The Idea of Precaution: Ethical Requirements for the Regulation of New Biotechnologies in the Environmental Field.

The rapid emergence of new biotechnologies for selectively altering genetic material-so-called genome editing-has sparked public controversy about how their development and application in the environmental fields are to be regulated. Since the use of these new technologies harbors not only considerable potential but also risks of serious damage whose occurrence is uncertain due to their application in complex environmental systems, many national and international legal authorities are currently adhering to policies of precaution. According to critics, however, precautionary measures and the legal principle of precaution on which they are based are unduly restrictive in the case of the new biotechnologies, hindering advancements in both research and various fields of application. At the same time, legal notions of precaution are highly ambiguous within and across different national and international formulations, thereby further complicating the controversy about their implications. This paper goes beyond the concept of precaution as found in environmental law by examining the significance and the justification of precautionary measures in the environmental field. In particular, it clarifies the criterion of potential damage, disambiguates different types of epistemic bases in precaution decisions, and considers the relevance and implications of different ethical risk theories as to their response to epistemic uncertainty and vagueness. The two main conclusions are that, first, irrespective of the ethical risk theory embraced, there is an ethical obligation to take precautionary measures whenever serious damage is possible and the probability of damage occurring epistemically uncertain or vague. Regarding the risk assessment, it is argued that the burden of proof lies not with those who fear the occurrence of serious environmental damage. Rather, it is up to those whose actions give rise to such fears to demonstrate that serious damage is extremely improbable or scientifically absurd. Second, the moral responsibility to determine precaution situations and to specify appropriate precautionary measures is attributed not only to state authorities but also to industrial players as well as research communities. Based on these two conclusions, recommendations are given as to how the precautionary principle should be incorporated in political and legal decision-making.