Organisms modified by CRISPR are legally GMOs

The scientific-economic-judicial battle has been raging for ten years. Are organisms (plants or animal species) modified by genetic engineering tools such as CRISPR GMOs or not? The Court of Justice of the European Union has just handed down its verdict, which will henceforth set a precedent: organisms modified by mutagenesis are indeed GMOs and must obey the same regulations in Europe. With this decision, the biotechnology industry and its lobbies are suffering a serious setback. The environmentalists, like all those who want to guarantee the integrity of the food on their plates, welcome this victory.

 

" Enfin!"exclaims Yves Bertheau, biochemist and plant pathologist, director of research at INRA, specialist in GMOs and their traceability, and coordinator of a European programme (Co-Extra) on the coexistence of GMO and non-GMO crops. It's been a lot of work, but it's been worth it... "he continues in an exchange with UP' Magazine. That's an understatement. Indeed, the controversy has been going on for about ten years, since the moment we became aware of the existence of molecular tools capable of modifying the genetic code of a living organism, as simply as one would do by correcting a mistake in a word processor. With one of these best-known tools, the CRISPR-Cas9 , it is possible to transform the characteristics of a living organism into a cut-and-paste with unparalleled precision of the code lines of the living.

 

The biotech industries immediately rushed into this innovation. And among them, the large phytosanitary industries of agriculture. For firms like Monsanto, Dupont, Bayer, this technology smelled like a big windfall. In fact, they could modify, in conditions of simplicity and therefore cost, whole sections of the living world, still recalcitrant to the productivist imperatives of the globalized economy. Biotechnology was going to consign the controversial GMOs to the dustbin of old memories. With mutagenesis, we do not bring an external element to living organisms as we do with "classic" GMOs. The genetic code of the organism is gently modified. Neither seen nor known, almost no trace, for an effect with formidable applications.

 

Already the labs were working to make plants resistant to this or that ecological situation or predator, to modify the taste, shape, appearance, of the most common of our food. Elsewhere, like Prometheus, we imagined ourselves radically transforming certain species in order to domesticate them more than ever, to make them fit better into the canons of mass consumption. In other labs, we were trying to modify a species, such as the mosquito, to the point of considering its extinction. All this while escaping all legislation, and even less so that of GMOs, which so wickedly hindered the hubris of unbridled production of certain industrial players.

 

The controversy has been about subtleties, details in which the devil sometimes hides. Where GMOs attack the genome of a crop with coarse tools, the CRISPR molecular chisel slices and reshapes the genetic code with perfect precision, like a scalpel. This precision of the technical gesture means that a grain of maize modified using CRISPR cannot be distinguished from a grain resulting from old-fashioned plant breeding.

 

For CRISPR's defenders, these products are not GMOs in the sense of the regulations, particularly European regulations. They would be of a different nature, thus escaping risk assessment, authorization, labeling or monitoring procedures. Their argument is that the techniques used so far to produce GMOs consist of taking the gene from one plant or organism and putting it into another. That is transgenesis. With new technologies in life, such as CRISPR, there is no need to involve an external gene. We can change the genes inside the cells of plant embryos. That is mutagenesis. With these new genetic engineering tools, labs can turn genes off, turn them on, mutate or replicate them. No outside input. For them, it's not a GMO, it's something else.

A decision taken last April by the US Department of Agriculture opened the legal floodgates for mutagenesis and freed up a huge market. A biotech market made up of startups like giants. Their common goal: to produce plants that are more robust, resistant to weather, disease and pests. The example of Mars is significant: the agri-food group is exploring ways to use CRISPR to protect its flagship ingredient, chocolate, from the onslaught of climate change.

All the scientists involved in this research swear by their hearts that their work corresponds to a vital necessity for humanity: to be able to feed a growing population on a planet where there is less and less arable land.

 

Experiences are multiplying all over the world. In China, for example, researchers are experimenting with the use of CRISPR to create cows that are better protected against tuberculosis, a chronic bacterial disease that can spread to humans and which has fuelled the scourge of antibiotic resistance. Closer to home, Swedish scientist Stefan Jansson, a researcher at Umea University, has used CRISPR to produce vegetables that are better protected against pests. He was the one who made a name for himself by preparing the first meal with CRISPR products. He told Business Insider that the role of CRISPR in the future of food is already beginning to take shape. « We're not talking about the future. We're talking about now. ", he said.

 

In this battle with global challenges, Europe was not spared. Under intense pressure from lobbies, Europe seemed to be moving, slowly but surely, towards deregulation of these "new" GMOs. Modified and patented plants could soon invade our fields incognito, escaping all labelling. Mainly plants made tolerant to herbicides, with as yet unknown but undoubtedly irreversible consequences on the environment, health, or the autonomy of farmers. « This enormous quantity of artificial beings that could be introduced into society and nature in a very short time is problematic.explains Frédéric Jaquemart, President of the International Group for Transdisciplinary Studies (Giet). This unbridled pace of change, which is out of all proportion to the changes taking place in the evolutionary process, has effects on the very organization of society, with deleterious effects on nature, even if the causalities are not obvious to establish."

Pierre-Henri Gouyon, professor at the Museum of Natural History, did not hesitate to insist: " We're screwing around with these GMOs! ». He added in a lecture given to the APHP: " Concentration of ownership of genetic resources in a few hands puts all the world's food at risk ». For him, there would be only one way to know whether or not an organism had been modified with these new technologies: " if a plant or seed is patented, it has been manipulated. "he confided to our Magazine. CQFD.

 

Yves Bertheau was alerting us in a interview to UP' Magazine: " Beyond the changes in agricultural practices induced by the new traits introduced, rapid, radical and often irreversible genetic modifications must be considered with caution, whereas conventional breeding linked to the conservation of genetic resources still constitutes the best source for improving production and adapting to environmental changes. It is feared that plants may be a testing ground for technologies whose application to humans is far from acceptable. ".

Yesterday, 26 July, the European Court of Justice whistled the end of the controversy. Against all odds, it ruled, in a decision that will go down in history, that plants and animals created by innovative genetic modification technology have been genetically modified and should be regulated as such. The EU judges said: " In today's judgment, the Court first of all considers that organisms obtained by mutagenesis are GMOs within the meaning of the GMO Directive, in so far as mutagenesis techniques and methods modify the genetic material of an organism in a way which does not occur naturally. It follows that such organisms fall, in principle, within the scope of the GMO Directive and are subject to the obligations laid down therein. "

 

Hearing at the Court of Justice of the European Union

 

The Court continues: « The Court considers that the risks associated with the use of those new mutagenic techniques could prove to be similar to those resulting from the production and dissemination of GMOs by means of transgenesis, since the direct modification of the genetic material of an organism by means of mutagenesis makes it possible to obtain the same effects as the introduction of a foreign gene into the organism (transgenesis) and those new techniques make it possible to produce genetically modified varieties at a rate and in proportions which are not comparable to those resulting from the application of traditional methods of mutagenesis. In view of these common risks, excluding from the scope of the GMO Directive organisms obtained by new mutagenesis techniques would undermine the objective of that Directive to avoid adverse effects on human health and the environment and would disregard the precautionary principle which the Directive seeks to implement. It follows that the directive on GMOs also applies to organisms obtained by mutagenic techniques developed after its adoption. "

 

With this decision, the European judges sided with the French agricultural union, the Confédération Paysannewhich brought the case before the Court, arguing that new and unconventional techniques of in vitro mutagenesis were likely to be used to produce herbicide-resistant plants with potential health risks.

Coincidentally, a study was published in the journal Nature last week. It revealed that the Crispr-Cas9 gene editing technology can cause genetic distortions far greater than expected, with "significant" "genetic distortions. pathogenic consequences "potential.

 

Advocates of living organisms transformed by biotechnology were quick to express their regret at such a decision. Such is the case of Professor Jonathan Napier, who leads the field trials of Crispr-edited plants at Rothamsted Research in the United Kingdom. He denounced the court's decision as "...a very bad decision. a step backwards, not a step forward.« . He told the Guardian : " This is a very disappointing result, which will hamper innovation, impact and scientific progress in Europe. The classification of organisms with published genomes as falling under the GMO Directive could close the door to this revolutionary technology. ".

 

Beat Späth, the director of EuropaBio, which represents biotech companies, said: " Billions of euros have been spent on genome research and development by taxpayers and industry. The big risk is that all this money will not be translated into products for European farmers. ".

Inevitable statements from actors directly concerned by the biotech economy. In response, the NGO Greenpeace, through Franziska Achterberg, Director of Food Policy, argues that the Court's decision had given priority to the protection of human health and the environment: "... the protection of human health and the environment is a priority for the European Union. The release of these new GMOs into the environment without appropriate safety measures is illegal and irresponsible. All the more so as genetic modification can lead to unintended side effects. The European Commission and European governments must now ensure that all new GMOs are fully tested and labelled, and that all field trials are subject to GMO rules. ".

For its part, the French government today issued a statement welcoming " this pending clarification. This judgment of the CJEU is a decisive step, which will enable the courts and competent authorities to have a harmonised framework at European level to protect consumers and the environment, in compliance with the precautionary principle. ".

 

The fact remains that the European Court's judgment is not insignificant. For legal experts, it is extremely binding. This is the opinion of Kai Purnhagen, a Dutch lawyer specialising in European and international law, who told the Review that the European Court's judgment is extremely binding for lawyers. Nature : " It's an important judgment, and it's a very rigid one. It means that for all new inventions such as CRISPR-Cas9 food, you will have to go through the long approval process of the European Union. ".

This decision is in contradiction with the current position of the US government on genetically modified crops. In April, U.S. Secretary of Agriculture Sonny Perdue issued a statement confirming that the U.S. Department of Agriculture (USDA) would not subject GM crops to the same regulations as GM crops.

 

Of course, since then, research has shown that CRISPR may not be as safe or reliable as scientists previously thought. This new information, combined with the European Court's decision, may cause U.S. regulators to rethink their position on genetic editing in the near future. This could continue to fuel, if necessary, trade tensions between the United States and Europe.

 

 

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