The Fallacy of Ranking Possible Carcinogen Hazards Using the TD50

Ames et al. have proposed a new model for evaluating carcinogenic hazards in the environment. They advocate ranking possible carcinogens on the basis of the TD50, the estimated dose at which 50% of the test animals would get tumors, and extrapolating that ranking to all other doses. We argue that implicit in this methodology is a simplistic and inappropriate statistical model. All carcinogens are assumed to act similarly and to have dose-response curves of the same shape that differ only in the value of one parameter. We show by counterexample that the rank order of cancer potencies for two chemicals can change over a reasonable range of doses. Ames et al.'s use of these TD50 ranks to compare the hazards from low level exposures to contaminants in our food and environment is wholly inappropriate and inaccurate. Their dismissal of public health concern for environmental exposures, in general, based on these comparisons, is not supported by the data.     

Accident Epidemiology and the U.S. Chemical Industry: Accident History and Worst-Case Data from RMP*Info

This article reports on the data collected on one of the most ambitious government-sponsored environmental data acquisition projects of all time, the Risk Management Plan (RMP) data collected under section 112(r) of the Clean Air Act Amendments of 1990. This RMP Rule 112(r) was triggered by the Bhopal accident in 1984 and led to the requirement that each qualifying facility develop and file with the U.S. Environmental Protection Agency a Risk Management Plan (RMP) as well as accident history data for the five-year period preceding the filing of the RMP. These data were collected in 1999-2001 on more than 15,000 facilities in the United States that store or use listed toxic or flammable chemicals believed to be a hazard to the environment or to human health of facility employees or off-site residents of host communities. The resulting database, RMP*Info, has become a key resource for regulators and researchers concerned with the frequency and severity of accidents, and the underlying facility-specific factors that are statistically associated with accident and injury rates. This article analyzes which facilities actually filed under the Rule and presents results on accident frequencies and severities available from the RMP*Info database. This article also presents summaries of related results from RMP*Info on Offsite Consequence Analysis (OCA), an analytical estimate of the potential consequences of hypothetical worst-case and alternative accidental releases on the public and environment around the facility. The OCA data have become a key input in the evaluation of site security assessment and mitigation policies for both government planners as well as facility managers and their insurers. Following the survey of the RMP*Info data, we discuss the rich set of policy decisions that may be informed by research based on these data.     

A Systematic Uncertainty Analysis of an Evaluative Fate and Exposure Model

Multimedia fate and exposure models are widely used to regulate the release of toxic chemicals, to set cleanup standards for contaminated sites, and to evaluate emissions in life-cycle assessment. CalTOX, one of these models, is used to calculate the potential dose, an outcome that is combined with the toxicity of the chemical to determine the Human Toxicity Potential (HTP), used to aggregate and compare emissions. The comprehensive assessment of the uncertainty in the potential dose calculation in this article serves to provide the information necessary to evaluate the reliability of decisions based on the HTP A framework for uncertainty analysis in multimedia risk assessment is proposed and evaluated with four types of uncertainty. Parameter uncertainty is assessed through Monte Carlo analysis. The variability in landscape parameters is assessed through a comparison of potential dose calculations for different regions in the United States. Decision rule uncertainty is explored through a comparison of the HTP values under open and closed system boundaries. Model uncertainty is evaluated through two case studies, one using alternative formulations for calculating the plant concentration and the other testing the steady state assumption for wet deposition. This investigation shows that steady state conditions for the removal of chemicals from the atmosphere are not appropriate and result in an underestimate of the potential dose for 25% of the 336 chemicals evaluated.     

Do environmental management systems improve business performance in an international setting?

With the worldwide increase in the adoption of environmental management systems (EMSs), some research has emerged that evaluates the reasons why facilities adopt them. However, there is little information about how these motivations extend to different international settings, and the link between the comprehensiveness of an EMS and business performance has yet to be demonstrated. While both institutional pressures and resources and capabilities may encourage EMS adoption and improved business performance, questions remain about whether organizations that are motivated mainly by their resources and capabilities benefit to the same extent as organizations that are driven to adopt an EMS mainly because of institutional pressures. We analyze these relationships using OECD survey data from manufacturing facilities operating in Canada, Germany, Hungary, and the United States. Our results show that facilities that are motivated to adopt more comprehensive EMSs because of their complementary resources and capabilities, such as export orientation, employee commitment and environmental R&D, (as opposed to institutional pressures) observe greater overall facility-level business performance.     

Risk Assessment of Escherichia coli O157 Illness from Consumption of Hamburgers in the United States Made from Australian Manufacturing Beef

We analyze the risk of contracting illness due to the consumption in the United States of hamburgers contaminated with enterohemorrhagic Escherichia coli (EHEC) of serogroup O157 produced from manufacturing beef imported from Australia. We have used a novel approach for estimating risk by using the prevalence and concentration estimates of E. coli O157 in lots of beef that were withdrawn from the export chain following detection of the pathogen. For the purpose of the present assessment an assumption was that no product is removed from the supply chain following testing. This, together with a number of additional conservative assumptions, leads to an overestimation of E. coli O157‐associated illness attributable to the consumption of ground beef patties manufactured only from Australian beef. We predict 49.6 illnesses (95%: 0.0–148.6) from the 2.46 billion hamburgers made from 155,000 t of Australian manufacturing beef exported to the United States in 2012. All these illness were due to undercooking in the home and less than one illness is predicted from consumption of hamburgers cooked to a temperature of 68 °C in quick‐service restaurants.     

Methodology for setting risk-based concentrations of contaminants in soil and groundwater and application to a model contaminated site

In Japan, environmental standards for contaminants in groundwater and in leachate from soil are set with the assumption that they are used for drinking water over a human lifetime. Where there is neither a well nor groundwater used for drinking, the standard is thus too severe. Therefore, remediation based on these standards incurs excessive effort and cost. In contrast, the environmental-assessment procedure used in the United States and the Netherlands considers the site conditions (land use, existing wells, etc.); however, a risk assessment is required for each site. Therefore, this study proposes a new framework for judging contamination in Japan by considering the merits of the environmental standards used and a method for risk assessment. The framework involves setting risk-based concentrations that are attainable remediation goals for contaminants in soil and groundwater. The framework was then applied to a model contaminated site for risk management, and the results are discussed regarding the effectiveness and applicability of the new methodology.     

Who Lives Near Coke Plants and Oil Refineries? An Exploration of the Environmental Inequity Hypothesis

Facility-specific information on pollution was obtained for 36 coke plants and 46 oil refineries in the United States and matched with information on populations surrounding these 82 facilities. These data were analyzed to determine whether environmental inequities were present, whether they were more economic or racial in nature, and whether the racial composition of nearby communities has changed significantly since plants began operations.The Census tracts near coke plants have a disproportionate share of poor and nonwhite residents. Multivariate analyses suggest that existing inequities are primarily economic in nature. The findings for oil refineries are not strongly supportive of the environmental inequity hypothesis. Rank ordering of facilities by race, poverty, and pollution produces limited (although not consistent) evidence that the more risky facilities tend to be operating in communities with above-median proportions of nonwhite residents (near coke plants) and Hispanic residents (near oil refineries). Over time, the racial makeup of many communities near facilities has changed significantly, particularly in the case of coke plants sited in the early 1900s. Further risk-oriented studies of multiple manufacturing facilities in various industrial sectors of the economy are recommended.The authors are all affiliated with the Harvard Center for Risk Analysis     

Cooperation Versus Confrontation: A Comparison of Approaches to Environmental Risk Management in Japan and the United States1

This paper compares approaches to environmental risk management in Japan and the United States. The paper includes an historical examination of two case studies of environmental risk management: synthetic detergents and lead in gasoline. In addition, the paper discusses several important differences between Japan and the United States, including (a) different attitudes toward separating environmental risk management from environmental risk assessment, and (b) different approaches toward environmental risk management. Specifically, the Japanese approach is based largely on a cooperative model of risk management, with a strong emphasis on negotiation and consensus-building, while the U.S. approach is based largely on a confrontational model of risk management, with a strong emphasis on rigorous scientific analysis and open adverserial processes.     

An Overview of a Multimedia Benchmarking Analysis for Three Risk Assessment Models: RESRAD, MMSOILS, and MEPAS

Multimedia modelers from the United States Environmental Protection Agency (EPA) and the United States Department of Energy (DOE) collaborated to conduct a detailed and quantitative benchmarking analysis of three multimedia models. The three models—RESRAD (DOE), MMSOILS (EPA), and MEPAS (DOE)—represent analytically-based tools that are used by the respective agencies for performing human exposure and health risk assessments. The study is performed by individuals who participate directly in the ongoing design, development, and application of the models. Model form and function are compared by applying the models to a series of hypothetical problems, first isolating individual modules (e.g., atmospheric, surface water, groundwater) and then simulating multimedia-based risk resulting from contaminant release from a single source to multiple environmental media. Study results show that the models differ with respect to environmental processes included (i.e., model features) and the mathematical formulation and assumptions related to the implementation of solutions. Depending on the application, numerical estimates resulting from the models may vary over several orders-of-magnitude. On the other hand, two or more differences may offset each other such that model predictions are virtually equal. The conclusion from these results is that multimedia models are complex due to the integration of the many components of a risk assessment and this complexity must be fully appreciated during each step of the modeling process (i.e., model selection, problem conceptualization, model application, and interpretation of results).     

A Look at State‐Level Risk Assessment in the United States: Making Decisions in the Absence of Federal Risk Values

State environmental agencies in the United States are charged with making risk management decisions that protect public health and the environment while managing limited technical, financial, and human resources. Meanwhile, the federal risk assessment community that provides risk assessment guidance to state agencies is challenged by the rapid growth of the global chemical inventory. When chemical toxicity profiles are unavailable on the U.S. Environmental Protection Agency's Integrated Risk Information System or other federal resources, each state agency must act independently to identify and select appropriate chemical risk values for application in human health risk assessment. This practice can lead to broad interstate variation in the toxicity values selected for any one chemical. Within this context, this article describes the decision‐making process and resources used by the federal government and individual U.S. states. The risk management of trichloroethylene (TCE) in the United States is presented as a case study to demonstrate the need for a collaborative approach among U.S. states toward identification and selection of chemical risk values while awaiting federal risk values to be set. The regulatory experience with TCE is contrasted with collaborative risk science models, such as the European Union's efforts in risk assessment harmonization. Finally, we introduce State Environmental Agency Risk Collaboration for Harmonization, a free online interactive tool designed to help to create a collaborative network among state agencies to provide a vehicle for efficiently sharing information and resources, and for the advancement of harmonization in risk values used among U.S. states when federal guidance is unavailable.     

The Contrast Between Risk Assessment and Rules of Evidence in the Context of International Trade Disputes: Can the U.S. Experience Inform the Process?

Risk assessment provides a formalized process to evaluate human, animal, and ecological responses associated with exposure to environmental agents. The purpose of risk assessment is to answer two related questions.

• ? How likely is an (adverse) event to occur?
• ? If it does, how severe will the impact be?

In the United States, the science of risk assessment has evolved out of the necessity to make public health decisions in the face of scientific uncertainty. Its basic propositions have been established over the past three decades and its applications have impacted virtually every aspect of public health and environmental protection in many countries, including the United States. More recently, the World Trade Organization's (WTO) dispute‐settlement process has provided additional incentive for the reliance on risk assessments internationally through the requirement that member countries be able to provide scientific justification, based on a risk assessment, for public health and environmental regulatory measures that are challenged. The purpose of this article is to review the history of risk assessment in the United States, emphasizing the development of both its scientific and policy aspects, as one example of the development of institutional capacity for risk assessment. This article discusses the importance of the social, political, and economic contexts of risk assessment and risk management in shaping the approaches taken while highlighting the reality that the analytic or risk assessment part of the decision‐making process, in the absence of scientific data, can be completed only by inserting inferences, or policy judgments, which may differ among countries. This article recognizes these differences, and the consequent difference between risk assessment that incorporates public health protective assumptions and the rules of evidence that seek to answer questions of causality, and discusses implications for the WTO dispute‐settlement process. It further explores the value of country‐specific risk assessment guidelines to facilitate consistency within a country along with the appropriateness and feasibility of international risk assessment guidelines.     

The Application of Bioassays in Risk Assessment of Environmental Pollution

Increased contamination of the environment by toxic chemicals has resulted in the need for sensitive assays to be used in risk assessment of polluted sites. Traditional tests are useful to detect and measure concentrations of chemicals in the environment and in tissues. However, physicochemical assays possess deficiencies that impair their use in evaluating complex environmental contamination. We have developed cytogenetic procedures, including chromosomal, micronucleus, and flow cytometric assays, to assess the mutagenic damage of petrochemicals and low-level radioactivity on indigenous terrestrial and aquatic wildlife populations. These procedures are sensitive to the perturbation of DNA that results from exposure to mutagenic contaminants in both field and laboratory studies. The use of natural populations of animals in biomonitoring, combined with traditional chemical assays, will ultimately provide sufficient information to estimate the risk to human health and environmental quality from anthropogenic pollution.     

Concise or comprehensive? Predictors of impact assessment choices for electric transmission line projects

Environmental impact assessment (EIA) procedures required in the United States and many other countries are often highlighted as a major hindrance to timely and efficient deployment of critical infrastructure projects. Under the U.S. National Environmental Policy Act, a more extensive environmental impact statement (EIS) review can take several more years and cost much more than a succinct environmental assessment (EA). This not only affects the project in question, but also likely informs how—or whether—additional projects are pursued. Thus, understanding key predictors of the EA versus EIS choice sheds light on supply-side considerations affecting infrastructure deficits. Using the case of NEPA reviews conducted for 244 transmission line projects between 2005 and 2018 by two U.S. federal agencies in the western United States, the Bureau of Land Management (BLM) and Department of Energy (DOE), this addresses the following question: What project features most predict whether EA or an EIS is used to assess a transmission line project? Drawing upon NEPA assessment guidance and agency NEPA records, we use a regression classification tree to analyze how protocols and project attributes relate to assessment choice. The result is essentially a null finding: transmission line length is by far the most important predictor of whether a project receives an extensive EIS or a shorter EA, with little predictive value provided by other attributes. While absolute project size undoubtedly influences impacts, the lack of further differentiation in what predicts use of EISs versus EAs suggests assessment does not simply respond to project details but also shapes proposal and design choices beforehand.     

The U.S. EPA Geographic Information System for Mapping Environmental Releases of Toxic Chemical Release Inventory (TRI) Chemicals

This study characterizes the environmental releases of toxic chemicals of the Toxic Chemical Release Inventory (TRI) in the southeastern United States by using the U.S. Environmental Protection Agency (EPA) Geographic Information System (GIS) to map them. These maps show that the largest quantities of TRI releases in the Southeast are usually near densely populated areas. This GIS mapping approach takes the first steps in defining those areas in the region which may be potential exposure zones and which could be strategic targets for future risk screening efforts in this geographic area.     

Emissions from Mass Burn Resource Recovery Facilities

Recent resource recovery facility stack tests have increased the available pool of data on emissions from these facilities. This has led to more accurate predictions of emissions from proposed facilities. The source, type, and rate of emissions presented are based upon a review of the literature, theoretical approaches, stack test data from existing facilities, permit levels of other facilities, and discussions with equipment manufacturers. The pollutants selected for study are those regulated by United States Environmental Protection Agency (USEPA) Prevention of Significant Deterioration (PSD) regulations and other pollutants of concern. The pollutants studied are particulate matter, sulfur dioxide, nitrogen oxides, carbon monoxide, nonmethane hydrocarbons, hydrogen sulfide, reduced sulfide, reduced sulfur compounds, total reduced sulfur, lead, mercury, beryllium, arsenic, cadmium, chromium, chromium +6, copper, manganese, nickel, vanadium, zinc, hydrogen chloride, fluorides, sulfuric acid mist, polynuclear aromatic hydrocarbons, polychlorinated biphenyls, vinyl chloride, dioxins, furans, formaldehyde, and asbestos.     

Health Risk Assessment for Planned Waste Incinerators: Getting the Right Science and the Science Right

Health risk assessment is widely advocated in the United Kingdom as the most comprehensive means of assessing the health risks posed by the emissions of a planned waste incinerator. Its main advantage over other methods of assessment, such as air quality impact assessment, is its ability to address explicitly the direct (inhalation) and indirect (ingestion and dermal contact) health risks posed by different chemicals, including those that are not thought to have a threshold below which no adverse effect will take place. This article examines the level and quality of the emissions assessments included in 61 waste incinerator environmental statements (ESs); in particular, it focuses on the quality of the exposure assessment and risk characterization stages of the health risk assessment process. The article concludes that the ES has not always provided interested stakeholders with the best available information upon which to determine the tolerability of the health risks posed by waste incinerator emissions Some recommendations are made as to how this problem might be addressed in future environmental impact assessment (EIA) processes.     

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.     

Quantifying Human Health Risks from Virginiamycin Used in Chickens

The streptogramin antimicrobial combination Quinupristin-Dalfopristin (QD) has been used in the United States since late 1999 to treat patients with vancomycin-resistant Enterococcus faecium (VREF) infections. Another streptogramin, virginiamycin (VM), is used as a growth promoter and therapeutic agent in farm animals in the United States and other countries. Many chickens test positive for QD-resistant E. faecium, raising concern that VM use in chickens might compromise QD effectiveness against VREF infections by promoting development of QD-resistant strains that can be transferred to human patients. Despite the potential importance of this threat to human health, quantifying the risk via traditional farm-to-fork modeling has proved extremely difficult. Enough key data (mainly on microbial loads at each stage) are lacking so that such modeling amounts to little more than choosing a set of assumptions to determine the answer. Yet, regulators cannot keep waiting for more data. Patients prescribed QD are typically severely ill, immunocompromised people for whom other treatment options have not readily been available. Thus, there is a pressing need for sound risk assessment methods to inform risk management decisions for VM/QD using currently available data. This article takes a new approach to the QD-VM risk modeling challenge. Recognizing that the usual farm-to-fork ("forward chaining") approach commonly used in antimicrobial risk assessment for food animals is unlikely to produce reliable results soon enough to be useful, we instead draw on ideas from traditional fault tree analysis ("backward chaining") to reverse the farm-to-fork process and start with readily available human data on VREF case loads and QD resistance rates. Combining these data with recent genogroup frequency data for humans, chickens, and other sources (Willems et al., 2000, 2001) allows us to quantify potential human health risks from VM in chickens in both the United States and Australia, two countries where regulatory action for VM is being considered. We present a risk simulation model, thoroughly grounded in data, that incorporates recent nosocomial transmission and genetic typing data. The model is used to estimate human QD treatment failures over the next five years with and without continued VM use in chickens. The quantitative estimates and probability distributions were implemented in a Monte Carlo simulation model for a five-year horizon beginning in the first quarter of 2002. In Australia, a Q1-2002 ban of virginiamycin would likely reduce average attributable treatment failures by 0.35 x 10(-3) cases, expected mortalities by 5.8 x 10(-5) deaths, and life years lost by 1.3 x 10(-3) for the entire population over five years. In the United States, where the number of cases of VRE is much higher, a 1Q-2002 ban on VM is predicted to reduce average attributable treatment failures by 1.8 cases in the entire population over five years; expected mortalities by 0.29 cases; and life years lost by 6.3 over a five-year period. The model shows that the theoretical statistical human health benefits of a VM ban range from zero to less than one statistical life saved in both Australia and the United States over the next five years and are rapidly decreasing. Sensitivity analyses indicate that this conclusion is robust to key data gaps and uncertainties, e.g., about the extent of resistance transfer from chickens to people.