Today, the Court of Justice of the European Union ("CJEU") has issued its much awaited decision on the classification of genome-editing tools such as CRISPR/Cas9, Talen or zinc finger within the framework of the EU's Directive 2001/18/EC on the deliberate release of genetically modified organisms into the environment ("GMO Directive").
In essence, the court held that:
- Organisms obtained by mutagenesis are GMOs and are, in principle, subject to the obligations laid down by the GMO Directive.
- Only organisms obtained by mutagenesis techniques that have conventionally been used in a number of applications and have a long safety record are exempt from those obligations ("Exempted Technologies"). Such exemptions would not apply for new technologies like CRISPR/Cas9.
- Genetically modified varieties of beet, fodder plant, cereal, potato and oil and fibre plant obtained by mutagenesis techniques, except for Exempted Technologies, can only be listed in the 'common catalogue of varieties of agricultural plant species the seed of which may be marketed' if appropriate measures to avoid risks to human health and the environment have been taken.
- The EU Member States are free to adopt stricter regulations regarding Exempted Technologies in compliance with general EU law principles (in particular, the principle of free movement of goods).
The CJEU's decision that GM rules apply to every plant that is not produced by natural breeding comes as a surprise to the industry. Back in January, the Advocate General to the CJEU (AG) took a more industry-friendly view in his Advisory Opinion in this aspect, proposing that the rules should be applied differently depending upon the nature of the plant produced to encourage innovation in plant breeding techniques for the EU to remain competitive in this field—and, in the past, the CJEU regularly followed the AG's opinion.
The approach now taken by the CJEU is not only contrary to the opinion of the AG, it is also very different to the approach taken by the U.S. In March 2018, the U.S. Department of Agriculture stated that, in order to "allow innovation when there is no risk present," it does not have any plans to regulate plants that could otherwise have been developed through traditional breeding techniques, as long as such plants are not considered plant pests or developed using plant pests. That is, while the EU is much more about the process of how the plant is created, in the U.S. the analysis is very much results-oriented and depends upon the donor plant, the recipient plant, and what is introduced into the plant.
In sum, Ag Companies employing new breeding technologies, such as CRISPR, will yet again need to deal with two different regulatory frameworks when engaging in transatlantic business. In contrast to the U.S., relevant products in the EU are likely going to be subject to significant costs resulting from stricter authorization and risk assessment measures. Such products will likely also need to be labelled as GMOs.
In contrast to traditional mutagenesis techniques such as random chemical mutagenesis, novel techniques, such as CRISPR/Cas9, Talen or zinc finger, can allow for the precise breeding of crops with desired characteristics much easier and faster by selectively modifying specific sections or even individual nucleotides of the DNA, while the results are indistinguishable from those developed through traditional breeding methods. These technologies have been controversial since their conception.
The case heard by the CJEU (C-528/16) was initiated by a reference for a preliminary ruling made by the French Conseil d'État (French Council of State, supreme court for administrative justice) after the Confédération paysanne, a French agricultural union representing the interests of small-scale farming, joined by eight other associations, challenged the legality of Article D531-2 of the French Environmental Code before the court. The contested provision implements the GMO Directive into French national law by generally exempting organisms obtained by mutagenesis from GMO regulation.
The Confédération paysanne argued that the mutagenesis exemption should be interpreted in the light of the factual conditions that existed in 2001 when the GMO Directive was adopted and, therefore, apply only to conventional random mutagenesis techniques that involve ionizing radiations or exposing plants to chemical agents that were used routinely at this time. Organisms developed with novel, targeted mutagenesis techniques, such as oligonucleotide-directed mutagenesis or directed nuclease mutagenesis, on the other hand, should not be eligible for the GMO Directive's exemption, as it could not have been the EU legislature's intent to also exempt products that impose safety risks due to not being "tried and tested."
The CJEU has essentially followed the arguments of the Confédération paysanne.
Firstly, the court ruled that organisms obtained by mutagenesis are the result of alterations made to genetic material in a way that does not occur naturally and, therefore, constitute genetically modified organisms (GMO's) within the meaning of Article 2(2) of the GMO Directive. The established exemption for "mutagenesis" laid down in Article 3 and Annex I B of the GMO Directive only covers organisms obtained by mutagenesis techniques that (i) do not involve the use of recombinant nucleic acid molecules or GMOs other than those produced by the methods listed in Annex I B, (ii) have conventionally been used in a number of applications, and (iii) have a long safety record at the time the GMO Directive was adopted, hence in 2001, (Exempted Technologies).
Referring to Article 1 and recitals 8 and 55 of the GMO Directive, the court argues that such a strict reading is warranted in light of the objective of the GMO Directive, which seeks, in accordance with the so-called precautionary principle, to protect human health and the environment. Based on the facts presented, the court sees risks linked to the use of these new mutagenesis techniques, which prove to be similar to those that result from the production and release of a GMO through transgenesis. Direct modification of the genetic material of an organism through mutagenesis now makes it possible to obtain the same effects as transgenesis and to produce genetically modified varieties at a rate out of all proportion to those resulting from the application of conventional methods of mutagenesis.
Secondly, the court stated that organisms obtained by directed mutagenesis techniques also fall within the concept of a "genetically modified variety" used in the EU's Directive 2002/53/EC on the common catalogue of varieties of agricultural plant species ("PV Catalogue Directive") to avoid inconsistencies with the GMO Directive. Hence, unless organisms resulting from Exempted Technologies are concerned, varieties of beet, fodder plant, cereal, potato and oil and fibre plant produced by using mutagenesis techniques can only be listed in the 'common catalogue of varieties of agricultural plant species the seed of which may be marketed' if appropriate measures to avoid risks to human health and the environment within the meaning of Article 4(4) of PV Catalogue Directive have been taken.
Lastly, it was held that EU Member States are free to subject organisms obtained by means of Exempted Technologies to stricter rules than the GMO Directive in compliance with EU law, in particular, with the rules on the free movement of goods set out in Articles 34 to 36 of the Treaty of the Functioning of the European Union (TFEU).
Because of the generality of this update, the information provided herein may not be applicable in all situations and should not be acted upon without specific legal advice based on particular situations.
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