France - On February 7, 2020 The Council of State rendered a decision to reconcile French law with European directive 2001/18 of March 12, 2001 relating to the deliberate release of genetically modified organisms (GMOs) in the environment. 'Deliberate release' is an important distinction, as we shall see.
In October of 2016, the Confédération paysanne and eight associations asked preliminary questions at the Court of Justice of the European Union (CJEU) about other forms of genetic engineering. The questions, according to the interpretation of the request made by the Council of State “[c]onsidering the arguments of the request ”, were:
- Are the varieties produced by mutagenesis - resulting from mutations caused by the human hand - GMOs, falling under the regulatory provisions on the dissemination and the placing on the market of genetically modified organisms (GMOs)?
- should a moratorium be put in place on the dissemination, cultivation and use of varieties made tolerant to - according to improper terminology - herbicides (VRTH) - in reality to a herbicide or a family of herbicides?
The judgment was delivered on July 25, 2018 (analyzed in (Organic farming must go back in time ... 70 years!) and now farmers have been given six months to comply.
The Council Of State Is Handcuffed By Misguided Rulings At The Court Of Justice Of The European Union
The Court of Justice of the European Union (CJEU) refused to follow the science-based recommendation of its Advocate General and its judgment was strongly criticized, both for its legal relevance and for its disastrous economic and social consequences. The general opinion remains that opposition in principle to GMOs, Directive 2001/18, is obsolete and must be revised, or Europe will be left behind when it comes to new selection techniques such as CRISPR / Cas9 in the agricultural sector.
Yet when faced with this situation, and this looming danger, the decision-making bodies in the state capitals and in Brussels did nothing, only engaging from time-to-time with posturing and pretense .
Now, because of the conclusions of the CJEU, the Council of State decreed that any method of varietal selection developed since 2001 (the date of the European directive) must undergo evaluation as a GMO and fall under those regulations. It is therefore up to the government to modify, within six months, article D. 531-2 of the Environment Code, paragraph 2 ° .a), "by fixing by decree taken after opinion of the High Council for Biotechnology, the limiting list of mutagenesis techniques or methods traditionally used for various applications and whose safety has been proven for a long time ”.
The only way these techniques or methods can escape the regulation will mean doing no innovation. France wants to ban the cultivation of GMOs on its territory so if everything is a GMO, including mutagenesis or CRISPR, no improvements can occur.
In Europe, The Clock Of Science And Technology Stopped Ticking In 2001, At Least Food Science And Varietal Creation.
Given this ruling, French farmers will be deprived of innovative varieties using New Breeding Techniques (NBT), and even of random mutagenesis carried out in vitro, on cells isolated according to the ruling but logically also on tissue cultures, explants, etc. Instead of being locally created, consumers will only be able to enjoy benefits such as improved nutritional quality, shelf life or ease of use if the products are authorized for import and marketing.
This paradox has already been noted in connection with the CJEU ruling: random mutagenesis techniques (by irradiation or the action of chemical substances), with unpredictable effects, will remain authorized. They " have been traditionally used for various applications " and that their "safety has been proven for a long time ".
This is what the legislator decreed in the recitals of his directive and the judge agreed in his ruling.
It makes little sense to allow random effects from mutagenesis while directed mutagenesis and precise “molecular scissors” with greater safety are banned from French territory.
The Right To Test Science And Good Faith
" ... it 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 ", writes the state Council. Simple internet research, however, shows that these techniques have been described and used at least since the 1970s (see for example Broertjes, C., The development of (new) in vivo and in vitro techniques of significance for mutation breeding of vegetatively propagated crops , IAEA, 1975; Mutation Breeding: Theory and Practical Applications , AM van Harten, Cambridge University Press , 1998).
Has the record been established in good faith? Has the government responded adequately?
This judgment of the Council of State poses a fundamental problem of the functioning of a justice which decides in its ivory tower, on the basis of the files presented by the parties. A reflection is essential on the means to be implemented so that justice is not exploited.
With No Reason For Deletion, Litigation Will Still Happen?
Did the Council of State, while remaining within the limits of its discretionary power, side with the opposition to science and genetic technology and more generally agriculture thanks to acceptance of qualifiers such as "intensive", "productivist" or "industrial"?
It instructs the competent authorities to identify, within nine months, within the common catalog of varieties of agricultural plant species, those of the varieties which would have been listed there without the assessment being carried out as GMOs.
This poses several problems.
On one hand, the reference to the common catalog implies, at least in principle, that the French authorities decide on varieties initially listed in the national catalog of another Member State.
On the other hand, it is obvious that if this injunction is respected to the letter, the challenge will require the extension to vegetable varieties and that will mean new litigation. Activists are ready. The Peasant Confederation and others now maintain that 85% of endives consumed in France are GMOs.
After identification, then what? 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. Article 14.2 provides for the possibility of deleting a variety from the catalog " if the laws, regulations or administrative provisions […] are not respected " or if " when applying for admission or during the procedure for examining false or have been provided regarding the data upon which admission depends ."
Neither of these conditions are met in this case, the first having to be assessed in terms of the law as it was interpreted and applied at the time of the registration decision.
So authorities have created a scenario where identification has occurred but there is no reason for deletion, yet it will still be used in litigation by opponents GMOs, according to the meaning of the decisions made.
A Judgment That 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, but it will be a challenge because the information was unneeded at the time of the registration request and will probably not have been provided. The reason is obvious. When a variety is the result of a mutation, it is irrelevant for 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 relate to the progeny of varieties suddenly qualified as GMOs, which will also be GMOs, at least if they have acquired the mutation in question, but given the tintamarre on so-called “off target” effects, it would be ironic to subject others to the same fate.
A Social Safety Switch?
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 ”.
Here, they are assuming that there may have been a deliberate release of a GMO that would not have been subject to required authorization. It's absurd to think a company spent the money to create a product and then avoided registration, the only way they could earn their investment back, and instead illegally released it for free.
Let us repeat: the varieties resulting from an in vitro mutagenesis only became GMOs by the decision of the Council of State (the CJEU stating that they are not "excluded from the scope of the said directive [of regulatory, assessment procedures, etc.] than organisms obtained by mutagenesis techniques / methods which have been traditionally used for various applications and whose safety has been proven for a long time ”.
According to these articles of the Environment Code "dependent on the criminal proceedings which may be brought, […] the administrative authority […] orders the suspension " of the release and " may order the deposit of the products placed on the market without authorization or their seizure ”.
These two articles also envisage the possibility of taking provisional measures in the event of a serious threat to public health or the environment.
What will the government do?
What will local elected officials who defy the authority of the state do with decrees fixing untreated areas around dwellings of up to one kilometer?
Should We Push That Far?
Should we go beyond the applicants' first conclusion, which was to set aside an implicit decision by Prime Minister Manuel Vals, with the consequence, in application of the CJEU judgment, that the current one will have to establish Article D. 531-2 of the Environment Code, paragraph 2 ° .a), "the limitative list of mutagenesis techniques or methods traditionally used for various applications and whose safety has been proven for a long time "?
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 not the Council of State go beyond the - formal - conclusions of the request of the Confédération paysanne and eight associations by disserting on the fate of the varieties now labeled as GMOs and blaming it?
This judgment raises serious and important questions.
This article also appeared on Contrepoints in French.