ML20069B157
| ML20069B157 | |
| Person / Time | |
|---|---|
| Site: | SHINE Medical Technologies, 99902034 |
| Issue date: | 02/24/2020 |
| From: | SHINE Medical Technologies |
| To: | Office of Nuclear Reactor Regulation |
| Shared Package | |
| ML20069B152 | List: |
| References | |
| 2020-SMT-0020 | |
| Download: ML20069B157 (40) | |
Text
39 pages follow 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
SHINE Safety Analysis Methodology John Olvera, Safety Analysis Manager
SHINE Medical Technologies l 2 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 Topics Covered
SHINE Medical Technologies l 3 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 Overview
SHINE Medical Technologies l 4 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)
Overview
SHINE Medical Technologies l 5 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 Overview
SHINE Medical Technologies l 6 Overview Final ISG Augmenting NUREG-1537 SHINE Safety Analysis (SSA)
Accident Catagories FSAR Chapter 13 Format & Content High consequence events Intermediate consequence events Criticality events Processsafety information SSA Report Hazard Identification Radiological hazards Chemical hazards Other facility hazards Hazard Evaluations Process Hazards Analysis Accident sequences Likelihood & consequence Safety-Related SSCs Administrative controls FSAR Chapter 13 Accident Sequences FSAR Chapter 13 Engineered &
Administrative Controls Technical Specifications Material hazards Process technology Process equipment Dose Consequence Analysis
SHINE Medical Technologies l 7 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 Hazard Identification and Evaluation
SHINE Medical Technologies l 8 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 Hazard Identification and Evaluation Security-Related Information - Withheld Under 10 CFR 2.390(d)
SHINE Medical Technologies l 9 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 Hazard Identification and Evaluation Security-Related Information - Withheld Under 10 CFR 2.390(d)
SHINE Medical Technologies l10 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 Hazard Identification and Evaluation
SHINE Medical Technologies l11 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 Hazard Identification and Evaluation
SHINE Medical Technologies l12 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 Hazard Identification and Evaluation
SHINE Medical Technologies l13
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 Hazard Identification and Evaluation
SHINE Medical Technologies l14 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 Hazard Identification and Evaluation
SHINE Medical Technologies l15 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)
Process Hazard Analysis & Accident Sequence Development
SHINE Medical Technologies l16 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)
Process Hazard Analysis & Accident Sequence Development
SHINE Medical Technologies l17 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)
Process Hazard Analysis & Accident Sequence Development
SHINE Medical Technologies l18 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 Process Hazard Analysis & Accident Sequence Development
SHINE Medical Technologies l19 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 Process Hazard Analysis & Accident Sequence Development
SHINE Medical Technologies l20 Risk Matrix Development
SHINE Medical Technologies l21 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 Likelihood Evaluation Method
SHINE Medical Technologies l22 Likelihood Evaluation Method
SHINE Medical Technologies l23 Example: Process Hazard Analysis Accident Sequence Security-Related Information - Withheld Under 10 CFR 2.390(d)
SHINE Medical Technologies l24 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 Consequence Analysis Method
SHINE Medical Technologies l25 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 Consequence Analysis Method
SHINE Medical Technologies l26 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 Consequence Analysis Method 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)
SHINE Medical Technologies l27 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)
Consequence Analysis Method
SHINE Medical Technologies l28 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 Consequence Analysis Method
SHINE Medical Technologies l29 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 Nuclear Criticality Safety Evaluation Process
SHINE Medical Technologies l30 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 Nuclear Criticality Safety Evaluation Process
SHINE Medical Technologies l31 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 Nuclear Criticality Safety Evaluation Process
SHINE Medical Technologies l32 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 Safety-Related Controls
SHINE Medical Technologies l33 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)
Safety-Related Controls
SHINE Medical Technologies l34 Example: Safety-Related Control Selection Security-Related Information - Withheld Under 10 CFR 2.390(d)
SHINE Medical Technologies l35 Example: Safety-Related Control Selection (from SSA)
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)
SHINE Medical Technologies l36 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 Integration into the Chapter 13 Accident Analysis
SHINE Medical Technologies l37 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 Maximum Hypothetical Accident
SHINE Medical Technologies l38 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 Integration into the Chapter 13 Accident Analysis
SHINE Medical Technologies l39 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 Integration into the Technical Specifications