Science and Decisions: Advancing Risk Assessment

At the request of the U.S. Environmental Protection Agency (EPA), the National Research Council (NRC) recently completed a major report, Science and Decisions: Advancing Risk Assessment, that is intended to strengthen the scientific basis, credibility, and effectiveness of risk assessment practices and subsequent risk management decisions. The report describes the challenges faced by risk assessment and the need to consider improvements in both the technical analyses of risk assessments (i.e., the development and use of scientific information to improve risk characterization) and the utility of risk assessments (i.e., making assessments more relevant and useful for risk management decisions). The report tackles a number of topics relating to improvements in the process, including the design and framing of risk assessments, uncertainty and variability characterization, selection and use of defaults, unification of cancer and noncancer dose‐response assessment, cumulative risk assessment, and the need to increase EPA's capacity to address these improvements. This article describes and summarizes the NRC report, with an eye toward its implications for risk assessment practices at EPA.     

Personal Values, Beliefs, and Ecological Risk Perception

A mail survey on ecological risk perception was administered in the summer of 2002 to a randomized sample of the lay public and to selected risk professionals at the U.S. Environmental Protection Agency (US EPA). The ranking of 24 ecological risk items, from global climate change to commercial fishing, reveals that the lay public is more concerned about low-probability, high-consequence risks whereas the risk professionals are more concerned about risks that pose long-term, ecosystem-level impacts. To test the explanatory power of the value-belief-norm (VBN) theory for risk perception, respondents were questioned about their personal values, spiritual beliefs, and worldviews. The most consistent predictors of the risk rankings are belief in the new ecological paradigm (NEP) and Schwartz's altruism. The NEP and Schwartz's altruism explain from 19% to 46% of the variance in the risk rankings. Religious beliefs account for less than 6% of the variance and do not show a consistent pattern in predicting risk perception although religious fundamentalists are generally less concerned about the risk items. While not exerting as strong an impact, social-structural variables do have some influence on risk perception. Ethnicities show no effect on the risk scales but the more educated and financially well-off are less concerned about the risk items. Political leanings have no direct influence on risk rankings, but indirectly affect rankings through the NEP. These results reveal that the VBN theory is a plausible explanation for the differences measured in the respondents' perception of ecological risk.     

An Emerging New Risk Analysis Science: Foundations and Implications

To solve real‐life problems—such as those related to technology, health, security, or climate change—and make suitable decisions, risk is nearly always a main issue. Different types of sciences are often supporting the work, for example, statistics, natural sciences, and social sciences. Risk analysis approaches and methods are also commonly used, but risk analysis is not broadly accepted as a science in itself. A key problem is the lack of explanatory power and large uncertainties when assessing risk. This article presents an emerging new risk analysis science based on novel ideas and theories on risk analysis developed in recent years by the risk analysis community. It builds on a fundamental change in thinking, from the search for accurate predictions and risk estimates, to knowledge generation related to concepts, theories, frameworks, approaches, principles, methods, and models to understand, assess, characterize, communicate, and (in a broad sense) manage risk. Examples are used to illustrate the importance of this distinct/separate risk analysis science for solving risk problems, supporting science in general and other disciplines in particular.     

Values and Risk Perceptions: A Cross‐Cultural Examination

This article examines the relationship between values and risk perceptions regarding terror attacks. The participants in the study are university students from Turkey (n = 536) and Israel (n = 298). Schwartz value theory (1992, 1994) is applied to conceptualize and measure values. Cognitive (perceived likelihood and perceived severity) and emotional (fear, helplessness, anger, distress, insecurity, hopelessness, sadness, and anxiety) responses about the potential of (i) being personally exposed to a terror attack, and (ii) a terror attack that may occur in one's country are assessed to measure risk perceptions. Comparison of the two groups suggests that the Turkish participants are significantly more emotional about terror risks than the Israeli respondents. Both groups perceive the risk of a terror attack that may occur in their country more likely than the risk of being personally exposed to a terror attack. No significant differences are found in emotional representations and perceived severity ratings regarding these risks. Results provide support for the existence of a link between values and risk perceptions of terror attacks. In both countries, self‐direction values are negatively related to emotional representations, whereas security values are positively correlated with emotions; hedonism and stimulation values are negatively related to perceived likelihood. Current findings are discussed in relation to previous results, theoretical approaches (the social amplification of risk framework and cultural theory of risk), and practical implications (increasing community support for a course of action, training programs for risk communicators).     

Risk Communication,Values Clarification,and Vaccination Decisions

Many health‐related decisions require choosing between two options, each with risks and benefits. When presented with such tradeoffs, people often make choices that fail to align with scientific evidence or with their own values. This study tested whether risk communication and values clarification methods could help parents and guardians make evidence‐based, values‐congruent decisions about children's influenza vaccinations. In 2013–2014 we conducted an online 2×2 factorial experiment in which a diverse sample of U.S. parents and guardians (n = 407) were randomly assigned to view either standard information about influenza vaccines or risk communication using absolute and incremental risk formats. Participants were then either presented or not presented with an interactive values clarification interface with constrained sliders and dynamic visual feedback. Participants randomized to the risk communication condition combined with the values clarification interface were more likely to indicate intentions to vaccinate (β = 2.10, t(399) = 2.63, p < 0.01). The effect was particularly notable among participants who had previously demonstrated less interest in having their children vaccinated against influenza (β = –2.14, t(399) = –2.06, p < 0.05). When assessing vaccination status reported by participants who agreed to participate in a follow‐up study six months later (n = 116), vaccination intentions significantly predicted vaccination status (OR = 1.66, 95%CI (1.13, 2.44), p < 0.05) and rates of informed choice (OR = 1.51, 95%CI (1.07, 2.13), p < 0.012), although there were no direct effects of experimental factors on vaccination rates. Qualitative analysis suggested that logistical barriers impeded immunization rates. Risk communication and values clarification methods may contribute to increased vaccination intentions, which may, in turn, predict vaccination status if logistical barriers are also addressed.     

Facts and Values in Risk Analysis for Environmental Toxicants

The U.S. Office of Science and Technology Policy describes toxic substance regulation as composed of two stages. Stage I (facts) uses empirical data and scientific judgment to characterize human exposure and risk. Stage II (values) uses social and political judgment to decide regulatory action based on significance of the risk, benefits of the agent, and costs of its control. This paper argues that such a view represents an unrealistic and unattainable goal. We present examples showing how values enter virtually every part of risk analysis, and we review work on the vagaries in human judgment concerning both facts and values. These issues indicate that U.S. regulatory policy needs reconsideration.     

The Effect of Risk Beliefs on Property Values: A Case Study of a Hazardous Waste Site1

Health risk beliefs of homeowners near a landfill site were assessed in a survey and compared to expert judgments of the health risks of living near the site. A bimodal distribution of health risk beliefs suggested sharp disagreement between the experts and at least some of the residents. Correlates of high risk beliefs included perception of odor from the site, exposure to media coverage of the problem, having children living at home, age (younger respondents more concerned), and gender (females more concerned). An aggregated neighborhood health risk belief predicted reductions in home prices even after controlling for home physical characteristics, such as size and other disamenities such as proximity to a freeway. In the 4100 homes near the site, the estimated depression in property values was estimated to total about $40.2 million before the site was closed and to be about $19.7 million after closure. Implications of these results for community conflict and for benefit-cost analysis of hazard site remediation are discussed.     

Risk Science Contributions: Three Illustrating Examples

This article aims to demonstrate that risk science is important for society, industry and all of us. Rather few people today, including scientists and managers, are familiar with what this science is about—its foundation and main features—and how it is used to gain knowledge and improve communication and decision making in real-life situations. The article seeks to meet this challenge, by presenting three examples, showing how risk science works to gain new generic, fundamental knowledge on risk concepts, principles, and methods, as well as supporting the practical tackling of actual risk problems.     

Part I––Comparing Noncancer Chronic Human Health Reference Values: An Analysis of Science Policy Choices

The goal of this study was to systematically evaluate the choices made in deriving a chronic oral noncancer human health reference value (HHRV) for a given chemical by different organizations, specifically those from the U.S. Environmental Protection Agency, Health Canada, RIVM (the Netherlands), and the U.S. Agency for Toxic Substances and Disease Registry. This analysis presents a methodological approach for comparing both the HHRVs and the specific choices made in the process of deriving an HHRV across these organizations. Overall, across the 96 unique chemicals and 171 two‐way organizational comparisons, the HHRV agreed approximately 26% of the time. A qualitative method for identifying the primary factors influencing these HHRV differences was also developed, using arrays of HHRVs across organizations for the same chemical. The primary factors identified were disagreement on the critical or principal study and differential application of the total uncertainty factor across organizations. Of the cases where the total UF was the primary factor influencing HHRV disagreement, the database UF had the greatest influence.     

Recommended Reference Values for Risk Assessment of Oral Exposure to Copper

The U.S. Environmental Protection Agency's (EPA) Integrated Risk Information System (IRIS) database, the authoritative source of U.S. risk assessment toxicity factors, currently lacks an oral reference dose (RfD) for copper. In the absence of such a value, various health-based reference values for copper are available for use in risk assessment. We summarize the scientific bases and differences in assumptions among key reference values for ingested copper to guide selection of appropriate values for risk assessment. A comprehensive review of the scientific literature best supports the oral RfD of 0.04 mg/kg body weight/day derived by EPA from their Drinking Water Action Level. This value is based on acute gastrointestinal effects but is further supported by broader analysis of copper deficiency and toxicity.     

Presenting Uncertainty in Health Risk Assessment: Initial Studies of Its Effects on Risk Perception and Trust

Some analysts suggest that discussing uncertainties in health risk assessments might reduce citizens'perceptions of risk and increase their respect for the risk-assessing agency. We tested this assumption with simulated news stories varying simple displays of uncertainty (e.g., a range of risk estimates, with and without graphics). Subjects from Eugene, Oregon, read one story each, and then answered a questionnaire. Three studies tested between 180 and 272 subjects each. Two focus groups obtained more detailed responses to these stories. The results suggested that (1) people are unfamiliar with uncertainty in risk assessments and in science; (2) people may recognize uncertainty when it is presented simply; (3) graphics may help people recognize uncertainty; (4) reactions to the environmental problems in the stories seemed affected less by presentation of uncertainty than by general risk attitudes and perceptions; (5) agency discussion of uncertainty in risk estimates may signal agency honesty and agency incompetence for some people; and (6) people seem to see lower risk estimates (10^-6, as opposed to 10^-3) as less credible. These findings, if confirmed, would have important implications for risk communication.     

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.     

Cross-Cultural Differences in Risk Perception: A Model-Based Approach

The present study assessed cross-cultural differences in the perception of financial risks. Students at large universities in Hong Kong, Taiwan, the Netherlands, and the U.S., as well as a group of Taiwanese security analysts rated the riskiness of a set of monetary lotteries. Risk judgments differed with nationality, but not with occupation (students vs. security analysts) and were modeled by the Conjoint Expected Risk (CER) model.⁽¹⁾ Consistent with cultural differences in country uncertainty avoidance,⁽²⁾ CER model parameters of respondents from the two Western countries differed from those of respondents from the two countries with Chinese cultural roots: The risk judgments of respondents from Hong Kong and Taiwan were more sensitive to the magnitude of potential losses and less mitigated by the probability of positive outcomes.     

Unquestioned Answers or Unanswered Questions: Beliefs About Science Guide Responses to Uncertainty in Climate Change Risk Communication

In two experimental studies we investigated the effect of beliefs about the nature and purpose of science (classical vs. Kuhnian models of science) on responses to uncertainty in scientific messages about climate change risk. The results revealed a significant interaction between both measured (Study 1) and manipulated (Study 2) beliefs about science and the level of communicated uncertainty on willingness to act in line with the message. Specifically, messages that communicated high uncertainty were more persuasive for participants who shared an understanding of science as debate than for those who believed that science is a search for absolute truth. In addition, participants who had a concept of science as debate were more motivated by higher (rather than lower) uncertainty in climate change messages. The results suggest that achieving alignment between the general public's beliefs about science and the style of the scientific messages is crucial for successful risk communication in science. Accordingly, rather than uncertainty always undermining the effectiveness of science communication, uncertainty can enhance message effects when it fits the audience's understanding of what science is.     

Decisions,Science, and Values: Crafting Regulatory Alternatives Analysis

Emerging “prevention‐based” approaches to chemical regulation seek to minimize the use of toxic chemicals by mandating or directly incentivizing the adoption of viable safer alternative chemicals or processes. California and Maine are beginning to implement such programs, requiring manufacturers of consumer products containing certain chemicals of concern to identify and evaluate potential safer alternatives. In the European Union, the REACH program imposes similar obligations on manufacturers of certain substances of very high concern. Effective prevention‐based regulation requires regulatory alternatives analysis (RAA), a methodology for comparing and evaluating the regulated chemical or process and its alternatives across a range of relevant criteria. RAA has both public and private dimensions. To a significant degree, alternatives analysis is an aspect of product design; that is, the process by which private industry designs the goods it sells. Accordingly, an RAA method should reflect the attributes of well‐crafted product design tools used by businesses. But RAA adds health and environmental objectives to the mix of concerns taken into account by the product designer. Moreover, as part of a prevention‐based regulatory regime, it implicates important public values such as legitimacy, equity, public engagement, and accountability. Thus, an RAA should reflect both private standards and public values, and be evaluated against them. This article adopts that perspective, identifying an integrated set of design principles for RAA, and illustrating the application of those principles.     

Perceived Risk and Uncertainty of Nuclear Waste: Differences Among Science,Business, and Environmental Group Members1

This paper presents survey results on perceived risk regarding the management of nuclear waste. Using data taken from random mail surveys of members of scientific, business, and environmental groups in Colorado and New Mexico in the summer of 1990, we examine differences between the groups in their expressed perceptions of risk and also their assessments of the certainty of their beliefs. We consider whether (a) greater uncertainty is associated with greater perceived risks and (b) whether there is greater responsiveness to new information for those whose beliefs are least certain. We find that there are connections between perceived risk and uncertainty, and there is a greater tendency to update risk assessements from a position of greater initial uncertainty. There are, however, differences between the groups as well as asymmetries in their responses to new information. The latter suggests that perceived risks will ratchet upward over time even when information is not biased toward more or less risk.     

Variability and Uncertainty Meet Risk Management and Risk Communication

In the past decade, the use of probabilistic risk analysis techniques to quantitatively address variability and uncertainty in risks increased in popularity as recommended by the 1994 National Research Council that wrote Science and Judgment in Risk Assessment. Under the 1996 Food Quality Protection Act, for example, the U.S. EPA supported the development of tools that produce distributions of risk demonstrating the variability and/or uncertainty in the results. This paradigm shift away from the use of point estimates creates new challenges for risk managers, who now struggle with decisions about how to use distributions in decision making. The challenges for risk communication, however, have only been minimally explored. This presentation uses the case studies of variability in the risks of dying on the ground from a crashing airplane and from the deployment of motor vehicle airbags to demonstrate how better characterization of variability and uncertainty in the risk assessment lead to better risk communication. Analogies to food safety and environmental risks are also discussed. This presentation demonstrates that probabilistic risk assessment has an impact on both risk management and risk communication, and highlights remaining research issues associated with using improved sensitivity and uncertainty analyses in risk assessment.     

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.