Technology Biotechnology Draft French Decree on Mutagenesis Breeding, Consequent Draft Lists of Banned Herbicide...

Draft French Decree on Mutagenesis Breeding, Consequent Draft Lists of Banned Herbicide Tolerant Rapeseed Varieties: A Saga History Of Interpretations

-

A legal challenge to the French interpretation of EU Directive 2001/18/CE on GMOs

In December 2014, nine NGOs challenged the transposition of the EU Directive 2001/18/EC – on the deliberate release of GMOs into the environment – by the French government as regards the exemption of varieties obtained from mutagenesis. Focusing on herbicide tolerant varieties in rapeseed and sunflower, and considering those products as ‘hidden GMOs’, they claimed no assessment was carried out prior to marketing. Consequently, they asked the Prime Minister to repeal the corresponding part of the French law and to adopt a moratorium on sales and cultivation whilst evaluating the risks as legally required by the said Directive. In March 2015, as no answer was given, the same NGOs brought the matter before the French Conseil d’Etat, as the highest court of justice which settles disputes between citizens and the administration. Citing ‘a serious difficulty in interpreting European Union law’, the Conseil d’Etat referred four preliminary questions to the Court of Justice of the European Union (ECJ) on 3 October 2016.

The European Court of Justice interprets EU Directive 2001/18/CE

In July 2018, the European Court of Justice (ECJ) answered the four preliminary questions raised by the French Conseil d’Etat on the GMO directive 2001/18/EC as well as directive 2002/53/CE, on the common catalogue of varieties of agricultural plant species.

The ruling of the European Court of Justice (ECJ) stated that all organisms obtained by means of mutagenesis (recent or not) must be considered to be GMOs as defined in article 2(2) of the GMO directive. An exemption applies to organisms obtained by methods of mutagenesis which have conventionally been used in a number of applications and have a long safety record. Consequently, breeding methods developed after the adoption of the directive, e.g. targeted mutagenesis, fully fall in its scope.

The ECJ also stated that the mutagenesis exemption cannot be interpreted as preventing Member States from legislating in that area. They may subject such organisms to obligations as long as such obligations comply with EU law and in particular with the rules on the free movement of goods.

The French Conseil d’Etat interprets the ECJ ruling

In its decision of February 2020, considering that no evidence of long safety records was provided for random in vitro mutagenesis, the Conseil d’Etat confirmed that all plants resulting from this technique are subject to the obligations of the GMO-Directive. Consequently, the Court asked the French government to amend the French Environment Code. The government should in this context establish by decree, after consulting the High Council for Biotechnology, a restrictive list of mutagenesis techniques traditionally used for various applications and for which safety has long been proven. This closed list should be a list of techniques exempted from the scope of the directive 2001/18/CE.

As a consequence, the competent authorities are then required to identify within the Common Catalogue which varieties, in particular among the herbicide tolerant ones, should be withdrawn because of the lack of evaluation they should have been subject to according to the Environment Code.

In addition, the French government was asked to take the necessary measures to assess the risks associated to herbicide tolerant varieties, following the recommendations of the French safety agency ANSES. The appropriate growing conditions for those varieties should then be notified to the European Commission as a consequence of the procedure laid down in Article 16(2) of the common catalogue Directive 2002/53/EC.

The French government interprets the decision of the Conseil d’Etat and notifies the European Commission

Bound by strict deadlines set by the Conseil d’Etat decision, the French government followed-up and released on May 6, 2020, a draft decree “amending the list of techniques for obtaining genetically modified organisms traditionally used without any noted drawbacks on public health and the environment.”

The draft decree, which refers to genetic modification techniques mentioned in the French Environment Code, specifies mutagenesis techniques to be exempted from the scope of the regulations relating to GMOs in France, with the exception of in vitro random mutagenesis “consisting in subjecting plant cells cultivated in vitro to chemical or physical mutagenic agents.”

Emmanuel Lesprit

As a consequence, France also released two draft orders i) to delete from the French catalogue the listing of 7 Clearfield® rapeseed varieties resulting from in vitro mutagenesis and ii) to list 96 Clearfield® rapeseed varieties, listed in the EU Common Catalogue, that will be banned for cultivation in France after the decree enters into force.

Being susceptible to affect the free movement of seeds and products within the EU, France notified their draft decree and subsequent orders to the European Commission, under the specific and mandatory TRIS tool. For more details, please refer to Petra Jorasch’ paper ‘EU must stop French interpretation of mutagenesis plant breeding and preserve common market for seed’, elsewhere in this issue.

On the way to the final adoption of their draft decree, France therefore also referred to the High Council for Biotechnology (HCB) and opened a public consultation for the modification of the Environment Code. While the consultation is still to be held, the HCB released its opinions mid-July.

The High Council for Biotechnology goes back to interpret the EU Directive

As stated above, the Conseil d’Etat had called upon the HCB to provide advice on a possible classification of mutagenesis techniques. Nevertheless, the French government only referred to the HCB on the restrictive text of the draft decree, focusing on random in vitro mutagenesis alone.

The scientific advice of the HCB clearly states it does not identify biochemical differences between the mutations, whether they are obtained by random mutagenesis in vitro, in vivo, or spontaneously. Only their probability of appearance and their selection easiness vary.

The scientific advice of the High Council for Biotechnology clearly states it does not identify biochemical differences between the mutations, whether they are obtained by random mutagenesis in…

The socioeconomic committee of the HCB concentrated on the legal question whether the draft decree allows the application of the decision of the Conseil d’Etat and the ruling of ECJ. It criticizes the shortcomings in the draft decree as not establishing a precise list of techniques of mutagenesis traditionally used for various applications and for which safety is proven for a long time, as requested by the Conseil d’Etat.

Uncertainties Mount in French Value Chain

While the draft decree also provides some transitional measures for the cultivation and harvesting of the 2020 crop which was sown or planted before the decree comes into force, uncertainties begin to mount in the French value chain. No specific provisions are made regarding the steps following harvest, until oilseed crushing and rapeseed meal making. This brings legal uncertainty to all economic operators among the agri-food value chain.

As the national seed association, Union Française des Semenciers (UFS) initiated a collective action with 28 other national partners to demonstrate that the draft decree will impact not only seed companies but also agricultural and food chains. They mainly raise their concerns about the paradigm shift which could also lead to a new situation of low-level GMO presence in seeds, food and feed. This collective continues to be vocal towards the recently appointed French government, taking into account the outcome of the TRIS notification procedure at EU level.

The stacking of so many interpretations clearly shows how ambiguous and imprecise the existing text of the GMO Directive 2001/18/CE is.

Urgency to Review Dir. 2001/18, An Obsolete Regulation Which Ignores the Current State of Knowledge

The stacking of so many interpretations clearly shows how ambiguous and imprecise the existing text of the GMO Directive 2001/18/CE is. In addition, the directive doesn’t contain provisions of its own updating as regards the current state of scientific knowledge.

Moreover, the French case described above shows its further implementation may lead to a non-harmonized EU regulatory framework where member states may potentially use their leeway to require additional conditions for marketing products that were so far exempted from the obligations of the GMO Directive. It clearly has negative impacts for the internal market as well as the international one.

UFS with 28 other national partners definitely consider this obsolete regulation must be revised as soon as the EU Commission has completed its ongoing study on “New genomic Techniques” by April 2021.

Editor’s Note: Emmanuel Lesprit is Head of the Plant Breeding Unit at the Union Française des Semenciers (UFS).