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.     

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.     

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.     

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.     

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.     

Appraising the precautionary principle – a decision analysis perspective

The public and regulators are naturally concerned about any decision that has uncertain but potentially serious health and environmental consequences. When facing such decisions, some individuals say we should resolve significant uncertainties before taking expensive action that may be unnecessary. Others support the precautionary principle, which says that policy makers should err on the side of caution by acting now to avoid or limit potentially detrimental consequences. This paper appraises the precautionary principle from a perspective decision analytic point of view. We argue that neither the 'resolve uncertainties before taking action' nor the 'act now on the side of caution' are appropriate as general policies for all environmental decision problems. Instead, we conclude that policy makers need to conduct sound, in-depth analyses to resolve the pros and cons of acting now versus conducting more research on a case-by-case basis.     

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.     

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.     

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.     

From precautionary inadequacy to participatory risk management

This paper examines the case of mobile telephone infrastructure as an example of a contemporary risk defined by a lack of scientific evidence and consensus as regards potential or future harm. This uncertainty has led to recourse to the precautionary principle at the European, national, regional and local level of EMF risk management. Local risk governance of mobile telephone infrastructures in Catalonia can be seen as an example of a socio-technical complex system linked to risk perception which highlights the limitations of the precautionary principle in a scientifically uncertain context. Active participation of stakeholders and the public in risk management arenas is required if current technocratic risk management strategies are to be superseded by transparent processes of decision-making in risk management spheres.     

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.     

Problems with precaution: the transfusion medicine experience

The precautionary principle is a dominant paradigm governing risk-based decision-making. Today, there are increasing pressures to re-examine aggressive precautionary approaches, and to assess how the principle should be applied in the modern system. In this paper, we examined three key applications of precautionary approaches in the field of transfusion medicine to provide insight into the risks and benefits of these approaches. The three case studies examined were the donor deferral policies to safeguard against transfusion transmission of human immunodeficiency virus, variant Creutzfeldt–Jacob disease, and, lastly, xenotropic murine leukemia virus-related virus. Characterization of precautionary applications was conducted using an embedded case study design. Our findings indicate that transfusion transmission mitigation strategies have become increasingly aggressive in the face of theoretical risks. In contrast, the review processes for implementation and reversal of precautionary policies have been slow, and historical donor deferral policies are still in place today. Application of precautionary approaches has proved challenging with both benefits and pitfalls. In light of emerging threats to the blood system, policy-makers should consider the implementation of frameworks to guide the appropriate application of precaution in transfusion medicine in the future.     

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.     

Precautionary principle and discursive strategies: classifying and managing risks

The paper covers an integral risk concept consisting of a criteria-based risk evaluation, a novel proposal for risk classification and corresponding risk management strategies aimed at an analytic-deliberative approach in risk regulation. For this purpose, technical and scientific as well as social scientific concepts were integrated into a single conceptual framework. Eight criteria were selected for evaluating risks: probability of occurrence, extent of damage, incertitude, ubiquity, persistency, reversibility, delay effect and potential of mobilization. With respect to these criteria, six risk classes were formed in which risks may exceed thresholds determined by deliberative action. Effective and practicable management strategies were deduced for each risk class. The characterization and classification of risks provide a knowledge base for designing risk policies and class-specific management strategies. Three major management categories were identified: risk-based, precautionary and discursive strategies. In deliberative processes actors need to agree on norms and procedures to manage risks. If the results reflect the agreement of previous discourse procedures, political decisions become more legitimate. Because the risk evaluation, risk classification and management strategies are based on the concept of analytic-deliberative processes, the essential requirements for an effective and democratic risk policy are met.     

Public’s perceived overcrowding risk and their adoption of precautionary actions: a study of holiday travel in China

The importance of travel risk has been recognized, but only a limited number of studies have been conducted on this risk and the precautionary actions the public may take to manage it during holidays. This study applied the protective action decision model and the protection motivation theory to examine the public’s intent to take precautionary actions during holiday times to handle the risk of overcrowding in China. Our survey showed that efficacy-related attributes of precautionary actions were positively correlated, whereas resource-related attributes were negatively correlated, with the intention to take precautionary measures. Risk perception also significantly influenced the adoption intention, but the amount of variance in the intention to adopt precautionary actions that was motivated by risk perception was lower than that related to efficacy-related attributes. In addition, we found that risk perception mediated the influence of past overcrowding experiences on people’s intention to adopt precautionary measures. Travel frequency, length of time spent away for the holiday, and the number of underage family members involved were significantly correlated with the intention to adopt precautionary actions. Finally, this paper discussed suggestions and implications for travelers, tourist departments, and related stakeholders.     

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.     

Comparing precaution in the United States and Europe

The regulation of health and environmental risks has generated transatlantic controversy concerning precaution and the precautionary principle (PP). Conventional wisdom sees the European Union endorsing the PP and proactively regulating uncertain risks, while the United States opposes the PP and waits for evidence of harm before regulating. Without favouring either approach, this paper critically analyses the conventional depiction of transatlantic divergence. First, it reviews several different versions of the PP and their different implications. Second, it broadens the transatlantic comparison of precaution beyond the typical focus on single-risk examples, such as genetically modified foods. Through case studies, including hormones in beef and milk production and mad cow disease in beef and in blood donations, as well as reference to a wider array of risks, the paper demonstrates that relative precaution varies enormously. Sometimes the EU is more precautionary than the US (such as regarding hormones in beef), while sometimes the US is more precautionary than the EU (such as regarding mad cow disease in blood). Thus, neither the EU nor the US can claim to be categorically 'more precautionary' than the other. The real pattern is complex and risk-specific. Third, the paper seeks explanations for this complex pattern in five sets of hypotheses: optimal tailoring on the merits, political systems, risk perceptions, trade protectionism, and legal systems. None of these hypotheses fully explains the observed complex pattern of relative transatlantic precaution. The paper concludes that differences in relative precaution depend more on the context of the particular risk than on broad differences in national regulatory regimes.     

H1N1 – the social costs of élite confusion

In May 2011, the World Health Assembly will receive the report of its International Health Regulations Review Committee examining responses to the outbreak of the 2009 H1N1 pandemic influenza and identifying lessons to be learnt. This will emphasise the need for better risk communication in future. But risk and communication are not objective facts; they are socially mediated cultural products. Responses to crises are not only simply determined by the situation at hand, but also through mental models developed over protracted periods. Accordingly, those responsible for advocating the precautionary approach and encouraging the securitisation of health, that both helped encourage a catastrophist outlook in this instance, are unlikely to be held to account. These élite confusions have come at an enormous cost to society.     

Computing the finite-time expected discounted penalty function for a family of Lévy risk processes

Ever since the first introduction of the expected discounted penalty function (EDPF), it has been widely acknowledged that it contains information that is relevant from a risk management perspective. Expressions for the EDPF are now available for a wide range of models, in particular for a general class of Lévy risk processes. Yet, in order to capitalize on this potential for applications, these expressions must be computationally tractable enough as to allow for the evaluation of associated risk measures such as Value at Risk (VaR) or Conditional Value at Risk (CVaR). Most of the models studied so far offer few interesting examples for which computation of the associated EDPF can be carried out to the last instances where evaluation of risk measures is possible. Another drawback of existing examples is that the expressions are available for an infinite-time horizon EDPF only. Yet, realistic applications would require the computation of an EDPF over a finite-time horizon. In this paper we address these two issues by studying examples of risk processes for which numerical evaluation of the EDPF can be readily implemented. These examples are based on the recently introduced meromorphic processes, including the beta and theta families of Lévy processes, whose construction is tailor-made for computational ease. We provide expressions for the EDPF associated with these processes and we discuss in detail how a finite-time horizon EDPF can be computed for these families. We also provide numerical examples for different choices of parameters in order to illustrate how ruin-based risk measures can be computed for these families of Lévy risk processes.