Case C-528/16, Confédération paysanne – against new herbicide-resistant plants

American fields are being planted with seeds that have benefited from new techniques of genetic engineering like gene editing. These new seeds have been modified to produce plants that will even survive being sprayed with lethal herbicides. However, French environmental groups anticipate that these new seeds will be soon imported into the EU. They fear that the EU rules on genetically modified organisms in Directive 2001/18/EC are just not able to regulate these new seeds properly. The French courts simply wonder if the EU rules contravene the EU’s ‘precautionary principle’ enshrined in Article 191(2) TFEU.

Background
For centuries, man has used cross-breeding to improve his stock of plants and animals. Last century, industry managed to develop some new processes to enhance the genetic characteristics of particular plants and animals. In the 1980s, some of these processes  even benefited human health directly. For example, genetically-engineered ‘super’ mice were bred to produce the human protein tPA, which is used in the treatment of blood clots.

EU law regulates genetic engineering. In 2001, the EU implemented its ‘genetic modification of organisms’ Directive 2001/18/EC. Or rather, the Directive covered genetic engineering but it imposed specific legal ‘monitoring, inspection and information’ obligations in respect of one important technique, transgenesis – the one which had produced the super mice. This process involves a transgene being put into the genome of a living organism. When the organism reproduces, the transgene is automatically passed on into the offspring.

For ease, the technical wording of the trangenesis provision in the Directive is found in Annex IA Part I and it reads:

(1) recombinant nucleic acid techniques involving the formation of new combinations of genetic material by the insertion of nucleic acid molecules produced by whatever means outside an organism, into any virus, bacterial plasmid or other vector system and their incorporation into a host organism in which they do not naturally occur but in which they are capable of continued propagation;…

Despite the wide scope of the Directive covering genetic engineering, it imposed no legal obligations on another process of genetic engineering known as mutagenesis. Unlike transgenesis, in mutagenesis the organism itself is either blasted with a dose of radiation or it is exposed to certain chemicals. Either way, this causes the DNA inside the organism to change. Eventually, the cells or proteins mutate. And if the mutation turned out to contain particularly desirable properties, then the still-living organism could be cross-bred with other organisms. In this way, mutagenesis managed to produce all sorts of organisms which had very useful industrial applications – and one of them involved weeds.

The French Case
It is common knowledge that weeds are the bane of many a farmer’s life. Traditionally, farmers reach for the herbicides. However, a herbicide like glyphosate will kill not only every weed in sight but can also kill the economically valuable plant the farmer is trying to grow. One solution to this problem has been to develop via transgenesis plants that are resistant to the herbicide.

Another solution has been to develop, via mutagenesis, plants and seeds that are resistant to a selective herbicide. Here, France leads the way. No fewer than forty-six strains of sunflower and no less than 6 strains of rape, have already been bred. Each strain is duly recorded in accordance with the obligations enshrined in the EU’s ‘common catalogue of varieties of agricultural plant species’ Directive 2002/53/EC (OJ [2002] L193/1).

However, industry has continued to develop new mutagenic techniques for modifying DNA. A gene-editing technique like ‘oligonucleotide directed mutagenese’ enables scientists to introduce but a short fragment of DNA with a very defined chemical structure into just one cell. The scientist can then bring about very precise mutations in the gene. That modified cell can then be extracted and ‘regenerated’ in the lab to produce new, complete plants.

American industry has been at the cutting edge of developing these new mutagenic techniques. It has created herbicide-resistant rape seeds and plants. These are now freely traded on the open market, and the plants are already grown in American fields. In contrast, the European species catalogue does not contain any herbicide-resistant seeds or plants that have been developed with these new mutagenic techniques.

In France, the relevant French Minister of State has tacitly consented to mutagenic techniques remaining outside the regulatory purview of the French rules that implement the EU’s ‘genetic modification of organisms’ Directive 2001/18/EC. After all, the Directive imposes legal obligations on plants from transgenic techniques not those from mutagenic techniques.

Yet the French Minister’s tacit decision has upset several environmental and anti-GM groups, including the French-branch of Friends of the Earth. These groups have all gone to the French courts to challenge the Minister’s decision. Anticipating the future import into the EU of these new seeds, the claimants claim that these new products should be subject to the EU’s rules on organisms produced by ‘transgenesis’ techniques. They say that is necessary because of the potential harm that these new products can do to the environment. For example, weeds themselves could become super-resistant to  herbicides. An increased use of herbicides could affect man too because there will be a build-up of carcinogenic molecules in the soil, and the plants which are eaten by man or other animals.

At the Conseil d’État
Aware of the imperative to interpret the 2001 Directive correctly, the judges at the Conseil d’État decided to make a preliminary reference to the CJEU.

To start with, they wanted to know whether the new mutagenic techniques fell within the scope of the transgenesis rules in Annex IA Part I of 2001 Directive.

If the techniques were exempt from Annex IA Part I of the 2001 Directive, then the judges wanted to know if the plants and seeds should still be included in the
genetically modified products mentioned in the EU’s agricultural plant catalogue Directive 2002/53/EC.

A further issue troubled the French judges, namely, whether the French Minister’s decision contravened the EU’s precautionary principle. Here their main concern was that if the products were not regulated by the Directives, then there would be no obligation to conduct preliminary assessments, or do subsequent tests, or even inform farmers or consumers as to the risks of these new products.

Related to this was a judicial concern as to whether the Directive’s exclusion of mutagenesis formed part of minimum-harmonising rules, or a part of completely harmonising rules. If the rules were completely harmonising rules, then the judges wanted to know whether, in light of the latest scientific and academic research, a French court even probe whether the rules and exclusions in the EU’s Directives were incompatible with the precautionary principle that is enshrined in Article 191(2) TFEU.

Questions Referred
According to the website of the Conseil d’État, the questions referred read:

1° Les organismes obtenus par mutagénèse constituent-ils des organismes génétiquement modifiés au sens de l’article 2 de la directive du 12 mars 2001, bien qu’exemptés en vertu de l’article 3 et de l’annexe I B de la directive des obligations imposées pour la dissémination et la mise sur le marché d’organismes génétiquement modifiés ‘ En particulier, les techniques de mutagénèse, notamment les techniques nouvelles de mutagénèse dirigée mettant en oeuvre des procédés de génie génétique, peuvent-elle être regardées comme des techniques énumérées à l’annexe I A, à laquelle renvoie l’article 2 ‘ Par voie de conséquence, les articles 2 et 3 et les annexes I A et I B de la directive 2001/18 du 12 mars 2001 doivent-il être interprétés en ce sens qu’ils exemptent des mesures de précaution, d’évaluation des incidences et de traçabilité tous les organismes et semences génétiquement modifiés obtenus par mutagénèse, ou seulement les organismes obtenus par les méthodes conventionnelles de mutagénèse aléatoire par rayonnements ionisants ou exposition à des agents chimiques mutagènes existant antérieurement à l’adoption de ces textes ‘.

2° Les variétés obtenues par mutagénèse constituent-elles des variétés génétiquement modifiées au sens de l’article 4 de la directive 2002/53/CE du 13 juin 2002 concernant le catalogue commun des variétés des espèces de plantes agricoles, qui ne seraient pas exemptées des obligations prévues par cette directive ‘ Le champ d’application de cette directive est-il au contraire identique à celui qui résulte des articles 2 et 3 et de l’annexe I B de la directive du 12 mars 2001, et exempte-t-il également les variétés obtenues par mutagénèse des obligations prévues pour l’inscription de variétés génétiquement modifiées au catalogue commun des espèces de plantes agricoles par la directive du 13 juin 2002 ‘.

3° Les articles 2 et 3 et l’annexe I B de la directive 2001/18/CE du 12 mars 2001 relative à la dissémination volontaire d’organismes génétiquement modifiés dans l’environnement constituent-ils, dans la mesure où ils excluent la mutagénèse du champ d’application des obligations prévues par la directive, une mesure d’harmonisation complète interdisant aux Etats membres de soumettre les organismes obtenus par mutagénèse à tout ou partie des obligations prévues par la directive ou à toute autre obligation ou les Etats membres disposaient-ils, à l’occasion de leur transposition, d’une marge d’appréciation pour définir le régime susceptible d’être appliqué aux organismes obtenus par mutagénèse ‘.

4° La validité des articles 2 et 3 et des annexes I A et I B de la directive 2001/18/CE du 12 mars 2001 au regard du principe de précaution garanti par l’article 191-2 du traité sur le fonctionnement de l’Union européenne, en tant que ces dispositions ne soumettraient pas les organismes génétiquement modifiés obtenus par mutagénèse à des mesures de précaution, d’évaluation des incidences et de traçabilité peut-elle être mise en cause en tenant compte de l’évolution des procédés de génie génétique, de l’apparition de nouvelles variétés de plantes obtenues grâce à ces techniques et des incertitudes scientifiques actuelles sur leurs incidences et sur les risques potentiels en résultant pour l’environnement et la santé humaine et animale ‘.

Comment
This preliminary reference could be affected by disputes that have either been recently decided by the CJEU or are currently pending before it.

The CJEU recently discussed residues in the soil as emissions into the environment; see further, Case C-442/14, Bayer CropScience. The precautionary principle was also discussed in Case C-78/16, Pesce – against an overly fastidious state combating xylella fastidiosa and in  Case C-157/14, Neptune – mineral water salinity.

Currently, the precautionary principle is at stake in Case C-282/15, Queisser Pharma – an amino acid is not necessarily mean to human health.

Perhaps this reference from France’s Conseil d’État will also be affected by another case  in the CJEU’s ‘In-Tray’ for it involves an Italian farmer who has been punished for growing genetically modified maize; see further, Case C-107/16, Fidenato – growing genetically modified maize.

Update – 12 February 2017
There is another ‘precautionary principle’ reference, this time from the German courts; see further, Case C-683/16, Deutscher Naturschutzring – stop German fishing boats scraping the bottom.