ALBERT

Notes: When the transportation risk posed by shipments of hazardous chemical and radioactive materials is being assessed, it is necessary to evaluate therisks associated with both vehicle emissions and cargo-related risks. Diesel exhaust and fugitive dust emissions from vehicles transporting hazardous shipments lead to increased air pollution, which increases the risk of latent fatalities in the affected population along the transport route. The estimated risk from these vehicle-related sources can often be as large or larger than the estimated risk associated with the material being transported. In this paper, data from the U.S. Environmental Protection Agency's Motor Vehicle-Related Air Toxics Study are first used to develop latent cancer fatality estimates per kilometer of travel in rural and urban areas forall diesel truck classes. These unit risk factors are based on studies investigating the carcinogenic nature of diesel exhaust. With the same methodology, the current per-kilometer latent fatality risk factor used in transportation risk assessments for heavy diesel trucks in urban areas is revised and the analysis expanded to provide risk factors for rural areas and all diesel truck classes. These latter fatality estimates may include, but are not limited to, cancer fatalities and are based primarily on the most recent epidemiological data available on mortality rates associated with ambient air PM-10 concentrations.

Notes: Risk assessors often use different probability plots as a way to assessthe fit of a particular distribution or model by comparing the plotted points to a straight line and to obtain estimates of the parameters in parametric distributions or models. When empirical data do not fall in a sufficiently straight line on a probability plot, and when no other single parametricdistribution provides an acceptable (graphical) fit to the data, the risk assessor may consider a mixture model with two component distributions. Animated probability plots are a way to visualize the possible behaviors of mixture models with two component distributions. When no single parametric distribution provides an adequate fit to an empirical dataset, animated probability plots can help an analyst pick some plausible mixture models for the data based on their qualitative fit. After using animations during exploratory data analysis, the analyst must then use other statistical tools, including but not limited to: Maximum Likelihood Estimation (MLE) to find the optimal parameters, Goodness of Fit (GoF) tests, and a variety of diagnostic plots to check the adequacy of the fit. Using a specific example with two LogNormal components, we illustrate the use of animated probability plots asa tool for exploring the suitability of a mixture model with two component distributions. Animations work well with other types of probability plots, and they may be extended to analyze mixture models with three or more component distributions.

Notes: For carcinogens, this paper provides a quantitative examination of the roles of potency and weight-of-evidence (WOE) in setting permissible exposure limits (PELs) at the U.S. Occupational Safety and Health Administration (OSHA) and threshold limit values (TLVs) at the private American Conference of Governmental Industrial Hygienists (ACGIH). On normative grounds, both of these factors should influence choices about the acceptable level of exposures. Our major objective is to examine whether and in what ways these factors have been considered by these organizations. A lesser objective is to identify outliers, which might be candidates for further regulatory scrutiny. Our sample (N=48) includes chemicals for which EPA has estimated a unit risk as a measure of carcinogenic potency and for which OSHA or the ACGIH has a PEL or TLV. Different assessments of the strength of the evidence of carcinogenicity were obtained from EPA, ACGIH, and the International Agency for Research on Cancer. We found that potency alone explains 49% of the variation in PELs and 62% of the variation in TLVs. For the ACGIH, WOE plays a much smaller role than potency. TLVs set by the ACGIH since 1989 appear to be stricter than earlier TLVs. We suggest that this change represents evidence that the ACGIH had responded to criticisms leveled at it in the late 1980s for failing to adopt sufficiently protective standards. The models developed here identify 2-nitropropane, ethylene dibromide, and chromium as having OSHA PELs significantly higher than predicted on the basis of potency and WOE.

Notes: Much has been written about the development and application of quantitative methods for estimating under uncertainty the long-term radiological performance of underground disposal of radioactive wastes. Until recently, interest has been focused almost entirely on the technical challenges regardless of the role of the organization responsible for these analyses. Now the dialogue between regulators, the repository developer or operator, and other interested parties in the decision-making process receives increasing attention, especially in view of some current difficulties in obtaining approvals to construct or operate deep facilities for intermediate or high-level wastes. Consequently, it is timely to consider the options for regulators’review and evaluation of safety submissions, at the various stages in the site selection to repository closure process, and to consider, especially, the role for performance assessment (PA) within the programs of a regulator both before and after delivery of such a submission. The origins and broad character of present regulations in the European Union (EU) and in the OECD countries are outlined and some regulatory PA reviewed. The issues raised are discussed, especially in regard to the interpretation of regulations, the dangers from the desire for simplicity in argument, the use of regulatory PA to review and challenge the PA in the safety case, and the effects of the relationship between proponent and regulator. Finally, a very limited analysis of the role of PA in public hearings is outlined and recommendations are made, together with proposals for improving the mechanisms for international collaboration on technical issues of regulatory concern.

Notes: In this paper the problem of high-level nuclear waste disposal is viewed as a five-stage, cascaded decision problem. The first four of these decisions having essentially been made, the work of recent years has been focused on the fifth stage, which concerns specifics of the repository design. The probabilistic performance assessment (PPA) work is viewed as the outcome prediction for this stage, and the site characterization work as the information gathering option. This brief examination of the proposed Yucca Mountain repository through a decision analysis framework resulted in three conclusions: (1) A decision theory approach to the process of selecting and characterizing Yucca Mountain would enhance public understanding of the issues and solutions to high-level waste management; (2) engineered systems are an attractive alternative to offset uncertainties in the containment capability of the natural setting and should receive greater emphasis in the design of the repository; and (3) a strategy of “waste management” should be adopted, as opposed to “waste disposal,” as it allows for incremental confirmation and confidence building of a permanent solution to the high-level waste problem.

Notes: Physiologically-based toxicokinetic (PBTK) models are widely used to quantify whole-body kinetics of various substances. However, since they attempt to reproduce anatomical structures and physiological events, they have ahigh number of parameters. Their identification from kinetic data alone is often impossible, and other information about the parameters is needed to render the model identifiable. The most commonly used approach consists of independently measuring, or taking fom literature sources, some of the parameters, fixing them in the kinetic model, and then performing model identification on a reduced number of less certain parameters. This results in a substantial reduction of the degrees of freedom of the model. In this study, we show that this method results in final estimates of the free parameters whose precision is overestimated. We then compared this approach with an empirical Bayes approach, which takes into account not only the mean value, but also the error associated with the independently determined parameters. Blood and breath 2H8- toluene washout curves, obtained in17 subjects, were analyzed with a previously presented PBTK model suitable for person-specific dosimetry. Model parameters with the greatest effect onpredicted levels were alveolar ventilation rate QPC, fat tissue fraction VFC, blood air partition coefficient Kb, fraction of cardiac output to fat Qa/co and rate of extrahepatic metabolismVmax.p. Differences in the measured and Bayesian-fitted values of QPC, VFc and Kb were significant (p 〈 0.05), andthe precision of the fitted values Vmax.p and Qa/co went from 11 ± 5% to 75 ± 170% (NS) and from 8 ± 2% to 9 ± 2% (p 〈 0.05) respectively. The empirical Bayes approach did not result in less reliable parameter estimates: rather, it pointed out that the precision of parameter estimates can be overly optimistic when other parameters in the model, eitherdirectly measured or taken from literature sources, are treated as known without error. In conclusion, an empirical Bayes approach to parameter estimation resulted in a better model fit, different final parameter estimates, and more realistic parameter precisions.

Notes: The US Department of Transportation was interested in the risks associated with transporting Hydrazine in tanks with and without relief devices. Hydrazine is both highly toxic and flammable, as well as corrosive. Consequently, there was a conflict as to whether a relief device should be used or not. Data were not available on the impact of relief devices on release probabilities or the impact of Hydrazine on the likelihood of fires and explosions. In this paper, a Monte Carlo sensitivity analysis of the unknown parameters was used to assess the risks associated with highway transport of Hydrazine. To help determine whether or not relief devices should be used, fault trees and event trees were used to model the sequences of events that could lead to adverse consequences during transport of Hydrazine. The event probabilities in the event trees were derived as functions of the parameters whose effects were not known. The impacts of these parameters on the riskof toxic exposures, fires, and explosions were analyzed through a Monte Carlo sensitivity analysis and analyzed statistically through an analysis of variance. The analysis allowed the determination of which of the unknown parameters had a significant impact on the risks. It also provided the necessary support to a critical transportation decision even though the values of several key parameters were not known.

Notes: During the modernization of the municipal waste incinerator (MWI, maximum capacity of 180,000 tons per year) of Metropolitan Grenoble (405,000 inhabitants), in France, a risk assessment was conducted, based on four tracerpollutants: two volatile organic compounds (benzene and 1,1,1 trichloroethane) and two heavy metals (nickel and cadmium, measured in particles). A Gaussian plume dispersion model, applied to maximum emissions measured at the MWI stacks, was used to estimate the distribution of these pollutants in the atmosphere throughout the metropolitan area. A random sample telephone survey (570 subjects) gathered data on time-activity patterns, according to demographic characteristics of the population. Life-long exposure was assessed as a time-weighted average of ambient air concentrations. Inhalation alone was considered because, in the Grenoble urban setting, other routes of exposure are not likely. A Monte Carlo simulation was used to describe probability distributions of exposures and risks. The median of the life-long personal exposures distribution to MWI benzene was 3.2 · 10−5μg/m3 (20th and 80th percentiles = 1.5 · 10−5 and 6.5 · 10−5μg/m3), yielding a 2.6 · 10−10 carcinogenic risk (1.2 · 10−10 - 5.4 · 10−10). For nickel, the corresponding life-time exposure and cancer risk were 1.8 ·10−4μg/m3 (0.9 ·10−4 - 3.6 ·10−4μg/m3) and 8.6 · 10−8 (4.3 · 10−8 - 17.3 ·10−8); for cadmium they were respectively 8.3 ·10−6μg/m3 (4.0 ·10−6 - 17.6 ·10−6) and 1.5 · (7.2 · 10−9 - 3.1. · 10−8). Inhalation exposure to cadmium emitted by the MWI represented less than 1% of the WHO Air Quality Guideline (5 ng/m3), while there was a margin of exposure of more than 109 between the NOAEL (150 ppm) and exposure estimates to trichloroethane. Neither dioxins nor mercury, a volatile metal, were measured. This could lessen the attributable life-long risks estimated. The minute (VOCs and cadmium) to moderate (nickel) exposure and risk estimates are in accord with other studies on modern MWIs meeting recent emission regulations, however.

Notes: Methods of quantitative risk assessment for toxic responses that are measured on a continuous scale are not well established. Although risk-assessment procedures that attempt to utilize the quantitative information in such data have been proposed, there is no general agreement that these procedures are appreciably more efficient than common quantal dose-response procedures that operate on dichotomized continuous data. This paper points out an equivalence between the dose-response models of the nonquantal approach of Kodell and West(1)) and a quantal probit procedure, and provides results from a Monte Carlo simulation study to compare coverage probabilities of statistical lower confidence limits on dose corresponding to specified additional risk based on applying the two procedures to continuous data from a dose-response experiment. The nonquantal approach is shown to be superior, in terms of both statistical validity and statistical efficiency.

Notes: This paper discusses a successful public involvement effort that addressed and resolved several highly controversial water management issues involving environmental and flood risks associated with an electrical generation facility in British Columbia. It begins with a discussion of concepts for designing public involvement, summarizing research that indicates why individuals and groups may find it difficult to make complex choices. Reasons for public involvement, and the range of current practices are discussed. Next, four principles for designing group decision process are outlined, emphasizing decision-aiding concepts that include “value-focused thinking” and “adaptive management.” The next sections discuss the Alouette River Stakeholder Committee process in terms of objectives, participation, process, methods for structuring values and creating alternatives, information sources, and results. Discussion and conclusions complete the paper.

Notes: During the 1980s, seismic research suggested that Oregon and the City of Portland had a higher risk of a major earthquake than had previously been assumed. In 1993, the State of Oregon adopted a new version of the Oregon Structural Specialty Code, which changed the designation of western Oregon from seismic zone 2b to seismic zone 3. The City of Portland established a program and a Task Force on Seismic Strengthening of Buildings to recommend actions that would encourage upgrading of city buildings. A survey of adult city residents was conducted in April, 1996 to determine public attitudes and opinions about earthquake risks, management and mitigation of earthquake hazards, priorities for protection by strengthening buildings, evaluations of strategies for informing the public about earthquake risks, and support for specific options the city might take to protect citizens against earthquake events. Social and demographic information on individuals and households was also collected. Respondents provided ratings for a wide range of social and environmental risks, provided information on priorities for strengthening key buildings and infrastructure facilities, and answered hypothetical questions about voting for bond measures to pay for city earthquake mitigation programs. Respondents recognized significant risk from earthquakes and supported programs to protect people, especially vulnerable residents such as children and the sick. There was strong support for protecting emergency response capabilities. There was much less support for using public funds to reduce the risks associated with privately owned buildings. There were also some strong pockets of resistance to publicly funded mitigation programs in response to the hypothetical bond measures.

Notes: From a comprehensive search of the literature, the hormesis phenomenon was found to occur over a wide range of chemicals, taxonomic groups, and endpoints. By use of computer searches and extensive cross-referencing, nearly 3000 potentially relevant articles were identified. Evidence of chemical and radiation hormesis was judged to have occurred in approximately 10oO of these by use of a priori criteria. These criteria included study design features (e.g., number of doses, dose range), dose-response relationship, statistical analysis, and reproducibility of results. Numerous biological endpoints were assessed, with growth responses the most prevalent, followed by metabolic effects, reproductive responses, longevity, and cancer. Hormetic responses were generally observed to be of limited magnitude with an average maximum stimulation of 30 to 60 percent over that of the controls. This maximum usually occurred 4- to 5-fold below the NOAEL for a particular endpoint. The present analysis suggests that hormesis is a reproducible and generalizable biological phenomenon and is a fundamental component of many, if not most, dose-response relationships. The relatively infrequent observation of homesis in the literature is believed to be due primarily to experimental design considerations, especially with respect to the number and range of doses and endpoint selection. Because of regulatory considerations, most toxicologic studies have been carried out at high doses above the low-dose region where the hormesis phenomenon occurs.

Notes: As the use of digital computers for instrumentation and control of safety-critical systems has increased, there has been a growing debate over the issue of whether probabilistic risk assessment techniques can be applied to these systems. This debate has centered on the issue of whether software failures can be modeled probabilistically. This paper describes a “context-based” approach to software risk assessment that explicitly recognizes the fact that the behavior of software is not probabilistic. The source of the perceived uncertainty in its behavior results from both the input to the software as well as the application and environment in which the software is operating. Failures occur as the result of encountering some context for which the software was not properly designed, as opposed to the software simply failing “randomly.” The paper elaborates on the concept of “error-forcing context” as it applies to software. It also illustrates a methodology which utilizes event trees, fault trees, and the Dynamic Flowgraph Methodology (DFM) to identify “error-forcing contexts” for software in the form of fault tree prime implicants.

Notes: Australian state and federal agencies use a broad range of methods for setting conservation priorities for species at risk. Some of these are based on rule sets developed by the International Union for the Conservation ofNature, while others use point scoring protocols to assess threat. All of them ignore uncertainty in the data. In this study, we assessed the conservation status of 29 threatened vascular plants from Tasmania and New South Wales using a variety of methods including point scoring and rule-based approaches. In addition, several methods for dealing with uncertainty in the data were applied to each of the prioritysetting schemes. The results indicatethat the choice of a protocol for setting priorities and the choice of the way in which uncertainty is treated may make important differences to the resulting assessments of risk. The choice among methods needs to be rationalized within the management context in which it is to be applied. These methods are not a substitute for more formal risk assessment.

Notes: This paper describes a multi-stakeholder process designed to assess thepotential health risks associated with adverse air quality in an urban industrial neighborhood. The paper briefly describes the quantitative health risk assessment conducted by scientific experts, with input by a grassroots community group concerned about the impacts of adverse air quality on theirhealth and quality of life. In this case, rather than accept the views of the scientific experts, the community used their powers of perception toadvantage by successfully advocating for a professionally conducted community health survey. This survey was designed to document, systematically and rigorously, the health risk perceptions community members associated with exposure to adverse air quality in their neighborhood. This paper describes theinstitutional and community contexts within which the research is situated as well as the design, administration, analysis, and results of the community health survey administered to 402 households living in an urban industrial neighborhood in Hamilton, Ontario, Canada. These survey results served tolegitimate the community's concerns about air quality and tohelp broaden operational definitions of ‘health.’ In addition, the resultsof both healthrisk assessment exercises served to keep issues of air quality on the localpolitical agenda. Implications of these findings for our understanding of theenvironmental justice process as well as the ability of communitiesto influence environmental health policy are discussed.

Notes: Psychometric data on risk perceptions are often collected using the method developed by Slovic, Fischhoff, and Lichtenstein, where an array of risk issues are evaluated with respect to a number of risk characteristics, such as how dreadful, catastrophic or involuntary exposure to each risk is. The analysis of these data has often been carried out at an aggregate level, where mean scores for all respondents are compared between risk issues. However, this approach may conceal important variation between individuals, and individual analyses have also been performed for single risk issues. This paper presents a new methodological approach using a technique called multilevel modelling for analysing individual and aggregated responses simultaneously, to produce unconditional and unbiased results at both individual and aggregate levels of the data. Two examples are given using previously published data sets on risk perceptions collected by the authors, and results between the traditional and new approaches compared. The discussion focuses on the implications of and possibilities provided by the new methodology.

Notes: Food-related illness in the United States is estimated to affect over six million people per year and cost the economy several billion dollars. These illnesses and costs could be reduced if minimum infectious doses were established and used as the basis of regulations and monitoring. However, standard methodologies for dose-response assessment are not yet formulated for microbial risk assessment. The objective of this study was to compare dose response models for food-borne pathogens and determine which models were most appropriate for a range of pathogens. The statistical models proposed in the literature and chosen for comparison purposes were log-normal,(19) log-logistic,(17) exponential,(7,9,17)ß-Poisson(7,9,18) and Welbull-Gamma.(3) These were fit to four data sets also taken from published literature, Shigella fiexneri,(9,12,13)Shigella dysenteriae,(9,11)Campylobacter jejuni,(15,16) and Salmonella typhosa,(7,14) usingthe method of maximum likelihood. The Weibull-gamma, the only model with three parameters, was also the only model capable of fitting all the data sets examined using the maximum likelihood estimation for comparisons. Infectious doses were also calculated using each model. Within any given data set, the infectious dose estimated to affect one percent of the population ranged from one order of magnitude to as much as nine orders of magnitude, illustrating the differences in extrapolation of the dose response models. More data are needed to compare models and examine extrapolation from high to low doses for food-borne pathogens.

Notes: Environmental managers are increasingly charged with involving the public in the development and modification of policies regarding risks to huma health and the environment. Involving the public in environmental decision making first requires a broad understanding of how and why the public perceives various risks. The Savannah River Stakeholder Study was conducted withthe purpose of investigating individual, economic, and social characteristics of risk perceptions among those living near the Savannah River Nuclear Weapons Site. A number of factors were found to impact risk perceptions among those living near the site. One's estimated proximity to the site and relative river location surfaced as strong determinants of risk perceptions among SRS residents. Additionally, living in a quality neighborhood and demonstrating a willingness to accept health risks for economic gain strongly abated heightened risk perceptions.

Notes: Five atmospheric transport models were evaluated for use in Phase I1 ofthe Historical Public Exposures Studies at the Rocky Flats Plant. Models included a simple straight-line Gaussian plume model (ISCST2), several integrated puff models (RATCHET, TRIAD, and INPUFF2), and a complex terrain mode (TRAC). Evaluations were based on how well model predictions compared with sulfur hexafluoride tracer measurements taken in the vicinity of Rocky Flats in February 1991. Twelve separate tracer experiments were conducted, eac lasting 9 hr and measured at 140 samplers in arcs 8 and 16 km from the release point at Rocky Flats. Four modeling objectives were defined based on the endpoints of the overall study: (1) the unpaired maximum hourly average concentration, (2) paired time-averaged concentration, (3) unpaired time-averaged concentration, and (4) arc-integrated concentration. Performance measures were used to evaluate models and focused on the geometric mean and standard deviation of the predicted-to-observed ratio and the correlation coefficient between predicted and observed concentrations. No one model consistently outperformed the others in all modeling objectives and performance measures. About 75% of the maximum hourly concentration predictions were within a factor of 5 of the observations. About 64% of the paired and 80% of the unpaired time-averaged model predictions were within a factor of 5 of theobservations. The overall performance of the RATCHET model was somewhat better than the other models. All models appeared to experience difficulty defining plume trajectories, which was attributed to the influence of multilayered flow initiated by terrain complexities and the diurnal flow patterns characteristic of the Colorado Front Range.

Notes: Calculation of accident dose-risk estimates with the RADTRAN code requires input data describing the population likely to be affected by the plumeof radioactive material (RAM) released in a hypothetical transportation accident. In the existing model, population densities within 1/2 mile (0.8 km)of the route centerline are tabulated in three ranges (Rural, Suburban, andUrban). These population densities may be of questionable validity since the plume in the RADTRAN analysis is assumed to extend out to 120 km from thehypothetical accident site. We present a GIs-based population model which accounts for the actual distribution of population under a potential plume, and compare accident-risk estimates based on the resulting population densities with those based on the existing model. Results for individual points along a route differ greatly, but the cumulative accident risks for a sample route of a few hundred kilometers are found to be comparable, if not identical. We conclude, therefore, that for estimation of aggregate accident risks over typical routes of several hundred kilometers, the existing, simpler RADTRAN model is sufficiently detailed and accurate.

Notes: This paper discusses a number of the key challenges to the acceptance and aplication of probabilistic risk analysis (PRA). Those challenges include:(a) the extensive reliance on subjective judgment in PRA, requiring the development of guidance for the use of PRA in risk-informed regulation, and possibly the development of “robust” or “reference” prior distributions to minimize the reliance on judgment; and (b) the treatment of human perfor-mance in PRA, including not only human errorperse but also management and organizational factors more broadly. All of these areas are seen as presentinginteresting research challenges at the interface between engineering and other disciplines.

Notes: Rational decision making requires that the total uncertainty about a variate of interest (a predictand) be quantified in terms of a probability distribution, conditional on all available information and knowledge. Supposethe state-of-knowledge is embodied in a deterministic model, which is imperfect and outputs only an estimate of the predictand. Fundamentals are presented of two Bayesian methods for producing a probabilistic forecast via anydeterministic model. The Bayesian Processor of Forecast (BPF) quantifies the total uncertainty in terms of a posterior distribution, conditional on model output. The Bayesian Forecasting System (BFS) decomposes the total uncertainty into input uncertainty and model uncertainty, which are characterized independently and then integrated into a predictive distribution. The BFS is compared with Monte Carlo simulation and “ensemble forecasting” technique, none of which can alone produce a probabilistic forecast that quantifies the total uncertainty, but each can serve as a component of the BFS.

Notes: This article describes an application of a method for assessing risks associated with the introduction of an organism into a new environment. The test organism was a binucleate Rhizoctonia fungal isolate that has potential for commercial development as a biological control agent for damping-off diseases in bedding plants. A test sample of host plant species was selected using the centrifugal phylogenetic host range principles, but with an emphasis on economic species. The effect of the fungus on the plant was measured for each species and expressed on a logarithmic scale. The effects on weights of shoots and roots per container were not normally distributed, nor were the effects on the number of plants standing (those which survived). Statements about the effect on the number standing and the shoot weight per container involved using the observed (empirical) distribution. This is illustrated with an example. Problems were encountered in defining the population of species at risk, and in deciding how this population should be formally sampled. The limitations of the method are discussed.

Notes: The heuristic-systematic information processing model (HSM) holds that individuals will use one or both of these modes of information processing when attempting to evaluate information in order to arrive at a judgment. Systematic processing is defined by effortful scrutiny and comparison of information, whereas heuristic processing is defined by the use of cues to amve more easily at a judgment. Antecedents to the two processing modes include information sufficiency, motivation, and self-efficacy. Structural equation modeling is used to examine competing configuration of this model and to evaluate the model as appropriate for predicting risk judgment. The model also is evaluated across three groups that vary with respect to their level of concern. These analyses are executed within a case study involving an epidemiological investigation of a suspected cancer cluster. The analysis confirms the HSM's theoretically proposed structure and shows it to be a useful vehicle for evaluating risk judgment. In the overall analysis, antecedent variables generally function as specified by theory. Systematic processing is predicted by greater motivation. Heuristic processing is predicted by information sufficiency. Self-efficacy is a significant predictor of both processing modes. And heuristic processing is shown to be associated with judgment of less risk. However, when the analysis is contrasted across three groups (those concerned about cancer, not concerned and uncertain) it is shown that the model is significantly more robust for the uncertain group. This finding may have implications for the use of the HSM in risk research specifically, and in field research generally.

Notes: South Carolina has issued fish consumption advisories for the Savannah River based on mercury and radionuclide levels. We examine differences in fishing rates and fish consumption of 258 people interviewed while fishing along the Savannah River, as a function of age, education, ethnicity, employment history, and income, and test the assumption that the average consumption of fish is less than the recreational value of 19 kg/year assumed by risk assessors. Ethnicity and education contributed significantly to explaining variations in number of fish meals per month, serving size, and total quantity of fish consumed per year. Blacks fished more often, ate more fish meals of slightly larger serving sizes, and consumed more fish per year than did Whites. Although education and income were correlated, education contributed most significantly to behavior; people who did not graduate from high school ate fish more often, ate more fish per year, and ate more whole fish than people who graduated from high school. Computing consumption of fish for each person individually indicates that (1) people who eat fish more often also eat larger portions, (2) a substantial number of people consume more than the amount of fish used to compute risk to recreational fishermen, (3) some people consume more than the subsistence level default assumption (50 kglyear) and (4) Blacks consume more fish per year than Whites, putting them at greater risk from contaminants in fish. Overall, ethnicity, age, and education contributed to variations in fishing behavior and consumption.

Notes: The association between daily fluctuations in ambient particulate matter and daily variations in nonaccidental mortality have been extensively investigated. Although it is now widely recognized that such an association exists, the form of the concentration-response model is still in question. Linear, no threshold and linear threshold models have been most commonly examined. In this paper we considered methods to detect and estimate threshold concentrations using time series data of daily mortality rates and air pollution concentrations. Because exposure is measured with error, we also considered the influence of measurement error in distinguishing between these two completing model specifications. The methods were illustrated on a 15-year daily time series of nonaccidental mortality and particulate air pollution data in Toronto, Canada. Nonparametric smoothed representations of the association between mortality and air pollution were adequate to graphically distinguish between these two forms. Weighted nonlinear regression methods for relative risk models were adequate to give nearly unbiased estimates of threshold concentrations even under conditions of extreme exposure measurement error. The uncertainty in the threshold estimates increased with the degree of exposure error. Regression models incorporating threshold concentrations could be clearly distinguished from linear relative risk models in the presence of exposure measurement error. The assumption of a linear model given that a threshold model was the correct form usually resulted in overestimates in the number of averted premature deaths, except for low threshold concentrations and large measurement error.

Notes: 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.

Notes: We investigated the way results of human health risk assessments are used, and the theory used to describe those methods, sometimes called the “NAS paradigm.” Contrary to a key tenet of that theory, current methods have strictly limited utility. The characterizations now considered standard, Safety Indices such as “Acceptable Daily Intake,”“Reference Dose,” and so on, usefully inform only decisions that require a choice between two policy alternatives (e.g., approve a food additive or not), decided solely on the basis of a finding of safety. Riskis characterized as the quotient of one of these Safety Indices divided by an estimate of exposure: a quotient greater than one implies that the situation may be considered safe. Such decisions are very widespread, both in the U. S. federal government and elsewhere. No current method is universal; different policies lead to different practices, for example, in California's “Proposition 65,” where statutory provisions specify some practices. Further, an important kind of human health risk assessment is not recognized by this theory: this kind characterizes risk as likelihood of harm, given estimates of exposure consequent to various decision choices. Likelihood estimates are necessary whenever decision makers have many possible decision choices and must weigh more than two societal values, such as in EPA's implementation of “conventional air pollutants.” These estimates can not be derived using current methods; different methods are needed. Our analysis suggests changes needed in both the theory and practice of human health risk assessment, and how what is done is depicted.

Notes: The prominent role of animal bioassay evidence in environmental regulatory decisions compels a careful characterization of extrapolation uncertainties. In noncancer risk assessment, uncertainty factors are incorporated to account for each of several extrapolations required to convert a bioassay outcome into a putative subthreshold dose for humans. Measures of relative toxicity taken between different dosing regimens, different endpoints, or different species serve as a reference for establishing the uncertainty factors. Ratios of no observed adverse effect levels (NOAELs) have been used for this purpose; statistical summaries of such ratios across sets of chemicals are widely used to guide the setting of uncertainty factors. Given the poor statistical properties of NOAELs, the informativeness of these summary statistics is open to question. To evaluate this, we develop an approach to “calibrate” the ability of NOAEL ratios to reveal true properties of a specified distribution for relative toxicity. A priority of this analysis is to account for dependencies of NOAEL ratios on experimental design and other exogenous factors. Our analysis of NOAEL ratio summary statistics finds (1) that such dependencies are complex and produce pronounced systematic errors and (2) that sampling error associated with typical sample sizes (50 chemicals) is nonnegligible. These uncertainties strongly suggest that NOAEL ratio summary statistics cannot be taken at face value; conclusions based on such ratios reported in well over a dozen published papers should be reconsidered.

Notes: We compare the regulatory implications of applying the traditional (linearized) and exact two-stage dose-response models to animal carcinogenic data. We analyze dose-response data from six studies, representing five different substances, and we determine the “goodness- of-fit” of each model as well as the 95% confidence lower limit ofthe dose corresponding to a target excess risk of 10-5 (the target risk doseTRD). For the two concave datasets, we find that the exact model gives a substantially better fit to the data than the traditional model, and that the exact model gives aTRD that is an order of magnitude lower than that given by the traditional model. In the other cases, the exact model gives a fit equivalent to or better than the traditional model. We also show that although the exact two-stage model may exhibit dose-response concavity at moderate dose levels, it is always linear or sublinear, and never supralinear, in the low-dose limit. Because regulatory concern is almost always confined to the low-dose region extrapolation, supralinear behavior seems not to be of regulatory concern in the exact two-stage model. Finally, we find that when performing this low-dose extrapolation in cases of dose-response concavity, extrapolating the model fit leads to a more conservative TRD than taking a linear extrapolation from 10% excess risk. We conclude with a set of recommendations.

Notes: The characterization and treatment of uncertainty poses special challenges when modeling indeterminate or complex coupled systems such as those involved in the interactions between human activity, climate and the ecosystem. Uncertainty about model structure may become as, or more important than, uncertainty about parameter values. When uncertainty grows so large that prediction or optimization no longer makes sense, it may still be possible to use the model as a “behavioral test bed” to examine the relative robustness of alternative observational and behavioral strategies. When modelsmust be run into portions of their phase space that are not well understood, different submodels may become unreliable at different rates. A common example involves running a time stepped model far into the future. Several strategies can be used to deal with such situations. The probability of model failure can be reported as a function of time. Possible alternative “surprises” can be assigned probabilities, modeled separately, and combined. Finally, through the use of subjective judgments, one may be able to combine, and over time shift between models, moving from more detailed to progressively simpler order-of-magnitude models, and perhaps ultimately, on to simple bounding analysis.

Notes: In any model the values of estimates for various parameters are obtained from different sources each with its own level of uncertainty. When the probability distributions of the estimates are obtained as opposed to point values only, the measurement uncertainties in the parameter estimates may be addressed. However, the sources used for obtaining the data and the models used to select appropriate distributions are of differing degrees of uncertainty. A hierarchy of different sources of uncertainty based upon one's ability to validate data and models empirically is presented. When model parameters are aggregated with different levels of the hierarchy represented, this implies distortion or degradation in the utility and validity of the models used. Means to identify and deal with such heterogeneous data sourcesare explored, and a number of approaches to addressing this problem is presented. One approach, using Range/confidence Estimates coupled with an Information Value Analysis Process, is presented as an example.

Notes: Variability arises due to differences in the value of a quantity among different members of a population. Uncertainty arises due to lack of knowledge regarding the true value of a quantity for a given member of a population. We describe and evaluate two methods for quantifying both variability and uncertainty. These methods, bootstrapsimulation and a likelihood-based method, are applied to three datasets. The datasetsinclude a synthetic sample of 19 values from a Lognormal distribution, a sample of nine values obtained from measurements of the PCB concentration in leafy produce, and asample of five values for the partitioning of chromium in the flue gas desulfurization system of coal-fired power plants. For each of these datasets, we employ the two methods to characterize uncertainty in the arithmetic mean and standard deviation, cumulative distribution functions based upon fitted parametric distributions, the 95th percentile of variability, and the 63rd percentile of uncertainty for the 81st percentile of variability. The latter is intended to show that it is possible to describe anypoint within the uncertain frequency distribution by specifying an uncertainty percentile and a Variability percentile. Using the bootstrap method, we compare results based upon use of the method of matching moments and the method of maximum likelihood for fitting distributions to data. Our results indicate that with only 5-19 data pointsas in the datasets we have evaluated, there is substantial uncertainty based upon random sampling error. Both the boostrap and likelihood-based approaches yield comparable uncertainty estimates in most cases.

Notes: Suppose that a residential neighborhood may have been contaminated by anearby abandoned hazardous waste site. The suspected contamination consistsof elevated soil concentrations of chemicals that are also found in the absence of site-related contamination. How should a risk manager decide which residential properties to sample and which ones to clean? This paper introduces an adaptive spatial sampling approach which uses initial observations to guide subsequent search. Unlike some recent model-based spatial data analysis methods, it does not require any specific statistical model for the spatial distribution of hazards, but instead constructs an increasingly accurate nonparametric approximation to it as sampling proceeds. Possible cost-effective sampling and cleanup decision rules are described by decision parameters such as the number of randomly selected locations used to initialize the process, the number of highest-concentration locations searched around, the number of samples taken at each location, a stopping rule, and a remediation action threshold. These decision parameters are optimized by simulating the performance of each decision rule. The simulation is performed using the data collected so far to impute multiple probable values ofunknown soil concentration distributions during each simulation run. This optimized adaptive spatial sampling technique has been applied to real data using error probabilities for wrongly cleaning or wrongly failing to clean each location (compared to the action that would be taken if perfect information were available) as evaluation criteria. It provides a practical approach for quantifying trade-offs between these different types of errors and expected cost. It also identifies strategies that are undominated with respect to all of these criteria.

Notes: 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 approachthat 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 carcinogenicrisks (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.

Notes: The paper applies classical statistical principles to yield new tools for risk assessment and makes new use of epidemiological data for human riskassessment. An extensive clinical and epidemiological study of workers engaged in the manufacturing and formulation of aldrin and dieldrin provides occupational hygiene and biological monitoring data on individual exposures over the years of employment and provides unusually accurate measures of individual lifetime average daily doses. In the cancer dose-response modeling, each worker is treated as a separate experimental unit with his own unique dose. Maximum likelihood estimates of added cancer risk are calculated for multistage, multistage-Weibull, and proportional hazards models. Distributional characterizations of added cancer risk are based on bootstrap and relative likelihood techniques. The cancer mortality data on these male workerssuggest that low-dose exposures to aldrin and dieldrin do not significantlyincrease human cancer risk and may even decrease the human hazard rate for all types of cancer combined at low doses (e.g., 1μg/kg/day). The apparent hormetic effect in the best fitting dose-response models for this data set is statistically significant. The decrease in cancer risk at low doses ofaldrin and dleldrin is in sharp contrast to the U.S. Environmental Protection Agency's upper bound on cancer potency based on mouse liver tumors. The EPA's upper bound implies that lifetime average daily doses of 0.0000625 and 0.00625 pμg/kg body weight/day would correspond to increased cancer risks of 0.000001 and O.OOO1, respectively. However, the best estimate from the Pernis epidemiological data is that there is no increase in cancer risk in these workers at these doses or even at doses as large as 2 μg/kg/day.

Notes: Ethylene oxide (EO) research has significantly increased since the 1980s, when regulatory risk assessments were last completed on the basis of theanimal cancer chronic bioassays. In tandem with the new scientific understanding, there have been evolutionary changes in regulatory risk assessment guidelines, that encourage flexibility and greater use of scientific information. The results of an updated meta-analysis of the findings from 10 unique EO study cohorts from five countries, including nearly 33,000 workers, and over 800 cancers are presented, indicating that EO does not cause increased risk of cancers overall or of brain, stomach or pancreatic cancers. The findings for leukemia and non-Hodgkin's lymphoma (NHL) are inconclusive. Two studies with the requisite attributes of size, individual exposure estimates and follow up are the basis for dose-response modeling and added lifetime risk predictions under environmental and occupational exposure scenariosand a variety of plausible alternative assumptions. A point of departure analysis, with various margins of exposure, is also illustrated using human data. The two datasets produce remarkably similar leukemia added risk predictions, orders of magnitude lower than prior animal-based predictions under conservative, default assumptions, with risks on the order of 1 × 10−6 or lower for exposures in the low ppb range. Inconsistent results for “lymphoid” tumors, a non-standard grouping using histologic information from death certificates, are discussed. This assessment demonstrates the applicability of the current risk assessment paradigm to epidemiological data.

Notes: The human toxicity potential, a weighting scheme used to evaluate toxicemissions for life cycle assessment and toxics release inventories, is based on potential dose calculations and toxicity factors. This paper evaluatesthe variance in potential dose calculations that can be attributed to the uncertainty in chemical-specific input parameters as well as the variabilit in exposure factors and landscape parameters. A knowledge of the uncertainty allows us to assess the robustness of a decision based on the toxicity potential; a knowledge of the sources of uncertainty allows us to focus our resources if we want to reduce the uncertainty. The potential dose of 236 chemicals was assessed. The chemicals were grouped by dominant exposure route, and a Monte Carlo analysis was conducted for one representative chemical in each group. The variance is typically one to two orders of magnitude. For comparison, the point estimates in potential dose for 236 chemicals span ten orders of magnitude. Most of the variance in the potential dose is due to chemical-specific input parameters, especially half-lives, although exposure factors such as fish intake and the source of drinking water can be important for chemicals whose dominant exposure is through indirect routes. Landscape characteristics are generally of minor importance.

Notes: To assess soil and groundwater quality two generic (i.e. multifunctional) risk-based standards, Target and Intervention Value, have been developed, in the framework of the Dutch Soil Protection Act. These standards allow soil and groundwater to be classified as clean, slightly contaminated or seriously contaminated. The Target Value is basedon potential risks to ecosysystems, while the Intervention Value is based oqpotential risks to humans and ecosystems. In the case of serious soil contamination the site has, in principle, to be remediated, making it necessary to determine the remediation urgency on the basis of actual (i.e. site-specific) risks to humans and ecosystems and, besides, actual risks due to contaminant migration.

Notes: The Waste Isolation Pilot Plant (WIPP) is a geological repository for disposal ofU.S. defense transuranic radioactive waste. Built and operated by the U.S. Departmentof Energy (DOE), it is located in the Permian age salt beds in southeastern New Mexico at a depth of 655 m. Performance assessment for the repository's compliance with the 10,000-year containment standards was completed in 1996 and the U.S. Environmental Protection Agency (EPA) certified in 1998 that the repository meets compliance with the EPA standards 40 CFR 191 and 40 CFR 194. The Environmental Evaluation Group (EEG) review of the DOE'S application for certification identified a number of issues. These related to the scenarios, conceptual models, and values of the input parameters used in the calculations. It is expected that these issues will be addressed and resolved during the first 5-year recertification process that began with the first receipt of waste at WIPP on March 26, 1999, and scheduled to be completed in March 2004.

Notes: The estimation of health risks from exposure to a mixture of chemical carcinogens is generally based on the combination of information from several available single compound studies. The current practice of directly summing the upper bound risk estimates of individual carcinogenic components as an upper bound on the total risk of a mixture is known to be generally too conservative. Gaylor and Chen (1996, Risk Analysis) proposed a simple procedure to compute an upper bound on the total risk using only the upper confidence limits and central risk estimates of individual carcinogens. The Gaylor-Chen procedure was derived based on an underlying assumption of the normality for the distributions of individual risk estimates. In this paper we evaluated the Gaylor-Chen approach in terms of the coverage probability. The performance of the Gaylor-Chen approach in terms the coverages of the upper confidence limits on the true risks of individual carcinogens. In general, if the coverage probabilities for the individual carcinogens are all approximately equal to the nominal level, then the Gaylor-Chen approach shouldperform well. However, the Gaylor-Chen approach can be conservative or anti-conservative if some or all individual upper confidence limit estimates are conservative or anti-conservative.

Notes: Political context may play a large role in influencing the efficiency of environmental and health regulations. This case study uses data from a 1989 update of the Occupational Safety and Health Administration (OSHA) Permissible Exposure Limits (PELS) program to determine the relative effects of legislative mandates, costly acquisition of information by the agency, and pressure applied by special interest groups upon exposure standards. The empirical analysis suggests that federal agencies successfully thwart legislative attempts to limit agency discretion, and that agencies exercise bounded rationality by placing greater emphasis on more easily obtained information. The 1989 PEL were less significantly related to more costly information, contained “safety factors” for chemicals presenting relatively more ambiguous risks, and the proposed standard stringencies showed evidence of beinginfluenced by vying industry and labor interests.

Notes: Monte Carlo methods in risk assessment are finding increasingly widespread application. With the recognition that inputs may be correlated, the incorporation of such correlations into the simulation has become important. Most implementations rely upon the method of Iman and Conover for generating correlated random variables. In this work, alternative methods using copulas are presented for deriving correlated random variables. It is further shown that the particular algorithm or assumption used may have a substantial effect on the output results, due to differences in higher order bivariate moments.

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

Notes: This paper reviews existing data on the variability in parameters relevant for health risk analyses. We cover both exposure-related parameters andparameters related to individual susceptibility to toxicity. The toxicity/susceptibility data base under construction is part of a longer term research effort to lay the groundwork for quantitative distributional analyses of non-cancer toxic risks. These data are broken down into a variety of parameter types that encompass different portions of the pathway from external exposure to the production of biological responses. The discrete steps in this pathway, as we now conceive them, are:〈list xml:id="l2" style="custom"〉•Contact Rate (Breathing rates per body weight; fish consumption per bodyweight)•Uptake or Absorption as a Fraction of Intake or Contact Rate•General Systemic Availability Net of First Pass Elimination and Dilutionvia Distribution Volume (e.g., intial blood concentration per mg/kg of uptake)•Systemic Elimination (half life or clearance)•Active Site Concentration per Systemic Blood or Plasma Concentration•Physiological Parameter Change per Active Site Concentration (expressed as the dose required to make a given percentage change in different people, or the dose required to achieve some proportion of an individual's maximum response to the drug or toxicant)•Functional Reserve Capacity-Change in Baseline Physiological Parameter Needed to Produce a Biological Response or Pass a Criterion of Abnormal FunctionComparison of the amounts of variability observed for the different parameter types suggests that appreciable variability is associated with the final step in the process-differences among people in “functional reserve capacity.” This has the implication that relevant information for estimatingeffective toxic susceptibility distributions may be gleaned by direct studies of the population distributions of key physiological parameters in people that are not exposed to the environmental and occupational toxicants thatare thought to perturb those parameters. This is illustrated with some recent observations of the population distributions of Low Density Lipoprotein Cholesterol from the second and third National Health and Nutrition Examination Surveys.

Notes: Proposed in this article is one possible framework for classifying multiple types of ethical issues in risk communication research and practice to help continue a discussion initiated in 1990 by Morgan and Lave. Some of the questions that each stage of the process for planning risk communication strategies appears to pose for ethics are discussed (e.g., selecting issues to be communicated, knowing the issue, dealing with constraints). Also discussed briefly are some issues raised by the possibility that risk communicators aspire to the status of a profession. The purpose is to foster discussion rather than issue a conclusive statement on the topic, because its very nature makes a definitive pronouncement indefensible.

Notes: The ultimate goal of the research reported in this series of three articles is to derive distributions of doses of selected environmental tobacco smoke (ETS)-related chemicals for nonsmoking workers. This analysis uses data from the 16-City Study collected with personal monitors over the course of one workday in workplaces where smoking occurred. In this article, we describe distributions of ETS chemical concentrations and the characteristicsof those distributions (e.g., whether the distribution was log normal for agiven constituent) for the workplace exposure. Next, we present population parameters relevant for estimating dose distributions and the methods used for estimating those dose distributions. Finally, we derive distributions of doses of selected ETS-related constituents obtained in the workplace for people in smoking work environments. Estimating dose distributions providedinformation beyond the usual point estimate of dose and showed that the preponderance of individuals exposed to ETS in the workplace were exposed at the low end of the dose distribution curve. The results of this analysis include estimations of hourly maxima and time-weighted average (TWA) doses of nicotine from workplace exposures to ETS (extrapolated from 1 day to 1 week) and doses derived from modeled lung burdens of ultraviolet-absorbing particulate matter (UVPM) and solanesol resulting from workplace exposures to ETS (extrapolated from 1 day to 1 year).

Notes: Through surveys of students and junior professionals and interviews with business and government executives, we studied Chinese choices and fairness perceptions in risky health and safety decisions. The survey responses were compared with American responses from an earlier study by Keller and Sarin.The survey results show that the American and Chinese respondents had similar fairness perceptions, but the Chinese did not make decisions that were consistent with their fairness perceptions, whereas the Americans did. We found that the middle-age Chinese professionals tended to make choices that were more different from the Americans than were the choices of the young Chinese management students. It is likely that these discrepancies were caused by cultural differences, with the younger Chinese tending to face a stronger Western influence.The insights from the survey results were enriched by interviews that revealed fairness perceptions of Chinese business and government executives.A framework to interpret cultural influences on decision making was also proposed.

Notes: The risk of catastrophic failures, for example in the aviation and aerospace industries, can be approached from different angles (e.g., statistics when they exist, or a detailed probabilistic analysis of the system). Each new accident carries information that has already been included in the experience base or constitutes new evidence that can be used to update a previous assessment of the risk. In this paper, we take a different approach and consider the risk and the updating from the investor's point of view. Based on the market response to past airplane accidents, we examine which ones have created a “surprise response” and which ones are considered part of the risk of the airline business as previously assessed. To do so, we quantify the magnitude and the timing of the observed market response to catastrophic accidents, and we compare it to an estimate of the response that would be expected based on the true actual cost of the accident including direct and indirect costs (“full-cost information” response). First, we develop a method based on stock market data to measure the actual market response to an accident and we construct an estimate of the “full-cost information” response to such an event. We then compare the two figures for the immediate and the long-term response of the market for the affected firm, as well as for the whole industry group to which the firm belongs. As an illustration, we analyze a sample of ten fatal accidents experienced by major US domestic airlines during the last seven years. In four cases, we observed an abnormal market response. In these instances, it seems that the shareholders may have updated their estimates of the probability of a future accident in the affected airlines or more generally of the firm's future business prospects. This market reaction is not always easy to explain much less to anticipate, a fact which management should bear in mind when planning a firm's response to such an event.

Notes: This paper describes the application of two multimedia models, PRESTO and MMSOILS, to predict contaminant migration from a landfill that contains an organic chemical (methylene chloride) and a radionuclide (uranium-238). Exposure point concentrations and human health risks are predicted, and distributions of those predictions are generated using Monte Carlo techniques. Analysis of exposure point concentrations shows that predictions of uranium-238 in groundwater differ by more than one order of magnitude between models. These differences occur mainly because PRESTO simulates uranium-238 transport through the groundwater using a one-dimensional algorithm and vertically mixes the plume over an effective mixing depth, whereas MMSOILS uses a three-dimensional algorithm and simulates a plume that resides near the surface of the aquifer.A sensitivity analysis, using stepwise multiple linear regression, is performed to evaluate which of the random variables are most important in producing the predicted distributions of exposure point concentrations and health risks. The sensitivity analysis shows that the predicted distributions can be accurately reproduced using a small subset of the random variables. Simple regression techniques are applied, for comparison, to the same scenarios, and results are similar. The practical implication of this analysis is the ability to distinguish between important versus unimportant random variables in terms of their sensitivity to selected endpoints.

Notes: A sample of 323 residents of New Jersey stratified by neighborhood quality (excellent, good, fair, poor) was gathered to determine if trust in science and technology to protect public health and environment at the societal scale was associated with trust of the local officials, such as the mayor, health officer, developers, mass media, and legislators who are guardians of the local environment. Societal (trust of science and technology) and neighborhood (mayor, health officer) dimensions of trust were found. These societal and neighborhood trust dimen-sions were weakly correlated. Respondents were divided into four trust-of-authority groups: high societal-high neighborhood, low societal-low neighborhood, high societal-low neigh-borhood, and low societal-high neighborhood. High societal-high neighborhood trust re-spondents were older, had lived in the neighborhoods for many years, were not troubled much by neighborhood or societal environmental threats, and had a strong sense of control over their environment. In strong contrast, low societal-low neighborhood trust respondents were relatively young, typically had lived in their present neighborhood for a short time, were troubled by numerous neighborhood and societal environmental threats, did not practice many personal public health practices, and felt little control over their environment.

Notes: Recreational and subsistence angling are important aspects of urban culture for much of North America where people are concentrated near the coasts or major rivers. Yet there are fish and shellfish advisories for many estuaries, rivers, and lakes, and these are not always heeded. This paper examines fishing behavior, sources of information, perceptions, and compliance with fishing advisories as a function of ethnicity for people fishing in the Newark Bay Complex of the New York-New Jersey Harbor. We test the null hypothesis that there were no ethnic differences in sources of information, perceptions of the safety of fish consumption, and compliance with advisories. There were ethnic differences in consumption rates, sources of information about fishing, knowledge about the safety of the fish, awareness of fishing advisories or of the correct advisories, and knowledge about risks for increased cancer and to unborn and young children. In general, the knowledge base was much lower for Hispanics, was intermediate for blacks, and was greatest for whites. When presented with a statement about the potential risks from eating fish, there were no differences in their willingness to stop eating fish or to encourage pregnant women to stop. These results indicate a willingness to comply with advisories regardless of ethnicity, but a vast difference in the base knowledge necessary to make informed risk decisions about the safety of fish and shellfish. Although the overall median income level of the population was in the $25,000-34,999 income category, for Hispanics it was on the border between $15,OOO-24,999 and $25,000-34,999.

Notes: Water pollution from agricultural pesticides continues to be a public concern. Given that the use of such pesticides on the farm is largely governed by voluntary behavior, it is important to understand what drives farmer behavior. Health belief models in public health and social psychology argue that persons who have adverse health experiences are likely to undertake preventive behavior. An analogous hypothesis set was tested here: farmers who believe they have had adverse health experiences from pesticides are likely to have heightened concerns about pesticides and are more likely to take greater precautions in dealing with pesticides. This work is based on an original survey of a population of 2700 corn and soybean growers in Maryland, New York, and Pennsylvania using the U.S. Department of Agriculture data base. It was designed as a mail survey with telephone follow-up, and resulted in a 60 percent response rate. Farm operators report experiencing adverse health problems they believe are associated with pesticides that is equivalent to an incidence rate that is higher than the reported incidence of occupational pesticide poisonings, but similar to the reported incidence of all pesticide poisonings. Farmers who report experiencing such problems have more heightened concerns about water pollution from fertilizers and pesticides, and illness and injury from mixing, loading, and applying pesticides than farmers who have not experienced such problems. Farmers who report experiencing such problems also are more likely to report using alternative pest management practices than farmers who do not report having such problems. This implies that farmers who have had such experiences do care about the effects of application and do engage in alternative means of pest management, which at least involve the reduction in pesticide use.

Notes: The approximate solution of the two-stage clonal expansion model of cancer may substantially deviate from the exact solution, and may therefore lead to erroneous conclusions in particular applications. However, for time-varying parameters the exact solution (method of characteristics) is not easy to implement, hampering the accessibility of the model to nonmathematicians. Based on intuitive reasoning, Clewell et al. (1995) proposed an improved approximate solution that is easy to implement whatever time-varying behavior the parameters may have. Here we provide the mathematical foundation for the approximation suggested by Clewell et al. (1995) and show that, after a slight modification, it is in fact an exact solution for the case of time-constant parameters. We were not able to prove that it is an exact solution for time-varying parameters as well. However, several computer simulations showed that the numerical results do not differ from the exact solution as proposed by Moolgavkar and Luebeck (1990). The advantage of this alternative solution is that the hazard rate of the first malignant cell can be evaluated by numerically integrating a single differential equation.

Notes: The regional economic impacts of the U.S. Department of Energy's accelerated environmental cleanup plan are estimated for the major nuclear weapons sites in Colorado, Idaho, New Mexico, South Carolina, Tennessee, and Washington. The analysis shows that the impact falls heavily on the three relatively rural regions around the Savannah River (SC), Hanford (WA), and Idaho National Engineering and Environmental Laboratory (ID) sites. A less aggressive phase-down of environmental management funds and separate funds toinvest in education and infrastructure in the regions helps buffer theimpacts on jobs, personal income, and gross regional product. Policy options open to the federal and state and local governments are discussed.

Notes: The concept of exposure is central to chemical risk assessment and plays an important role in communicating to the public about the potential healthrisks 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 aboutchemical 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'sbeliefs about chemical exposure (and its risks) are based on two broad categories of inferences. One category of inferences relates to the nature inwhich contact with a chemical has taken place, including the amount of a chemical involved and its potential health consequences. A second category ofinferences about chemical exposure relates to the pragmatics of languageinterpretation, 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 leadto conflicting conclusions on the part of the public about chemical safety.

Notes: Risk management has become increasingly politicized and contentious. Polarized views, controversy, and conflict have become pervasive. Research has begun to provide a new perspective on this problem by demonstrating the complexity of the concept “risk” and the inadequacies of the traditionalview of risk assessment as a purely scientific enterprise. This paper argues that danger is real, but risk is socially constructed. Risk assessment is inherently subjective and represents a blending of science and judgmentwith important psychological, social, cultural, and political factors. In addition, our social and democratic institutions, remarkable as they are in many respects, breed distrust in the risk arena. Whoever controls the definition of risk controls the rational solution to the problem at hand. Ifrisk is defined one way, then one option will rise to the top as the most cost-effective or the safest or the best. If it is defined another way, perhaps incorporating qualitative characteristics and other contextual factors, one will likely get a different ordering of action solutions. Definingrisk is thus an exercise in power. Scientific literacy and public education are important, but they are not central to risk controversies. The public is not irrational. Their judgments about risk are influenced by emotion and affect in a way that is both simple and sophisticated. The same holds true for scientists. Public views are also influenced by worldviews, ideologies, and values; so are scientists' views, particularly when they are working at the limits of their expertise. The limitations of risk science, the importance and difficulty of maintaining trust, and the complex, sociopolitical nature of risk point to the need for a new approach-one that focuses upon introducing more public participation into both risk assessment and risk decision making in order to make the decision process more democratic, improve the relevance and quality of technical analysis, and increasethe legitimacy and public acceptance of the resulting decisions.

Notes: This paper examines the impact that insurance coupled with specific risk mitigation measures (RMMs) could have on reducing losses from hurricanes and earthquakes as well as improving the solvency position of insurers who provide coverage against these hazards. We first explore why relatively fewindividuals adopt cost-effective RMMs by reporting on the results of empirical studies and controlled laboratory studies. We then investigate the impact that an RMM has on both the expected losses and those from a worst case scenario in two model cities-Oakland (an earthquake-prone area) and Miami/Dade County (a hurricane-prone area) which were constructed respectively with the assistance of two modeling firms. The paper then explores three programs for forging a meaningful public-private sector partner- ship: well-enforced building codes, insurance premium reductions linked with long-term loans, and lower deductibles on insurance policies tied to mitigation. We conclude by briefly examining four issues for future research on linking mitigation with insurance.

Notes: The 16-City Study analyzed for gas-phase environmental tobacco smoke (ETS) constituents (nicotine, 3-ethenyl pyridine [3-EP], and myosmine) and for particulate-phase constituents (respirable particulate matter [RSP], ultraviolet-absorbing particulate matter [UVPM], fluorescing particulate matter [FPM], scopoletin, and solanesol). In this second of three articles, we discussthe merits of each constituent as a marker for ETS and report pair-wise comparisons of the markers. Neither nicotine nor UVPM were good predictors for RSP. However, nicotine and UVPM were good qualitative predictors of each other. Nicotine was correlated with other gas-phase constituents. Comparisons between UVPM and other particulate-phase constituents were performed. Its relation with FPM was excellent, with UVPM approximately 11/2 times FPM. The correlation between UVPM and solanesol was good, but the relationship between the two was not linear. The relation between UVPM and scopoletin was not good, largely because of noise in the scopoletin measures around its limit of detection. We considered the relation between nicotine and saliva cotinine, a metabolite of nicotine. The two were highly correlated on the group level. That is, for each cell (smoking home and work, smoking home but nonsmoking work, and so forth), there was high correlation between average cotinine and 24-hour time-weighted average (TWA) nicotine concentrations. However, on the individual level, the correlations, although significant, were not biologically meaningful. A consideration of cotinine and nicotine or 3-EP on a subset of the study whoseonly exposure to ETS was exclusively at work or exclusively at home showed that home exposure was a more important source of ETS than work exposure.

Notes: In the design, development, and manufacturing stage of industrial products, engineers usually focus on the problems caused by hardware or software, but pay less attention to problems caused by “human error,” which may significantly affect system reliability and safety. Although operating procedures are strictly followed, human error still may occur occasionally. Among the influencing factors, the inappropriate design of standard operation procedure (SOP) or standard assembly procedure (SAP) is an important and latent reason for unexpected results found during human operation. To reduce the error probability and error effects of these unexpected behaviors in the industrial work process, overall evaluation of SOP or SAP quality has become an essential task. The human error criticality analysis (HECA) method was developed to identify the potentially critical problems caused by human error in the human operation system. This method performs task analysis on the basis of operation procedure. For example, SOP, analyzes the human error probability (HEP) for each human operation step, and assesses its error effects to the whole system. The results of the analysis will show the interrelationship that exists between critical human tasks, critical human error modes, and human reliability information of the human operation system. To identify the robustness of the model, a case study of initiator assembly tasks was conducted. Results show that the HECA method is practicable in evaluating the operation procedure, and the information is valuable in identifying the means to upgrade human reliability and system safety for human tasks.

Notes: The research reported here examines the relationship between risk perceptions and willingness to address climate change. The data are a national sample of 1225 mail surveys that include measures of risk perceptions and knowledge tied to climate change, support for voluntary and government actions to address the problem, general environmental beliefs, and demographic variables. Risk perceptions matter in predicting behavioral intentions. Risk perceptions are not a surrogate for general environmental beliefs, but have their own power to account for behavioral intentions. There are four secondary conclusions. First, behavioral intentions regarding climate change are complex and intriguing. People are neither “nonbelievers” who will take no initiatives themselves and oppose all government efforts, nor are they “believers” who promise both to make personal efforts and to vote for every government proposal that promises to address climate change. Second, there are separate demographic sources for voluntary actions compared with voting intentions. Third, recognizing the causes of global warming is a powerful predictor of behavioral intentions independent from believing that climate change will happen and have bad consequences. Finally, the success of the risk perception variables to account for behavioral intentions should encourage greater attention to risk perceptions as independent variables. Risk perceptions and knowledge, however, share the stage with general environmental beliefs and demographic characteristics. Although related, risk perceptions, knowledge, and general environmental beliefs are somewhat independent predictors of behavioral intentions.

Notes: This paper concerns the combination of experts' probability distributions in risk analysis, discussing a variety of combination methods and attempting to highlight the important conceptual and practical issues to be considered in designing a combination process in practice. The role of experts is important because their judgments can provide valuable information, particularly in view of the limited availability of “hard data” regarding many important uncertainties in risk analysis. Because uncertainties are represented in terms of probability distributions in probabilistic risk analysis (PRA), we consider expert information in terms of probability distributions. The motivation for the use of multiple experts is simply the desire to obtain as much information as possible. Combining experts' probability distributions summarizes the accumulated information for risk analysts and decision-makers. Procedures for combining probability distributions are often compartmentalized as mathematical aggregation methods or behavioral approaches, and we discuss both categories. However, an overall aggregation process could involve both mathematical and behavioral aspects, and no single process is best in all circumstances. An understanding of the pros and cons of different methods and the key issues to consider is valuable in the design of acombination process for a specific PRA. The output, a ”combined probabilitydistribution,” can ideally be viewed as representing a summary of the current state of expert opinion regarding the uncertainty of interest.

Notes: The reliability of a treatment process is addressed in terms of achieving a regulatory effluent concentration standard and the design safety factors associated with the treatment process. This methodology was then appliedto two aqueous hazardous waste treatment processes: packed tower aeration and activated sludge (aerobic) biological treatment. The designs achieving 95 percent reliability were compared with those designs based on conventional practice to determine their patterns of conservatism. Scoping-level treatment costs were also related to reliability levels for these treatment processes. The results indicate that the reliability levels for the physicalkhemical treatment process (packed tower aeration) based on the deterministic safety factors range from 80 percent to over 99 percent, whereas those for the biological treatment process range from near 0 percent to over 99 percent, depending on the compound evaluated. Increases in reliability per unit increase in treatment costs are most pronounced at lower reliability levels(less than about 80 percent) than at the higher reliability levels (greaterthan 90 percent, indicating a point of diminishing returns. Additional research focused on process parameters that presently contain large uncertainties may reduce those uncertainties, with attending increases in the reliability levels of the treatment processes.

Notes: A mechanistic model and associated procedures are proposed for cancer risk assessment of genotoxic chemicals. As previously shown for ionizing radiation, a linear multiplicative model was found to be compatible with published experimental data for ethylene oxide, acrylamide, and butadiene. The validity of this model was anticipated in view of the multiplicative interaction of mutation with inherited and acquired growth-promoting conditions. Concurrent analysis led to rejection of an additive model (i.e. the model commonly applied for cancer risk assessment). A reanalysis of data for radiogenic cancer in mouse, dog and man shows that the relative risk coefficient is approximately the same (0.4 to 0.5 percent per rad) for tumours induced in the three species.Doses in vivo, defined as the time-integrated concentrations of ultimate mutagens, expressed in millimol X kg-1 x h (mMh) are, like radiation doses given in Gy or rad, proportional to frequencies of potentially mutagenic events. The radiation dose equivalents of chemical doses are, calculated by multiplying chemical doses (in mMh) with the relative genotoxic potencies (in rad X mMh-1) determined in vitro. In this way the relative cancer incidence increments in rats and mice exposed to ethylene oxide were shown to be about 0.4 percent per rad-equivalent, in agreement with the data for radiogenic cancer.Our analyses suggest that values of the relative risk coefficients for genotoxic chemicals are independent of species and that relative cancer risks determined in animal tests apply also to humans. If reliable animal test data are not available, cancer risks may be estimated by the relative potency. In both cases exposure dose/target dose relationships, the latter via macromolecule adducts, should be determined.

Notes: This paper is a challenge from a pair of lifelong technical specialists in risk assessment for the risk-management community to better define social decision criteria for risk acceptance vs. risk control in relation to the issues of variability and uncertainty. To stimulate discussion, we offer a variety of “straw man” proposals about where we think Variability and uncertainty are likely to matter for different types of social policy considerations in the context of a few different kinds of decisions. In particular, we draw on recent presentations of uncertainty and variability data that have been offered by EPA in the context of the consideration of revised ambient air quality standards under the Clean Air Act.

Notes: Risk assessors attempting to use probabilistic approaches to describe uncertaintyoften find themselves in a data-sparse situation: available data are only partially relevant to the parameter of interest, so one needs to adjust empirical distributions, use explicit judgmental distributions, or collect new data. In determining whether ornot to collect additional data, whether by measurement or by elicitation of experts, it is useful to consider the expected value of the additional information. The expected value of information depends on the prior distribution used to represent current information; if the prior distribution is too narrow, in many risk-analytic cases the calculated expected value of information will be biased downward. The well-documentedtendency toward overconfidence, including the neglect of potential surprise, suggeststhis bias may be substantial. We examine the expected value of information, includingthe role of surprise, test for bias in estimating the expected value of information, and suggest procedures to guard against overconfidence and underestimation of the expected value of information when developing prior distributions and when combining distributions obtained from multiple experts. The methods are illustrated with applications to potential carcinogens in food, commercial energy demand, and global climate change.

Notes: Residential building codes intended to promote health and safety may produce unintended countervailing risks by adding to the cost of construction. Higher construction costs increase the price of new homes and may increase health and safety risks through “income” and “stock” effects. The income effect arises because households that purchase a new home have less income remaining for spending on other goods that contribute to health and safety. The stock effect arises because suppression of new-home construction leads to slower replacement of less safe housing units. These countervailing risks are not presently considered in code debates. We demonstrate the feasibility of estimating the approximate magnitude of countervailing risks by combining the income effect with three relatively well understood and significant home-health risks. We estimate that a code change that increases the nationwide cost of constructing and maintaining homes by $150 (0.1% of the average cost to build a single-family home) would induce offsetting risks yielding between 2 and 60 premature fatalities or, including morbidity effects, between 20 and 800 lost quality-adjusted life years (both discounted at 3%)each year the code provision remains in effect. To provide a net health benefit, the code change would need to reduce risk by at least this amount. Future research should refine these estimates, incorporate quantitative uncertainty analysis, and apply a full risk-tradeoff approach to real-world casestudies of proposed code changes.

Notes: When pathogenic microorganisms enter the human body via ingestion with food or drinking water, they encounter a system of barriers mounted by the host. In order to reach parts of the intestinal tract that are suitable forgrowth and attachment, each of the bamers must be overcome successfully. The present view on infection states that at least one of the ingested pathogens must survive to start colonization. This is the basis for dose responsemodels, used for quantitative risk assessment. In this paper, the usefulness of the Beta Poisson model for multiple barriers is corroborated. Infection is associated with the presence of elevated numbers of reproducing pathogens in the intestinal tract. This does not necessarily imply illness symptoms: when intestinal microorganisms engage in damaging activities, this may lead to illness symptoms. At the same time, these activities probably elicit defensive measures from the host, promoting the removal of pathogens and terminating infection. The duration of the period of colonization reflects the balance between the colonization potential of pathogens and the strength of host defenses. Starting from the assumption that during infection the host has a certain hazard of becoming ill, a simple dose response relation for acute gastroenteritis is developed. With the use of literature data from volunteer experiments, we show that examples can be found for three possible alternatives: an increase in the probability of illness with increasingdose, a decrease with higher doses, and a probability of illness (given infection) independent of the ingested dose. These alternatives may reflect different modes of interaction between pathogens and host.

Notes: The U.S. Nuclear Regulatory Commission (NRC) staff has developed a performance assessment capability to address three programmatic areas in nuclear waste management: high-level waste, low-level waste, and decommissioning of licensed facilities (license termination). The NRC capability consists of (1) methodologies for performance assessment; (2) models and computer codes for estimating system performance; (3) regulatory guidance in various forms, such as regulations, Branch Technical Positions, and Standard Review Plans; and (4) a technical staff experienced in executing and evaluating performance assessments for a variety of waste systems. Although the tools and techniques are refined for each programmatic area, general approaches and similar issues are encountered in all areas.

Notes: The Electric Power Research Institute (EPRI) has sponsored the development of a model to assess the long-term, overall “performance” of the candidate spent fuel and high-level radioactive waste (HLW) disposal facility at Yucca Mountain, Nevada. The model simulates the processes that lead to HLW container corrosion, HLW mobilization from the spent fuel, and transport by groundwater, and contaminated groundwater usage by future hypothetical individuals leading to radiation doses to those individuals. The model must incorporate a multitude of complex, coupled processes across a variety of technical disciplines. Furthermore, because of the very long time frames involved in the modeling effort (〉104 years), the relative lack of directly applicable data, and many uncertainties and variabilities in those data, a probabilistic approach to model development was necessary. The developers of the model chose a logic tree approach to represent uncertainties in both conceptual models and model parameter values. The developers felt the logic tree approach was the most appropriate. This paper discusses the value and use of logic trees applied to assessing the uncertainties in HLW disposal, the components of the model, and a few of the results of that model. The paper concludes with a comparison of logic trees and Monte Carlo approaches.

Notes: Performance Assessment (PA) is the use of mathematical models to simulate the long-term behavior of engineered and geologic barriers in a nuclear waste repository; methods of uncertainty analysis are used to assess effects of parametric and conceptual uncertainties associated with the model system upon the uncertainty in outcomes of the simulation. PA is required by the U.S. Environmental Protection Agency as part of its certification process for geologic repositories for nuclear waste. This paper is a dialogue to explore the value and limitations of PA. Two “skeptics” acknowledge the utility of PA in organizing the scientific investigations that are necessary for confident siting and licensing of a repository; however, they maintain that the PA process, at least as it is currently implemented, is an essentially unscientific process with shortcomings that may provide results of limited use in evaluating actual effects on public health and safety. Conceptual uncertainties in a PA analysis can be so great that results can be confidently applied only over short time ranges, the antithesis of the purpose behind long-term, geologic disposal. Two “proponents” of PA agree that performance assessment is unscientific, but only in the sense that PA is an engineering analysis that uses existing scientific knowledge to support public policy decisions, rather than an investigation intended to increase fundamental knowledge of nature; PA has different goals and constraints than a typical scientific study. The “proponents” describe an ideal, sixstep process for conducting generalized PA, here called probabilistic systems analysis (PSA); they note that virtually all scientific content of a PA is introduced during the model-building steps of a PSA, they contend that a PA based on simple but scientifically acceptable mathematical models can provide useful and objective input to regulatory decision makers. The value of the results of any PA must lie between these two views and will depend on the level of knowledge of the site, the degree to which models capture actual physical and chemical processes, the time over which extrapolations are made, and the proper evaluation of health risks attending implementation of the repository. The challenge is in evaluating whether the quality of the PA matches the needs of decision makers charged with protecting the health and safety of the public.

Notes: Should We Risk It? David M. Kammen and David M. Hassenzahl

Notes: Exposure to persistent organochlorines in breast milk was estimated probabilistically for Canadian infants. Noncancer health effects were evaluated by comparing the predicted exposure distributions to published guidance values. For chemicals identified as potential human carcinogens, cancer risks were evaluated using standard methodology typically applied in Canada, aswell as an alternative method developed under the Canadian Environmental Protection Act. Potential health risks associated with exposure to persistentorganochlorines were quantitatively and qualitatively weighed against the benefits of breast-feeding. Current levels of the majority of contaminants identified in Canadian breast milk do not pose unacceptable risks to infants. Benefits of breast-feeding are well documented and qualitatively appear to outweigh potential health concerns associated with organochlorine exposure. Furthermore, the risks of mortality from not breast-feeding estimated by Rogan and colleagues exceed the theoretical cancer risks estimated for infant exposure to potential carcinogens in Canadian breast milk. Although levels of persistent compounds have been declining in Canadian breast milk, potentially significant risks were estimated for exposure to polychlorinatedbiphenyls, dibenzo-p-dioxins, and dibenzofurans. Follow-up work is suggested that would involve the use of a physiologically based toxicokinetic modelwith probabilistic inputs to predict dioxin exposure to the infant. A more detailed risk analysis could be carried out by coupling the exposure estimates with a dose-response analysis that accounts for uncertainty.

Notes: The US. Environmental Protection Agency (EPA) recommends the use of th one-sided 95% upper confidence limit of the arithmetic mean based on eithe a normal or lognormal distribution for the contaminant (or exposure point) concentration term in the Superfund risk assessment process. When the data are not normal or lognormal this recommended approach may overestimate the exposure point concentration (EPC) and may lead to unecessary cleanup at a hazardous waste site. The EPA concentration term only seems to perform lik alternative EPC methods when the data are well fit by a lognormal distribution. Several alternative methods for calculating the EPC are investigated and compared using soil data collected from three hazardous waste sites in Montana, Utah, and Colorado. For data sets that are well fit by a lognormal distribution, values for the Chebychev inequality or the EPA concentration term may be appropriate EPCs. For data sets where the soil concentration data are well fit by gamma distributions, Wong's method may be used for calculating EPCs. The studentized bootstrap-t and Hall's bootstrap-t transformation are recommended for EPC calculation when all distributionfits are poor. If a data set is well fit by a distribution, parametric bootstrap may provide a suitable EPC.

Notes: We present the results of a quantitative assessment of the lung cancer risk associated with occupational exposure to refractory ceramic fibers (RCF). The primary sources of data for our risk assessment were two long-term oncogenicity studies in male Fischer rats conducted to assess the potentialpathogenic effects associated with prolonged inhalation of RCF. An interesting feature of the data was the availability of the temporal profile of fiber burden in the lungs of experimental animals. Because of this information, we were able to conduct both exposure-response and dose-response analyse. Our risk assessment was conducted within the framework of a biologically based model for carcinogenesis, the two-stage clonal expansion model, which allows for the explicit incorporation of the concepts of initiation and promotion in the analyses. We found that a model positing that RCF was an initiator had the highest likelihood. We proposed an approach based on biological considerations for the extrapolation of risk to humans. This approach requires estimation of human lung burdens for specific exposure scenarios, which we did by using an extension of a model due to Yu. Our approach acknowledges that the risk associated with exposure to RCF depends on exposure to other lung carcinogens. We present estimates of risk in two populations: (1)a population of nonsmokers and (2) an occupational cohort of steelworkers not exposed to coke oven emissions, a mixed population that includes both smokers and nonsmokers.

Notes: This study estimates the effect risk characteristics, described as outrage factors by Hadden, have on consumers' risk perceptions toward the food-related biotechnology, recombinant bovine growth hormone (rbGH). The outrage factors applicable to milk from rbGH treated herds are involuntary risk exposure, unfamiliarity with the product's production process, unnatural product characteristics, lack of trust in regulator's ability to protectconsumers in the marketplace, and consumers' inability to distinguish milkfrom rbGH treated herds compared to milk from untreated herds. An empirical analysis of data from a national survey of household food shoppers reveals that outrage factors mediate risk perceptions. The results support the inclusion of outrage factors into the risk perception model for the rbGH product, as they add significantly to the explanatory power of the model and therefore reduce bias compared to a simpler model of attitudinal and demographic factors. The study indicates that outrage factors which have a significant impact on risk perceptions are the lack of trust in the FDA as afood-related information source, and perceiving no consumer benefits from farmers' use of rbGH. Communication strategies to reduce consumer risk perceptions therefore could utilize agencies perceived as more trustworthy and emphasize the benefits of rbGH use to consumers.

Notes: The management of spent nuclear fuel and high-level nuclear waste has the deserved reputation as one of the most intractable policy issues facing the United States and other nations using nuclear reactors for electric power generation. This paper presents the author's perspective on this complexissue, based on a decade of service with the Nuclear Waste Technical ReviewBoard and Board on Radioactive Waste Management of the National Research Council.

Notes: Concentrating on exposure in workplaces where smoking occurs, we examined environmental tobacco smoke (ETS)-related concentration data from the 16-City This study.(1,2) This study involved a large population of nonsmokers, used personal monitors, and encompassed a wide selection of ETS-related constituents. This first article in a series of three describes the 16-City Study, considers the impact of demographic variables, and concludes that these variables did not explain differences in exposure to ETS. We compared 16-City Study concentrations obtained in the workplace to previously reported workplace concentrations and determined that data from this study were representative of current ETS exposure in nonmanufacturing workplaces where smoking occurs. Considering factors other than demographic factors, we found that, not surprisingly, the number of cigarettes observed in the workplace had an impact on exposure concentrations. Finally, we compared people from homes where smoking occurs with people from nonsmoking homes and found that people from smoking homes observed more smoking in the workplace and experienced higher concentrations of ETS-related compounds in the workplace, even when they observed the same number of cigarettes being smoked in the workplace. In two subsequent articles in this series, we discuss relationships between various ETS markers and provide estimates of distributions of doses to nonsmoking workers employed in workplaces where smoking occurs.

Notes: Many different radionuclides have been released to the environment from the Savannah River Site (SRS) during the facility's operational history. However, as shown by this analysis, only a small number of the released radionuclides have been significant contributors to potential doses and risks to off-site people. This article documents the radiological critical contaminant/critical pathway analysis performed for SRS. If site missions and operations remain constant over the next 30 years, only tritium oxide releases are projected to exceed a maximally exposed individual (MEI) risk of 1.0E-06 for either the airborne or liquid pathways. The critical exposure pathways associated with site airborne releases are inhalation and vegetation consumption, whereas the critical exposure pathways associated with liquid releases are drinking water and fish consumption. For the SRS-specific, nontypical exposure pathways (i.e., recreational fishing and deer and hog hunting), cesium-137 is the critical radionuclide.

Notes: This article describes the evolution of the process for assessing the hazards of a geologic disposal system for radioactive waste and, similarly, nuclear power reactors, and the relationship of this process with other assessments of risk, particularlyassessments of hazards from manufactured carcinogenic chemicals during use and disposal. This perspective reviews the common history of scientific concepts for risk assessment developed until the 1950s. Computational tools and techniques developed in the late 1950s and early 1960s to analyze the reliability of nuclear weapon delivery systems were adopted in the early 1970s for probabilistic risk assessment of nuclear power reactors, a technology for which behavior was unknown. In turn, these analyses became an important foundation for performance assessment of nuclear waste disposal in the late 1970s. The evaluation of risk to human health and the environment from chemical hazards is built on methods for assessing the dose response of radionuclides in the1950s. Despite a shared background, however, societal events, often in the form of legislation, have affected the development path for risk assessment for human health, producing dissimilarities between these risk assessments and those for nuclear facilities. An important difference is the regulator's interest in accounting for uncertainty.

Notes: This article begins with some history of the derivation of 40 CFR Part 191, the U.S. Environmental Protection Agency (EPA) standard that governs the geologic disposal of spent nuclear fuel and high-level and transuranic radioactive wastes. This is followed by criticisms of the standard that were made by a Sub-committee of the EPA Science Advisory Board, by the staff of the U.S. Nuclear Regulatory Commission, and by a panel of the National Academies of Science and Engineering. The large disparity in the EPA approaches to regulation of disposal of radioactive wastes and disposal of hazardous, long-lived, nonradioactive chemical waste is illustrated. An examination of the intertwined matters of intergenerational equity and the discounting of future health effects follows, together with a discussion of the conflict between intergenerational equity and intragenerational equity. Finally, issues related to assumptions in the regulations concerning the future state of society and the biosphere are treated, as is the absence of any national philosophy or guiding policy for how to deal with societal activities that pose very long-term risks.

Notes: The conceptual and computational structure of a performance assessment (PA) for the Waste Isolation Pilot Plant (WIPP) is described. Important parts of this structure are (1) maintenance of a separation between stochastic (i.e., aleatory) and subjective (i.e., epistemic) uncertainty, with stochastic uncertainty arising from the many possible disruptions that could occur over the 10,000-year regulatory period that applies to the WIPP, and subjective uncertainty arising from the imprecision with which many of the quantities required in the analysis are known, (2) use of Latin hypercube sampling to incorporate the effects of subjective uncertainty, (3) use of Monte Carlo (i.e., random) sampling to incorporate the effects of stochastic uncertainty, and (4) efficient use of the necessarily limited number of mechanistic calculations that can be performed to support the analysis. The WIPP is under development by the U.S. Department of Energy (DOE) for the geologic (i.e., deep underground) disposal of transuranic (TRU) waste, with the indicated PA supporting a Compliance Certification Application (CCA) by the DOE to the U.S. Environmental Protection Agency (EPA) in October 1996 for the necessary certifications for the WIPP to begin operation. The EPA certified the WIPP for the disposal of TRU waste in May 1998, with the result that the WIPP will be the first operational facility in the United States for the geologic disposal of radioactive waste.

Notes: Uncertainty analyses and the reporting of their results can be misinterpreted when these analyses are conditional on a set of assumptions generally intended to bring some conservatism in the decisions. In this paper, two cases of conditional uncertainty analysis are examined. The first case includes studies that result, for instance, in a family of risk curves representing percentiles of the probability distribution of the future frequency of exceeding specified consequence levels conditional on a set of hypotheses. The second case involves analyses that result in an interval of outcomes estimated on the basis of conservative assumptions. Both types of results are difficult to use because they are sometimes misinterpreted as if they represented the output of a full uncertainty analysis. In the first case, the percentiles shown on each risk curve may be taken at face value when in reality (in marginal terms) they are lower if the chosen hypotheses are conservative. In the second case, the fact that some segments of the resulting interval are highly unlikely-or that some more benign segments outside the range of results are quite possible-does not appear. Also, these results are difficult to compare to those of analyses of other risks, possibly competing for the same risk management resources, and the decision criteria have to be adapted to the conservatism of the hypotheses. In this paper, the focus is on the first type (conditional risk curves) more than on the second and the discussion is illustrated by the case of the performance assessment of the Waste Isolation Pilot Plant in New Mexico. For policy-making purposes, however, the problems of interpretation, comparison, and use of the results are similar.