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At least 19 records

Simple Acceptance Decisions and Acceptance Risk

Acceptance risk may be estimated using cumulative probability distribution functions applied to populations of measurands and test measurement values. “Simple acceptance” is a decision rule that sets the acceptance range of a test result equal to the tolerance range specification. While acceptance risk is comprised of both consumer risk and producer risk, this paper compares the effects of simple acceptance decision rules and guardbanding decision rules on consumer risk. Consumer risk is also known as the probability of false acceptance. The terms describe the risk of accepting test results as passing when the actual values exceed specification limits. False acceptance is only possible when the true value of a measurand is out of tolerance and the test result indicates that the measurand is within tolerance. Metrologists generally have some information about the test uncertainty regarding a specific acceptance test result. Along with a general lack of knowledge regarding the measurand population parameters, the complicated interplay between risk, dispersion, and central values generally prevents calibration laboratories from fully characterizing acceptance probabilities. Organizations that model the measurand populations can reduce consumer risk by avoiding certification of items whose measurand populations are not well centered. The models in this paper present a recurring trend: guardbanding reduces nonnegligible risks of false acceptance when compared to simple acceptance. However, guardbanding is not the most effective means of acceptance risk mitigation. Systematic characterization of measurand populations can provide the information a calibration laboratory needs to reliably control acceptance risk.

42 ENGINEERING↗

Evaluation of Risk Acceptance Criteria for Transporting Hazardous Materials

This report reviews and offers recommendations from Sandia National transportation of hazardous materials in the U.S. The risk criteria should be used with the results of a quantitative risk assessment (QRA) in risk acceptance decision-making. The QRA for transportation is fundamentally the same as a fixed facility. However, there are differences in calculations of both the probabilities of occurrence and location of hazards. Involuntary individual fatality risk is recommended to be acceptable for annual probabilities of less than 3 x 10 -7 for any population, including vulnerable populations, and may be considered acceptable at the regulators discretion for non-sensitive/non-vulnerable populations if less than 5 x 10 -5 and demonstrated to be as low as reasonably practicable (ALARP). Societal risk is recommended to be acceptable if the annual frequency of events that would result in N or more fatalities is less than 10 -5 /N events per year and may be considered acceptable at the regulators discretion if less than 10 -3 /N events per year and demonstrated to be ALARP. These criteria should be applied to the societal risk over the entire transportation route, not normalized per-distance. These values are adapted from the National Fire Protection Association (NFPA) 59A, a U.S. and international standard for liquefied natural gas (LNG) facility siting.

54 ENVIRONMENTAL SCIENCES↗

Implications of Bioremediation of Polycyclic Aromatic Hydrocarbon-Contaminated Soils for Human Health and Cancer Risk

Background: Bioremediation uses microorganisms to degrade polycyclic aromatic hydrocarbons (PAHs) in contaminated soils. Its success is largely evaluated through targeted analysis of PAH concentrations in soil and cancer risk (exposure) estimates. However, bioremediation often fails to significantly degrade the most carcinogenic PAHs and can initiate formation of more polar metabolites, some of which may be more toxic. Objectives: We aimed to investigate whether the cancer risk associated with PAH-contaminated soils was reduced post-bioremediation and to identify the most effective bioremediation strategies for degrading the carcinogenic and high molecular weight (≥MW302) PAHs. Methods: Pre- and post-bioremediation concentrations of eight B2 group carcinogenic PAHs in soils were collated from the literature and used to calculate excess lifetime cancer risks (ELCR) for adult populations exposed via non-dietary ingestion, per current U.S. Environmental Protection Agency (USEPA) recommendations. Due to the nature of the collated data (reported as mean concentrations ± standard deviations pre- and post-bioremediation), we used simulation methods to reconstruct the datasets and enable statistical comparison of ELCR values pre- and post-bioremediation. Additionally, we measured MW302 PAHs in a contaminated soil prior to and following treatment in an aerobic bioreactor and examined their contributions to cancer risk. Results: 120 of 158 treated soils (76%) exhibited a statistically significant reduction in cancer risk following bioremediation; however, 67% (106/158) of soils had post-bioremediation ELCR values over 10 fold higher than the USEPA health-based ‘acceptable’ risk level. Composting treatments were most effective at biodegrading PAHs in soils and reducing the ELCR. MW302 PAHs were not significantly degraded during bioremediation and dibenzo(a,l)pyrene, alone, contributed an additional 35% to the cancer risk associated with the eight B2 group PAHs in the same bioremediated soil. Conclusions: Bioremediation strategies often fail to reduce carcinogenic PAH concentrations in contaminated soils below USEPA acceptable cancer risk levels. Additionally, MW302 PAHs and ‘unknown’ metabolites (compounds not routinely measured) are not included in current cancer risk assessments and could significantly contribute to soil carcinogenicity.

bioremediation↗

Triton: Survivability Enhancement of a Multi-Mode Point Absorber

This submission includes final project deliverables for DE-FOA-0001310. The overall goal of the project was to design and validate a survival mode for the Triton WEC that allows for a reduction in peak loads, while simultaneously allowing for a reduction of capital cost due to the elimination of overdesign to account for uncertainty. In addition, the project sought to carefully understand performance of the design without survival mode engaged under extreme wave conditions so as to better understand how system loads vary and hence determine conditions where survival mode needs to be engaged, thereby allowing for an optimum balance between maximum power capture and acceptable risk within the capabilities of the design.

16 TIDAL AND WAVE POWER↗

Miscalculation, Misperception and Risk Reduction

In the current security environment, the most likely wars for which the US and its allies must be prepared are wars against nuclear-armed states. Such wars bring unique risks of both vertical and horizontal escalation. Some are “accepted risks;” for example, the US may choose to escalate a conflict to clarify its commitment to an issue and defend its interest. Other are “unacceptable risks;” especially, the risk of miscalculation by the U.S. or an adversary. The focus here is on this latter category. Miscalculation is an error of judgment—the failure to accurately assess a situation. Miscalculation can result from hidden, incomplete, or ambiguous information, or from inaccurate processing of available information because of bias, overconfidence, denial, delusion, etc. Miscalculation is related to misperception. For some, they are synonymous. This paper characterizes the risks of miscalculation and introduces a discussion of a risk mitigation strategy.

45 MILITARY TECHNOLOGY, WEAPONRY, AND NATIONAL DEF↗

Assessing the Potential for Inadvertent Human Intrusion at the Area 3 and Area 5 Radioactive Waste Management Sites on the Nevada National Security Site, Nye County, Nevada

This paper recommends an approach to inadvertent human intrusion (IHI) at the Area 3 and Area 5 Radioactive Waste Management Sites (RWMSs) on the Nevada National Security Site (NNSS). IHI analysis uses the consequences of an individual inadvertently contacting buried waste to set waste concentration limits for near-surface disposal of low-level radioactive waste (LLW). Regulatory agencies are increasingly applying risk-informed decision-making to LLW waste management (NRC 2006). Risk-informed decision-making combines scientific risk assessment with stakeholder values and perceptions to determine a level of acceptable risk. Risk considers not only the consequences of an event, but also its probability of occurring.

12 MANAGEMENT OF RADIOACTIVE AND NON-RADIOACTIVE W↗

Analyses in Support of Risk-Informed Natural Gas Vehicle Maintenance Facility Codes and Standards: Phase I

Safety standards development for maintenance facilities of liquid and compressed gas fueled large-scale vehicles is required to ensure proper facility design and operation envelopes. Standard development organizations are utilizing risk-informed concepts to develop natural gas vehicle (NGV) codes and standards so that maintenance facilities meet acceptable risk levels. The present report summarizes Phase I work for existing NGV repair facility code requirements and highlights inconsistencies that need quantitative analysis into their effectiveness. A Hazardous and Operability study was performed to identify key scenarios of interest. Finally, scenario analyses were performed using detailed simulations and modeling to estimate the overpressure hazards from HAZOP defined scenarios. The results from Phase I will be used to identify significant risk contributors at NGV maintenance facilities, and are expected to form the basis for follow-on quantitative risk analysis work to address specific code requirements and identify effective accident prevention and mitigation strategies.

33 ADVANCED PROPULSION SYSTEMS↗

Analyses in Support of Risk-Informed Natural Gas Vehicle Maintenance Facility Codes and Standards: Phase II

Safety standards development for maintenance facilities of liquid and compressed natural gas fueled vehicles is required to ensure proper facility design and operating procedures. Standard development organizations are utilizing risk-informed concepts to develop natural gas vehicle (NGV) codes and standards so that maintenance facilities meet acceptable risk levels. The present report summarizes Phase II work for existing NGV repair facility code requirements and highlights inconsistencies that need quantitative analysis into their effectiveness. A Hazardous and Operability study was performed to identify key scenarios of interest using risk ranking. Detailed simulations and modeling were performed to estimate the location and behavior of natural gas releases based on these scenarios. Specific code conflicts were identified, and ineffective code requirements were highlighted and resolutions proposed. These include ventilation rate basis on area or volume, as well as a ceiling offset which seems ineffective at protecting against flammable gas concentrations. ACKNOWLEDGEMENTS The authors gratefully acknowledge Bill Houf (SNL -- Retired) for his assistance with the set-up and post-processing of the numerical simulations. The authors also acknowledge Doug Horne (retired) for his helpful discussions. We would also like to acknowledge the support from the Clean Cities program of DOE's Vehicle Technology Office.

03 NATURAL GAS↗

Economics of Crop Rotations With and Without Carinata for Sustainable Aviation Fuel Production in the SE United States

In 2019, the aviation sector in the United States emitted 255 million metric tons of carbon dioxide (CO 2 ) emissions, i.e., about five percent of the total domestic CO 2 emissions from the energy sector. The sustainable aviation fuel (SAF) derived from carinata (Brassica carinata) could reduce CO 2 emissions of the aviation sector in the United States. Therefore, it is important to estimate changes in farm economics with and without carinata for ascertaining its production feasibility. In this context, the current study first assesses a combination of 12 popular rotations of corn, cotton, peanut, and soybean with winter crops of winter wheat and carinata in South Georgia over 4 years. Then, the net present values (NPVs) of 292 feasible cropping systems over 4 years are calculated. Finally, this study develops a risk model for ascertaining the probability distributions of NPVs for selected cropping systems subject to uncertainties related to prices and yields of summer and winter crops. Carinata in the corn-corn-soybean rotation has the highest NPV ($\$$2,996/ha). The least risky rotation is cotton-cotton-peanut, with a 58.9% probability of a positive NPV. Carinata can decrease the risk level of crop rotations by 8.1%, only if a contract price of $\$$440.9/t is offered. Therefore, a risk averse, risk neutral, or risk acceptant farmer can potentially include carinata in the rotation. Overall, carinata would increase the profitability of farm operations and decrease risk in the SE United States, and therefore, a high likelihood exists, that farmers would adopt it for meeting the growing demand for SAF in the United States.

09 BIOMASS FUELS↗

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↗

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↗

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↗

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↗

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↗

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↗