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.     

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.     

Risk Communication and the Precautionary Principle

The perception of risks for environment and health deriving from globalization processes and an uncontrolled use of modern technologies is growing everywhere. The greater the capacity of controlling living conditions, the larger is the possibility of misusing this power. In environmental and occupational health research we tend to reduce the complexity of the observed phenomena in order to facilitate conclusions. In social and political sciences complexity is an essential element of the context, which needs to be continuously considered. The Precautionary Principle is a tool for facing complexity and uncertainty in health risk management. This paper is aimed at demonstrating that this is not only a problem of technical risk assessment. Great attention should also be paid to improve risk communication. Communication between the stakeholders (experts, decision makers, political and social leaders, media, groups of interest and people involved) is possibly the best condition to be successful in health risk management. Nevertheless, this process usually runs up against severe obstacles. These are not only caused by existing conflicts of interest. Differences in values, languages, perceptions, resources to have access to information, and to express one's own point of view are other key aspects.     

Applying USEPA Risk Assessment Guidance in the 90s

Over the past decade, risk assessment has become increasingly relied upon for helping to make environmental management decisions. This trend has been accompanied by research and refinements in basic risk assessment methodologies to improve our ability to understand and evaluate the human health risks associated with chemical exposures.Despite this progress, significant uncertainties continue to be associated with the risk assessment process. These uncertainties typically derive from gaps in available data regarding chemical toxicity, and from difficulties in reliably estimating the magnitude of chemical exposures. Given these limitations, risk assessment is generally most valuable in evaluating relative risk; for example, when comparing alternatives to achieving a specified goal, setting priorities for protecting human health, or establishing procedures for properly allocating resources. Risk assessment can also be useful for developing regulatory benchmarks such as permit limits for air or water. In many cases, however, the limitations of the risk assessment process make it difficult (if not impossible) to reliably estimate an absolute level of risk, especially for a specific individual in an exposed population. In such cases, risk assessment can be seriously misapplied, and its results misinterpreted.This paper discusses some of the challenges that have been faced by the field of risk assessment during the 1990s. Current trends in risk assessment, and its use by regulatory agencies in making risk management decisions, are also described.     

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.     

The Precautionary Principle in the Information Society

The Precautionary Principle aims to anticipate and minimize potentially serious or irreversible risks under conditions of uncertainty. Thus it preserves the potential for future developments. It has been incorporated into many international treaties and pieces of national legislation for environmental protection and sustainable development. However the Precautionary Principle has not yet been applied systematically to novel Information and Communication Technologies (ICTs) and their potential environmental, social, and health effects. In this article we argue that precaution is necessary in this field and show how the general principle of precaution can be put in concrete terms in the context of the information society. We advocate precautionary measures directed towards pervasive applications of ICT (Pervasive Computing) because of their inestimable potential impacts on society.     

ENVIRONMENTAL RISK ASSESSMENT: TASKS AND OBLIGATIONS

Synthesizing, characterizing, and communicating the risk science information used in environmental decision-making depends in the first instance on the nature and quality of the technical analysis. At the same time, other important features of the risk analysis, features that require special attention to provide context for the analysis as a whole, are frequently overlooked in practice or in presentation. Now, as the field expands to meet new challenges and to include new participants, all practitioners — government, academics, industry, and interest groups — must give renewed emphasis to certain hall marks of sound risk assessment: identifying incomplete information and its influence on the risk assessment process, articulating alternative assumptions and the scientific or policy reasons for choices made among alternatives, describing process considerations and limitations as well as numerical results, and fully informing decision makers, the press, and the interested public. The resulting greater clarity and transparency in the scientific analyses that under lie environmental decision making can enhance credibility and public confidence in the scientific foundation for those decisions.     

Implementing the Precautionary Principle: Rigorous Science and Solid Ethics

The Precautionary Principle came out of European efforts to clean-up and protect marine ecosystems in the 1980s. Since then, several North American activities have elaborated on this approach in U.S. environmental programs. Unfortunately, US organizations and agencies have not developed strategies and guidelines for implementing the Precautionary Principle in either statutory or voluntary environmental programs. Recent interest in this approach from some members of the scientific, non-profit, and regulatory communities highlights the need to understand the history and conceptual basis of the Precautionary Principle. In this paper we address several of these issues. First, we summarize the pertinent US history of the Precautionary Principle. Next, we describe the scientific framework for the principle. Finally, we make the case that this provides unique opportunities for scientists to obtain meaning in their work by fulfilling what has been called the new Social Contract.     

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。     

Adjusting Scientific Practices to the Precautionary Principle

In most discussions of the Precautionary Principle, it is implicitly assumed that we are at a point near risk neutrality, so that the principle aims at moving away from risk neutrality in the direction of more risk-averse behavior. In this paper it is argued that actual decision-making in environmental issues is often on the opposite, risk taking, side of risk neutrality. A minimal version of the Precautionary Principle consists in moving from such a position in the direction of risk neutrality. Some methods for achieving this are discussed, such as less consensus-seeking scientific procedures, requirements that scientific committees identify less probable but serious scenarios, interpretative presumptions, and supplementary statistical measures for type II errors.     

Challenges and Research Needs for Risk Assessment of Pesticides for Registration in Africa

Risk assessment is necessary for registration and risk management of new pesticides. The aim of this article is to discuss challenges that risk assessors in Africa face when conducting risk assessment of pesticides. Risk assessment requires toxicity assessment, environmental fate studies, and the use of models for occupational, dietary, residential, and environmental exposure assessments. Toxicity studies are very costly with the result that toxicity data used to register pesticides in Africa are often sourced from northern hemisphere countries. Assessors also often use exposure modeling results from the northern hemisphere. This is not an ideal approach as occupational exposure is influenced by agricultural practices, climatic conditions, and other factors. Furthermore, residential exposure models require time-location-activity information, exposure factors, and toxicokinetic rate constants for particular pesticides. Dietary exposure assessment needs accurate and comprehensive local food consumption data. Authorities in African countries should therefore generate the required data, despite these being very costly and tedious. Authorities should also provide guidance on the type of models and standard scenarios for estimating predicted environmental concentrations in various environmental compartments. It is recommended that higher educational institutions in Africa should incorporate risk assessment in general and pesticide toxicity and exposure models in particular in their curricula.     

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.     

Scientific data and theories for salmonellosis dose–response assessment

An “expansive” risk assessment approach is illustrated, characterizing dose–response relationships for salmonellosis in light of the full body of evidence for human and murine superorganisms. Risk assessments often require analysis of costs and benefits for supporting public health decisions. Decision-makers and the public need to understand uncertainty in such analyses for two reasons. Uncertainty analyses provide a range of possibilities within a framework of present scientific knowledge, thus helping to avoid undesirable consequences associated with the selected policies. And, it encourages the risk assessors to scrutinize all available data and models, thus helping avoid subjective or systematic errors. Without the full analysis of uncertainty, decisions could be biased by judgments based solely on default assumptions, beliefs, and statistical analyses of selected correlative data. Alternative data and theories that incorporate variability and heterogeneity for the human and murine superorganisms, particularly colonization resistance, are emerging as major influences for microbial risk assessment. Salmonellosis risk assessments are often based on conservative default models derived from selected sets of outbreak data that overestimate illness. Consequently, the full extent of uncertainty of estimates of annual number of illnesses is not incorporated in risk assessments and the presently used models may be incorrect.     

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。     

Nanomaterials as a potential environmental pollutant: Overview of existing risk assessment methodologies

The development and use of engineered nanomaterials is increasing rapidly and there are already a large number of consumer products containing nanomaterials. The possible release of nanomaterials from these products is still uncertain, as is their final fate and effects in the environment. Regulators need to deal with this lack of data when carrying out risk assessment and modify the existing risk assessment approaches to adapt them to the unique features of nanomaterials. Here we give an overview of various risk assessment approaches for nanomaterials developed worldwide, in which we describe their strengths and limitations, and have evaluated two of them, the Nano Risk Framework and the Precautionary Matrix for specific cases. Many properties of engineered nanomaterials are unknown and this causes deficiencies in the approaches studied. It is therefore essential to increase the present scarce data on nanomaterials released in the environment and close the gaps in the current methodologies to perform adequate risk assessment for nanomaterials.     

The U.S. Environmental Protection Agency's Generic Ecological Assessment Endpoints

The U.S. Environmental Protection Agency determined that one of the major impediments to the advancement and application of ecological risk assessment is doubt concerning appropriate assessment endpoints. The Agency's Risk Assessment Forum determined that the best solution to this problem was to define a set of generic ecological assessment endpoints (GEAEs). They are assessment endpoints that are applicable to a wide range of ecological risk assessments; because they reflect the programmatic goals of the Agency, they are applicable to a wide array of environmental issues, and they may be estimated using existing assessment tools. They are not specifically defined for individual cases; some ad hoc elaboration by users is expected. The GEAEs are not exhaustive or mandatory. Although most of the Agency's ecological decisions have been based on organism-level effects, GEAEs are also defined for populations, ecosystems, and special places.     

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.     

Risk analysis: an overview

Risk analysis increasingly is considered as an integral part of the environmental management decision-making process. Risk, defined as the probability of occurrence of a particular adverse effect on human health or the environment, should not be confounded with hazard, defined as a source of potential injury independent of occurrence. Risk analysis has to be followed by risk management. Some opponents of risk analysis make the reproach that the science used in risk analysis is immature and consequently that the entire process in laden with hidden value judgments. Attempts to overcome these critics are increasingly based on the use of robust biologic data the final considered values system being efficacy-based, efficiency-based or equity-based. Globalization has brought with it new problems, and there is an urgent need to improve risk analysts; to increase its public acceptability and to establish consensus regarding solutions to global environmental problems. In this context biologic-based models and biomarkers hold, the greatest promise for improving risk assessment. These considerations are illustrated by a few examples, also pertaining to low-dose extrapolation and to the problem of thresholds for carcinogenesis. Future directions for development are evoked.     

Adding Value to Ecological Risk Assessment with Population Modeling

Current measures used to estimate the risks of toxic chemicals are not relevant to the goals of the environmental protection process, and thus ecological risk assessment (ERA) is not used as extensively as it should be as a basis for cost-effective management of environmental resources. Appropriate population models can provide a powerful basis for expressing ecological risks that better inform the environmental management process and thus that are more likely to be used by managers. Here we provide at least five reasons why population modeling should play an important role in bridging the gap between what we measure and what we want to protect. We then describe six actions needed for its implementation into management-relevant ERA.     

The Precautionary Principle,Epidemiology and the Ethics of Delay

Ethics tells us: do good and do no harm and invokes the norms of justice, equity and respect for autonomy in protecting and promoting health and well-being. The Precautionary Principle, a contemporary re-definition of Bradford Hill's case for action, gives us a common sense rule for doing good by preventing harm to public health from delay: when in doubt about the presence of a hazard, there should be no doubt about its prevention or removal. It shifts the burden of proof from showing presence of risk to showing absence of risk, aims to do good by preventing harm, and subsumes the upstream strategies of the DPSEEA (Driving Forces Pressure Stress Exposure Effect Action) model and downstream strategies from molecular epidemiology for detection and prevention of risk. The Precautionary Principle has emerged because of the ethical import of delays in detection of risks to human health and the environment. Ethical principles, the Precautionary Principle, the DPSEEA model and molecular epidemiology all imply re-emphasizing epidemiology's classic rôle for early detection and prevention. Delays in recognizing risks from past exposures and acting on the findings (e.g., cigarette smoking and lung cancer, asbestos, organochlorines and endocrine disruption, radiofrequency, raised travel speeds) were examples of failures that were not only scientific, but ethical, since they resulted in preventable harm to exposed populations. These may delay results from, among other things, external and internal determinants of epidemiologic investigations of hazard and risk, including misuse of tests of statistical significance. Furthermore, applying the Precautionary Principle to ensure justice, equity, and respect for autonomy raises questions concerning the short-term costs of implementation to achieve long-term goals and the principles that guide compensation.