Tomorrow, the European Court of Justice is set to pronounce a verdict on the legal status of organisms produced through mutagenesis. In January, the opinion of the Advocate General Michal Bobek was variously interpreted, but scientists are hopeful that the judgment of Case C 528/16 will help the European Commission to reasonably regulate new breeding technologies such as CRISPR.
According to the analysis published by Nina Duensing et al. in Frontiers in Bioengineering and Biotechnology, during the hearing of October 3 last year, the EC vaguely stated that they were preparing something about this “new” problem, but expressed the opinion that mutagenesis is exempted from the Directive on deliberate release if no recombinant nucleic acid molecules are used. Indeed the regulatory trend throughout the world is not considering mutagenesis as subject to regulation under biosafety laws. The Frontiers article is a must-read to grasp how regulations could take into account the similarities and differences between traditional breeding, genetic engineering and genome editing. CRISPR and alike are in a state of “interpretative flexibility” which depends on social and political issues besides scientific and legal ones. Therefore the upcoming judgment will not be enough to answer the question “will edited crops be saved from the scourge of over-regulation?” However stakeholders’ reactions will shed some light on where the debate is going. Favourable opinions expressed by influential figures such as the organic leader Klaas Martens in America and the food entrepreneur Oscar Farinetti in Italy are just personal stances or the chance for a reset is real?