waste Management Procedures Radioactive Waste Management Program implementing procedures are developed to provide direction for efficient and safe conduct of waste operations. The procedures include applicable controls and limits significant to the waste management operation. The procedures include:

Waste minimization and pollution prevention, including process controls to minimize generation of waste and separation of radioactive waste and nonradioactive waste to reduce volumes of radioactive wastes.

Radiological characterization and waste classification.

Operating and process controls with parameters for processing wastes.

Verification of compliance with disposal and processor site WAC.

Preparation of radioactive waste for shipment, including preparation of manifests and notifications, and measures for security on site and during transport.

Container specifications, selection, packaging wastes, inspections, vehicle inspections, and proper loading and shoring of shipments.

Marking, labeling and placarding requirements.

Radioactive materials and contamination survey requirements and limits for shipment on public highways.

Waste disposal recordkeeping.

Interim waste storage controls and recordkeeping.

The Radiological Waste Management Program and implementing procedures are developed and controlled in accordance with SHINEs document control requirements.

11.2.1.7 Record Keeping and Document Controls Records are developed and retained in accordance with the requirements specified in the Radiation Protection Program (see Subsection 11.1.2.1.8), the SHINE Document Control

Chapter 11 - Radiation Protection Program and Waste Management Radioactive Waste Management SHINE Medical Technologies 11.2-4 Rev. 0 Program, and as specified in federal and state regulations applicable to the Radioactive Waste Management Program.

11.2.1.8 Waste Management Audits Facility radioactive waste management audits are conducted, at a minimum, on an annual basis in accordance with 10 CFR 20.1101(c) for the purpose of reviewing the functional and safety elements of the radioactive waste management program. The audits also evaluate programmatic efforts to minimize production of radioactive wastes. The audit activity is led by the Review and Audit Committee (see Section 12.2) as a subset of the Radiation Protection Program audit and the results are sent to executive management. Any deficiencies identified by the audit are addressed by the corrective action process.

11.2.1.9 Technical Specifications Variables, conditions, or other items that may be subjects of a technical specification associated with radioactive waste management are contained in the facility Technical Specifications.

11.2.2 RADIOACTIVE WASTE CONTROLS Radioactive waste is generally considered to be any item or substance which is no longer of use to the facility and which contains radioactivity above the established natural background radioactivity. The wastes generated by the SHINE facility are not spent nuclear fuel, high-level waste, or byproduct material as defined in paragraphs (2), (3) and (4) of the definition of Byproduct Material set forth in 10 CFR 20.1003. Therefore, the radioactive wastes generated by the SHINE facility are all classified as low level waste (LLW). The LLW generated by the SHINE facility during operation is expected to be classified as Class A, Class B or Class C waste. The neutron multipliers are designed for the life of the facility and will be disposed of as greater-than Class C (GTCC) waste during decommissioning.

For the purposes of transportation, packaged wastes may be categorized as low specific activity (LSA), requiring Type A packaging, or requiring Type B packaging.

For the purposes of both transportation and operational ALARA, wastes may be categorized as either contact handled or remote handled. The upper limit for remote handled waste dose rates is defined based on payload limits for the specific shielded transportation casks used and on WAC for the intended disposal site.

Radiation Protection Program requirements and the ALARA Program (see Section 11.1) apply to radioactive waste management, including, but not limited to, control of materials, monitoring and surveys, radiologically controlled area (RCA) access control, contamination control and personnel monitoring. ALARA goals and implementation are detailed in Subsection 11.1.3.

The material staging building is used for interim storage of wastes for decay and for preparation for shipment. Wastes are not stored for more than five years. The material staging building design evaluated the shielding provided by the building to ensure 10 CFR 20 site dose limits are met and ALARA principles are followed.

Chapter 11 - Radiation Protection Program and Waste Management Radioactive Waste Management SHINE Medical Technologies 11.2-5 Rev. 0 Radioactive waste management operating procedures are discussed in Subsection 11.2.1.6.

These procedures ensure proper identification, characterization, and separate treatment of radioactive wastes.

11.2.2.1 Radioactive Waste Minimization Waste minimization and pollution prevention are key elements of the Radiological Waste Management Program. Implementing procedures (see Subsection 11.2.1.6) address:

a.

Responsibilities for waste minimization and pollution prevention.

b.

Employee training and education on general environmental activities and hazards regarding the facility, operations, pollution prevention, waste minimization requirements, goals and accomplishments.

c.

Setting goals for reducing the volume or radioactivity in each waste stream.

d.

Sorting and compaction to reduce the volume of solid waste.

e.

Segregation of nonradiological and radiological wastes to reduce the volume of radiological waste due to contamination.

f.

Process controls that minimize generation of wastes.

g.

Periodic assessments to identify opportunities to reduce or eliminate the generation of wastes.

h.

Recognition of employees for efforts to improve waste minimization and environmental conditions.

11.2.2.2 Waste Stream Sources Waste management operations occur in the main production facility and the material staging building (see Figure 1.3-1 and Figure 1.3-3). At least 5,600 square feet (ft2) of the material staging building is for temporary storage to allow for decay. As allowed by the waste drum design, building design, and programmatic controls (e.g., inspection requirements), drums may be stored in multiple layers. Equipment and associated features for containment and/or packaging, storage, and disposal of solid, liquid, and gaseous radioactive waste are discussed in Subsection 9b.7.3, Subsection 9b.7.4, and Subsection 9b.7.5.

Changes to the facility will be performed in accordance with 10 CFR 50.59, Changes, Tests and Experiments, and will be assessed for their impact on radioactive waste sources or management, as applicable.

Table 11.2-1 summarizes the facility waste streams, characteristics, generation rates, and shipment categories. The waste streams and typical waste classifications are described in the following subsections.

11.2.2.2.1 Uranium Receipt and Storage System Waste generated by uranium receipt and storage includes used cannisters in which new uranium metal and uranium oxide are received. The used cannisters are processed as Class A waste, if not returned to the supplier. The uranium receipt and storage system (URSS) utilizes gloveboxes with high efficiency particulate air (HEPA) filters in the air supply and return lines. The spent HEPA filters are Class A waste.

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Chapter 11 - Radiation Protection Program and Waste Management Radioactive Waste Management SHINE Medical Technologies 11.2-6 Rev. 0 11.2.2.2.2 Target Solution Preparation System The target solution preparation process may generate waste in the form of spent filters from the uranyl sulfate dissolution tanks, if not cleaned and reused, and spent HEPA filters from glovebox air supply and return lines. The spent filters are Class A waste.

11.2.2.2.3 Irradiation Unit An irradiation unit (IU) consists of a subcritical assembly system (SCAS) coupled with a neutron driver assembly system (NDAS). The IU components become activated during their service life.

SCAS major components are designed for the life of the facility and are not anticipated waste streams. Spent NDAS components are Class A waste. Contaminated oil from the NDAS vacuum pumps is Class B waste.

11.2.2.2.4 TSV Off-Gas System The target solution vessel (TSV) off-gas system (TOGS) removes radiolysis and fission product gases from the TSV during irradiation operation and from the TSV dump tank during cool down operation. There are a total of eight independent TOGS, one for each IU.

The TOGS contains skid-mounted equipment that includes recombiner beds, demisters, and zeolite beds. Skid replacement occurs infrequently. Skids containing recombiner beds and demisters are treated with an acid flush and processed as Class A or B waste. Zeolite beds are designed for the life of the facility, however, if replaced more frequently and processed separately from the remainder of the skid components, the zeolite beds are expected to be Class B or Class C waste.

11.2.2.2.5 Molybdenum Extraction and Purification System The molybdenum extraction and purification system (MEPS) separates molybdenum from an irradiated uranyl sulfate target solution. The molybdenum is then concentrated and purified into a sodium molybdate solution. The MEPS is located within a series of hot cells. Waste generated from the MEPS includes spent molybdenum extraction columns, [

]PROP/ECI, and purification glassware. MEPS liquid wastes are processed by the radioactive liquid waste immobilization (RLWI) system.

Spent extraction columns [ ]PROP/ECI are stored in a hot cell, then transferred to the drum storage bore holes for decay, and ultimately disposed as Class B or C waste.

The glassware used in this process is not expected to contain significant quantities of long-lived radionuclides and is Class A waste.

[ ]PROP/ECI associated with MEPS column washes occurs in the RLWI system. The [ ]PROP/ECI are disposed as Class B or Class C waste.

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Chapter 11 - Radiation Protection Program and Waste Management Radioactive Waste Management SHINE Medical Technologies 11.2-7 Rev. 0 11.2.2.2.6 Process Vessel Vent System The process vessel vent system (PVVS) removes radioactive particulates, iodine, and noble gases that are generated within the radioisotope production facility (RPF) and primary system boundary (PSB) prior to being discharged to the atmosphere. PVVS waste consists of spent HEPA filters and spent carbon guard beds. The spent HEPA filters are Class A waste and the spent carbon guard beds are Class A or Class B waste. Condensate from PVVS can be blended with other waste streams and processed by RLWI.

11.2.2.2.7 Iodine and Xenon Purification and Packaging System The iodine and xenon purification and packaging (IXP) system separates the iodine fission products from the uranyl sulfate target solution or from [ ]PROP/ECI. The IXP system generates spent iodine recovery, [

]PROP/ECI.

Iodine recovery, [ ]PROP/ECI will be regularly changed out and are Class B or Class C waste.

11.2.2.2.8 Hot Cells Hot cells contain HEPA and carbon filter combinations on the air supply and return lines. Spent HEPA and carbon filters are Class A waste.

11.2.2.2.9 Primary Closed Loop Cooling System The primary closed loop cooling system (PCLS) has potential for radioactive contamination due to minor leakage from the PSB and activation products. Contamination would collect on the PCLS filters and deionizer resins. PCLS filters could become contaminated with radionuclides due to activation of corrosion particles as the water passes through the TSV, however, corrosion of the stainless steel components is expected to be small. The spent PCLS filters are expected to be Class A waste. PCLS deionizer resins are contained in disposable deionizer units. The tanks are designed for complete replacement without removal of the ion exchange resins in the tanks.

The disposable tanks are Class A waste.

11.2.2.2.10 Light Water Pool System The light water pool has potential for radioactive contamination due to minor leakage from the PSB and activation products. Any contamination would collect on the filters and deionizer resins used to cleanup the light water pool. Similar to the PCLS, the deionizer resins are contained in disposable deionizer units and are expected to be Class A waste. Spent filters are expected to be Class A waste.

11.2.2.2.11 Radioactive Liquid Waste Radioactive liquid waste streams include waste liquids from:

MEPS IXP system PVVS

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Chapter 11 - Radiation Protection Program and Waste Management Radioactive Waste Management SHINE Medical Technologies 11.2-8 Rev. 0 Decontamination liquid waste from decontamination of structures, systems, and components (SSCs) during normal operation Laboratory liquid waste The liquid waste streams are shown in Table 11.2-1.

Liquid waste streams are collected in uranium liquid waste and radioactive liquid waste collection tanks, consolidated in liquid waste blending tanks and treated for disposal using the RLWI system. The quantity and size of the tanks are managed to maximize decay time and provide a buffer for upset conditions. Each uranium liquid waste tank has at least [ ]PROP/ECI capacity and the liquid waste collection and blending tanks each have at least 600 gallons capacity. Hold times for decay are based on minimizing dose rates to workers during the immobilization process. Solidified liquid waste is expected to be Class A.

The chemical composition and relative radiological inventory of liquid waste streams is presented in Table 11.2-6.

11.2.2.2.12 Radioactive Gaseous Waste Airborne radioactive sources are present in the tritium purification system (TPS), PVVS, TOGS, vacuum transfer system (VTS), and the NDAS. Airborne radioactive sources and release are addressed in Subsection 11.1.1.1 and Table 11.1-5.

The RCA ventilation systems generate spent prefilters, HEPA filters and carbon filters that are Class A generated solid waste.

11.2.2.3 Technical Specifications Variables, conditions, or other items that may be subjects of a technical specification associated with radioactive waste controls are contained in the facility Technical Specifications.

11.2.3 RELEASE OF RADIOACTIVE WASTE Release, for the purposes of this subsection, means that wastes are processed and packaged as required to meet the WAC of an established, licensed LLW disposal facility. Processing may be comprised of one or more of several operations, including compaction, solidification with an appropriate solidification agent, adsorption onto a solid medium (e.g., elemental iodine onto activated carbon filters), interim storage for decay of radionuclides, consolidated handling and processing, extraction and consolidation of radionuclides by segregation, and mixing (possibly from more than one waste stream) so that the bulk volume of waste is readily disposable.

Radiation monitoring of effluent waste streams is described in Section 7.7. Radiation monitoring requirements are also described in the Radiation Protection Program. The Radiation Protection Program is described in detail in Subsection 11.1.2.

Liquid effluent is not routinely discharged from the RCA. Radioactive liquid discharges from the SHINE facility to the sanitary sewer are infrequent and made in accordance with 10 CFR 20.2003 and 10 CFR 20.2007. There are no piped liquid effluent pathways from the RCA to the sanitary sewer. Sampling is used to determine suitability for release.

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Chapter 11 - Radiation Protection Program and Waste Management Radioactive Waste Management SHINE Medical Technologies 11.2-9 Rev. 0 Table 11.2-1 shows the anticipated waste generation, classifications, shipment types, and expected disposal sites for the identified waste streams. Final determinations of waste classification and management will be made in accordance with the Radioactive Waste Management Program implementing procedures.

11.2.3.1 Solid Wastes The subsections below discuss the methodology for the eventual release of the major solid wastes generated by the SHINE facility. Processing requirements are in accordance with the receiving facilitys WAC and will be modified as needed to reflect any change in the disposal site or WAC.

11.2.3.1.1 Irradiation Units Solid waste streams associated with the IUs are the NDAS activated components. The NDAS is comprised of an accelerator section, pumping section, roots stack, and target chamber assembly. The target chamber assembly is expected to be Class A waste and the WAC specified by EnergySolutions will apply. The accelerator stage, pumping stage and roots stack are considered oversize and must meet specific WAC applicable to oversize components.

Table 11.2-2 displays the typical methodology associated with disassembly and processing of this waste stream.

11.2.3.1.2 Spent Columns Spent molybdenum extraction columns, [ ]PROP/ECI, and IXP recovery,

[ ]PROP/ECI will be held in hot cells for decay, then consolidated into supercell export waste drums prior to disposal.

The columns are removed from the process lines using quick-disconnect style inlet and outlet connectors specifically designed for use with remote manipulators in hot cell environments.

Radiation and wear-resistant seals and automatically closing valves built into the connectors provide leak tightness to minimize or prevent leakage.

After removing a spent column from the originating process, it is stored in a hot cell for sufficient time to allow short-lived fission products to decay. After several columns have decayed, they are transported out of the cell in one transfer to reduce personnel exposure and the number of transfer operations. The number of columns transferred is limited based on export waste drum capacity. The export waste drum is shielded to ensure personnel doses are maintained ALARA and within procedure limits during the transfer. The estimated dose rate for an extraction column, at the time of process removal is approximately 9500 rem/hr at 3 feet unshielded. The peak dose rate drops to approximately 580 rem/hr at 3 feet unshielded after storage in the hot cell.

When a set of columns are to be transferred out of the hot cell, they are remotely loaded into an export waste drum within a shielded cask. Dose rates from the cask and contamination levels are confirmed to be within limits, then the cask is remotely transported to a bore hole for interim below-grade storage. The shielded cask is surveyed and decontaminated, if needed, prior to reuse.

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Chapter 11 - Radiation Protection Program and Waste Management Radioactive Waste Management SHINE Medical Technologies 11.2-10 Rev. 0 When a shipment of columns is to be prepared, the export waste drum is retracted using the remote-controlled grappler and placed into a shielded cask and the cask is transported to an area for loading into a Type B shipping container.

The spent columns are expected to be Type B or C generated waste and have no specified time requirement in storage. The spent columns are stored in order to consolidate shipments to minimize handling for ALARA and to consolidate the columns to reduce disposal volumes.

Requirements for this waste stream are presented in Table 11.2-3.

[

]PROP/ECI 11.2.3.1.3 Process Glassware Spent molybdenum purification glassware is remotely handled to move the glassware from the hot cell to an export waste drum. The glassware may be crushed in the waste drum using a remotely controlled compactor and transported to the material staging building in a shielded transport cask. Requirements for this waste stream are presented in Table 11.2-4.

11.2.3.1.4 Zeolite Beds The silver coated zeolite beds are a component of the TOGS and are provided to remove iodine from the sweep gas. Toxicity characteristic leaching procedure (TCLP) would result in the classification of this waste as Resource Conservation and Recovery Act (RCRA) waste; however, the waste is also radioactive and as such may be a mixed low level waste (MLLW). The waste classification for this material is a function of both the efficiency of the zeolite beds and the change out frequency of the beds. The design goal is for the beds to last the lifetime of the facility; however, this waste stream is assumed to be replaced every five years. The zeolite bed has the potential to be Class B or Class C waste.

11.2.3.1.5 Recombiner Beds, Demister and Component Replacement This waste stream is associated with the TOGS. This waste stream is based on infrequent replacement of the TOGS skids. Acid flushing of the skid components (excluding the zeolite beds) will be performed prior to disposal. Cs-137 and Sr-90 are expected to dominate the waste classification. Remote handling and packaging may be required due to considerable dose rates expected should replacement be required. This waste stream is Class A or Class B waste.

11.2.3.1.6 PCLS and LWPS Deionizer Units The PCLS and LWPS deionizer resins are contained in disposable deionizer units. The spent units are dewatered and disposed as Class A generated waste.

11.2.3.2 Liquid Waste Streams Several waste streams are solidified on site to meet DOT criteria and disposal site WAC, as described in Subsection 11.2.2. The consolidated liquid waste stream (post-treatment) is amenable for disposal as Class A waste at EnergySolutions.

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Chapter 11 - Radiation Protection Program and Waste Management Radioactive Waste Management SHINE Medical Technologies 11.2-11 Rev. 0 11.2.3.2.1 Consolidated Liquids Radioactive liquid waste and estimated generated volumes are provided in Table 11.2-1.

Uranium liquid wastes and other radioactive liquid wastes are collected and processed separately, then blended prior to solidification. Uranium liquid wastes may consist of molybdenum extraction column acid wash, extraction column water wash, iodine recovery column [ ]PROP/ECI, VTS knockout pot contents, spent target solution, or decontamination waste. Radioactive liquid waste may consist of [

]PROP/ECI, purification waste, [ ]PROP/ECI, or PVVS condensate.Blending of wastes is performed without exceeding the maximum uranium concentration applicable to the receiving disposal site. Certain fissile material may be exempted under 10 CFR 71.15.

This waste stream process includes removal of radionuclides, radioactive decay, pH adjustment, blending of uranium and radioactive liquid wastes, and solidification in 55-gallon drums using a solidification agent.

The anticipated disposal site for the solidified liquid waste is EnergySolutions.

Requirements for this waste stream are presented in Table 11.2-5.

11.2.3.3 Gaseous Waste Streams Airborne radioactive sources are identified in Subsection11.1.1 and Table11.1-5. The RCA ventilation system filtering and exhaust stack discharge is described in Subsection 9a2.1.1. The exhaust stack location is shown on Figure1.3-2. Thestack release monitor provides continuous monitoring of radioactive noble gas stack releases and a means to sample and measure the stack air for particulate, iodine, and tritium concentration to ensure compliance with gaseous effluent regulatory limits. The estimate of annual release of radionuclides is provided in Table11.1-8. The effect of releases on the surrounding environment is addressed by the Environmental Monitoring Program described in Subsection11.1.7.

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Chapter 11 - Radiation Protection Program and Waste Management Radioactive Waste Management SHINE Medical Technologies 11.2-12 Rev. 0 Table 11.2 Estimated Annual Waste Stream Summary (Sheet 1 of 2)

Description Matrix Class as Generated As Generated Amount As Generated Units As Disposed (ft3)

Shipment Type Destination(a)

MEPS Extraction Columns [

]PROP/ECI

[

]PROP/ECI B or C

[ ]PROP/ECI ft3/yr 270 Type B WCS

[ ]PROP/ECI

[ ]PROP/ECI B or C 72 ft3/yr 72 Type B WCS IXP Separation Columns

[ ]PROP/ECI B or C

[ ]PROP/ECI ft3/yr 35 Type B WCS LWPS Deionizer Units Resin A

48 ft3/yr 80 Type A or LSA EnergySolutions PCLS Deionizer Units Resin A

48 ft3/yr 80 Type A or LSA EnergySolutions Uranium Canisters Solid A

2.0(b) ft3/yr 3.3 Type A or LSA EnergySolutions NDAS Accelerator Subassembly Solid A

[ ]PROP/ECI ft3/yr 13,600 Type A or LSA EnergySolutions NDAS Target Chamber Subassembly Solid A

[ ]PROP/ECI ft3/yr 1330 Type A or LSA EnergySolutions TOGS Skids Solid A or B 922 ft3/yr 1540 Type A, B, or LSA EnergySolutions or WCS TOGS Zeolite Beds Solid B or C 0.64 ft3/yr 1

Type B WCS LWPS Filters Solid A

1.6 ft3/yr 2.7 Type A or LSA EnergySolutions PCLS Filters Solid A

1.6 ft3/yr 2.7 Type A or LSA EnergySolutions TSPS, URSS, PVVS, Hot Cell, RVZ1, RVZ2, RLWI HEPA Filters Solid A

182 ft3/yr 142 Type A or LSA EnergySolutions Hot Cell, RVZ1, RVZ2 Charcoal Filters Solid A

32 ft3/yr 54 Type A or LSA EnergySolutions TSPS Uranyl Sulfate Solution Filters Solid A

0.35(c) ft3/yr 0.58 Type A or LSA EnergySolutions

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Export Controlled Information - Withheld from public disclosure under 10 CFR 2.390(a)(3)

Chapter 11 - Radiation Protection Program and Waste Management Radioactive Waste Management SHINE Medical Technologies 11.2-13 Rev. 0 PVVS Carbon Guard Bed Solid A or B 0.48 ft3/yr 0.81 Type B EnergySolutions or WCS MEPS Glassware Solid A

208 ft3/yr 347 Type A or LSA EnergySolutions Class A Trash Solid A

400(d) ft3/yr 677 Type A or LSA EnergySolutions Contaminated Oil Oil B

2 ft3/yr 3.3 Type A or LSA WCS Extraction Column Acid Wash Liquid(e)

A

[ ]PROP/ECI

[ ]PROP/ECI 2,599(f)(g)

Type A or LSA EnergySolutions Extraction Column Water Wash Liquid(e)

A

[ ]PROP/ECI

[ ]PROP/ECI

[ ]PROP/ECI Liquid(e)

A

[ ]PROP/ECI

[ ]PROP/ECI

[ ]PROP/ECI Liquid(e)

A

[ ]PROP/ECI

[ ]PROP/ECI

[ ]PROP/ECI Liquid(e)

A

[ ]PROP/ECI

[ ]PROP/ECI Iodine Recovery Column [ ]PROP/ECI Liquid(e)

A

[ ]PROP/ECI

[ ]PROP/ECI Spent Target Solution Liquid(e)

A

[ ]PROP/ECI

[ ]PROP/ECI Vacuum Transfer System Knockout Pot Liquid(e)

A 14 gal/yr Radiological Laboratory Waste Liquid(e)

A 275 gal/yr Decontamination Waste Liquid(e)

A 2,768 gal/yr Cintichem Purification Waste & Rotary Evaporator Condensate Liquid(e)

A 82 gal/yr

[ ]PROP/ECI Liquid(e)

A

[ ]PROP/ECI

[ ]PROP/ECI PVVS Condenser Condensate Liquid(e)

A 701 gal/yr

a. Waste destination may be subject to change.
b. Uranium metal and/or uranium oxide cannisters may be returned to the supplier in lieu of disposition as solid waste.
c. TSPS uranyl sulfate dissolution tank filter elements may not become a waste stream if reconditioned and reused.
d. Class A trash is exclusive of other solid wastes identified in the table.
e. Liquid waste streams may be reused or may be combined and treated as a homogenous influent waste stream and solidified together.

f.

As shipped volume of liquid waste streams is in the form of a uniform solidified matrix using a solidification agent.

g. 25 percent margin has been added to volume of solidified liquid shipped waste.

Table 11.2 Estimated Annual Waste Stream Summary (Sheet 2 of 2)

Description Matrix Class as Generated As Generated Amount As Generated Units As Disposed (ft3)

Shipment Type Destination(a)

Chapter 11 - Radiation Protection Program and Waste Management Radioactive Waste Management SHINE Medical Technologies 11.2-14 Rev. 0 Table 11.2 Waste Methodology for Accelerator Requirement Basis Disassemble irradiation unit (separate accelerator section, pumping section, and roots stack from the target chamber assembly).

Operational requirement.

Determine if free liquid is present and absorb liquids, if present.

Required to meet WAC maximum free liquids requirement of 1 percent. This is particularly applicable to drift tubes and target chamber section waste.

Make waste characterization measurements.

Waste must be characterized in the manner appropriate and in conformance with the procedures of the destination to which it will be sent.

Provide capability to load oversized debris into cargo container.

Ensure capability to maneuver radioactive oversize debris.

Provide storage, waste segregation, consolidation and packaging capacity.

Items meeting the "standard debris" definition are shipped in a roll-off. One roll-off may be continuously stored in the material staging building. Oversized items (non-standard debris) are shipped in a cargo container. One cargo container may be continuously on-site.

Fill void space (if required) in accordance with the WAC.

Required to meet WAC requirement to minimize void space.

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Export Controlled Information - Withheld from public disclosure under 10 CFR 2.390(a)(3)

Chapter 11 - Radiation Protection Program and Waste Management Radioactive Waste Management SHINE Medical Technologies 11.2-15 Rev. 0 Table 11.2 Waste Methodology for Spent Columns(a) a.

Applicable to spent molybdenum extraction columns [ ]PROP/ECI and IXP recovery, [ ]PROP/ECI.

Requirement Basis Hold spent columns in hot cell for a period of decay sufficient to allow short-lived fission products to decay.

Spent columns are highly radioactive when removed from active service. Hold time is for decay and consolidated processing.

Remote transfer from hot cell to export waste drum.

Maintain worker dose ALARA.

Provide safe, shielded storage outside of hot cell.

Protected on-site storage until a full shipment of spent columns is prepared for disposal.

Provide management controls to ensure proper hold time is applied to spent columns.

Since multiple columns can be held in each hot cell post service, it is necessary to ensure each column has been held for a sufficient time to meet radiological dose requirements during handling prior to being transferred.

Determine if free liquid is present and absorb liquids, if present.

Required to meet WAC maximum free liquids requirement of 1 percent.

Fill void space (if required) in accordance with the WAC.

Required to meet WAC requirement to minimize void space.

Chapter 11 - Radiation Protection Program and Waste Management Radioactive Waste Management SHINE Medical Technologies 11.2-16 Rev. 0 Table 11.2 Waste Methodology for Process Glassware Requirement Basis Remote transfer from hot cell to export waste drum.

Maintain worker dose ALARA.

Smear sample glassware.

Waste characterization to confirm disposal site and applicable WAC.

Glassware is compacted.

Glassware can be compacted for efficient packaging and transportation.

Determine if free liquid is present and absorb liquids, if present.

Required to meet WAC maximum free liquids requirement of 1 percent.

Fill void space (if required) in accordance with the WAC.

Required to meet WAC requirement to minimize void space.

Chapter 11 - Radiation Protection Program and Waste Management Radioactive Waste Management SHINE Medical Technologies 11.2-17 Rev. 0 Table 11.2 Waste Methodology for Consolidated Liquids Requirement Basis Collect uranium liquid waste and non-uranium liquid wastes separately.

Process separately prior to blending.

Apply hold time to uranium liquid waste.

Radioactive decay to achieve solidification product suitable for LSA or Type A packaging.

Consolidate uranium and non-uranium liquid wastes into blending tanks.

Liquid waste consolidation and processing.

Sample blended wastes after mixing.

A representative sample is required to verify maximum uranium concentration is not exceeded and for accurate waste characterization prior to solidification.

Solidify waste.

Use of a solidification agent to ensure final waste form meets requirements. Required to meet WAC maximum free liquids requirement for solidified waste forms (0.5 percent by volume).

Limit void space.

WAC requirement to minimize void space.

Establish dedicated area in the material staging building for decay or shipment consolidation.

Solidified waste may require decay post-processing to meet DOT limits.

Maintain records relative to drums in the storage area.

Drums may be held to decay to DOT limits.

Proprietary Information - Withheld from public disclosure under 10 CFR 2.390(a)(4)

Export Controlled Information - Withheld from public disclosure under 10 CFR 2.390(a)(3)

Chapter 11 - Radiation Protection Program and Waste Management Radioactive Waste Management SHINE Medical Technologies 11.2-18 Rev. 0 Table 11.2 Chemical Composition and Radiological Properties of Liquid Waste Streams (Sheet 1 of 2)

Description Chemical Composition (wt/wt)

Estimated Annual Volume Radiological Inventory(1)

Qualitative Radiological Properties Extraction Column Acid Wash

[ ]PROP/ECI

[ ]PROP/ECI

[ ]PROP/ECI

[ ]PROP/ECI

[ ]PROP/ECI Medium Most fission products pass through separation columns, though some are expected to be retained on the columns and then be removed with column washes.

Extraction Column Water Wash

>99% H2O trace H2SO4 trace UO2SO4

[ ]PROP/ECI

[ ]PROP/ECI

[

]PROP/ECI

[ ]PROP/ECI

[ ]PROP/ECI

[ ]PROP/ECI

[ ]PROP/ECI

[

]PROP/ECI

[ ]PROP/ECI

[ ]PROP/ECI

[ ]PROP/ECI

[ ]PROP/ECI

[

]PROP/ECI

[ ]PROP/ECI

[ ]PROP/ECI

[ ]PROP/ECI Iodine Recovery Column Washes

[ ]PROP/ECI

[ ]PROP/ECI

[ ]PROP/ECI

[ ]PROP/ECI

[ ]PROP/ECI

[

]PROP/ECI

[ ]PROP/ECI

[ ]PROP/ECI

[ ]PROP/ECI

[ ]PROP/ECI

[

]PROP/ECI

[ ]PROP/ECI

[ ]PROP/ECI

[ ]PROP/ECI

[ ]PROP/ECI Spent Target Solution

[ ]PROP/ECI

[ ]PROP/ECI

[ ]PROP/ECI

[ ]PROP/ECI

[ ]PROP/ECI High Fission products remaining in the target solution after useful lifetime contribute to a relatively high radiological inventory.

Proprietary Information - Withheld from public disclosure under 10 CFR 2.390(a)(4)

Export Controlled Information - Withheld from public disclosure under 10 CFR 2.390(a)(3)

Chapter 11 - Radiation Protection Program and Waste Management Radioactive Waste Management SHINE Medical Technologies 11.2-19 Rev. 0 Vacuum Transfer System Knockout Pot 100% H2O 14 gal.

Low Liquid collected in the Knockout pot generally consists of condensed water vapor.

Radiological Laboratory Waste 99% H2O 1.0% H2SO4 trace UO2SO4

[ ]PROP/ECI 280 gal.

Low Laboratory waste is expected to consist of small sample volumes of highly-diluted process fluids.

Decontamination Waste 98% H2O 1.0% H2SO4 1.0% UO2SO4

[ ]PROP/ECI 2,800 gal.

Varies Dependent on decontamination needs.

Cintichem Purification Liquid Waste including Rotary Evaporator Condensate 98% H2O 1.1% NH4OH 0.88% HNO3 trace HCl trace K3RuCl6 trace KMnO4 trace -benzoin oxime (ABO) trace MoO2(ABO)2 trace MoO2 trace NaNO3 trace RhCl3 82 gal.

Low Fission products remaining after majority removed in prior MEPS processing steps.

Process Vessel Vent System Condenser Condensate 100% H2O 700 gal.

Low Process vessel vent system condensate generally consists of condensed water vapor.

(1) Radiological inventory relative to other liquid waste streams.

Table 11.2 Chemical Composition and Radiological Properties of Liquid Waste Streams (Sheet 2 of 2)

Description Chemical Composition (wt/wt)

Estimated Annual Volume Radiological Inventory(1)

Qualitative Radiological Properties

Chapter 11 - Radiation Protection Program and Waste Management Respiratory Protection Program SHINE Medical Technologies 11.3-1 Rev. 0 11.3 RESPIRATORY PROTECTION PROGRAM In accordance with 10 CFR 20, Subpart H, the respiratory protection program:

Incorporates process and engineering controls, pursuant to 10 CFR 20.1701, to control the concentration of radioactive material in the air. The design of heating, ventilation, and air conditioning systems is described in Section 9a2.1.

Implements other controls, pursuant to 10 CFR 20.1702, when it is not practical to apply process or engineering controls to control the concentrations of radioactive material in the air to values below those that define an airborne radioactivity area. Consistent with the as low as reasonably achievable (ALARA) program described in Section 11.1, the respiratory protection program implements increased monitoring and limiting intakes by controlling access, limiting exposure times, and using respiratory protection equipment.

Implements controls, pursuant to 10 CFR 20.1703, for the use of individual respiratory protection equipment to limit the intake of radioactive material. The respiratory protection program includes evaluation of potential hazards and estimated doses by performing surveys, bioassays, air sampling, or other means as necessary. The program provides protection of personnel from airborne concentrations exceeding the limits of Appendix B to 10 CFR 20 and ensures that respiratory equipment is tested and certified, including testing of respirators for operability before usage. The program ensures that written procedures specify the selection, fitting, issuance, maintenance, testing, training of personnel, monitoring, medical evaluations, and recordkeeping for individual respiratory protection equipment and for specifying when such equipment is to be used. Procedures for the use of individual respiratory protection equipment are revised as applicable when making changes to processes, facility, or equipment. Records are maintained for the respiratory protection program, including training in respirator use and maintenance.

Chapter 11 - Radiation Protection Program and Waste Management References SHINE Medical Technologies 11.4-1 Rev. 0

11.4 REFERENCES

ANSI/ANS, 2007. The Development of Technical Specifications for Research Reactors, ANSI/ANS-15.1-2007, American National Standards Institute/American Nuclear Society, 2007.

ANSI/ANS, 2014. American National Standard for Radiation Protection Instrumentation Test and Calibration, Portable Survey Instruments, ANSI N323AB-2013, American National Standards Institute/American Nuclear Society, 2014.

ANSI/ANS, 2016. Radiation Protection at Research Reactor Facilities, ANSI/ANS 15.11-2016, American National Standards Institute/American Nuclear Society, 2016.

ASTM, 2013. Radiological Protection Training for Nuclear Facility Workers, ASTM E1168-95, American Society for Testing and Materials, 2013.

EPA, 2006. Guidance on Systematic Planning Using the Data Quality Objectives Process, EPA QA/G-4, Environmental Protection Agency, February 2006.

PNNL, 2012. GENII Version 2 Users Guide, PNNL-14583, Revision 4, Pacific Northwest National Laboratory, September 2012.

USNRC, 1977. Methods for Estimating Atmospheric Transport and Dispersion of Gaseous Effluents in Routine Releases from Light-Water-Cooled Reactors, Regulatory Guide 1.111, Revision 1, U.S. Nuclear Regulatory Commission, July 1977.

USNRC, 1978. Information Relevant to Ensuring that Occupational Radiation Exposures at Nuclear Power Stations Will be As Low As Is Reasonably Achievable, Regulatory Guide 8.8, Revision 3, U.S. Nuclear Regulatory Commission, June 1978.

USNRC, 1986. Relative Importance of Individual Elements to Reactor Accident Consequences Assuming Equal Release Fractions, NUREG/CR-4467, U.S. Nuclear Regulatory Commission, March 1986.

USNRC, 1991. Offsite Dose Calculation Manual Guidance: Standard Radiological Effluent Controls for Pressurized Water Reactors, Generic Letter 89-01, Supplement No. 1, NUREG-1301, U.S. Nuclear Regulatory Commission, April 1991.

USNRC, 1992. Monitoring Criteria and Methods to Calculate Occupational Radiation Doses, Regulatory Guide 8.34, Revision 0, U.S. Nuclear Regulatory Commission, July 1992.

USNRC, 1993. Acceptable Concepts, Models, Equations and Assumptions for a Bioassay Program, Regulatory Guide 8.9, Revision 1, U.S. Nuclear Regulatory Commission, July 1993.

USNRC, 1996. Instruction Concerning Risks from Occupational Radiation Exposure, Regulatory Guide 8.29, Revision 1, U.S. Nuclear Regulatory Commission, February 1996.

USNRC, 1999. Instruction Concerning Prenatal Radiation Exposure, Regulatory Guide 8.13, Revision 3, U.S. Nuclear Regulatory Commission, June 1999.

Chapter 11 - Radiation Protection Program and Waste Management References SHINE Medical Technologies 11.4-2 Rev. 0 USNRC, 2009. Radiological Environmental Monitoring for Nuclear Power Plants, Regulatory Guide 4.1, Revision 2, U.S. Nuclear Regulatory Commission, June 2009.

USNRC, 2011. Administrative Practices in Radiation Surveys and Monitoring, Regulatory Guide 8.2, Revision 1, U.S. Nuclear Regulatory Commission, May 2011.

USNRC, 2012. Health Physics Surveys During Enriched Uranium-235 Processing and Fuel Fabrication, Regulatory Guide 8.24, Revision 2, U.S. Nuclear Regulatory Commission, June 2012.

USNRC, 2016. Operating Philosophy for Maintaining Occupational Radiation Exposures As Low As Is Reasonably Achievable, Regulatory Guide 8.10, Revision 2, U.S. Nuclear Regulatory Commission, August 2016.

USNRC, 2018. Instructions for Recording and Reporting Occupational Radiation Exposure Data, Regulatory Guide 8.7, Revision 4, U.S. Nuclear Regulatory Commission, April 2018.