July 27, 2018

European Court of Justice Rules that Genetically Edited Crops Are Not Exempt From GMO Regulation

Several technological waves of genetic modification of crops have ensued over the last several decades. Genetic engineering has generally referred to the insertion of genetic material into an existing organism (often described as transgenic). Genetic editing is a later wave of genetic intervention, involving the direct alteration of a gene’s sequence on site (this CRISPR-fueled technology taking off since about 2012). A conceptual question of recent origin is whether both transgenic and genetically edited crops are classified as genetically modified organisms (GMOs). In the U.S., regulators have decided that genetically edited crops will not require any specific regulation, unlike transgenic organisms. In March, the U.S. government announced that it would not impose any particular regulation on genetically edited crops, regarding such crops as closer to those derived from traditional mutagenenesis. The U.S. Department of Agriculture (USDA) stated:
Under its biotechnology regulations, USDA does not regulate or have any plans to regulate plants that could otherwise have been developed through traditional breeding techniques as long as they are not plant pests or developed using plant pests. This includes a set of new techniques that are increasingly being used by plant breeders to produce new plant varieties that are indistinguishable from those developed through traditional breeding methods. The newest of these methods, such as genome editing, expand traditional plant breeding tools because they can introduce new plant traits more quickly and precisely, potentially saving years or even decades in bringing needed new varieties to farmers.
A new ruling from the European Court of Justice addresses whether genetically edited crops fall within the 2001 E.U. Directive on the Deliberate Release of Genetically Modified Organisms:
In today’s judgment, The European Court of Justice takes the view, first of all, that organisms obtained by mutagenesis are GMOs within the meaning of the GMO Directive, in so far as the techniques and methods of  mutagenesis alter  the  genetic  material  of  an  organism  in  a  way  that  does  not  occur  naturally. It  follows  that those organisms come,in principle, within  the  scope  of  the  GMO Directive and are subject to the obligations laid down by that directive.
In keeping with its more stringent regulation of genetically engineered (transgenic) crops, the E.U. has decided to maintain a cohesive scheme for modern genetic technologies, classifying genetically edited crops as GMOs. In contrast, the U.S. has bifurcated its oversight of genetically altered crops, with recent decision-making that allows genetically edited crops to advance quickly in field testing.

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