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The precautionary nature of risk regulation in the European Union (EU) and the United States (US) is an ongoing debate. Theoretical contentions over 'who is more precautionary' confirm that the degree of relative precaution may lead to different levels of protection, but also suggest that precaution needs to be evaluated against different parts of the regulatory process. This paper addresses a new case of transatlantic split which has occurred with the adoption of the EU regulation on alien invasive species. This regulation aims to drive important changes at the trade–environment nexus and reflects Europe's integrated policy approach to environmental, health, and safety risks. We have carried out a comparative analysis by examining parts of the regulatory process. We argue that differences in legal and policy frameworks, risk assessment, and risk management structures have left the EU and the US wide apart as to their risk governance ambitions. The EU exhibits more precautionary approach with regard to these parts, as compared to the US. Our finding suggests that policy divergence, as reflected in this case, is true for both stringency and regulatory process, expanding literature discussions on precaution in these systems. Yet, with the EU's regulation being relatively new, there are still implementation issues up for debate. [ABSTRACT FROM AUTHOR]

Many critics of bioenhancement go to considerable lengths to establish the existence of reasons against pursuing bioenhancements but do little to establish the absence of reasons in favor. This suggests that they accept what Allen Buchanan has called the conclusive reasons view (CRV). According to this view, our reasons against bioenhancement are obviously decisive, so there is no need to balance them against countervailing reasons. Buchanan criticizes the CRV by showing that the reasons most commonly adduced against bioenhancement are not decisive, or, at least, not obviously so.In this article, I suggest that both Buchanan and the authors to whom he is responding underestimate the strength of the case for the CRV. There are, I argue, harm-based reasons against bioenhancement that provide stronger support to the CRV than the reasons that have most often been adduced by critics of enhancement. However, I then argue that even these harm-based reasons are not obviously decisive. Thus, I ultimately agree with Buchanan about the falsity of the CRV, though I disagree with him about the reasons for its falsity. [ABSTRACT FROM PUBLISHER]

The problem of collecting, analysing and evaluating evidence on adverse drug reactions is an example of the more general class of epistemological problems related to scientific inference and prediction, as well as a central problem of health care practice. Philosophical discussions have analysed critically the methodological pitfalls and epistemological implications of evidence assessment in medicine; however, they have focused predominantly on evidence of treatment efficacy. Most of this work is devoted to statistical methods of causal inference with a special focus on the privileged role assigned to randomized controlled trials ( RCTs) in evidence-based medicine. Regardless of whether the RCT's privilege holds for efficacy assessment, it is nevertheless important to make a distinction between causal inference in relation to intended and unintended effects, in that the unknowns at stake are heterogeneous in the two contexts. This point has been emphasized by epidemiologists in the last decade. Their primary focus is methodological and regards the fact that bias and confounding factors do not affect studies on intended and unintended effects in the same way. However, deeper concerns ground the intuition for such a distinction; these are related to the constraints we impose on evidence and their epistemological justification. My thesis is that such constraints ought to be understood as being different in evidence for risk versus for efficacy. I present the recent debate on the causal association between acetaminophen and asthma in order to illustrate the point at issue. The upshot of my analysis is that different epistemologies confer different methodological choices, which in turn bring about relevant practical implications such as the decision to restrict or suspend drug use rather than leaving it on the market. Thus, it is worth considering the criteria underlying our evidence constraints because they may be ill suited to the purpose for which they are used. [ABSTRACT FROM AUTHOR]

This essay examines the relationship between the precautionary principle and uncertainty factors used by toxicologists to estimate acceptable exposure levels for toxic chemicals from animal experiments. It shows that the adoption of uncertainty factors in the United States in the 1950s can be understood by reference to the precautionary principle, but not by cost-benefit analysis because of a lack of relevant quantitative data at that time. In addition, it argues that uncertainty factors continue to be relevant to efforts to implement the precautionary principle and that the precautionary principle should not be restricted to cases involving unquantifiable hazards. [Copyright &y& Elsevier]