“How Exposed Is Exposed Enough?” Lay Inferences About Chemical Exposure

The concept of exposure is central to chemical risk assessment and plays an important role in communicating to the public about the potential health risks of chemicals. Research on chemical risk perception has found some indication that the model lay people use to judge chemical exposure differs from that of toxicologists, thereby leading to different conclusions about chemical safety. This paper presents the results of a series of studies directed toward developing a model for understanding how lay people interpret the concept of chemical exposure. The results indicate that people's beliefs about chemical exposure (and its risks) are based on two broad categories of inferences. One category of inferences relates to the nature in which contact with a chemical has taken place, including the amount of a chemical involved and its potential health consequences. A second category of inferences about chemical exposure relates to the pragmatics of language interpretation, leading to beliefs about the motives and purposes behind chemical risk communication. Risk communicators are encouraged to consider how alternative models of exposure and language interpretation can lead to conflicting conclusions on the part of the public about chemical safety.     

Interindividual Variation in Source-Specific Doses is a Determinant of Health Impacts of Combined Chemical Exposures

All individuals are exposed to multiple chemicals from multiple sources. These combined exposures are a concern because they may cause adverse effects that would not occur from an exposure recieved from any single source. Studies of combined chemical exposures, however, have found that the risks posed by such combined exposures are almost always driven by exposures from a few chemicals and sources and frequently by a single chemical from a single source. Here, a series of computer simulations of combined exposures are used to investigate when multiple sources of chemicals drive the largest risks in a population and when a single chemical from a single source is responsible for the largest risks. The analysis found that combined exposures drive the largest risks when the interindividual variation of source-specific doses is small, moderate-to-high correlations occur between the source-specific doses, and the number of sources affecting an individual varies across individuals. These findings can be used to identify sources with the greatest potential to cause combined exposures of concern.     

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.     

Assessments of Direct Human Exposure—The Approach of EU Risk Assessments Compared to Scenario-Based Risk Assessment

The awareness of potential risks emerging from the use of chemicals in all parts of daily life has increased the need for risk assessments that are able to cover a high number of exposure situations and thereby ensure the safety of workers and consumers. In the European Union (EU), the practice of risk assessments for chemicals is laid down in a Technical Guidance Document; it is designed to consider environmental and human occupational and residential exposure. Almost 70 EU risk assessment reports (RARs) have been finalized for high-production-volume chemicals during the last decade. In the present study, we analyze the assessment of occupational and consumer exposure to trichloroethylene and phthalates presented in six EU RARs. Exposure scenarios in these six RARs were compared to scenarios used in applications of the scenario-based risk assessment approach to the same set of chemicals. We find that scenarios used in the selected EU RARs to represent typical exposure situations in occupational or private use of chemicals and products do not necessarily represent worst-case conditions. This can be due to the use of outdated information on technical equipment and conditions in workplaces or omission of pathways that can cause consumer exposure. Considering the need for exposure and risk assessments under the new chemicals legislation of the EU, we suggest that a transparent process of collecting data on exposure situations and of generating representative exposure scenarios is implemented to improve the accuracy of risk assessments. Also, the data sets used to assess human exposure should be harmonized, summarized in a transparent fashion, and made accessible for all risk assessors and the public.     

Perception of Mobile Phone and Base Station Risks

Perceptions of risks associated with mobile phones, base stations, and other sources of electromagnetic fields (EMF) were examined. Data from a telephone survey conducted in the German- and French-speaking parts of Switzerland are presented (N = 1,015). Participants assessed both risks and benefits associated with nine different sources of EMF. Trust in the authorities regulating these hazards was assessed as well. In addition, participants answered a set of questions related to attitudes toward EMF and toward mobile phone base stations. According to respondents' assessments, high-voltage transmission lines are the most risky source of EMF. Mobile phones and mobile phone base stations received lower risk ratings. Results showed that trust in authorities was positively associated with perceived benefits and negatively associated with perceived risks. People who use their mobile phones frequently perceived lower risks and higher benefits than people who use their mobile phones infrequently. People who believed they lived close to a base station did not significantly differ in their level of risks associated with mobile phone base stations from people who did not believe they lived close to a base station. Regarding risk regulation, a majority of participants were in favor of fixing limiting values based on the worst-case scenario. Correlations suggest that belief in paranormal phenomena is related to level of perceived risks associated with EMF. Furthermore, people who believed that most chemical substances cause cancer also worried more about EMF than people who did not believe that chemical substances are that harmful. Practical implications of the results are discussed.     

Chemical and Radiation Environmental Risk Management: Differences, Commonalities, and Challenges

Driven by differing statutory mandates and programmatic separation of regulatory responsibilities between federal, state, and tribal agencies, distinct chemical and radiation risk management strategies have evolved. In the field this separation poses real challenges since many of the major environmental risk management decisions we face today require the evaluation of both types of risks. Over the last decade, federal, state, and tribal agencies have continued to discuss their different approaches and explore areas where their activities could be harmonized. The current framework for managing public exposures to chemical carcinogens has been referred to as a "bottom up approach." Risk between 10(-4) and 10(-6) is established as an upper bound goal. In contrast, a "top down" approach that sets an upper bound dose limit and couples with site specific As Low As Reasonably Achievable Principle (ALARA), is in place to manage individual exposure to radiation. While radiation risk are typically managed on a cumulative basis, exposure to chemicals is generally managed on a chemical-by-chemical, medium-by-medium basis. There are also differences in the nature and size of sites where chemical and radiation contamination is found. Such differences result in divergent management concerns. In spite of these differences, there are several common and practical concerns among radiation and chemical risk managers. They include 1) the issue of cost for site redevelopment and long-term stewardship, 2) public acceptance and involvement, and 3) the need for flexible risk management framework to address the first two issues. This article attempts to synthesize key differences, opportunities for harmonization, and challenges ahead.     

Workers’ Perception of Chemical Risks: A Focus Group Study

Workers’ perceptions with respect to health and safety at work are rarely taken into account when considering the development of prevention programs. The aim of this study was to explore workers’ perceptions of chemical risks at the workplace, in order to investigate the prerequisites for a workplace health program. A qualitative study was conducted involving seven focus groups of 5–10 participants (blue‐collar workers) each. All groups were homogeneous in terms of sex, work status, language, and company membership. Results showed that several factors have an important influence on workers’ perception of chemical risks. Workers assess risks by means of both sensory and empirical diagnosis and are concerned about the long‐term health consequences. They perceive the threat of chemical risks as high. Despite this, they are resigned to accepting the risks. Existing formal sources of information are rarely consulted because they are judged to be difficult to understand and not user friendly. Instead, workers tend to obtain information from informal sources. Communication problems with and lack of trust in prevention advisers and hierarchy are frequently mentioned. Workers feel that their specific knowledge of their working conditions and their proposals for practical, cost‐effective solutions to improve health and safety at the workplace are insufficiently taken into account. The use of focus groups yielded a useful insight into workers’ perceptions of chemical risks. Our findings suggest that training programs for prevention advisers should include topics such as understanding of workers’ perceptions, usefulness of a participatory approach, and communication and education skills.     

Risk Assessment and Alternatives Assessment: Comparing Two Methodologies

The selection and use of chemicals and materials with less hazardous profiles reflects a paradigm shift from reliance on risk minimization through exposure controls to hazard avoidance. This article introduces risk assessment and alternatives assessment frameworks in order to clarify a misconception that alternatives assessment is a less effective tool to guide decision making, discusses factors promoting the use of each framework, and also identifies how and when application of each framework is most effective. As part of an assessor's decision process to select one framework over the other, it is critical to recognize that each framework is intended to perform different functions. Although the two frameworks share a number of similarities (such as identifying hazards and assessing exposure), an alternatives assessment provides a more realistic framework with which to select environmentally preferable chemicals because of its primary reliance on assessing hazards and secondary reliance on exposure assessment. Relevant to other life cycle impacts, the hazard of a chemical is inherent, and although it may be possible to minimize exposure (and subsequently reduce risk), it is challenging to assess such exposures through a chemical's life cycle. Through increased use of alternatives assessments at the initial stage of material or product design, there will be less reliance on post facto risk‐based assessment techniques because the potential for harm is significantly reduced, if not avoided, negating the need for assessing risk in the first place.     

The European Commission''s White Paper "Strategy for a Future Chemicals Policy": A Review

The European Commission has proposed a radical new policy for the regulation of chemicals in the EU in the form of a White Paper. The current system has separate regulatory provisions for "new" chemicals (introduced to the market since September 18, 1981) and "existing" chemicals (on the market before September 18,1981). The proposed future policy will have a single unified regulatory system for all chemicals, which should result in better regulation of chemicals in the EU single market. It will be better because risk assessments will be targeted at the chemicals of greatest concern. Furthermore, the system will be streamlined, making regulatory decisions faster, and thus reducing the so-called burden of the past (the large number of chemicals that have never been assessed for their risks to human health or the environment). The new system incorporates the precautionary principle, which will be applied where there is an early indication of unacceptable risk or where there is undue delay in the regulatory process. Moreover, the new strategy is intended to promote greater transparency for all stakeholders.     

Peak Exposures in Epidemiologic Studies and Cancer Risks: Considerations for Regulatory Risk Assessment

We review approaches for characterizing “peak” exposures in epidemiologic studies and methods for incorporating peak exposure metrics in dose–response assessments that contribute to risk assessment. The focus was on potential etiologic relations between environmental chemical exposures and cancer risks. We searched the epidemiologic literature on environmental chemicals classified as carcinogens in which cancer risks were described in relation to “peak” exposures. These articles were evaluated to identify some of the challenges associated with defining and describing cancer risks in relation to peak exposures. We found that definitions of peak exposure varied considerably across studies. Of nine chemical agents included in our review of peak exposure, six had epidemiologic data used by the U.S. Environmental Protection Agency (US EPA) in dose–response assessments to derive inhalation unit risk values. These were benzene, formaldehyde, styrene, trichloroethylene, acrylonitrile, and ethylene oxide. All derived unit risks relied on cumulative exposure for dose–response estimation and none, to our knowledge, considered peak exposure metrics. This is not surprising, given the historical linear no‐threshold default model (generally based on cumulative exposure) used in regulatory risk assessments. With newly proposed US EPA rule language, fuller consideration of alternative exposure and dose–response metrics will be supported. “Peak” exposure has not been consistently defined and rarely has been evaluated in epidemiologic studies of cancer risks. We recommend developing uniform definitions of “peak” exposure to facilitate fuller evaluation of dose response for environmental chemicals and cancer risks, especially where mechanistic understanding indicates that the dose response is unlikely linear and that short‐term high‐intensity exposures increase risk.     

Bridging the Gap between Social Acceptance and Ethical Acceptability

New technology brings great benefits, but it can also create new and significant risks. When evaluating those risks in policymaking, there is a tendency to focus on social acceptance. By solely focusing on social acceptance, we could, however, overlook important ethical aspects of technological risk, particularly when we evaluate technologies with transnational and intergenerational risks. I argue that good governance of risky technology requires analyzing both social acceptance and ethical acceptability. Conceptually, these two notions are mostly complementary. Social acceptance studies are not capable of sufficiently capturing all the morally relevant features of risky technologies; ethical analyses do not typically include stakeholders’ opinions, and they therefore lack the relevant empirical input for a thorough ethical evaluation. Only when carried out in conjunction are these two types of analysis relevant to national and international governance of risky technology. I discuss the Rawlsian wide reflective equilibrium as a method for marrying social acceptance and ethical acceptability. Although the rationale of my argument is broadly applicable, I will examine the case of multinational nuclear waste repositories in particular. This example will show how ethical issues may be overlooked if we focus only on social acceptance, and will provide a test case for demonstrating how the wide reflective equilibrium can help to bridge the proverbial acceptance‐acceptability gap.     

Times Are Tough—Brother,Can You Paradigm?

Ten years ago, the National Academy of Science released its risk assessment/risk management (RA/RM) “paradigm” that served to crystallize much of the early thinking about these concepts. By defining RA as a four-step process, operationally independent from RM, the paradigm has presented society with a scheme, or a conceptually common framework, for addressing many risky situations (e.g., carcinogens, noncarcinogens, and chemical mixtures). The procedure has facilitated decision-making in a wide variety of situations and has identified the most important research needs. The past decade, however, has revealed that additional progress is needed. These areas include addressing the appropriate interaction (not isolation) between RA and RM, improving the methods for assessing risks from mixtures, dealing with “adversity of effect,” deciding whether “hazard” should imply an exposure to environmental conditions or to laboratory conditions, and evolving the concept to include both health and ecological risk. Interest in and expectations of risk assessment are increasing rapidly. The emerging concept of “comparative risk” (i.e., distinguishing between large risks and smaller risks that may be qualitatively different) is at a level comparable to that held by the concept of “risk” just 10 years ago. Comparative risk stands in need of a paradigm of its own, especially given the current economic limitations. “Times are tough; Brother, can you paradigm?”     

The Use of Mental Models in Chemical Risk Protection: Developing a Generic Workplace Methodology

We adopted a comparative approach to evaluate and extend a generic methodology to analyze the different sets of beliefs held about chemical hazards in the workplace. Our study mapped existing knowledge structures about the risks associated with the use of perchloroethylene and rosin-based solder flux in differing workplaces. "Influence diagrams" were used to represent beliefs held by chemical experts; "user models" were developed from data elicited from open-ended interviews with the workplace users of the chemicals. The juxtaposition of expert and user understandings of chemical risks enabled us to identify knowledge gaps and misunderstandings and to reinforce appropriate sets of safety beliefs and behavior relevant to chemical risk communications. By designing safety information to be more relevant to the workplace context of users, we believe that employers and employees may gain improved knowledge about chemical hazards in the workplace, such that better chemical risk management, self-protection, and informed decision making develop over time.     

Applicability of a Neuroprobabilistic Integral Risk Index for the Environmental Management of Polluted Areas: A Case Study

Recently, we developed a GIS-Integrated Integral Risk Index (IRI) to assess human health risks in areas with presence of environmental pollutants. Contaminants were previously ranked by applying a self-organizing map (SOM) to their characteristics of persistence, bioaccumulation, and toxicity in order to obtain the Hazard Index (HI). In the present study, the original IRI was substantially improved by allowing the entrance of probabilistic data. A neuroprobabilistic HI was developed by combining SOM and Monte Carlo analysis. In general terms, the deterministic and probabilistic HIs followed a similar pattern: polychlorinated biphenyls (PCBs) and light polycyclic aromatic hydrocarbons (PAHs) were the pollutants showing the highest and lowest values of HI, respectively. However, the bioaccumulation value of heavy metals notably increased after considering a probability density function to explain the bioaccumulation factor. To check its applicability, a case study was investigated. The probabilistic integral risk was calculated in the chemical/petrochemical industrial area of Tarragona (Catalonia, Spain), where an environmental program has been carried out since 2002. The risk change between 2002 and 2005 was evaluated on the basis of probabilistic data of the levels of various pollutants in soils. The results indicated that the risk of the chemicals under study did not follow a homogeneous tendency. However, the current levels of pollution do not mean a relevant source of health risks for the local population. Moreover, the neuroprobabilistic HI seems to be an adequate tool to be taken into account in risk assessment processes.     

Expert and Public Perception of Risk from Biotechnology

Risk perceptions of a series of biotechnology applications were examined in a public (nonexpert) sample and an expert sample. Compared with the experts, the public perceived all biotechnology applications as more risky. Both groups perceived food-related applications to be riskier than medical applications. Compared with the public, experts perceived both food and medical applications as less harmful and more useful. Experts also judged the risks posed from medical biotechnology applications as more familiar and acknowledged by people and science. Lay estimates of the risk of food applications were predicted by potential harm, potential benefits, science knowledge, and familiarity; experts' estimates were predicted only by harm and benefits. Lay estimates of the risk of medical applications were predicted by potential harm; experts' estimates were predicted by potential benefits, number and type of people exposed, and science knowledge. We discuss the implications of the results for risk communication about and management of different types of biotechnologies.     

Forty Years of Food Safety Risk Assessment: A History and Analysis

Before the founding of the Society for Risk Analysis (SRA) in 1980, food safety in the United States had long been a concern, but there was a lack of systematic methods to assess food-related risks. In 1906, the U.S. Congress passed, and President Roosevelt signed, the Pure Food and Drug Act and the Meat Inspection Act to regulate food safety at the federal level. This Act followed the publication of multiple reports of food contamination, culminating in Upton Sinclair's novel The Jungle, which highlighted food and worker abuses in the meatpacking industry. Later in the 20th century, important developments in agricultural and food technology greatly increased food production. But chemical exposures from agricultural and other practices resulted in major amendments to federal food laws, including the Delaney Clause, aimed specifically at cancer-causing chemicals. Later in the 20th century, when quantitative risk assessment methods were given greater scientific status in a seminal National Research Council report, food safety risk assessment became more systematized. Additionally, in these last 40 years, food safety research has resulted in increased understanding of a range of health effects from foodborne chemicals, and technological developments have improved U.S. food safety from farm to fork by offering new ways to manage risks. We discuss the history of food safety and the role risk analysis has played in its evolution, starting from over a century ago, but focusing on the last 40 years. While we focus on chemical risk assessment in the U.S., we also discuss microbial risk assessment and international food safety.     

Evaluating the Simplified Conjoint Expected Risk Model: Comparing the Use of Objective and Subjective Information

The simplified Conjoint Expected Risk (CER) model by Holtgrave and Weber posits that perceived risk is a linear combination of the subjective judgments of the probabilities of harm, benefit, and status quo, and the expected harm and benefit of an activity. It modifies Luce and Weber's original CER model—that uses objective information to evaluate financial gambles—to accommodate activities such as health/technology activities where values of the model variables are subjective. If the simplified model is a valid modification of the original model, its performance should not be sensitive to the use of subjective information. However, because people may evaluate information differently when objective information is provided to them than when they generate information on their own, the performance of the simplified CER model may not be robust to the source of model-variable information. We compared the use of objective and subjective information, and results indicate that the estimates of the simplified CER model parameters and the proportion of variance in risk judgments accounted for by the model are similar under these two conditions. Thus, the simplified CER model is viable with activities for which harm and benefit information is subjective.     

Judgments of Chemical Risks: Comparisons Among Senior Managers, Toxicologists, and the Public

Nineteen Senior Managers of a major chemical company in the United Kingdom participated in a survey to determine their attitudes, beliefs, and perceptions regarding risks from chemicals. Similar surveys had previously been conducted with toxicologists and members of the general public in the United States and Canada. In general, the Senior Managers tended to judge risks to be quite small for most chemicals. Moreover, they had lower risk perceptions than did members of the British Toxicological Society and even far lower perceptions of risk than a comparison group of members of the Canadian public. The managers held views that were similar to British toxicologists working in industry and government and dissimilar to the views of toxicologists working in academia. The observed differences between views of managers, toxicologists, and the public must be recognized and understood in order to facilitate communication and constructive efforts to manage chemical risks.     

Reducing Conservatism in Risk Estimation for Mixtures of Carcinogens

The excess cancer risk that might result from exposure to a mixture of chemical carcinogens usually must be estimated using data from experiments conducted with individual chemicals. In estimating such risk, it is commonly assumed that the total risk due to the mixture is the sum of the risks of the individual components, provided that the risks associated with individual chemicals at levels present in the mixture are low. This assumption, while itself not necessarily conservative, has led to the conservative practice of summing individual upper-bound risk estimates in order to obtain an upper bound on the total excess cancer risk for a mixture. Less conservative procedures are described here and are illustrated for the case of a mixture of four carcinogens.