Jul 31, 2018

New gene-editing to be regulated like GMOs, European court rules

The Court Justice of the European Union ruled July 25 that organisms obtained by newer, more precise, editing techniques will be regulated the same as other genetically modified organisms (GMOs).

“Organisms obtained by mutagenesis are GMOs and are, in principle, subject to the obligations laid down by the GMO Directive,” according to a media release from the Court Justice. “However, organisms obtained by mutagenesis techniques which have conventionally been used in a number of applications and have a long safety record are exempt from those obligations, on the understanding that the Member States are free to subject them, in compliance with EU law, to the obligations laid down by the directive or to other obligations.”

The court didn’t see a substantial difference between first-generation GMO’s, where genetic material was added to the organisms, and those obtained from new technologies, where an organism’s genome is edited. For example, CRISPR/cas9 technology allows more precise gene editing, or even muting specific genes.

“Unlike transgenesis, mutagenesis is a set of techniques which make it possible to alter the genome of a living species without the insertion of foreign DNA,” according to the court justice. “Mutagenesis techniques have made it possible to develop seed varieties which are resistant to selective herbicides.”

But the court added that “organisms obtained by mutagenesis techniques which have conventionally been used in a number of applications and have a long safety record” were exempt from the directive.

Industry groups such as EuropaBio, which promotes an innovative and dynamic European biotechnology industry, said the ruling wasn’t clear.

EuropaBio’s Secretary General John Brennan said that Europe could miss out on significant benefits of certain applications of genome editing.

“In addition to providing consumer and environmental benefits, such as enhanced nutrition, improved health or a more circular economy, innovations made possible by genome editing hold enormous promise to keep Europe at the forefront of socioeconomic development, continuing to generate jobs and growth in the EU,” he said in a statement.

U.S. Secretary of Agriculture Sonny Perdue also called the ruling as a “setback” for scientific innovation because “it narrowly considers newer genome editing methods to be within the scope of the European Union’s regressive and outdated regulations governing genetically modified organisms.”

“We encourage the European Union to seek input from the scientific and agricultural communities, as well as its trading partners, in determining the appropriate implementation of the ruling,” Perdue said in a released statement. “Innovations in precision biotechnology, such as genome editing, hold great promise. For consumers, potential benefits include healthier, higher-quality foods at affordable prices. For farmers, they include improvements in productivity, plant and animal health, and environmental sustainability.”

The EU’s legal action was initiated by Confédération paysanne, a French agricultural union that favors small-scale farming. With eight other associations, it brought an action before the Conseil d’État (Council of State, France) in order to contest French legislation that provided exemptions from the GMO Directive.

– FGN Assistant Editor Stephen Kloosterman

Above: The main courtroom of the Court of Justice of the European Union Photo: Court of Justice of the European Union