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.     

Developing A Regional Ecological Risk Assessment: A Case Study of a Tasmanian Agricultural Catchment

A regional ecological risk assessment was conducted for the Mountain River catchment in Tasmania, Australia. The Relative Risk Model was used in conjunction with geographic information systems interpretations. Stakeholder values were used to develop assessment endpoints, and regional stressors and habitats were identified. The risk hypotheses expressed in the conceptual model were that agriculture and land clearing for rural residential are producing multiple stressors that have potential for contamination of local waterbodies, eutrophication, changes in hydrology, reduction in the habitat of native flora and fauna, reductions in populations of beneficial insects in agricultural production systems, increased weed competition in pastures, and loss of aesthetic value in residential areas. In the risk analysis the catchment was divided into risk regions based on topography and land use. Stressors were ranked on likelihood of occurrence, while habitats were ranked on percentage land area. Risk characterization showed risks to the maintenance of productive primary industries were highest across all risk regions, followed by maintenance of a good residential environment and maintenance of fish populations. Sensitivity analysis was conducted to show the variability in risk outcomes stemming from uncertainty about stressors and habitats. Outcomes from this assessment provide a basis for planning regional environmental monitoring programs.     

Noncancer Risk Assessment: A Probabilistic Alternative to Current Practice

Based on imperfect data and theory, agencies such as the United States Environmental Protection Agency (USEPA) currently derive “reference doses” (RfDs) to guide risk managers charged with ensuring that human exposures to chemicals are below population thresholds. The RfD for a chemical is typically reported as a single number, even though it is widely acknowledged that there are significant uncertainties inherent in the derivation of this number.

In this article, the authors propose a probabilistic alternative to the EPA's method that expresses the human population threshold as a probability distribution of values (rather than a single RfD value), taking into account the major sources of scientific uncertainty in such estimates. The approach is illustrated using much of the same data that USEPA uses to justify their current RfD procedure.

Like the EPA's approach, our approach recognizes the four key extrapolations that are necessary to define the human population threshold based on animal data: animal to human, human heterogeneity, LOAEL to NOAEL, and subchronic to chronic. Rather than using available data to define point estimates of “uncertainty factors” for these extrapolations, the proposed approach uses available data to define a probability distribution of adjustment factors. These initial characterizations of uncertainty can then be refined when more robust or specific data become available for a particular chemical or class of chemicals.

Quantitative characterization of uncertainty in noncancer risk assessment will be useful to risk managers who face complex trade-offs between control costs and protection of public health. The new approach can help decision-makers understand how much extra control cost must be expended to achieve a specified increase in confidence that the human population threshold is not being exceeded.     

The Intersection of Independent Lies: Increasing Realism in Ecological Risk Assessment

In 1966, Levins presented a philosophical discussion on making inference about populations using clusters of models. In this article we provide an overview of model inference in ecological risk assessment, discuss the benefits and trade-offs of increasing model realism, show the similarities and differences between Levins' model clusters and those used in ecological risk assessment, and present how risk assessment models can incorporate Levins' ideas of truth through independent lies. Two aspects of Levins' philosophy are directly relevant to risk assessment. First, confidence in our interpretation of risk is increased when multiple risk assessments yield similar qualitative results. Second, model clusters should be evaluated to determine if they maximize precision, generality, or realism or a mix of the three. In the later case, the evaluation of each model will differ depending on whether it is more general, precise, or realistic relative to the other models used. We conclude that risk assessments can be strengthened using Levins' idea, but that Levins' caution that model outcome should not be mistaken for truth is still applicable.     

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.     

Extrapolation in Risk Assessment: Improving the Quantification of Uncertainty,and Improving Information to Reduce the Uncertainty

Risk assessments inevitably extrapolate from the known to the unknown. The resulting calculation of risk involves two fundamental kinds of uncertainty: uncertainty owing to intrinsically unpredictable (random) components of the future events, and uncertainty owing to imperfect prediction formulas (parameter uncertainty and error in model structure) that are used to predict the component that we think is predictable. Both types of uncertainty weigh heavily both in health and ecological risk assessments. Our first responsibility in conducting risk assessments is to ensure that the reported risks correctly reflect our actual level of uncertainty (of both types). The statistical methods that lend themselves to correct quantification of the uncertainty are also effective for combining different sources of information. One way to reduce uncertainty is to use all the available data. To further sharpen future risk assessments, it is useful to partition the uncertainty between the random component and the component due to parameter uncertainty, so that we can quantify the expected reduction in uncertainty that can be achieved by investing in a given amount of future data. An example is developed to illustrate the potential for use of comparative data, from toxicity testing on other species or other chemicals, to improve the estimates of low-effect concentration in a particular case with sparse case-specific data.     

Harmonizing the Incorporation of Uncertainty and Variability Into Risk Assessment: An International Approach

International harmonization of risk assessment approaches affords a number of opportunities and advantages. Overall, harmonization will lead to more efficient use of resources, but also will lead to better understanding amongst scientists and regulators worldwide. It is with these goals in mind that in 1994 the International Programme on Chemical Safety (IPCS) initiated its Project on the Harmonization of Approaches to the Assessment of Risk from Exposure to Chemicals (Harmonization Project). An ongoing activity under this project addresses uncertainty and variability in risk assessment. The goal of the overall activity is to promote harmonization of risk assessment methodologies for noncancer endpoints. However, given the common links in uncertainty and variability that apply across a range of end-point-specific activities, these links are identified wherever possible. This paper provides an overview of the IPCS Harmonization Project and reviews the activity and future plans related to uncertainty and variability.     

The Use of Probabilistic Risk Assessment in Establishing Drinking Water Quality Objectives

There has been a trend in recent years toward the use of probabilistic methods for the analysis of uncertainty and variability in risk assessment. By developing a plausible distribution of risk, it is possible to obtain a more complete characterization of risk than is provided by either best estimates or upper limits. We describe in this paper a general framework for evaluating uncertainty and variability in risk estimation and outline how this framework can be used in the establishment of drinking water quality objectives. In addition to characterizing uncertainty and variability in risk, this framework also facilitates the identification of specific factors that contribute most to uncertainty and variability. The application of these probabilistic risk assessment methods is illustrated using tetrachloroethylene and trihalomethanes as examples.     

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.     

Restoring Wild Salmon to the Pacific Northwest: Framing the Risk Question

In the Pacific Northwest of the United States, it is urgent to assess accurately the various options proposed to restore wild salmon. For the past 150 years, a variety of analytic approaches have been employed to assess the ecological consequences of salmon management options. Each approach provided useful information to decision makers, but each also suffered from limitations, some relatively minor, others sufficient to undermine any potential utility. Risk assessment has become the most widely used analytic approach to evaluate environmental policy options. To date its use in ecological policy has been largely constrained to evaluating relatively simple technical questions (e.g., regulatory actions associated with specific chemicals or hazardous waste sites). Recently, however, there has been interest in applying risk assessment to more complex ecological policy problems (e.g., the decline of wild salmon in the Pacific Northwest). Although its use has become commonplace and widely accepted, especially among regulatory and land management agencies, risk assessment remains contentious. The most heated debates revolve around delineating the specific meaning of risk; that is, framing the risk “question” to be answered.     

A Risk Assessment Framework for Waterborne Pathogens and Requirements for Producing a Complete Protocol

The U.S. Environmental Protection Agency (USEPA), Office of Water, is developing a risk assessment protocol for determining microbiological pathogen risks in water (drinking, recreational, waste waters, etc.). This effort has been conducted in collaboration with the International Life Sciences Institute. A microbiological risk assessment framework was prepared and has been peer reviewed in the open literature and vetted at the USEPA and other federal government risk assessment venues. Some goals in development of the Framework were to make it comprehensive, easy to understand and to use, since it is recognized that improvements to the framework structure and instructional material would facilitate its use. The USEPA's Office of Water wishes to develop improved tools, methods, and approaches for conducting the analysis phase for risk assessments and would like to evaluate its efficacy for a broad range of waterborne pathogens in water/wastewater media. Improved understanding of microbiological survival, infectivity, and virulence factors is needed, especially at the genomic and proteomic levels to accurately assess the occurrence and fate of pathogens in water and to predict what intrinsic factors allow pathogens to be invasive and virulent. Development of improved dose-response models (including animal models) for pathogen exposures focusing on the dynamic circumstances of immunity, secondary spread, and sensitive subpopulations, would be useful additions to the Framework. In the future, USEPA may consider establishing comprehensive pathogen risk assessment guidelines that all its program offices can use.     

Comparison of Risk Assessments of Boron: Alternate Approaches to Chemical-Specific Adjustment Factors

Health risk assessments of boron (B) have been performed in recent years by seven well-respected regulatory and scientific organizations, including the Institute for Evaluating Health Risks, European Centre for Ecotoxicology and Toxicology of Chemicals, International Programme on Chemical Safety, World Health Organization, National Academy of Sciences Food and Nutrition Board, U.K. Expert Group of Vitamins and Minerals (draft) and U.S. Environmental Protection Agency (draft). Of interest, all of these risk assessments employed chemical-specific adjustment factors, resulting in total uncertainty factors in the range of 25–62 and estimates of tolerable intake levels ranging from 10 to 24 mg B/day. These risk assessments are particularly instructive because they all used the same critical developmental toxicity study and the same NOAEL (10 mg B/kg/day). Therefore, the primary differences among these risk assessments reside in the choice of chemical-specific adjustment factors. It is generally agreed that renal clearance is the primary determinant of B pharmacokinetic variability, both within and among species. However, the methods used to select chemical-specific adjustment factors for pharmacokinetics vary among B risk assessments. Several have estimated intraspecies pharmacokinetic variability based on glomerular filtration rates (GFR) in pregnant women. Based on the results of renal clearance studies of B, the use of GFR is scientifically appropriate to estimate the intraspecies pharmacokinetic variability in B renal clearance. B homeostasis in humans appears to be primarily regulated by the kidney, and at typical low doses in humans, there is evidence of tubular reabsorption of B in the kidneys. Human studies indicate that urinary B excretion is a sensitive indicator of recent dietary intake. The major source of B exposure in humans is consumption of fruits, vegetables, nuts and legumes, which are naturally rich in B. Human dietary consumption of B is below the estimated tolerable intake levels established in these recent risk assessments. Considering the growing evidence of the nutritional role of B, it is important to consider both the benefits and risks of B consumption. By legitimately reducing the uncertainty factor for toxicity, the margin of safety is effectively increased to protect against the possibility of insufficient dietary intake. Risk assessments of B provide valuable lessons regarding how chemical-specific adjustment factors may be selected.     

Pathway-Related Factors: The Potential for Human Data to Improve the Scientific Basis of Risk Assessment

The default uncertainty factors used for risk assessment are applied either to allow for different aspects of extrapolation of the dose-response curve or to allow for database deficiencies. Replacement of toxicokinetic or toxicodynamics defaults by chemical-specific data allows the calculation of a chemical-specific “data-derived factor”, which is the product of chemical-specific values and default uncertainty factors. Such chemical-specific composite values will improve the scientific basis of the risk assessment of that chemical, but the necessary chemical-specific data are rarely available. Categorical defaults related to pathways of elimination and mechanisms of toxicity could be used when the overall fate or mechanism is known, but there are no chemical-specific data sufficient to allow replacement of the default, and the development of an overall data-derived factor. The development of pathway-related categorical defaults is being undertaken using data on selected probe substrates for which adequate data are available. The concept and difficulties of this approach are illustrated using data for CYP1A2.     

The Ecological Component of Ecological Risk Assessment: Lessons from a Field Experiment

To improve ecological relevance, regulatory agencies are promoting assessments of effects at higher levels of organization, an objective that requires an understanding of current ecological theories. One such theory, hierarchy theory, contends that the effects of a disturbance acting at one level of organization (e.g., population) are not, as a rule, transmitted to higher levels of organization (e.g., community). Conversely, effects at higher levels of organization only occur if lower level variables have been affected. Further, responses to disturbance depend on disturbance history. In this study, I determined the effects of a disturbance treatment at the population, guild, and community levels of organization for vegetation in five wetlands with a disturbance history ranging from highly to rarely disturbed. The 2-year field experiment revealed that the effects of the disturbance treatment were most strongly felt at the population level of organization in wetlands without a history of disturbance. These observed impacts took place against a backdrop of constant change. Thus, the eventual disappearance of treatment effects was not due to a return to the pre-treatment state, but rather a return to a trajectory similar to that exhibited by the control plots. The implications of these results for ecological risk assessment are: (1) the observed effects of a stressor in a system cannot be extrapolated to other systems unless they have similar disturbance histories, (2) detecting effects before they become serious requires monitoring at lower levels of organization, (3) recovery to a naturally innate state is not a viable concept, and (4) the traditional approach of using one post-treatment measurement to determine if reference and impact sites differ is of very questionable value.     

Risk taking during parental care: a test of the harm-to-offspring hypothesis

Amount of risk taking during parental care is often explainedin relation to the reproductive value of the offspring. The"harm-to-offspring hypothesis" focuses on the relative harma period of no parental care can do to the offspring. Accordingto this hypothesis, parents should take greater risks for offspringin poor condition than for offspring in good condition. We manipulatedoffspring condition in the pied flycatcher (Ficedula hypoleuca)and tested the harm-to-offspring hypothesis by exposing parentsto a predator model (a sparrowhawk, Accipiter nisus). Time elapseduntil a parent first entered the nest-box was used as a risk-takingmeasure. Parents spent significantly shorter time until first nestvisit for offspring in poor condition than for offspring ingood condition. Hence, the harm-to-offspring hypothesis wassupported.     

Assessing the Consequences from Marine Accidents: Introduction to a Risk Acceptance Criterion for Greece

The aim of this article is to shed some light on an appropriate criterion for assessing risk/consequences in the maritime transport industry, with respect to the view of society. A major problem is how to derive credible and exploitable data from/for the society and try to understand how it reacts to accidents (i.e., misfortunes) of different scale. Therefore the set problem is the assessment of the maximum risk that the society will tolerate for a specific activity. In the shipping industry, the problem is complicated due to the fact that a single maritime incident can produce consequences of different types, for example, both human losses and oil spillage can result from the same accident. In effect, this article focuses on the integration of different consequences of an accident into one metric that will allow the direct and exploitable comparison of accidents of different scales and characteristics and therefore present a clearer picture of the risks that the society takes and/or is willing to accept. Hence, a new framework for marine risk assessment is introduced, which is able to project the risk that a group of people (i.e., the society) can accept for accidents of different size or type.     

Ecological Risk Assessment for Terrestrial Ecosystems: The Summary of Discussions and Recommendations from the Adelaide Workshop (April 2004)

The Ecological Risk Assessment (ERA) workshop focused on the anthropogenic contaminants in the terrestrial environment, addressing various components of the ERA process. These included sources, exposure pathways, bioavailability, and toxicity to receptor organisms as well as risk communication. It was concluded that although the overseas experience on ERA for terrestrial ecosystems (e.g., International Standards or guidelines from the European Union and the United States) is very useful, it is not directly applicable to Australia due to the differences in receptor organisms, contaminants, soil, and environmental conditions. Workshop discussions stressed on the need for making ERA locally relevant (in terms of choice of receptor organisms, sampling strategy, and bioavailability considerations). The workshop discussions highlighted the need of better appreciation of both the similarities and the clear differences between aquatic and terrestrial ERAs. The availability of reliable data, problems with databases, estimation of bioavailability, and extrapolations from laboratory to field were noted among the key limitations. ERA—being inherently complex and involving a range of environmental compartments, target receptor, and exposure pathways—at a minimum requires a multidisciplinary approach to address the complexities. Bringing a multidisciplinary team together often proves a major challenge in ERA. The delegates called for continued efforts in this area and formation of a network or working group in Australia.     

Improving Risk Assessment: Research Opportunities in Dose Response Modeling to Improve Risk Assessment

Substantial improvements in dose response modeling for risk assessment may result from recent and continuing advances in biological research, biochemical techniques, biostatistical/mathematical methods and computational power. This report provides a ranked set of recommendations for proposed research to advance the state of the art in dose response modeling. The report is the result of a meeting of invited workgroup participants charged with identifying five areas of research in dose response modeling that could be incorporated in a national agenda to improve risk assessment methods. Leading topics of emphasis are interindividual variability, injury risk assessment modeling, and procedures to incorporate distributional methods and mechanistic considerations into now-standard methods of deriving a reference dose (RfD), reference concentration (RfC), minimum risk level (MRL) or similar dose-response parameter estimates.     

Comparison of Contaminated Site Human Health Risk Assessment Approaches in Canada: Application of Provincial Methods to a Hypothetical Site

Human health risk assessment, whether at the screening level or more complex phase, is not an exact science. A wide variety of advice and direction is offered by international, national, and provincial/state environmental agencies regarding the conduct of risk assessment, and different risk assessors access and rely on the available regulatory advice and direction differently. This may result in wide variability in the estimates of chemical exposure and risk. A comparison of human health risk assessment approaches practiced at the provincial level in Canada was undertaken, wherein each jurisdiction's approach was applied to a hypothetical contaminated site. Approaches were found to vary both in terms of methodological considerations, and in matters of policy. The exercise yielded results in terms of estimated exposures and predicted hazard quotients/indexes and incremental lifetime cancer risks that were in some cases quite consistent (varying by a factor of less than 1.5 times), and in other cases remarkably different (varying by orders of magnitude). This article reviews the various approaches/frameworks applied and discusses the results of the hypothetical risk assessments, in terms of both the observed variation and the source of this variability.     

A Human Health Risk Assessment Software for Facilitating Management of Urban Contaminated Sites: A Case Study: The Massa Site,Tuscany, Italy

The goal of this article is to present the Human Health Risk Assessment (HRA) software developed as one of the NORISC ^{1 1}NORISC is the acronym of the project “Network Oriented Risk assessment by In-situ Screening of Contaminated sites” realized under under the 5th European Union Community Framework Programme for Research, Technological Development and Demonstration Activities. View all notes decision support software system components that could be used as a tool for facilitating management of urban contaminated sites. The NORISC-HRA software provides sufficient technical and procedural support to conduct a simple site-specific risk assessment. The employed HRA methodology is generally based on U.S. Environmental Protection Agency (USEPA) procedures. The software determines the level and spatial distribution of human health risks at a given site and sets up site-specific preliminary Health-Based Remedial Goals (HBRGs)/Risk-Based Concentrations (RBCs) for soil and groundwater. The NORISC-HRA software is recommended for use when national soil and groundwater limit values are exceeded. Exposure pathways considered in this software are associated with three land use patterns—residential, industrial/commercial, and recreational. The aricle also presents the software testing results obtained at one of the NORISC test sites—the Massa site (Avenza-Carrara, Tuscany, Italy). Findings of the HRA indicated that the contaminated soil at the Massa test site might pose potential cancer and non-cancer risks to industrial workers in its present condition. Arsenic was the dominant substance responsible for most of the baseline risk and at the RBC of 1.77 mg/kg it was the primary driver of remedial decisions at the Massa site.