• The European Court of Justice has ruled that all techniques that induce DNA mutagenesis result in products that can be regulated as genetically modified organisms.  GMO regulation had previously been limited to products of genetic engineering where DNA from a separate organism was introduced into the target organism’s genome.  Newly developed gene editing techniques exploit the discovery of Clustered Regularly Interspaced Short Palindromic Repeats (CRISPR) to cut strands of DNA with molecular “scissors” so that a new DNA sequence can be inserted.  But, these gene editing techniques can also be used to induce mutations by removing select sequences of a plant’s DNA, or by inducing disruption of a DNA sequence at a targeted location to facilitate the opportunity for the organism’s own repair mechanism to give rise to a useful mutation.  Significantly, these latter two applications do not involve the insertion of any foreign DNA.  But, as a result of the European Court of Justice decision, all organisms obtained by mutagenesis, even if the mutation actually arises from induced errors in natural repair mechanisms, whether the mutation site is targeted by gene editing or random (e.g., radiation induced), are genetically modified organisms which are subject to regulation.
• 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that it narrowly considers newer genome editing methods to be within the scope of the European Union’s regressive and outdated regulations governing genetically modified organisms.”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.

Keller and Heckman will continue to monitor developments on the domestic and foreign treatment of novel DNA techniques as well as the implementation of the National Bioengineered Food Disclosure Standard.