Quantitative Links Between Arsenic Exposure and Influenza A (H1N1) Infection‐Associated Lung Function Exacerbations Risk

The objective of this study was to link arsenic exposure and influenza A (H1N1) infection‐induced respiratory effects to assess the impact of arsenic‐contaminated drinking water on exacerbation risk of A (H1N1)‐associated lung function. The homogeneous Poisson process was used to approximate the related processes between arsenic exposure and influenza‐associated lung function exacerbation risk. We found that (i) estimated arsenic‐induced forced expiratory volume in 1 second (FEV₁) reducing rates ranged from 0.116 to 0.179 mL/μg for age 15–85 years, (ii) estimated arsenic‐induced A (H1N1) viral load increasing rate was 0.5 mL/μg, (iii) estimated A (H1N1) virus‐induced FEV₁ reducing rate was 0.10 mL/logTCID50, and (iv) the relationship between arsenic exposure and A (H1N1)‐associated respiratory symptoms scores (RSS) can be described by a Hill model. Here we showed that maximum RSS at day 2 postinfection for Taiwan, West Bengal (India), and the United States were estimated to be in the severe range of 0.83, 0.89, and 0.81, respectively, indicating that chronic arsenic exposure and A (H1N1) infection together are most likely to pose potential exacerbations risk of lung function, although a 50% probability of lung function exacerbations risk induced by arsenic and influenza infection was within the mild and moderate ranges of RSS at day 1 and 2 postinfection. We concluded that avoidance of drinking arsenic‐containing water could significantly reduce influenza respiratory illness and that need will become increasingly urgent as the novel H1N1 pandemic influenza virus infects people worldwide.     

Exploring the Uncertainties in Cancer Risk Assessment Using the Integrated Probabilistic Risk Assessment (IPRA) Approach

Current methods for cancer risk assessment result in single values, without any quantitative information on the uncertainties in these values. Therefore, single risk values could easily be overinterpreted. In this study, we discuss a full probabilistic cancer risk assessment approach in which all the generally recognized uncertainties in both exposure and hazard assessment are quantitatively characterized and probabilistically evaluated, resulting in a confidence interval for the final risk estimate. The methodology is applied to three example chemicals (aflatoxin, N‐nitrosodimethylamine, and methyleugenol). These examples illustrate that the uncertainty in a cancer risk estimate may be huge, making single value estimates of cancer risk meaningless. Further, a risk based on linear extrapolation tends to be lower than the upper 95% confidence limit of a probabilistic risk estimate, and in that sense it is not conservative. Our conceptual analysis showed that there are two possible basic approaches for cancer risk assessment, depending on the interpretation of the dose‐incidence data measured in animals. However, it remains unclear which of the two interpretations is the more adequate one, adding an additional uncertainty to the already huge confidence intervals for cancer risk estimates.     

Ensuring the Quality of Occupational Safety Risk Assessment

In work environments, the main aim of occupational safety risk assessment (OSRA) is to improve the safety level of an installation or site by either preventing accidents and injuries or minimizing their consequences. To this end, it is of paramount importance to identify all sources of hazards and assess their potential to cause problems in the respective context. If the OSRA process is inadequate and/or not applied effectively, it results in an ineffective safety prevention program and inefficient use of resources. An appropriate OSRA is an essential component of the occupational safety risk management process in industries. In this article, we performed a survey to elicit the relative importance for identified OSRA tasks to enable an in‐depth evaluation of the quality of risk assessments related to occupational safety aspects on industrial sites. The survey involved defining a questionnaire with the most important elements (tasks) for OSRA quality assessment, which was then presented to safety experts in the mining, electrical power production, transportation, and petrochemical industries. With this work, we expect to contribute to the main question of OSRA in industries: “What constitutes a good occupational safety risk assessment?” The results obtained from the questionnaire showed that experts agree with the proposed OSRA process decomposition in steps and tasks (taxonomy) and also with the importance of assigning weights to obtain knowledge about OSRA task relevance. The knowledge gained will enable us, in the near future, to build a framework to evaluate OSRA quality for industrial sites.     

Assessing Uncertainty in Simulation-Based Maritime Risk Assessment

Recent work in the assessment of risk in maritime transportation systems has used simulation-based probabilistic risk assessment techniques. In the Prince William Sound and Washington State Ferries risk assessments, the studies' recommendations were backed up by estimates of their impact made using such techniques and all recommendations were implemented. However, the level of uncertainty about these estimates was not available, leaving the decisionmakers unsure whether the evidence was sufficient to assess specific risks and benefits. The first step toward assessing the impact of uncertainty in maritime risk assessments is to model the uncertainty in the simulation models used. In this article, a study of the impact of proposed ferry service expansions in San Francisco Bay is used as a case study to demonstrate the use of Bayesian simulation techniques to propagate uncertainty throughout the analysis. The conclusions drawn in the original study are shown, in this case, to be robust to the inherent uncertainties. The main intellectual merit of this work is the development of Bayesian simulation technique to model uncertainty in the assessment of maritime risk. However, Bayesian simulations have been implemented only as theoretical demonstrations. Their use in a large, complex system may be considered state of the art in the field of computational sciences.     

A Spatio‐Temporal Exposure‐Hazard Model for Assessing Biological Risk and Impact

We developed a simulation model for quantifying the spatio‐temporal distribution of contaminants (e.g., xenobiotics) and assessing the risk of exposed populations at the landscape level. The model is a spatio‐temporal exposure‐hazard model based on (i) tools of stochastic geometry (marked polygon and point processes) for structuring the landscape and describing the exposed individuals, (ii) a dispersal kernel describing the dissemination of contaminants from polygon sources, and (iii) an (eco)toxicological equation describing the toxicokinetics and dynamics of contaminants in affected individuals. The model was implemented in the briskaR package (b iological risk a ssessment with R ) of the R software. This article presents the model background, the use of the package in an illustrative example, namely, the effect of genetically modified maize pollen on nontarget Lepidoptera, and typical comparisons of landscape configurations that can be carried out with our model (different configurations lead to different mortality rates in the treated example). In real case studies, parameters and parametric functions encountered in the model will have to be precisely specified to obtain realistic measures of risk and impact and accurate comparisons of landscape configurations. Our modeling framework could be applied to study other risks related to agriculture, for instance, pathogen spread in crops or livestock, and could be adapted to cope with other hazards such as toxic emissions from industrial areas having health effects on surrounding populations. Moreover, the R package has the potential to help risk managers in running quantitative risk assessments and testing management strategies.     

Health Risk Characterization of Chlorpyrifos Using Epidemiological Dose‐Response Data and Probabilistic Techniques: A Case Study with Rice Farmers in Vietnam

Various methods for risk characterization have been developed using probabilistic approaches. Data on Vietnamese farmers are available for the comparison of outcomes for risk characterization using different probabilistic methods. This article addresses the health risk characterization of chlorpyrifos using epidemiological dose‐response data and probabilistic techniques obtained from a case study with rice farmers in Vietnam. Urine samples were collected from farmers and analyzed for trichloropyridinol (TCP), which was converted into absorbed daily dose of chlorpyrifos. Adverse health response doses due to chlorpyrifos exposure were collected from epidemiological studies to develop dose‐adverse health response relationships. The health risk of chlorpyrifos was quantified using hazard quotient (HQ), Monte Carlo simulation (MCS), and overall risk probability (ORP) methods. With baseline (prior to pesticide spraying) and lifetime exposure levels (over a lifetime of pesticide spraying events), the HQ ranged from 0.06 to 7.1. The MCS method indicated less than 0.05% of the population would be affected while the ORP method indicated that less than 1.5% of the population would be adversely affected. With postapplication exposure levels, the HQ ranged from 1 to 32.5. The risk calculated by the MCS method was that 29% of the population would be affected, and the risk calculated by ORP method was 33%. The MCS and ORP methods have advantages in risk characterization due to use of the full distribution of data exposure as well as dose response, whereas HQ methods only used the exposure data distribution. These evaluations indicated that single‐event spraying is likely to have adverse effects on Vietnamese rice farmers.     

Historical Relationship Between Performance Assessment for Radioactive Waste Disposal and Other Types of Risk Assessment

This article describes the evolution of the process for assessing the hazards of a geologic disposal system for radioactive waste and, similarly, nuclear power reactors, and the relationship of this process with other assessments of risk, particularly assessments of hazards from manufactured carcinogenic chemicals during use and disposal. This perspective reviews the common history of scientific concepts for risk assessment developed until the 1950s. Computational tools and techniques developed in the late 1950s and early 1960s to analyze the reliability of nuclear weapon delivery systems were adopted in the early 1970s for probabilistic risk assessment of nuclear power reactors, a technology for which behavior was unknown. In turn, these analyses became an important foundation for performance assessment of nuclear waste disposal in the late 1970s. The evaluation of risk to human health and the environment from chemical hazards is built on methods for assessing the dose response of radionuclides in the 1950s. Despite a shared background, however, societal events, often in the form of legislation, have affected the development path for risk assessment for human health, producing dissimilarities between these risk assessments and those for nuclear facilities. An important difference is the regulator's interest in accounting for uncertainty.     

Risk Mapping of Groundwater‐Drawdown‐Induced Land Subsidence in Heterogeneous Soils on Large Areas

Groundwater leakage into subsurface constructions can cause reduction of pore pressure and subsidence in clay deposits, even at large distances from the location of the construction. The potential cost of damage is substantial, particularly in urban areas. The large‐scale process also implies heterogeneous soil conditions that cannot be described in complete detail, which causes a need for estimating uncertainty of subsidence with probabilistic methods. In this study, the risk for subsidence is estimated by coupling two probabilistic models, a geostatistics‐based soil stratification model with a subsidence model. Statistical analyses of stratification and soil properties are inputs into the models. The results include spatially explicit probabilistic estimates of subsidence magnitude and sensitivities of included model parameters. From these, areas with significant risk for subsidence are distinguished from low‐risk areas. The efficiency and usefulness of this modeling approach as a tool for communication to stakeholders, decision support for prioritization of risk‐reducing measures, and identification of the need for further investigations and monitoring are demonstrated with a case study of a planned tunnel in Stockholm.     

Uncertainty Assessment in the Quantification of Risk Rates of Occupational Accidents

Occupational risk rates per hour of exposure have been quantified for 63 occupational accident types for the Dutch working population. Data were obtained from the analysis of more than 9,000 accidents that occurred over a period of six years in the Netherlands and resulted in three types of reportable consequences under Dutch law: (a) fatal injury, (b) permanent injury, and (c) serious recoverable injury requiring at least one day of hospitalization. A Bayesian uncertainty assessment on the value of the risk rates has been performed. Annual risks for each of the 63 occupational accident types have been calculated, including the variability in the annual exposure of the working population to the corresponding hazards. The suitability of three risk measures—individual risk rates, individual annual risk, and number of accidents—is examined and discussed.     

A Nuclear Utility's Views on the Use of Probabilistic Risk Assessment

Probabilistic risk assessment (PRA) is a relatively new tool in the nuclear industry. The Reactor Safety Study started the present trend of conducting PRAs for nuclear power plants when it was published in 1975. Now, nine years later, those in the industry currently using PRA techniques are frequently asked the same question: Why should the nuclear utility industry, with so many accepted analytical tools already available, invest the time and manpower to develop a new technique with so many uncertainties?     

A Discourse on the Incorporation of Organizational Factors into Probabilistic Risk Assessment: Key Questions and Categorical Review

This article presents a discourse on the incorporation of organizational factors into probabilistic risk assessment (PRA)/probabilistic safety assessment (PSA), a topic of debate since the 1980s that has spurred discussions among industry, regulatory agencies, and the research community. The main contributions of this article include (1) identifying the four key open questions associated with this topic; (2) framing ongoing debates by considering differing perspectives around each question; (3) offering a categorical review of existing studies on this topic to justify the selection of each question and to analyze the challenges related to each perspective; and (4) highlighting the directions of research required to reach a final resolution for each question. The four key questions are: (I) How significant is the contribution of organizational factors to accidents and incidents? (II) How critical, with respect to improving risk assessment, is the explicit incorporation of organizational factors into PRA? (III) What theoretical bases are needed for explicit incorporation of organizational factors into PRA? (IV) What methodological bases are needed for the explicit incorporation of organizational factors into PRA? Questions I and II mainly analyze PRA literature from the nuclear domain. For Questions III and IV, a broader review and categorization is conducted of those existing cross-disciplinary studies that have evaluated the effects of organizational factors on safety (not solely PRA-based) to shed more light on future research needs.     

Methods for Assessing Uncertainty in Fundamental Assumptions and Associated Models for Cancer Risk Assessment

The distributional approach for uncertainty analysis in cancer risk assessment is reviewed and extended. The method considers a combination of bioassay study results, targeted experiments, and expert judgment regarding biological mechanisms to predict a probability distribution for uncertain cancer risks. Probabilities are assigned to alternative model components, including the determination of human carcinogenicity, mode of action, the dosimetry measure for exposure, the mathematical form of the dose‐response relationship, the experimental data set(s) used to fit the relationship, and the formula used for interspecies extrapolation. Alternative software platforms for implementing the method are considered, including Bayesian belief networks (BBNs) that facilitate assignment of prior probabilities, specification of relationships among model components, and identification of all output nodes on the probability tree. The method is demonstrated using the application of Evans, Sielken, and co‐workers for predicting cancer risk from formaldehyde inhalation exposure. Uncertainty distributions are derived for maximum likelihood estimate (MLE) and 95th percentile upper confidence limit (UCL) unit cancer risk estimates, and the effects of resolving selected model uncertainties on these distributions are demonstrated, considering both perfect and partial information for these model components. A method for synthesizing the results of multiple mechanistic studies is introduced, considering the assessed sensitivities and selectivities of the studies for their targeted effects. A highly simplified example is presented illustrating assessment of genotoxicity based on studies of DNA damage response caused by naphthalene and its metabolites. The approach can provide a formal mechanism for synthesizing multiple sources of information using a transparent and replicable weight‐of‐evidence procedure.     

On the Relationship between Safety and Decision Significance

Risk analysts are often concerned with identifying key safety drivers, that is, the systems, structures, and components (SSCs) that matter the most to safety. SSCs importance is assessed both in the design phase (i.e., before a system is built) and in the implementation phase (i.e., when the system has been built) using the same importance measures. However, in a design phase, it would be necessary to appreciate whether the failure/success of a given SSC can cause the overall decision to change from accept to reject (decision significance). This work addresses the search for the conditions under which SSCs that are safety significant are also decision significant. To address this issue, the work proposes the notion of a θ‐importance measure. We study in detail the relationships among risk importance measures to determine which properties guarantee that the ranking of SSCs does not change before and after the decision is made. An application to a probabilistic safety assessment model developed at NASA illustrates the risk management implications of our work.     

GIS‐Based Integration of Social Vulnerability and Level 3 Probabilistic Risk Assessment to Advance Emergency Preparedness,Planning, and Response for Severe Nuclear Power Plant Accidents

In the nuclear power industry, Level 3 probabilistic risk assessment (PRA) is used to estimate damage to public health and the environment if a severe accident leads to large radiological release. Current Level 3 PRA does not have an explicit inclusion of social factors and, therefore, it is not possible to perform importance ranking of social factors for risk‐informing emergency preparedness, planning, and response (EPPR). This article offers a methodology for adapting the concept of social vulnerability, commonly used in natural hazard research, in the context of a severe nuclear power plant accident. The methodology has four steps: (1) calculating a hazard‐independent social vulnerability index for the local population; (2) developing a location‐specific representation of the maximum radiological hazard estimated from current Level 3 PRA, in a geographic information system (GIS) environment; (3) developing a GIS‐based socio‐technical risk map by combining the social vulnerability index and the location‐specific radiological hazard; and (4) conducting a risk importance measure analysis to rank the criticality of social factors based on their contribution to the socio‐technical risk. The methodology is applied using results from the 2012 Surry Power Station state‐of‐the‐art reactor consequence analysis. A radiological hazard model is generated from MELCOR accident consequence code system, translated into a GIS environment, and combined with the Center for Disease Control social vulnerability index (SVI). This research creates an opportunity to explicitly consider and rank the criticality of location‐specific SVI themes based on their influence on risk, providing input for EPPR.     

Managing Safety‐Related Disruptions: Evidence from the U.S. Nuclear Power Industry

Low‐probability, high‐impact events are difficult to manage. Firms may underinvest in risk assessments for low‐probability, high‐impact events because it is not easy to link the direct and indirect benefits of doing so. Scholarly research on the effectiveness of programs aimed at reducing such events faces the same challenge. In this article, we draw on comprehensive industry‐wide data from the U.S. nuclear power industry to explore the impact of conducting probabilistic risk assessment (PRA) on preventing safety‐related disruptions. We examine this using data from over 25,000 monthly event reports across 101 U.S. nuclear reactors from 1985 to 1998. Using Poisson fixed effects models with time trends, we find that the number of safety‐related disruptions reduced between 8% and 27% per month in periods after operators submitted their PRA in response to the Nuclear Regulatory Commission's Generic Letter 88‐20, which required all operators to conduct a PRA. One possible mechanism for this is that the adoption of PRA may have increased learning rates, lowering the rate of recurring events by 42%. We find that operators that completed their PRA before Generic Letter 88‐20 continued to experience safety improvements during 1990–1995. This suggests that revisiting PRA or conducting it again can be beneficial. Our results suggest that even in a highly safety‐conscious industry as nuclear utilities, a more formal approach to quantifying risk has its benefits.     

Risk Ranking of Antimicrobial‐Resistant Hazards Found in Meat in Switzerland

Human exposure to bacteria resistant to antimicrobials and transfer of related genes is a complex issue and occurs, among other pathways, via meat consumption. In a context of limited resources, the prioritization of risk management activities is essential. Since the antimicrobial resistance (AMR) situation differs substantially between countries, prioritization should be country specific. The objective of this study was to develop a systematic and transparent framework to rank combinations of bacteria species resistant to selected antimicrobial classes found in meat, based on the risk they represent for public health in Switzerland. A risk assessment model from slaughter to consumption was developed following the Codex Alimentarius guidelines for risk analysis of foodborne AMR. Using data from the Swiss AMR monitoring program, 208 combinations of animal species/bacteria/antimicrobial classes were identified as relevant hazards. Exposure assessment and hazard characterization scores were developed and combined using multicriteria decision analysis. The effect of changing weights of scores was explored with sensitivity analysis. Attributing equal weights to each score, poultry‐associated combinations represented the highest risk. In particular, contamination with extended‐spectrum β‐lactamase/plasmidic AmpC‐producing Escherichia coli in poultry meat ranked high for both exposure and hazard characterization. Tetracycline‐ or macrolide‐resistant Enterococcus spp., as well as fluoroquinolone‐ or macrolide‐resistant Campylobacter jejuni , ranked among combinations with the highest risk. This study provides a basis for prioritizing future activities to mitigate the risk associated with foodborne AMR in Switzerland. A user‐friendly version of the model was provided to risk managers; it can easily be adjusted to the constantly evolving knowledge on AMR.     

Assessing End‐Of‐Supply Risk of Spare Parts Using the Proportional Hazard Model

Operators of long field‐life systems like airplanes are faced with hazards in the supply of spare parts. If the original manufacturers or suppliers of parts end their supply, this may have large impacts on operating costs of firms needing these parts. Existing end‐of‐supply evaluation methods are focused mostly on the downstream supply chain, which is of interest mainly to spare part manufacturers. Firms that purchase spare parts have limited information on parts sales, and indicators of end‐of‐supply risk can also be found in the upstream supply chain. This article proposes a methodology for firms purchasing spare parts to manage end‐of‐supply risk by utilizing proportional hazard models in terms of supply chain conditions of the parts. The considered risk indicators fall into four main categories, of which two are related to supply (price and lead time) and two others are related to demand (cycle time and throughput). The methodology is demonstrated using data on about 2,000 spare parts collected from a maintenance repair organization in the aviation industry. Cross‐validation results and out‐of‐sample risk assessments show good performance of the method to identify spare parts with high end‐of‐supply risk. Further validation is provided by survey results obtained from the maintenance repair organization, which show strong agreement between the firm's and the model's identification of high‐risk spare parts.     

QRA Model‐Based Risk Impact Analysis of Traffic Flow in Urban Road Tunnels

Road tunnels are vital infrastructures providing underground vehicular passageways for commuters and motorists. Various quantitative risk assessment (QRA) models have recently been developed and employed to evaluate the safety levels of road tunnels in terms of societal risk (as measured by the F/N curve). For a particular road tunnel, traffic volume and proportion of heavy goods vehicles (HGVs) are two adjustable parameters that may significantly affect the societal risk, and are thus very useful in implementing risk reduction solutions. To evaluate the impact the two contributing factors have on the risk, this article first presents an approach that employs a QRA model to generate societal risk for a series of possible combinations of the two factors. Some combinations may result in F/N curves that do not fulfill a predetermined safety target. This article thus proposes an “excess risk index” in order to quantify the road tunnel risk magnitudes that do not pass the safety target. The two‐factor impact analysis can be illustrated by a contour chart based on the excess risk. Finally, the methodology has been applied to Singapore's KPE road tunnel and the results show that in terms of meeting the test safety target for societal risk, the traffic capacity of the tunnel should be no more than 1,200 vehs/h/lane, with a maximum proportion of 18% HGVs.     

A Survey of Approaches for Assessing and Managing the Risk of Extremes

In this paper, we review methods for assessing and managing the risk of extreme events, where extreme events are defined to be rare, severe, and outside the normal range of experience of the system in question. First, we discuss several systematic approaches for identifying possible extreme events. We then discuss some issues related to risk assessment of extreme events, including what type of output is needed (e.g., a single probability vs. a probability distribution), and alternatives to the probabilistic approach. Next, we present a number of probabilistic methods. These include: guidelines for eliciting informative probability distributions from experts; maximum entropy distributions; extreme value theory; other approaches for constructing prior distributions (such as reference or noninformative priors); the use of modeling and decomposition to estimate the probability (or distribution) of interest; and bounding methods. Finally, we briefly discuss several approaches for managing the risk of extreme events, and conclude with recommendations and directions for future research.     

Assessing Risk‐Based Upper Limits of Melamine Migration from Food Containers

Melamine contamination of food has become a major food safety issue because of incidents of infant disease caused by exposure to this chemical. This study was aimed at establishing a safety limit in Taiwan for the degree of melamine migration from food containers. Health risk assessment was performed for three exposure groups (preschool children, individuals who dine out, and elderly residents of nursing homes). Selected values of tolerable daily intake (TDI) for melamine were used to calculate the reference migration concentration limit (RMCL) or reference specific migration limit (RSML) for melamine food containers. The only existing values of these limits for international standards today are 1.2 mg/L (0.2 mg/dm²) in China and 30 mg/L (5 mg/dm²) in the European Union. The factors used in the calculations included the specific surface area of food containers, daily food consumption rate, body weight, TDI, and the percentile of the population protected at a given migration concentration limit (MCL). The results indicate that children are indeed at higher risk of melamine exposure at toxic levels than are other groups and that the 95th percentile of MCL (specific surface area = 5) for children aged 1–6 years should be the RMCL (0.07 mg/dm²) for protecting the sensitive and general population.