ML15342A247

SHN-026 - Shine Overview Panel Presentation

ML15342A247
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: ML15342A247 (23)

Text

Exhibit SHN-026 Commission Mandatory Hearing SHINE Construction Permit Application O

i Overview December 15, 2015

SHINE Medical Technologies, Inc. Mission SHINE is dedicated to being the world leader in safe, g

clean, affordable production of medical tracers and cancer treatment elements Highest priority is safely delivering a highly reliable Highest priority is safely delivering a highly reliable, high-quality supply of the medical ingredients required by nearly 100,000 patients globally each day, while maintaining a minimal environmental impact maintaining a minimal environmental impact Will fill gap in supply chain caused by exiting foreign reactors, and ensure continuity of essential treatments y

for U.S. patients for decades to come 2

Medical Isotopes Molybdenum-99 (Mo-99),

y

(

)

the most widely-used medical isotope, decays into technetium-99m, which is used in more than 40 million doses annually Stress tests and bone scans most common of dozens of uses dozens of uses 3

Supply Situation with No New Capacity Canada will stop operating the NRU reactor in p

p g

March 2018 Following Canadian exit, there will be no North American producer American producer Highly relevant because Mo-99 deca s 1% per NEA Demand Growth (+35% ORC) vs.

current processing capacity, 2015-2020 decays ~1% per hour Domestic supply is necessary to ensure US patient health 4

SHINE Medical Technologies, Inc. Core Values SHINE mission driven by our core values y

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 enriched rani m (HEU) reactors or Eliminate need for highly enriched uranium (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 d

i b i d

production reactors being used 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 facility is located y

on a previously undeveloped 91 acre parcel in the southern boundaries of the southern boundaries of the City of Janesville in Rock County, Wisconsin 7

SHINE Facility Layout The SHINE facility consists of an irradiation facility (IF)

Irradiation Facility y

y (

)

and a radioisotope production facility (RPF) y Radioisotope Radioisotope Production Facility 8

SHINE Irradiation Facility The SHINE IF consists of eight subcritical irradiation g

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 the NRC To align the licensing process with potential 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 a neutron An IU consists of a subcritical assembly, a neutron driver, and supporting systems 9

SHINE Radioisotope Production Facility The RPF is the portion of the SHINE facility used for p

y preparing target solution; extracting, purifying, and packaging Mo-99; and the recycling and cleaning of target solution g

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 2 defined in 10 CFR 50.2 10

SHINE Construction Permit Application SHINE submitted the CP Application in two parts, pursuant to an i

10 CFR 2 101( )(5) exemption to 10 CFR 2.101(a)(5)

Part 1 of the Application submitted March 26, 2013 PSAR Chapter 2 (Site Characteristics) p

(

)

PSAR Chapter 19 (Environmental Review)

General and Financial Information P

t 2 f th A li ti b

itt d M 31 2013 Part 2 of the Application submitted May 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 and p

g Reviewing Applications for the Licensing of Non-Power Reactors Interim Staff Guidance augmenting NUREG 1537 Interim Staff Guidance augmenting NUREG-1537 Incorporates relevant guidance from NUREG-1520, Standard Review Plan for the Review of a License Application for a Fuel Cycle Facility Cycle Facility Additional guidance (e.g., Regulatory Guides, ANSI Standards) used

)

12

SHINE Facility Layout Production, processing, and packaging operations

, p g,

p g g p

located within one controlled, confined area Irradiation Facility Radioisotope Radioisotope Production Facility 13

SHINE Process Overview 4

Supercell Recycle Loop 4

y p

Product UREX and Recycle tank TSV and Irradiation Unit Cell Periodic Cleanup Loop Hold tank 2

3 5

associated cleanup processes Target Solution 6

14 Target Solution Preparation 1

SHINE Irradiation Facility An IU consists of a subcritical assembly, a neutron d i d

ti t

N P D

SHINEs Fusion-Fission Coupling driver, and supporting systems Major supporting systems include:

Light water pool system (LWPS)

Target solution vessel (TSV) off gas system (TOGS)

N P

N D

T Neutron Target solution vessel (TSV) off-gas system (TOGS)

Primary closed loop cooling system (PCLS)

Tritium purification system (TPS)

Primary system at near-atmospheric pressure N

N Driver N

Neutron Multiplier N

a y syste at ea at osp e c p essu e Target solution is drained to dump tank via gravity Dump tank is criticality-safe by geometry and passively-cooled N

N P

N N

P N

P N

N P

N P

P N

N Target Solution Vessel N

Redundant, fail-open dump valves TSV is an annular vessel to be constructed of Zircaloy-4 Natural convection within TSV N

N P

N P

N N P

N N

P N

P N

P N

N P

N N

N U

N P

Natural convection within TSV 15 Radioisotopes in solution

Subcritical Assembly Subcritical Subcritical Assembly Support Structure (SASS)

TSV and Neutron Multiplier (Internal to SASS)

TSV Dump Tank TSV Dump and Overflow Lines 16 TSV Dump and Overflow Lines (2 each)

Neutron Driver and Tritium Purification System One Neutron Driver per p

IU cell Electrostatic accelerator with a gas target Neutron Driver g

g D-T fusion reaction generates 14 MeV neutrons that drive the fission process IU Cell Floor Grating p

Tritium purification system Isotopically separates gases, and supplies clean tritium to Target Chamber of Neutron Driver (Hidden) and supplies clean tritium to neutron drivers Tritium lines and processing equipment in gloveboxes and Subcritical Assembly Support Structure (SASS)

(Hidden) equipment in gloveboxes and double-walled pipe 17

TSV Off-Gas and Primary Cooling Systems TSV off-gas system (TOGS)

Contains the fission product gases Removes iodine from the TOGS off-gas Recombines hydrogen and oxygen to maintain hydrogen gas belo the lo er Target Chamber of Neutron Driver (Hidden) gas below the lower flammability limit (LFL)

Subcritical assembly b

d i li ht t

Pool Subcritical Assembly Support Structure (SASS)

(Hidden) submersed in light water pool Provides shielding and heat l

removal 18

Subcritical Assembly Irradiation Process Uranium concentration of solution and any other y

necessary parameters are measured Operators use a 1/M startup methodology to monitor the reactivity increase in the TSV the reactivity increase in the TSV TSV is filled in discrete increments Final fill level is approximately 5% by volume below critical pp y

y Automatic safety systems will be designed to protect the primary system boundary (PSB) and ensure the TSV remains subcritical TSV remains subcritical High flux trips Primary cooling system temperature trips Primary cooling system temperature trips 19

Subcritical Assembly Irradiation Process When irradiating the TSV:

g Further solution addition is prevented Tritium is supplied to the target, and neutron driver output is gradually increased g

y Reactivity decreases significantly in the assembly due to the strong negative feedback Normal irradiation mode operations are approximately p

pp y

5.5 days Following shutdown, light water pool provides decay heat removal 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 Laboratory scale purification process Noble Gas Removal System (NGRS) stores TSV off-gas Held for 40 days of decay prior to sampling for release p

g Released through the Process Vessel Vent System (PVVS)

Monitored and filtered discharge t

l t li it to ensure regulatory limits are met Recycling and cleaning target solution 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 confinement system Radionuclide inventory in any one confinement area is approximately 10,000 times less than a power reactor Low dispersion forces in processes Confinement functions provided by:

Biological shielding (IU cells, hot cells trenches tank vaults)

IF RPF Zone 1 hot cells, trenches, tank vaults)

Isolation valves on piping systems Ventilation systems Zone 1 Zone 2 Zone 3 Zone 4 Ventilation Zones in Production Facility Instrument and control systems:

Engineered Safety Features Actuation System (ESFAS)

Radiological Integrated Control 22 Ventilation Zones in Production Facility g

g System (RICS)

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, and our workers The plant is being designed with safety as the primary criterion 23

Exhibit SHN-026 Commission Mandatory Hearing SHINE Construction Permit Application O

i Overview December 15, 2015

SHINE Medical Technologies, Inc. Mission SHINE is dedicated to being the world leader in safe, g

clean, affordable production of medical tracers and cancer treatment elements Highest priority is safely delivering a highly reliable Highest priority is safely delivering a highly reliable, high-quality supply of the medical ingredients required by nearly 100,000 patients globally each day, while maintaining a minimal environmental impact maintaining a minimal environmental impact Will fill gap in supply chain caused by exiting foreign reactors, and ensure continuity of essential treatments y

for U.S. patients for decades to come 2

Medical Isotopes Molybdenum-99 (Mo-99),

y

(

)

the most widely-used medical isotope, decays into technetium-99m, which is used in more than 40 million doses annually Stress tests and bone scans most common of dozens of uses dozens of uses 3

Supply Situation with No New Capacity Canada will stop operating the NRU reactor in p

p g

March 2018 Following Canadian exit, there will be no North American producer American producer Highly relevant because Mo-99 deca s 1% per NEA Demand Growth (+35% ORC) vs.

current processing capacity, 2015-2020 decays ~1% per hour Domestic supply is necessary to ensure US patient health 4

SHINE Medical Technologies, Inc. Core Values SHINE mission driven by our core values y

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 enriched rani m (HEU) reactors or Eliminate need for highly enriched uranium (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 d

i b i d

production reactors being used 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 facility is located y

on a previously undeveloped 91 acre parcel in the southern boundaries of the southern boundaries of the City of Janesville in Rock County, Wisconsin 7

SHINE Facility Layout The SHINE facility consists of an irradiation facility (IF)

Irradiation Facility y

y (

)

and a radioisotope production facility (RPF) y Radioisotope Radioisotope Production Facility 8

SHINE Irradiation Facility The SHINE IF consists of eight subcritical irradiation g

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 the NRC To align the licensing process with potential 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 a neutron An IU consists of a subcritical assembly, a neutron driver, and supporting systems 9

SHINE Radioisotope Production Facility The RPF is the portion of the SHINE facility used for p

y preparing target solution; extracting, purifying, and packaging Mo-99; and the recycling and cleaning of target solution g

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 2 defined in 10 CFR 50.2 10

SHINE Construction Permit Application SHINE submitted the CP Application in two parts, pursuant to an i

10 CFR 2 101( )(5) exemption to 10 CFR 2.101(a)(5)

Part 1 of the Application submitted March 26, 2013 PSAR Chapter 2 (Site Characteristics) p

(

)

PSAR Chapter 19 (Environmental Review)

General and Financial Information P

t 2 f th A li ti b

itt d M 31 2013 Part 2 of the Application submitted May 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 and p

g Reviewing Applications for the Licensing of Non-Power Reactors Interim Staff Guidance augmenting NUREG 1537 Interim Staff Guidance augmenting NUREG-1537 Incorporates relevant guidance from NUREG-1520, Standard Review Plan for the Review of a License Application for a Fuel Cycle Facility Cycle Facility Additional guidance (e.g., Regulatory Guides, ANSI Standards) used

)

12

SHINE Facility Layout Production, processing, and packaging operations

, p g,

p g g p

located within one controlled, confined area Irradiation Facility Radioisotope Radioisotope Production Facility 13

SHINE Process Overview 4

Supercell Recycle Loop 4

y p

Product UREX and Recycle tank TSV and Irradiation Unit Cell Periodic Cleanup Loop Hold tank 2

3 5

associated cleanup processes Target Solution 6

14 Target Solution Preparation 1

SHINE Irradiation Facility An IU consists of a subcritical assembly, a neutron d i d

ti t

N P D

SHINEs Fusion-Fission Coupling driver, and supporting systems Major supporting systems include:

Light water pool system (LWPS)

Target solution vessel (TSV) off gas system (TOGS)

N P

N D

T Neutron Target solution vessel (TSV) off-gas system (TOGS)

Primary closed loop cooling system (PCLS)

Tritium purification system (TPS)

Primary system at near-atmospheric pressure N

N Driver N

Neutron Multiplier N

a y syste at ea at osp e c p essu e Target solution is drained to dump tank via gravity Dump tank is criticality-safe by geometry and passively-cooled N

N P

N N

P N

P N

N P

N P

P N

N Target Solution Vessel N

Redundant, fail-open dump valves TSV is an annular vessel to be constructed of Zircaloy-4 Natural convection within TSV N

N P

N P

N N P

N N

P N

P N

P N

N P

N N

N U

N P

Natural convection within TSV 15 Radioisotopes in solution

Subcritical Assembly Subcritical Subcritical Assembly Support Structure (SASS)

TSV and Neutron Multiplier (Internal to SASS)

TSV Dump Tank TSV Dump and Overflow Lines 16 TSV Dump and Overflow Lines (2 each)

Neutron Driver and Tritium Purification System One Neutron Driver per p

IU cell Electrostatic accelerator with a gas target Neutron Driver g

g D-T fusion reaction generates 14 MeV neutrons that drive the fission process IU Cell Floor Grating p

Tritium purification system Isotopically separates gases, and supplies clean tritium to Target Chamber of Neutron Driver (Hidden) and supplies clean tritium to neutron drivers Tritium lines and processing equipment in gloveboxes and Subcritical Assembly Support Structure (SASS)

(Hidden) equipment in gloveboxes and double-walled pipe 17

TSV Off-Gas and Primary Cooling Systems TSV off-gas system (TOGS)

Contains the fission product gases Removes iodine from the TOGS off-gas Recombines hydrogen and oxygen to maintain hydrogen gas belo the lo er Target Chamber of Neutron Driver (Hidden) gas below the lower flammability limit (LFL)

Subcritical assembly b

d i li ht t

Pool Subcritical Assembly Support Structure (SASS)

(Hidden) submersed in light water pool Provides shielding and heat l

removal 18

Subcritical Assembly Irradiation Process Uranium concentration of solution and any other y

necessary parameters are measured Operators use a 1/M startup methodology to monitor the reactivity increase in the TSV the reactivity increase in the TSV TSV is filled in discrete increments Final fill level is approximately 5% by volume below critical pp y

y Automatic safety systems will be designed to protect the primary system boundary (PSB) and ensure the TSV remains subcritical TSV remains subcritical High flux trips Primary cooling system temperature trips Primary cooling system temperature trips 19

Subcritical Assembly Irradiation Process When irradiating the TSV:

g Further solution addition is prevented Tritium is supplied to the target, and neutron driver output is gradually increased g

y Reactivity decreases significantly in the assembly due to the strong negative feedback Normal irradiation mode operations are approximately p

pp y

5.5 days Following shutdown, light water pool provides decay heat removal 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 Laboratory scale purification process Noble Gas Removal System (NGRS) stores TSV off-gas Held for 40 days of decay prior to sampling for release p

g Released through the Process Vessel Vent System (PVVS)

Monitored and filtered discharge t

l t li it to ensure regulatory limits are met Recycling and cleaning target solution 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 confinement system Radionuclide inventory in any one confinement area is approximately 10,000 times less than a power reactor Low dispersion forces in processes Confinement functions provided by:

Biological shielding (IU cells, hot cells trenches tank vaults)

IF RPF Zone 1 hot cells, trenches, tank vaults)

Isolation valves on piping systems Ventilation systems Zone 1 Zone 2 Zone 3 Zone 4 Ventilation Zones in Production Facility Instrument and control systems:

Engineered Safety Features Actuation System (ESFAS)

Radiological Integrated Control 22 Ventilation Zones in Production Facility g

g System (RICS)

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, and our workers The plant is being designed with safety as the primary criterion 23