Adequacy Conditions for Reporting Uncertainty in Chemical Risk Assessments

Uncertainty may influence decision-making. A prerequisite for a decision to be well founded is thus that scientific experts inform decision-makers about all decision relevant uncertainty. A set of conditions is provided for adequate characterization of scientific uncertainty for the purposes of regulatory decision-making. These conditions require specification of (1) the character and degree of uncertainty about the assessment variables, (2) the possibility of reducing the uncertainty, and (3) the degree of agreement among experts. Furthermore, it is required that (4) the information covered by the previous conditions is presented in a clear and comprehensible way. The point of departure is that characterizing scientific uncertainty conceptually means specifying all potentially important possibilities that are consistent with the state of scientific knowledge. The conditions are intended to be applied to human health risk assessment of chemicals. However, the basic approach, to consider potentially important possibilities, should be useful also to environmental, and site-specific risk assessment.     

Identifying Uncertainty in Environmental Risk Assessments: The Development of a Novel Typology and Its Implications for Risk Characterization

Environmental risk analysts need to draw from a clear typology of uncertainties when qualifying risk estimates and/or significance statements about risk. However, categorizations of uncertainty within existing typologies are largely overlapping, contradictory, and subjective, and many typologies are not designed with environmental risk assessments (ERAs) in mind. In an attempt to rectify these issues, this research provides a new categorization of uncertainties based, for the first time, on the appraisal of a large subset of ERAs, namely 171 peer-reviewed environmental weight-of-evidence assessments. Using this dataset, a defensible typology consisting of seven types of uncertainty (data, language, system, extrapolation, variability, model, and decision) and 20 related sub-types is developed. Relationships between uncertainties and the techniques used to manage them are also identified and statistically evaluated. A highly preferred uncertainty management option is to take no action when faced with uncertainty, although where techniques are applied they are commensurate with the uncertainty in question. Key observations are applied in the form of guidance for dealing with uncertainty, demonstrated through ERAs of genetically modified higher plants in the European Union. The presented typology and accompanying guidance will have positive implications for the identification, prioritization, and management of uncertainty during risk characterization.     

Distribution of Daily Breathing Rates For Use in California's Air Toxics Hot Spots Program Risk Assessments

Data were combined from a study measuring breathing rates at various activities and two activity pattern studies to generate breathing rate distributions for children and adults. The children and adult breathing rate distributions were combined using a Monte Carlo technique to generate a breathing rate distribution for a lifetime spanning ages 0 to 70. The children's breathing rate distribution has a mean, standard deviation, median and 95^th percentile of 452, 67.7, 441, and 581 L/kg-day, respectively. The adult breathing rate distribution has a mean, standard deviation, median and 95^th percentile of 232, 64.6, 209, and 381 L/kg-day, respectively. The simulated 70-year distribution has a mean, standard deviation, median and 95^th percentile of 271, 57.9, 253, and 393 L/kg-day, respectively. The adult breathing rate distribution is based on 24-hour recall activity data that would not necessarily capture average activity patterns and therefore breathing rates. We utilized the human energy expenditure literature to validate the breathing rate distribution. We conclude that the breathing rate distribution is reasonable for chronic long-term risk assessment in California's Air Toxics Hot Spots program.     

The Anna Karenina Principle Applied to Ecological Risk Assessments of Multiple Stressors

Successful ecological risk assessments are all alike; every unsuccessful ecological risk assessment fails in its own way. Tolstoy posited a similar analogy in his novel Anna Karenina: “Happy families are all alike; every unhappy family is unhappy in its own way.” By that, Tolstoy meant that for a marriage to be happy, it had to succeed in several key aspects. Failure on even one of these aspects, and the marriage is doomed. In this paper, I argue that the Anna Karenina principle also applies to ecological risk assessments involving multiple stressors. In particular, I argue that multiple stressors assessments and environmental decision making will not have a happy marriage unless the following can be achieved: (1) there must be societal and political buy-in to the assessment and decision-making process; (2) the assessment must have the latitude to consider a wide range of stressors and potential risk management options; (3) there must be a commitment to following a rigorous focusing of the assessment and to expending resources for model development and data collection; and (4) an adaptive management strategy must be adopted wherein risk management actions are undertaken, system response intensively observed and assessed, and revised management actions taken as appropriate. Failure to meet any of the above criteria for success will doom a multiple stressors assessment and prevent its use in effective decision-making.     

Extrapolation in Human Health and Ecological Risk Assessments: Proceedings of a Symposium

A symposium was conducted in April 1998 by the U.S. Environmental Protection Agency's National Health and Environmental Effects Research Laboratory (NHEERL) to explore issues of extrapolation in human health and ecological risk assessments. Over the course of three and one half days, leading health and ecology experts presented and discussed research methods and approaches for extrapolating data among taxa and across levels of biological organization, through time, and across spatial scales. The intended result of this symposium was enhanced interaction among a diverse array of scientists, policymakers, and risk assessors to promote identification of approaches for reducing the uncertainties of extrapolation in risk assessment.     

Indicators for Human and Ecological Risk Assessment: A U.S. Environmental Protection Agency Perspective

Assessment of risk to public health or environmental resources requires competent characterization of stressors and corresponding effects. Because of the complexity of most stressor-response relationships, it is impossible to completely characterize all the variables, so a select set of measurements is made to reflect the most critical components. Such measurements, or indicators, are included in monitoring programs to estimate trend, stressor source, or magnitude of effects and lead to thresholds for management action or restoration. Although a wide variety of programs and program objectives exists, there are some common challenges for indicator development, including a strong link to management actions. Indicator measurements used in U.S. Environmental Protection Agency (USEPA) risk assessment activities must stem from collaboration among managers, risk assessors, scientists and stakeholders. The primary objective of the USEPA's Fifth Symposium of the National Health and Ecological Effects Research Laboratory was to improve health and ecological risk assessment through dedicated sessions that maximized interaction and discussion among these groups. Existing measurements were challenged for appropriateness, efficiency and scientific validity. Emerging science was explored for greater understanding, better interpretation, and improved methodology. A secondary objective was to uncover and exploit common indicators and supporting data for human health and ecological models.     

Evaluation of Software for Propagating Uncertainty Through Risk Assessment Models

Quantitative uncertainty analysis has become a common component of risk assessments. In risk assessment models, the most robust method for propagating uncertainty is Monte Carlo simulation. Many software packages available today offer Monte Carlo capabilities while requiring minimal learning time, computational time, and/or computer memory. This paper presents an evalu ation of six software packages in the context of risk assessment: Crystal Ball, @Risk, Analytica, Stella II, PRISM, and Susa-PC. Crystal Ball and @Risk are spreadsheet based programs; Analytica and Stella II are multi-level, influence diagram based programs designed for the construction of complex models; PRISM and Susa-PC are both public-domain programs designed for incorpo rating uncertainty and sensitivity into any model written in Fortran. Each software package was evaluated on the basis of five criteria, with each criterion having several sub-criteria. A ‘User Preferences Table’ was also developed for an additional comparison of the software packages. The evaluations were based on nine weeks of experimentation with the software packages including use of the associated user manuals and test of the software through the use of example problems. The results of these evaluations indicate that Stella II has the most extensive modeling capabilities and can handle linear differential equations. Crystal Ball has the best input scheme for entering uncertain parameters and the best reference materials. @Risk offers a slightly better standard output scheme and requires a little less learning time. Susa-PC has the most options for detailed statistical analysis of the results, such as multiple options for a sensitivity analysis and sophisticated options for inputting correlations. Analytica is a versatile, menu- and graphics-driven package, while PRISM is a more specialized and less user friendly program. When choosing between software packages for uncertainty and sensitivity analysis, the choice largely depends on the specifics of the problem being modeled. However, for risk assessment problems that can be implemented on a spreadsheet, Crystal Ball is recommended because it offers the best input options, a good output scheme, adequate uncertainty and sensitivity analysis, superior reference materials, and an intuitive spreadsheet basis while requiring very little memory.     

Comparing Injury and Illness Risk Assessments for Occupational Hazards

One common framework for describing the evaluation and assessment of hazards in the workplace includes the four steps of hazard identification, exposure assessment, exposure-response modeling, and risk characterization (NAS, 1983). We discuss hazards for occupational injury and illness in light of this framework, and we contrast the evaluation of injury hazards with the evaluation of illness hazards. In particular, the nature of the hazards, typical exposure patterns, quantification of exposure, and the attribution of outcome to exposure are discussed. Finally, we discuss the management of occupational illness and injury hazards and issues encountered when evaluating efforts designed to mitigate the effects of occupational hazards.     

Uncertainty in Impact and Externality Assessments - Implications for Decision-Making (13 pp)

Goal, Scope and Background Many disciplines, amongst them LCIA, environmental impact and external cost assessments, are often faced with evaluating trade-offs between two or more alternative options in terms of a range of incommensurable indicators. Using process modeling and valuation, these indicators are quantified at mid- or endpoint levels. Recent discussion amongst LCA experts showed that because of the mutually exclusive aspects of uncertainty and relevance, the midpoint/endpoint debate is controversial and difficult to reconcile. This article is aimed at a more quantitative analysis of mid- and endpoint impacts, and the implications of uncertainty for decision-making. Methods The consequences for decision-making of uncertainties of endpoints are analysed quantitatively for the example of ExternE results, by employing statistical hypothesis testing. The Analytic Hierarchy Process (AHP) is then used to demonstrate the use of multi-criteria techniques at midpoint levels. Results and Discussion Statistical hypothesis testing at the endpoint level shows that for the ExternE example, probabilities of mistakenly favouring one alternative over another when they are in reality indistinguishable can be as high as 80%. Therefore, the best estimate of external cost is inadequate for most policy making purposes. Indicators at midpoint levels are more certain, but since they are only \proxy attributes\, they carry a hidden uncertainty in their relevance. Conclusion If endpoint information is too uncertain to allow a decision to be made with reasonable confidence, then the assessment can be carried out in midpoint terms. However, midpoint indicators are generally further removed from people's experience, and less relevant to the question that people actually want to solve. Nevertheless, if this ultimate question is unanswerable (within the certainty required by the decision-maker), a decision can be made on the basis of stakeholders' subjective judgments about the more certain midpoint levels. The crucial point is that these judgments are able to intuitively incorporate many aspects that impact modeling and valuation has trouble quantifying, such as perceived risk, distribution of burdens and benefits, equity, ethical, moral, religious and political beliefs and principles, immediacy and reversibility of potential impacts, voluntariness, controllability and familiarity of exposure, or perceived incompleteness of human knowledge.     

Challenges in Defining Background Levels for Human and Ecological Risk Assessments

A robust approach to defining, understanding, and tracking contaminant levels is crucial to human and ecological risk evaluation and risk management. Whether materials are present in the environment naturally (mercury, radon, nitrogen, phosphorous) and enhanced by human activities or are man-made (DDT and PCBs), the complexity of contaminant distributions and sources requires careful design and implementation of studies to characterize background. Before collection or analyses of data are initiated, an explicit definition of background appropriate to specific risk assessments is needed. Problems associated with determining background levels of contaminants in fish and seafood illustrate some challenges faced by risk assessors. Major differences in estimates of background may result from differences in sampling and analytical methods including selection of sampling locations, approaches to data analysis and synthesis, and tissues selected for analysis. Different approaches may yield background exposure or risk estimates that differ by 50% or more. Methodological transparency is essential in data collection and analysis to establish background and to ensure that data are used appropriately in both human and ecological risk assessments.     

Consideration of Background Radiation in Ecological Risk Assessments

Background or ambient concentrations are often considered in the evaluation of potential risks to ecological receptors from exposure to hazardous chemicals in the environment. Such an evaluation may be a component of the screening or final risk management process and sets the baseline from which risks contributed by site-related activities can be addressed. Although the process for the evaluation of potential radiological risks to ecological receptors is less formalized than the chemical hazard assessment process, background remains an issue that should be addressed when considering potential site-related impacts. This paper briefly presents the ecological risk assessment approaches used to address background radionuclide concentrations at three United States Department of Defense Facilities. The concepts of total radiation dose, and tolerance and adaptation of populations to radiation are also discussed within the context of background radiation.     

Potential for the Adoption of Probabilistic Risk Assessments by End-Users and Decision-Makers

In the area of risk assessment associated with ecotoxicological and plant protection products, probabilistic risk assessment (PRA) methodologies have been developed that enable quantification of variability and uncertainty. Despite the potential advantages of these new methodologies, end-user and regulatory uptake has not been, to date, extensive. A case study, utilizing the Theory of Planned Behavior, was conducted in order to identify potential determinants of end-user adoption of probabilistic risk assessments associated with the ecotoxicological impact of pesticides. Seventy potential end-users, drawn from academia, government, industry, and consultancy organizations, were included in the study. The results indicated that end-user intention to adopt PRA varied across the different end-user groups. The regulatory acceptance of PRA was contingent on social acceptance across the regulatory community regarding the reliability and utility of the outputs. Training in interpretation of outputs is therefore highly relevant to regulatory acceptance. In other end-user sectors, a positive attitude toward PRA, “hands on” experience, and perceived capability of actually performing PRA is an important determinant of end-user intention to adopt PRA. It is concluded that training programs targeted to the specific needs of different end-user sectors should be developed if end-user adoption of PRA is to be increased.     

Distribution Characteristics and Risk Assessments of PAHs in Fish from Lake Taihu,China

The concentrations of PAHs in four species of fish (Common carp, Crucian carp, Bighead carp, and Topmouth culter) from Lake Taihu were tested, and the human health risks of PAHs by fish consumption were evaluated. Results showed that concentrations of PAHs in fish from Lake Taihu were 52.5–247.6 ng/g wet weight (ww), and the BaP equivalent concentrations of total PAHs (B[a]P_eq) were 0.2–0.6 ng/g ww, which were less than the screening value of 2.6 ng/g wet for human consumption. The concentration sequences of PAHs in fish from Lake Taihu from high to low were Bighead carp > Crucian carp > Common carp > Topmouth culter. The human health risk level of PAHs by fish consumption was 5.8 ± 2.5 × 10^?6, which was less than the maximum acceptable risk level of 1 × 10^?5 for human health set by the U.S. Environmental Protection Agency. The tissue residue guideline (TRG) of PAHs for protecting aquatic wildlife was 1.3 mg/kg diet ww, which was higher than the concentrations of PAHs in fish from Lake Taihu. The results indicated that fish consumption from Lake Taihu would not cause health risk or harmful effects on wildlife that consume aquatic biota.     

Challenges for Risk Assessors

At the early part of the 21st century, occupational safety and health risk assessors face a variety of challenges. In addition to technical issues, the challenges for risk assessors include: assessment of risks of mixtures/and synergistic effects; incorporation of biological information into risk assessments; development of different ways of presenting risk information to better inform policy makers and the public; better expressions of uncertainty and assumptions; and harmonization of assessments across agencies and countries. All of these challenges will occur against a background of unfolding understanding of human and other genomes. Risk assessors will be motivated and pressured to use genomic and related technologies, but ethical, social, and technical issues need to be addressed before widespread use.     

Use of Indicators in Ecological Risk Assessments for Persistent,Bioaccumulative Toxicants

This paper synthesizes several presentations on the use of indicators in ecological risk assessments for persistent, bioaccumulative toxicants (PBTs). The presentations were organized around two chemical case studies: (1) mercury, and (2) compounds that exhibit an Ah-receptor based mode-of-action. Presenters summarized the current practice of ecological risk assessment for these compounds and described research on known or suspected impacts. In addition, this paper addresses three special topics that apply broadly to all PBTs: (1) the convergence of ecological assessment and ecological risk assessment, (2) integration of ecological and human health risk assessment, and (3) risk assessments for population-level effects.     

Metals that Drive Health-Based Remedial Decisions for Soils at U.S. Department of Defense Sites

This study was undertaken to establish which metals are most likely to drive the risk-based remedial decision-making process at those U.S. Department of Defense (DoD) sites that are affected by metals in site soils. Our approach combined queries of various databases, interviews with U.S. Environmental Protection Agency (USEPA) experts in each Region, and communication with database administrators and DoD personnel. The databases that were used were comprehensive for DoD sites, yet sometimes contained inaccuracies. Metal concentration data for various DoD facilities were screened against established regulatory criteria for both human health and ecological endpoints. Results from this analysis were compared against the information gleaned from the interviews. This preliminary analysis indicates that the five metals that most frequently exceeded risk-based screening criteria for potential human health concerns at DoD sites, in descending order of frequency, are lead, arsenic, cadmium, chromium, and antimony. The metals that most frequently exceeded ecological screening criteria, in order, are lead, cadmium, mercury, zinc, arsenic, chromium, and selenium. Although the majority of USEPA personnel interviewed indicated that human health risk, rather than ecological endpoints, generally drives remedial decision-making, the data indicated that ecological screening thresholds were exceeded more often than human health standards.