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 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.     

Multidisciplinary Research: Strategies for Assessing Chemical Mixtures to Reduce Risk of Exposure and Disease

The Precautionary Principle is founded on the use of comprehensive, coordinated research to protect human health in the face of uncertain risks. Research directed at key data gaps may significantly reduce the uncertainty underlying the complexities of assessing risk to mixtures. The National Institute of Environmental Health Sciences (NIEHS) has taken a leadership rôle in building the scientific infrastructure to address these uncertainties. The challenge is to incorporate the objectives as defined by the Precautionary Principle with the knowledge gained in understanding the multifactorial nature of gene-environment interactions. Through efforts such as the National Center for Toxicogenomics, the National Toxicology Program, and the Superfund Basic Research Program, NIEHS is translating research findings into public health prevention strategies using a 3-pronged approach: (1) identify/evaluate key deviations from additivity for mixtures; (2) develop/apply/link advanced technologies and bioinformatics to quantitative tools for an integrated science-based approach to chemical mixtures; (3) translate/disseminate these technologies into useable, practical means to reduce exposure and the risk of disease. Preventing adverse health effects from environmental exposures requires translation of research findings to affected communities and must include a high level of public involvement. Integrating these approaches are necessary to advance understanding of the health relevance of exposure to mixtures.     

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.     

The Precautionary Principle: Implications for Risk Management Strategies

The European Commission has published a Communication on the Precautionary Principle and a White Book on Governance. These provide us (as research civil servants of the Commission) an institutional framework for handling scientific information that is often incomplete, uncertain, and contested. But, although the Precautionary Principle is intuitively straightforward to understand, there is no agreed way of applying it to real decision-making. To meet this perceived need, researchers have proposed a vast number of taxonomies. These include ignorance auditing, type one-two-three errors, a combination of uncertainty and decision stakes through post-normal science and the plotting of ignorance of probabilities against ignorance of consequences. Any of these could be used to define a precautionary principle region inside a multidimensional space and to position an issue within that region. The rôle of anticipatory research is clearly critical but scientific input is only part of the picture. It is difficult to imagine an issue where the application of the Precautionary Principle would be non-contentious. From genetically-modified food to electro-smog, from climate change to hormone growth in meat, it is clear that: 1) risk and cost-benefit are only part of the picture; 2) there are ethical issues involved; 3) there is a plurality of interests and perspectives that are often in conflict; 4) there will be losers and winners whatever decision is made. Operationalisation of the Precautionary Principle must preserve transparency. Only in this way will the incommensurable costs and benefits associated with different stakeholders be registered. A typical decision will include the following sorts of considerations: 1) the commercial interests of companies and the communities that depend on them; 2) the worldviews of those who might want a greener, less consumerist society and/or who believe in the sanctity of human or animal life; 3) potential benefits such as enabling the world's poor to improve farming; 4) risks such as pollution, gene-flow, or the effects of climate change. In this paper we will discuss the use of a combination of methods on which we have worked and that we consider useful to frame the debate and facilitate the dialogue among stakeholders on where and how to apply the Precautionary Principle.     

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.     

Methodologic Implications of the Precautionary Principle: Causal Criteria

Applying the Precautionary Principle to public health requires a re-evaluation of the methods of inference currently used to make claims about disease causation from epidemiologic and other forms of scientific evidence. In current thinking, a well-established, near-certain causal relationship implies highly consistent statistically significant results across many different studies, large relative risk estimates, extensive understanding of biological mechanisms and dose-response relationships, positive prevention trial results, a clear temporal relationship between cause and effect, and other conditions spelled out in terms of the widely-used causal criteria. The Precautionary Principle, however, states that preventive measures are to be taken when cause and effect relationships are not fully established scientifically. What evidentiary conditions, as reflected in the causal criteria, will be certain enough to warrant precautionary preventive action? This paper argues that minimum evidentiary requirements for causation need to be articulated if the Precautionary Principle is to be successfully incorporated into public health practice. Two precautionary changes to criteria-based methods of causal inference are examined: reducing the number of criteria and weakening the rules of inference accompanying the criteria. Such changes point in the direction of identifying minimum evidentiary conditions, but would be premature without better understanding how well current methods of causal inference work.     

Commentary: The Rôle of Toxicology in Prevention and Precaution

Advocates of the Precautionary Principle have recently called for a “new science” to support the goals of precaution-based environmental and occupational health policy. While much attention has been given to epidemiology, the evidentiary science most relevant to precaution, or prevention, is toxicology. Opportunities for enhancing the rôle of toxicology in public policy must consider current biases in the field. Thus, rather than a “new science,” advocates for change should focus upon ensuring that current scientific methods are appropriate and that interpretations of scientific data are accurate.     

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.     

Major Concerns in Developing Countries: Applications of the Precautionary Principle in Ecuador

Ecuador is a Latin American country with one of the biggest biodiversities. At the same time, social and environmental problems are also big. Poverty, political and social problems as well as questions like old transport systems, imported hazards from industrialized countries and lack of information and weak health care systems are the framework of this situation. The most common problems are the use of heavy metals in many activities without safety and health protection, a low technological oil production during two decades, intensive use of pesticides in agriculture, and some other chemical risks. A limited capacity to develop prevention strategies, reduced technical and scientific skills, and the absence of a reliable information and control system, lead to a weak response mechanism. The Precautionary Principle could help to stimulate prevention, protection and to have a new tool to improve the interest in environment and health problems. Reinforcing the presence of international organizations like WHO and ILO, establishing bridges among scientific organizations from developed and developing countries and introducing the Precautionary Principle in the legislation and daily practices of industry and agriculture could lead to an improvement in our environment and health.     

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.     

The Precautionary Principle,Science and Human Health Protection

As technology advances rapidly, so do applications with potential adverse implications on human health. The possible threats include risks that can be substantial, far-reaching and irreversible, and currently available methods of investigation, designed to deal with direct exposure-disease associations, are not always suitable. Growing interest is being paid to health effects that may be the consequence of distal, “upstream” determinants. Considering the complex chain of events that links such determinants with health can be extremely difficult, and exposes severe limitations in science. Thus, there is often a mismatch between what is known and what would be required to inform rational, evidence-based decision making, which is increasingly called for. It has become apparent how production and use of scientific evidence in decision making must be accompanied by precaution, especially in those circumstances, more and more common in recent times, where there is an uncertain possibility that serious health consequences might take place. Several cautionary approaches have been proposed, but the Precautionary Principle (PP) has been the object of especially intense debate in recent years. Developed in the field of environmental health, the PP has been clarified, and has been applied or called for in several instances in public health. Although a unique definition is not available, the principle has been characterised, and criteria for its application have been proposed. However, many questions remain open on general as well as specific issues. In this paper, we address some of the questions that are relevant for the PP to support rational decision making in environment and health and more in general to strengthen its contribution towards human health protection.     

Assessing the Human,Social, and Environmental Risks of Pervasive Computing

The vision of Pervasive Computing is built on the assumption that computers will become part of everyday objects, augmenting them with information services and enhanced functionality. This article reports on the approach we have used to assess potential side effects of this development on human health and the environment, and the major risks we identified. Social risks such as the risk of conflicts between users and non-users of the technology were also included because of their potential indirect adverse health effects. Assessing a technological vision before it has materialized makes it necessary to deal with two types of uncertainty: first, the uncertainty of how fast and to what extent the technology will be taken up and how it will be used; second, the uncertainty of causal models connecting technology-related causes with potential health or environmental effects. Due to these uncertainties, quantitative methods to evaluate expected risks are inadequate. Instead, we developed a “risk filter” that makes it possible to rank risks according to a set of qualitative criteria based on the Precautionary Principle. As the overall result, it turned out that Pervasive Computing bears potential risks to health, society, and/or the environment in the following fields: Non-ionizing radiation, stress imposed on the user, restriction of consumers' and patients' freedom of choice, threats to ecological sustainability, and dissipation of responsibility in computer-controlled environments.     

On Being Careful What We Wish for: Some Difficulties with Operationalizing the Precautionary Principle

An important part of the Precautionary Principle is that taking action is justified for protecting public health even when there is some scientific uncertainty. We examine here the two components of this central feature of the precautionary principle, scientific uncertainty and decision making. In order to operationalize the principle we should examine the consequences of its decision rules and how they perform under various conditions. The performance of decision rules in disease screening is measured by the sensitivity and specificity of the rule, but the consequences for the patient are given by the positive and negative predictive values, determined not only by the performance of the rule by the prevalence of the disease in the population. We look at positive and negative predictive value of the Precautionary Principle from the standopoint of the costs to one or other parts of society, show that the usual rule which tends to maximize sensitivity in favor of specificity may have unexpected consequences, and demonstrate that it is sometimes possible to trade sensitivity and specificity off against each other in a way the improves both positive and negative predictive value, or worse, degrades both.We conclude by asking if certain strategies are better for one or the other kinds of uncertainty.     

Getting ready for malaria elimination: a check list of critical issues to consider

In recent years, a renewed interest in malaria elimination and eradication has emerged and seems to be rooting in the minds of the scientific community, public health specialists, funding bodies, policy makers and politicians. Malaria eradication will certainly benefit from improved and innovative tools; notwithstanding novel knowledge in fields ranging from basic science to mathematical modelling and health systems research. However, the elimination of malaria also encompasses a broad range of essential aspects that countries and other actors need to consider when thinking of embarking on such an adventure, including the implementation of innovative strategies, the ability to incorporate the most up-to-date evidence into policy, the integration of malaria into the broader health agenda, the strengthening of surveillance and health systems, capacity building, funding, advocacy and, very importantly, research. While in some cases this enthusiasm is clearly justified, some countries are still a long way from realistically advancing towards elimination. This paper attempts to provide guidance on all the necessary issues that should be considered when initiating a malaria elimination program.     

Dimensions of the Precautionary Principle

This essay attempts to provide an analytical apparatus which may be used for finding an authoritative formulation¹ of the Precautionary Principle. Several formulations of the Precautionary Principle are examined. Four dimensions of the principle are identified: (1) the threat dimension, (2) the uncertainty dimension, (3) the action dimension, and (4) the command dimension. It is argued that the Precautionary Principle can be recast into the following if-clause, containing these four dimensions: “If there is (1) a threat, which is (2) uncertain, then (3) some kind of action (4) is mandatory.” The phrases expressing these dimensions may vary in (a) precision and (b) strength. It is shown that it is the dimension containing the weakest phrase that determines the strength of the entire principle. It is suggested that the four-dimensional if-clause be used as an analytical apparatus in negotiations of the Precautionary Principle.     

Some Legal Implications of the Precautionary Principle: Improving Information-Generation and Legal Protections

In creating a legal agenda in service of the Precautionary Principle, the idea of precaution requires more inventories and better monitoring of the condition of public and workforce health than at present. Rectifying problems of the past to better serve the aims of precaution will require more affirmative pre-market and much more post-market knowledge-generation by those who create and use potentially toxic substances, improved pre-market review of substances, better responses to early warnings, and quicker protective post-market responses to evidence of toxicity. This paper conceptualizes a model pre-market screening law to highlight the need for primary prevention measures and to provide philosophic ideas for improving post-market laws and addressing a large universe of existing substances that have been poorly characterized. Although retrospective personal injury law does not have good mechanisms for precaution, even this can be more protective than it is at present by enhancing causes of action for reasonable fear of disease and medical monitoring, and moving to create new causes of action for failure to develop and disseminate information needed to assess the toxicity of substances.     

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.     

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.