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.     

Precautionary risk assessment of Bt maize: what uncertainties?

GM crops have become a test case for the conflicting slogans of 'the precautionary principle' versus 'sound science.' The issues can be illustrated by developments in regulatory science for Bt maize in the European Union. As this case study suggests, risk assessment is always framed by some account of the relevant uncertainties. These in turn depend upon how the environment is valued and how scientific questions are posed about cause-effect pathways of potential harm. The slogan of 'sound science' hides such judgements, by representing ignorance or value-judgements as 'science.' By contrast, precaution can challenge such judgements, identify new unknowns, generate different criteria for evidence, open up new scientific questions, and make these judgements more transparent. It is doubtful whether these complexities have been fully acknowledged by specialists, and thus whether the continued risk debate is due solely to a public misunderstanding of science.     

Integrated Human and Ecological Risk Assessment: A Case Study of Organophosphorous Pesticides in the Environment

This study was chosen as an example of integrated risk assessment because organophosphorous esters (OPs) share exposure characteristics for different species, including human beings and because a common mechanism of action can be identified. The “Framework for the integration of health and ecological risk assessment” is being tested against a deterministic integrated environmental health risk assessment for OPs used in a typical farming community. It is argued that the integrated approach helps both the risk manager and the risk assessor in formulating a more holistic approach toward the risk of the use of OP-esters. It avoids conclusions based on incomplete assessments or on separate assessments. The database available can be expanded and results can be expressed in a more coherent manner. In the integrated exposure assessment of OPs, the risk assessments for human beings and the environment share many communalities with regards to sources and emissions, distribution routes and exposure scenarios. The site of action of OPs, acetylcholinesterase, has been established in a vast array of species, including humans. It follows that in the integrated approach the effects assessment for various species will show communalities in reported effects and standard setting approaches. In the risk characterization, a common set of evidence, common criteria, and common interpretations of those criteria are used to determine the cause of human and ecological effects that co-occur or are apparently associated with exposure to OPs. Results of health and ecological risk assessments are presented in a common format that facilitates comparison of results. It avoids acceptable risk conclusions with regard to the environment, which are unacceptable with regard to human risk and vice versa. Risk managers will be prompted to a more balanced judgement and understanding and acceptance of risk reduction measures will be facilitated.     

The effect of essentiality on risk assessment

Metals are ubiquitous in the human environment, making exposure inevitable and requiring scientifically sound risk assessment methodology to ensure adequate health protection. Within this area, as part of its ongoing efforts to improve and harmonize internationally approaches to risk assessments, the International Program on Chemical Safety (IPCS) has initiated work to improve the risk assessment procedures for essential trace elements (ETEs). Zn, Cu, Se, Cr, and MO are ETEs for humans, with increasing evidence of an essential role for boron (B). For ETEs, there is a range of daily intake within which the organism maintains homeostasis. At intakes below this range, there is an increased risk from deficiency, and at intakes above the range toxicity may develop. Obviously, for ETEs one cannot assume zero exposure is without risk. Adequate health protection will require the cooperative effort of scientists in nutrition and toxicology to develop the limits of the accepted range for ETEs considering such unique properties of metals as bioavailability, speciation, interactions, and biokinetics. Based on previous work by other groups and the recommendations of an IPCS consultation, a scientific monograph will be completed by IPCS. It will examine present risk assessment methodology for ETEs, and develop scientific principles supporting use of a homeostatic model for the development of dietary reference values and tolerable daily intakes. The objective is to develop an internationally accepted methodology for assessing ETEs as part of the IPCS effort to harmonize approaches to risk assessment worldwide. A recent IPCS Task Group on Zn highlighted some of the scientific issues that require resolution to avoid an overlap of the recommended daily intake based on nutritional needs with that based on toxicity and will serve as a case study.     

Risk Assessment of Tropospheric Ozone: Human Health,Natural Resources,and Ecology

Ozone is an unusual trace gas in the atmosphere, presenting a challenge for risk assessors and risk managers. The challenge can be traced to the gas’ complex chemistry in the atmosphere (exposure), toxicology in biological systems (response), and the fledgling enterprise of risk assessment for widely distributed, highly reactive pollutants. This paper addresses the (i) co-evolution of the scientific data underlying ozone risk assessment on human health, natural resources (crops and managed forests), and unmanaged ecosystems, (ii) similarities and differences in risk assessment among these receptors, and (iii) utility of indicators in risk assessment. The scientific community has developed a sound database to underpin the ozone risk assessment, although the breadth and depth differ markedly among the three receptors. There are similarities in ozone risk assessment among human health, natural resources, and ecology, including features of exposure (e.g., temporal variation), response of plants and humans (e.g., sensitive cohorts), and integration of exposure and response (e.g., importance of peak and cumulative exposures). Equally important are the notable differences, and the more prominent are scaling of exposure-response relationships, air quality monitoring, economic valuation, and models to complement more traditional experimental approaches. Of the three receptors, the status of indicators for conducting ecological ozone risk assessment is the weakest.     

Framework for Human Health Risk Assessment

The U.S. Environmental Protection Agency has recognized the need to develop a framework for human health risk assessment that puts a perspective on the approaches in practice throughout the Agency. In response, the Agency's Risk Assessment Forum has begun the long-term process of developing a framework for human health risk assessment. The framework will be a communication piece that will lay out the scientific basis, principles, and policy choices underlying past and current risk assessment approaches and will provide recommendations for integrating/harmonizing risk assessment methodologies for all human health endpoints.     

土壤污染生态毒性效应评价研究进展

随着社会经济的高度发展,人类活动加剧,我国土壤污染问题突出,不仅威胁人体健康,同时也严重威胁动植物及微生物的安全,生态安全问题不容忽视。但是我国土壤污染风险管控目前主要关注人体健康,对生态系统的关注较少,缺乏土壤污染生态风险评估技术指南及基于生态风险的土壤环境质量基准及标准。准确评价土壤污染生态毒性效应,是制定土壤环境质量标准、实现生态风险评估及预警与管控的重要基础。针对土壤污染生态毒性效应评价问题,分别对土壤污染生态毒性效应特征、评价方法、评价终点、暴露-效应关系构建、生态毒性效应外推,以及群落水平与复合污染生态毒性效应评价等方面的关键问题展开了讨论,指出目前土壤污染生态毒性效应评价主要是基于单物种的急性毒性测试,利用个体和亚个体水平的指示物作为评价终点,缺乏针对群落及生态系统高水平评价终点的生态毒性效应评价方法,定量评价污染物尤其是复合污染物对土壤生物群落及生态系统的影响,是土壤污染生态毒性效应评价的关键问题和难点问题。建议今后重点开展以下3方面的工作1)群落及生态系统水平评价终点的筛选;2)土壤污染生态毒性效应环境影响因子识别及影响机制研究;3)土壤复合污染联合毒性效应定量评价及...     

Implications of the Precautionary Principle: Is it a Threat to Science?

Scientific research is of proven value to protecting public health and the environment from current and future problems. We explore the extent to which the Precautionary Principle is a threat to this rôle for science and technology. Not surprisingly for a relatively simple yet still incompletely defined concept, supporters of the Precautionary Principle come from different viewpoints, including a viewpoint that is at least uneasy with the rôle of science, and particularly its use in risk assessment. There are also aspects of the Precautionary Principle that inherently restrict obtaining and using science. The Hazardous Air Pollutant (HAP) provisions in the US Clean Air Act Amendments are an example of the Precautionary Principle, which both shifted the burden of proof so that the onus is now on showing a listed compound is harmless, and required maximum available control technology (MACT) instead of a primarily risk-based approach to pollution control. Since its passage in 1990 there has been a decrease in research funding for studies of HAPs. Other potential problems include that once MACT regulations are established, it may be difficult to develop new technological approaches that will further improve air pollution control; that by treating all regulated HAPs similarly, no distinction is made between those that provide a higher or lower risk; and that there is a perverse incentive to use less well studied agents that are not on the existing list. As acting on the Precautionary Principle inherently imposes significant costs for what is a potentially erroneous action, additional scientific study should be required to determine if the precautionary action was successful. If we are to maximize the value of the Precautionary Principle to public health and the environment, it is crucial that its impact not adversely affect the potent preventive rôle of science and technology.     

The Importance of Type II Error and Falsifiability

Aim. Before intergovernmental consensus under the Rio Declaration in 1992, ignorance of type I errors had been disfavoured in science. However, the Precautionary Principle (PP) counsels the avoidance of type II errors, rather than of type I errors. We need a new academic code for the PP. Material and methods. The risk of extinction has usually been evaluated based on conservative estimates of the present population size. I define the weight of evidence as the extinction risk of Japanese vascular plants based on unbiased estimates. Catch quotas in the fisheries are usually decided by precautionary approach. I calculate the long-term yield and risk of stock collapse under a simple stock dynamics model. Results. The weight of evidence depends on the frequency of grids with size unknown. In a few plant species, rankings based on conservative estimates have differed from rankings based on unbiased estimates. In fishery management, a catch quota based on a precautionary approach proved neither sufficient nor necessary to avoid stock collapse. The precautionary approach is one of the reasons that prevent us from maximizing a sustainable yield. Conclusions. We need to clarify the endpoint of risks, and check whether it is necessary to adopt a PP. We can obtain the weight of evidence that is measured under unbiased estimates, while the risk based on a PP is measured under conservative estimates.     

WHO health risk assessment process for static fields

The World Health Organization (WHO) has a commitment to helping Member States achieve safe, sustainable and health-enhancing human environments, protected from biological, chemical and physical agents. The latter includes advising on the health impact of electromagnetic fields (EMFs) and radiation.

The results of the WHO/ICNIRP/NRPB workshop on static magnetic fields, published in this volume, provide a valuable and much needed contribution to the health risk assessment of exposure to static electric and magnetic fields, which is currently being coordinated by the WHO's International EMF Project. This WHO health risk assessment will be published as an environmental health criteria (EHC) monograph in early 2005.

This paper briefly gives an overview of the process of developing the WHO static fields EHC monograph, the criteria applied to studies that could contribute to the EHC, along with the ‘weight-of-evidence’ approach to health risk assessment. In addition, there is an increasing awareness of the need to account for uncertainty in the science database. This is traditionally addressed by further research, and the EMF project addresses these needs through the development of a ‘research agenda’. However, research programmes may take several years to complete, and the long latency associated with diseases such as cancer in people may also preclude a rapid outcome in some studies. The issue of current uncertainty is being addressed by the WHO EMF project through the development of a ‘precautionary framework’ in which precautionary measures will be applied to policy recommendations.     

基于改进的“证据-权重法”评估污染土壤生态风险:以江苏靖江某电镀场地为例

污染场地土壤生态风险评估能够为准确制定土壤环境质量标准、污染土壤修复目标、土壤修复后效果评估及安全利用提供科学依据,是保障土壤健康和安全的重要手段。“证据-权重法”由于具有系统性、整体性和科学性的特点在风险评估中应用广泛。然而,当前“证据-权重法”大多依赖专家打分法进行权重设置,并且在实际操作中难以获得定量化的、信息全面的完整证据链,风险评估结果缺乏客观性和可比性。针对以上问题,本研究耦合美国EPA的四步法与层级法构建了“证据-权重法”污染场地土壤生态风险评估框架,统一了每个层级的评估方法与程序。采用多标准决策分析对权重进行定量化,通过预先设置证据链之间的层级来保证其相对独立性,基于基质试验和野外调查保证场地的针对性。最后,以靖江某电镀场地为案例进行实证研究,结果表明: 所构建的方法具有较强的可操作性,评估结果具有较高的客观性、科学性和准确性。     

基于禽流感发生风险的生态安全评价研究进展

禽流感是危害公共健康、社会经济和政治稳定重要的传染性疾病。近年来,禽流感引发的区域生态安全(公共卫生安全和生物安全)问题日益受到学界关注。为此,有必要从禽流感发生风险的角度来开展区域生态安全评价。根据1996—2017年发表的禽流感发生风险与生态安全评价英文文献,运用Citespace软件综合分析了禽流感与生态安全评价的最新研究进展。在阐述禽流感发生风险与生态安全评价关系基础上,结合生态安全评价理论框架,从数据来源、适用范围、优缺点等方面分别对禽流感发生风险评估方法以及基于禽流感发生风险的生态安全评价方法进行对比与总结。综述表明:禽流感发生风险对生物物种安全和公共卫生安全的威胁已经严重影响到区域生态安全,其引发的公共卫生危机和生物多样性减少是生态安全评价研究的重要内容,从禽流感发生风险视角评价区域生态安全具有其必要性和紧迫性,并迫切需要加强相关模型方法及其应用研究。目前,禽流感研究主要以病毒学、流行病学为主,与生态安全领域结合研究较为缺乏,在生态安全评价中有关禽流感发生风险内容的研究基本被忽视。既可为深入揭示禽流感发生与传播的动力学机制与防控和监测禽流感提供科学依据,亦可为未来开展基于禽流感发生风险的区域生态安全评价研究提供方法借鉴。     

Determination of Field Effects of Contaminants—Significance of Pollution-Induced Community Tolerance

The concept of pollution-induced community tolerance (PICT) consists of the phenomenon that communities in an ecosystem exhibit increased tolerance as a result of exposure to contaminants. Although a range of ‘classic’ ecological principles explains the processes that increase tolerance of a community, the value of PICT for ecological risk assessment was recognized only recently (Blanck et al. 1988). The following issues are recognized: First, regarding the question on the role of suspect compounds causing ecological effects, the PICT approach covers the issue of causality better than ‘classical’ ecological community response parameters like species densities or species diversity indices. This relates to the fact that the level of PICT is assumed to be relatively constant (compared to density and diversity), whereas the suspect compound causing the observed effect can be deduced with relative clear inference from artificial exposure experiments. Second, PICT directly addresses a level of biological organization (the community), the level of concern for many ecological risk assessment methods. Other methods for risk assessment, like toxicity testing or bioassays, focus on individual or population-level effects, and need extrapolation of the results to the field. Such extrapolation step may pose problems regarding validity of the outcome of risk assessment. The occurrence of PICT is, however, not (yet) a community endpoint that is sufficiently underpinned to trigger risk mitigation activities. This paper especially focuses on the possibility to improve risk assessment approaches by incorporation of PICT assessments, especially focusing on the issue of causality and on the ecological meaning of PICT. Despite the advantages over ‘classical’ parameters, literature analysis suggests that the PICT approach may be strengthened by determining to which degree the PICT approach relates to ecological changes, like shifts in community structure, functioning, and stability. The aim of this paper is to summarize some literature, putting the emphasis on terrestrial studies, to get insights whether PICT is a sensitive and powerful tool to quantify ecological effects in field conditions, to link them to toxicant stress, and thus to determine whether PICT may be taken into consideration in risk assessment.     

Chronic Physical Illness: A Psychophysiological Approach for Chronic Physical Illness

Growing evidence demonstrates that psychological risk variables can contribute to physical disease. In an effort to thoroughly investigate potential etiological origins and optimal interventions, this broad review is divided into five sections: the stress response, chronic diseases, mind-body theoretical models, psychophysiological interventions, and integrated health care solutions. The stress response and its correlation to chronic disorders such as cardiovascular, gastrointestinal, autoimmune, metabolic syndrome, and chronic pain are comprehensively explored. Current mind-body theoretical models, including peripheral nerve pathway, neurophysiological, and integrative theories, are reviewed to elucidate the biological mechanisms behind psychophysiological interventions. Specific interventions included are psychotherapy, mindfulness meditation, yoga, and psychopharmacology. Finally, the author advocates for an integrated care approach as a means by which to blur the sharp distinction between physical and psychological health. Integrated care approaches can utilize psychiatric nurse practitioners for behavioral assessment, intervention, research, advocacy, consultation, and education to optimize health outcomes.     

An Assessment of Integrated Risk Assessment

In order to promote international understanding and acceptance of the integrated risk assessment process, the World Health Organization/International Programme on Chemical Safety (WHO/IPCS), in collaboration with the U.S. Environmental Protection Agency and the Organization for Economic Cooperation and Development, initiated a number of activities related to integrated risk assessment. In this project, the WHO/IPCS defines integrated risk assessment as a science-based approach that combines the processes of risk estimation for humans, biota, and natural resources in one assessment. This article explores the strengths and weaknesses of integration as identified up to this date and the degree of acceptance of this concept by the global risk assessment/risk management community. It discusses both opportunities and impediments for further development and implementation.

The major emerging opportunities for an integrated approach stem from the increasing societal and political pressure to move away from vertebrate testing leading to a demand for scientific integrated approaches to in vitro and in vivo testing, as well as to computer simulations, in so-called Intelligent Testing Strategies. In addition, by weighing the evidence from conventional mammalian toxicology, ecotoxicology, human epidemiology, and eco-epidemiology, risk assessors could better characterize mechanisms of action and the forms of the relationships of exposures to responses. It is concluded that further demonstrations of scientific, economic and regulatory benefits of an integrated approach are needed. As risk assessment is becoming more mechanistic and molecular this may create an integrated approach based on common mechanisms and a common systems-biology approach.     

Precaution,threshold risk and public deliberation

It has been argued that the precautionary principle is incoherent and thus useless as a guide for regulatory policy. In a recent paper in Bioethics, Wareham and Nardini propose a response to the ‘precautionary paradox’ according to which the precautionary principle's usefulness for decision making in policy and regulation contexts can be justified by appeal to a probability threshold discriminating between negligible and non‐negligible risks. It would be of great significance to debates about risk and precaution if there were a sound method for determining a minimum probability threshold of negligible risk. This is what Wareham and Nardini aim to do. The novelty of their approach is that they suggest that such a threshold should be determined by a method of public deliberation. In this article I discuss the merits of Wareham and Nardini’s public deliberation method for determining thresholds. I raise an epistemic worry about the public deliberation method they suggest, and argue that their proposal is inadequate due to a hidden assumption that the acceptability of a risk can be completely analysed in terms of its probability.     

Species Sensitivity Distributions Revisited: A Critical Appraisal

We revisit the assumptions associated with the derivation and application of species sensitivity distributions (SSDs). Our questions are (1) Do SSDs clarify or obscure the setting of ecological effects thresholds for risk assessment? and (2) Do SSDs reduce or introduce uncertainty into risk assessment? Our conclusions are that if we could determine a community sensitivity distribution, this would provide a better estimate of an ecologically relevant effects threshold and therefore be an improvement for risk assessment. However, the distributions generated are typically based on haphazard collections of species and endpoints and by adjusting these to reflect more realistic trophic structures we show that effects thresholds can be shifted but in a direction and to an extent that is not predictable. Despite claims that the SSD approach uses all available data to assess effects, we demonstrate that in certain frequently used applications only a small fraction of the species going into the SSD determine the effects threshold. If the SSD approach is to lead to better risk assessments, improvements are needed in how the theory is put into practice. This requires careful definition of the risk assessment targets and of the species and endpoints selected for use in generating SSDs.     

Managing marine mollusc diseases in the context of regional and international commerce: policy issues and emerging concerns

Marine mollusc production contributes to food and economic security worldwide and provides valuable ecological services, yet diseases threaten these industries and wild populations. Although the infrastructure for mollusc aquaculture health management is well characterized, its foundations are not without flaws. Use of notifiable pathogen lists can leave blind spots with regard to detection of unlisted and emerging pathogens. Increased reliance on molecular tools has come without similar attention to diagnostic validation, raising questions about assay performance, and has been accompanied by a reduced emphasis on microscopic diagnostic expertise that could weaken pathogen detection capabilities. Persistent questions concerning pathogen biology and ecology promote regulatory paralysis that impedes trade and which could weaken biosecurity by driving commerce to surreptitious channels. Solutions that might be pursued to improve shellfish aquaculture health management include the establishment of more broad-based surveillance programmes, wider training and use of general methods like histopathology to ensure alertness to emerging diseases, an increased focus on assay assessment and validation as fundamental to assay development, investment in basic research, and application of risk analyses to improve regulation. A continual sharpening of diagnostic tools and approaches and deepening of scientific knowledge is necessary to manage diseases and promote sustainable molluscan shellfish industries.     

On the Even Greater Need for Precaution Under Global Change

The greater the potential for disastrous, large-scale, or catastrophic impacts on health, the greater the case for precaution. The imperative for precautionary action, critical also for downstream determinants of health, is at least as compelling where macro-level concerns about the sustainability of life on Earth are at issue. In this context, I propose that a higher threshold of uncertainty is needed where large-scale harms to health and well-being are possible. Initial efforts must focus on the training of researchers and risk managers for competencies in complexity, and in systems approaches to transdisciplinary enquiry. Revisiting the intent behind Bradford Hill on causation is an essential first step. Focus on the more proximate causes of diseases, such as those related either to occupational exposures or to more downstream environmental exposures, is left to others in this collection.     

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.