ALBERT

Notes: The paper by Metz challenges the view that stigma associated with a nuclear waste repository might lead to significant economic losses to the host region. We have been invited to comment on the general issues raised by this paper. We find that much of the evidence presented in the paper consists of factual and conceptual errors and misrepresentations of the research literature. Based on our review of evidence documenting the social and economic impacts of perceived risk, we conclude that stigma is an important phenomenon that is symptomatic of fundamental problems with the way in which nuclear waste facilities are sited.

Notes: Although public perceptions of food-related hazards receive much media comment and debate, the research literature on such perceptions is sparse and piecemeal. In the reported study, 216 people completed a questionnaire relating to their perceptions of the “risk characteristics” of potential hazards associated with various aspects of food production and food consumption. Responses were examined via principal-components analysis to obtain a structural representation of risk perception of the kind provided by Fischhoff, Slovic, and their colleagues in their seminal psychometric work.(1,2) A three-component solution accounting for 87% of the variance was obtained, with the dimensions labeled as “severity,”“unknown,” and “number of people exposed.” The findings also yielded information pointing to evidence of the phenomenon of unrealistic optimism. We conclude that our findings offer a useful base upon which further in-depth research integrating different perspectives on risk perception with respect to food-related hazards may be developed.

Notes: There has been considerable discussion regarding the conservativeness of low-dose cancer risk estimates based upon linear extrapolation from upper confidence limits. Various groups have expressed a need for best (point) estimates of cancer risk in order to improve risk/benefit decisions. Point estimates of carcinogenic potency obtained from maximum likelihood estimates of low-dose slope may be highly unstable, being sensitive both to the choice of the dose–response model and possibly to minimal perturbations of the data. For carcinogens that augment background carcinogenic processes and/or for mutagenic carcinogens, at low doses the tumor incidence versus target tissue dose is expected to be linear. Pharmacokinetic data may be needed to identify and adjust for exposure-dose nonlinearities. Based on the assumption that the dose response is linear over low doses, a stable point estimate for low-dose cancer risk is proposed. Since various models give similar estimates of risk down to levels of 1%, a stable estimate of the low-dose cancer slope is provided by ŝ= 0.01/ED01, where ED01 is the dose corresponding to an excess cancer risk of 1%. Thus, low-dose estimates of cancer risk are obtained by, risk =ŝ× dose. The proposed procedure is similar to one which has been utilized in the past by the Center for Food Safety and Applied Nutrition, Food and Drug Administration. The upper confidence limit, s, corresponding to this point estimate of low-dose slope is similar to the upper limit, q1 obtained from the generalized multistage model. The advantage of the proposed procedure is that ŝ provides stable estimates of low-dose carcinogenic potency, which are not unduly influenced by small perturbations of the tumor incidence rates, unlike q̂1.

Notes: The goal of Louisiana's 1990–1991 comparative risk project, also called the Louisiana Environmental Action Plan (LEAP), was to incorporate risk assessment into state environmental planning and policymaking. Scientists, government officials, and citizens were brought together to estimate the relative risk to human health, natural resources, and quality of life posed by 33 selected environmental issues. The issues were then ranked according to their relative estimated risks. It was hoped that this ranking of “comparative risks” would enable state policymakers to target the most important environmental problems and allocate scarce public resources more rationally and efficiently. As a result of the project, the governor issued an Executive Order forming a permanent Public Advisory Committee to continue this type of comparative risk assessment in Louisiana.

Notes: Book Reviewed in this article: Oncogene and Transgenics Correlates of Cancer Risk Assessments (NATO ASI Series, Series A: Life Sciences Vol. 232) Edited by Constantine Zervos SPSSIPC+ Made Simple By Paul R. Kinnear and Colin D. Gray Rkk: Analysis, Perception and Management (Report of a Royal Society Study Group) Floodplain Management in the United States: An Assessment Report (2 vol.) Paradoxes of Belief and Strategic Rational (Cambridge Studies in Probability, Induction, and Decision Theory) By Robert C. Koons The Chemistry of Environmental Tobacco Smoke: Composition and Measurement By M. R. Guerin, R. A. Jenkins, and B. A. Tomkins Risk-Taking Behavior (Wiley Series in Human Performance and Cognition) Edited by J. Frank Yates Statistical Methods for Survival Data Analysis By Elisa T. Lee

Notes: Techniques for performing scientific risk assessments for a wide variety of chemical and radiological hazards present in the environment and workplace are available. Speakers at a workshop sponsored by the Environmental and Public/Occupational Health Standard's Steering Group addressed both the state-of-the-art in risk assessment and areas of difficulty that require further research. The Steering Group concluded that within the limits of the available data, risk-assessment techniques are a useful tool in decision-making. In the past, many government agencies have not been effective either in listening to public concerns or in communicating technical or scientific information about risks. This has been true at all levels of government. Workshop speakers discussed some ways that government agencies can more effectively communicate with the public. The Steering Group concluded that major efforts must be made to ensure that two-way communication takes place. Thus the results of the workshop show that effective management of risk requires both a scientific assessment of risk and a responsive consideration of the public's perception of risk. Intensive efforts must be made to ensure that effective two-way communication takes place between members of the public and the appropriate government agencies.

Notes: Compounded conservatism (or “creeping safety”) describes the impact of using conservative, upper-bound estimates of the values of multiple input variates to obtain a conservative estimate of risk modeled as an increasing function of those variates. In a simple multiplicative model of risk, for example, if upper p-fractile (100pth percentile) values are used for each of several statistically independent input variates, the resulting risk estimate will be the upper p'-fractile of risk predicted according to that multiplicative model, where p' 〉 p. The amount of compounded conservativism reflected by the difference between p' and p may be substantial, depending on the number of inputs, their relative uncertainties, and the value of p selected. Particular numerical examples of compounded conservatism are often cited, but an analytic approach may better serve to conceptualize and communicate its potential quantitative impact. This note briefly outlines such an approach and illustrates its application to the case of risk modeled as a product of lognormally distributed inputs.

Notes: The rate of fish consumption is a critical variable in the assessment of human health risk from water bodies affected by chemical contamination and in the establishment of federal and state Ambient Water Quality Criteria (AWQC). For 1973 and 1974, the National Marine Fisheries Service (NMFS) analyzed data on the consumption of salt-water finfish, shellfish, and freshwater finfish from all sources in 10 regions of the United States for three age groups in the general population: children (ages 1 through 11 years), teenagers (ages 12 through 18 years), and adults (ages 19 through 98 years). Even though the NMFS data reported in Ref. 14 are 20 years old, they remain the most complete data on the overall consumption of all fish by the general U.S. population and they have been widely used to select point values for consumption. Using three methods, we fit lognormal distributions to the results of the survey as analyzed and published in Ref. 14. Strong lognormal fits were obtained for most of the 90 separate data sets. These results cannot necessarily be used to model the consumption of fish by sport or subsistence anglers from specific sites or from single water bodies.

Notes: Concern about the degree of uncertainty and potential conservatism in deterministic point estimates of risk has prompted researchers to turn increasingly to probabilistic methods for risk assessment. With Monte Carlo simulation techniques, distributions of risk reflecting uncertainty and/or variability are generated as an alternative. In this paper the compounding of conservatism(1) between the level associated with point estimate inputs selected from probability distributions and the level associated with the deterministic value of risk calculated using these inputs is explored. Two measures of compounded conservatism are compared and contrasted. The first measure considered, F, is defined as the ratio of the risk value, Rd, calculated deterministically as a function of n inputs each at the jth percentile of its probability distribution, and the risk value, Rj that falls at the jth percentile of the simulated risk distribution (i.e., F=Rd/Rj). The percentile of the simulated risk distribution which corresponds to the deterministic value, Rd, serves as a second measure of compounded conservatism. Analytical results for simple products of lognormal distributions are presented. In addition, a numerical treatment of several complex cases is presented using five simulation analyses from the literature to illustrate. Overall, there are cases in which conservatism compounds dramatically for deterministic point estimates of risk constructed from upper percentiles of input parameters, as well as those for which the effect is less notable. The analytical and numerical techniques discussed are intended to help analysts explore the factors that influence the magnitude of compounding conservatism in specific cases.

Notes: For noncancer effects, the degree of human interindividual variability plays a central role in determining the risk that can be expected at low exposures. This discussion reviews available data on observations of interindividual variability in (a) breathing rates, based on observations in British coal miners; (b) systemic pharmacokinetic parameters, based on studies of a number of drugs; (c) susceptibility to neurological effects from fetal exposure to methyl mercury, based on observations of the incidence of effects in relation to hair mercury levels; and (d) chronic lung function changes in relation to long-term exposure to cigarette smoke. The quantitative ranges of predictions that follow from uncertainties in estimates of interindividual variability in susceptibility are illustrated.

Notes: It has recently been suggested that “standard” data distributions for key exposure variables should be developed wherever appropriate for use in probabilistic or “Monte Carlo” exposure analyses. Soil-on-skin adherence estimates represent an ideal candidate for development of a standard data distribution: There are several readily available studies which offer a consistent pattern of reported results, and more importantly, soil adherence to skin is likely to vary little from site-to-site. In this paper, we thoroughly review each of the published soil adherence studies with respect to study design, sampling, and analytical methods, and level of confidence in the reported results. Based on these studies, probability density functions (PDF) of soil adherence values were examined for different age groups and different sampling techniques. The soil adherence PDF developed from adult data was found to resemble closely the soil adherence PDF based on child data in terms of both central tendency (mean = 0.49 and 0.63 mg-soil/cm2-skin, respectively) and 95th percentile values (1.6 and 2.4 mg-soil/cm2-skin, respectively). Accordingly, a single, “standard” PDF is presented based on all data collected for all age groups. This standard PDF is lognormally distributed; the arithmetic mean and standard deviation are 0.52 ± 0.9 mg-soil/cm2-skin. Since our review of the literature indicates that soil adherence under environmental conditions will be minimally influenced by age, sex, soil type, or particle size, this PDF should be considered applicable to all settings. The 50th and 95th percentile values of the standard PDF (0.25 and 1.7 mg-soil/cm2-skin, respectively) are very similar to recent U.S. EPA estimates of “average” and “upper-bound” soil adherence (0.2 and 1.0 mg-soil/cm2-skin, respectively).

Notes: Advocates of quantitative uncertainty analysis (QUA) have invested substantial effort in explaining why uncertainty is a crucial aspect of risk and yet have devoted much less effort to explaining how QUA can improve the risk manager's performance. This paper develops a teaching example, using a personal decision problem with subtle parallels to societal risk management, to show how choices made with increasing appreciation of uncertainty are superior ones. In the hypothetical, five analysts explain the same uncertain prospect (whether to invest in a volatile stock issue), with increasing attention to the nuances of uncertainty. The path through these different perspectives on the decision demonstrates four general points applicable to environmental risk management: (1) Various point estimates with equal claim to being “best estimates” can differ markedly from each other and lead to diametrically different choices; (2) “conservatism” has both relative and absolute meanings, with different implications for decision-making; (3) both inattention to and fixation on “outliers” in the uncertainty distribution can lead the manager astray; and (4) the best QUA is one that helps discriminate among real options, that points to optimum pathways toward new information, and that spurs on the iterative search for new decision options that may outperform any of the initial ones offered.

Notes: Surveys of public opinion about perceptions of risk associated with the nuclear fuel cycle have shown that the public professes a widespread feeling of dread, a fear of associated stigmas, and a concern about possible catastrophic nuclear accidents. Various interest groups and state governments that oppose congressionally mandated siting of centralized high-level radioactive waste (HLW) storage and disposal facilities are using this negative imagery to create a powerful, emotional obstacle to the siting process. From statistical analyses of images and location preferences, researchers have claimed that possible significant economic losses could potentially accompany the siting of HLW facilities. However, several paradoxes, or self-contradictory statements, apparently exist between the responses expressed in surveys and the actual economic and demographic behavior evidenced in the marketplace. Federal policymakers need to evaluate whether the request for a change in siting policy is based on subjective fear of a potential negative economic effect or on proven negative effects. Empirically observed behavior does not support predicted negative economic effects based on survey responses.

Notes: Reproductive and developmental anomalies induced by toxic chemicals may be identified using laboratory experiments with small mammalian species such as rats, mice, and rabbits. In this paper, dose-response models for correlated multinomial data arising in studies of developmental toxicity are discussed. These models provide a joint characterization of dose-response relationships for both embryolethality and teratogenicity. Generalized estimating equations are used for model fitting, incorporating overdispersion relative to the multinomial variation due to correlation among littermates. The fitted dose-response models are used to estimate benchmark doses in a series of experiments conducted by the U.S. National Toxicology Program. Joint analysis of prenatal death and fetal malformation using an extended Dirichlet-trinomial covariance function to characterize overdispersion appears to have statistical and computational advantages over separate analysis of these two end points. Benchmark doses based on overall toxicity are below the minimum of those for prenatal death and fetal malformation and may, thus, be preferred for risk assessment purposes.

Notes: In this article, the operating characteristics of recently proposed tests for trend in correlated binary data arising in laboratory studies of developmental toxicity are examined using both computer-generated and experimental data. Specifically, we consider adjusted Cochran-Armitgc tests based on the Rao-Scott transformation which are of the same general form as that for uncorrelated data. In addition, generalized score tests based on generalized estimating equations allowing for extra-binomial variation in the data are discussed. Specific forms of these statistics demonstrating favorable type I and type II error rates are identified and recommended for use in practice. The application of these tests is illustrated using data from studies of developmental toxicity that have been reported in the literature.

Notes: Food web models have two uses in assessments of environmental contaminants. First, they are used to determine whether remediation is needed by estimating exposure of end-point species and subsequent effects. Second, they are used to establish cleanup goals by estimating concentrations of contaminants in ambient media that will not cause significant effects. This paper demonstrates how achievement of these goals can be enhanced by the use of stochastic food web models. The models simulate the dynamics of PCBs and mercury in the food webs of mink and great blue herons. All parameters of the models are treated as having knowledge uncertainty, due to imperfect knowledge of the actual parameter values for the site, chemicals, and species of interest. This uncertainty is an indicator of the potential value of additional measurements. In addition, those parameters that are responsible for variance among individual organisms are assigned stochastic uncertainty. This uncertainty indicates the range of body burdens that are expected when the end-point species are monitored. These two types of uncertainty are separately accounted for in Monte Carlo simulations of the models. Preliminary monitoring results indicate that the models give reasonably good estimates of heron egg and nestling body burdens and of variance among individuals.

Notes: This work presents a comparison of probabilistic and deterministic health risk estimates based on data from an industrial site in the northeastern United States. The risk assessment considered exposures to volatile solvents by drinking water ingestion and showering. Probability densities used as inputs included concentrations, contact rates, and exposure frequencies; dose-response inputs were single values. Deterministic risk estimates were calculated by the “reasonable maximum exposure” (RME) approach recommended by the EPA Superfund program. The RME non-carcinogenic risk fell between the 90th and the 95th percentile of the probability density; the RME cancer risk fell between the 95th percentile and the maximum. These results suggest that in this case (1) EPA's deterministic RME risk was reasonably protective, (2) results of probabilistic and deterministic calculations were consistent, and (3) commercially available software Monte Carlo software effectively provided multiple risk estimates recommended by recent EPA guidance.

Notes: I use an analogy with the history of physical measurements, population and energy projections, and analyze the trends in several data sets to quantify the overconfidence of the experts in the reliability of their uncertainty estimates. Data sets include (i) time trends in the sequential measurements of the same physical quantity; (ii) national population projections; and (iii) projections for the U.S., energy sector. Probabilities of large deviations for the true values are parametrized by an exponential distribution with the slope determined by the data. Statistics of past errors can be used in probabilistic risk assessment to hedge against unsuspected uncertainties and to include the possibility of human error into the framework of uncertainty analysis. By means of a sample Monte Carlo simulation of cancer risk caused by ingestion of benzene in soil, I demonstrate how the upper 95th percentiles of risk are changed when unsuspected uncertainties are included. I recommend to inflate the estimated uncertainties by default safety factors determined from the relevant historical data sets.

Notes: This paper presents a general model for exposure to homegrown foods that is used with a Monte Carlo analysis to determine the relative contributions of variability (Type A uncertainty) and true uncertainty (Type B uncertainty) to the overall variance in prediction of the dose-to-concentration ratio. Although classification of exposure inputs as uncertain or variable is somewhat subjective, food consumption rates and exposure duration are judged to have a predicted variance that is dominated by variability among individuals by age, income, culture, and geographical region. Whereas, biotransfer factors and partition factors are inputs that, to a large extent, involve uncertainty. Using ingestion of fruits, vegetables, grains, dairy products, and meat and soils assumed to be contaminated by hexachlorbenzene (HCB) and benzo(a)pyrene (BaP) as cases studies, a Monte Carlo analysis is used to explore the relative contribution of uncertainty and variability to overall variance in the estimated distribution of potential dose within the population that consumes homegrown foods. It is found that, when soil concentrations are specified, variances in ratios of dose-to-concentration for HCB are equally attributable to uncertainty and variability, whereas for BaP, variance in these ratios is dominated by true uncertainty.

Notes: Although it has been over two decades since Congress passed the Clean Air Act of 1968, ozone in the lower atmosphere remains a serious environmental concern in the United States. Significant scientific progress has been made over the past three decades, yet many important uncertainties remain unresolved. How to manage in a situation characterized by these uncertainties is a major challenge that must be overcome to develop an effective ozone abatement strategy. In this paper, we describe a decision framework for evaluation of alternative ozone abatement strategies. The framework, which embodies two major components-a simulation module and a decision module–incorporates uncertainty in a dynamic decision-making process and enables evaluation of NOx and VOC controls on a systematic basis. We demonstrate the application of the framework through an illustrative analysis to provide insight into the value of flexible ozone abatement strategies in reducing the total cost of achieving air-quality goals and the tradeoffs between the timing and the accuracy of additional information.

Notes: We propose 14 principles of good practice to assist people in performing and reviewing probabilistic or Monte Carlo risk assessments, especially in the context of the federal and state statutes concerning chemicals in the environment. Monte Carlo risk assessments for hazardous waste sites that follow these principles will be easier to understand, will explicitly distinguish assumptions from data, and will consider and quantify effects that could otherwise lead to misinterpretation of the results. The proposed principles are neither mutually exclusive nor collectively exhaustive. We think and hope that these principles will evolve as new ideas arise and come into practice.

Notes: Fish consumption rates play a critical role in the assessment of human health risks posed by the consumption of fish from chemically contaminated water bodies. Based on data from the 1989 Michigan Sport Anglers Fish Consumption Survey, we examined total fish consumption, consumption of self-caught fish, and consumption of Great Lakes fish for all adults, men, women, and certain higher risk subgroups such as anglers. We present average daily consumption rates as compound probability distributions consisting of a Bernoulli trial (to distinguish those who ate fish from those who did not) combined with a distribution (both empirical and parametric) for those who ate fish. We found that the average daily consumption rates for adults who ate fish are reasonably well fit by lognormal distributions. The compound distributions may be used as input variables for Monte Carlo simulations in public health risk assessments.

Notes: The parameters in a physiologically based pharmacokinetic (PBPK) model of methylene chloride were varied systematically, and the resulting variation in a number of model outputs was determined as a function of time for mice and humans at several exposure concentrations. The importance of the various parameters in the model was highly dependent on the conditions (concentration, species) for which the simulation was performed and the model output (dose surrogate) being considered. Model structure also had a significant impact on the results. For sensitivity analysis, particular attention must be paid to conservation equations to ensure that the variational calculations do not alter mass balance, introducing extraneous effects into the model. All of the normalized sensitivity coefficients calculated in this study ranged between −1.12 and 1, and most were much less than 1 in absolute value, indicating that individual input errors are not greatly amplified in the outputs. In addition to ranking parameters in terms of their impact on model predictions, time-dependent sensitivity analysis can also be used as an aid in the design of experiments to estimate parameters by predicting the experimental conditions and sampling points which will maximize parameter identifiability.

Notes: When viewed at a high level, performance assessments (PAs) for complex systems involve two types of uncertainty: stochastic uncertainty, which arises because the system under study can behave in many different ways, and subjective uncertainty, which arises from a lack of knowledge about quantities required within the computational implementation of the PA. Stochastic uncertainty is typically incorporated into a PA with an experimental design based on importance sampling and leads to the final results of the PA being expressed as a complementary cumulative distribution function (CCDF). Subjective uncertainty is usually treated with Monte Carlo techniques and leads to a distribution of CCDFs. This presentation discusses the use of the Kaplan/Garrick ordered triple representation for risk in maintaining a distinction between stochastic and subjective uncertainty in PAs for complex systems. The topics discussed include (1) the definition of scenarios and the calculation of scenario probabilities and consequences, (2) the separation of subjective and stochastic uncertainties, (3) the construction of CCDFs required in comparisons with regulatory standards (e.g., 40 CFR Part 191, Subpart B for the disposal of radioactive waste), and (4) the performance of uncertainty and sensitivity studies. Results obtained in a preliminary PA for the Waste Isolation Pilot Plant, an uncertainty and sensitivity analysis of the MACCS reactor accident consequence analysis model, and the NUREG-1150 probabilistic risk assessments are used for illustration.

Notes: Uncertainties are usually evaluated by Monte Carlo analysis. However, multiplicative models with lognormal uncertainties, which are ubiquitous in risk assessments, allow for a simple and quick analytical uncertainty analysis. The necessary formulae are given, which may be evaluated by a desk calculator. Two examples illustrate the method.

Notes: Although there has been nearly complete agreement in the scientific community that Monte Carlo techniques represent a significant improvement in the exposure assessment process, virtually all state and federal risk assessments still rely on the traditional point estimate approach. One of the rate-determining steps to a timely implementation of Monte Carlo techniques to regulatory decision making is the development of “standard” data distributions that are considered applicable to any setting. For many exposure variables, there is no need to wait any longer to adopt Monte Carlo techniques into regulatory policy since there is a wealth of data from which a robust distribution can be developed and ample evidence to indicate that the variable is not significantly influenced by site-specific conditions. In this paper, we propose several distributions that can be considered standard and customary for most settings. Age-specific distributions for soil ingestion rates, inhalation rates, body weights, skin surface area, tapwater and fish consumption, residential occupancy and occupational tenure, and soil-on-skin adherence were developed. For each distribution offered in this paper, we discuss the adequacy of the database, derivation of the distribution, and applicability of the distribution to various settings and conditions.

Notes: There is more information we don't know than we do know for making most critical decisions involving risks. Our focus must be on understanding and effectively dealing with what we don't know. As a first step in achieving this focus, a classification of the types of uncertainties that must be addressed and the sources of these types of uncertainties is presented. The purpose is to provide a framework for discussion about addressing uncertainty, particularly in risk analyses.Both uncertainty and variability of information are addressed using four main classes:〈list xml:id="l1" style="custom"〉1) Metrical uncertainty and variability in measurement,2) Structural uncertainty due to complexity, including models and their validation,3) Temporal uncertainty in future and past states4) Translational uncertainty in explaining uncertain results.The factors that contribute uncertainty and error to these classes are identified, and their interrelationships indicated. Both subjective and objective aspects are addressed.

Notes: Use of probability distributions by regulatory agencies often focuses on the extreme events and scenarios that correspond to the tail of probability distributions. This paper makes the case that assessment of the tail of the distribution can and often should be performed separately from assessment of the central values. Factors to consider when developing distributions that account for tail behavior include (a) the availability of data, (b) characteristics of the tail of the distribution, and (c) the value of additional information in assessment. The integration of these elements will improve the modeling of extreme events by the tail of distributions, thereby providing policy makers with critical information on the risk of extreme events. Two examples provide insight into the theme of the paper. The first demonstrates the need for a parallel analysis that separates the extreme events from the central values. The second shows a link between the selection of the tail distribution and a decision criterion. In addition, the phenomenon of breaking records in time-series data gives insight to the information that characterizes extreme values. One methodology for treating risk of extreme events explicitly adopts the conditional expected value as a measure of risk. Theoretical results concerning this measure are given to clarify some of the concepts of the risk of extreme events.

Notes: In recent years the U.S. Environmental Protection Agency has been challenged both externally and internally to move beyond its traditional conservative single-point treatment of various input parameters in risk assessments. In the first section, we assess when more involved distribution-based analyses might be indicated for such common types of risk assessment applications as baseline assessments of Superfund sites. Then in two subsequent sections, we give an overview with some case studies of technical analyses of (A) variability/heterogeneity and (B) uncertainty. By “inter-individual variability” is meant the real variation among individuals in exposure-producing behavior, in exposures, or some other parameter (such as differences among individual municipal solid waste incinerators in emissions). In contrast, “uncertainty” is a description of the imperfection in knowledge of the true value of a particular parameter or its real variability in an individual or a group. In general uncertainty is reducible by additional information-gathering or analysis activities (better data, better models), whereas real variability will not change (although it may be more accurately known) as a result of better or more extensive measurements. The purpose of the rather long-winded exposition of these two final sections is to show the differences between analyses of these two different things, both of which are described using the language of probability distributions.

Notes: Developmental toxicity, an area of public concern, suffers from the lack of accessible, reliable, peer-reviewed compilations of data and substantial gaps in testing. These deficits frequently make it necessary for regulatory agencies to use other toxicological end points to regulate developmental toxicants. We have utilized a database of chemicals identified as developmental toxicants in rats, mice, rabbits, and humans and an expert system which learns the association between molecular structure and biological response (Computer Automated Structure Evaluation; CASE) to explore structure-activity relationships in developmental toxicity. Developmental toxicity was defined as death, growth retardation, or structural or functional malformations. In analyzing the data CASE selects its own molecular descriptors from a learning set of active and inactive molecules. Using randomly constructed learner and tester sets, the concordance of the predictions with the actual data was between 77 and 82%. CASE identified 13 major structural fragments associated with developmental toxicity in mice, IS in rats, 9 in rabbits, and 7 in humans. These analyses indicate that there is indeed a structural basis for developmental toxicity which may be used to predict the developmental hazard of untested or inadequately tested chemicals.

Notes: An international consensus on the need to reduce the use of chlorofluorocarbons (CFCs) and other ozone-depleting gases such as the halons led to the adoptions of the 1987 Montreal Protocol and Title VI of the 1990 Clean Air Act Amendments, “Protecting Stratospheric Ozone.” These agreements included major provisions for reducing and eventually phasing out production and use of CFCs and halons as well as advancing the development of replacement chemicals. Because of the ubiquitous use and benefits of CFCs and halons, an expeditious search for safe replacements to meet the legislative deadlines is of critical importance. Toxicity testing and health risk assessment programs were established to evaluate the health and environmental impact of these replacement chemicals. Development and implementation of these programs as well as the structural-activity relationships significant for the development of the replacement chemicals are described below. A dose-response evaluation for the health risk assessment of the replacement chemical HCFC-123 (2,2-dichloro-1,1,1-trifluoroethane) is also presented to show an innovative use of physiologically based pharmacokinetic (PBPK) modeling. This is based on a parallelogram approach using data on the anesthetic gas halothane, a structural analog to HCFC-123. Halothane and HCFC-123 both form the same metabolite, trifluoroacetic acid (TFA), indicative of the same metabolic oxidative pathway attributed to hepatotoxicity. The parallelogram approach demonstrates the application of template model structures and shows how PBPK modeling, together with judicious experimental design, can be used to improve the accuracy of health risk assessment and to decrease the need for extensive laboratory animal testing.

Notes: In 1989, a Committee on Risk Assessment Methodology (CRAM) was convened by the National Research Council (NRC) to identify and investigate important scientific issues in risk assessment. One of the first issues considered by the committee was the development of a conceptual framework for ecological risk assessment, defined as “the characterization of the adverse ecological effects of environmental exposures to hazards imposed by human activities.” Adverse ecological effects include all biological and nonbiological environmental changes that society perceives as undesirable. The committee's opinion was that a general framework is needed to define the relationship of ecological risk assessment to environmental management and to facilitate the development of uniform technical guidelines. The framework for human health risk assessment proposed by the NRC in 1983 was adopted as a starting point for discussion. CRAM concluded that, although ecological risk assessment and human health risk assessment differ substantially in terms of scientific disciplines and technical problems, the underlying decision process is the same for both. Therefore, CRAM recommended that the 1983 risk assessment framework be modified to accommodate both human health and ecological risk assessment. CRAM defined an integrated health/ ecological risk assessment framework consisting of the four components: Hazard Identification, Exposure Assessment, Exposure-Response Assessment, and Risk Characterization. CRAM further provided recommendations on the scope of issues to be addressed in ecological risk assessment, critical research needs, and mechanisms for providing more detailed guidance on the scientific content of ecological risk assessments.

Notes: Normal human cells in culture have never been neoplastically transformed by carcinogen exposure. One possible explanation is that the life span of such cells is too short for them to acquire the necessary changes. To test this hypothesis, we needed normal human cells with a greatly extended or an infinite life span. We transfected the v-myc gene and a selectable marker into normal human fibroblasts, identified a drug-resistant clone expressing v-myc protein, and passaged the progeny of the clone until they senesced. A few cells continued to proliferate and gave rise to a diploid, infinite life span cell strain, MSU-1.0, that has normal growth control and is nontumorigenic in athymic mice. Analysis showed that one more genetic change, in addition to unregulated expression of the v-myc gene, was involved in generating MSU-1.0 cells. They spontaneously gave rise to a variant strain, designated MSU-1.1, that grows more rapidly and is less dependent on exogenous growth factors. Analysis showed that at least two additional changes were involved in generating this cell strain. It has a stable karyotype composed of 45 chromosomes, including two markers. Transfection of specific oncogenes was used to determine the number and nature of additional changes required to transform MSU-1.1 cells into malignant cells. Analysis indicated that two changes were involved, but no change in karyotype. Exposure of MSU-1.1 cells to a single carcinogen treatment, followed by selection for cells with the characteristics of oncogene-trans-formed MSU-1.1 cells also yielded malignant human cells. We conclude that malignant transformation of normal human fibroblasts requires six or seven genetic changes, some of which involve suppressor genes.

Notes: There are often several data sets that may be used in developing a quantitative risk estimate for a carcinogen. These estimates are usually based, however, on the dose-response data for tumor incidences from a single sex/strain/species of animal. When appropriate, the use of more data should result in a higher level of confidence in the risk estimate. The decision to use more than one data set (e.g., representing different animal sexes, strains, species, or tumor sites) can be made following biological and statistical analyses of the compatibility of these data sets. Biological analysis involves consideration of factors such as the relevance of the animal models, study design and execution, dose selection and route of administration, the mechanism of action of the agent, its pharmacokinetics, any species- and/or sex-specific effects, and tumor site specificity. If the biological analysis does not prohibit combining data sets, statistical compatibility of the data sets is then investigated. A generalized likelihood ratio test is proposed for determining the compatibility of different data sets with respect to a common dose-response model, such as the linearized multistage model. The biological and statistical factors influencing the decision to combine data sets are described, followed by a case study of bromodichloromethane.

Notes: Recent advances in quantitative morphology provide all the tools necessary to obtain structural information in the lung that can be quantified and interpreted in the three-dimensional world of toxicology. Structural hierarchies of conducting airways and parenchyma of the lung provide: (1) numbers of cells per airway, lobe, or lung; (2) surface areas of cells, airways, and alveoli; (3) length of airways and vessels; and (4) volumes of cells, alveoli, airways, vessels, and individual lobes or the entire lung. Unbiased sampling of these subcompartments of the lung requires fractionation of lobes or individual airways. Individual airways of proximal and distal generations are obtained by airway microdissection along one axial pathway and comparisons made between airway generations. Vertical sections of selected airways are used to sample epithelium and interstitium. Using this unbiased approach of quantitative morphology, we have shown that inhalation of low ambient concentrations of ozone ([O3]0.15 ppm) near or at the United States National Ambient Air Quality Standard (NAAQS) (0.12 ppm O3) induces significant alterations in bronchiolar epithelium and interstitium in nonhuman primates but not rats. The alterations do not appear to be concentration- or time-dependent, thereby bringing into question the current NAAQS that may be at or above the threshold for distal airway injury in primates. Unbiased morphometric methods are critical in a quantitative evaluation of toxicological injury of mammalian tracheobronchial airways.

Notes: Formaldehyde is a nasal carcinogen in the rat but the cancer risk this chemical poses for humans remains to be determined. Formaldehyde induces nonlinear, concentration-dependent increases in nasal epithelial cell proliferation and DNA-protein cross-link formation following short-term exposure. Presented in this review are results from a mechanistically based formaldehyde inhalation study in which an important endpoint was the measurement of cell proliferation indices in target sites for nasal tumor induction. Male Fischer 344 rats were exposed to 0, 0.7, 2, 6, 10, or 15 ppm formaldehyde for up to 2 years (6 hr/day, 5 day/week). Statistically significant increases in cell proliferation were confined to the 10 and 15 ppm groups, which remained elevated throughout the study. The concentration-dependent increases in cell proliferation correlated strongly with the tumor response curve, supporting the proposal that sustained increases in cell proliferation are an important component of formaldehyde carcinogenesis. The nonlinearity observed in formaldehyde-induced rodent nasal cancer is consistent with a high-concentration effect of regenerative cell proliferation of the target organ coupled with the genotoxic effects of formaldehyde. Cell kinetic data from these studies provide important information that may be utilized in the assessment of risk for humans exposed to formaldehyde.

Notes: Long recognized as a normal component of organogenesis during development, apoptosis (programmed cell death) has recently been implicated in alterations of cell growth and differentiation. Tissue homeostasis is normally maintained by a balance between cell division and cell death, with apoptosis often functioning in complement to cell growth. Thus, antithetical parallels in chemical carcinogenesis can be drawn between apoptosis and the proliferative events more commonly addressed. While enhanced cell replication may contribute to an increased frequency of mutation, apoptosis within a tissue may counteract chemical carcinogenesis through loss of mutated cells. Many strong carcinogens act as tumor promoters, selectively expanding an initiated cell population advantageously over surrounding cells. Similarly, chemicals with a selective inhibition of apoptosis within an initiated population would offer a growth advantage. In contrast, chemicals causing selective apoptosis of initiated cells would be expected to have an anticarcinogenic effect. Selective apoptosis, in concert with cell-specific replication, may explain the unique promoting effects of different carcinogens such as the peroxisome-proliferating chemicals, phenobarbital, and 2,3,7,8-tetrachloro-dibenzo-p-dioxin (TCDD). Cell turnover, both cell growth and cell death, is central to the process of chemically induced carcinogenesis in animals and understanding its impact is a critical determinant of the relevance of chemically induced effects to man.

Notes: The normal development and health of all multicellular organisms, including the human being, depend on the adaptive maintenance of the integrity of the genetic information (e.g., DNA protective and repair mechanisms), as well as of the homeostatic and cybernetic regulatory systems within and between tissues. The primary focus of the past and current toxicological studies and risk assessment practices has been to ascertain and predict the “genotoxicity” of various physical and chemical agents. The paradigm of “carcinogen as mutagen,” while valuable for stimulating studies of the detection of mutagens and of their potential role in “causing” somatic and germ line diseases, has tended to blunt research on the role of nongenotoxic mechanisms in disease causation. This brief analysis will emphasize the need to consider the role of modulated gap junctional intercellular communication (GJIC) in any biological risk assessment model. It is based on the following assumptions and facts. Because gap junctions exist in all metazoans, they have been associated with the regulation of cell proliferation, development, differentiation, and the adaptive function of both excitable and nonexcitable coupled cells. A highly evolutionary conserved family of genes codes for proteins (connexins), which, as hexameric units (connexons), form membrane-associated channels of gap junctions. Cells coupled by gap junctions will have their ions and small regulatory molecules equilibrated. Regulation of GJIC can be at the transcriptional, translational, or posttranslational levels. Transient down or up regulation of GJIC can be induced by endogenous or exogenous chemicals via many mechanisms at any of these three levels. Stable abnormal regulation has been associated with activated oncogenes, and normal regulation has been associated with several tumor suppressor genes. The dysfunction of these gap junctions might play a role in the actions of various toxic chemicals that have cell type/tissue/organ specificity. This could bring about distinct clinical consequences, such as embryo lethality or teratogenesis, reproductive dysfunction in the gonads, neurotoxicity of the central nervous system, hyperplasia of the skin, and tumor promotion of initiated tissue. Modulation of GJIC should be viewed as a scientific basis of “epigenetic toxicology” because the alteration of intercellular communication would alter the internal physiological state of the cell. The inhibition of GJIC is a necessary component of mitogenesis (a necessary component of the multistage carcinogenic process). The modulation of GJIC can have both toxicological, as well as therapeutic potential.

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

Notes: Tetrachloroethylene (PCE) is a commonly used organic solvent and a suspected human carcinogen, reportedly transferred to human breast milk following inhalation exposure. Transfer of PCE to milk may represent a threat to the nursing infant. A physiologically based pharmacokinetic (PBPK) model was developed to quantitatively assess the transfer of inhaled PCE into breast milk and the consequent exposure of the nursing infant. The model was validated in lactating rats. Lactating Sprague-Dawley female rats were exposed via inhalation to PCE at concentrations ranging from 20-1000 ppm, and then returned to their nursing, 10- to 11-day-old pups. Tetrachloroethylene concentrations in the air, blood, milk, and tissue were determined by gas chromatography and compared to model predictions. The model described the distribution of inhaled PCE in maternal blood and milk, as well as the nursed pup's gastrointestinal tract, blood, and tissue. Several computer simulations of PCE distribution kinetics in exhaled air, blood, and milk of exposed human subjects were run and compared with limited human data available from the literature. It is concluded that the PBPK model successfully described the concentration of PCE in both lactating rats and humans. Although predictions vs. observations were good, the model slightly underpredicted the peak whole pup PCE concentration and underpredicted systemic clearance of PCE from the pup.

Notes: Lessons learned from environmental and occupational hazard risk management practices over the past 30 years have led the Department of Defense to explore alternative risk management approaches. Policies for cleanup of environmentally hazardous waste sites are undergoing examination and are being reframed. A Demonstration Risk Communication Program is described which incorporates principles that integrate risk-based scientific information as well as community values, perceptions, and needs in a democratic process that includes the public as an active participant from the earliest stages. A strong scientific foundation for assessment and characterization of risk is viewed as necessary but not sufficient; the public's values must be actively integrated into the negotiated criteria. The Demonstration Program uses a model to prepare the participants and to guide them through the process. A five-step process is presented: (1) create risk communications process action team including at least one member of the specific site audience; (2) professionally train participants on team dynamics including interpersonal communication skills; (3) train risk communicators to deliver a cogent presentation of the message to secure a decision acceptable to both the government and the public; (4) identify existing biases, perceptions, and values held by all participants; and (5) develop risk message incorporating science and values. The process action team approach assumes the participants enter into the effort with the goal of improved environment and safeguarded public health. The team approach avoids confrontational or adversarial interactions and focuses on a dialogue from which a negotiated team response develops. Central to the program is the recognition that communication is only effective when the dialogue is two-way.

Notes: The author advocates adoption of a convergence model in place of the traditional source-receiver model of communication for communicating with members of the public who have a stake in remediation of a nearby site. The source-receiver model conceives of communication as the transmission of a message from a risk management agency (sender) to a target audience of the public (receivers). The underlying theme is that the sender intends to change the perception of the receiver of either the issue or the sender of information. The author draws on her experience at a Department of Energy (DoE) site undergoing remediation to illustrate why the convergence model is more appropriate in the context of cleanup. This alternative model focuses on the Latin derivation of communication as sharing or making common to many (i.e., as involving a relationship between participants who engage in a process of communication). The focus appears to be consistent with recently issued DoE policy that calls for involving the public in identifying issues and problems and in formulating and evaluating decision alternatives in cleanup. By emphasizing context, process, and participants, as opposed to senders and receivers, the model identifies key issues to address in facilitating consensus concerning the risks of cleanup. Similarities between the institutional context of DoE and Department of Defense (DoD) suggest that a convergence model may also prove to be an appropriate conceptual foundation for risk communication at contaminated DoD sites.

Notes: Current work on risk communication offers practitioners helpful guidelines and rules such as “speak clearly” and “speak with compassion.” While important, these guidelines have limitations. They offer practitioners and scholars little aid in determining why a communication encounter failed. Also, they do not help practitioners anticipate and overcome likely difficulties in future risk situations, nor can they help locate information about how to reduce these difficulties. To overcome the limitations of rule-based approaches to risk communication, this paper describes a diagnostic or problem-solving approach. This approach maintains that instead of rules, people need bases for anticipating likely obstacles to effective communication and selecting approaches that reduce these difficulties. Research on building trust, increasing awareness, deepening comprehension, gaining agreement, and motivating action is available in fields such as communication, educational psychology, science education, marketing, counseling, negotiation, and disaster response. This paper describes a framework that assists scholars and practitioners in: (a) identifying communication goals; (b) determining principal obstacles to those goals; and (c) selecting research-based methods for overcoming or minimizing these difficulties and achieving communication objectives.

Notes: Many journalists, public interest groups and other recipients of risk assessment information are familiar with the National Academy of Sciences risk assessment paradigm. From time to time, paradigm concepts appear in news features or community group discussions on environmental issues. With knowledge of the paradigm common to scientists, journalists, and other interested parties, the paradigm is a potentially important medium for communication between risk scientists, journalists, and the public. Specifically, the paradigm offers widely-accepted organizing principles for presenting risk information, a common language for addressing a variety of issues and concepts, and a flexible analytical system that accommodates the diversity of scientific information and policy perspectives that characterize the risk assessment process. In addition, the paradigm outlines important relationships and distinctions between risk assessment and risk management. Informed and creative use of these features of the paradigm can guide and simplify interviews between journalists or community groups and their expert sources, clarify presentation of risk information, and promote collaboration between risk scientists, journalists, and others to assure complete, objective and fair comment on risk issues of interest to the public.

Notes: A Latin Hypercube probabilistic risk assessment methodology was employed in the assessment of health risks associated with exposures to contaminated sediment and biota in an estuary in the Tidewater region of Virginia. The primary contaminants were polychlorinated biphenyls (PCBs), polychlorinated terphenyls (PCTs), polynuclear aromatic hydrocarbons (PAHs), and metals released into the estuary from a storm sewer system. The exposure pathways associated with the highest contaminant intake and risks were dermal contact with contaminated sediment and ingestion of contaminated aquatic and terrestrial biota from the contaminated area. As expected, all of the output probability distributions of risk were highly skewed, and the ratios of the expected value (mean) to median risk estimates ranged from 1.4 to 14.8 for the various exposed populations. The 99th percentile risk estimates were as much as two orders of magnitude above the mean risk estimates. For the sediment exposure pathways, the stability of the median risk estimates was found to be much greater than the stability of the expected value risk estimates. The interrun variability in the median risk estimate was found to be +/-1.9% at 3000 iterations. The interrun stability of the mean risk estimates was found to be approximately equal to that of the 95th percentile estimates at any number of iterations. The variation in neither contaminant concentrations nor any other single input variable contributed disproportionately to the overall simulation variance. The inclusion or exclusion of spatial correlations among contaminant concentrations in the simulation model did not significantly effect either the magnitude or the variance of the simulation risk estimates for sediment exposures.

Notes: This report summarizes the proceedings of a conference on quantitative methods for assessing the risks of developmental toxicants. The conference was planned by a subcommittee of the National Research Council's Committee on Risk Assessment Methodology/〉 in conjunction with staff from several federal agencies, including the U.S. Environmental Protection Agency, U.S. Food and Drug Administration, U.S. Consumer Products Safety Commission, and Health and Welfare Canada. Issues discussed at the workshop included computerized techniques for hazard identification, use of human and animal data for defining risks in a clinical setting, relationships between end points in developmental toxicity testing, reference dose calculations for developmental toxicology, analysis of quantitative dose-response data, mechanisms of developmental toxicity, physiologically based pharmacokinetic models, and structure-activity relationships. Although a formal consensus was not sought, many participants favored the evolution of quantitative techniques for developmental toxicology risk assessment, including the replacement of lowest observed adverse effect levels (LOAELs) and no observed adverse effect levels (NOAELs) with the benchmark dose methodology.

Notes: The kinetics of disposition of drugs and environmental chemicals will be altered as a result of the rapid and pronounced anatomic and physiologic changes that occur during pregnancy. These include changes in maternal intestinal motility, pulmonary tidal volume and minute volume, cardiac output, and renal function as well as in maternal tissue and fluid volumes and in the weight of the embryo/fetus and its developing organs. Physiologically-based models of pregnancy are capable of taking these temporal changes into account. Several such models have been developed. They vary in their characteristics, depending on the chemical under consideration and the period of gestation of concern to the developers of the models. Several physiologically-based models of gestation are outlined, and an example is given of the application of a physiologically-based model of gestation to predict dose to the rat and mouse fetus.

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

Notes: Health risk assessments have become so widely accepted in the United States that their conclusions are a major factor in many environmental decisions. Although the risk assessment paradigm is 10 years old, the basic risk assessment process has been used by certain regulatory agencies for nearly 40 years. Each of the four components of the paradigm has undergone significant refinements, particularly during the last 5 years. A recent step in the development of the exposure assessment component can be found in the 1992 EPA Guidelines for Exposure Assessment. Rather than assuming worst-case or hypothetical maximum exposures, these guidelines are designed to lead to an accurate characterization, making use of a number of scientific advances. Many exposure parameters have become better defined, and more sensitive techniques now exist for measuring concentrations of contaminants in the environnment. Statistical procedures for characterizing variability, using Monte Carlo or similar approaches, eliminate the need to select point estimates for all individual exposure parameters. These probabilistic models can more accurately characterize the full range of exposures that may potentially be encountered by a given population at a particular site, reducing the need to select highly conservative values to account for this form of uncertainty in the exposure estimate. Lastly, our awareness of the uncertainties in the exposure assessment as well as our knowledge as to how best to characterize them will almost certainly provide evaluations that will be more credible and, therein, more useful to risk managers. If these refinements are incorporated into future exposure assessments, it is likely that our resources will be devoted to problems that, when resolved, will yield the largest improvement in public health.

Notes: Noncancer risk assessment traditionally relies on applied dose measures, such as concentration in inhaled air or in drinking water, to characterize no-effect levels or low-effect levels in animal experiments. Safety factors are then incorporated to address the uncertainties associated with extrapolating across species, dose levels, and routes of exposure, as well as to account for the potential impact of variability of human response. A risk assessment for chloropentafluorobenzene (CPFB) was performed in which a physiologically based pharmacokinetic model was employed to calculate an internal measure of effective tissue dose appropriate to each toxic endpoint. The model accurately describes the kinetics of CPFB in both rodents and primates. The model calculations of internal dose at the no-effect and low-effect levels in animals were compared with those calculated for potential human exposure scenarios. These calculations were then used in place of default interspecies and route-to-route safety factors to determine safe human exposure conditions. Estimates of the impact of model parameter uncertainty, as estimated by a Monte Carlo technique, also were incorporated into the assessment. The approach used for CPFB is recommended as a general methodology for noncancer risk assessment whenever the necessary pharmacokinetic data can be obtained.

Notes: The regulation of noncancer toxicants, including neurotoxicants, has usually been based upon a reference dose (allowable daily intake). A reference dose is obtained by dividing a no-observed-effect level by uncertainty (safety) factors to account for intraspecies and interspecies sensitivities to a chemical. It is assumed that the risk at the reference dose is negligible, but no attempt generally is made to estimate the risk at the reference dose. A procedure is outlined that provides estimates of risk as a function of dose. The first step is to establish a mathematical relationship between a biological effect and the dose of a chemical. Knowledge of biological mechanisms and/or pharmacokinetics can assist in the choice of plausible mathematical models. The mathematical model provides estimates of average responses as a function of dose. Secondly, estimates of risk require selection of a distribution of individual responses about the average response given by the mathematical model. In the case of a normal or lognormal distribution, only an estimate of the standard deviation is needed. The third step is to define an adverse level for a response so that the probability (risk) of exceeding that level can be estimated as a function of dose. Because a firm response level often cannot be established at which adverse biological effects occur, it may be necessary to at least establish an abnormal response level that only a small proportion of individuals would exceed in an unexposed group. That is, if a normal range of responses can be established, then the probability (risk) of abnormal responses can be estimated. In order to illustrate this process, measures of the neurotransmitter serotonin and its metabolite 5-hydroxyindoleacetic acid in specific areas of the brain of rats and monkeys are analyzed after exposure to the neurotoxicant methylene-dioxymethamphetamine. These risk estimates are compared with risk estimates from the quantal approach in which animals are classified as either abnormal or not depending upon abnormal serotonin levels.

Notes: This paper presents a model for predicting blood lead levels in adults who are exposed to elevated environmental levels of lead. The model assumes a baseline blood lead level based on average blood lead levels for adults described in two recent U.S. studies. The baseline blood lead level in adults arises primarily from exposure to lead in diet. Media-specific ingestion and absorption parameters are assessed for the adult population, and a biokinetic slope factor that relates uptake of lead into the body to blood lead levels is estimated. These parameters are applied to predict blood lead levels for adults exposed to a hypothetical site with elevated lead levels in soil, dust and air. Blood lead levels ranging from approximately 3-57 μg/dl are predicted, depending on the exposure scenarios and assumptions.

Notes: Generally, hazards research and literature has treated natural and technological disasters as separate entities. This study attempts to determine how frequently interaction between these two types of disaster took place in the United States from 1980-1989. Data were collected by performing a literature review, contacting organizations and individuals active in hazards research and mitigation, and through a questionnaire sent to the emergency management agencies of all 50 states. The consensus derived from the data is that the number of incidents where natural and technological disasters interact is rising while preparations, which recognize the complications inherent in such combined events, remain cursory. There is a pressing need for states to record, and make available to managers, information regarding the number of combined natural/technological events affecting their areas. Only when such data are available will it be possible to make appropriate decisions regarding the best way to reduce the effects of a natural disaster causing a catastrophic release of hazardous materials.

Notes: In quantitative uncertainty analysis, it is essential to define rigorously the endpoint or target of the assessment. Two distinctly different approaches using Monte Carlo methods are discussed: (1) the end point is a fixed but unknown value (e.g., the maximally exposed individual, the average individual, or a specific individual) or (2) the end point is an unknown distribution of values (e.g., the variability of exposures among unspecified individuals in the population). In the first case, values are sampled at random from distributions representing various “degrees of belief” about the unknown “fixed” values of the parameters to produce a distribution of model results. The distribution of model results represents a subjective confidence statement about the true but unknown assessment end point. The important input parameters are those that contribute most to the spread in the distribution of the model results. In the second case, Monte Carlo calculations are performed in two dimensions producing numerous alternative representations of the true but unknown distribution. These alternative distributions permit subject confidence statements to be made from two perspectives: (1) for the individual exposure occurring at a specified fractile of the distribution or (2) for the fractile of the distribution associated with a specified level of individual exposure. The relative importance of input parameters will depend on the fractile or exposure level of interest. The quantification of uncertainty for the simulation of a true but unknown distribution of values represents the state-of-the-art in assessment modeling.

Notes: We review approaches to dose-response modeling and risk assessment for binary data from developmental toxicity studies. In particular, we focus on jointly modeling fetal death and malformation and use a continuation ratio formulation of the multinomial distribution to provide a model for risk. Generalized estimating equations are used to account for clustering of animals within litters. The fitted model is then used to calculate doses corresponding to a specified level of excess risk. Two methods of arriving at a lower confidence limit or Benchmark dose are illustrated and compared. We also discuss models based on single binary end points and compare our approach to a binary analysis of whether or not the animal was ‘affected’ (either dead or malformed). The models are illustrated using data from four developmental toxicity studies in EG, DEHP, TGDM, and DYME conducted through the National Toxicology Program.

Notes: Book Reviewed in this article: Element of Risk: The Politics of Radon By Leonard A. Cole Ecology for Environmental Professionals By Dorothy J. Howell

Notes: The skin is a route of exposure that needs to be considered when conducting a risk assessment. It is necessary to identify the potential for dermal penetration by a chemical as well as to determine the overall importance of the dermal route of exposure as compared with inhalation or oral routes of exposure. The physical state of the chemical, vapor or liquid, the concentration, neat or dilute, and the vehicle, lipid or aqueous, is also important. Dermal risk is related to the product of the amounts of penetration and toxicity. Toxicity involves local effects on the skin itself and the potential for systemic effects. Dermal penetration is described in large part by the permeability constant. When permeability constants are not known, partition coefficients can be used to estimate a chemical's potential to permeate the skin. With these concepts in mind, a tiered approach is proposed for dermal risk assessment. A key first step is the determination of a skin-to-air or skin-to-medium partition coefficient to estimate a potential for dermal absorption. Building a physiologically-based pharmacokinetic (PBPK) model is another step in the tiered approach and is useful prior to classical in vivo toxicity tests. A PBPK model can be used to determine a permeability constant for a chemical as well as to show the distribution of the chemical systemically. A detailed understanding of species differences in the structure and function of the skin and how they relate to differences in penetration rates is necessary in order to extrapolate animal data from PBPK models to the human. A study is in progress to examine anatomical differences for four species.

Notes: There is continuing concern for the exposure of persons to various chlorinated organics via the environment, for example, chlorinated disinfection byproducts in drinking water.(1) Some of these may be carcinogenic,(2) although the evidence is far from strong.(3) There is an accumulating body of evidence that one of the normal human immunological responses to foreign agents is the generation of hypochlorous acid. This evidence will be summarized. The possibility that this HOCl generated in vivo could result in the formation of organo-chlorine compounds does not appear to have been seriously considered. Based on best available information, the amount of such byproduct formation will be estimated.

Notes: The National Institute of Occupational Safety and Health (NIOSH) recently completed a vital status update adding 6 years of observation on the rubber workers known as the Pliofilm cohort. Using traditional standardized mortality ratio (SMR) analysis, we investigate the impact of the additional information gathered in the NIOSH update. We also compare the effect of using three sets of job-, plant-, and year-specific exposure estimates on the evaluation of benzene's leukemogenicity. The lack of any additional cases of multiple myeloma does not support trends toward elevated risks for this endpoint (as had been observed earlier), and there is no indication of increased incidences of solid tumors (as predicted by animal studies). Qualitatively, which exposure estimates are used does not alter the conclusions. The data added in the update did not greatly modify the estimated relative risk of leukemia associated with benzene exposure, but did confirm previous findings that occupational exposure to high concentrations had leukemogenic potential. The fact that leukemia has not been observed in any individual who started employment in Pliofilm production after 1950 suggests that the observed leukemia cases could be a response to very high levels of benzene exposure that occurred during the early years of this manufacturing process.

Notes: The People's Republic of China suffers each year from various environmental hazards. Although risk perception study has a 40-year history in Europe and North America, little is known about risk perception in China. Previous studies of risk perception have primarily focused on unnatural hazards, but China has experinced many natural environmental hazards. Therefore, the Chinese public's perceptions of environmental hazard risks must be considered in order to support the IDNDR program. The Chinese public's perceptions of environmental hazards are similar to those of Europeans and North Americans, but different characteristics are observed.

Notes: The detailed work histories of the individual workers composing the Pliofilm cohort represent a unique resource for estimating the dose-respoonse for leukemia that may follow occupational exposure to benzene. In this paper, we report the results of analyzing the updated Pliofilm cohort using the proportional hazards model, a more sophisticated technique that uses more of the available exposure data than the conditional logistic model used by Rinsky et al. The more rigorously defined exposure estimates derived by Paustenbach et al. are consistent with those of Crump and Allen in giving estimates of the slope of the leukemogenic dose-response that are not as steep as the slope resulting from the exposure estimates of Rinsky et al. We consider estimates of 0.3-0.5 additional leukemia deaths per thousand workers with 45 ppm-years of cumulative benzene exposure to be the best estimates currently available of leukemia risk from occupational exposure to benzene. These risks were estimated in the proportional hazards model when the exposure estimates of Crump and Allen or of Paustenbach et al. were used to derive a cumulative concentration-by-time metric.

Notes: Risk-perception research plays an active role in discussions of risk-management alternatives. However, little guidance is provided regarding how public concerns should be weighed against other sources of cost and benefits. This paper reports the results of two experiments that measure tradeoffs among cost (in dollars), a quantitative risk measure (number of deaths or injuries), and several qualitative characteristics associated with perceived risk. Most subjects were willing to make the requested trade. However, the perceived risk information led others to reject the proposed technology.

Notes: A tank car derailment in northern California in 1991 spilled metam sodium into the Sacramento River, and released its breakdown product, methyl isothiocyanate (MITC), into the air. This paper describes the risk evaluation process used. Over 240 individuals reported symptoms such as eye and throat irritation, dizziness, and shortness of breath. Reference exposure levels (RELs) for 1 hr were developed for MITC and compared to exposure concentrations. Ocular irritation in cats was the most sensitive endpoint reported. The no observed adverse effect level (NOAEL), divided by an uncertainty factor (UF) of 100, produced an REL of 0.5 ppb of MITC in air to prevent discomfort. An REL to prevent disability was estimated to be 40 ppb. An REL to prevent life-threatening injury was estimated to be 150 ppb. Measured MITC levels ranged from 0.2-37 ppb and estimated peak levels ranged from 140-1600 ppb. The usefulness of RELs for emergency planning is discussed.

Notes: Book Reviewed in this article: Development and Transfer of Pollution Prevention Technology By Ann Rappaport

Notes: Few organizations have the courage to evaluate their own use of risk assessment (identifying hazards and estimating their probability and magnitude) and risk communication (interacting with internal and external stakeholder groups about risks). The USDA Animal and Plant Health Inspection Service (APHIS) wants to enhance its overall risk analysis process for managing a wide range of risks to animals, plants, and human health. We gathered survey data for a baseline of APHIS professionals’ understanding and use of risk assessment and risk communication. APHIS professionals spend a surprisingly large share of their time communicating about risks. They perceive that risk estimates influence decisions, but that risk estimates should have more influence. Respondents reported little opposition to APHIS risk management decisions, and little use of channels such as USDA Extension Service for disseminating risk messages. Substantial variance across responses is explained mostly by differences in the roles of the 11 work units (now 10) within the agency. Location also contributes to the variance. Demographic variables seem less important.

Notes: In January 1987, an incident occurred at a petrochemical complex in Salavat, Russia. The incident resulted in the poisioning of 17 people by the products of photochemical smog. This paper describes the incident and discusses the possibility of chemical reactions that pose toxic hazardous situations for chemical plant personnel. Pollutants present in the atmosphere as a result of continuous releases can result in the formation of toxic substances and the poisioning of people, even when permissible levels of concentrations are not exceeded for the initial pollutants. In addition, this paper addresses the need to consider the possibility of secondary chemical reactions in the environment while planning chemical plant activity.

Notes: The study compares societal risk ratings by inhabitants of two countries which differ markedly in terms of geography, economics, politics, and ethnic background, but which are similar as regards media coverage. The two populations were represented by a sample of French students and a sample of Burkina Faso intellectuals. The overall Burkinabè mean ratings appeared much closer to the mean observed in France (and in the United States–roughly 40 out of 100) than the means reported for other countries like Norway or Hungary. The correlation between Burkinabè and French ratings was very high:.852. The findings argue in favor of a practically totally determinant effect of the media in risk perception.

Notes: Transportation of hazardous materials, and particularly radioactive wastes, on public highways has become an important risk management issue. The unfavorability of public attitudes regarding hazardous and nuclear wastes signals the potential for strong public opposition to programs for transporting these materials. This paper presents the results of a survey conducted to assess public reactions to a long-term nuclear waste transport program planned to follow a route through a portion of rural Oregon. The survey assessed a number of key risk perception issues, including perceived health and safety risks of nuclear waste transport, relative risks of transport vs. storage at an existing site, trust in state officials, and satisfaction with life in communities along the transport route. The survey identified a number of attitudes and concerns that need to be understood and considered by those in charge of designing and implementing the waste-transportation program.

Notes: Since cancer risk at very low doses cannot be directly measured in humans or animals, mathematical extrapolation models and scientific judgment are required. This article demonstrates a probabilistic approach to carcinogen risk assessment that employs probability trees, subjective probabilities, and standard bootstrapping procedures. The probabilistic approach is applied to the carcinogenic risk of formaldehyde in environmental and occupational settings. Sensitivity analyses illustrate conditional estimates of risk for each path in the probability tree. Fundamental mechanistic uncertainties are characterized. A strength of the analysis is the explicit treatment of alternative beliefs about pharmacokinetics and pharmacodynamics. The resulting probability distributions on cancer risk are compared with the point estimates reported by federal agencies. Limitations of the approach are discussed as well as future research directions.

Notes: Efforts to explain risk magnitude often rely on a “risk ladder” in which exposure levels and associated risk estimates are arrayed with low levels at the bottom and high ones at the top. Two experiments were conducted to test the hypothesis that perceived threat and intended mitigation vary with the location of the subject's assigned level on the risk ladder. Subjects were New Jersey homeowners, asked to assume a particular level of radon or asbestos contamination in their homes, to read a brochure explaining the risk, and then to complete a questionnaire. Both studies found that the difference between an assigned level one-quarter of the way up the ladder and the same level three-quarters of the way up the ladder significantly affected threat perception; the effect on mitigation intentions was significant in only one of the studies. Variations in assigned risk also affected threat perception and mitigation intentions. Variations in test magnitude (e.g., 15 fibers per liter vs. 450 fibers per cubic foot, roughly equivalent risks) had no effect, nor did the distinction between radon and asbestos affect the dependent variables. These findings suggest that communicators can design risk ladders to emphasize particular risk characteristics.

Notes: A method for estimating long-term distributions of exposure based on repeated short-term measurements within the same population is developed. If the short-term measurements span seasonal variation, and if the distributions are log-normal or nearly so, then long-term distributions can be estimated from as few as two visits to the same population. The method is illustrated using examples drawn from EPA's TEAM Study of exposures to volatile organic compounds.

Notes: Population growth in California has increased the pressure to convert agricultural land to commercial, industrial, or residential uses. In the ensuing property transactions, buyers and sellers must address the presence of toxic materials in soils such as pesticides, several of which are known to the State of California to cause cancer under Proposition 65. While this statute does not specifically address soil contaminants, the potential scope of its enforcement is sufficiently broad that owners of former agricultural properties may be obliged to provide warning of exposure to potential buyers, occupants, or construction workers about exposure to residues in soil from pesticide applications. However, Proposition 65 provides no guidance on how to assess exposures to chemicals in soil. The U.S. EPA Risk Assessment Guidance for Superfund (RAGS) provides a method for assessing soil-related exposure pathways that is consistent with the intent of Proposition 65. Using this approach, we have calculated the lifetime average concentrations of DDT in soil corresponding to the no-significant-risk level stipulated under Proposition 65 (1 × 10−5) for a hypothetical residential exposure scenario. The concentration of DDT in soil corresponding to a no-significant-risk ranges from 7.9-18.8 mg/kg, depending upon which exposure pathways are deemed to be complete for residential land use. It is argued that Proposition 65 forces the assessment and possible cleanup of such a situation through the threat of creating a health risk perception that could affect the market value of a property.

Notes: Implementation of article 8.1 of the EC-“Seveso” Directive (82/501/EC) is now under way in many countries in Europe. In The Netherlands, the implementation of the Directive started with a carefully monitored introduction of active information provision at two sites (Dordrecht and Elst). This introduction was supported by a multidisciplinary research group. This group helped to develop the risk communication program and also played a role in the evaluation of the program. This paper describes these processes and their evaluation. We will focus on the design of the risk communication programs and the effects of the programs on knowledge and attitudes of the local target groups. This effort and its results clearly started an institutional learning process involving governmental bodies at several organizational levels (local, regional, and national), and industrial organizations (individual firms and organizations of industries). Monitoring the design, the implementation, and the effects of active information provision proves an effective means to gain experience with the implementation of the Seveso Directive and could help to facilitate further implementation.

Notes: Probabilistic risk assessments are enjoying increasing popularity as a tool to characterize the health hazards associated with exposure to chemicals in the environment. Because probabilistic analyses provide much more information to the risk manager than standard “point” risk estimates, this approach has generally been heralded as one which could significantly improve the conduct of health risk assessments. The primary obstacles to replacing point estimates with probabilistic techniques include a general lack of familiarity with the approach and a lack of regulatory policy and guidance. This paper discusses some of the advantages and disadvantages of the point estimate vs. probabilistic approach. Three case studies are presented which contrast and compare the results of each. The first addresses the risks associated with household exposure to volatile chemicals in tapwater. The second evaluates airborne dioxin emissions which can enter the food-chain. The third illustrates how to derive health-based cleanup levels for dioxin in soil. It is shown that, based on the results of Monte Carlo analyses of probability density functions (PDFs), the point estimate approach required by most regulatory agencies will nearly always overpredict the risk for the 95th percentile person by a factor of up to 5. When the assessment requires consideration of 10 or more exposure variables, the point estimate approach will often predict risks representative of the 99.9th percentile person rather than the 50th or 95th percentile person. This paper recommends a number of data distributions for various exposure variables that we believe are now sufficiently well understood to be used with confidence in most exposure assessments. A list of exposure variables that may require additional research before adequate data distributions can be developed are also discussed.

Notes: The volume of publications on any given topic makes it difficult to select an appropriate subset of publications for review by an expert panel. This paper proposes a method for selecting a subset using a protocol that attempts to order publications based upon good research methods. The protocol was followed by graduate students with no expert knowledge of the area they were reviewing. They reduced 11730 articles on the topic of EMF and Health risk to 68 articles that were reviewed by an expert panel. The interrater reliability was 96% and 94% of the relevant articles were captured by this process.

Notes: Exposures to chlorination by-products (CBP) within public water supplies are multiroute in water. Cold water is primarily used for ingestion while a mixture of cold water and hot water is used for showering, bathing others, dish washing, etc. These latter two activities result in inhalation and dermal exposure. Heating water was observed to change the concentration of various CBP. An increase in the trihalomethanes (THM) concentrations and a decrease in the haloacetonitriles and halopropanones concentration, though an initial rise in the concentration of dichloropropanone, were observed. The extent of the increase in the THM is dependent on the chlorine residual present. Therefore, estimates of total exposure to CBP from public water supplies need to consider any changes in their concentration with different water uses. The overall THM exposures calculated using the THM concentration in heated water were 50% higher than those calculated using the THM concentration present in cold water. The estimated lifetime cancer risk associated with exposure to THM in water during the shower is therefore underestimated by 50% if the concentration of THM in cold water is used in the risk assessment.

Notes: National strategies to manage nuclear waste from commercial nuclear power plants are analyzed and compared. The current strategy is to try to operate a repository at Yucca Mountain, Nevada, to dispose of high-level nuclear waste underground. The main alternatives involve temporary above-ground storage at a centralized facility or next to nuclear power plants. If either of these is pursued now, the analysis assumes that a repository will be built in 2100 for waste not subsequently put to use. The analysis treats various uncertainties: whether a repository at Yucca Mountain would be licensed, possible theft and misuse of the waste, innovations in repository design and waste management, the potential availability of a cancer cure by 2100, and possible future uses of nuclear waste. The objectives used to compare alternatives include concerns for health and safety, environmental and socioeconomic impacts, and direct economic costs, as well as equity concerns (geographical, intergenerational, and procedural), indirect economic costs to electricity ratepayers, federal government responsibility to manage nuclear waste, and implications of theft and misuse of nuclear waste. The analysis shows that currently building an underground repository at Yucca Mountain is inferior to other available strategies by the equivalent of $10,000 million to $50,000 million. This strongly suggests that this policy should be reconsidered. A more detailed analysis using the framework presented would help to define a new national policy to manage nuclear waste.

Notes: Book Reviewed in this article:Philosophical and Foundation Issues in Measurement Theory Edited by C. Wade Savage and Philip EhrlichUnderstanding Social Science Statistics: A Spreadsheet Approach By Roger Bakeman HillsdaleTest Theory for a New Generation of Tests Edited by Norman Frederiksen, Robert J. Jislevy, and Issac I. BejarStatistical Models in Behavioral Research By William K. Estes HillsdaleOrganizations, Uncertainties, and Risk Edited by James F. Short and Lee ClarkeA First Course in Factor Analysis, 2nd Edition By Andrew L. Comrey and Howard B. Lee HillsdaleLight, Lasers, and Synchrotron Radiation: A Health Risk Assessment (NATO ASI Series; Series B: Physics Vol. 242) Edited by M. Grandolfo, A. Rindi, and D.H. SlineySurface Level Ozone Exposures and Their Effects on Vegetation Edited by Allen S. Lefohn

Notes: Current federal ground water monitoring statistical regulation dates from the revised RCRA Subtitle C Final Rule of 1988. That rule was a considerable advance over previous RCRA statistical rules. However, two major problem areas remained: facility-wide false positive rate (FWFPR) control and spatial variability. Progress has been made in the 1991 Subtitle D Final Rule and in guidance: the 1992 Addendum to Interim Final Guidance in particular includes a substantial conceptual advance toward resolving the FWFPR problem. Other areas of improvement include normality testing and distribution assumptions, dropping the four independent samples per monitoring period requirement, allowing a preliminary evaluation short of a 40 CFR Part 258 Appendix II assessment upon finding a statistically significant increase, and suggesting superior alternatives to analyses of variance (ANOVAs) and tests of proportions.The problem of dealing with natural spatial variability remains. Although certain techniques listed in the regulations can control for inherent spatial variability and the performance standards require doing so “when necessary,” little attention has been paid to the ubiquity of such spatial variation. Moreover, regulatory traditions favoring upgradient-downgradient comparisons often make control of natural spatial variation difficult and ineffective. With new. lined facilities easily implemented statistical solutions are available; however, dealing with the several existing solid waste facilities which will now be regulated under Subtitle D will present major challenges.In short, the 1988 revision of the Subtitle C rules made it more possible to provide statistically sound monitoring programs, and there has been steady progress since then. Challenges remain, however. These vary from slate to slate, particularly with regard to controlling false positives and false negatives in the presence of natural spatial variability.

Notes: Hydrogen gas was discovered within the steel casing above standing water in a percussion-drilled borehole on the Hanlord Site in south-central Washington state. In situ measurements of the borehole fluids indicated anoxic, low-Eh (〈-400 mV) conditions. Ground water sampled from adjacent wells in the same formation indicated that the ground water was oxygenated. H2 was generated during percussion drilling, due to the decomposition of borehole waters as a result of aqueous reactions with drilled sediment and steel from the drilling tools or casing. The generation of H2 within percussion-drilled boreholes that extend below the water table may be more common than previously realized. The ambient concentration of H2 produced during drilling was limited by microbial activity within the casing-resident fluids. H2 was generated abiotically in the laboratory, whereby sterilized borehole slurry samples produced 100 times more H2 than unsterilizcd samples. It appears that H2 is metabolized by microorganisms and concentrations might be significantly greater if not for microbial metabolism.

Notes: Measurement accuracy was increased by nearly one order of magnitude by outfitting the thermal-pulse flowmeter (TFM) with an inflatable packer. To accurately measure slow water velocities in boreholes greater than 15 cm diameter, it is necessary to divert borehole fluids through the TFM by inflating a packer. During calibration it was noted that the TFM's accuracy decreased as the borehole diameter increased. With Lhe packer inflated the TFM has a useful flow measurement range of 0.08 to 15 L/min (with flow velocities of 0.24 ± 0.012 cm/inin to 45.7 ± 0.61 cm/min, respectively, in 20-cm-diameter pipe), compared to 0.8 to 57 L/min for a packcrless TFM. A computer interlace was added to the TFM to provide a real-time graphical display of the differential voltage output from the TFM, a running mean and standard deviation of the pulse-response time, and a mean flow rate and velocity based on calibration curve fits.

Notes: Cone penetromcler testing (CPT). combined with discrete-depth ground water sampling methods, can significantly reduce the time and expense required to characterize large sites that have multiple aquifers. Results from the screening site characterization can then be used to design and install a cost-effective monitoring well network. At a site in northern California, it was necessary to characterize the stratigraphy and the distribution of volatile organic compounds (VC)Cs) to a depth of 80 feet within a ½-mile-by-½-mile residential and commercial area in a complex alluvial fan setting. To expedite characterization, a five-week field screening program was implemented that consisted of a shallow ground water survey, CPT soundings and pore-pressure measurements, and discrete-depth ground water sampling. Based on continuous lithologic information provided by the CPT soundings, four predominantly coarse-grained, water yielding stratigraphic packages were identified. Individual coarse-grained units within each package are discontinuous, as they coalesce and pinch out in longitudinal and transverse directions. Seventy-nine discrete-depth ground water samples were collected using either shallow ground water survey techniques, the BAT Enviroprobe, or the QED HydroPunch I, depending on subsurface conditions.Using results from these efforts, a 20-well monitoring network was designed and installed to monitor critical points within each stratigraphic package. Good correlation was found for hydraulic head and chemical results between discrete-depth screening data and monitoring well data. Understanding the vertical VOC distribution and concentrations produced substantial time and cost savings by minimizing the number of permanent monitoring wells and reducing the number of costly conductor casings that had to be installed. Additionally, significant long-term cost savings will result from reduced sampling costs, because fewer wells comprise the monitoring network. We estimate these savings to be 50 percent for site characterization costs, 65 percent for site characterization time, and 60 percent for long term monitoring costs.

Notes: Water-level probes, even of the same make and model, may not give the same water-level measurement. If more than one probe is used on a site, it may be useful to measure the differences in water-level measurements, and, if necessary, to normalize the water levels to a single reference probe.