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 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.     

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.     

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 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.     

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.     

The Precautionary Principle and Marine Environmental Protection: Slippery Shores,Rough Seas,and Rising Normative Tides

Law and policy implications of the precautionary principle in the field of marine environmental protection are explored in this paper in a three-part analysis. First, seven slippery aspects of the precautionary principle are highlighted, including confusion in terminology, definitional variations, definitional generalities, the spectrum of precautionary measures available, ongoing philosophical tensions and competing socioeconomic interests, debate over who should be responsible for making precautionary decisions, and limited interpretation by international tribunals. Second, the rather feeble precautionary responses to the tempestuous issues of climate change, hazardous chemicals, and overfishing are described. Third, the potential for the precautionary principle to synergize with human rights norms, such as the emerging right to a healthy environment, and other principles of sustainable development is discussed.     

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.     

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.     

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.     

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.     

Global Climate Change: Benefit-Cost Analysis vs. the Precautionary Principle

The precautionary principle appears to be directly applicable to the prospect that human activities will cause substantial changes to global climate. The magnitude and characteristics of the change in climate and its effects on human activities and unmanaged ecosystems are highly uncertain, potentially catastrophic, and nearly irreversible on human time scales. Nevertheless, the precautionary principle adds little to benefit cost analysis for evaluating climate policies. Benefit cost analysis can incorporate aversion to uncertainty about future outcomes, and also provides a method for balancing this concern against concern for uncertain near term policy costs. The policies favored by setting constraints on future outcomes, such as atmospheric stabilization and tolerable windows, may be less precautionary than the policies favored by benefit cost analysis, as benefit cost analysis can more readily accommodate concerns for moderate as well as severe harms. Concerns about possible climate catastrophes can also be incorporated in benefit cost analysis and, in any event, may have limited implications for policy choice.     

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.     

Toward a New Generation of Environmental Technology: The Need For Legislative Reform

Given near unanimity in the environmental and industrial communities about the need for a new generation of environmental technology, the policy process unfortunately lags behind in moving toward this objective. This article examines causes and remedies for this gap in the context of American environmental policy. U.S. environmental laws continue to be pervaded by structural biases against new technology, and the complexity of their administration exacerbates the problem. Within the last few years, several important reform initiatives have arisen from inside the regulatory community; however, these can only go so far, given the current statutory framework Congress, too long quiescent, needs to become involved. A legislative reform package is proposed consisting of four main elements: a legislative mandate that makes promotion of technological innovation an explicit environmental objective; elimination of structural features in current law that impede innovation; creation of a new framework for standard-setting and enforcement that puts every firm on a trajectory toward environmental and technological improvement; and enlisting regulation as a "demand-pull" for environmentally superior technology.     

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.     

Ecological restoration as precaution and not as restitutional compensation

Ecological restoration has become a major issue in environmental management. To overcome the backward orientation of the restoration concept (focusing on reference states and natural ecosystems) the introduction of a precautionary principle is proposed. The principle has been developed for decision-making under high uncertainty about the probability and severity of an environmental damage. Meanwhile, it has been accepted in many countries of the world as a guiding principle for environmental legislation. Likewise it is the basis for international conventions aiming at the conservation of biodiversity. Nevertheless, biodiversity is still neglected in large reclamation projects. Several links between precaution and restoration are described. Restoration can be used to prevent future damage. Otherwise restoration is plagued by uncertainty about the outcome of the measures and may have negative effects or even fail. An analysis of common evaluation methods of restoration projects shows that most approaches focus on comparison of restoration results with a reference state, and are thus useless in a precautionary context. Other methods (e.g. comparing restored with unrestored sites) require data gathered by long-term observation (monitoring) of socio-economically defined desired states (Leitbild). Two large-scale restoration projects are analyzed, coastal land reclamation in Korea and open cast mining reclamation in Germany. Both projects had or have honorific aims and are legally admissible. However, they violate both international law based on precaution and simple rules of prudence or wise use. Costly post hoc ‘restoration’ measures are the usual consequence.     

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.     

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.     

Old Efforts at New Uses: A Brief History of Chemurgy and the American Search for Biobased Materials

The American search for biobased and renewable raw materials has a long history of intermittent success and frustration. This article traces the history of the chemurgy movement-a precursor to what are now sometimes called agricultural "new uses" initiatives-from its context of the 1920s through its emergence as a political force in the mid-1930s, when chemurgy offered a strategy for industries and governments interested in reviving the agricultural economy and reducing dependence upon foreign sources of industrial raw materials. Chemurgists put pressure upon the U.S. Department of Agriculture to devote greater attention to crop utilization research, efforts that were operational in time to make important contributions to the U.S. economy during World War II. This article devotes considerable attention to the postwar era, a period not discussed in most histories of chemurgy. The article concludes with a tentative assessment of issues that caused chemurgy to falter in the past as well as precautionary lessons for the contemporary study of biobased materials.     

美国与欧盟的转基因食品安全性政策演变比对

随着转基因食品的研究与发展,人们对待转基因食品的态度表现为主要以美国和欧盟为主的两种代表性政策.美国采取遵循可靠科学原则,坚决反对预防原则,即对转基因食品采取积极支持,自愿标识的宽松政策;欧盟采取谨慎预防原则,必须标识和可追溯.从管理原则出发,结合相应采取的监管措施和相关条例,对两国从开始颁布转基因食品政策到当下态势的发展,并结合最新出台的政策进行跟踪分析,比对美国及欧盟对这些指令和条例的执行情况.