Qualitative Risk Assessment of the Acquisition of Meticillin‐Resistant Staphylococcus aureus in Pet Dogs

This article presents a qualitative risk assessment of the acquisition of meticillin‐resistant Staphylococcus aureus (MRSA) in pet dogs, representing an important first step in the exploration of risk of bidirectional MRSA transfer between dogs and humans. A conceptual model of the seven potential pathways for MRSA acquisition in a dog in any given 24‐hour period was developed and the data available to populate that model were considered qualitatively. Humans were found to represent the most important source of MRSA for dogs in both community and veterinary hospital settings. The environment was found to be secondary to humans in terms of importance and other dogs less still. This study highlights some important methodological limitations of a technique that is heavily relied upon for qualitative risk assessments and applies a novel process, the use of relative risk ranking, to enable the generation of a defensible output using a matrix combination approach. Given the limitations of the prescribed methods as applied to the problem under consideration, further validation, or repudiation, of the findings contained herein is called for using a subsequent quantitative assessment.     

Multicriteria Decision Analysis: A Comprehensive Decision Approach for Management of Contaminated Sediments

Contaminated sediments and other sites present a difficult challenge for environmental decisionmakers. They are typically slow to recover or attenuate naturally, may involve multiple regulatory agencies and stakeholder groups, and engender multiple toxicological and ecotoxicological risks. While environmental decision-making strategies over the last several decades have evolved into increasingly more sophisticated, information-intensive, and complex approaches, there remains considerable dissatisfaction among business, industry, and the public with existing management strategies. Consequently, contaminated sediments and materials are the subject of intense technology development, such as beneficial reuse or in situ treatment. However, current decision analysis approaches, such as comparative risk assessment, benefit-cost analysis, and life cycle assessment, do not offer a comprehensive approach for incorporating the varied types of information and multiple stakeholder and public views that must typically be brought to bear when new technologies are under consideration. Alternatively, multicriteria decision analysis (MCDA) offers a scientifically sound decision framework for management of contaminated materials or sites where stakeholder participation is of crucial concern and criteria such as economics, environmental impacts, safety, and risk cannot be easily condensed into simple monetary expressions. This article brings together a multidisciplinary review of existing decision-making approaches at regulatory agencies in the United States and Europe and synthesizes state-of-the-art research in MCDA methods applicable to the assessment of contaminated sediment management technologies. Additionally, it tests an MCDA approach for coupling expert judgment and stakeholder values in a hypothetical contaminated sediments management case study wherein MCDA is used as a tool for testing stakeholder responses to and improving expert assessment of innovative contaminated sediments technologies.     

Sensitivity Analysis of a Two‐Dimensional Quantitative Microbiological Risk Assessment: Keeping Variability and Uncertainty Separated

The aim of quantitative microbiological risk assessment is to estimate the risk of illness caused by the presence of a pathogen in a food type, and to study the impact of interventions. Because of inherent variability and uncertainty, risk assessments are generally conducted stochastically, and if possible it is advised to characterize variability separately from uncertainty. Sensitivity analysis allows to indicate to which of the input variables the outcome of a quantitative microbiological risk assessment is most sensitive. Although a number of methods exist to apply sensitivity analysis to a risk assessment with probabilistic input variables (such as contamination, storage temperature, storage duration, etc.), it is challenging to perform sensitivity analysis in the case where a risk assessment includes a separate characterization of variability and uncertainty of input variables. A procedure is proposed that focuses on the relation between risk estimates obtained by Monte Carlo simulation and the location of pseudo‐randomly sampled input variables within the uncertainty and variability distributions. Within this procedure, two methods are used—that is, an ANOVA‐like model and Sobol sensitivity indices—to obtain and compare the impact of variability and of uncertainty of all input variables, and of model uncertainty and scenario uncertainty. As a case study, this methodology is applied to a risk assessment to estimate the risk of contracting listeriosis due to consumption of deli meats.     

A Risk Assessment Model for Campylobacter in Broiler Meat

A quantitative microbiological risk assessment model describes the transmission of Campylobacter through the broiler meat production chain and at home, from entering the processing plant until consumption of a chicken breast fillet meal. The exposure model is linked to a dose-response model to allow estimation of the incidence of human campylobacteriosis. The ultimate objective of the model is to serve as a tool to assess the effects of interventions to reduce campylobacteriosis in the Netherlands. The model describes some basic mechanistics of processing, including the nonlinear effects of cross-contamination between carcasses and their leaking feces. Model input is based on the output of an accompanying farm model and Dutch count data of Campylobacters on the birds' exterior and in the feces. When processing data are lacking, expert judgment is used for model parameter estimation. The model shows that to accurately assess of the effects of interventions, numbers of Campylobacter have to be explicitly incorporated in the model in addition to the prevalence of contamination. Also, as count data usually vary by several orders of magnitude, variability in numbers within and especially between flocks has to be accounted for. Flocks with high concentrations of Campylobacter in the feces that leak from the carcasses during industrial processing seem to have a dominant impact on the human incidence. The uncertainty in the final risk estimate is large, due to a large uncertainty at several stages of the chain. Among others, more quantitative count data at several stages of the production chain are needed to decrease this uncertainty. However, this uncertainty is smaller when relative risks of interventions are calculated with the model. Hence, the model can be effectively used by risk management in deciding on strategies to reduce human campylobacteriosis.     

The Role of Decision Analysis in Risk Analysis: A Retrospective

In commemorating the 40th anniversary of Risk Analysis, this article takes a retrospective look at some of the ways in which decision analysis (as a “sibling field”) has contributed to the development both of the journal, and of risk analysis as a field. I begin with some early foundational papers from the first decade of the journal's history. I then review a number of papers that have applied decision analysis to risk problems over the years, including applications of related methods such as influence diagrams, multicriteria decision analysis, and risk matrices. The article then reviews some recent trends, from roughly the last five years, and concludes with observations about the parallel evolution of risk analysis and decision analysis over the decades—especially with regard to the importance of representing multiple stakeholder perspectives, and the importance of behavioral realism in decision models. Overall, the extensive literature surveyed here supports the view that the incorporation of decision-analytic perspectives has improved the practice of risk analysis.     

An Integrated Framework for Environmental Multi‐Impact Spatial Risk Analysis

Quantitative risk analysis is being extensively employed to support policymakers and provides a strong conceptual framework for evaluating decision alternatives under uncertainty. Many problems involving environmental risks are, however, of a spatial nature, i.e., containing spatial impacts, spatial vulnerabilities, and spatial risk‐mitigation alternatives. Recent developments in multicriteria spatial analysis have enabled the assessment and aggregation of multiple impacts, supporting policymakers in spatial evaluation problems. However, recent attempts to conduct spatial multicriteria risk analysis have generally been weakly conceptualized, without adequate roots in quantitative risk analysis. Moreover, assessments of spatial risk often neglect the multidimensional nature of spatial impacts (e.g., social, economic, human) that are typically occurring in such decision problems. The aim of this article is therefore to suggest a conceptual quantitative framework for environmental multicriteria spatial risk analysis based on expected multi‐attribute utility theory. The framework proposes: (i) the formal assessment of multiple spatial impacts; (ii) the aggregation of these multiple spatial impacts; (iii) the assessment of spatial vulnerabilities and probabilities of occurrence of adverse events; (iv) the computation of spatial risks; (v) the assessment of spatial risk mitigation alternatives; and (vi) the design and comparison of spatial risk mitigation alternatives (e.g., reductions of vulnerabilities and/or impacts). We illustrate the use of the framework in practice with a case study based on a flood‐prone area in northern Italy.     

Advances on a Decision Analytic Approach to Exposure-Based Chemical Prioritization

The volume and variety of manufactured chemicals is increasing, although little is known about the risks associated with the frequency and extent of human exposure to most chemicals. The EPA and the recent signing of the Lautenberg Act have both signaled the need for high-throughput methods to characterize and screen chemicals based on exposure potential, such that more comprehensive toxicity research can be informed. Prior work of Mitchell et al. using multicriteria decision analysis tools to prioritize chemicals for further research is enhanced here, resulting in a high-level chemical prioritization tool for risk-based screening. Reliable exposure information is a key gap in currently available engineering analytics to support predictive environmental and health risk assessments. An elicitation with 32 experts informed relative prioritization of risks from chemical properties and human use factors, and the values for each chemical associated with each metric were approximated with data from EPA's CP_CAT database. Three different versions of the model were evaluated using distinct weight profiles, resulting in three different ranked chemical prioritizations with only a small degree of variation across weight profiles. Future work will aim to include greater input from human factors experts and better define qualitative metrics.     

Using In Vitro High‐Throughput Screening Data for Predicting Benzo[k]Fluoranthene Human Health Hazards

Today there are more than 80,000 chemicals in commerce and the environment. The potential human health risks are unknown for the vast majority of these chemicals as they lack human health risk assessments, toxicity reference values, and risk screening values. We aim to use computational toxicology and quantitative high‐throughput screening (qHTS) technologies to fill these data gaps, and begin to prioritize these chemicals for additional assessment. In this pilot, we demonstrate how we were able to identify that benzo[k]fluoranthene may induce DNA damage and steatosis using qHTS data and two separate adverse outcome pathways (AOPs). We also demonstrate how bootstrap natural spline‐based meta‐regression can be used to integrate data across multiple assay replicates to generate a concentration–response curve. We used this analysis to calculate an in vitro point of departure of 0.751 μM and risk‐specific in vitro concentrations of 0.29 μM and 0.28 μM for 1:1,000 and 1:10,000 risk, respectively, for DNA damage. Based on the available evidence, and considering that only a single HSD17B4 assay is available, we have low overall confidence in the steatosis hazard identification. This case study suggests that coupling qHTS assays with AOPs and ontologies will facilitate hazard identification. Combining this with quantitative evidence integration methods, such as bootstrap meta‐regression, may allow risk assessors to identify points of departure and risk‐specific internal/in vitro concentrations. These results are sufficient to prioritize the chemicals; however, in the longer term we will need to estimate external doses for risk screening purposes, such as through margin of exposure methods.     

Application of Graph Theory to Cost‐Effective Fire Protection of Chemical Plants During Domino Effects

In the present study, we have introduced a methodology based on graph theory and multicriteria decision analysis for cost‐effective fire protection of chemical plants subject to fire‐induced domino effects. By modeling domino effects in chemical plants as a directed graph, the graph centrality measures such as out‐closeness and betweenness scores can be used to identify the installations playing a key role in initiating and propagating potential domino effects. It is demonstrated that active fire protection of installations with the highest out‐closeness score and passive fire protection of installations with the highest betweenness score are the most effective strategies for reducing the vulnerability of chemical plants to fire‐induced domino effects. We have employed a dynamic graph analysis to investigate the impact of both the availability and the degradation of fire protection measures over time on the vulnerability of chemical plants. The results obtained from the graph analysis can further be prioritized using multicriteria decision analysis techniques such as the method of reference point to find the most cost‐effective fire protection strategy.     

Some Limitations of Qualitative Risk Rating Systems

Qualitative systems for rating animal antimicrobial risks using ordered categorical labels such as “high,”“medium,” and “low” can potentially simplify risk assessment input requirements used to inform risk management decisions. But do they improve decisions? This article compares the results of qualitative and quantitative risk assessment systems and establishes some theoretical limitations on the extent to which they are compatible. In general, qualitative risk rating systems satisfying conditions found in real‐world rating systems and guidance documents and proposed as reasonable make two types of errors: (1) Reversed rankings, i.e., assigning higher qualitative risk ratings to situations that have lower quantitative risks; and (2) Uninformative ratings, e.g., frequently assigning the most severe qualitative risk label (such as “high”) to situations with arbitrarily small quantitative risks and assigning the same ratings to risks that differ by many orders of magnitude. Therefore, despite their appealing consensus‐building properties, flexibility, and appearance of thoughtful process in input requirements, qualitative rating systems as currently proposed often do not provide sufficient information to discriminate accurately between quantitatively small and quantitatively large risks. The value of information (VOI) that they provide for improving risk management decisions can be zero if most risks are small but a few are large, since qualitative ratings may then be unable to confidently distinguish the large risks from the small. These limitations suggest that it is important to continue to develop and apply practical quantitative risk assessment methods, since qualitative ones are often unreliable.     

Quantifying Uncertainty in a Risk Assessment Using Human Data

A call for risk assessment approaches that better characterize and quantify uncertainty has been made by the scientific and regulatory community. This paper responds to that call by demonstrating a distributional approach that draws upon human data to derive potency estimates and to identify and quantify important sources of uncertainty. The approach is rooted in the science of decision analysis and employs an influence diagram, a decision tree, probabilistic weights, and a distribution of point estimates of carcinogenic potency. Its results estimate the likelihood of different carcinogenic risks (potencies) for a chemical under a specific scenario. For this exercise, human data on formaldehyde were employed to demonstrate the approach. Sensitivity analyses were performed to determine the relative impact of specific levels and alternatives on the potency distribution. The resulting potency estimates are compared with the results of an exercise using animal data on formaldehyde. The paper demonstrates that distributional risk assessment is readily adapted to situations in which epidemiologic data serve as the basis for potency estimates. Strengths and weaknesses of the distributional approach are discussed. Areas for further application and research are recommended.     

Decision Making Under Uncertainty—An Example for Seismic Risk Management

Decision-making techniques are used to select the "best" alternatives under multiple and often conflicting criteria. Multicriteria decision making (MCDM) necessitates to incorporate uncertainties in the decision-making process. The major thrust of this article is to extend the framework proposed by Yager^{( 1 )} for multiple decisionmakers and fuzzy utilities (payoffs). In addition, the concept of expert credibility factor is introduced. The proposed approach is demonstrated for an example of seismic risk management using a heuristic hierarchical structure. A step-by-step formulation of the proposed approach is illustrated using a hypothetical example and a three-story reinforced concrete building.     

Assessing the Exacerbations Risk of Influenza‐Associated Chronic Occupational Asthma

The purpose of this article was to conduct a risk‐based study based on a linkage of experimental human influenza infections and fluctuation analysis of airway function to assess whether influenza viral infection was risk factor for exacerbations of chronic occupational asthma. Here we provided a comprehensive probabilistic analysis aimed at quantifying influenza‐associated exacerbations risk for occupational asthmatics, based on a combination of published distributions of viral shedding and symptoms scores and lung respiratory system properties characterized by long‐range peak expiratory flow (PEF) dynamics. Using a coupled detrended fluctuation analysis‐experimental human influenza approach, we estimated the conditional probability of moderate or severe lung airway obstruction and hence the exacerbations risk of influenza‐associated occupational asthma in individuals. The long‐range correlation exponent (α) was used as a predictor of future exacerbations risk of influenza‐associated asthma. For our illustrative distribution of PEF fluctuations and influenza‐induced asthma exacerbations risk relations, we found that the probability of exacerbations risk can be limited to below 50% by keeping α to below 0.53. This study also found that limiting wheeze scores to 0.56 yields a 75% probability of influenza‐associated asthma exacerbations risk and a limit of 0.34 yields a 50% probability that may give a representative estimate of the distribution of chronic respiratory system properties. This study implicates that influenza viral infection is an important risk factor for exacerbations of chronic occupational asthma.     

What's Wrong with Hazard‐Ranking Systems? An Expository Note

Two commonly recommended principles for allocating risk management resources to remediate uncertain hazards are: (1) select a subset to maximize risk-reduction benefits (e.g., maximize the von Neumann-Morgenstern expected utility of the selected risk-reducing activities), and (2) assign priorities to risk-reducing opportunities and then select activities from the top of the priority list down until no more can be afforded. When different activities create uncertain but correlated risk reductions, as is often the case in practice, then these principles are inconsistent: priority scoring and ranking fails to maximize risk-reduction benefits. Real-world risk priority scoring systems used in homeland security and terrorism risk assessment, environmental risk management, information system vulnerability rating, business risk matrices, and many other important applications do not exploit correlations among risk-reducing opportunities or optimally diversify risk-reducing investments. As a result, they generally make suboptimal risk management recommendations. Applying portfolio optimization methods instead of risk prioritization ranking, rating, or scoring methods can achieve greater risk-reduction value for resources spent.     

An Integrated Approach to Oversight Assessment for Emerging Technologies

Analysis of oversight systems is often conducted from a single disciplinary perspective and by using a limited set of criteria for evaluation. In this article, we develop an approach that blends risk analysis, social science, public administration, legal, public policy, and ethical perspectives to develop a broad set of criteria for assessing oversight systems. Multiple methods, including historical analysis, expert elicitation, and behavioral consensus, were employed to develop multidisciplinary criteria for evaluating oversight of emerging technologies. Sixty‐six initial criteria were identified from extensive literature reviews and input from our Working Group. Criteria were placed in four categories reflecting the development, attributes, evolution, and outcomes of oversight systems. Expert elicitation, consensus methods, and multidisciplinary review of the literature were used to refine a condensed, operative set of criteria. Twenty‐eight criteria resulted spanning four categories: seven development criteria, 15 attribute criteria, five outcome criteria, and one evolution criterion. These criteria illuminate how oversight systems develop, operate, change, and affect society. We term our approach “integrated oversight assessment” and propose its use as a tool for analyzing relationships among features, outcomes, and tradeoffs of oversight systems. Comparisons among historical case studies of oversight using a consistent set of criteria should result in defensible and evidence‐supported lessons to guide the development of oversight systems for emerging technologies, such as nanotechnology.     

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 Multicriteria Decision Analysis Model and Risk Assessment Framework for Carbon Capture and Storage

Multicriteria decision analysis (MCDA) has been applied to various energy problems to incorporate a variety of qualitative and quantitative criteria, usually spanning environmental, social, engineering, and economic fields. MCDA and associated methods such as life‐cycle assessments and cost‐benefit analysis can also include risk analysis to address uncertainties in criteria estimates. One technology now being assessed to help mitigate climate change is carbon capture and storage (CCS). CCS is a new process that captures CO₂ emissions from fossil‐fueled power plants and injects them into geological reservoirs for storage. It presents a unique challenge to decisionmakers (DMs) due to its technical complexity, range of environmental, social, and economic impacts, variety of stakeholders, and long time spans. The authors have developed a risk assessment model using a MCDA approach for CCS decisions such as selecting between CO₂ storage locations and choosing among different mitigation actions for reducing risks. The model includes uncertainty measures for several factors, utility curve representations of all variables, Monte Carlo simulation, and sensitivity analysis. This article uses a CCS scenario example to demonstrate the development and application of the model based on data derived from published articles and publicly available sources. The model allows high‐level DMs to better understand project risks and the tradeoffs inherent in modern, complex energy decisions.     

Use of Advances in Technology for Maritime Risk Assessment

The maritime industry is moving toward a "goal-setting" risk-based regime. This opens the way to safety engineers to explore and exploit flexible and advanced risk modeling and decision-making approaches in the design and operation processes. In this article, following a brief review of the current status of maritime risk assessment, a design/operation selection framework and a design/operation optimization framework are outlined. A general discussion of control engineering techniques and their application to risk modeling and decision making is given. Four novel risk modeling and decision-making approaches are then outlined with illustrative examples to demonstrate their use. Such approaches may be used as alternatives to facilitate risk modeling and decision making in situations where conventional techniques cannot be appropriately applied. Finally, recommendations on further exploitation of advances in general engineering and technology are suggested with respect to risk modeling and decision making.     

Variations in Concepts of "Susceptibility" in Risk Assessment

The Food Quality Protection Act and the 1996 amendments to the Safe Drinking Water Act are two of the most recent examples of legislation calling for protection of susceptible subpopulations. As regulatory deadlines draw nearer, controversies in scientific and policy arenas increase about incorporating susceptibility in risk assessment. The previously accepted working definition of "susceptibility" has already been called into question. Part of the controversy results from different disciplines conceiving of susceptibility in different ways. Understanding the conceptual differences embodied within definitions can provide a basis on which a revised working definition may be developed across disciplines. The purposes of this article are to describe the varying definitions of susceptibility, discuss the differing concepts incorporated in the definitions, and recommend ways in which susceptibility may be defined and framed to meet current risk assessment needs. The present analysis of definitions from the fields of ecology, biology, engineering, medicine, epidemiology, and toxicology revealed different emphases that relate to the underlying perspectives and methods of each field. It is likely that susceptibility will need to be formally defined for public policy purposes, but until that time, the use of more informal communication and decision-making processes is suggested to develop and utilize a new working consensus on the definition of susceptibility.