Challenges for Risk Assessors

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

外来有害生物风险评估方法研究进展

外来有害生物给生态环境、农业生产、人类健康带来的影响和造成的经济损失越来越受到人们的关注。与此同时,对外来有害生物风险评估方法的研究及其应用也在逐步深入。通过对多指标综合评估法、农业气候相似距法、地理信息系统、生态气候模型评价、模糊综合评判等方法的分析,概述了外来有害生物风险评估方法的含义和利弊,探讨了不同外来物种在不同环境条件下的适生性,综述了国内外评估方法应用的研究进展,对该研究领域的发展趋势进行了展望。     

Risk management decisions for pesticides and threatened and endangered species: The role of uncertainty analysis

Despite data gaps and information shortfalls, government agencies in the United States are expected to produce timely and defensible decisions to regulate pesticide use under the Federal Insecticide, Fungicide, and Rodenticide Act and in compliance with the Endangered Species Act. The decision to register a pesticide is predicated on a conclusion that no unreasonable effects will accrue to the environment, including threatened and endangered species. We recognize that the definition of acceptable risk is a policy judgment stemming from legislative language and judicial interpretation. However, a common risk assessment approach with similar technical underpinnings and a high degree of transparency used by all the agencies would be cost effective and more likely to achieve consensus among interested parties. Quantitative probabilistic risk assessment (PRA) methods can be used to develop risk estimates and to describe the level of confidence in these estimates. PRA methods can also differentiate among the contributions of natural stochasticity, measurement variability, and lack of knowledge. Because this approach enhances transparency and increases understanding of the implications of limited data sets and associated assumptions, we encourage the appropriate agencies to implement PRA methods as a means of reaching common ground when assessing risks of pesticides to listed species.     

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

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

Trends in Risk Assessment of Chemicals in the European Union

Current legislation in the European Union (EU) requires a risk assessment for industrial chemicals. The underlying procedures and paradigms of such EU risk assessment for new and existing chemicals are explained. The risk assessment is performed according to a harmonised methodology, laid down in the Technical Guidance Documents (TGD). Important new, technical risk assessment aspects covered in a recent revision round of the TGD are highlighted. The most prominent change in the environmental TGD part is the addition of the marine risk assessment, including a Persistent Bioaccumulation and Toxicity (PBT) assessment. In the human health part a significant change is the new data requirement for reproductive toxicity. The performance of both the risk assessment and the risk reduction phase of EU existing chemicals have been evaluated. An important conclusion was that our a priori knowledge on possible risks of chemicals is poor. The European Commission has recently launched a proposal (REACH) for drastically changing the risk management process of industrial chemicals in the EU. Major changes are a shift in responsibility from authorities to industry (including downstream users) for the safe use of chemicals, an acceleration of data collection for ‘non-assessed’ chemicals, and an authorization step for substances of very high concern.     

Downscaling Pest Risk Analyses: Identifying Current and Future Potentially Suitable Habitats for Parthenium hysterophorus with Particular Reference to Europe and North Africa

Pest Risk Assessments (PRAs) routinely employ climatic niche models to identify endangered areas. Typically, these models consider only climatic factors, ignoring the ‘Swiss Cheese’ nature of species ranges due to the interplay of climatic and habitat factors. As part of a PRA conducted for the European and Mediterranean Plant Protection Organization, we developed a climatic niche model for Parthenium hysterophorus, explicitly including the effects of irrigation where it was known to be practiced. We then downscaled the climatic risk model using two different methods to identify the suitable habitat types: expert opinion (following the EPPO PRA guidelines) and inferred from the global spatial distribution. The PRA revealed a substantial risk to the EPPO region and Central and Western Africa, highlighting the desirability of avoiding an invasion by P. hysterophorus. We also consider the effects of climate change on the modelled risks. The climate change scenario indicated the risk of substantial further spread of P. hysterophorus in temperate northern hemisphere regions (North America, Europe and the northern Middle East), and also high elevation equatorial regions (Western Brazil, Central Africa, and South East Asia) if minimum temperatures increase substantially. Downscaling the climate model using habitat factors resulted in substantial (approximately 22–53%) reductions in the areas estimated to be endangered. Applying expert assessments as to suitable habitat classes resulted in the greatest reduction in the estimated endangered area, whereas inferring suitable habitats factors from distribution data identified more land use classes and a larger endangered area. Despite some scaling issues with using a globally conformal Land Use Systems dataset, the inferential downscaling method shows promise as a routine addition to the PRA toolkit, as either a direct model component, or simply as a means of better informing an expert assessment of the suitable habitat types.     

《生物多样性公约》框架下合成生物学 谈判新进展及我国对策

合成生物学技术和产品因其广阔的应用前景和难以预知的生态风险, 受到各国的广泛关注。2014年10月在韩国平昌召开的《生物多样性公约》第十二次缔约方大会上, 合成生物学首次被作为正式议题进行讨论。本文梳理了《生物多样性公约》框架下合成生物学从提出到成为“新的与正在出现的议题”的过程, 分析了《生物多样性公约》在该议题上对缔约国的最新要求, 以及我国合成生物学技术发展和风险评估现状。当前我国合成生物学研究处于起步阶段,近年来的科研投入不断增大,但距离成熟的商业化仍有相当距离。我国对相关技术风险评估能力欠缺,且尚未明确负责其生物安全管理的主管部门。本文提出了以严控风险、适度鼓励研究开发和要求发达国家提供更多技术支持的谈判对策, 以及明确合成生物学安全风险管理的政府主管部门、通过技术开发以推动风险评估、构建国家合成生物学数据库和建立专业风险评估团队等履约建议。     

Environmental Risk Controllability and Management of VOCs during Remediation of Contaminated Sites

The environmental risk controllability assessment system and its method of controlling volatile organic compounds (VOCs) during remediation of contaminated sites are established in this article based on soil vapor extraction (SVE) technology. According to the properties of VOCs and the technical and operational characteristics of the site remediation process, the environmental risk controllability index system includes environmental risk identification, risk source analysis, and risk assessment. Environmental risk management during site remediation was focused on technical control methods and engineering control technologies. Specifically, acceptance based on risk management was suitable for low-risk levels such as RRI3 and RRI4. Furthermore, control methods for high-level risk (RRI1 or RRI2) could be developed along with transformation and control, combined with the necessary emergency risk plan.     

Life Cycle Perspectives to Achieve Business Benefits: From Concept to Technique

The purpose of this paper is to describe how one pollution prevention tool, life-cycle assessment, can be used to identify and manage environmental issues associated with product systems. Specifically, this paper will describe what life-cycle assessment is, determine the key players in its development and application, and present ideas on how life-cycle assessment can be used today. LCA provides a systematic means to broaden the perspective of a company's decisionmaking process to incorporate the consideration of energy and material use, transportation, post-customer use, and disposal, and the environmental releases associated with the product system. LCA provides a framework to achieve a better understanding of the trade-offs associated with specific change in a product, package, or process. This understanding lays the foundation for subsequent risk assessments and risk management efforts by decision-makers.     

Current Perspectives on Issues in Risk Assessment Methods

The Office of Research and Development (ORD) of the U.S. Environmental Protection Agency was reorganized in 1995 to follow the risk assessment paradigm developed by the National Research Council. With the reorganization, a number of different research strategies and plans were developed on problem-driven topics (e.g., arsenic, particulate matter, and microbial pathogens/disinfectant byproducts) as well as on core research (e.g., ecological research, human health risk assessment research, and pollution prevention research). The human health risk assessments research strategy, which is currently under development, addresses a variety of issues which affect all human health risk assessments. These include mechanism of action, variation in response, aggregate risk, and effect on public health. While all of the issues that have been identified are important, the challenge to ORD is to identify which will have the greatest impact on improving risk assessment so that resources can be most strategically applied.     

The Use of Epidemiology in Risk Assessment: Challenges and Opportunities

The assessment of risk from environmental and occupational exposures incorporates and synthesizes data from a variety of scientific disciplines including toxicology and epidemiology. Epidemiological data have offered valuable contributions to the identification of human health hazards, estimation of human exposures, quantification of the exposure–response relation, and characterization of risks to specific target populations including sensitive populations. As with any scientific discipline, there are some uncertainties inherent in these data; however, the best human health risk assessments utilize all available information, characterizing strengths and limitations as appropriate. Human health risk assessors evaluating environmental and occupational exposures have raised concerns about the validity of using epidemiological data for risk assessment due to actual or perceived study limitations. This article highlights three concerns commonly raised during the development of human health risk assessments of environmental and occupational exposures: (a) error in the measurement of exposure, (b) potential confounding, and (c) the interpretation of non-linear or non-monotonic exposure–response data. These issues are often the content of scientific disagreement and debate among the human health risk assessment community, and we explore how these concerns may be contextualized, addressed, and often ameliorated.     

Role of Ecological Modeling in Risk Assessment

Ecological models are useful tools for evaluating the ecological significance of observed or predicted effects of toxic chemicals on individual organisms. Current risk estimation approaches using hazard quotients for individual-level endpoints have limited utility for assessing risks at the population, ecosystem, and landscape levels, which are the most relevant indicators for environmental management. In this paper, we define different types of ecological models, summarize their input and output variables, and present examples of the role of some recommended models in chemical risk assessments. A variety of population and ecosystem models have been applied successfully to evaluate ecological risks, including population viability of endangered species, habitat fragmentation, and toxic chemical issues. In particular, population models are widely available, and their value in predicting dynamics of natural populations has been demonstrated. Although data are often limited on vital rates and doseresponse functions needed for ecological modeling, accurate prediction of ecological effects may not be needed for all assessments. Often, a comparative assessment of risk (e.g., relative to baseline or reference) is of primary interest. Ecological modeling is currently a valuable approach for addressing many chemical risk assessment issues, including screening-level evaluations.     

U.S. EPA Reference Dose/Reference Concentration Methodology: Update on a Review of the Process

The U.S. Environmental Protection Agency (USEPA) has been reviewing several approaches to testing and risk assessment related to implementation of the Food Quality Protection Act (FQPA) and the Amendments to the Safe Drinking Water Act (SDWA), both signed into law in 1996. Based on recommendations from a review of issues related to children's health protection under these laws, the USEPA established the RfD Technical Panel to evaluate in depth the current reference dose (RfD) and reference concentration (RfC) process in general, and in particular with respect to how well children and other potentially sensitive subpopulations are protected. The RfD Technical Panel also was asked to consider scientific issues that have become of greater concern in RfD and RfC derivation (e.g., neurotoxicity, immunotoxicity), and to raise issues that should be explored or developed further for application in the RfD/RfC process. This paper provides the current status of the activities of the RfD Technical Panel. The Technical Panel has recommended that acute, short- term, and intermediate reference values should be set for chemicals, where possible, and that these values should be incorporated into the USEPA's Integrated Risk Information System (IRIS) Database. A review of current testing procedures is underway, including the endpoints assessed, life stages covered by exposure and outcome evaluation, and information that can be derived from current protocols on various durations of exposure. Data gaps identified for risk assessment include the types of pharmacokinetic data that should be collected, especially for developmental toxicity studies, the impact of aging on toxic responses occurring after early exposure as well as concomitant with exposure in old age, and information available on latency to response. The implications of the RfD Technical Panel's recommendations for various uncertainty factors are also being explored.     

Low Risks,High Public Concern? The Cases of Persistent Organic Pollutants (POPs), Heavy Metals,and Nanotech Particles

Risk is an ancient, historic concept; almost everybody has some subjective understanding of what is meant by it. However, there are different types of knowledge, notions, interests, and processes involved both in science-based risk assessment and subjective risk perception. In the present article, we show how risk assessment and risk perception are intricately intertwined. This is exemplified by introducing the state-of-the-art risk assessments applied to three cases (i.e., heavy metals, POPs, and nanotech particles), each with their own unique history and degree of scientific understanding. We elaborate that, when dealing with risk, actors employ different notions (e.g., pure vs. speculative risk), processes (e.g., affective involvement in case) and relations (e.g., trust depending on benefiting from risk) depending on their knowledge, concern, and interests. Finally, we argue that it is important to combine studies on risk perception and risk assessment at an early stage of technology development. The issues and problems of public risk perception are discussed.     

区域生态风险评价的关键问题与展望

区域生态风险评价具有多风险因子、多风险受体、多评价终点、强调不确定性因素以及空间异质性的特点,它与传统的生态风险评价在风险源、胁迫因子和评价尺度上具有明显区别。尝试建立了一个基于陆地生态系统的区域生态风险评价框架,同时针对目前区域生态风险评价的研究现状,指出不确定性分析、尺度外推难、评价指标不统一、评价标准不统一、风险因子筛选及优先排序、区域内污染物复合、水生过渡到陆生生态系统风险评价、特殊的人为因素等是目前区域生态风险评价存在的关键问题及难点所在,并提出解决这些问题可能所需的工具、手段和理论方法突破。最后指出区域生态风险观测与数据采集加工、区域生态风险指标体系的统一与整合、区域生态风险评价方法论、区域生态风险的空间分布特征与表达以及区域生态风险评价反馈与管理机制5个方面是区域生态风险评价未来的研究重点。     

基于遥感技术的森林健康研究综述

遥感技术可以有效完成复杂时空尺度海量信息的收集处理,其与森林健康研究的交叉、融合大大提高了复杂时空尺度上森林健康研究的表达能力.目前,森林健康遥感研究正处于各学科交叉、融合、调整,由静态向动态、单一向复杂、零散向系统转变的关键发展时期,但缺乏对森林健康问题的全面考量、逻辑安排和系统的顶层设计.在把握森林健康活力、组织结构和恢复力核心理念的基础上,从森林资源调查、森林生态功能评估、森林健康风险控制和森林植被参数提取四个方面构建和丰富基于遥感技术森林健康研究体系,对国内外森林健康遥感研究进行综述.通过对以上研究内容的总结分析,明确基于遥感技术的森林健康研究各领域的研究进展,及其在理论、技术和应用方面的不足.分析认为:(1)未来应加强森林生态和遥感技术重大基础理论研究,以明确森林结构、过程、功能与遥感数据之间的耦合关系;(2)发展完善新型遥感技术、遥感数据解译算法与软件工具,提高遥感数据的精确度、利用率和利用效率;(3)提升森林健康遥感研究成果的科技转化水平,推进快速分析评价与辅助决策功能研究,指导相关森林健康经营活动和科学研究的开展,以及林业政策的制定.     

The use of environmental assays for impact assessment

The assessment of impacts of chemically contaminated aquatic environments on animal systems has a number of shortcomings. These include problems with analyses for toxic chemicals and the relevance of bioassays for predicting risk to ecosystems. Research is urgently needed to find better ways to solve these problems, particularly with respect to chronic exposures.     

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 to Ecological Risk Characterization and Management: Selecting the Right Tools for the Job

Chemical-specific hazard quotient (HQ) risk characterization in ecological risk assessment (ERA) can be a value-added tool for risk management decision-making at chemical release sites, when applied appropriately. However, there is little consensus regarding how HQ results can be used for risk management decision-making at the population, community, and ecosystem levels. Furthermore, stakeholders are reluctant to consider alternatives to HQ results for risk management decisions. Chemical-specific HQs risk characterization should be viewed as only one of several approaches (i.e., tools) for addressing ecological issues; and in many situations, other quantitative and qualitative approaches will likely result in superior risk management decisions. The purpose of this paper is to address fundamental issues and limitations associated with chemical-specific HQ risk characterization in ERA, to identify when it may be appropriate, to explore alternatives that are currently available, and to identify areas that could be developed for the future. Several alternatives (i.e., compensatory restoration, performance-based ecological monitoring, ecological significance criteria, net environmental benefit analysis), including their limitations, that can supplement, augment, or substitute for HQs in ERA are presented. In addition, areas of research (i.e., wildlife habitat assessment/landscape ecology/population biology, and field validated risk-based screening levels) that could yield new tools are discussed.     

Implementing Probabilistic Risk Assessment in USEPA Superfund Program

Application of probabilistic risk analysis to human health and ecological risk assessment is a young science. Probabilistic risk assessment (PRA), as exemplified by Monte Carlo Analysis (MCA), is more suitable to quantify the confidence or level of uncertainty in risk estimates compared with the traditional point estimate approach. Within the United States Environmental protection Agency (USEPA) the Office of Emergency and Remedial Response (OERR) is implementing PRA as part of the Superfund administrative reform activities. The OERR is completing a guidance document accompanied by a workbook. OERR is continuing its outreach effort to present PRA to the public and USEPA staff, and is organizing a training course. This paper presents an overview of the OERR's PRA implementation effort to date.