What should be
the best regulatory framework
for Gene Editing
This article raises the touchy question of the state of the debate on GMOs, in the context of the multiplication of new genomic techniques (or NGT).
To date there is no adequacy of the current framework with regard to all these so-called new genomic techniques, often referred to as New Genomic Techniques or NGTs.
The European Commission has announced a proposal for the end of 2023 for plants produced by certain NGTs.
Given that since several years, a more favourable attitude - especially among young consumers - towards GMOs has been noticeable, is it more realistic to imagine a new global regulatory framework for both techniques rather than a tailor-made approach for gene editing alongside the current GMO framework?
State of the art/Analogs
This article raises the delicate question of the state of the debate on GMOs in the context of the multiplication of new genomic techniques.
For consumers, gene editing and genetic modification techniques seem to be interchangeable. In reality, there are significant differences between these methods.
Advancements in biotechnology have led to the development of new genomic techniques that help breed new plant varieties by altering the genetic material of an organism with higher precision than conventional breeding techniques. While genetically modified organisms (GMOs) introduce novel configurations of genetic material typically derived from other organisms, some gene editing methods can lead to limited changes that may also occur through conventional breeding or happen in nature. For instance, CRISPR allows multiple modifications to be made in a single experiment without permanently inducing foreign DNA.
However, to date, the current framework does not seem to be adequate for these new genomic techniques.
In the European Union, the marketing and cultivation of all genetically modified organisms (“GMO”) are governed by Directive 2001/18 relating to the deliberate release of genetically modified organisms into the environment (1) and Regulation 1829/2003 on genetically modified food and feed (2). As such, genetically modified organisms may only be released into the environment or placed on the market only if consent has been given, subject to specific conditions and granted with a view to specified uses, after a scientific assessment of the risks of each Member State.
It is therefore a cumbersome process that raises questions as to its suitability, particularly concerning genomic techniques that appear to be, scientifically, close to conventional selection.
Of interest, in 2018, the European Court of Justice made an important ruling (3) that could have had a significant impact on the liberalisation of new genomic techniques. But unfortunately while it had the opportunity to totally exclude organisms of certain genomic techniques (i.e., mutagenesis) from the GMO legal framework, the Court took a narrower approach and ruled out that all organisms obtained by mutagenesis are to be considered, in fact, genetically modified organisms subject to the 2001 EU GMO directive, except: “organisms obtained by means of techniques/methods of mutagenesis which have conventionally been used in a number of applications and have a long safety record are excluded from the scope of that directive”.
Aim – Fill in the gap
In this context, there has always been a certain reluctance towards "traditional" GMOs, often perceived as injurious to health.
But however, and more recently, there has appeared to be a growing consensus – especially among young consumers – that certain new genomic techniques could be excluded from the GMO legislation, based on scientific, legal and societal considerations. Indeed, in a perspective of a more sustainable world, the GMO legislation does not seem fit for genetic manipulations that do not lead to permanent mutation in the DNA, especially regarding some new genomic techniques which can provide plants that are more resistant to natural hazards and that require fewer natural resources.
In fact, on 7 February the European Court of Justice issued a new ruling on this topic, and more precisely, on the status of in vitro random mutagenesis (4). The Court recognised that random mutagenesis is a technique that has conventionally been used in a number of in vivo applications and has a long safety record with regard to those applications. Therefore, the Court declared that organisms obtained by in vitro random mutagenesis should be exempted form the scope of the EU GMO directive.
It now remains to be seen whether the European Commission will build on this momentum when it publishes its initiative on EU rules on New Genomic technique, expected for the second quarter of 2023.
This initiative aims to propose a legal framework for plants obtained from targeted mutagenesis and cisgenesis, which, according to the Commission can help “maintain a high level of protection for human and animal health and the environment, enable innovation in the agri-food system and contribute to the goals of the European Green Deal and the ‘Farm to Fork’ strategy”. Following a published consultation that closed two months ago, a legislative proposal is expected for the second quarter of 2023.
It has become evident that a distinction must be made between the different techniques. The question is no longer whether NGTs will be regulated, but how they will be regulated. The Commission has not yet given a clear indication of the legal framework to which it intends to subject NGTs. But it seems reasonable to assume that some methods will be exempted from the GMO Regulation.
References and notes
Directive 2001/18/EC of the European Parliament and of the Council of 12 March 2001 on the deliberate release into the environment of genetically modified organisms and repealing Council Directive 90/220/EEC
- Regulation (EC) No 1829/2003 of the European Parliament and of the Council of 22 September 2003 on genetically modified food and feed
- Judgment of the Court (Grand Chamber) of 25 July 2018 Confédération paysanne and Others v Premier ministre and Ministre de l’agriculture, de l’agroalimentaire et de la forêt Request for a preliminary ruling from the Conseil d'État
- ECJ, Confédération paysanne and Others, C-688/21