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.     

Reliability rating and reflective questioning: a case study of extended review on Australia's risk assessment of Bt cotton

The governance of emerging technologies is frequently constructed around risk assessment processes. However, when risk assessment as a decision‐making tool is applied to controversial fields such as genetic modification, stem cell research and nano‐scaled science and technology, inherent uncertainties and conflicting social values arise to challenge the adequacy of traditional approaches. In this paper, I propose a framework through which risk assessments may be exposed to a process of ‘extended review’, incorporating both natural and social science quality criteria and modes of reflection. I call this framework ‘Reliability Rating and Reflective Questioning’. The framework is developed through a detailed case study review of a particular risk assessment document. The case study risk assessment reviewed in this paper is that performed by an Australian governmental authority on the impact of genetically modified ‘Bt’ cotton on non‐target organisms. Through highlighting errors, misrepresentations, assumptions and embedded value judgements within the risk assessment document, I argue that the framework of ‘Reliability Rating and Reflective Questioning’ can serve as a useful tool for gauging and improving the quality of risk assessment, especially when used as a decision‐making tool for emerging technologies with high levels of uncertainty and strongly conflicting values.     

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.     

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 ‘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.     

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.     

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.     

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.     

Towards Analytic‐deliberative Forms of Risk Governance in the UK? Reflecting on Learning in Radioactive Waste

While participatory forms of risk assessment and management have been the focus of much conceptualisation, experimentation, and evaluation, relatively less effort has gone into understanding how so called ‘analytic‐deliberative’ processes are developing across policy‐for‐real decision contexts. This paper develops a novel typology of citizen‐science interaction as a basis for analysing the nature and extent of recent participatory risk assessment practice in the UK. It draws on the reflections of professional actors operating across the UK environmental risk domain, focusing down on practice in the area of radioactive waste between 1998 and 2003. Compared with past science‐centred approaches, analysis shows an ‘opening up’ of risk decision processes to extended actors, knowledges, and values, with particular importance placed on public involvement in front‐end framing. This is being constrained by a failure to integrate engagement throughout decision processes, the exclusion of publics from assessing/evaluating environmental risks, and the upholding of a strict separation between citizens/science. These patterns of analytic‐deliberative practice — determined by contextual influences, barriers and challenges operating across UK environmental risk issue‐areas — highlight the need for further methodological development and systematic evaluation of relations between processes and outcomes.     

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.     

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.     

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.     

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.     

A generalized probability framework to model economic agents' decisions under uncertainty

The applications of techniques from statistical (and classical) mechanics to model interesting problems in economics and finance have produced valuable results. The principal movement which has steered this research direction is known under the name of ‘econophysics’. In this paper, we illustrate and advance some of the findings that have been obtained by applying the mathematical formalism of quantum mechanics to model human decision making under ‘uncertainty’ in behavioral economics and finance. Starting from Ellsberg's seminal article, decision making situations have been experimentally verified where the application of Kolmogorovian probability in the formulation of expected utility is problematic. Those probability measures which by necessity must situate themselves in Hilbert space (such as ‘quantum probability’) enable a faithful representation of experimental data. We thus provide an explanation for the effectiveness of the mathematical framework of quantum mechanics in the modeling of human decision making. We want to be explicit though that we are not claiming that decision making has microscopic quantum mechanical features.     

Precautionary advice about mobile phones: public understandings and intended responses

There is a widespread academic and policy debate about public responses to precaution in public health campaigns. This paper explores these issues in relation to the precautionary stance adopted in the UK around the regulation of mobile telecommunications. The aim of the paper is to examine the nature of attitudes to precaution, and the way in which these, along with other relevant variables, relate to the intention to adopt relevant behaviours. The results from an experimental study (n = 173) indicate that people distinguish between two dimensions of precaution: firstly in relation to its value or necessity per se and secondly as anchored to notions of governance. The two variables differentially relate to other variables including trust and uncertainty, and are predictive of intended behaviour change indirectly, through worry about mobile phone risks. Precautionary advice was generally interpreted as causing concern rather than providing reassurance. The results suggest that precaution may be considered a valuable stance but this does not mean that it is seen as good governance or that it will reduce concern. Whilst the discourse of precaution is aimed at reducing concern, it appears that the uptake of relevant behaviours is largely triggered by worry.     

Ethical assessment in radioactive waste management: a proposed reflective equilibrium‐based deliberative approach

Radioactive waste management facility siting has often been surrounded by political controversy. By attempting to overcome accusations of technocracy, radioactive waste management organisations are reframing the problem in terms of socio‐technical issues requiring the integrative assessment of complex scientific, political and ethical issues and establishing analytic‐deliberative decision‐making processes involving public and stakeholder involvement. One important aspect of a publicly supportable radioactive waste management strategy is that adequate ethical assessment is incorporated throughout the process. There are, however, certain incompatibilities between pluralistic public and stakeholder‐led engagement processes and the types of ethical justification stemming from normative ethical theory and the input of ethical expertise. An evaluation of previous work on ethics by the UK Committee on Radioactive Waste Management highlights some of the pitfalls of utilising these types of ‘top‐down’ inputs in a primarily ‘bottom‐up’ decision‐making process. This paper then proposes the development of a new approach inspired by John Rawls's concept of ‘reflective equilibrium’, to better bridge the divide between pluralistic analytic‐deliberative decision‐making and ethical assessment.     

Science and proven experience: a Swedish variety of evidence-based medicine and a way to better risk analysis?

A key question for evidence-based medicine (EBM) is how best to model the way in which EBM should ‘[integrate] individual clinical expertise and the best external evidence’. We argue that the formulations and models available in the literature today are modest variations on a common theme and face very similar problems when it comes to risk analysis, which is here understood as a decision procedure comprising a factual assessment of risk, the risk assessment, and the decision what to do based on this assessment, the risk management. Both the early and updated models of evidence-based clinical decisions presented in the writings of Haynes, Devereaux and Guyatt assume that EBM consists of, among other things, evidence from clinical research together with information about patients’ values and clinical expertise. On this A-view, EBM describes all that goes on in a specific justifiable medical decision. There is, however, an alternative interpretation of EBM, the B-view, in which EBM describes just one component of the decision situation (a component usually based on evidence from clinical research) and in which, together with other types of evidence, EBM leads to a justifiable clincial decision but does not describe the decision itself. This B-view is inspired by a 100-years older version of EBM, a Swedish standard requiring medical decision-making, professional risk-taking and practice to be in accordance with ‘science and proven experience’ (VBE). In the paper, we outline how the Swedish concept leads to an improved understanding of the way in which scientific evidence and clinical experience can and cannot be integrated in light of EBM. How scientific evidence and clinical experience is integrated influences both the way we do risk assessment and risk management. In addition, the paper sketches the as yet unexplored historical background to VBE and EBM.     

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.