The Precautionary Principle in Practice: Applying the Ashford Framework to Technological Risk

The precautionary principle reflects an old adage — an ounce of prevention is worth a pound of cure. Its four central components include: taking preventative action in the face of uncertainty; shifting the burden of proof to proponents of an activity; exploring a wide range of alternatives to possibly harmful actions; and increasing public participation in decision processes. Scholars in a range of fields have identified U.S. environmental laws, regulations, and decisions exhibiting precaution de facto. This study moves beyond the traditional treatments of the subject, the morass of definitions systematizing precaution into its basic elements. It poses a further question, within the current legal system and existing laws, how might the precautionary principle be implemented by modifying aspects of a statute? By applying a conceptual legal precautionary framework to a specific example of technological risk management, Washington State's energy facility siting statute, we reveal deficiencies in four areas: compensation issues; burden of proof; Type I or II error preferences; and systematic comparisons. Supplying these would, in all likelihood, ensure a more effective statute and process as well as an outcome consistent with legislative goals. However, were an explicit statement of the precautionary principle introduced, parties dissatisfied with an outcome would seek judicial review, and extensive litigation could counter the legislative mandate of abundant energy at a reasonable cost.     

The Default Value Approach to the Precautionary Principle

In science, when information is lacking, the reasonable response is to suspend judgement. When incomplete scientific information is to be used for decision-making purposes, such as regulation, the option of suspending judgement is not available. In such situations the precautionary principle may be used. One of several problems with the precautionary principle is that it is poorly defined and difficult to operationalize. We propose a way of operationalizing the precautionary principle through assigning cautious default values to variables that are needed in the risk analysis but are nevertheless unknown. A formalized model is introduced, in which the precautionary principle is interpreted in terms of default values of chemicals regulation. Four different methods for choosing default values (positive list, negative list, statistical expectation, and precaution) are discussed.     

The Precautionary Preference: An American Perspective on the Precautionary Principle

The precautionary principle, a familiar constituent of international and European environmental law, has only very recently entered the vocabulary of domestic environmental policy debates in the United States. The question naturally arises what role such a principle should play in American law. By breaking down statements of the precautionary principle into distinct ele ments, one can more readily find ways in which U.S. law reflects the precau tionary principle. This analysis reveals that American environmental law con tains precautionary elements and goals in many and varied settings, from the management of natural ecosystems, to pollution control standards, to risk assessment methodology. However, the precautionary approach appears in a highly diluted or compromised form. With rare exceptions, U.S. law balances precaution against other considerations, most importantly cost. Therefore, while precautionary elements are firmly entrenched in U.S. environmental law, it is more accurate to say that it reflects a precautionary preference rather than the precautionary principle.     

Ecological Risk Assessment and the Precautionary Principle

The Precautionary Principle, generated during the late 1980s as a unifying principle for regulating discharge of hazardous material into the North Sea, has been broadened to include a shifting of the burden of proof to the proponent of a proposed activity, adoption of a more holistic assessment process, and encompassing all environmental management decisions, not just pollution prevention activities. We argue that the Precautionary Principle remains a management philosophy, not a substitute for risk assessment. Risk assessment is a tool for organizing information used in environmental management decisions. However, increasing attention to reducing the Type II error of risk assessment studies would significantly reduce the skepticism with which many view the risk assessment process. A critical review of default assumptions used in risk assessments, inclusion of indirect effects within an ecologically relevant spatial/temporal framework, and better communication between risk assessors and risk managers also would enhance the acceptability of the process. Risk assessment can provide a sound basis for management decisions regardless of the underlying philosophies of environmental conservation or utilitarianism, but only if the inherent biases in the risk assessment assumptions are acknowledged explicitly throughout the assessment and management processes.     

Safety,Risk and the Precautionary Principle: Rethinking Precautionary Approaches to the Regulation of Transgenic Plants

Operationalizing the Cartagena Protocol on Biosafety will require resolving disputes about the meaning of the term 'precautionary approach' in the treaty text. Although the terms precautionary approach and precautionary principle have been referred to in the regulation of transgenic plants for nearly a decade, no customary expectation of what actions either requires has developed. If specific obligations for regulators, regulated entities, or both are not established, compliance will be impossible. This essay examines various interpretations of the precautionary principle, discusses their shortcomings, and suggests a way to rethink the regulation of transgenic plants that focuses on genuine uncertainty. Transgenic plants with familiar phenotypes should be subject to considerably less regulatory scrutiny than those whose risks are genuinely unknown, or known to pose heightened risk.     

The Precautionary Principle: A European Perspective

The ‘precautionary principle’, as formulated in the 1992 Rio Declaration on Environ ment and Development, calls for regulatory action in the face of serious environmental risks even in the absence of full scientific certainty. This paper traces negotiation of the principle at the Rio Conference, and its history in Europe from 1969 Swedish legislation to the latest directives of the European Union. As illustrated by recent court cases from Germany and France, in particular (on nuclear power plants, electro magnetic fields, and genetically modified organisms), judicial interpretation of the principle has tended to be restrictive. Future law making in this field is likely to focus on public access to environmental risk information, and on the development of new ‘right to know’ instru ments such as mandatory product labelling and transnational pollutant release inven tories, an area where Europe can still learn from North American experience.     

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.     

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.     

Policy on Synthetic Biology: Deliberation,Probability, and the Precautionary Paradox

Synthetic biology is a cutting‐edge area of research that holds the promise of unprecedented health benefits. However, in tandem with these large prospective benefits, synthetic biology projects entail a risk of catastrophic consequences whose severity may exceed that of most ordinary human undertakings. This is due to the peculiar nature of synthetic biology as a ‘threshold technology’ which opens doors to opportunities and applications that are essentially unpredictable. Fears about these potentially unstoppable consequences have led to declarations from civil society groups calling for the use of a precautionary principle to regulate the field. Moreover, the principle is prevalent in law and international agreements. Despite widespread political recognition of a need for caution, the precautionary principle has been extensively criticized as a guide for regulatory policy. We examine a central objection to the principle: that its application entails crippling inaction and incoherence, since whatever action one takes there is always a chance that some highly improbable cataclysm will occur. In response to this difficulty, which we call the ‘precautionary paradox,’ we outline a deliberative means for arriving at threshold of probability below which potential dangers can be disregarded. In addition, we describe a Bayesian mechanism with which to assign probabilities to harmful outcomes. We argue that these steps resolve the paradox. The rehabilitated PP can thus provide a viable policy option to confront the uncharted waters of synthetic biology research.     

The Precautionary Principle and Statistical Approaches to Uncertainty

The central challenge from the Precautionary Principle to statistical methodology is to help delineate (preferably quantitatively) the possibility that some exposure is hazardous, even in cases where this is not established beyond reasonable doubt. The classical approach to hypothesis testing is unhelpful, because lack of significance can be due either to uninformative data or to genuine lack of effect (the Type II error problem). Its inversion, bioequivalence testing, might sometimes be a model for the Precautionary Principle in its ability to ‘prove the null hypothesis.’ Current procedures for setting safe exposure levels are essentially derived from these classical statistical ideas, and we outline how uncertainties in the exposure and response measurements affect the No Observed Adverse Effect Level (NOAEL), the Benchmark approach and the “Hockey Stick” model. A particular problem concerns model uncertainty: usually these procedures assume that the class of models describing dose/response is known with certainty; this assumption is however often violated, perhaps particularly often when epidemiological data form the source of the risk assessment, and regulatory authorities have occasionally resorted to some average based on competing models. The recent methodology of Bayesian model averaging might be a systematic version of this, but is this an arena for the Precautionary Principle to come into play?     

Precautionary Health Risk Assessment: Case Study of Biological Insecticides

In conventional risk assessment approaches, experts define the scientific questions that can legitimately be asked and the burden of proof is on the potentially exposed community to show that a proposal is unsafe. Here I propose an alternative approach, precautionary health risk assessment, in which the scientific questions to be addressed are defined by community consultation. I illustrate the approach with a case study of exposure to biological insecticides. This illustrates how community consultation can have a critical influence on the outcome of a health risk assessment. Government agencies may be reluctant to involve stakeholders in health risk assessments because this involves a loss of political control of the process. However, precautionary approaches are likely to lead to better health outcomes where decision stakes and scientific uncertainty are both high.     

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.     

Global Climate Change and the Precautionary Principle

The precautionary principle is promoted as a common sense approach that avoids unreasonable delays in taking action. A weak form of the precautionary principle, that action should not wait until all uncertainties are resolved, is indeed common sense and consistent with even the most elementary application of the methods of decision making under uncertainty to the climate change problem. The standard tools of decision analysis imply conclusions consistent with a weak precau tionary principle of taking some action before all the evidence is in. Decision theory also reveals what the basis is for stronger recommendations from the precautionary principle, to the effect that action should be based on the most pessimistic possible interpretation of the future. This conclusion is only possible if prior beliefs are so pessimistic and so strong that they would outweigh any possible new scientific evidence.     

Unraveling the Chimera: A Corporate View of the Precautionary Principle

Current controversy regarding how and when the precautionary principle should be applied to the introduction of new technology has created a false dichotomy, a dichotomy between conventional, risk-based decision making and an alternative paradigm that seemingly denounces risk assessment. As we compare views of the precautionary principle relative to our own operating standards for ensuring human and environmental safety, we perceive no irreconcilable conflict. Due precaution is entirely consistent with sound, cost-effective management of the risks and uncertainties inherent in new technologies. The principle guides prudent risk management actions under a prescribed set of circumstances, i.e., potentially serious or irreversible risks, or incomplete characterization (high uncertainty). In order to enable technological innovation toward a more sustainable future, it is critical that any preventative measures taken under these circumstances be provisional in nature, pending adequate risk characterization. As with all risk management decisions, we contend that the principle requires consideration of a suite of factors beyond risk assessment, including political, social, legal and cultural considerations to tailor the measures proportionately to the risk at hand. Overall, we are encouraged to find relatively broad agreement in this interpretation with a number of key multinational governmental and trade institutions.     

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.     

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 and Chemical Regulation in the U.S.

Although the statutory goals for chemical regulation are consistent with the precau tionary principle, the current U.S. regulatory program governing synthetic chemicals generally adopts little precautionary controls for the manufacture of most chemicals. For the vast majority of chemicals in use, current law places the burden of producing scientific evidence on the regulatory agency, which actually may serve to discourage companies from testing the safety of their chemicals, since the results could then be used against them in regulatory proceedings. By contrast, for a small subset of chemicals — new chemicals that belong to suspect categories — regulatory controls are quite precautionary. The result of this schizophrenic approach to chemical regulation is a regulatory system that is characterized by the absence of preventative regulation for most existing chemicals, an inequitable barrier to entry for newer safer chemicals, and a lack of information upon which to understand the safety of most chemicals in the U.S. Informal reforms of the current regulatory program are already underway to provide a more consistent and precautionary approach to chemical regulation, although to fully advance the dual goals of regulatory consistency and precaution in the regulation of chemicals, legislative action is necessary.     

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.     

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 release of genetically modified crops into the environment. Part I. Overview of current status and regulations

In the past 6 years, the global area of commercially grown, genetically modified (GM) crops has increased more than 30-fold to over 52 million hectares. The number of countries involved has more than doubled. Especially in developing countries, the GM crop area is anticipated to increase rapidly in the coming years. Despite this high adoption rate and future promises, there is a multitude of concerns about the impact of GM crops on the environment. Regulatory approaches in Europe and North America are essentially different. In the EU, it is based on the process of making GM crops; in the US, on the characteristics of the GM product. Many other countries are in the process of establishing regulation based on either system or a mixture. Despite these differences, the information required for risk assessment tends to be similar. Each risk assessment considers the possibility, probability and consequence of harm on a case-by-case basis. For GM crops, the impact of non-use should be added to this evaluation. It is important that the regulation of risk should not turn into the risk of regulation. The best and most appropriate baseline for comparison when performing risk assessment on GM crops is the impact of plants developed by traditional breeding. The latter is an integral and accepted part of agriculture.