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NASA NTRSDate not supplied

Probabalistic Risk Analysis and Thermal Margin Process for an Inflatable Aeroshell

Uncertainties always exist in atmospheric entry aeroheating environments and the thermal response of thermal protection system (TPS) material. These uncertainties are mitigated in the design by ap-plying margin and factors of safety to the TPS. Entry vehicle TPS is often conservatively over-sized for the heat loads that are experienced along the entry trajectory by stacking worst-case scenarios together. Additionally, the current TPS design and margin process used by NASA offers very little insight into the risk of over-temperature during flight and the reliability of the heat shield performance [1,3]. A probabilistic margin process can be used to calculate the amount of TPS margin necessary to survive a given entry heat load at a specified level of risk [2,3,4]. The vehicle’s initial entry state (entry velocity, flight path angle, and entry mass) determines the expected atmospheric entry environmental conditions and resulting heat load that the entry vehicle will experience. If there is flexibility in the entry state, then this process can be used to select an appropriate combination of entry state parameters and TPS size to target a desired reentry reliability. This probabilistic margin process allows engineers to make informed aeroshell design, entry-trajectory design, and TPS performance risk trades while preventing excessive TPS margin from being applied. The probabilistic TPS margin process has been performed to determine TPS thickness and entry heating constraints given an acceptable risk level for the Low Earth Orbit Flight Experiment of an Inflatable Decelerator (LOFTID) flight project. The process is used in a manner to size the entry heat load for a given flexible TPS (FTPS) thickness so that it meets project reliability standards while allowing the FTPS and the underlying inflatable structure (IS) to be pushed to adequately high temperatures. Since the LOFTID project is an experimental flight demonstration, it is de-sired to drive the FTPS and IS to temperatures that cover a large range of their thermal response models’ applicability. This will allow the thermal response models to be better improved and validated post-flight using LOFTID’s extensive instrumentation embedded within the aeroshell. The presentation demonstrates how uncertainty analysis is carried out using an end-to-end Monte Carlo process where three separate Monte Carlo simulations are run in sequence. The first Monte Carlo simulation operates on the entry trajectory model to generate trajectory parameter dispersions that are fed into the second Monte Carlo simulation. The second Monte Carlo simulation operates on the aerothermodynamics model to generate aeroheating parameter dispersions that are fed into the third Monte Carlo simulation. The third Monte Carlo simulation operates on the FTPS material thermal response model to generate the final FTPS/IS thermal response dispersions. The end-to-end Monte Carlo simulation propagates the uncertainties of each model into the next to quantify the resulting uncertainty of the FTPS/IS thermal response. The fractional contributions of the uncertain parameters in the trajectory, aerothermal, and thermal response models to the variance in the FTPS/IS thermal response is determined as a byproduct of the Monte Carlo analysis. The structural uncertainty of the FTPS thermal response model is evaluated by flight relevant ground testing and model error analysis using test measurements. This probabilistic TPS margin process had never been applied to an entry vehicle and it is one of the LOFTID project’s goals to demonstrate its merits.

Steven A. Tobin↗

DOE OSTI2018

Industrial Control Systems: Cyber Security Risk Candidate Methods Analysis

In recognition of their mission and in response to continuously evolving cyber threats against nuclear facilities, Department of Energy - Nuclear Energy (DOE-NE) is building the Nuclear Energy Cyber security Research, Development, and Demonstration (RD&D) Program, which includes a cyber risk management thrust. This report supports the cyber risk management thrust objective which is to deliver "Standardized methodologies for credible risk-based identification, evaluation and prioritization of digital components." In a previous task, the Sandia National Laboratories (SNL) team presented evaluation criteria and a survey to review methods to determine the most suitable techniques. In this task we will identify and evaluate a series of candidate methodologies. In this report, 10 distinct methodologies are evaluated. The overall goal of this effort was to identify the current range of risk analysis techniques that were currently available, and how they could be applied, with an focus on industrial control systems (ICS). Overall, most of the techniques identified did fall into accepted risk analysis practices, though they generally addressed only one step of the multi-step risk management process. A few addressed multiple steps, but generally their treatment was superficial. This study revealed that the current state of security risk analysis in digital control systems was not comprehensive and did not support a science-based evaluation. The papers surveyed did use mathematical formulation to describe the addressed problems, and tied the models to some kind of experimental or experiential evidence as support. Most of the papers, however, did not use a rigorous approach to experimentally support the proposed models, nor did they have enough evidence supporting the efficacy of the models to statistically analyze model impact. Both of these issues stem from the difficulty and expense associated with collecting experimental data in this domain.

45 MILITARY TECHNOLOGY, WEAPONRY, AND NATIONAL DEF↗

DOE OSTI2011

Assessing the health risks of natural CO2 seeps in Italy

Industrialized societies which continue to use fossil fuel energy sources are considering adoption of Carbon Capture and Storage (CCS) technology to meet carbon emission reduction targets. Deep geological storage of CO2 onshore faces opposition regarding potential health effects of CO2 leakage from storage sites. There is no experience of commercial scale CCS with which to verify predicted risks of engineered storage failure. Studying risk from natural CO2 seeps can guide assessment of potential health risks from leaking onshore CO2 stores. Italy and Sicily are regions of intense natural CO2 degassing from surface seeps. These seeps exhibit a variety of expressions, characteristics (e.g., temperature/ flux), and location environments. Here we quantify historical fatalities from CO2 poisoning using a database of 286 natural CO2 seeps in Italy and Sicily. We find that risk of human death is strongly influenced by seep surface expression, local conditions (e.g., topography and wind speed), CO2 flux, and human behavior. Risk of accidental human death from these CO2 seeps is calculated to be 10-8 year-1 to the exposed population. This value is significantly lower than that of many socially accepted risks. Seepage from future storage sites is modeled to be less than Italian natural flux rates. With appropriate hazard management, health risks from unplanned seepage at onshore storage sites can be adequately minimized.

54 ENVIRONMENTAL SCIENCES↗

DOE OSTI2022

The modeling of risk perception in the use of structural health monitoring information for optimal maintenance decisions

This paper proposes an approach to select a maintenance strategy from a predefined set of choices considering the decision maker’s behavioral risk profile. It is assumed that the damage state is characterized by a continuous state parameter probabilistically inferred from observable sensor data. This work applies an engineering application of consequence-based decision-making incorporating the acceptable risk intensity of the decision-maker, i.e., the decision-maker’s (individual or an organization) valuation of the outcome of a decision, using a risk profile model. The utility of a decision-maker is subjective, and this paper considers the fact that different decision-makers mentally assign a different importance factor (the utility) to the seriousness or urgency to take necessary actions with the increasing intensity of structural damage. The approach herein incorporates a layer of human psychology on selecting appropriate maintenance strategies that not only depend on the posterior distribution of unmeasurable damage state but also consider the behavioral risk profile of the decision-maker. Further, the collective decision-making of an organization consisting of many individuals is also investigated. The approach is exemplified in a case study involving life cycle monitoring of a miter gate, part of a lock system enabling navigation of inland waterways.

42 ENGINEERING↗

NASA NTRS2012

Human Health Countermeasures (HHC) Element Management Plan: Human Research Program

NASA s Human Research Program (HRP) is an applied research and technology program within the Human Exploration and Operations Mission Directorate (HEOMD) that addresses human health and performance risk mitigation strategies in support of exploration missions. The HRP research and technology development is focused on the highest priority risks to crew health and safety with the goal of ensuring mission success and maintaining long-term crew health. Crew health and performance standards, defined by the NASA Chief Health and Medical Officer (CHMO), set the acceptable risk level for exploration missions. The HRP conducts research to inform these standards as well as provide deliverables, such as countermeasures, that ensure standards can be met to maximize human performance and mission success. The Human Health Countermeasures (HHC) Element was formed as part of the HRP to develop a scientifically-based, integrated approach to understanding and mitigating the health risks associated with human spaceflight. These health risks have been organized into four research portfolios that group similar or related risks. A fifth portfolio exists for managing technology developments and infrastructure projects. The HHC Element portfolios consist of: a) Vision and Cardiovascular; b) Exercise and Performance; c) Multisystem; d) Bone; and e) Technology and Infrastructure. The HHC identifies gaps associated with the health risks and plans human physiology research that will result in knowledge required to more fully understand risks and will result in validated countermeasures to mitigate risks.

Norsk, Peter↗

DOE OSTI2022

Risk-Informed Approach for Regulatory Approval of Microreactor Transport

Pacific Northwest National Laboratory (PNNL) is addressing the challenges associated with safe transport of microreactors including the development and evaluation of regulatory options. PNNL developed a risk-informed regulatory framework for the licensing of the transportation of microreactors in which irradiated nuclear fuel is part microreactor transportation package. The framework lays out a viable regulatory pathway, including decision points for regulatory options and the supporting technical evaluations for those options in phases from near to long term. A microreactor and its contents will likely not be able to meet all the federal regulatory requirements as a Type B or fissile material transportation package under 10 CFR Part 71 (“Packaging and Transportation of Radioactive Material”). However, the regulatory framework developed by PNNL lays out a viable risk-informed licensing options that are safe and feasible. Risk assessment such as probabilistic risk assessment (PRA) can be used to show comparable safety to that provided by a Type B or fissile material package for surface transport. The framework includes guidance on applicable regulations and discusses historical precedence in using risk information for transportation licensing. The framework includes guidance for performing a microreactor transportation PRA, use and development of risk evaluation criteria, and factors such of defense-in-depth and safety margin concepts. Key advantages of using the approach are (1) increasing the likelihood of successfully obtaining regulatory transportation package approval, (2) informing the design on the relative risk significance of microreactor containment and shielding, and (3) informing the need for transportation compensatory measures. This paper focuses on two primary elements of the framework which are development of a transportation PRA for microreactor packages and development of the risk acceptance guidelines to assess the results of the PRA for regulatory decision-making.

microreactor, micro nuclear power plant, MNPP, ris↗

NASA NTRS1993

Thermal performance testing of the Explorer Platform

The Explorer Platform (EP) has been designed to accommodate on-orbit payload and bus module changeout via Space Transportation System (STS) servicing. Such a versatile spacecraft platform designed to experience widely different environmental exposures and operational conditions, coupled with program constraints on schedule and budget, presented a challenge to implementing a technically sound thermal vacuum/thermal balance test program. This paper discusses thermal performance tests implemented at the subsystem and system levels, and the risks accepted resulting from test sequence, configuration. and tests omitted from the program. No thermal cycling or thermal balance tests were performed on the integrated spacecraft level, although both the Payload (EUVE) and Platform (EP) received independent testing. The decision to take this approach is discussed with respect to the thermal design and the associated risks taken to maintain budget and schedule.

Wasson, David↗

NASA NTRSDate not supplied

Analysis and Prediction of VFR Vs IFR Traffic Behavior to Support Uncrewed Aircraft Flight Operations at Regional Airports

Uncrewed Aircraft flight operations at a regional airport will be affected by the uncertainty in the Visual Flight Rules traffic around. This paper analyzes Visual Flight Rules traffic behavior, compares it with Instrument Flight Rules traffic and develops traffic prediction methods to support uncrewed aircraft flight operations. The spatio-temporal distribution of traffic operating under Visual Flight Rules and Instrument Flight Rules was analyzed from one month of historical track data around Fort Worth Alliance airport as a representative regional airport. The traffic behavior was visualized as occupancy maps generated at different altitudes. The Instrument Flight Rules traffic was concentrated in fewer regions of the airspace along structured routes where the risk of interacting with one or more flights reached close to fifty percent in some areas. Visual Flight Rules traffic was spread over more regions, mostly segregated from the Instrument Flight Rules regions, and the risk of interaction was lower reaching up to twenty-five percent on average over the month in some regions. The interaction risk was predicted using predictive occupancy maps over multiple time horizons and conditioned on time and partial observation of traffic in the vicinity. The month-to-month predictability of Visual Flight Rules risk was lower than that of the Instrument Flight Rules traffic, consistently over all the conditions analyzed. However, the prediction and its accuracy were demonstrated to be sensitive to the conditions used. The predictive models generated can be used to support both strategic planning and in-flight decision-making by uncrewed aircraft during flight operations while maintaining an acceptable risk of interacting with other traffic.

VFR↗

NASA NTRSDate not supplied

Analysis and Prediction of VFR Vs IFR Traffic Behavior to Support Uncrewed Aircraft Flight Operations at Regional Airports

VFR↗

NASA NTRS2019

A Proposal for Standardized MMOD Shielding for Robotic Spacecraft

NASA robotic spacecraft are required to assess the potential for small debris induced failure for all disposal-critical components. Additional shielding might then be necessary in order to meet the acceptable risk requirement for the overall mission. Traditionally this requirement had been met with little or no additional shielding. Since the introduction of a high density debris population in ORDEM 3.0, some missions, especially those in higher portions of Low Earth Orbit, have needed additional MMOD-specific shielding in order for the mission to meet the requirement. This is a costly design effort when performed late in the project life cycle, which adds unexpected mass to the spacecraft components during the integration phase, and could disrupt thermal management.A proposal is discussed to develop a more cost-effective approach to MMOD-shielding, which can be employed earlier in the hardware design phase. The development and adoption of standardized shielding assemblies allows early tailoring of the shielding around a component, so that the mass is accounted for, as well as the small particle penetration risk, at a point in the design phase when the cost and schedule impact are more manageable. A set of several assemblies can be developed with a range of protection thresholds, in order to control mass where less shielding is needed. Such shielding assemblies would be developed in collaboration with blanket assembly specialists and thermal control engineers to ensure manufacturability and thermal performance challenges are known and acceptable. One clear benefit of such an approach is that hypervelocity testing can be performed on each of the standard shield assemblies to refine and confirm their performance prior to use.The challenges inherent in designing supplemental MMOD shielding will be discussed, including variations in the orbital debris environment and performance prediction. The benefits of a standardized shielding approach and example applications will also be presented.

Hull, Scott M.↗

NASA NTRS2019

A Proposal for Standardized MMOD Shielding for Robotic Spacecraft

NASA robotic spacecraft are required to assess the potential for small debris induced failure for all disposal-critical components. Additional shielding might then be necessary in order to meet the acceptable risk requirement for the overall mission. Traditionally this requirement had been met with little or no additional shielding. Since the introduction of a high density debris population in ORDEM 3.0, some missions, especially those in higher portions of Low Earth Orbit, have needed additional MMOD-specific shielding in order for the mission to meet the requirement. This is a costly design effort when performed late in the project life cycle, which adds unexpected mass to the spacecraft components during the integration phase, and could disrupt thermal management. A proposal is discussed to develop a more cost-effective approach to MMOD-shielding, which can be employed earlier in the hardware design phase. The development and adoption of standardized shielding assemblies allows early tailoring of the shielding around a component, so that the mass is accounted for, as well as the small particle penetration risk, at a point in the design phase when the cost and schedule impact are more manageable. A set of several assemblies can be developed with a range of protection thresholds, in order to control mass where less shielding is needed. Such shielding assemblies would be developed in collaboration with blanket assembly specialists and thermal control engineers to ensure manufacturability and thermal performance challenges are known and acceptable. One clear benefit of such an approach is that hypervelocity testing can be performed on each of the standard shield assemblies to refine and confirm their performance prior to use.The challenges inherent in designing supplemental MMOD shielding will be discussed, including variations in the orbital debris environment and performance prediction. The benefits of a standardized shielding approach and example applications will also be presented.

Hull, Scott M.↗

NASA NTRSDate not supplied

Gateway Program Safety and Mission Assurance Integration - the Future of Safe Deep Space Human Exploration

As a foundational element of the National Aeronautics and Space Administration (NASA) Artemis Campaign, the Gateway is an incrementally built cislunar spacecraft that will serve as a platform for deep space human exploration, science, and technology demonstration. The Gateway will be a unifying catalyst for international partners around the world to establish sustained deep space scientific investigations, lunar surface access, and missions to Mars. As human exploration moves farther away from Earth, spacecraft designs must prioritize and optimize mass and volume allocations, while minimizing human and spacecraft risk. To accomplish this objective, the Gateway Program Safety and Mission Assurance functions develop, implement, and ensure compliance with requirements, in concert with the accurate characterization and transparent communication of residual hazard risks, for integrated safety, reliability and maintainability and quality assurance. Safety and Mission Assurance was a key contributor during Gateway program pre-formulation and formulation activities where safety and reliability analysis was embedded in the Gateway Systems Engineering and Integration team. During these early program stages, a preliminary Gateway Integrated Hazard Analysis and Preliminary Gateway Probabilistic Risk Assessment assisted in Gateway architectural and operational definition as part of a risk-informed design process. As the deep space architecture has matured, the integrated Safety and Mission Assurance analyses have matured, new safety review processes have been developed, and requirements have been refined to ensure compliance with integrated safety and mission assurance objectives. The Gateway Program is currently concluding the preliminary design review informed milestone, where the primary objectives included: - Ensured completeness and consistency of the preliminary design, including the meeting of all requirements within appropriate margins and acceptable risk posture. - Identification of any major issues moving forward to the Critical Design phase. At this milestone, Safety and Mission Assurance provided numerous products, including Gateway Top Risks and Risk Mitigation Plans, updated integrated hazard analyses, updated probabilistic risk assessment, Crew Survival Analysis Report, and updated Safety and Mission Assurance Requirements and Plans. These products provide a many-faceted perspective on the inherent risk and available mitigations involved in flying the current proposed vehicle design and anticipated stack configurations. In addition, Safety and Mission Assurance identified top technical, process and workforce concerns to be addressed as the program progresses toward the critical design phase. This paper will detail the evolution of the Gateway Program Safety and Mission Assurance integration functions, provide its current status and lessons learned for future human spaceflight programs. Throughout this paper the key tenets of the Gateway Program Safety and Mission Assurance will be discussed: - Application of a risk-informed approach to identify and mitigate areas of highest risk. - Leverage of valuable processes and lessons learned from earlier spaceflight programs. - Development of Safety and Mission Assurance products to inform design risk trades. - Utilization of common Safety and Mission Assurance practices to identify safety risks for multiple perspectives: top-down, bottom-up, and across lines of integration. - Approval of safety hazards at the appropriate level of authority, keeping most deliberation closest to design expertise and elevating risks of greatest concern for program-level consideration. - Championing of Safety and Mission Assurance processes and forums to foster a pervasive safety culture that is transparent, inclusive, and collaborative between all partners. These tenets have allowed the Gateway Safety and Mission Assurance function to play a key role in optimized vehicle design evolution, and early identification and mitigation of Gateway program and Artemis mission risk.

Helen Vaccaro↗

NASA NTRS2012

Does Commercial Space Really Need MOA?

The Mission Operations Assurance (MOA) discipline actively participates as a project member to achieve their common objective of full mission success while also providing an independent risk assessment to the Project Manager. The cornerstone element of MOA is the independent assessment of the risks the project faces in executing its mission. Especially as the project approaches critical mission events, it becomes imperative to clearly identify and assess the risks the project faces. This has been the paradigm for robotic space exploration missions, but does the same apply to commercial space operations? This is the question which is the driver for this year's MOA track at the 18th Annual Improving Space Operations workshop in April at the Jet Propulsion Laboratory, and the question we examine in this paper. Corollaries to this driving question are why shouldn't MOA apply and are there factors beyond mission success with acceptable risk which apply to commercial space operations that are not present in government scientific missions? To address these questions, areas we focus on include risk (both mission and profit) management for commercial space operations and the practical extension of robotic mission MOA to commercial space operations. Another key area to look at is command file errors which are a major concern for deep space robotic missions, but can we worry about them less with manned missions or unmanned supply mission? Further, with the growing concern about space debris, we delve into the role of MOA relative to End-of-Mission activities. This paper examines these topics and in particular the perspectives presented at the workshop to begin charting the appropriate course for MOA in the emerging sector of Commercial Space Operations.

commercial space↗

NASA NTRS2003

Risk-based Classification of Incidents

As the penetration of software into safety-critical systems progresses, accidents and incidents involving software will inevitably become more frequent. Identifying lessons from these occurrences and applying them to existing and future systems is essential if recurrences are to be prevented. Unfortunately, investigative agencies do not have the resources to fully investigate every incident under their jurisdictions and domains of expertise and thus must prioritize certain occurrences when allocating investigative resources. In the aviation community, most investigative agencies prioritize occurrences based on the severity of their associated losses, allocating more resources to accidents resulting in injury to passengers or extensive aircraft damage. We argue that this scheme is inappropriate because it undervalues incidents whose recurrence could have a high potential for loss while overvaluing fairly straightforward accidents involving accepted risks. We then suggest a new strategy for prioritizing occurrences based on the risk arising from incident recurrence.

Greenwell, William S.↗

NASA NTRS2013

Fifteen-minute Extravehicular Activity Prebreathe Protocol Using NASA's Exploration Atmosphere (8.2 psia/ 34% 02)

A TBDM DCS probability model based on an existing biophysical model of inert gas bubble growth provides significant prediction and goodness-of-fit with 84 cases of DCS in 668 human altitude exposures. 2. Model predictions suggest that 15-minute O2 prebreathe protocols used in conjunction with suit ports and an 8.2 psi, 34% O2, 66% N2 atmosphere may enable rapid EVA capability for future exploration missions with the risk of DCS ≤ 12%.  EVA could begin immediately at 6.0 psi, with crewmembers decreasing suit pressure to 4.3 psi after completing the 15-minute in-suit prebreathe. 3. Model predictions suggest that intermittent recompression during exploration EVA may reduce decompression stress by 1.8% to 2.3% for 6 hours of total EVA time. Savings in gas consumables and crew time may be accumulated by abbreviating the EVA suit N2 purge to 2 minutes (20% N2) compared with 8 minutes (5% N2) at the expense of an increase in estimated decompression risk of up to 2.4% for an 8-hour EVA.  Increased DCS risk could be offset by IR or by spending additional time at 6 psi at the beginning of the EVA.  Savings of 0.48 lb of gas and 6 minutes per person per EVA corresponds to more than 31 hours of crew time and 1800 lb of gas and tankage under the Constellation lunar architecture. 6. Further research is needed to characterize and optimize breathing mixtures and intermittent recompression across the range of environments and operational conditions in which astronauts will live and work during future exploration missions. 7. Development of exploration prebreathe protocols will begin with definition of acceptable risk, followed by development of protocols based on models such as ours, and, ultimately, validation of protocols through ground trials before operational implementation.

Abercromby, Andrew F. J.↗

DOE OSTI2017

Adjuvant Intensity Modulated Whole-Abdominal Radiation Therapy for High-Risk Patients With Ovarian Cancer (International Federation of Gynecology and Obstetrics Stage III): First Results of a Prospective Phase 2 Study

Purpose: To assess treatment tolerance and toxicity rates of consolidative whole-abdominal radiation therapy (WART) following cytoreductive surgery and carboplatin/paclitaxel chemotherapy in high-risk patients with advanced ovarian cancer (International Federation of Gynecology and Obstetrics stage III) using intensity modulated radiation therapy. Methods and Materials: The OVAR-IMRT-02 study is a multicenter, single-arm, phase 2 trial. Twenty patients with optimally debulked ovarian cancer (International Federation of Gynecology and Obstetrics stage III) with complete remission after chemotherapy were treated with intensity modulated WART as a consolidation therapy. A total dose of 30 Gy in 20 fractions of 1.5 Gy was applied to the entire peritoneal cavity. The primary endpoint was treatment tolerability, defined as lack of any Common Terminology Criteria for Adverse Events grade 4 toxicity within 10 weeks after start of treatment; secondary objectives were acute and chronic toxicity, quality of life, rates of therapy disruption and abortion, and progression-free and overall survival. Results: Intensity modulated WART resulted in excellent coverage of the whole peritoneal cavity, with effective sparing of all organs at risk. The primary analysis included all 20 enrolled patients, of whom 19 did not experience Common Terminology Criteria for Adverse Events grade 4 toxicity. Only 1 patient experienced acute grade 4 hematologic toxicity. Thus, the tolerability rate of intensity modulated WART was significantly higher than 70%. No gastrointestinal acute toxicities higher than grade 2 have been observed. During WART, mean global health status decreased by 18.1 points (95% confidence interval 7.1, 29.0). Six weeks after WART, global health status had already increased, with a mean score difference of 4.6 (95% confidence interval −11.1, 20.4) compared with baseline. Similar characteristics were observed for all function scale scores. Conclusion: Intensity modulated WART after aggressive surgery and carboplatin/paclitaxel chemotherapy is associated with an acceptable risk of acute toxicity and a treatment tolerability rate significantly higher than 70%. Together with our knowledge about clinical feasibility, meaning excellent coverage of the planning target volume and effective sparing of organs at risk, intensity modulated WART could offer a new therapeutic option for consolidation treatment of patients with advanced ovarian cancer.

62 RADIOLOGY AND NUCLEAR MEDICINE↗

DOE OSTI2015

A systematic approach to the analysis of double faults within design basic accident methodology - 14501

Within the UK there is a general trend towards adopting Design Basis Accident (DBA) methodology for the assessment of radiological hazards, including criticality. DBA is a single fault methodology and comprises identifying the initiating event, its frequency and consequence. A fault with a very low initiating event frequency will not require further analysis. A fault sequence that terminates in a sub-critical configuration would also not require further analysis; although the identified passive features ensuring sub-criticality are subjected to engineering substantiation. Where faults do not pass this initial screening, two safety measures are generally required to ensure the fault does not progress to a criticality incident. This methodology provides a robust approach to single faults ensuring that an appropriate level and range of plant measures are identified and subjected to appropriate substantiation. However, a criticality is a cliff-edge effect and is dependent on multiple parameters. It is entirely possible under DBA to evaluate several single fault sequences and conclude that no measures are required because the single faults terminate in a sub-critical configuration. Importantly, for criticality safety, under DBA, there is no requirement to prevent important parameters from deviating from normal or upper bound 'safe' levels leaving the plant at greater risk in the event that further faults initiate. The combination of two faults could lead to a criticality incident but there is no current driver within DBA methodology to analyze these coincident or double faults. There is, therefore, potential to significantly under estimate the risk of criticality. This understanding is embodied within other methodologies such as the Double Contingency Principle. However, within the UK the DBA methodology has so significantly improved the analysis of single faults that, in some instances, consideration of double faults has taken a back seat. This is despite the UK regulator stating that 'criticality safety cases should employ the double contingency approach'. This paper presents a systematic approach to ensure that the potential for double faults or multiple parameter deviations to result in a criticality is effectively evaluated within the wider DBA methodology. The methodology determines which faults may be screened out from double fault analysis on the grounds of being 'unlikely' to initiate and being present for a 'short' duration. For those faults screened into double fault analysis, this guidance sets out the potential means of determining acceptable risk. These means include the specific evaluation of the risk of two criticality control parameters deviating simultaneously, the definition of additional safety measures and the definition of the boundary of safety for multiple parameters and the risk of exceeding this boundary. (authors)

42 ENGINEERING↗

DOE OSTI2019

Efficacy and safety of cabazitaxel for castration-resistant prostate cancer in patients with > 10 cycles of docetaxel chemotherapy: a multi-institutional study

This multi-institutional study aimed to investigate the efficacy and safety profiles of cabazitaxel after prior docetaxel chemotherapy in patients with castration-resistant prostate cancer (CRPC). This study included 63 Japanese patients with CRPC who were treated with cabazitaxel from 2014 to 2017. The oncological outcomes and adverse events (AEs) were documented, and prognostic factors for oncological outcomes and predictive factors for AEs were analysed. PSA decline was observed in 68.3% of patients, including 25.4% who achieved a ≥ 50% decline. The median progression-free survival, treatment failure-free survival, and overall survival were 4.3, 4.1, and 9.0 months, respectively. More cycles of prior docetaxel therapy was identified as common favourable prognostic factors for progression-free survival, treatment failure-free survival, and overall survival. Severe neutropenia, febrile neutropenia, and severe non-haematological AEs were observed in 73.0%, 33.3%, and 23.8% of patients, respectively. However, > 10 cycles of docetaxel was not associated with increased incidence of AEs. In conclusion, cabazitaxel chemotherapy was still active in Japanese CRPC patients treated with > 10 cycles of docetaxel chemotherapy, with an acceptable risk of AE burden. Treatment with cabazitaxel after > 10 cycles of docetaxel may be an appropriate option when it can be administered.

62 RADIOLOGY AND NUCLEAR MEDICINE↗