- As previously reported on this blog, the European Court of Justice ruled that all techniques that induce DNA mutagenesis result in products that can be regulated as genetically modified organisms. As a result of the decision, new products created by using CRISPR and similar gene-editing techniques are genetically modified organisms within the scope of the European Union’s GMO Directive and are therefore subject to the stringent approval process for all genetically modified organisms.
- In response to the decision, the German Bioeconomy Council, a panel of 17 researchers who advise the German Federal Government, has called for new EU legislation governing crops created by plant-breeding technologies, such as CRISPR. In a statement, the Council noted, “[i]n its current form, EU genetic engineering legislation cannot do justice to the opportunities and challenges of the technologies. We need an amendment to bring it in line with advances in the field. It is important to have a regulation that distinguishes between mutations and gene transfers and provides for risk-oriented approval and release procedures.” In addition to calling for legislation that is suited to the different applications of new technologies, the Council also argued that mandatory product labeling is not practical since modifications cannot always be scientifically or technically detected or proven in the end product. Scientists and industry leaders in the UK also put out an open letter calling on the UK government to provide clarity on the future of gene-edited crops following the EU ruling, particularly in the context of Brexit and the future relationship between the UK and the EU.
- In March, the United States Department of Agriculture (USDA) Secretary Sonny Perdue announced that under its biotechnology regulations, it has no plans to regulate genome editing when used to produce new plants varieties that are indistinguishable from those developed through traditional breeding methods as long as they are not plant pests or developed using plant pests. Separately, USDA’s Agricultural Marketing Service (AMS) is working to implement the National Bioengineered Food Disclosure Standard, which will regulate the labeling of bioengineered foods in the US.
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.