Genomics: Applications,Challenges, and Opportunities for the U.S. Environmental Protection Agency

Genomics information has great potential to enhance assessment of risks to human health and the environment. Although understanding genomic responses with respect to adverse ecological and human health outcomes is not, as yet, established, it is important to consider the likely future impacts of genomics technologies on risk assessment and decision-making. Four areas are identified as those likely to be influenced by the generation of genomics information within, and the submission of such information to, the U.S. Environmental Protection Agency (USEPA): risk assessment, prioritization of contaminants and contaminated sites, monitoring, and reporting provisions. For each of these risk assessment and regulatory applications, representative activities are presented to illustrate the application. Three major challenges for the USEPA associated with genomics are also identified in the areas of research, technical development, and capacity. The USEPA's initial activities to address these challenges are discussed. The Agency recognizes it must be prepared to use genomics information, and that many scientific, policy, ethical, and legal concerns will need to be addressed. The USEPA also recognizes it is essential to continue to collaborate with other federal agencies, academia, the regulated community, and other stakeholders in order to benefit from ongoing advances in genomics in the wider scientific and regulatory communities.     

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。     

Integrated Risk Assessment — Results from an International Workshop

The World Health Organization's International Programme on Chemical Safety and international partners have developed a framework for integrated assessment of human health and ecological risks and four case studies. An international workshop was convened to consider how ecological and health risk assessments might be integrated, the benefits of and obstacles to integration, and the research and mechanisms needed to facilitate implementation of integrated risk assessment. Using the case studies, workshop participants identified a number of opportunities to integrate the assessment process. Improved assessment quality, efficiency, and predictive capability were considered to be principal benefits of integration. Obstacles to acceptance and implementation of integrated risk assessment included the disciplinary and organizational barriers between ecological and health disciplines. A variety of mechanisms were offered to overcome these obstacles. Research recommendations included harmonization of exposure characterization and surveillance methods and models, development of common risk endpoints across taxa, improved understanding of mechanisms of effect at multiple scales of biological organization, and development of methods to facilitate comparison of risks among endpoints.     

光和噪声污染胁迫下城市生态斑块鸟类风险评价

为应对城市生态斑块光污染、噪声污染范围快速扩张和强度增加对鸟类带来的生态风险,探讨了将微观鸟类风险阈值与宏观光污染、噪声污染分布数据结合进行生态风险评价的全链条研究方法,具体包括：探究微观层面光、声污染胁迫下鸟类生态风险阈值,分别获得光污染对黄雀和栗鹀寤寐节律及声污染对画眉鸟退避行为的生态风险阈值,并提出由实验室环境中获得的鸟类光污染强度风险阈值推算室外夜间混合光环境中鸟类光污染强度风险阈值的方法;同时获取宏观光、声环境分布数据,其中光环境分布数据基于Luojia 1-01和Jilin 1-7B夜光遥感影像获得,声环境分布数据通过软件模拟、实测校核、ArcGIS属性赋予等系列操作获得;结合微观鸟类风险阈值和宏观光、声环境分布数据开展生态风险评价,以典型城市生态斑块为实例分析光污染和噪声污染胁迫下鸟类生态风险分布特征;搭建生态风险评价平台并进行鸟类生态风险可视化展现。该生态风险评价方法可为城市宏观区域光、声污染生态风险的快速评价提供科学规范的研究和技术范例。     

Risk-Based Approaches to Managing Contaminants in Catchments

Risk-based methods promise improved decision-making for managing of contaminants, such as salinity, sediments, nutrients, and toxicants, that can adversely affect the ecological condition of aquatic ecosystems. Two aspects of ecological risk assessment (ERA) and management—stakeholder involvement and more quantitative approaches to risk analysis—are particularly challenging. Stakeholder involvement is crucial both in the risk assessment process and the development, acceptance, and implementation of a risk management plan. Additionally, a number of quantitative approaches (particularly Bayesian approaches and multi-criteria decision-making) have been identified as having the potential to include expert-based inputs into risk-based decision-making. These offer promise for better inclusion of stakeholder knowledge and preferences into the decision-making process, and for improving the links between stakeholder inputs and potential risks to the ecological condition of the system. A major challenge for ecologists and natural resource managers is to make the ERA process more quantitative. Most ERAs conducted to date have been qualitative assessments that suffer from a number of deficiencies, the most serious being the lack of transparency and a reliance on subjective judgments. This article argues that the most productive way forward may be to use Bayesian methods to couple existing process-based models, empirical relationships based on good data, and expert opinion, to make the analysis of ecological risks more robust, consistent, and repeatable.     

Harmonization: Developing Consistent Guidelines for Applying Mode of Action and Dosimetry Information to Cancer and Noncancer Risk Assessment

The 1983 book, Risk Assessment in the Federal Government: Managing the Process, recommended developing consistent inference guidelines for cancer risk assessment. Over the last 15 years, extensive guidance have been provided for hazard assessment for cancer and other endpoints. However, as noted in several recent reports, much less progress has occurred in developing consistent guidelines for quantitative dose response assessment methodologies. This paper proposes an approach for dose response assessment guided by consideration of mode of action (pharmacodynamics) and tissue dosimetry (pharmacokinetics). As articulated here, this systematic process involves eight steps in which available information is integrated, leading first to quantitative analyses of dose response behaviors in the test species followed by quantitative analyses of relevant human exposures. The process should be equally appropriate for both cancer and noncancer endpoints. The eight steps describe the necessary procedures for incorporating mechanistic data and provide multiple options based upon the mode of action by which the chemical causes the toxicity. Given the range of issues involved in developing such a procedure, we have simply sketched the process, focusing on major approaches for using toxicological data and on major options; many details remain to be filled in. However, consistent with the revised carcinogen risk assessment guidance (USEPA, 1996c), we propose a process that would ultimately utilize biologically based or chemical specific pharmacokinetic and pharmacodynamic models as the backbone of these analyses. In the nearer term, these approaches will be combined with analysis of data using more empirical models including options intended for use in the absence of detailed information. A major emphasis in developing any harmonized process is distinguishing policy decisions from those decisions that are affected by the quality and quantity of toxicological data. Identification of data limitations also identifies areas where further study should reduce uncertainty in the final risk evaluations. A flexible dose response assessment procedure is needed to insure that sound toxicological study results are appropriately used to influence risk management decision-making and to encourage the conduct of toxicological studies oriented toward application for dose response assessments.     

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.     

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.     

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.     

高潜水位煤矿区生态风险识别与评价

生态风险评价是生态环境保护与管理的重要研究内容,并广泛运用于流域与较大范围的区域尺度的研究。以区域生态风险评价理论为基础,结合高潜水位煤矿区生态环境以及煤炭开采对生态系统造成的危害的特点,通过分析风险源、风险受体、生态终点以及暴露—响应过程,对高潜水位煤矿区生态风险的识别与评价方法进行了研究,构建了典型高潜水位煤矿区的生态风险识别与评价概念模型与空间分析框架,分析了煤矿区生态风险识别的主要技术手段与方法,并构建了以缓冲为主要手段的综合生态风险评价方法。选择山东东滩煤矿作为研究对象,针对研究区内存在的采煤塌陷、洪涝、污染、景观及社会等生态风险类型,定量评价其空间差异,并提出相应的风险防范措施。案例分析结果表明,研究区综合生态风险重度、中度、一般、轻度分别占到研究区的4.70%,64.00%,24.09%,7.20%。生态风险较高的区域主要位于矿区中西部,为煤矸石山、裸露煤炭堆积与发电厂分布区域;中度风险是研究区主要的风险类型。从降低生态风险保障矿区生态安全角度,在未来矿区规划与生态治理过程中,提出了具体的应对措施,包括:(1)注重源头控制;(2)建立高生态风险区域阻隔带;(3)加强污染的监测与控制;(4)采用边开采边治理技术。建议加强生态风险高区域的阻隔,建立生态缓冲带,减缓对整个矿区的综合影响,构建东滩煤矿生态风险防范的空间结构。     

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.     

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。     

An Evaluation of Risk Drivers from a Sample of Risk Assessments Conducted for the U.S. Army

We evaluate risk drivers at selected U.S. Army installations by developing a database containing contaminant-pathway-receptor combinations that exceed regulatory thresholds for ecological (toxicity quotient greater than one), human health cancer risk (predicted incremental lifetime cancer risk greater than one in ten thousand), and noncancer human health (hazard index greater than one). We compare the risk drivers from the database to reported corrective action objectives from available decision documents. For noncancer hazards, explosives (particularly in ground water) dominate the reported exceedances of regulatory thresholds in the database. PAHs in home-grown produce show the highest number of exceedances of regulatory thresholds for cancer risk. For ecological risks, PAHs in both terrestrial and aquatic environments dominate the exceedances of regulatory thresholds. All available cleanup levels were derived based on human health exposures rather than ecological exposures, except for one site. In general, ecological risks were considered to be “more uncertain,” and that was used as a basis for not relying on backcalculated target levels on the basis of ecological risk. The reverse was true for human health risks: the “conservative” assumptions incorporated into the modeling provided the justification for backcalculating health-protective target levels.     

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     

Hormesis and ecological risk assessment: Fact or fantasy?

Hormesis is a widespread phenomenon across occurring many taxa and chemicals, and, at the single species level, issues regarding the application of hormesis to human health and ecological risk assessment are similar. However, interpreting the significance of hormesis for even a single species in an ecological risk assessment can be complicated by competition with other species, predation effects, etc. In addition, ecological risk assessments may involve communities of hundreds or thousands of species as well as a range of ecological processes. Applying hormetic adjustments to threshold effect levels for chemicals derived from sensitivity distributions for a large number of species is impractical. For ecological risks, chemical stressors are frequently of lessor concern than physical stressors (e.g., habitat alteration) or biological stressors (e.g., introduced species), but the relevance of hormesis to non‐chemical stressors is unclear. Although ecological theories such as the intermediate disturbance hypothesis offer some intriguing similarities between chemical hormesis and hormetic‐like responses resulting from physical disturbances, mechanistic explanations are lacking. While further exploration of the relevance of hormesis to ecological risk assessment is desirable, it is unlikely that hormesis is a critical factor in most ecological risk assessments, given the magnitude of other uncertainties inherent in the process.     

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.     

Ecological Risk Assessment of Organochlorine Pesticides in Surface Waters of Lake Taihu,China

The residues of organochlorine pesticides (OCPs) in surface waters from Meiliang Bay, Gonghu Bay, and Xukou Bay of Lake Taihu, China, were investigated, and their ecological risks were assessed using the risk quotient method and probabilistic risk assessment. Environmental concentrations of OCPs in surface water of these bays were relatively lower compared with other rivers or lakes in China. Calculation of risk quotient associated with taxonomic groups indicates moderate ecological risks from OCPs for crustaceans and insects in these bays, while the ecological risks were low for fish and negligible for phytoplankton. The ecological risk quotients associated with individual OCPs were lower than 0.01 in these bays, suggesting a negligible risk to aquatic organisms. Ecological risk from α-HCH was relatively lower compared with DDTs, endosulfans, and γ-HCH. The combined ecological risks were evaluated using probabilistic risk assessment for only eight OCPs owing to a lack of available toxicity data for β-HCH and δ-HCH. The percentage of species with the potential to be at risk from mixture of OCPs was lower than the criteria of 5% in each bay, indicating that the combined ecological risks were acceptable.     

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.     

城市化的生态风险及其管理

城市化体现在人口向城市聚集和城市景观扩张的同时,社会结构发生了极大变化,城市生产生活方式向更加广泛的地区扩散。然而,随着人口的过度密集和城市的日益扩张,交通拥堵、空气污染、废物堆积、流行病肆虐等"城市病"频发。城市通过大量汲取和消耗自然资源,向周围环境排放大量污染物,改变了区域生态系统的原有结构和功能,产生了严峻的生态风险,进而制约着城市生态系统的可持续发展。城市化的生态风险正逐步得到广泛关注,但对其具体的内涵和影响尚不明晰。归类描述了城市化过程中面临的各种生态风险,分析了导致生态风险的主要因素,阐述了辨识与评价生态风险的基本方法,提出了城市化生态风险的调控管理对策。