Mutation not genetic modification could revive EU bioscience
A “LANDMARK opinion” from the European Court of Justice on the definition of genetically modified organisms could pave the way for a revival of crop biotechnology in Europe.
According to Rothamsted Research’s senior plant geneticist, Professor Nigel Halford, the ambiguities of legislation in Europe have long caused problems for biotechnology, but this latest legal opinion – if it gets endorsed by the court’s judges – could break that deadlock.
“As a plant geneticist in Europe, I must carefully pick my way through some of the most onerous
constraints to scientific and technological developments ever devised by politicians and policymakers,” claimed Prof Halford.
“However, I’m now encouraged by what could be a landmark opinion for the European Court of Justice that could pave the way for new techniques in crop biotechnology to be used with more freedom.”
Due to EU regulations on genetically modified crops, only two GM crops have ever been licensed for cultivation in Europe, and one of those, the Amflora potato, was subsequently withdrawn because the company that produced and marketed it, BASF, decided to walk away from crop biotech in Europe. That leaves a single variety of insect-resistant maize, MON810, as the only GM crop available to European farmers, and that is not available everywhere because some Member States impose their own national bans.
GM crops can be cultivated or used for food or feed in Europe only with the Commission’s permission, after a detailed and lengthy assessment of health and environmental safety data; and food derived from GM crops must be clearly labelled.
Quite right, you might think.
Prof Halford pointed out that that approval is extremely hard to obtain, as each case comes before a working group with representatives from all 28 Member States, and delegates to this group are, he said, “notorious for ignoring scientific evidence and voting politically”.
As a result, biotech companies have abandoned efforts to develop new GM crop varieties for cultivation in Europe, and focused instead on obtaining permission for GM crops grown elsewhere to be imported into Europe for food and feed.
EU Directive 1829/2003 defines a genetically modified organism as an organism in which the genetic material has been altered in a way that does not occur naturally. Prof Halford noted that this was an extremely broad definition, and had “caused problems right from the start”.
“For example, crop varieties carrying gene mutations induced by radiation or chemical treatment, which had been around since the 1950s, are clearly GMOs as defined in the directive and had to be exempted from the regulations; this was called the ‘mutagenesis exemption’,” he explained.
“These problems have multiplied over the past decade with the emergence of a raft of techniques that have been given the umbrella term of genome (or gene) editing. These techniques also result in gene mutations, but whereas chemical and radiation treatment cause thousands of random mutations, genome editing causes mutations only in specific targeted genes.
“So, from a scientific point of view, the result of genome editing is a mutant, not a GM plant,” he asserted. “Furthermore, if crop varieties carrying thousands of random mutations introduced by chemical or radiation treatment are exempt from Europe’s GM regulations, then varieties carrying precise, single mutations introduced by genome editing should also be exempt.”
Prof Halford said that the European Commission has been ‘prevaricating’ over the matter for years: “As a result, the Commission has deterred investment and stymied the application of these technologies for crop improvement in Europe, when they ought to be encouraging the use of all available technologies to safeguard food security, ensure food safety and make European agriculture more sustainable. Europe risks missing out on a second crop biotechnology revolution,” he said.
But earlier this month, an Advocate General of the European Court of Justice, Michal Bobek, issued an opinion on the matter (Opinion Case C-528/16), which ECJ judges are now considering. The proceedings were brought jointly by Confédération Paysanne, a French agricultural union, and others. The plaintiffs sought an annulment of the exemption from GM regulations for organisms obtained by mutagenesis.
The Advocate General reasserted that organisms obtained by mutagenesis are genetically modified organisms within the meaning of directive 1829/2003. However, he went on to state that the “mutagenesis exemption” applied to all organisms obtained by any technique of mutagenesis, on the condition that they do not involve the use of recombinant nucleic acid molecules.
“In fact, all organisms naturally contain recombinant DNA because DNA recombines during processes such as reproduction; in this instance, we take it that the Advocate General is referring to organisms containing DNA introduced by genetic modification, which does not apply to genome-edited plants,” said Prof Halford.
“This opinion could prompt a green light for crop scientists and plant breeders to start using genome editing for crop improvements in Europe. It is an extremely important assessment, and a rare bit of good news for Europe’s plant biotechnologists,” he concluded.