Back a few years ago
In July 2014, the North American biotechnology company Cibus approached the BVL, the German Federal Agency for Food Safety and Consumer Protection, about the regulatory status of an herbicide-tolerant rapeseed (canola) obtained during a variety selection program based on “gene editing”. This genetic modification, in the scientific sense of the term, did not use transgenesis (transfer of genes in the laboratory) which in Europe falls under the definition – a legal one this time – of a “genetic modification” (“GMOs”); which implies a heavy and costly burden of regulatory obligations. In the relevant European Directives (first in 1990, then 2001), mutagenesis is exempted from these obligations which are essentially aimed at transgenesis, because it was the new technique at the time these Directives on “GMOs” were written. Apparently logically, the BVL decided that this Cibus rapeseed should not be considered a “GMO” (in its legal sense), because it results from a form of mutation (occasional modifications of letters in DNA), certainly induced by humans, but which could also have occurred naturally.
This did not please the powerful anti-GMO organizations which challenged the BVL’s advice. This rapeseed, as well as all the products obtained by gene editing thus found themselves literally in the limbo of European regulation (see M. Fladung, 2016 ).
An intense debate
Many discussions, forums and scientific articles followed, debating the question whether, according to the European Directive on GMOs, new plant varieties generated by gene editing should or should not be subject to the obligations laid down for “genetically modified organisms” (in the legal sense of the term). The semantic analysis of the key phrases of the said Directive left jurists divided… A consensus was established among scientists first of all to say that the mutations which could also have occurred naturally should not be concerned, and therefore not either gene editing. Secondly, that the European Directive is now meaningless, because it targets techniques for producing, for example, varieties of plants, whereas it would be more reasonable to focus on the properties of these plants, because the latter determine the benefits and risks.
The judgement by the Court of Justice of the European Union (CJEU)
On July 25, 2018, the CJEU, asked by the French Conseil d’Etat, itself responding to a request of anti-GMO organizations, issued a disappointing opinion for scientists and seed companies: “Organisms obtained by mutagenesis are GMOs and are, in principle, subject to the obligations laid down by the GMO Directive”. “However, organisms obtained by mutagenesis techniques which have conventionally been used in a number of applications and have a long safety record are exempt from those obligations, on the understanding that the Member States are free to subject them, in compliance with EU law, to the[se] obligations”. Gene editing is therefore affected, although the judgement did not specifically target it.
The judgment was criticized by the United States government, widely commented and also subject to semantic interpretations (see for example Vives-Vallés and Collonnier). The judgment appears consistent with the legal basis of the GMO Directive and the interpretation of the Precautionary Principle prevailing in Europe. Rather, it is the legislation that is absurd from a rational point of view…
After the CJEU judgement, the idea of a revision of the EU legal framework on GMOs gained momentum and even more even after the Nobel Prize in Chemistry was awarded in 2020 to Emmanuelle Charpentier and Jennifer Doudna for their work on the CRISPR-Cas system, which paved the way for the most promising gene editing technique (see A. Ricroch ).
The European Commission taking over
At the request of the Council of the EU, the Commission promised to deliver a report before the end of April 2021, which it did. Following the Euro-Brussels tradition, the preparation of this report gave rise to intense lobbying from “stakeholders”. Unsurprisingly, political ecology organizations have pushed for maximum constraints, with the aim to prevent the deployment of applications of these new biotechnologies. Scientific initiatives have drawn attention to the importance of these innovations. The initiative “European Sustainable Agriculture through Genome Editing” (EU-SAGE) worked “to provide information about genome editing and promote the development of European and EU member state policies that enable the use of genome editing for sustainable agriculture and food production”. These ideas were also taken up by the “Re-Imagine Europe” think-tank which highlighted their compatibility with the objectives of the European Green Deal and its “From farm to fork” strategy.
A report that tries to reconcile divergent points of view
“The study identified limitations to the capacity of the legislation to keep pace with scientific developments; these cause implementation challenges and legal uncertainties”. The legislation must therefore be adapted… because “it may not be justified to apply different levels of regulatory oversight to similar products with similar levels of risk, as is the case for plants conventionally bred and obtained from certain new genomic techniques”.
Taking an ‘at the same time’ approach, the report confirms that these techniques “have the potential to contribute to sustainable agri-food systems in line with the objectives of the European Green Deal and Farm to Fork Strategy, and also states that their “applications in the agricultural sector should not undermine other aspects of sustainable food production, e.g. as regards organic agriculture”.
The report also identified “knowledge gaps and limitations” and recommendations to address them and that “more effort should be made to inform and engage with the public and assess their views”.
Marcel Kuntz is a research director at the National Center for Scientific Research in Grenoble, France. This article is adapted from an essay published in Frontiers in Bioengineering and Biotechnology. Find Marcel on Twitter @marcel_kuntz