ML15351A281
| ML15351A281 | |
| Person / Time | |
|---|---|
| Site: | SHINE Medical Technologies |
| Issue date: | 12/15/2015 |
| From: | SHINE Medical Technologies |
| To: | NRC/OCM |
| SECY RAS | |
| References | |
| Mandatory Hearing 2, RAS 28628, 50-608-CP | |
| Download: ML15351A281 (23) | |
Text
United States Nuclear Regulatory Commission Official Hearing Exhibit In the Matter of: SHINE MEDICAL TECHNOLOGIES, INC.
(Medical Radioisotope Production Facility)
Commission Mandatory Hearing Docket #: 05000608 Exhibit #: SHN-026-MA-CM01 Identified: 12/15/2015 Admitted: 12/15/2015 Withdrawn:
Rejected: Stricken: Exhibit SHN-026 Other:
Commission Mandatory Hearing SHINE Construction Permit Application O
Overview i
December 15, 2015
SHINE Medical Technologies, Inc. Mission SHINE is dedicated to being g the world leader in safe, clean, affordable production of medical tracers and cancer treatment elements Highest priority is safely delivering a highly reliable reliable, high-quality supply of the medical ingredients required by nearly 100,000 patients globally each day, while maintaining a minimal environmental impact Will fill gap in supply chain caused by exiting foreign reactors, and ensure continuityy of essential treatments for U.S. patients for decades to come 2
Medical Isotopes Molybdenum-99 y ((Mo-99),
)
the most widely-used medical isotope, decays into technetium-99m, which is used in more than 40 million doses annuallyy Stress tests and bone scans most common of dozens of uses 3
Supply Situation with No New Capacity Canada will stopp operating p g the NRU reactor in March 2018 Following Canadian exit, there will be no North American producer NEA Demand Growth (+35% ORC) vs.
Highly relevant current processing capacity, 2015-2020 because Mo-99 deca s ~1%
decays 1% per hour Domestic supply is necessary to ensure US patient health 4
SHINE Medical Technologies, Inc. Core Values SHINE mission driven byy our core values Ensure health and safety of the public and our workforce Minimize environmental impacts of medical isotope production Ensure minimal or no disruption to patient supply chain Ensure cost effectiveness and therefore patient access Eliminate need for highl highly enriched uranium rani m (HEU) reactors or targets in medical isotope supply chain SHINE believes each of these points are essential to fulfill our mission 5
Technological Approach Reflects Core Values Small systems: Hundreds of times less power than isotope production d i reactors b being i used d Low source termhelps ensure safety of public and workforce Decay heat per system < 1 kW within 5 hours5.787037e-5 days <br />0.00139 hours <br />8.267196e-6 weeks <br />1.9025e-6 months <br /> Minimizes waste nuclide generation compared to reactors Low enriched uranium (LEU) reusable target Reduces waste and cost Product compatible with current supply chain Eliminates need for HEU Driven by low-energy electrostatic accelerator System must be driven to operate, no criticality Hundreds of times less waste than reactors Electrostatic technology simple, demonstrated and cost effective 6
SHINE Medical Technologies, Inc.
The SHINE facilityy is located on a previously undeveloped 91 acre parcel in the southern boundaries of the City of Janesville in Rock County, Wisconsin 7
SHINE Facility Layout The SHINE facilityy consists of an irradiation facilityy ((IF))
and a radioisotope production facility (RPF)
Irradiation Facilityy Radioisotope Production Facility 8
SHINE Irradiation Facility The SHINE IF consists of eight g subcritical irradiation units (IUs), which are comparable in thermal power level and safety considerations to existing non-power reactors licensed under 10 CFR Part 50 However, due to subcriticality, the IUs did not meet the existing definition of utilization facility in 10 CFR 50.2 To align the licensing process with potential hazards, hazards the NRC issued a direct final rule modifying 10 CFR 50.2 definition of utilization facility to include SHINE IUs An IU consists of a subcritical assembly assembly, a neutron driver, and supporting systems 9
SHINE Radioisotope Production Facility The RPF is the pportion of the SHINE facilityy used for preparing target solution; extracting, purifying, and packaging Mo-99; and the recycling and cleaning of g solution target Based on batch size (i.e., greater than 100 grams), the RPF meets the definition of a production facility as defined in 10 CFR 50 50.22 10
SHINE Construction Permit Application SHINE submitted the CP Application in two parts, pursuant to an exemption i to 10 CFR 2 2.101(a)(5) 101( )(5)
Part 1 of the Application submitted March 26, 2013 PSAR Chapter p 2 ((Site Characteristics))
PSAR Chapter 19 (Environmental Review)
General and Financial Information Part P t 2 off the th Application A li ti submitted b itt d May M 31,31 2013 Remaining PSAR Chapters A discussion of the preliminary plans for coping with emergencies, in accordance with 10 CFR 50.34(a)(10), provided September 25, 2013 The SHINE facility will be licensed under 10 CFR Part 50, Domestic Licensing of Production and Utilization Facilities 11
Regulatory Guidance and Acceptance Criteria NUREG-1537, Guidelines for Preparing p g and Reviewing Applications for the Licensing of Non-Power Reactors Interim Staff Guidance augmenting NUREG-1537 NUREG 1537 Incorporates relevant guidance from NUREG-1520, Standard Review Plan for the Review of a License Application for a Fuel Cycle Facility Facility Additional guidance (e.g., Regulatory Guides, ANSI Standards)) used 12
SHINE Facility Layout Production,, processing, p g, and p packaging g g operations p
located within one controlled, confined area Irradiation Facility y
Radioisotope Production Facility 13
SHINE Process Overview 4 Supercell Recycle y Loop p Product TSV and Recycle tank 5 3 Irradiation Unit Cell Hold 2 tank Periodic Cleanup Loop UREX and associated cleanup 6 processes Target Solution 1 Preparation 14
SHINE Irradiation Facility SHINEs Fusion-Fission Coupling An IU consists of a subcritical assembly, a neutron N P di driver, and d supportingti systems t
D Major supporting systems include:
Light water pool system (LWPS) T N P N
Neutron Target solution vessel (TSV) off off-gas gas system (TOGS) Driver Primary closed loop cooling system (PCLS) N Neutron Tritium purification system (TPS) Multiplier Primary a y syste system at near-atmospheric ea at osp e c p pressure essu e N N
N Target solution is drained to dump tank via gravity Target Solution Dump tank is criticality-safe by geometry and N Vessel N N P passively-cooled P N P N N P N P N P N N Redundant, fail-open dump valves P N N P N P N N P N N N TSV is an annular vessel to be constructed of N P N N P Zircaloy-4 U
Natural convection within TSV Radioisotopes in solution 15
Subcritical Assembly Subcritical Assembly Support TSV and Neutron Structure Multiplier (SASS) (Internal to SASS)
TSV Dump Tank TSV Dump and Overflow Lines (2 each) 16
Neutron Driver and Tritium Purification System One Neutron Driver per p Neutron Driver IU cell Electrostatic accelerator with aggas target g
D-T fusion reaction generates 14 MeV neutrons that drive IU Cell Floor Grating the fission p process Tritium purification system Isotopically separates gases, Target Chamber of Neutron Driver and supplies clean tritium to (Hidden) neutron drivers Subcritical Tritium lines and processing Assembly Support Structure (SASS) equipment in gloveboxes and double-walled pipe 17
TSV Off-Gas and Primary Cooling Systems TSV off-gas system (TOGS)
Contains the fission product TOGS gases Removes iodine from the off-gas Recombines hydrogen and oxygen to maintain hydrogen gas belo below the lower lo er flammability limit (LFL) Pool Subcritical assembly Target Chamber of Neutron Driver submersed b d iin lilight ht water t
(Hidden) pool Subcritical Assembly Support Provides shielding and heat Structure (SASS) removall 18
Subcritical Assembly Irradiation Process Uranium concentration of solution and anyy other necessary parameters are measured Operators use a 1/M startup methodology to monitor the reactivity increase in the TSV TSV is filled in discrete increments pp y 5%
Final fill level is approximately % by y volume below critical Automatic safety systems will be designed to protect the primary system boundary (PSB) and ensure the TSV remains subcritical High flux trips Primary cooling system temperature trips 19
Subcritical Assembly Irradiation Process When irradiating g the TSV:
Further solution addition is prevented Tritium is supplied to the target, and neutron driver output is gradually g y increased Reactivity decreases significantly in the assembly due to the strong negative feedback Normal irradiation mode operations p are approximately pp y 5.5 days Following shutdown, light water pool provides decay heat removal On a loss of off-site power, pool passively removes heat Temperature rise of 12°F (7°C) after 90 days without cooling 20
Radioisotope Production Facility Extracting, purifying and packaging Mo-99 in supercells Laboratory scale purification process Noble Gas Removal System (NGRS) stores TSV off-gas Held for 40 days of decay prior to sampling p g for release Released through the Process Vessel Vent System (PVVS)
Monitored and filtered discharge t ensure regulatory to l t li it are limits met Recycling and cleaning target solution Uranium extraction (UREX) process separates uranium for reuse Extract Purify Package 21
Engineered Safety Features (ESFs)
SHINE protects public health and safety during postulated accidents via a confinement system Radionuclide inventory in any one confinement area is approximately 10,000 times less than a power reactor Low dispersion forces in processes IF RPF Confinement functions provided by:
Biological shielding (IU cells, hot cells, cells trenches trenches, tank vaults)
Isolation valves on piping systems Ventilation systems Zone 1 Instrument and control systems: Zone 2 Zone 3 Engineered Safety Features Zone 4 Actuation System (ESFAS)
Radiological g Integrated g Control System (RICS) Ventilation Zones in Production Facility 22
Summary Preliminary design described in the PSAR shows the SHINE facility can be constructed such that it meets the applicable regulatory requirements Robust engineered and administrative controls have been identified to ensure protection of the public, the environment and our workers environment, The plant is being designed with safety as the primary criterion 23
United States Nuclear Regulatory Commission Official Hearing Exhibit In the Matter of: SHINE MEDICAL TECHNOLOGIES, INC.
(Medical Radioisotope Production Facility)
Commission Mandatory Hearing Docket #: 05000608 Exhibit #: SHN-026-MA-CM01 Identified: 12/15/2015 Admitted: 12/15/2015 Withdrawn:
Rejected: Stricken: Exhibit SHN-026 Other:
Commission Mandatory Hearing SHINE Construction Permit Application O
Overview i
December 15, 2015
SHINE Medical Technologies, Inc. Mission SHINE is dedicated to being g the world leader in safe, clean, affordable production of medical tracers and cancer treatment elements Highest priority is safely delivering a highly reliable reliable, high-quality supply of the medical ingredients required by nearly 100,000 patients globally each day, while maintaining a minimal environmental impact Will fill gap in supply chain caused by exiting foreign reactors, and ensure continuityy of essential treatments for U.S. patients for decades to come 2
Medical Isotopes Molybdenum-99 y ((Mo-99),
)
the most widely-used medical isotope, decays into technetium-99m, which is used in more than 40 million doses annuallyy Stress tests and bone scans most common of dozens of uses 3
Supply Situation with No New Capacity Canada will stopp operating p g the NRU reactor in March 2018 Following Canadian exit, there will be no North American producer NEA Demand Growth (+35% ORC) vs.
Highly relevant current processing capacity, 2015-2020 because Mo-99 deca s ~1%
decays 1% per hour Domestic supply is necessary to ensure US patient health 4
SHINE Medical Technologies, Inc. Core Values SHINE mission driven byy our core values Ensure health and safety of the public and our workforce Minimize environmental impacts of medical isotope production Ensure minimal or no disruption to patient supply chain Ensure cost effectiveness and therefore patient access Eliminate need for highl highly enriched uranium rani m (HEU) reactors or targets in medical isotope supply chain SHINE believes each of these points are essential to fulfill our mission 5
Technological Approach Reflects Core Values Small systems: Hundreds of times less power than isotope production d i reactors b being i used d Low source termhelps ensure safety of public and workforce Decay heat per system < 1 kW within 5 hours5.787037e-5 days <br />0.00139 hours <br />8.267196e-6 weeks <br />1.9025e-6 months <br /> Minimizes waste nuclide generation compared to reactors Low enriched uranium (LEU) reusable target Reduces waste and cost Product compatible with current supply chain Eliminates need for HEU Driven by low-energy electrostatic accelerator System must be driven to operate, no criticality Hundreds of times less waste than reactors Electrostatic technology simple, demonstrated and cost effective 6
SHINE Medical Technologies, Inc.
The SHINE facilityy is located on a previously undeveloped 91 acre parcel in the southern boundaries of the City of Janesville in Rock County, Wisconsin 7
SHINE Facility Layout The SHINE facilityy consists of an irradiation facilityy ((IF))
and a radioisotope production facility (RPF)
Irradiation Facilityy Radioisotope Production Facility 8
SHINE Irradiation Facility The SHINE IF consists of eight g subcritical irradiation units (IUs), which are comparable in thermal power level and safety considerations to existing non-power reactors licensed under 10 CFR Part 50 However, due to subcriticality, the IUs did not meet the existing definition of utilization facility in 10 CFR 50.2 To align the licensing process with potential hazards, hazards the NRC issued a direct final rule modifying 10 CFR 50.2 definition of utilization facility to include SHINE IUs An IU consists of a subcritical assembly assembly, a neutron driver, and supporting systems 9
SHINE Radioisotope Production Facility The RPF is the pportion of the SHINE facilityy used for preparing target solution; extracting, purifying, and packaging Mo-99; and the recycling and cleaning of g solution target Based on batch size (i.e., greater than 100 grams), the RPF meets the definition of a production facility as defined in 10 CFR 50 50.22 10
SHINE Construction Permit Application SHINE submitted the CP Application in two parts, pursuant to an exemption i to 10 CFR 2 2.101(a)(5) 101( )(5)
Part 1 of the Application submitted March 26, 2013 PSAR Chapter p 2 ((Site Characteristics))
PSAR Chapter 19 (Environmental Review)
General and Financial Information Part P t 2 off the th Application A li ti submitted b itt d May M 31,31 2013 Remaining PSAR Chapters A discussion of the preliminary plans for coping with emergencies, in accordance with 10 CFR 50.34(a)(10), provided September 25, 2013 The SHINE facility will be licensed under 10 CFR Part 50, Domestic Licensing of Production and Utilization Facilities 11
Regulatory Guidance and Acceptance Criteria NUREG-1537, Guidelines for Preparing p g and Reviewing Applications for the Licensing of Non-Power Reactors Interim Staff Guidance augmenting NUREG-1537 NUREG 1537 Incorporates relevant guidance from NUREG-1520, Standard Review Plan for the Review of a License Application for a Fuel Cycle Facility Facility Additional guidance (e.g., Regulatory Guides, ANSI Standards)) used 12
SHINE Facility Layout Production,, processing, p g, and p packaging g g operations p
located within one controlled, confined area Irradiation Facility y
Radioisotope Production Facility 13
SHINE Process Overview 4 Supercell Recycle y Loop p Product TSV and Recycle tank 5 3 Irradiation Unit Cell Hold 2 tank Periodic Cleanup Loop UREX and associated cleanup 6 processes Target Solution 1 Preparation 14
SHINE Irradiation Facility SHINEs Fusion-Fission Coupling An IU consists of a subcritical assembly, a neutron N P di driver, and d supportingti systems t
D Major supporting systems include:
Light water pool system (LWPS) T N P N
Neutron Target solution vessel (TSV) off off-gas gas system (TOGS) Driver Primary closed loop cooling system (PCLS) N Neutron Tritium purification system (TPS) Multiplier Primary a y syste system at near-atmospheric ea at osp e c p pressure essu e N N
N Target solution is drained to dump tank via gravity Target Solution Dump tank is criticality-safe by geometry and N Vessel N N P passively-cooled P N P N N P N P N P N N Redundant, fail-open dump valves P N N P N P N N P N N N TSV is an annular vessel to be constructed of N P N N P Zircaloy-4 U
Natural convection within TSV Radioisotopes in solution 15
Subcritical Assembly Subcritical Assembly Support TSV and Neutron Structure Multiplier (SASS) (Internal to SASS)
TSV Dump Tank TSV Dump and Overflow Lines (2 each) 16
Neutron Driver and Tritium Purification System One Neutron Driver per p Neutron Driver IU cell Electrostatic accelerator with aggas target g
D-T fusion reaction generates 14 MeV neutrons that drive IU Cell Floor Grating the fission p process Tritium purification system Isotopically separates gases, Target Chamber of Neutron Driver and supplies clean tritium to (Hidden) neutron drivers Subcritical Tritium lines and processing Assembly Support Structure (SASS) equipment in gloveboxes and double-walled pipe 17
TSV Off-Gas and Primary Cooling Systems TSV off-gas system (TOGS)
Contains the fission product TOGS gases Removes iodine from the off-gas Recombines hydrogen and oxygen to maintain hydrogen gas belo below the lower lo er flammability limit (LFL) Pool Subcritical assembly Target Chamber of Neutron Driver submersed b d iin lilight ht water t
(Hidden) pool Subcritical Assembly Support Provides shielding and heat Structure (SASS) removall 18
Subcritical Assembly Irradiation Process Uranium concentration of solution and anyy other necessary parameters are measured Operators use a 1/M startup methodology to monitor the reactivity increase in the TSV TSV is filled in discrete increments pp y 5%
Final fill level is approximately % by y volume below critical Automatic safety systems will be designed to protect the primary system boundary (PSB) and ensure the TSV remains subcritical High flux trips Primary cooling system temperature trips 19
Subcritical Assembly Irradiation Process When irradiating g the TSV:
Further solution addition is prevented Tritium is supplied to the target, and neutron driver output is gradually g y increased Reactivity decreases significantly in the assembly due to the strong negative feedback Normal irradiation mode operations p are approximately pp y 5.5 days Following shutdown, light water pool provides decay heat removal On a loss of off-site power, pool passively removes heat Temperature rise of 12°F (7°C) after 90 days without cooling 20
Radioisotope Production Facility Extracting, purifying and packaging Mo-99 in supercells Laboratory scale purification process Noble Gas Removal System (NGRS) stores TSV off-gas Held for 40 days of decay prior to sampling p g for release Released through the Process Vessel Vent System (PVVS)
Monitored and filtered discharge t ensure regulatory to l t li it are limits met Recycling and cleaning target solution Uranium extraction (UREX) process separates uranium for reuse Extract Purify Package 21
Engineered Safety Features (ESFs)
SHINE protects public health and safety during postulated accidents via a confinement system Radionuclide inventory in any one confinement area is approximately 10,000 times less than a power reactor Low dispersion forces in processes IF RPF Confinement functions provided by:
Biological shielding (IU cells, hot cells, cells trenches trenches, tank vaults)
Isolation valves on piping systems Ventilation systems Zone 1 Instrument and control systems: Zone 2 Zone 3 Engineered Safety Features Zone 4 Actuation System (ESFAS)
Radiological g Integrated g Control System (RICS) Ventilation Zones in Production Facility 22
Summary Preliminary design described in the PSAR shows the SHINE facility can be constructed such that it meets the applicable regulatory requirements Robust engineered and administrative controls have been identified to ensure protection of the public, the environment and our workers environment, The plant is being designed with safety as the primary criterion 23