Viewpoint: French court ruling that already-approved mutagenized crops should be heavily restricted as GMOs reaffirms need to revamp Europe’s antiquated biotech regulations

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A woman holds a placard, "Poison - Stop GMO" in Lyon, France, May 23, 2015. Credit: REUTERS/Emmanuel Foudrot - RTX1E8PK

Unless there is an unexpected change in European and French policy on GMOs, the February 7 judgment by the Council of State mandates that French farmers can no longer legally grow crop varieties derived from a breeding technique known as mutagenesis that has been used since the 1930s. Consumers will now only have access to varieties using this technique if they are authorized for import and marketing.

[Editor’s note: This feature was composed from a two-part series published in the French news outlet Contrepoints. You can access the original articles in French here: GMOs: The French Council of State’s hits agricultural innovation, part one and part two. These two articles have been auto-translated and lightly edited for clarity. Some portions may be less than clear and will be replaced with more accurate translations if they become available.]

The Council of State decision centered around how France will apply the European Union directive of Directive 2001/18 [March 12, 2001] relating to the release of genetically modified organisms (GMOs) in the environment. The questions posed were as follows:
  • Are plant varieties produced by mutagenesis–resulting from mutations caused by exposure to chemicals or radiation–GMOs, falling under the EU’s regulatory provisions on cultivating and marketing genetically modified organisms (GMOs)?
  • Should a moratorium be put in place on the dissemination, cultivation and use of varieties made tolerant to herbicides (VRTH)?

The Council of State bound by an unfortunate EU Court of Justice decision

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Europe’s Court of Justice ruled that CRISPR crops are GMOs in 2018

In its 2018 ruling, the EU Court of Justice (CJEU) didn’t follow the conclusions of its Advocate General [who had recommended that restrictive regulations developed for GMOs in 2001 should not apply to plants and animals bred using CRISPR or other gene editing techniques], and its judgment was strongly criticized, both for its legal relevance and for its disastrous economic and social consequences. The general opinion was that Directive 2001/18 was obsolete and needed to be urgently revised otherwise Europe’s agricultural sector would miss out on new breeding techniques (NBTs) like CRISPR/Cas9.

Bound by the 2019 conclusions of the CJEU, the Council of State concluded that any method of varietal selection developed since 2001 (the date of the original European directive) generates a product considered to be a GMO that falls under the regulations. It is therefore up to the French government to modify, within six months, the environmental regulations to identify within the catalog of varieties of agricultural plants those that have been obtained by mutagenesis and which should have been subjected to the evaluations applicable to GMOs.

The progress of science and technology stopped in 2001

French farmers will thus be deprived of innovative gene-edited crop varieties, and even those developed via mutagenesis. Consumers will only be able to enjoy benefits of these varieties, such as improved nutritional quality, shelf life or ease of use, if the products in question are authorized for import and marketing.

The paradox had already been noted in connection with the CJEU ruling: Random mutagenesis techniques (by radiation or the action of chemical substances), with unpredictable effects, will remain authorized. They “have been traditionally used for various applications” and their “safety has been proven for a long time,” the EU court ruled in 2018. On the other hand, the far more precise techniques of site-directed mutagenesis, such as CRISPR, will in practice be excluded from Europe.

The right to test science and good faith

” … [I]t appears from the documents in the file […] that the techniques of random mutagenesis in vitro […] appeared after the date of adoption of Directive 2001/18/EC or have mainly developed since that date,” the state Council wrote. Simple internet research, however, shows that these techniques have been described and used at least since the 1970s. This judgment by the Council of State poses a fundamental problem to the proper functioning of a justice system, which currently makes decisions in its ivory tower for political purposes.

A retroactive application of the judgment?

In fact, we can take it one step further: Did not the Council of State, while remaining within the limits of its discretionary power, side with the critics of science and genetic technology and agriculture more generally who denigrate farming with qualifiers like “intensive” or “industrial”? The decision instructs the competent authorities to identify, within nine months, within the common catalog.

of agricultural plant species varieties, those crops that would have been listed there without being designated as GMOs. This poses several problems. On the one hand, the reference to the common catalog implies, at least in principle, that the French authorities must decide on varieties initially listed in the national catalog of another EU Member State.

On the other hand, it is obvious that if this injunction is respected to the letter, it will have to be extended to vegetable varieties developed through mutagenesis. More litigation is in sight, since activists always have a reason to go to court; for example, the Peasant Confederation and other pro-organic groups now maintain that 85% of endives consumed in France are GMOs [because these varieties were developed decades ago using mutagenesis].

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Identifying these varieties is one thing, but for what purpose? The authorities will also have to assess whether to cancel the entries in the catalog, in accordance with Article 14.2 of Directive 2002/53 / EC concerning the common catalog of varieties of agricultural plant species. That’s amazing because this article provides for the possibility of deleting a variety from the catalog “if the laws, regulations or administrative provisions […] are not respected,” or if “during the application for admission or during the procedure for examining, false indications have been provided regarding the data upon which admission depends.”

Neither of these conditions were met in this case, the first having to be assessed in terms of how the law was interpreted and applied at the time of the registration decision. The authorities thus face inevitable litigation initiated either by the seed and agrochemical industry or by anti-GMO groups, depending on how the Council of State decision is interpreted.

 

A judgment may be impossible to execute

Theoretically, it will be necessary to verify the method of obtaining some 17,000 varieties registered in the common catalog, on the basis of information which will probably not have been provided at the time of the registration request. When a variety is the result of a mutation, it is immaterial to the regulatory procedure whether the mutation is natural or obtained by mutagenesis and, in this case, in vitro or not. The origin of the mutation is often undetectable in seeds or plants.

And, unless I am mistaken, there is no legal obligation for applicants to define the procurement process with the level of detail required for the application of the judgment. This verification will also have to apply to the progeny of crop varieties suddenly qualified as GMOs, which will also be considered GMOs, at least if they have acquired the mutation in question.

A stop that is not excessively repugnant

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The judgment also enjoins the authorities to examine “whether there is reason to apply the provisions […] of articles L. 535-6 and L. 535-7 of the Environment Code.” This part of the decision assumes there has been a deliberate release of a GMO into the environment when that crop variety would not have been subject to the required authorization—an absurd hypothesis! Let us repeat: the varieties resulting from mutagenesis only became GMOs by the decision of the Council of State (the CJEU had confined itself by stating that these plants are “excluded from the scope” of the said directive, because mutagenesis techniques “have been traditionally used for various applications and whose safety has been proven for a long time.”

Should we push that far?

Does the Council of State have authority to interpret the text cited above and in particular to declare that mutagenesis in vitro is excluded? Did the Council of State not go beyond the request of the Confédération paysanne and eight associations by deciding the fate of the varieties now labeled as GMOs? Are the varieties made tolerant to a herbicide or a family of herbicides under the guillotine? This judgment raises serious and important questions.

Related article:  If consumers fear GMOs, why do they keep buying Impossible Burgers?

The last two substantive articles of the State Council judgment deal with VRTH (varieties made tolerant to herbicides). According to the press release from the Council of State:

The Council of State also considered that, under the precautionary principle, the Prime Minister could not refuse to take preventive measures for the use of varieties of plants made tolerant to herbicides …. Indeed, various expert opinions […] have identified risk factors corresponding to the development of weeds tolerant to herbicides and to the consequent increase in the use of herbicides, even if these risks are only ”incomplete assessment due to gaps in available data.”

But this explanation leaves one wondering. Where is the assessment of the “serious and irreversible” nature of the damage that could occur to the environment?

A very anachronistic explanation

The Council of State essentially based its decision on a November 2019 opinion by the French National Food Safety Agency, Environment and Work (ANSES) relating to the use of crop varieties made tolerant to herbicides.

The Council of State did not grant the request for a moratorium. This was not a heavy defeat for the applicants, nor a small victory for rationality, taking into account the main decision and what follows. First of all, the government is urged to implement the recommendations made by ANSES “in terms of risk assessment related to VRTHs, or to take any other equivalent measure likely to respond to the observations from the agency on the gaps in the data currently available.”

We can find the wording ambiguous, but the recommendations are made to be followed. So, what is ANSES position? In short, a manifest excess of precaution. ANSES notes in the preamble to its general conclusions:

According to the a priori assessment of the risks associated with the use of herbicides on VRTHs, conducted under the European regulatory framework for plant protection products, the risks associated with the use of plant protection products are acceptable and marketing authorizations have have been issued in France for the uses concerned.

Elsewhere, ANSES writes:

Although no undesirable effects could be observed according to the data collected, the study of the agricultural practices associated with the cultivation of VRTH shows that these could be accompanied, in the long term, by certain undesirable effects.

It then produces a long list of recommendations to find out more about risks, consisting essentially of the appearance of weeds that have become resistant to herbicides (these already exist).

VRTHs are made tolerant to a herbicide or class of herbicides that have been used for a long time on other cultivated species. Using them on rapeseed or sunflower can modify the agronomic landscape and the dynamics of weed resistance. This is why growers have implemented a charter of good weed control practices, including VRTHs, in order to minimize the aforementioned risks (and to preserve the interest of VRTHs). The uncertainty that sounded the alarm for the application of the precautionary principle was this statement: “ … Could be accompanied, in the long term, by certain undesirable effects …” The Council of State enumerated without hindsight or critical thinking the arguments of the applicants.

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For example, they did not hesitate to mention the risks of  “pollution of water and the environment […] and of accumulation of carcinogenic molecules or endocrine disruptors in cultivated plants intended for human consumption or animal ”… all things which, if they were credible, should have already happened a long time ago, and would have also occurred with herbicides not associated with varieties made tolerant to herbicides.

The Council of State did not specifically rely on these gesticulating elements in its judgment. However, they clearly contributed to the various aspects of the decision. Seeing a court rule on the conclusions of a party to the dispute involving scientific questions, without resorting to expert advice, is problematic, especially when justice is exploited by activism.

Prohibit or restrict VRTH?

Article 16.2 of Directive 2002/53/EC concerning the common catalog of varieties of agricultural plant species allows Member States to request authorization to prohibit, for all or part of their territory, the use of a variety or prescribe appropriate conditions for the cultivation of the variety, in particular “if there are valid reasons […] for considering that the variety poses a risk to human health or the environment .”

The prohibition of the use of VRTH is not envisaged at this point in the judgment but could result from decisions taken by the authorities in application of a previous article of the judgment. On the other hand, the government was told to activate the procedure within six months    “to prescribe appropriate culture conditions for VRTHs resulting from mutagenesis used in France. ”

What will be the “appropriate cultivation conditions”—beyond the charter of good practices? Is it reasonable to think that they can be defined in the space of six months? Is it even reasonable to consider that varieties made tolerant to herbicides “present a risk to human health or the environment”? Is the appearance of a weed that has become resistant to a herbicide, supposedly due to the use of a VRTH, a risk to the environment? But there’s more: “HTVs”—varieties tolerant to a herbicide or a class of herbicides that have acquired their tolerance through a natural, spontaneous mutation, would be excluded from this regulatory framework if the judgment is applied to the letter! In any case, obsessive-compulsive disorder regulation has struck again.

Impact on organic farming

The Council of State did not have to resort to the first point of the judgment of the CJEU, according to which the Community law “must be interpreted in the sense that the organisms obtained by means of techniques/methods of mutagenesis constitute organisms genetically modified within the meaning of this provision.”

I showed in my article “Organic farming must go back in time by … 70 years! that the definition of GMOs produced by the CJEU also applies to the texts governing organic farming. Those in this mode of production also trumpet that it excludes GMOs. Until now, without being sufficiently challenged, biobusiness has been able to simultaneously nail “hidden GMOs” to the pillory and feed its profits with them. Biocoop has even succeeded in selling “mower chips” containing oleic sunflower oil in support of the delinquency of “voluntary mowers”.  The character “rich in oleic acid” comes from an induced mutation;  the oil must therefore be marked with the seal of infamy—”GMO.”

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The Council of State asked that one identifies in the common catalog the plant varieties “which would have been registered without the evaluation to which they should have been subjected, taking into account the technique having made it possible to obtain them.” The authorities could take advantage of this to include “not usable in organic farming” whenever there is a variety resulting, directly or indirectly, from a mutation.

This would leave many organic fields fallow and empty the shelves of many specialty stores. I bet this would considerably speed up work on the necessary review and update of the “GMO” directive—and would bring the anti-GMO activist world to better terms. What is needed is legislation regulating varieties and their products based on their (new) characteristics and a reasonable a priori risk assessment, not the breeding methods that produced them. It is urgent legislation. We will sacrifice our agriculture and our food production if we fail to produce it.

André Heitz is a retired agricultural engineer and international civil servant with the United Nations. He held positions with the International Union for the Protection of New Varieties of Plants (UPOV) and the World Intellectual Property Organization (WIPO).

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