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European Union’s Top Court Rules on Gene-Editing Technology

  • The European Court of Justice has ruled that modern gene-editing methods which utilize direct DNA mutagenesis fall under current rules regulating organisms modified via incorporation of foreign DNA sequences. Whereas traditional genetic engineering involves the introduction of DNA into an organism’s genome, gene editing techniques allow the precise replacement of one DNA sequence with another or the removal of select sequences of a plant’s DNA. One of the more recognized technologies, known as CRISPR, involves cutting strands of DNA with molecular “scissors” where scientists can then insert a new DNA sequence.

  • In a statement, the Court of Justice said it “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.” While the ruling exempted crops produced through mutagenesis techniques which have been “conventionally used in a number of applications and have a long safety record,” ultimately, under this ruling, crops or livestock that have undergone gene editing through new mutagenesis techniques that have emerged since the adoption of the GMO Directive would need to be labeled as genetically modified.  In response, U.S. Secretary of Agriculture Sonny Perdue issued a statement criticizing the ruling. The statement reads, in part, “[g]overnment policies should encourage scientific innovation without creating unnecessary barriers or unjustifiably stigmatizing new technologies. Unfortunately, this week’s ECJ ruling is a setback in this regard in that it narrowly considers newer genome editing methods to be within the scope of the European Union’s regressive and outdated regulations governing genetically modified organisms.” The statement concludes that “USDA will re-double its efforts to work with partners globally towards science and risk-based regulatory approaches.”

  • The Court of Justice’s ruling comes as USDA’s Agricultural Marketing Service (AMS) works to implement the National Bioengineered Food Disclosure Standard (NBFDS). The comment period for the proposed rule closed on July 3, 2018, and the agency is now working to publish a final rule. As previously covered on this blog, the proposed rule defines “bioengineered food” as, “…a food that contains genetic material that has been modified through in vitro recombinant deoxyribonucleic acid (DNA) techniques and for which the modification could not otherwise be obtained through conventional breeding or found in nature.”  In the preamble to the proposed rule, USDA AMS notes that the proposed list concept for BE labeling would provide the vehicle through which AMS could evaluate whether foods resulting from particular technologies meet the definition of “bioengineered food.” Following AMS’s publication of the proposed rule, on June 14, 2018, USDA’s Animal and Plant Health Inspection Service announced that under its biotechnology regulations, it was not planning to regulate gene-edited plants as it does plants with foreign genes inserted with recombinant DNA. Whether this position extends to labeling of BE food remains to be seen.

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Keller and Heckman offers global food and drug services to its clients. Our comprehensive and extensive food and drug practice is one of the largest in the world. We promote, protect, and defend products made by the spectrum of industries regulated by the U.S. Food and Drug Administration (FDA), the European Commission and Member States authorities in the European Union (EU) and similar authorities throughout the world. The products we help get to market include foods, pharmaceuticals, medical devices, veterinary products, dietary supplements, and cosmetics. In addition...

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