Plants traits introduced by Crispr gene editing will be subject to the same lengthy regulatory process as 1980s-style genetically modified organisms containing genes from other species, Europe’s highest court rules
Crops developed by modern targeted plant breeding techniques – that improve characteristics without introducing foreign DNA - should fall under strict laws governing 1980s-style genetically modified organisms (GMOs) containing genes from other species, the European Court of Justice (CJEU) said on Wednesday.
The decision is what plant scientists dreaded, and will have far-reaching consequences for new breeding techniques, using Crispr–Cas9, that offer a precision tool for introducing positive traits and removing negative ones from a plant’s genetic code.
Plant breeders working with CRISPR and other gene editing techniques see them as the means to speed development of a new generation of hardier, more productive, more nutritious food crops, by improving traits such as pest, salinity or drought resistance, or boosting nutritional content.
Gene editing is being looked to as the route for crop sciences to finally recover from the dead weight of the EU’s GMO rules, which prompted a withering of Europe’s agricultural research base.
The ruling means plant science in Europe cannot fully enter the modern age of genomics, said Nigel Halford, crop scientist at Rothamsted. “We are already a generation behind. Young scientists interested in agbiotech are likely to move to places where common sense and scientific evidence prevail,” he said.
For example, the US announced in March it has no plans to regulate genome editing when used to produce new plant varieties that are indistinguishable from those bred through traditional breeding methods.
The case was referred to the CJEU by the French Conseil d’Etat after nine NGOs initiated a court case in France over concerns that gene editing would be used to make crop plants herbicide resistant, thus leading to an increased use of these chemicals.
The decision “is the deathblow for plant biotech in Europe,” that “could slam the door shut on this revolutionary technology,” said Sarah Schmidt, project coordinator at the Institute for Molecular Physiology in the Heinrich Heine University Düsseldorf.
“This is a backward step, not progress,” said Johnathan Napier, a crop geneticist at the Rothamsted agricultural research centre in the UK.
Maurice Moloney, CEO, Global Institute for Food Security in Canada agreed, “This is a real step backwards for the EU, for innovation and in the wider context, for global food security,” he said. “It will have the consequence of further disrupting world trade in agricultural products at a critical time for world trading policy.”
The ruling was a surprise, as it went against the opinion of the court’s advocate general, Michal Bobek, who argued in January that the new techniques for tweaking plants’ existing DNA were different from older GMO methods that involve inserting a foreign gene into the plant to create a new trait.
It was also unexpected because conventional mutagenesis techniques that use radiation or chemicals to randomly alter the genome of plants with the aim of throwing up mutations with a beneficial effect, are excluded from the EU’s GMO rules. Specifically, the court ruling was intended to clarify the scope of the mutagenesis exemption in the GMO Directive, to provide legal certainty and predictability.
The advice of the advocate general is not binding, but is usually followed by ECJ judges.
“This ruling is surprising given the opinion of chief advocate Bobek on this issue just a few months ago,” Moloney said. “Advocate Bobek used the scientific evidence to reach the logical conclusion that precision breeding technologies like genome editing were indistinguishable in outcome from plants produced through conventional mutagenesis. The court’s ruling is logically absurd in that it asserts that modern techniques with high precision are somehow more risky than random mutagenesis which is replete with unknown changes in the genome.”
Scientists and the biotech industry say making Crispr techniques subject to laws developed for older breeding techniques imposes expensive and risky hurdles.
Currently the only commercial GM crop grown at a large scale in Europe is BT maize, which is engineered with a gene from the bacterium Bacillus thuringiensis to express a protein that poisons insect pests. Even when crops pass strict regulatory criteria, EU countries can ban them.
“The costs of fulfilling regulatory science and administration to obtain approval for GMO crops are around $35 million,” said Schmidt. “Only the largest agribusinesses can afford these costs.”
Regulate the trait, not the method
“Every single plant on our planet is here because of mutations occurring during evolution. Human society as we know it, relies on the deliberate selection of mutations to improve food crops,” said Wendy Harwood of the Crop Transformation Group at the John Innes Centre in the UK.
The ruling that plants developed with gene editing are GMOs, when those derived through conventional mutagenesis are not, is a disappointing setback for the use of valuable new technologies in crop improvement, Harwood said. “It is not a logical approach based on the scientific evidence.”
The failure to follow the evidence will make oversight difficult, according to Nicola Patron, Head of Synthetic Biology at the Earlham Institute in the UK. “In most cases, it will not be possible to determine which technique was used to induce the mutation,” she said.
“It is important genome editing is properly assessed and regulated according to evidence-based scientific criteria,” said Denis Murphy, professor of biotechnology at the University of South Wales. By simply lumping together genome editing with transgenic GM crops, the CJEU “has missed a historic opportunity to create a new regulatory framework for this new biotechnology,” he said.
Ottoline Leyser, Director of the Sainsbury Laboratory at Cambridge University, agreed gene editing needs to a new system of regulation. “This ruling has arisen because of an action brought to the court arguing that herbicide resistant seed varieties pose the same risks to the environment regardless of how they are produced. I agree with this argument. We need a future-proof risk-based regulatory framework based on the traits being introduced, not the way in which they were introduced,” Leyser said.