Multi‐Case Review of the Application of the Precautionary Principle in European Union Law and Case Law

The precautionary principle was formulated to provide a basis for political action to protect the environment from potentially severe or irreversible harm in circumstances of scientific uncertainty that prevent a full risk or cost‐benefit analysis. It underpins environmental law in the European Union and has been extended to include public health and consumer safety. The aim of this study was to examine how the precautionary principle has been interpreted and subsequently applied in practice, whether these applications were consistent, and whether they followed the guidance from the Commission. A review of the literature was used to develop a framework for analysis, based on three attributes: severity of potential harm, standard of evidence (or degree of uncertainty), and nature of the regulatory action. This was used to examine 15 pieces of legislation or judicial decisions. The decision whether or not to apply the precautionary principle appears to be poorly defined, with ambiguities inherent in determining what level of uncertainty and significance of hazard justifies invoking it. The cases reviewed suggest that the Commission's guidance was not followed consistently in forming legislation, although judicial decisions tended to be more consistent and to follow the guidance by requiring plausible evidence of potential hazard in order to invoke precaution.     

Application of the Precautionary Principle by Senior Policy Officials: Results of a Canadian Survey

Though use of the controversial precautionary principle in risk management has increasingly been recommended as a guide for the construction of public policy in Canada and elsewhere, there are few data available characterizing its use in risk management by senior public policymakers. Using established survey methodology we sought to investigate the perceptions and terms of application of the precautionary principle in this important subset of individuals. A total of 240 surveys were sent out to seven departments or agencies in the Canadian government. The overall survey response rate was 26.6%, and our findings need to be interpreted in the context of possible responder bias. Of respondents, the overwhelming majority perceived the precautionary principle and the management of risk as complementary, and endorsed a role for the precautionary principle as a general guideline for all risk management decisions. However, 25% of respondents responded that the lack of clarity of the definition of the principle was a limitation to its effective use. The majority of respondents viewed their own level of understanding of the precautionary principle as moderate. Risk managers appeared to favor an interpretation of the precautionary principle that was based on the seriousness and irreversibility of the threat of damage, and did not endorse as strongly the need for cost effectiveness in the measures taken as a precaution against such threats. In contrast with its perceived role as a general guideline, the application of the precautionary principle by respondents was highly variable, with >60% of respondents reporting using the precautionary principle in one-quarter or less of all risk management decisions. Several factors influenced whether the precautionary principle was applied with the perceived seriousness of the threat being considered the most influential factor. The overwhelming majority of risk managers felt that "preponderance of evidence" was the level of evidence required for precautionary action to be instituted against a serious negative event. Overall, the majority of respondents viewed the precautionary principle as having a significant and positive impact on risk management decisions. Importantly, respondents endorsed a net result of more good than harm to society when the precautionary principle was applied to the management of risk.     

The Precautionary Principle Versus Risk Analysis

Precautionary behavior serves a valuable protective purpose as a first response to the new. It causes a quick retreat to the safety of the familiar; it provides time for a realistic "friend or foe" assessment of a new event. This rational assessment is often delayed by the sluggishness of government bureaucratic processes, or stopped by an implied challenge to a status quo. At the public level, reassurance may be slow to overcome an early uncertainty. However, a precautionary response does not provide an operational governing principle, although it makes publicly plausible an indefinite concealment of de facto political actions, or nonaction. The alternative of rational decision making at the policy level should flow from a comparative benefit/cost/risk analysis. Such early risk analyses have pragmatic uncertainties based on the limited available knowledge base and, accordingly, require judgmental application.     

Risk Management and the Precautionary Principle: A Fuzzy Logic Model

The aim of this article is to illustrate a procedure for applying the precautionary principle within a strategy for reducing the possibility of underestimating the effective risk caused by a phenomenon, product, or process, and of adopting insufficient risk reduction measures or overlooking their need. We start by simply defining risk as the product between the numerical expression of the adverse consequences of an event and the likelihood of its occurrence or the likelihood that such consequences will occur. Uncertainty in likelihood estimates and several key concepts inherent to the precautionary principle, such as sufficient certainty, prevention, and desired level of protection, are represented as fuzzy sets. The strategy described may be viewed as a simplified example of a precautionary decision process that has been chiefly conceived as a theoretical contribution to the debate concerning the precautionary principle, the quantification of its application, and the formal approach to such problems.     

On the Risk Management and Risk Governance of Petroleum Operations in the Barents Sea Area

In this article, we discuss issues of risk management and risk governance with respect to petroleum operations in the Barents Sea area. We will focus on the decision problems related to whether or not to open the Barents Sea for petroleum activities in special vulnerable areas. We will explore to what extent the International Risk Governance Council risk governance framework provides valuable insights for and assistance to the decisionmaker and other stakeholders (including the industry and NGOs). The study covers issues related to risk assessment and appraisal, risk acceptance and tolerability, the use of the precautionary principle, risk perception, stakeholder involvement, risk communication, and risk management. The overall aim of the article is to point to areas where the risk governance could have been and can be improved for these and similar decision problems.     

The 1991 Cholera Epidemic in Peru: Not a Case of Precaution Gone Awry

The precautionary principle calls on decisionmakers to take preventive action in light of evidence indicating that there is a potential for harm to public health and the environment, even though the nature and magnitude of harm are not fully understood scientifically. Critics of the precautionary principle frequently argue that unbridled application of the principle leads to unintended damage to health and ecosystems (risk tradeoffs) and that precautious decision making leaves us vulnerable to "false-positive" risks that divert resources away from "real risks." The 1991 cholera epidemic in Peru is often cited as an example of these pitfalls of the precautionary principle. It has been mistakenly argued that application of the precautionary principle caused decisionmakers to stop chlorinating the water supply due to the risks of disinfection byproducts (DBPs), resulting in the epidemic. Through analyses of investigations conducted in the cities of Iquitos and Trujillo, Peru, literature review, and interviews with leading Peruvian infectious disease researchers, we determined that the epidemic was caused by a much more complex set of circumstances, including poor sanitation conditions, poor separation of water and waste streams, and inadequate water treatment and distribution systems. The evidence indicates that no decision was made to stop chlorinating on the basis of DBP concerns and that concerns raised about DBPs masked more important factors limiting expansion of chlorination. In fact, outside of Peru's capital Lima, chlorination of drinking water supplies at the time of the epidemic was limited at best. We conclude that the Peruvian cholera epidemic was not caused by a failure of precaution but rather by an inadequate public health infrastructure unable to control a known risk: that of microbial contamination of water supplies.     

Anticipating or Accommodating to Public Concern? Risk Amplification and the Politics of Precaution Reexamined

Regulatory use of the precautionary principle (PP) tends to be broadly characterized either as a responsible approach for safeguarding against health and environmental risks in the face of scientific uncertainties, or as “state mismanagement” driven by undue political bias and public anxiety. However, the “anticipatory” basis upon which governments variably draw a political warrant for adopting precautionary measures often remains ambiguous. Particularly, questions arise concerning whether the PP is employed preemptively by political elites from the “top down,” or follows from more conventional democratic pressures exerted by citizens and other stakeholders from the “bottom up.” This article elucidates the role and impact of citizen involvement in the precautionary politics shaping policy discourse surrounding the U.K. government's “precautionary approach” to mobile telecommunications technology and health. A case study is presented that critically reexamines the basis upon which U.K. government action has been portrayed as an instance of anticipatory policy making. Findings demonstrate that the use of the PP should not be interpreted in the preemptive terms communicated by U.K. government officials alone, but also in relation to the wider social context of risk amplification and images of public concern formed adaptively in antagonistic precautionary discourse between citizens, politicians, industry, and the media, which surrounded cycles of government policy making. The article discusses the sociocultural conditions and political dynamics underpinning public influence on government anticipation and responsiveness exemplified in this case, and concludes with research and policy implications for how society subsequently comes to terms with the emergence and precautionary governance of new technologies under conflict.     

The Precautionary Principle Is Incoherent

This article argues that no version of the precautionary principle can be reasonably applied to decisions that may lead to fatal outcomes. In support of this strong claim, a number of desiderata are proposed, which reasonable rules for rational decision making ought to satisfy. Thereafter, two impossibility theorems are proved, showing that no version of the precautionary principle can satisfy the proposed desiderata. These theorems are directly applicable to recent discussions of the precautionary principle in medicine, biotechnology, environmental management, and related fields. The impossibility theorems do not imply, however, that the precautionary principle is of no relevance at all in policy discussions. Even if it is not a reasonable rule for rational decision making, it is possible to interpret the precautionary principle in other ways, e.g., as an argumentative tool or as an epistemic principle favoring a reversed burden of proof.     

Exploring Risk Judgments in a Trade Dispute Using Bayesian Networks

Bayesian networks (BNs) are graphical modeling tools that are generally recommended for exploring what‐if scenarios, visualizing systems and problems, and for communication between stakeholders during decision making. In this article, we investigate their potential for exploring different perspectives in trade disputes. To do so, we draw on a specific case study that was arbitrated by the World Trade Organization (WTO): the Australia‐New Zealand apples dispute. The dispute centered on disagreement about judgments contained within Australia's 2006 import risk analysis (IRA). We built a range of BNs of increasing complexity that modeled various approaches to undertaking IRAs, from the basic qualitative and semi‐quantitative risk analyses routinely performed in government agencies, to the more complex quantitative simulation undertaken by Australia in the apples dispute. We found the BNs useful for exploring disagreements under uncertainty because they are probabilistic and transparently represent steps in the analysis. Different scenarios and evidence can easily be entered. Specifically, we explore the sensitivity of the risk output to different judgments (particularly volume of trade). Thus, we explore how BNs could usefully aid WTO dispute settlement. We conclude that BNs are preferable to basic qualitative and semi‐quantitative risk analyses because they offer an accessible interface and are mathematically sound. However, most current BN modeling tools are limited compared with complex simulations, as was used in the 2006 apples IRA. Although complex simulations may be more accurate, they are a black box for stakeholders. BNs have the potential to be a transparent aid to complex decision making, but they are currently computationally limited. Recent technological software developments are promising.     

Risk Assessment for Invasive Species

Although estimates vary, there is a broad agreement that invasive species impose major costs on the U.S. economy, as well as posing risks to nonmarket environmental goods and services and to public health. The domestic effort to manage risks associated with invasive species is coordinated by the National Invasive Species Council (NISC), which is charged with developing a science-based process to evaluate risks associated with the introduction and spread of invasive species. Various international agreements have also elevated invasive species issues onto the international policy agenda. The World Trade Organization (WTO) Sanitary and Phytosanitary (SPS) Agreement establishes rights and obligations to adhere to the discipline of scientific risk assessment to ensure that SPS measures are applied only to the extent required to protect human, animal, and plant health, and do not constitute arbitrary or unjustifiable technical barriers to trade. Currently, however, the field of risk assessment for invasive species is in its infancy. Therefore, there is a pressing need to formulate scientifically sound methods and approaches in this emerging field, while acknowledging that the demand for situation-specific empirical evidence is likely to persistently outstrip supply. To begin addressing this need, the Society for Risk Analysis Ecological Risk Assessment Specialty Group and the Ecological Society of America Theoretical Ecology Section convened a joint workshop to provide independent scientific input into the formulation of methods and processes for risk assessment of invasive species to ensure that the analytic processes used domestically and internationally will be firmly rooted in sound scientific principles.     

Building Blocks for a Precautionary Approach to the Use of Nanomaterials: Positions Taken by Trade Unions and Environmental NGOs in the European Nanotechnologies Debate

As partners in the European capacity‐building project NanoCap, trade unions and environmental nongovernmental organizations (NGOs) have established positions on the development of nanotechnologies. Key in their positioning is their view that the use of nanomaterials with currently unknown occupational and environmental hazards must have consequences for the risk management and use of nanoproducts. They have made proposals for responsible manufacturing and for applying the precautionary principle to the use of nanoproducts and they urgently call for the acceptance and the operationalization of a precautionary approach by the industry and governments. The trade unions and NGOs are calling for transparency and openness regarding processes and products that contain nanomaterials and have proposed specific tools for nanomaterial use that put the precautionary principle into practice, including the principles no data → no exposure and no data → no emission. The proposed tools also include compulsory reporting of the type and content of nanoparticles applied in products, a register of workers possibly exposed to nanoparticles, and the use of nano reference values as guides to assess workplace exposure to nanoparticles.     

Does Concern‐Driven Risk Management Provide a Viable Alternative to QRA?

This article discusses a concept of concern-driven risk management, in which qualitative expert judgments about whether concerns warrant specified risk management interventions are used in preference to quantitative risk assessment (QRA) to guide risk management decisions. Where QRA emphasizes formal quantitative assessment of the probable consequences caused by the recommended actions, and comparison to the probable consequences of alternatives, including the status quo, concern-driven risk management instead emphasizes perceived urgency or severity of the situation motivating recommended interventions. In many instances, especially those involving applications of the precautionary principle, no formal quantification or comparison of probable consequences for alternative decisions is seen as being necessary (or, perhaps, possible or desirable) prior to implementation of risk management measures. Such concern-driven risk management has been recommended by critics of QRA in several areas of applied risk management. Based on case studies and psychological literature on the empirical performance of judgment-based approaches to decision making under risk and uncertainty, we conclude that, although concern-driven risk management has several important potential political and psychological advantages over QRA, it is not clear that it performs better than (or as well as) QRA in identifying risk management interventions that successfully protect human health or achieve other desired consequences. Therefore, those who advocate replacing QRA with concern-driven alternatives, such as expert judgment and consensus decision processes, should assess whether their recommended alternatives truly outperform QRA, by the criterion of producing preferred consequences, before rejecting the QRA paradigm for practical applications.     

Risk Analysis, Life Cycle Assessment—The Common Challenge of Dealing with the Precautionary Frame (Based on the Toxicity Controversy in Sweden and the Netherlands)

Life cycle impact assessment (LCIA) and comparative risk assessment (RA) use the same building blocks for analyzing fate and potential effects of toxic substances. It is tacitly assumed that emission-effect calculations can give uniform and decisive answers in debates on toxicity problems. For several decades, mainstream policy sciences have taken a different starting point when analyzing decision making on complex, controversial societal issues. Such controversies in essence are thought to be caused by the fact that different actor coalitions adhere to a different, but in scientific terms equally reasonable, conceptualization or "framing" of the problem. A historical, argumentative analysis of the Dutch chlorine debate and the Swedish PVC debate shows that this is also true in the discussions on toxic substances. Three frames have been identified, which were coined the "risk assessment frame," "the strict control frame," and the "precautionary frame." These frames tacitly disagree about the extent of knowledge/ignorance about the impacts of substances, the robustness/fallibility of emission-reduction schemes, and the robustness/vulnerability of nature. The latter frame, adhered to by environmentalists, seeks to judge substances mainly on their inherent safety. Under the current institutional arrangements and practices, RA and LCIA are executed mainly in line with the philosophy expressed by the risk assessment frame. This article gives various suggestions for dealing with framing in debates on toxic substances. One of the options is elaborated in somewhat more detail, i.e., the development of multiple indicators and calculation schemes for RA and LCIA that reflect the different frames. An outline is given for a possible indicator system reflecting the precautionary principle.     

The Precautionary Principle Has Not Been Shown to Be Incoherent: A Reply to Peterson

In this journal, I have objected to Peterson's 2006 claim that the precautionary principle is an incoherent decision rule. I defend my objections to Peterson's recent replies, and I still claim that the precautionary principle has not been shown to be incoherent.     

Rapid Benefit-Risk Assessments: No Escape from Expert Judgments in Risk Management

The "human health impacts assessment" described by Cox and Popken (this issue) is intended to be a benefit-risk tool that avoids pitfalls of using expert judgments for policy analysis or during strict application of the precautionary principle in risk management. The proposed benefit-risk calculation uses numerous assumptions and suppositions to calculate a ratio of quality-adjusted life years (QALYs) lost for the number of human illness days prevented by the use of a food-animal antimicrobial drug, to the number of human illness days caused by the use of the antimicrobial drug. Assumptions about data--e.g., expert judgments on the representativeness of parameter estimates--are commonly used in risk assessment and risk management, including Cox and Popken's method. Cox and Popken apply the technique to specific examples of enrofloxacin and macrolides antimicrobial drugs, sometimes used in broiler chickens for human food. Although enthusiastically portrayed as a straightforward calculation of QALYs lost for two decision alternatives, Cox and Popken were silent on the pivotal expert judgment subsumed in their method: quality weights for illnesses caused by antimicrobial-resistant and antimicrobial-sensitive microbes are tacitly assumed to be equal. Yet, the costs in terms of prolonged illness, additional medications, repeat medical visits, and dread of more serious sequelae are expected to differ substantially for antimicrobial-resistant versus antimicrobial-sensitive illnesses. Despite their enthusiasm to the contrary, the "human health impacts assessment" by Cox and Popken is not immune from expert judgments in risk management.     

中欧纺织品贸易障碍分析与国际市场营销策略研究

近几年来,我国与欧盟纺织服装进出口贸易不断增长,中国业已成为欧盟纺织服装进口消费的第一大供应国,同时也是欧盟诸国纺织服装原材料出口的第二大市场。随着中国加入WTO日期的逐渐临近,中欧纺织品贸易也面临着众多的机遇与挑战。本文从分析中欧纺织品贸易发展障碍入手,着重研究了影响中欧贸易发展的障碍因素,并从国际市场营销的角度,探讨开拓欧盟市场的国际营销策略。     

Risk Communication in the Real World

Rigorous health risk assessments of site-specific projects are generally little understood by nontechnical decision makers and the public and often appear to them to obfuscate a straightforward answer to their fundamental question: “Is the project safe?” The focus on risk, usually out of context of benefits, deprives the reader of the opportunity to make a fully informed decision on the proposal. While the risk assessment tools may need to be refashioned, confidence in the analytical process can be improved, partly through more citizen involvement, as well as through more effective communication of the conservatism of the assumptions, the thoroughness of the process, and the significance of the results in comparison to other commonly accepted involuntary exposures and risks.     

Quantitative Estimates of Risk for Noncancer Endpoints

While quantitative estimates of risk have been a standard practice in cancer risk assessment for many years, no similar practice is evident in noncancer risk assessment. We use two recent examples involving methylmercury and arsenic to illustrate the negative impact of this discrepancy on risk communication and cost-benefit analysis. We argue for a more balanced treatment of cancer and noncancer risks and suggest an approach for reaching this goal.