Most gene editing techniques should not come under the Europe Union’s strict regulatory regime for genetically modified organisms, according to a preliminary legal opinion.
The opinion by an “advocate general” of the European Court of Justice isn’t a binding legal decision, but it’s considered highly persuasive for the panel of judges who will issue a ruling on the matter this summer.
Advocates of biotechnology see the opinion as an early step in the right direction regarding Europe’s gene editing policy, but critics say it’s unlikely to sway wary European consumers.
“I think this is an opening volley in what will be a continuing debate in Europe,” said Jaydee Hanson, senior policy analyst with the Center for Food Safety, a nonprofit that wants stronger biotech regulations.
New gene editing techniques generally involve deleting specific genes or changing genetic sequences without inserting DNA from other organisms.
For U.S. agriculture, Europe’s approach to gene editing is significant because the technology is expected to become more widely commercialized among American farmers in coming years.
Already, the USDA has cleared numerous gene-edited crops for the market without subjecting them to the environmental review required under the deregulatory process for GMOs.
Apart from affecting exports of such crops to the European Union, the continent’s biotech policies have a “huge impact” on other global regions, particularly in the developing world, said Mary Boote, CEO of the Global Farmer Network, which supports gene editing.
“Its importance is felt well beyond the borders of Europe,” Boote said.
A French agricultural union representing small growers, Confédération Paysanne, claimed that new gene-edited crops resistant to herbicides should not be exempt from the EU’s “GMO directive” for regulating genetically engineered crops.
The directive involves environmental analysis, labeling, traceability and monitoring requirements for GMOs.
Crops developed through traditional mutagenesis, in which radiation or chemicals randomly alter plant genes, are exempt from the GMO directive.
However, Confédération Paysanne argued that targeted mutagenesis — including the CRISPR or TALEN methods of gene editing — is a new technology that shouldn’t qualify for this exemption.
Advocate General Michal Bobek found that targeted mutagenesis should remain part of the exemption as long as the alteration can occur naturally and doesn’t incorporate foreign genes.
However, he held that member nations of the European Union may still develop their own rules for such targeted mutagenesis.
Bobek’s view is heartening, as gene editing can accomplish the same changes as traditional breeding but much faster, said Boote of the Global Farmer Network.
“It’s meant to give some direction,” Boote said of the advisory ruling. “It’s not the end of the conversation but it is good news.”
The distinction drawn between gene editing and transgenic methods is a key part of the decision, she said.
“That may be the most important thing to come out of this, not only for how it’s regulated but for public perception,” Boote said.
Hanson, of the Center for Food Safety, is skeptical the advisory decision will warm European consumers to gene editing, since the public in Europe is more resistant to food biotechnology than in the U.S.
Countries within the EU, such as Germany or France, can still decide to prohibit planting of gene-edited crops, even if the European Justice Court adopts the advisory opinion, he said.
Gene editing will also probably continue to fall under the international definition of genetic engineering established by the United Nations, he said.
The Center for Food Safety isn’t entirely opposed to CRISPR and other gene editing technologies, but the group believes the U.S. and Europe should adopt new laws to regulate such crops.
Bobek’s ruling makes the same mistake as the USDA by approaching gene editing based on laws that predated the technology, Hanson said. “Trying to fit new techniques into old laws doesn’t work so well.”