Obituary

The environmental risk associated with genetically modified organisms (GMO) implies that new approaches to risk assessment, risk management and risk communication are needed. In this paper we discuss the role of the precautionary principle in policy responses to GMO risk. We first discuss application of the criteria in the European Environment Agency report “Late lessons from early warnings: The precautionary principle 1896–2000” to environmental GMO risk, with focus on crop plants. Moreover, we discuss Bayesian analysis in the context of improving the informational basis for decision‐making under uncertainty. Finally, environmental uncertainties are intertwined with economic uncertainties. Providing incentives for improved risk assessment, risk management and risk communication is crucial for enhancing environmental and social responsibility and thereby facilitate implementation of precautionary approaches. We discuss environmental and social screening of companies as an example of how such incentives can be provided.     

The influence of the precautionary principle on science-based decision-making: questionable applications to risks of radiofrequency fields

The precautionary principle, recognized by the European Commission as a 'full-fledged and general principle of international law,' has been advanced as a paradigm for response to potential risks to the environment or health when scientific data are uncertain. But lacking the elements and operational qualities that characterize principles that have proven useful in law, politics, science, and ethics, the precautionary principle lends itself to regulation based on the perception of a threat or fear itself. In the absence of scientific evidence for risk, recent application of the precautionary principle to questions about radiofrequency electromagnetic fields of cellular telephones and cellular telephone base stations has produced wasteful and misguided regulations and questionable advice to the public. The formation of scientific 'fire brigades' is suggested for rapid acquisition of targeted scientific data needed so that precautionary policies on technologically driven issues can be based on quantitative risk assessment.     

Europe's precautionary principle: promise and pitfalls

The European Union, through a recent 'Communication' from the Commission, has sought to legitimize the precautionary principle while establishing criteria for adoption of appropriate precautionary measures. Although the precautionary principle is not new and indeed reflects a basic human instinct, this article argues that the EC makes a constructive contribution towards formalizing it by describing the principle in the context of established processes of risk analysis: objective scientific evaluation, risk assessment, risk management and risk communication. The EC's reference to a broad spectrum of precautionary measures, subject to specific managerial criteria, also offers some assurance that the principle shall be implemented through thoughtful processes of decision making. There are pitfalls in the EC approach that should be rectified in future refinements of the principle. Critical terms need to be defined, the evidentiary hurdles for precaution need to be clarified, and checks and balances against ill-considered application of the principle need to be strengthened. A systematic process of ranking hazards and targeting cost-effective protection opportunities should be implemented by the EC as a counterweight to enactment of precautionary measures on a crisis-by-crisis basis.     

The precautionary principle: an 'unprincipled' approach to biotechnology regulation

A tenet of administrative law, particularly in the United States, is that regulators must base their decisions on 'intelligible principles' to provide consistency, predictability, transparency and accountability. The precautionary principle, which purports to provide a new decision rule for making environmental decisions under conditions of uncertainty, fails to provide such an intelligible principle for making decisions. The precautionary principle is ambiguous on the use of the two major criteria currently used to make environmental decisions - significant risk and cost-benefit balancing - yet offers no new specific decision criteria in their place. The second fundamental problem with the precautionary principle is that it is based on the unsubstantiated premise that the current regulatory system is insufficiently protective. The current system already tends to err on the side of the safety, as it should, but the relevant question is just how precautious should we be? As illustrated by the example of genetically modified organisms, the prudent level of precaution depends on factors such as the magnitude, distribution and uncertainty of risks, the extent of exposure, and the trade-offs and lost benefits in foregoing the risk. These are precisely the factors that are considered under the current risk-based approach, which the precautionary principle seeks to replace.     

The EC courts' contribution to refining the parameters of precaution

By virtue of its ambiguity, it has largely been left to the courts to flesh out the scope and application of the precautionary principle. This paper examines the contribution made by EC courts to defining the parameters of precautionary decision making. In so doing, it illustrates that, though the precautionary principle is seen to operate in a number of regulatory contexts, discernible trends in judicial interpretations of precaution and the underlying notion of ‘uncertainty’ can nevertheless be identified. In contrast with early judgments, the courts are beginning to explicitly interpret risk assessment processes as having a pivotal role in determining precautionary intervention. Rather than finding simply that circumstances of uncertainty warrant precautionary measures, the courts have started to require that clear, or ‘concrete’, evidence of harm, deriving from risk assessment, is established before intervention is justified. This paper posits three explanations for this shift: (i) the ‘better regulation’ initiative within Europe; (ii) the Commission's Communication on the Precautionary Principle; and (iii) WTO litigation on precautionary safeguard measures. The judicial move to affiliate precaution with risk assessment processes in decision making can be seen as a reflection of these factors.     

Choosing between precautions for nanoparticles in the workplace: complementing the precautionary principle with caring

Workers who develop and use nanoparticles are on the front line of exposure to the purported risks of nanoparticles. Employers have a legal duty to protect their employees against any work-related harm. However, it is difficult to perform the required risk assessment and management when dealing with uncertainty. Risk ethicists have therefore argued for using the precautionary principle to guide such decisions on uncertain risks. In this paper, I argue that if we want to make use of innovative products, such as nanomaterials, but lack the knowledge and shared standards for choosing between protective measures, the precautionary principle is underdetermined. For the use of nanoparticles in working environments, there are several guidelines that suggest different precautionary strategies for dealing with their purported risks, but choosing between these guidelines proves difficult in the absence of a clear, scientific, decision principle. I therefore explore the ethics of care to develop a complementary decision criterion for the precautionary principle. From this perspective, the caring qualities of working relationships are key in comparing precautions with each other. I propose three conditions for assessing risk management strategies based on (1) the existence of a mutual concern for employee health and safety, (2) the connectedness and continuity of the relationships between employer and employee, and (3) the responsiveness of employers to employee needs. Using these criteria will support choosing between precautions, by shifting attention from the acceptability of imposing a risk to creating a social context in which the imposition of the residual risks can be considered acceptable.     

How to deal with dissent among experts. Risk evaluation of EMF in a scientific dialogue

This article describes the results of a scientific discourse which aimed at exploring the reasons for differences in expert health risk assessment of radio frequency electromagnetic fields of mobile telephony.

It starts with describing the structure of the discourse. Then, the reasons for the conflicting risk assessments are discussed. Differences are due to the selection and evaluation of relevant scientific studies by applying different scientific quality standards, to the methods used for generating a research synthesis and an overall risk evaluation. Consensus could be achieved regarding the selection of and the quality requirements for the scientific studies used for risk assessment as well as their significance for risk evaluation. However, dissent remained about the synthesis of scientific evidence into an overall risk evaluation and about the relevance of the precautionary principle for risk evaluation and its implications for the risk assessment framework.

Based on the analysis of these problems, a transparent, consistent and rational procedure for risk assessment is suggested to facilitate a risk characterization which better meets the demands of policy making and the public for an appropriate risk evaluation.     

Procedure for the Implementation of the Precautionary Principle in Biosafety Commissions

In order to fulfil their responsibilities under the precautionary principle, biosafety commissions should lay down guidelines concerning the understanding and application of this principle and work towards an operational procedure. With this contribution, we propose a step‐wise procedure that aims to establish the understanding of the precautionary principle within biosafety commissions and to provide a methodological approach for the application of this principle to specific cases in the course of risk assessment. This approach is based on systematically investigating the consensus view within a group of 15 biosafety experts with the help of sets of checklists. For step 1, we propose a checklist of 13 criteria aimed at defining the understanding of the precautionary principle. For step 2, we propose 4 criteria for the decision on whether or not to use the precautionary principle. For step 3, 11 criteria for the use of the precautionary principle are presented. In step 4, additional criteria for specific applications could be included. In step 5, possible recommendations to decision‐making authorities are proposed.     

Forms of talk in policy dialogue: distinguishing between adversarial and collaborative discourse

Uncertainty, the precautionary principle and scenario are three important concepts in current regulatory debates concerned with risk management. In this paper, each concept is described in relation to its regulatory context and a linkage between the three concepts is established. Three scenarios relating to increasing scientific and technical uncertainty are presented. The most obvious regulatory approach to uncertainty is to ban a product, process or substance under the aegis of the precautionary principle. However, this may not be appropriate in all cases and a range of other possible policy responses to uncertainty are discussed and avenues for further research suggested.     

The precautionary principle and EMF: implementation and evaluation

The precautionary principle, a recommendation to consider action to avoid a possible harm even if it is not certain to occur, is variously defined and interpreted. We present a range of definitions with an emphasis on their requirements for strength of evidence of harm and for actions to be taken. We describe the variety of approaches that have been adopted in developing policy to address the issue of possible health effects of electric and magnetic fields (EMF) in the face of scientific uncertainty. Further, we discuss specific aspects of scientific uncertainty regarding EMF health risks particularly relevant to the development of precautionary principle policy. We define and discuss prudent avoidance and other unique features of applications of the precautionary principle to EMF. We conclude with examples from EMF policy decisions of risk tradeoffs that need to be considered in developing any precautionary principle policy, and provide recommendations for better ways to define and implement the precautionary principle.     

Technocratic precautionary principle: Korean risk governance of mad cow disease

This study investigates the multiplicity of sciences and the assemblage of technocracy with the precautionary principle (PP) in the Korean risk governance of mad cow disease (Bovine Spongiform Encephalopathy [BSE]). It conducts a policy typological analysis and a sociocultural analysis of the PP. Korean BSE policies are built on the technocratic PP. This principle emphasizes the scientific evidence of risk, although taking precautionary policy actions against BSE. This principle led to the absence of a total BSE inspection, a specified risk material policy for Korean cattle, a Hazard Analysis and Critical Control Point policy for beef processing and circulation, and an animal feed ban on nonruminants. Moreover, the BSE debate is not one about a unified science vs. a unified PP, but rather it concerns complex struggles between PPs in alliance with different sciences.     

The morality of managing risk: paternalism,prevention and precaution,and the limits of proceduralism

A widespread trend in risk management recently might be described as proceduralismthe search for procedures by which parties can be brought together, in the hope of bypassing substantive moral and political disagreements. This article argues that there are severe limits to what can be expected of proceduralism, distinguishing four basic types. It goes on to argue that a central area of substantive disagreement that must be addressed in risk management theory concerns the scope of justifiable paternalism and the scope of justifications for measures that place obligations on the ground that people have limited rights to impose costs, harms or risks upon others. The article sets out an argument about how far paternalistic arguments can be taken, and under what kind of constraints paternalism is acceptable, before setting out for comparison similar considerations in respect of arguments about harms to others. The implications of these arguments for the idea of autonomy are explored. Finally, various formulations of the precautionary principle are considered in the light of these consideration, and consequently doubt is cast upon the merits of these formulations of precaution. The article concludes by drawing together the consequences for a post-proceduralist conception of risk management that recognizes the importance of addressing substantive moral and political arguments in the course of conflict resolution.     

Genetically modified plants and the precautionary principle

The European regulation of genetically modified plants is a particular example of technological risk management that has become an essential part of the management of change. The role of regulators in this management process, when there are demands for regulatory action concerning unquantified (and sometimes unquantifiable) technological risks – with regulation under conditions of uncertainty – is explored. Where the retrospective evidence concerning a postulated risk scenario is sparse, the precautionary principle (PP) may be invoked. The origins of the European regulatory system, which applied until 17 October 2002 (Directive 90/220), why this has been revised (Directive 2001/18) and the probable impact of this revision are described. This is illustrated with risk assessments that have accompanied submissions for marketing approval for genetically modified plants under Directive 90/220. Some of the problems associated with the PP and the regulation of GM plants are discussed.     

Decision-analytic refinements of the precautionary principle

In public decision making about uncertain technological hazards, the precautionary principle calls for prompt protective action rather than delay of protections until scientific uncertainty is resolved. The precautionary principle has a sound basis in decision theory, particularly in situations where the potential hazards are serious and the costs of protective actions are tolerable. This article suggests that the precautionary principle should be refined to address three complications: (1) situations where the exposures to be reduced or prevented may have beneficial as well as hazardous consequences; (2) situations where the protective action itself will create potential hazards; and (3) situations where targeted research investments, coupled with delay of protective action, are likely to support wiser public decisions than prompt protective action. Each of these complications is shown to be relevant to contemporary policy debates about application of the precautionary principle. The usefulness of the precautionary principle in public decision making will be enhanced if these decision-analytic refinements are adopted in formal definitions of the principle.     

Five charges against the precautionary principle

We defend the precautionary principle against five common charges, namely that it is ill-defined, absolutist, and a value judgement, increases risk-taking, and marginalizes science. We argue, first, that the precautionary principle is, in principle, no more vague or ill-defined than other decision principles and like them it can be made precise through elaboration and practice. Second, the precautionary principle need not be absolutist in the way that has been claimed. A way to avoid this is through combining the precautionary principle with a specification of the degree of scientific evidence required to trigger precaution, and/or with some version of the de minimis rule. Third, the precautionary principle does not lead to increased risk-taking, unless the framing is too narrow, and then the same problem applies to other decision rules as well. Fourth, the precautionary principle is indeed value-based, but only to the same extent as other decision rules. Fifth and last, the precautionary principle is not unscientific other than in the weak sense of not being exclusively based on science. In that sense all decision rules are unscientific.     

Application of early risk detection concepts and methods to environmental health. A German feasibility study

Early risk detection is essential for being able to address the most important environmental health risk‐topics in a persistent and prospective manner. In support of the action programme “Environment and Health” (APUG) of the German Federal Ministry of Health and Social Security (BMGS) and the Federal Ministry for the Environment, Nature Conservation, and Nuclear Safety (BMU) which recommended that a detection and evaluation system for the timely recognition of emerging risk problems be developed, a qualitative feasibility study was commissioned. The results of this study are presented here and support the development of an early risk detection system based on the insights gained from the investigation of case studies and the differentiation and presentation of a risk typology, methods, tools, and suggested organizational processes.

The study has shown that early risk detection includes the identification, characterization, evaluation and dissemination of information on possible risks as well as the circumstances of appearance and distribution. The goal is the recognition of possible risks in order for risk management to be able to introduce swift and appropriate measures. Consequently, it can also serve as an instrument towards further development of a balanced and structured implementation of the precautionary principle in the environmental health policy.     

The ‘Plateau‐ing’ of the European Better Regulation Agenda: An Analysis of Activities Carried out by the Barroso Commission

In this paper we examine cases commonly characterised as risk‐risk tradeoffs (i.e., creating new risks while solving existing ones), in an attempt to learn lessons that can be valuable for future regulatory decision‐making. A broad range of environmental and health literature was reviewed and numerous cases of proclaimed risk‐risk tradeoffs were analysed in order to determine: 1) why regulatory measures were initially taken, 2) why these measures caused a countervailing risk to emerge, 3) how tradeoffs could have been avoided, and 4) whether the case is a good example of a risk‐risk tradeoff. The analysis reveals that only a small number of these cases can actually be considered risk‐risk tradeoffs. In a large number of cases safer alternatives are and were available at the time decisions were made. In some cases the proclaimed risk‐risk tradeoff simply did not exist or occur, and in some cases countervailing risks were ignored for reasons unknown. In many cases, the countervailing risks could have been anticipated and avoided by proactively seeking safer alternatives, completing a tradeoff and impact assessment, or increasing stakeholder input in the decision‐making process. We conclude that concerns about risk‐risk tradeoffs are not a reasonable argument against future application of the precautionary principle. Indeed, sound decision‐making processes in the face of uncertainty should always consider and attempt to mitigate reasonable risk‐risk tradeoffs.     

GUEST EDITORIAL: Cutting corners in chemical risk limitation

The first genetically modified crops and foods to be approved for commercial use in the European Union have prompted intense controversy. Food retailers and processors have been forced to take up the concerns voiced by their customers. New networks of groups have formed to oppose the technology. In response to these pressures, regulators who approved the products have had to reconsider questions they had previously dismissed or officially resolved. Governments have devised more precautionary measures of various kinds. For example, they have increased the burden of evidence for demonstrating safety, have broadened the practical definition of the ‘adverse effects’ which must be prevented, and have devised marketstage precautions for such effects. These extra measures manage the risk debate as well as any risks. In such ways, the technocratic model of European harmonization is being challenged and superseded. This may allow differences in national practices to be viewed as valuable expert resources for a different harmonization model, rather than as deviations from a universal rational norm. Regulatory conflicts offer precautionary opportunities, which could lead to more flexible and democratic procedures. Theoretical perspectives – on risk, uncertainty, precaution, European integration, expertise and the internal market – help illuminate these possibilities.