From ‘mad cow’ crisis to synthetic biology: challenges to EU regulation of GMOs beyond the European context

This paper provides a historical and legal perspective of EU regulation on genetically modified organisms (GMOs)—through its initial development to its current position—in view of major advancements of modern molecular biotechnologies used for agriculture. We argue that the emergence and development of EU regulation of GMOs were shaped by antecedent events, notably bovine spongiform encephalopathy (BSE) or ‘mad cow disease’ and the public fears that ensued around food safety. These regulatory emergencies were a key factor prompting national governments and EU institutions to work out the framework for the application of the precautionary principle to agricultural biotechnology. Moreover, while modern biotechnology techniques eliminate many of the perceived health and safety risks of earlier predecessors, the EU regulatory framework has been slow to keep up, lacking the proper regulatory tools that allow for a balanced policy approach towards the techniques underlying genome editing and synthetic biology. Difference in approaches to the regulation of GMOs between the EU and US, to a large extent, precipitated the transatlantic conflict over agricultural biotechnology. Specifically, a significant incompatibility between the application of the precautionary principle in the EU and the substantial equivalence in the US to assess GM food and feed risk was the main reason for the international trade dispute. The ruling of the Court of Justice of the European Union that genome editing techniques will not be warranted exemption from authorisation process suggests that EU policy on agricultural biotechnology is likely to remain stringent. This may complicate the progress of synthetic biology and render the EU vulnerable to future food security and economic contingencies.