Environmental Risk Management Decision-Making in a Societal Context

Recent studies point to the need for improved understanding of environmental management frameworks designed to combine qualitative public and quantitative technical inputs in decision-making processes. Flux in public perception and concern about risks imply frameworks must be iterative in nature and incorporate a variety of assessment triggers in the form of decision points. A conceptual model is proposed here to explain the de facto operation of standard risk analytic frameworks within the broader sociopolitical milieu of public policy. The model is presented as a decision flow diagram that emphasizes setting environmental management goals based on societal input and the formulation of decision criteria for selecting management actions to achieve those goals. Prospective and retrospective decision control points operate to select management options that, respectively, avoid or reduce actual or predicted effects. Feedback loops that modify risk management outcomes are identified. Technical and scientific inputs (i.e., risk analysis) are assigned an essential information role within the framework and are responsible for informing the management process with the results of appropriately conducted and reviewed investigations. The proposed model is intended primarily to indicate how environmental risk management decision-making and associated technical assessments may be influenced by social pressures. It is hoped this understanding will lead to analytical transparency and better public communication of the environmental implications of policy options.     

美国、加拿大环境和健康风险管理方法

对目前美国和加拿大多个部门使用的风险评价与风险管理方法进行了全面回顾和综合分析,论述各种不同方法的特征,深入探讨各种管理方法的基础、利弊、使用经验,辨识环境、人类健康和职业健康风险综合方法中应该包含的要素,阐述风险管理目标的确定方法,以期为中国的环境风险管理提供经验。     

水生动物进口风险评估综述

随着全球水产养殖业的发展,水产动物活体或水产品贸易日益频繁,不可避免地给进口国带来病原风险,造成疾病引入和传播,甚至生物入侵,严重危害水产养殖业的发展。水生动物进口风险评估(IRA),是指从别国或地区进口水生动物活体包括其受精卵、稚鱼、幼鱼、苗种、成体以及商品等的风险分析。风险分析是指对风险事件进行科学、透明、系统分析的一个过程,它由危害识别、风险评估、风险交流和风险管理4个部分构成。目前,常用的风险评估方法有定性风险评估、半定量风险评估和定量风险评估3种。定性风险评估具有灵活性强、适用范围广、易掌握的特点,能够综合各种资料、数据和信息,尤其适合初次风险评估,但容易受评估人员主观因素的影响。定量风险评估可避免主观因素的影响,评估结果准确、可靠,但需要收集大量数据,工作量巨大,评估成本也很高。通常,定性评估结果若能够提供很好的防范措施,则不必进行定量评估。将外来水生病原阻止在引进之初远比引入后根除更加容易。因此,开展水生动物进口风险评估对于阻止水生动物疾病传播和水生态环境破坏具有重要意义,同时也可为各国进行水产贸易提供参考。     

The Concept of Data Utility in Health Risk Assessment: A Multi-Disciplinary Perspective

Human and ecological health risk assessments and the decisions that stem from them require the acquisition and analysis of data. In agencies that are responsible for health risk decision-making, data (and/or opinions/judgments) are obtained from sources such as scientific literature, analytical and process measurements, expert elicitation, inspection findings, and public and private research institutions. Although the particulars of conducting health risk assessments of given disciplines may be dramatically different, a common concern is the subjective nature of judging data utility. Often risk assessors are limited to available data that may not be completely appropriate to address the question being asked. Data utility refers to the ability of available data to support a risk-based decision for a particular risk assessment. This article familiarizes the audience with the concept of data utility and is intended to raise the awareness of data collectors (e.g., researchers), risk assessors, and risk managers to data utility issues in health risk assessments so data collection and use will be improved. In order to emphasize the cross-cutting nature of data utility, the discussion has not been organized into a classical partitioning of risk assessment concerns as being either human health- or ecological health-oriented, as per the U.S. Environmental Protection Agency's Superfund Program.     

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.     

Types of Integration in Risk Assessment and Management,And Why They Are Needed

Risk-based decision making requires that the decision makers and stakeholders are informed of all risks that are potentially significant and relevant to the decision. The International Programme on Chemical Safety of the World Health Organization has developed a framework for integrating the assessment of human health and ecological risks. However, other types of integration are needed to support particular environmental decisions. They are integration of exposure and effects, of multiple chemicals and other hazardous agents, of multiple routes of exposure, of multiple endpoints, multiple receptors, multiple spatial and temporal scales, a product's life cycle, management alternatives, and socioeconomics with risk assessment. Inclusion of all these factors in an integrated assessment could lead to paralysis by analysis. Therefore, it is important that assessors be cognizant of the decision process and that decision makers and those who will influence the decision (stakeholders) be involved in planning the assessment to ensure that the degree of integration is necessary and sufficient.     

Is There a Role for Risk Assessment within Precautionary Legislation?

Posing the question of whether the precautionary principle has a role in risk assessment effectively constrains any debate of the issue within a framework predicated on the assumption that application of risk assessment is inevitable in the formulation of regulatory decisions. The question can equally validly be expressed in terms of whether there is a role for risk assessment in the formulation of precautionary legislation. This allows the debate then to turn on consideration of two questions: Firstly, does the precautionary principle have a role in policy development? and secondly, is this role consistent and compatible with a risk based approach to regulation? When recast in these terms, a more holistic comparison of the aims and objectives of both approaches and of their relative power in the formulation of regulation becomes possible. This leads to the conclusion that the precautionary principle is, when defined and applied correctly, scientifically more robust than risk assessment. Precautionary approaches utilize scientific information and conform robustly to a scientific process but also explicitly incorporate indeterminacies into the decision making framework. Moreover, the precautionary principle when applied to environmental regulation, is more likely to lead to regulation consistent with global sustainability. On this premise, this paper argues that risk based approaches are essentially incompatible with approaches based on the precautionary paradigm, and that of the two, risk assessment is more likely to lead to unsustainable underprotection of the environment.     

Risk Assessment in Navy Deployment Toxicology

The risk assessment process is a critical function for deployment toxicology research. It is essential to the decision making process related to establishing risk reduction procedures and for formulating appropriate exposure levels to protect naval personnel from potentially hazardous chemicals in the military that could result in a reduction in readiness operations. These decisions must be based on quality data from well-planned laboratory animal studies that guide the judgements, which result in effective risk characterization and risk management. The process of risk assessment in deployment toxicology essentially uses the same principles as civilian risk assessment, but adds activities essential to the military mission, including intended and unintended exposure to chemicals and chemical mixtures. Risk assessment and Navy deployment toxicology data are integrated into a systematic and well-planned approach to the organization of scientific information. The purpose of this paper is to outline the analytical framework used to develop strategies to protect the health of deployed Navy forces.     

Abuse of hypothesis testing statistics in ecological risk assessment

Statistical hypothesis testing is commonly used inappropriately to analyze data, determine causality, and make decisions about significance in ecological risk assessment. Hypothesis testing is conceptually inappropriate in that it is designed to test scientific hypotheses rather than to estimate risks. It is inappropriate for analysis of field studies because it requires replication and random assignment of treatments. It discourages good toxicity testing and field studies, it provides less protection to ecosystems or their components that are difficult to sample or replicate, and it provides less protection when more treatments or responses are used. It provides a poor basis for decision‐making because it does not generate a conclusion of no effect, it does not indicate the nature or magnitude of effects, it does not address effects at untested exposure levels, and it confounds effects and uncertainty. Attempts to make hypothesis testing less problematical cannot solve these problems. Rather, risk assessors should focus on analyzing the relationship between exposure and effects, on presenting a clear estimate of expected or observed effects and associated uncertainties, and on providing the information in a manner that is useful to decision‐makers and the public.     

Incorporating Science,Technology, Fairness,and Accountability in Environmental,Health, and Safety Decisions

The Precautionary Principle is in sharp political focus today because (1) the nature of scientific uncertainty is changing and (2) there is increasing pressure to base governmental action on more “rational” schemes, such as cost-benefit analysis and quantitative risk assessment, the former being an embodiment of ‘rational choice theory’ promoted by the Chicago school of law and economics. The Precautionary Principle has been criticized as being both too vague and too arbitrary to form a basis for rational decision making. The assumption underlying this criticism is that any scheme not based on cost-benefit analysis and risk assessment is both irrational and without secure foundation in either science or economics. This paper contests that view and makes explicit the rational tenets of the Precautionary Principle within an analytical framework as rigorous as uncertainties permit, and one that mirrors democratic values embodied in regulatory, compensatory, and common law. Unlike other formulations that reject risk assessment, this paper argues that risk assessment can be used within the formalism of tradeoff analysis—a more appropriate alternative to traditional cost-benefit analysis and one that satisfies the need for well-grounded public policy decision making. This paper will argue that the precautionary approach is the most appropriate basis for policy, even when large uncertainties do not exist, especially where the fairness of the distributions of costs and benefits of hazardous activities and products are a concern. Furthermore, it will offer an approach to making decisions within an analytic framework, based on equity and justice, to replace the economic paradigm of utilitarian cost-benefit analysis.     

Ecological Risk Assessment and the Precautionary Principle

The Precautionary Principle, generated during the late 1980s as a unifying principle for regulating discharge of hazardous material into the North Sea, has been broadened to include a shifting of the burden of proof to the proponent of a proposed activity, adoption of a more holistic assessment process, and encompassing all environmental management decisions, not just pollution prevention activities. We argue that the Precautionary Principle remains a management philosophy, not a substitute for risk assessment. Risk assessment is a tool for organizing information used in environmental management decisions. However, increasing attention to reducing the Type II error of risk assessment studies would significantly reduce the skepticism with which many view the risk assessment process. A critical review of default assumptions used in risk assessments, inclusion of indirect effects within an ecologically relevant spatial/temporal framework, and better communication between risk assessors and risk managers also would enhance the acceptability of the process. Risk assessment can provide a sound basis for management decisions regardless of the underlying philosophies of environmental conservation or utilitarianism, but only if the inherent biases in the risk assessment assumptions are acknowledged explicitly throughout the assessment and management processes.     

Plan for an Integrated Human and Environmental Risk Assessment in the S. Domingos Mine Area (Portugal)

The need for the integration of the assessment of human and ecological risks in contaminated areas, such as derelict mines, widely increases. The risk assessment process is becoming a powerful tool to provide sound scientific bases for decision-making processes. In Portugal, the risk assessment process is in its early years and the lack of multidisciplinary teams of experts is frequently mentioned as the main obstacle to its implementation. Therefore, the majority of the reclamation actions are based on impact assessment studies that usually are characterized by few biological and toxicological considerations. In order to account for some of these constraints, the ecological risk assessment framework proposed by the U.S. Environmental Protection Agency was used to plan the assessment of human and ecological risks posed by the high concentrations of metals scattered in the vicinity of S. Domingos mine, a cuprous pyrite mine located in the Southeast Alentejo (Portugal). This study presents the problem formulation phase of the assessment. It includes all the scientific information available for the area, a conceptual model, and an analysis plan for the risk assessment process. Following a tiered approach, several tasks were planned in order to acquire chemical, toxicological, and ecological information, in order to compensate for the lack of toxicity data for site-specific species.     

Applicability of indicator monitoring to ecological risk assessment

Although ecological risk assessment (ERA) and environmental monitoring would seem to be potentially complimentary activities, they have been disjunct in practice. This is because of differences in goals and products. Environmental monitoring determines status and trends in indicators to determine whether the environment is improving. ERA estimates effects of stressors on endpoint attributes to support decision making. Indicators are, by definition, indicative of some unmeasured condition. Assessment endpoints are valued properties of the environment that are susceptible to stressors of concern. Indicators are justified by the logic of the monitoring program, which may be self-referential. Assessment endpoints are justified by their potential susceptibility and by environmental policies and public values. Indicators are often expressed in terms of indices or scores that obscure the actual condition of the environment. Because assessment endpoints must be clear to decision makers and the public, they require real units of actual environmental properties. Monitoring programs are peripherally concerned about causal relationships, while risk assessment is devoted to elucidating causal relationships. As a result, risk assessments may use the results of monitoring studies, but only after disaggregating the indicators to their components and choosing those that are appropriate. Monitoring programs could be more useful if they used a risk-based approach to address important problems rather than simply tracking indicators.     

Probabilistic Environmental Risk Assessment for Dibutylphthalate (DBP)

In the risk assessment methods for new and existing chemicals in the European Union (EU), environmental “risk” is characterized by the deterministic quotient of exposure and effects (PEC/PNEC). From a scientific viewpoint, the uncertainty in the risk quotient should be accounted for explicitly in the decision making, which can be done in a probabilistic risk framework. To demonstrate the feasibility and benefits of such a framework, a sample risk assessment for an existing chemical (dibutylphthalate, DBP) is presented in this paper. The example shows a probabilistic framework to be feasible with relatively little extra effort; such a framework also provides more relevant information. The deterministic risk quotients turned out to be worst cases at generally higher than the 95th percentile of the probability distributions. Sensitivity analysis proves to be a powerful tool in identifying the main sources of uncertainty and thus will be effective for efficient further testing. The distributions assigned to the assess ment factors (derivation of the PNEC) dominate the total uncertainty in the risk assessment; uncertainties in the release estimates come second. Large uncertainties are an inherent part of risk assessment that we have to deal with quantitatively. However, the most appropriate way to characterise effects and risks requires further attention. Recommendations for further study are identified.     

Genotoxicity risk assessment: a proposed classification strategy

Recent advances in genetic toxicity (mutagenicity) testing methods and in approaches to performing risk assessment are prompting a renewed effort to harmonize genotoxicity risk assessment across the world. The US Environmental Protection Agency (EPA) first published Guidelines for Mutagenicity Risk Assessment in 1986 that focused mainly on transmissible germ cell genetic risk. Somatic cell genetic risk has also been a risk consideration, usually in support of carcinogenicity assessments. EPA and other international regulatory bodies have published mutagenicity testing requirements for agents (pesticides, pharmaceuticals, etc.) to generate data for use in genotoxicity risk assessments. The scheme that follows provides a proposed harmonization approach in which genotoxicity assessments are fully developed within the risk assessment paradigm used by EPA, and sets out a process that integrates newer thinking in testing battery design with the risk assessment process. A classification strategy for agents based on inherent genotoxicity, dose-responses observed in the data, and an exposure analysis is proposed. The classification leads to an initial level of concern for genotoxic risk to humans. A total risk characterization is performed using all relevant toxicity data and a comprehensive exposure evaluation in association with the genotoxicity data. The result of this characterization is ultimately used to generate a final level of concern for genotoxic risk to humans. The final level of concern and characterized genotoxicity risk assessment are communicated to decision makers for possible regulatory action(s) and to the public.     

转基因植物环境安全评价策略

构建完善的转基因植物环境安全评价技术体系是保障转基因生物产业健康发展的重要组成部分。本文综述了转基因植物环境安全评价技术发展历程与趋势,归纳了转基因植物环境安全评价的思路与内容。转基因植物环境安全评价应分为潜在风险分析、风险假设验证、风险特征描述等3个步骤,并采用逐层评价模式;安全评价应贯穿转基因植物新品种研发与产业化全程,包括应用前预测、研发中筛选、推广前评价、推广后监测。此外,基于科学性和个案分析原则,本文对复合性状、非生物胁迫抗性等新型转基因植物环境安全评价策略进行了探讨。     

Comparison of Approaches for Developing Distributions for Carcinogenic Slope Factors

In recent years, risk assessors have increasingly been moving away from deterministic risk assessment approaches and are applying probabilistic approaches that incorporate distributions of possible values for each input parameter. This paper reviews several approaches that are being used or that could potentially be used to develop distributions for carcinogenic slope factors (CSFs). Based on the primary tool or framework that is applied, these approaches have been divided into the following three categories: the statistical framework, the decision analysis framework, and the biological framework. Work that has been done on each approach is summarized, and the aspects of variability and uncertainty that are incorporated into each approach are examined. The implications of the resulting distributional information for calculating risk estimates or risk-based concentrations is explored. The approaches differ in their stage of development, the degree to which they diverge from the U.S. Environmental Protection Agency's (EPA) current practice in establishing CSF values, their flexibility to accommodate varying data sets or theories of carcinogenicity, and their complexity of application. In some cases, wide ranges of potential potency estimates are indicated by these approaches. Such findings suggest widely divergent risk assessment implications and the need for additional evaluation of the goals of developing CSF distributions for use in risk assessment applications and the types of information that should be reflected in such distributions. Some combination of the features offered by these approaches may best support risk assessment and risk management decisions.     

Are all risk perceptions created equal? Comparing general risk assessments and specific risk assessments associated with climate change

For policy-making to address public risk perceptions effectively, policy-makers must have a clear understanding of the nature of public risks. Public opinion polls regularly solicit perceptions of risk toward a variety of topics. These assessments, though, tend to be general with no specificity offered for a nuanced interpretation. Yet, there is good reason to assume that risk perceptions are not based on the same criteria. If true, policy-makers may be unable to address risks adequately without a better understanding of the drivers of risk perceptions. This project focuses on two primary research questions: (1) Does the public weigh the risk associated with global climate change differently in specific sub-domains? (2) If so, which climate change sub-domains are various members of the public most concerned about when offering a general assessment of global climate change risk? We assess public risk perceptions of climate change in three sub-domains—public health, economic development, and environment—and find that two of the three sub-domains are predictors of a general assessment of risk.     

A HIVE model for regional integrated environmental risk assessment: A case study in China

Regional environmental risk assessment has been a significant means of environmental management and decision-making. To assess the regional integrated environmental risk at a nationwide scale, a new index system named the Hazard, Intensity, Vulnerability, and Effectiveness (HIVE) model was designed and evolved from previous researches. The HIVE model consisted of a relatively complete framework with accessible indexes related to environment and social economy, and it considered different risk sources, pathways, and receptors as well as the influence of the risk control. As an important segment of the assessment process, a simple gridding information diffusion method was also proposed to assess the diffusion effect of risk factors in nationwide rivers. Taking China as a case study, this study calculated the environmental risk value of every sub-unit. Through the clustering function of Statistical Package for Social Sciences and the visual representation of a geographic information system, the study area was divided into nine zones that were visualized on maps according to their different risk levels and risk characteristics. This study also identified the dominant factors of each zone, which could provide the foundation for regional environmental management. Moreover, the results implied some significant correlations between risk system components and the regional social economy in China.     

Incorporating Information on Bioavailability of Soil-Borne Chemicals into Human Health Risk Assessments

Definition of the term bioavailability varies in the environmental sciences. In human health risk assessment, bioavailability is defined as the fraction of the dose of chemical delivered that is absorbed into the systemic circulation. Bioavailability can be expressed as either absolute or relative bioavailability, and both are important in calculating risks from contaminants in soils. Bioavailability of chemicals is addressed in all risk assessments, although not always in a transparent manner. Because data on bioavailability are limited, approximations and assumptions regarding chemical uptake are extensively used. The risk assessment process could benefit from new information on the bioavailability of chemicals, but there are important questions about the best means to develop this information and how it should be used. To foster discussion on these issues, three articles are presented in this issue of the journal offering different perspectives on bioavailability method development, validation, and use.