ML20069B157

Enclosure 4 - Shine Safety Analysis Methodology - Public Version

ML20069B157
Person / Time
Site:	SHINE Medical Technologies, 99902034
Issue date:	02/24/2020
From:	SHINE Medical Technologies
To:	Office of Nuclear Reactor Regulation
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ML20069B152	List: ML20069B154 ML20069B157 ML20069B159 ML20069B161
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2020-SMT-0020
Download: ML20069B157 (40)

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ENCLOSURE 4 SHINE MEDICAL TECHNOLOGIES, LLC MEETING SLIDES FOR THE MARCH 4 AND 5, 2020 PUBLIC MEETING BETWEEN SHINE MEDICAL TECHNOLOGIES, LLC AND THE NRC SHINE SAFETY ANALYSIS METHODOLOGY PUBLIC VERSION 39 pages follow

SHINE Safety Analysis Methodology John Olvera, Safety Analysis Manager

Topics Covered Approach to Performing the SHINE Safety Analysis (SSA)

Overview Hazard Identification & Evaluation Process Hazard Analysis & Accident Sequence Development Likelihood Evaluation Method Consequence Analysis Method Nuclear Criticality Safety Evaluation Process Safety-Related Controls Integration into the Final Safety Analysis Report & Technical Specifications SHINE Medical Technologies l 2

Overview Guidance documents:

Final Interim Staff Guidance (ISG) Augmenting NUREG-1537, Part 1, Guidelines for Preparing and Reviewing Applications for the Licensing of Non-Power Reactors: Format and Content, for Licensing Radioisotope Production Facilities and Aqueous Homogeneous Reactors, October 17, 2012 Final Interim Staff Guidance (ISG) Augmenting NUREG-1537, Part 2, Guidelines for Preparing and Reviewing Applications for the Licensing of Non-Power Reactors: Standard Review Plan and Acceptance Criteria, for Licensing Radioisotope Production Facilities and Aqueous Homogeneous Reactors, October 17, 2012 NUREG/CR-6410, Nuclear Fuel Cycle Facility Accident Analysis Handbook, March 1998 SHINE Medical Technologies l 3

Overview The SHINE Safety Analysis (SSA) methodology is based on the guidance in the ISG augmenting NUREG-1537, Parts 1 & 2 Chapter 13 of the ISG augmenting NUREG-1537 is the primary guidance for performing the safety analysis for the irradiation facility (IF) and the radioisotope production facility (RPF) as described in Chapter 13 of the Final Safety Analysis Report (FSAR)

Subsection 13a2 identifies the categories of accident scenarios that are applicable to aqueous homogeneous reactor accident analysis, which is applied in the SSA for the IF accident analysis Subsection 13b identifies the categories of accident scenarios that are applicable to radioisotope production facility accident analysis, which is applied in the SSA for the RPF accident analysis Provides the content guidance for the licensing basis accident analysis (i.e., FSAR Chapter 13)

SHINE Medical Technologies l 4

Overview The SSA methodology is a risk-based approach to develop accident sequences and controls that includes:

Identification and evaluation of radiological and chemical hazards Development of accident sequences with estimation of likelihood, and potential consequences categorized as high, intermediate, and low.

Risk assessment of unmitigated accident sequences uses a 3x3 matrix to determine the need for additional controls.

Identification of controls to reduce risk through reduction of likelihood and/or mitigation of consequences to an acceptable level of risk The SSA acceptance criteria for radiological and chemical dose is defined as the SHINE Safety Criteria SHINE Medical Technologies l 5

Overview Final ISG Augmenting NUREG-1537 Process safety Accident FSAR Chapter 13 information Catagories Format & Content Material hazards Process technology SHINE Safety Process equipment Analysis (SSA)

Hazard Identification Radiological hazards FSAR Chapter 13 High consequence Chemical hazards Accident Sequences events Intermediate Other facility hazards consequence Hazard Evaluations events Process Hazards Analysis Criticality events Accident sequences FSAR Chapter 13 Likelihood & consequence Engineered &

Safety-Related SSCs Administrative Administrative controls Controls Dose Consequence Technical Analysis SSA Report Specifications SHINE Medical Technologies l 6

Hazard Identification and Evaluation Hazard identification and evaluations Hazard and Operability (HAZOP) - applied to process-oriented systems Failure Modes and Effects Analysis (FMEA) - applied to complex mechanical systems The hazard evaluation methods are performed in accordance with the Center for Chemical Process Safety Guidelines for Hazard Evaluation Procedures The hazard evaluations identify process failures that have the potential to result in adverse radiological or chemical consequences and candidate control for prevention or mitigation Provides input to the accident sequence development step SHINE Medical Technologies l 7

Security-Related Information - Withheld Under 10 CFR 2.390(d)

Hazard Identification and Evaluation SRI Hazard identification Hazard categories are initially defined based on the process descriptions Hazards specific to the process being analyzed are identified prior to the hazard evaluation Additional hazards or interactions that are identified during the hazard evaluation are added Example: Subcritical Assembly System (SCAS) hazard identification table from SCAS HAZOP report SHINE Medical Technologies l 8

Security-Related Information - Withheld Under 10 CFR 2.390(d)

Hazard Identification and Evaluation SRI Consequences of interest Consequence categories are defined to characterize the type of consequence that may result from a process deviation or equipment failure Consequence categories may include safety or operational outcomes A process deviation or equipment failure may have more than one consequence Example: SCAS consequence table from SCAS HAZOP report SHINE Medical Technologies l 9

Hazard Identification and Evaluation Hazard evaluation tables The hazard evaluation team discussions (HAZOP or FMEA) are documented in a set of tables that include:

Process deviations and/or equipment failures and their causes Resulting consequences and associated category Possible engineered (passive or active) and administrative controls Recommendations for additional investigation, analysis, or design changes SHINE Medical Technologies l10

Hazard Identification and Evaluation Hazard evaluation results The results are summarized for each system in a SHINE technical report The results provide a basis for potential accident sequences to be developed in the next analysis phase, the process hazards analysis (PHA)

Potential candidates for preventive and/or mitigative controls Recommendations for design improvements Hazard evaluations will be reviewed and updated for final design SHINE Medical Technologies l11

Hazard Identification and Evaluation Hazard Evaluations Conducted Nuclear Systems SCAS - Subcritical assembly system TOGS - Target solution vessel (TSV) off-gas system NDAS - Neutron driver assembly system TPS - Tritium purification system Process Systems TSPS - Target solution preparation system TSSS - Target solution staging system VTS - Vacuum transfer system PVVS - Process vessel vent system SHINE Medical Technologies l12

Hazard Identification and Evaluation Process Systems (continued)

RLWS - Radioactive liquid waste storage RLWI - Radioactive liquid waste immobilization RDS - Radioactive drain system MEPS - Molybdenum (Mo) extraction and purification system IXP - Iodine and xenon purification and packaging URSS - Uranium receipt and storage system Auxiliary Systems RVZ1 - Radiologically controlled area ventilation zone 1 RVZ2 - Radiologically controlled area ventilation zone 2 RVZ3 - Radiologically controlled area ventilation zone 3 N2PS - Nitrogen purge system SHINE Medical Technologies l13

Hazard Identification and Evaluation Supporting Systems Evaluated During Hazard Evaluations Shielding and Confinement Systems ICBS - Irradiation cell biological shield PFBS - Production facility biological shield Auxiliary Systems PCLS - Primary closed loop cooling system LWPS - Light water pool system RPCS - Radioisotope process facility cooling system FSTR - Facility structure Auxiliary Systems TRPS - TSV reactivity protection system NFDS - Neutron flux detection system ESFAS - Engineered safety features actuation system CAAS - Criticality accident alarm system UPSS - Uninterruptible electrical power supply system SHINE Medical Technologies l14

Process Hazard Analysis & Accident Sequence Development Identification of relevant accident categories Relevant accident categories as identified in the ISG are carried forward Hazard evaluations identify potential initiating events, consequences, and controls that may be applied Hazard evaluations also identify SHINE specific accident types (e.g., tritium, neutron driver)

SHINE Medical Technologies l15

Process Hazard Analysis & Accident Sequence Development Irradiation facility (IF) accident categories:

Maximum hypothetical accident (MHA)

Insertion of excess reactivity Reduction in cooling Mishandling or malfunction of fuel (target solution)

Loss of normal electric power External events Mishandling or malfunction of equipment Large undamped power oscillations Detonation and deflagration in the primary system boundary Unintended exothermic reaction other than detonation Facility system interactions Facility specific events (e.g., NDAS, TPS, heavy load drop)

SHINE Medical Technologies l16

Process Hazard Analysis & Accident Sequence Development Radioisotope production facility (RPF) accident categories:

Malfunction or mishandling of equipment Facility specific events (e.g., heavy load drops)

Inadvertent nuclear criticality in the RPF Hazardous chemicals (e.g., uranium uptake)

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Process Hazard Analysis & Accident Sequence Development External event accident categories:

Seismic event Severe weather (e.g., Tornado, high winds, heavy snow, lightning)

External flooding events (i.e., probable maximum precipitation)

External fire events (e.g., vegetation, natural gas, vehicle fires)

Transportation accidents (e.g., aircraft impact, chemical truck accident)

Flooding events internal to the IF and RPF On-site chemical/gas releases (e.g., spills)

Fire events internal to the IF and RPF are evaluated on a fire area basis SHINE Medical Technologies l18

Process Hazard Analysis & Accident Sequence Development PHA for internal and external events Identify accident sequences based on the hazard evaluation results and the ISG to NUREG-1537 guidance Estimate a risk index for each potential unmitigated accident sequence (likelihood x consequences)

Identify engineered and administrative controls for those sequences which have an unacceptable risk Evaluate controlled risk indices crediting risk reduction from controls Develop list of safety-related controls SHINE Medical Technologies l19

Risk Matrix Development SHINE Medical Technologies l20

Likelihood Evaluation Method Initiating events For most accident sequences the failure frequency index number (FFIN) is estimated based on type of control (e.g., single specific administrative control, single passive or active control, redundant controls) to represent an initiating event frequency Some accident sequences are based on evidence from published sources (e.g., seismic events, severe weather events, loss of offsite power)

A few accident sequences may apply combinations of FFIN, equipment failure probability (FPIN) and recovery times estimation represented by a duration index number (DIN)

Failure probability estimates for controls For most accident sequences FPIN is also estimated based on type of control (e.g., single specific administrative control, single passive or active control, redundant controls)

In general, lower bound estimates are used for FPIN SHINE Medical Technologies l21

Likelihood Evaluation Method SHINE Medical Technologies l22

Security-Related Information - Withheld Under 10 CFR 2.390(d)

Example: Process Hazard Analysis Accident Sequence SRI SHINE Medical Technologies l23

Consequence Analysis Method Consequence analysis is performed for radiological and chemical hazards as applicable for each accident sequence Radiological and chemical dose cases are defined to represent the potential release conditions for postulated accident scenarios including material-at-risk (MAR) quantities Radiological dose cases are defined to represent the potential release conditions for postulated accident scenarios Hazardous chemical consequence assessment includes release scenarios for all potentially hazardous chemicals within the facility Acceptance criteria for all dose consequence scenarios are defined in the SHINE Safety Criteria SHINE Medical Technologies l24

Consequence Analysis Method SHINE Safety Criteria An acute worker dose of 5 rem or greater total effective dose equivalent (TEDE)

An acute dose of 0.5 rem or greater TEDE to any individual located outside the owner controlled area An intake of 30 mg or greater of uranium in soluble form by any individual located outside the owner controlled area An acute chemical exposure to an individual from licensed material or hazardous chemicals produced from licensed material that could lead to irreversible or other serious, long-lasting health effects to the worker or could cause mild transient health effects to any individual located outside the owner controlled area Criticality in the RPF: under normal and credible abnormal conditions, all nuclear processes in the RPF shall remain subcritical, including use of an approved margin of subcriticality for safety Loss of capability to reach safe shutdown conditions SHINE Medical Technologies l25

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

Consequence Analysis Method Radiological consequence analysis Radiological dose cases are defined to represent the potential release conditions for postulated accident scenarios The radiological dose consequence analysis is based on the five-factor formula as described in NUREG/CR-6410, Nuclear Fuel Cycle Facility Accident Analysis Handbook Materials at risk are determined for the process locations and conditions, including physical state (e.g., liquid, gas, aerosol)

Bounding assumptions in the analysis includes:

Corresponding fission power: 137.5 kW (license limit +10%)

Irradiation time per cycle: 30 days Total time between irradiations: [ ]PROP/ECI Extraction between irradiations: none Length of target solution recovery: [ ]PROP/ECI SHINE Medical Technologies l26

Consequence Analysis Method Radiological consequence analysis Radionuclide transport models the initial release location and radionuclide transport (leakpaths) into the RCA and to the environment as a ground release Radionuclides are tracked as noble gases, halogens, and aerosols Atmospheric dispersion (/Q) factors are calculated using the PAVAN computer code Dose conversion factors include:

Public: ICRP-72 (2012), FGR-12 (1993)

Worker: ICRP-68 (2012), FGR-11 (1988), FGR-12 (1993)

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Consequence Analysis Method Hazardous chemical consequence assessment Chemical release cases are performed for all hazardous toxic chemicals within the facility This assessment determines if the release of hazardous chemicals from the SHINE facility could lead to exceeding Protective Action Guideline (PAC) categories (i.e., PAC-1 (public) or PAC-2 (worker))

Meteorological data is obtained from the Southern Wisconsin Regional Airport to estimate evaporation rates and dispersion The analysis for the chemical dose to the public uses the ALOHA (Areal Locations of Hazardous Atmospheres) computer code to determine the exposure at the boundary of the owner-controlled and the nearest resident The analysis for the chemical dose to facility workers uses evaporation or dispersion rates inside the facility and determines an average concentration within the RCA based on building free volume.

A worker evacuation time of 10 minutes is assumed in this analysis SHINE Medical Technologies l28

Nuclear Criticality Safety Evaluation Process SHINE maintains a nuclear criticality safety program (CSP) that complies with applicable American National Standards Institute/American Nuclear Society (ANSI/ANS) standards as endorsed by Regulatory Guide 3.71, Revision 3 The CSP meets the applicable criticality safety requirements of 10 CFR Part 70 (i.e., § 70.24(a) and

§ 70.52)

Nuclear criticality safety evaluations (NCSEs) are conducted for each fissile material operation within the RPF to ensure that under normal and credible abnormal conditions, all nuclear processes remain subcritical with an approved margin of subcriticality A fissionable material operation is any process or system that has the potential to contain more than 250 g of non-exempt fissile material In systems where the equipment is not safe-by-design, the double contingency principle is used ensuring at least two unlikely, independent, and concurrent changes in process conditions are required before a criticality accident is possible SHINE Medical Technologies l29

Nuclear Criticality Safety Evaluation Process The preferred hierarchy of nuclear criticality safety controls is:

1. Passive engineered

2. Active engineered

3. Enhanced administrative

4. Administrative Control on two independent criticality parameters is preferred over multiple controls on a single parameter If redundant controls on a single parameter are used, a preference is given to diverse means of control on that parameter SHINE Medical Technologies l30

Nuclear Criticality Safety Evaluation Process Nuclear criticality safety (NCS) calculations NCSEs What-if checklist to identify process upsets that may challenge typical criticality safety parameters Credible process upsets evaluated if it is Safe-by-Design Further evaluation using event tree analysis to identify process changes that must occur to result in criticality Controls are identified as needed to eliminate or reduce the likelihood of occurrence to highly unlikely Results of the NCSEs are summarized in the SSA and in the FSAR SHINE Medical Technologies l31

Safety-Related Controls Selection of engineered controls from accident sequences Reduce the likelihood of occurrence of the accident sequence Mitigate the consequences of the accident sequence Administrative controls in place Programmatic administrative controls: Ensure that the safety-related SSCs continue to perform their safety-related functions (e.g., surveillance and testing, periodic maintenance)

Specific administrative controls to perform some safety-related actions (e.g., operating procedures, sampling)

Nonsafety-related defense-in-depth controls also identified in the SSA Report Safety-related controls are included in the Technical Specifications SHINE Medical Technologies l32

Safety-Related Controls Types of Controls - Safety-Related Active engineered controls (AEC)

Passive engineered controls (PEC)

Specific administrative controls (SAC)

Types of Controls - Nonsafety-Related Defense-in-depth (DID)

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Security-Related Information - Withheld Under 10 CFR 2.390(d)

Example: Safety-Related Control Selection SRI SHINE Medical Technologies l34

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)

Security-Related Information - Withheld Under 10 CFR 2.390(d)

Example: Safety-Related Control Selection (from SSA)

SRI SHINE Medical Technologies l35

Integration into the Chapter 13 Accident Analysis Accident sequences identified in the SSA and Part 1 of the ISG augmenting NUREG-1537 Postulated accident sequences that can result in unacceptable risk are candidates for inclusion in Chapter 13 of the FSAR Initialing events, scenarios, and determination of consequences are detailed Controls that are credited with preventive or mitigative safety functions are identified Engineered and administrative controls (AEC, PEC, and SAC) are included in the Technical Specifications An MHA is also defined for the IF and the RPF The MHA is provided as a hypothetical accident scenario with radiological consequences that exceed those of any credible accident The MHA need not be credible, but the potential consequences are evaluated For SHINE, the MHA is provided for information only since radiological consequence analyses are performed to cover all credible accident scenarios SHINE Medical Technologies l36

Maximum Hypothetical Accident MHA for the IF:

The postulated MHA for the IF is a failure of the TSV off-gas system (TOGS) pressure boundary leading to a release of TSV radioactive gases into the TOGS confinement cell.

The N2PS actuates, but the PVVS flow path is assumed to be completely blocked, causing a maximum pressurization of the TOGS cell MHA for the RPF:

The MHA in the RPF is a fire in a carbon guard bed with degraded performance of the downstream carbon delay beds The carbon guard bed releases its inventory to the downstream carbon delay beds which are normally credited with adsorbing 99 percent of the released iodine.

For the MHA, the carbon delay beds are assumed to be operating at a reduced efficiency of 95 percent SHINE Medical Technologies l37

Integration into the Chapter 13 Accident Analysis Results from the SSA are directly mapped into the Chapter 13 accident analysis Postulated accident scenarios identified in the SSA that have potential uncontrolled consequences are included in Chapter 13 of the FSAR Controls that are identified as credited for prevention or mitigation in the SSA are also included in Chapter 13 of the FSAR Consequence analyses results demonstrate that the SHINE Safety Criteria accident dose and hazardous chemical consequence limits are met SHINE Medical Technologies l38

Integration into the Technical Specifications Section 3.0 of the SHINE Technical Specifications, Limiting Conditions for Operation (LCO) and Surveillance Requirements Includes the safety-related engineered controls identified in the SSA, including a Basis discussion for each LCO identifies the safety function performed by the SSC and the irradiation unit modes or other conditions during which the SSC is required to be operable Section 4.0 of the SHINE Technical Specifications, Design Features Identifies aspects of the facility design and other physical conditions (e.g., distance to the site boundary, building free volume) that are inputs or assumptions in the radiological dose calculations that support the SSA dose consequence analysis.

Section 5.0 of the SHINE Technical Specifications, Administrative Controls Identifies the programmatic administrative controls (e.g., configuration management) that are required to be implemented to ensure that safety-related SSCs will be capable of performing their design functions Development and use of procedures that implement the specific administrative controls identified in the SSA SHINE Medical Technologies l39