Applying Precaution in EU Authorisation of Genetically Modified Products—Challenges and Suggestions for Reform

Abstract

In this article, I endeavour to examine concrete challenges that arise with regard to implementation of the precautionary principle in the field of European Union regulation of genetically modified organisms (GMOs). Developed by the European courts into a general legal principle, precaution requires EU regulators to strike a balance between scientific and political legitimacy when taking decisions on risk-entailing products. Following this understanding, the current GMO legislation creates precautionary governance structures that allow for a broad input into the authorisation process, not only of scientific, but also of 'other legitimate factors'. At the same time, it can be criticised for narrowly defining precaution as a decision rule, which, if applied correctly, will lead the decision maker to the 'right' decision. I argue that this misconception is one of the reasons why, in the current authorisation practice, the EU institutions fail to apply the principle in a balanced way, falling into the extremes of either purely science-based decision making or a highly politicised precautionary rhetoric. I suggest that in order not to be paralysing, precaution should be understood as a procedural principle that provides for precautionary governance, thus enabling regulators to make appropriate risk choices.

Invited review: Breeding and ethical perspectives on genetically modified and genome edited cattle

“…In some cases, the damage done by denying the application might exceed the potential risks associated with a new technique (Hathcock, 2000). A balanced use of the precautionary principle has been advocated (Tait, 2001), and according to Weimer (2010), it should be seen rather as a procedural principle facilitating thorough reflection.…”

The Regulatory Challenge of Animal Cloning for Food – The Risks of Risk Regulation in the European Union

“…This means, however, that the precautionary principle (Article 191 II TFEU, ex Article 174 II EC Treaty) could eventually be invoked as a justification for the inclusion of food from cloned animals in the Novel Foods Regulation in view of the present insufficiency of scientific evidence. Without going into further detail here, it can be stated that the application of this principle in European risk regulation has until today been impeded by many difficulties, 45 one of them being its politicisation. The problematic example of EU regulation of GMOs 46 once again comes to mind: given the strong public opposition to and political contestation surrounding animal cloning at present, the scenario of a de-facto moratorium of the same kind as occurred in the Community authorisations of biotech products 47 can also be imagined for future authorisations of foods from cloned animals under the amended Novel Foods Regulation.…”

The Origins of “Risk” as an Idea and the Future of Risk Regulation

“…legal certainty, rights protection and for democratic legitimation), as can be seen in the controversy surrounding the application of the precautionary principle in EU regulation. 37 Legal practice and scholarship have to address this challenge not by retreating to out-dated doctrinal constructions, but by developing new concepts of uncertainty tolerant law. 38 So far, the EU's search for the "right" model of risk regulation has been accompanied by an inner struggle, and many contradictions both in legal norms and regulatory practices.…”