The European Court of Justice (ECJ)—the European Union’s (EU’s) highest court—has ruled that gene-edited products should be treated like genetically modified organisms (GMOs), which are subject to substantial regulation in the EU.
The decision may seem distant and removed from American farmers, but it could affect future crop traits that are produced with gene-editing techniques in the U.S.
Gene-editing techniques such as CRISPR-Cas9, TALEN, or Zinc-finger nucleases allow scientists to edit a single gene, or a small group of genes, to create a crop trait that would have taken many years of conventional breeding to produce. Although a gene-edited crop using these techniques has yet to be fully commercialized in the U.S., agricultural companies, universities, and government institutions are busy developing plant traits with these techniques.
For example, DuPont Pioneer (now Corteva Agriscience) has used CRISPR to develop corn hybrids with improved resistance to Northern Corn Leaf Blight and is nearing commercialization of a CRISPR-produced waxy corn hybrid. USDA scientists are developing soybean plants with improved drought and salt tolerance using the same technique.
Crops such as these could face long regulatory delays from the EU before commercialization, as their GMO counterparts already do—but only if the court decision affects future government policy there, said Bernice Slutsky, senior vice president of domestic and international policy with the American Seed Trade Association.
“One thing to keep in mind is that this is a legal interpretation of existing EU law,” she explained. “It is not a policy or a political decision. Now that the court has made their ruling, then the next step is to determine what the European Commission will do with that.”
The ECJ ruling was met with concern and disappointment from U.S. industry and academia, and earned a condemnation from the USDA, which has taken an opposite stance on gene-edited crops. The agency announced in April that gene-edited crops would not fall under the USDA’s regulation, unless they were produced with “plant pest” material.
“Government policies should encourage scientific innovation without creating unnecessary barriers or unjustifiably stigmatizing new technologies,” Secretary of Agriculture Sonny Perdue said in a press release.
“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 ruling continues the current EU policy of focusing on the breeding process used to develop a trait, rather than evaluating the risks of the final product, noted Greg Jaffe, director of biotechnology for the Center for Science in the Public Interest.
“The regulatory system should use its scarce resources to review and ensure the safety of products that pose potential risks, rather than wasting time on products that don’t raise any safety concerns, which could be the case for some gene-edited products,” he wrote in his Biotech Blog.
If the EU does decide to subject all gene-edited crops to GMO regulation, trade disruptions are almost certain, Jaffe said.
“The world already has experienced the economic impact of asynchronous approvals for GMOs, when China and Europe rejected U.S. grain imports because a GMO crop was not approved in that country,” he said. “However, the impact could be several times greater this time because there are so many gene-edited crops in the commercial development pipeline.”
There is no simple test to determine if a crop is gene-edited, such as exists for GMO crop traits, which could cause further confusion if the EU subjects them to regulatory hold-ups, Jaffe added.
In contrast, the ECJ ruling was welcomed by environmentalist groups, including Friends of the Earth, the group that filed the 2015 lawsuit that led to this court decision.
“We applaud the European Court of Justice for this forward-thinking decision and encourage the USDA to follow its lead,” said Friends of the Earth spokesperson Dana Perls. “All products made with genetic engineering, including ones made with gene-editing tools like CRISPR, should be regulated, assessed for health and environmental impacts, and labeled.” — Emily Unglesbee, DTN