The New Genomic Techniques and the RIS8ttimo project: a new challenge for the Law
By Maria Chiara Errigo
Between the night of June 20 and June 21, 2024, in a field close to Pavia, an experimental cultivation of some rice seedlings, obtained through the use of New Genomic Techniques and started for the first time, was hit by a serious act of vandalism, destroying, almost completely, the laboriously created crops. However, in order to better understand what actually happened, it is necessary to start at beginning of the story and specifying what is meant by the expression “New Genomic Techniques” and what are the regulatory issues involved in their application.
More specifically, New Genomic Techniques (New Genomic Techniques - NGT) represent the most recent frontier of genetic ‘improvement’, identifying sophisticated modification mechanisms with important applications in both clinical and agrifood sectors. In particular, considering their application in agriculture, the use of such techniques can lead to the production of varieties characterized by greater sustainability, making them more resilient to climate change, as well as 'immune' to certain pathogens, in order to meet food security needs.
The difference with the traditional means of genetic engineering results in more sophisticated tools: in the case of GMOs, scientists use the technique of transgenesis, involving the transfer of a gene belonging to a different organism, with which no interbreeding would be possible in nature. In contrast, in the case of New Genomic Techniques, mutations can be carried out by affecting directly the gene sequence of the organism, without drawing on external DNA (gene editing); or through the introduction of a gene belonging to varieties of the same species or a related one, such that the changes could also occur in spontaneous crosses (cisgenesis).
Among these techniques, the most promising has to be identified in CRISPR (Clustered Regularly Interspaced Short Palindromic Repeats), a gene editing technique, that has enormous potential, both in the medical-health field and in the agrifood (A. Meldolesi, E l’uomo creò l’uomo, Bollati Boringhieri, 2017; see also A. Meldolesi, Blog CRISPeR Mania, updated on the most recent news of Crispr Tecnique).
The technique is inspired by the natural processes of genetic modification in organisms and allows material to be edited, added or removed in an extremely precise manner. Normally, CRISPR works in conjunction with the Cas9 protein, and resembles a kind of word processor that allows the selection and the editing of a specific sequence of interest. Moreover, these techniques ‘leave no trace’, making the modified DNA sequence almost indistinguishable from the ‘natural’ one.
Regarding the regulation and, with reference to their use in the agri-food field, the most recent genomic techniques have been treated as equivalent to GMOs: the Court of Justice of the European Union, in the judgment of July 25, 2018, Confédération paysanne and Others v Premier ministre and Ministre de l’agriculture, de l’agroalimentaire et de la forêt (C-518/16)11, has placed them under the application of Directive 2001/18/EC, which regulates the deliberate release into the environment and the placing on the market of genetically modified organisms.
However, this decision did not find support among the relevant scientific community, which was concerned that the application of such a rigid and articulated discipline could become a further limitation to agrifood innovation, as it has already happened in the case of GMOs (for a complete analysis on the subject of GMOs, see F. Rossi Dal Pozzo, Profili recenti in tema di organismi geneticamente modificati nel settore agroalimentare fra procedure di comitato e tutela giurisdizionale, in Il diritto del commercio internazionale, 2, 2014).
So, after carrying out dedicated studies, also involving EFSA (Commission Staff Working document, Study on the status of new genomic techniques under Union law and in light of the Court of Justice ruling in Case C-528/16, 29 Aprile 2021), on July 5, 2023, the European Commission presented a proposal Regulation on plants obtained through certain new genomic techniques, and food and feed derived, and amending Regulation (EU) 2017/625, aimed at regulating the release into the environment of the new varieties and the placing on the market of feed, products or food produced from them.
The proposal pursues several goals, including ensuring a high level of human and animal health protection, with a focus also on environmental protection, and allowing the development and marketing of crops that contribute to achieving those sustainability and innovation goals set by the European Green Deal.
More specifically, the Commission proposed the classification of crops into two categories: the first (the proposed regulation refers to this group by the acronym NGT 1) includes plants resulting from the application of genetic mutation techniques (in particular, these are site-directed mutagenesis and cisgenesis), which could also be naturally occurring or considered equivalent to those obtained by conventional techniques. In this case, the proposal provides for a highly simplified procedure compared to that present in the field of GMOs; on the other hand, the second (known by the acronym NGT 2) includes all other plants, food or feed resulting from the application of the new techniques that do not fall into the first category: in this case, the current (articulated) regulation on GMOs would continue to apply, albeit with some adaptations (for example, it exclude the possibility that Member States could prohibit or restrict the cultivation of NGT varieties on their territory: today, this option is possible with regard to GMOs, since the Directive No. 2015/412). Currently, in Italy is not possible to cultivate GMOs, although the variety has been authorized at the EU level; however, it is possible to import them.
Albeit with some amendments that did not change the original framework, the proposal was approved by the European Parliament on February 7, 2024, in a plenary session with 307 votes in favor, 263 votes against, and 41 abstentions. The text is now at the attention of Member States within the Council of the EU.
Specifically, with regard to the Italian system, it should be noted that New Genomic Techniques (NGT) are known as Assisted Evolution Technologies (TEA). This linguistic choice was determined by the fear that the term 'genomic' could bring back the adjective ‘genetic’ and thus evoke the phenomenon of GMOs, raising concerns related to the artificiality of the product and the consequent difficulties of acceptance of the new techniques. Therefore, this different expression aims to avoid misunderstandings, favoring a more effective communication with the public: it refers to an idea of natural evolution, more respectful of the cultivation rhythms, making modifications that could also occur spontaneously, without the hand of man.
Furthermore, within the national regulation, the Drought Decree introduced a new possibility: the cultivation of “organisms produced by genome editing techniques through site-directed mutagenesis or cisgenesis" for experimental and scientific purposes (Art. No. 9 bis “Urgent provisions on agricultural genetics”, Law No. 68/2023).
Therefore, the legislation has authorized the possible experimentation of TEA (or NGT) varieties no longer only in vitro but also in practice; the related steps of authorization procedure are expressed by the Legislative Decree No. 224/2003 on GMOs, identifying the competent authority in the Ministry of the Environment and Energy Security and entrusting the Italian Institute for Environmental Protection and Research (ISPRA) with a central role of evaluation about the safety of the ‘new’ variety. Anyway, this new possibility is subjected to a time limit: while initially it is on December 31, 2024, it has recently been extended to the following year (December 2025) by an amendment introduced with the Agriculture Decree (converted in Law, on July 11, 2024; see, specifically, Art. No. 1, par. 9bis). Moreover, this decree introduces the possibility to realize trial also for crops with improved qualitative and nutritional characteristics (not only for varieties pursuing sustainability goals related to increased resistance to climate stresses).
Thanks to the amendment introduced in June 2023 with the Law No. 68/2023 (‘Drought Decree’), a first experiment, conducted by Vittoria Brambilla and Fabio Fornara (University of Milan), with their research team, started. The project, titled RIS8imo, involved the experimental cultivation of a genetically modified rice variety through the use of the CRISPR technique, in an attempt to make it resistant to certain fungus (Pyricularia oryzae), responsible for the most important disease of the rice plant (the ‘brusone’ disease), which can lead to very significant production losses.
The project was authorized by Italian Institutions and in May 2024, the scientists planted several edited rice seedlings in the field of the Radice Fossati farm in the province of Pavia. However, as anticipated at the beginning of this text, despite the importance of the experiment (it also has the merit of having ‘paved the way’ for the submission of further applications for experiment authorization of other products), the field was devastated overnight, with the destruction of almost all the seedlings.
Therefore, the experiment will not be able to continue as initially planned; however, some plants are saved and this fact gives us a little hope in a context that still appears ‘dark’, with a strong resistance against the uses of innovation in agrifood sector.
On this topic, the Department of Law, Political and International Studies hosted a meeting on July 2, 2024 (entitled “Crispr e il settore agroalimentare: problematiche regolatorie e prime sperimentazioni), which featured, among the speakers, Vittoria Brambilla and Roberto Defez, researcher at the CNR in Naples, which has supported the RIS8ttimo project from the beginning; both tell their direct experience and underlie the difficulties on the political and regulatory contexts for the activation an experiment in this sector (in addition to these scholars, other professors from the University of Parma also took part in the discussion: Lucia Scaffardi, full professor of Comparative Public Law, Maria Chiara Errigo, researcher of Constitutional Law, and Tommaso Ganino, associate professor of General Arboriculture and Tree Crops).
In conclusion, it is possible to underline that the proposed European Regulation and the amendments to the Italian legislation, previously described, testify to an initial awareness of the issue, regarding the importance of agrifood innovation and the need to provide more appropriate rules, in line with the scientific framework and with the multiple interests involved in the agrifood biotechnology context.