Application of the Hazard Quotient Method in Remedial Decisions: A Comparison of Human and Ecological Risk Assessments

This paper evaluates the relative roles of the human health hazard index (HI) and the ecological risk assessment hazard quotient (HQ) in remedial decision-making. Through an analysis of HI outcomes drawn from Superfund Records of Decision, the reduced importance of the HI statistic in human health risk assessments is demonstrated, and the high visibility of the ecological risk assessment (ERA) HQ for terrestrial receptors (birds and mammals) is underscored. Three HQ method limitations common to both HHRA and ERA, deriving either from the mathematical construct of the HQ (a simple binary measure, indicating that an animal's exposure either exceeds its toxicity value or does not) or from dose-response outcomes in animal trials, are reviewed. Two additional HQ limitations unique to ERA (i.e., a propensity for the HQ to easily exceed its threshold value, and a propensity for it to assume values that are unreasonably high), and deriving from the complexities of estimating bird and mammal dietary intakes of contaminants and the availability of toxicological effects information, are also identified. The paper cautions of the potential to err in concluding that terrestrial site receptors are at risk when the HQ threshold is exceeded, and regardless of the toxicological information (NOAELs, LOAELs, etc.) used. It recognizes that because other methods of terrestrial assessment are presently unavailable, HQs are sometimes, out of necessity, used to justify a remedial action. The analysis and discussion are intended to remind ecological risk assessors that the HQ is a measure of a level of concern only and not a measure of risk     

Can Ecological Receptors Really Be At Risk?

Birds and mammals at hazardous waste sites are routinely modeled for their potential to display harmful toxicological effects as a result of their exposures to contaminants. Although standard desktop measures of the potential for toxicological endpoints to be reached commonly suggest that these receptors should be at ill health (e.g., experiencing reproductive impairment), evidence is lacking from the field that such effects are occurring. Plausibly, the excessive time lapse (frequently several decades) from contaminant release event to site ecological risk assessment, can explain the disconnect. Aided by their relatively brief life spans, these modeled ecological receptors have produced multiple generations to date and may have outbred the chemical stress. In light of the absence of observed health impacts in birds and mammals since the creation of the U.S. Environmental Protection Agency's Superfund program, there may be no need to continue assessing the health of these species. Additionally, given the very few reported instances of observed health effects at terrestrial sites, it may be prudent to replace risk assessment with impact assessment as the essence of a revamped ecological assessment process.     

Approaches for Integrated Risk Assessment

Recognizing the need to enhance the effectiveness and efficiency of risk assessments globally, the World Health Organization's International Programme on Chemical Safety, the U.S. Environmental Protection Agency, the European Commission, and the Organization for Economic Cooperation and Development developed a collaborative partnership to foster integration of assessment approaches used to evaluate human health and ecological risks. The objectives of this effort included: improving understanding of the benefits of integration, identifying obstacles to the integration process, and engaging key agencies, organizations, and scientific societies to promote integration. A framework with supporting documentation was developed to describe an approach for integration. Four case studies were constructed to illustrate how integrated risk assessments might be conducted for chemical and nonchemical stressors. The concepts and approaches developed in the project were evaluated in an international workshop. The goal of this effort was international acceptance of guidance for integrated risk assessment.     

Trends in the Development of Ecological Risk Assessment and Management Frameworks

Ecological risk assessment and management have grown from a long history of assessment and management activities aimed at improving the everyday lives of humans. The background against which ecological risk assessment and management has developed is discussed and recent trends in the development of risk assessment and management frameworks documented. Seven frameworks from five different countries are examined. All maintain an important role for science, suggest adaptive approaches to decision-making and have well-defined analytical steps. Differences in approaches toward the separation of policy and science, the preference for management over assessment, the inclusion of stakeholders, the iterative nature of the analytical cycle, the use of decision criteria and economic information suggest considerable evolution in framework design over time. Despite the changes, no consensus on the design of a framework is apparent and work remains to be done on refining an integrative framework that effectively incorporates both policy and science considerations for environmental management purposes.     

Framework for the Integration of Health and Ecological Risk Assessment

The World Health Organization's International Programme on Chemical Safety (IPCS), the Organization for Economic Cooperation and Development (OECD), and the U.S. Environmental Protection Agency have developed a collaborative partnership to foster integration of assessment approaches for human health and ecological risks. This paper presents the framework developed by that group. Integration provides coherent expressions of assessment results, incorporates the interdependence of humans and the environment, uses sentinel organisms, and improves the efficiency and quality of assessments relative to independent human health and ecological risk assessments. The paper describes how integration can occur within each component of risk assessment, and communicates the benefits of integration at each point. The goal of this effort is to promote the use of this internationally accepted guidance as a basis for harmonization of risk assessment.     

The Changing Focus of the Ecological Risk Assessment of Aquaculture Operations: From Local to Cumulative Risk Assessment

Ecological risk assessment (ERA) methodologies must be continually improved so that resource managers, activity proponents, and stakeholders can better manage the environmental impacts of human activities. One of the largest challenges facing ERA methodologies and approaches is to develop the ability to encompass cumulative and far-field effects of human activities. It is argued here that the ERAs of industrial aquaculture activities have been an example of where ERA practitioners and researchers have responded to the challenge of managing the cumulative risks of a new and rapidly growing industry by developing innovative ERA approaches that can be applied elsewhere.     

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.     

Ecological Indicators in Risk Assessment: Workshop Summary

Ecological indicators can be defined as relatively simple measurements that relay scientific information about complex ecosystems. Such indicators are used to characterize risk in ecological risk assessment (ERA) and to mark progress toward resource management goals. In late 1997, scientists from the U.S. Environmental Protection Agency and from the Chemical Manufacturers Association (CMA) held a workshop to explore opportunities for collaborative research and scientific exchange on the development and application of ecological indicators. Several scientific challenges were identified as they relate to problem formulation, exposure and effects assessment, and risk characterization. Chief among these were a better understanding of multiple stressors (both chemical and non-chemical), characterization of reference sites and natural variability, extrapolation of measures to ecologically relevant scales, development of comprehensive, ecosystem-based models that incorporate multiple stressors and receptors, and a consistent system for evaluating ecological indicators.     

Bioindicators Versus Biomarkers in Ecological Risk Assessment

The biomarker approach, adopted from medical toxicology, is subject to several theoretical and practical difficulties when used to address environmental problems. The problems are related to the definition that emphasizes measurement but does not specify a requirement to establish cause-effect linkages. An improved definition for a bioindicator is reviewed. The sentinel species approach is judged to be a biomarker rather than a bioindicator, and therefore of limited use for environmental risk assessment. An empirical weight of evidence approach to improve the utility of sentinel species is proposed.     

Terrestrial Metals Bioavailability: A Comprehensive Review and Literature-Derived Decision Rule for Ecological Risk Assessment

Interstudy variation among bioavailability studies is a primary deterrent to a universal methodology to assess metals bioavailability to soil-dwelling organisms and is largely the result of specific experimental conditions unique to independent studies. Accordingly, two datasets were established from relevant literature; one includes data from studies related to bioaccumulation (total obs = 520), while the other contains data from studies related to toxicity (total obs = 1264). Experimental factors that affected toxicity and bioaccumulation independent of the effect of soil chemical/physical properties were statistically apportioned from the variation attributed to soil chemical/physical properties for both datasets using a linear mixed model. Residual bioaccumulation data were then used to develop a non-parametric regression tree whereby bootstrap and cross-validation techniques were used to internally validate the resulting decision rule. A similar approach was employed with the toxicity dataset as an independent external validation. A validated decision rule is presented as a quantitative assessment tool that characterizes typical aerobic soils in terms of their potential to sequester common divalent cationic metal contaminants and mitigate their bioavailability to soil-dwelling biota.     

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.     

Ten Years of the Relative Risk Model and Regional Scale Ecological Risk Assessment

It has been 10 years since the publication of the relative risk model (RRM) for regional scale ecological risk assessment. The approach has since been used successfully for a variety of freshwater, marine, and terrestrial environments in North America, South America, and Australia. During this period the types of stressors have been expanded to include more than contaminants. Invasive species, habitat loss, stream alteration and blockage, temperature, change in land use, and climate have been incorporated into the assessments. Major developments in the RRM have included the extensive use of geographical information systems, uncertainty analysis using Monte Carlo techniques, and its application to retrospective assessments to determine causation. The future uses of the RRM include assessments for forestry and conservation management, an increasing use in invasive species evaluation, and in sustainability. Developments in risk communication, the use of Bayesian approaches, and in uncertainty analyses are on the horizon.     

Recommended Avian Toxicity Reference Value for Cadmium: Justification and Rationale for Use in Ecological Risk Assessments

The understanding of Cd impacts to avian species has been improved by recent studies and the extensive literature review completed as part of the development of the U.S. Environmental Protection Agency's Ecological Soil Screening Levels (Eco-SSLs). Therefore, we sought to update the Cd toxicity reference value (TRV) for birds used by regulatory agencies and resource trustees in California for predictive ecological risk assessments. We surveyed the available literature sources, particularly TRVs between the currently used TRV (0.08 mg/kg/d) and the Eco-SSL TRV (1.47 mg/kg/d) to identify the lowest, ecologically relevant no observed adverse effect levels (NOAELs) for oral exposure of birds to Cd. As a result, we identified an ecologically protective NOAEL TRV of 0.7 mg/kg/d, based primarily on renal effects in wood ducks, but supported by another study with both renal and reproductive endpoints. In addition, a lowest observed adverse effect level (LOAEL) of 1.0 mg/kg/d was selected based on kidney nephrosis in mallards. Overall, these updated TRVs incorporate more recent studies on Cd toxicity in birds while establishing thresholds based on ecologically relevant endpoints.     

Ecological Risk Assessment Approaches Within the Regulatory Framework

Ecological risk assessment has a short history but a framework similar to human health risk assessment. The Toxic Substances Control Act (TSCA) and the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) played a significant role in the development of the ecological risk process. Data developed and risk procedures used within TSCA and FIFRA have become generally standardized. Fundamental components of the risk process require data on the effects of chemicals in the form of concentration (or dose) — response profiles for species and an exposure profile to quantify the magnitude, spatial and temporal patterns of exposure relevant to significant biological endpoints being studied. Risk characterization generally involves comparing exposure and effects using point estimates (e.g., quotient method) but risk estimation is moving toward a probabilistic approach by comparing distributions of values with more consideration of the sources of uncertainty. Ecological testing guidelines in TSCA and FIFRA are discussed along with the risk characterization process used in each statute.     

生态风险研究述评

生态风险(ＥｃｏｌｏｇｉｃａｌＲｉｓｋ,ＥＲ),指一个种群、生态系统或整个景观的正常功能受外界胁迫,从而在目前和将来减小该系统健康、生产力、遗传结构、经济价值和美学价值的一种状况[20]。生态风险评估(ＥｃｏｌｏｇｉｃａｌＲｉｓｋＡｓｓｅｓｓｍｅｎｔ,ＥＲＡ)指受一个或多个胁迫因素影响后,对不利的生态后果出现的可能性进行的评估。美国环保局(ＥＰＡ)把这种尚不为人们所重视的领域叫做生态风险评估[20,48]。随着新技术和新方法的应用,ＥＲＡ的研究领域迅速扩展。早期的生态风险评估主要是针对人类健康而言的,也就是人类健康风险…     

Conducting Ecological Risk Assessments of Inorganic Metals and Metalloids: Current Status

Ecological risk assessment (ERA) of inorganic metals and metalloids (metals) must be specific to these substances and cannot be generic because most metals are naturally occurring, some are essential, speciation affects bioavailability, and bioavailability is determined by both external environmental conditions and organism physiological/biological characteristics. Key information required for ERA of metals includes: emissions, pathways, and movements in the environment (Do metals accumulate in biota above background concentrations?); the relationship between internal dose and/or external concentration (Are these metals bioreactive?); and the incidence and severity of any effects (Are bioreactive metals likely to result in adverse or, in the case of essential metals, beneficial effects?) — ground-truthed in contaminated areas by field observations. Specific requirements for metals ERA are delineated for each ERA component (Hazard Identification, Exposure Analysis, Effects Analysis, Risk Characterization), updating Chapman and Wang (2000). In addition, key specific information required for ERA is delineated by major information category (conceptual diagrams, bioavailability, predicted environmental concentration [PEC], predicted no effect concentration [PNEC], tolerance, application [uncertainty] factors, risk characterization) relative to three different tiered, iterative levels of ERA: Problem Formulation, Screening Level ERA (SLERA), and Detailed Level ERA (DLERA). Although data gaps remain, a great deal of progress has been made in the last three years, forming the basis for substantial improvements to ERA for metals.     

An Ecological Risk Assessment of Inorganic Chloramines in Surface Water

Inorganic chloramines are formed when chlorine and ammonia are combined in water. These substances are frequently used as a secondary disinfectant for drinking water and are by-products of processes involving the disinfection of wastewaters and the control of biological fouling in cooling water systems. For chloraminate drinking water, the total residual chlorine (TRC) concentration may be almost completely due to monochloramine. Based on 1995 and 1996 survey data, the most significant and prevalent TRC loading to the Canadian environment is from municipal wastewater releases. Drinking water releases are the next most important source of chloramine entry into the Canadian environment, while TRC releases from other sources, such as cooling water, zebra mussel control practices and industrial wastewater, are much less important. A probabilistic water quality model was used to model two wastewater discharges and a cooling water discharge to different freshwater systems. The resulting exposure distributions were then compared with three incipient lethality endpoints, i.e., 50% mortality to the invertebrate Ceriodaphnia dubia and 50% and 20% mortality to juvenile chinook salmon (Oncorhynchus tshawytscha). For each discharge scenario studied, there were moderate to high probabilities of significant adverse effects on aquatic life up to 1.9?km from the effluent sources.     

An Ecological Risk Assessment of Formaldehyde

A multi-tiered environmental risk assessment of formaldehyde determined the possibility of harmful effects on organisms in certain environmental compartments in Canada. A review of the relevant information indicates that biota are exposed to formaldehyde primarily in air and, to a lesser extent, in water. Worst-case scenarios predict that the estimated exposure values likely to be encountered in Canada for water and air are not expected to exceed estimated no-effects values. Therefore, the environmental risks associated with concentrations of formaldehyde likely to be found in Canada are low.     

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.