The EU is late to the race for plant genetic editing and its proposal to regulate it raises doubts

• The BIOTECH ATTRACTION Congress of BIOVEGEN held at FRUIT ATTRACTION highlights that new techniques are “faster, more efficient and more precise”: not only CRISPR mutagenesis, but also base editing, priming, cisgenesis and intragenesis and synthetic biology. Their applications in the EU will depend on the wording of the “small print” of the future regulation.

• Europe is turning its back, for the moment, on a new generation of CRISPR-derived crops already approved in the USA, China and Japan - starch-rich corn, mildew-resistant wheat, tomatoes to lower blood pressure... - and the regulations that support these techniques are also approved in Canada, Australia, England, China, Israel, India, Brazil and Argentina.

More than 350 scientists and agricultural entrepreneurs filled the Fruit Forum during the 1st Congress organised by BIOVEGEN, the platform that promotes biotechnology in this sector, held during the recent edition of Fruit Attraction (Madrid). One of the major themes addressed was the scope of the proposed regulation by the European Commission (EC), approved on 7 February by Parliament, on New Genomic Techniques (NGT's) and the developments achieved in plant improvement by these methods. Diego Orzáez, a CSIC researcher at the IBMCP (Institute of Molecular and Cellular Biology of Plants, in Valencia), highlighted how these techniques have evolved in recent years to be more "fast, effective and precise". In this race for genetic editing, the EU - which has not yet concluded the debate on the regulations that will regulate them - is moving behind the rest of the Western powers. As Orzáez described, there is already a “first generation of commercial fruits” obtained by CRISPR on the market: corn with a high starch content, tomatoes enriched with GABA to lower blood pressure (both approved in Japan); a romaine lettuce that does not brown, mustard leaves that are less bitter and soft, soybean oil low in saturated fats and zero trans fats, a mushroom that does not oxidize and prevents them from turning brown and soft, a potato resistant to certain pests, with reduced sugars and low acrylamide content (in the USA); varieties of apples that do not oxidize (Canada) or a wheat resistant to mildew fungus (China). Crops already approved and available thanks to favorable legislation that, beyond the powers cited, also occurs in Australia, England, India, Pakistan, the Philippines, Israel, Brazil, Argentina or Chile, among others.

The IBMCP researcher explained how, starting with CRISPR-Cas 9-directed mutagenesis ('editing' pieces of a molecule without inserting foreign material), progress has been made towards analogous techniques but with additional functionalities that, in turn, can be combined. Among them, he mentioned the most relevant ones, such as base editing (to modify a single nucleotide of a DNA molecule); prime editing (which allows small sections of the genome of a few nucleotides to be rewritten with great precision); cisgenesis (which induces changes from genes of sexually compatible plants) and intragenesis (which combines sequences from the same species or from another closely related species) and, ultimately, synthetic biology (which aims to design or redesign biological systems and give them new and/or improved qualities).

For her part, Leire Escajedo, a professor at the University of the Basque Country, addressed the new European legislation on plant breeding. She also recalled that the current legislative body is based on the genetics of the 1990s and that it was the Court of Justice of the EU (CJEU) that ruled in 2018 that it was necessary to review it to adapt it to NTGs, to which the current restrictions for transgenic crops (GMOs) still apply today. She also analysed the text that, as a result of this ruling, was proposed by the EC and which was supported, with some amendments, by the European Parliament (EP) in February. Escajedo valued as a "step forward" that the proposal - which still needs to be debated in the Council, that is, at the level of Member States and then start the so-called trilogue process between the EC, the EP and the Council itself before being approved - includes a "differentiated legal status" for NGTs. He clarified that the text being debated today divides the plants obtained by these techniques into two: NGT-1, whose genetic modifications could easily have been obtained by traditional methods (with successive crosses and selection), although investing a lot of time and after many generations, and for this reason they are considered equivalent (these plants would be exempt from the GMO directive); and NGT-2, whose modifications would continue to be regulated by the aforementioned directive, although with a risk assessment that would take into account other considerations (for example, if the resulting plant were more sustainable, they might not have to face the complete dossier that must be prepared today in the case of GMOs). The supposedly 'objective' difference between one and the other, beyond such a description, would be the number of genetic changes brought about in the genome: up to 20 would fall into the first group, more would fall into the second.

But this criterion of the 20 modifications, as Orzáez himself confirmed, is not so clear, so “we will have to pay attention to what the fine print of the final text says,” added the lawyer. “If, in practice, the only thing we are going to regulate is what we could already do (with more time and less precision than the NGT's, it is understood, referring to the innovations that are included in the NGT-1) for this trip we did not need these saddlebags,” said the scientist from the IBMCP bluntly. The key will therefore be in how these modifications are quantified because, if a restrictive interpretation is made of it, “many of the uses and applications of the new techniques that we are already working on would not be viable,” Orzáez sentenced.

Biostimulants, innovations and financing
The situation of European regulation of biostimulants - of substances, mixtures and microorganisms that are not actually nutrient inputs and are responsible for activating the natural processes of plants, improving their performance - is quite different. It was Estefanía Hinarejos, Director of Regulatory Affairs at Alga-Energy - a Spanish multinational company specialized in these products - who analyzed the perspectives generated from the entry into force, in July 2022, of Regulation EU 2019/1009. Hinarejos positively valued the approval of this regulation, which requires its manufacturers to prove its function through efficacy tests. The expert regretted, however, that in all this time and "despite the fact that there are many microbial biostimulants of proven efficacy that have been marketed for years under national laws", the regulation only recognizes 4 types of microorganisms. The Commission concluded that the standard still suffers from “deficiencies that, for the moment, are being compensated for by partial harmonisation” (i.e. by resorting to the legislation of the Member States). It also called for development to be guided by “proportionality” and to be “realistic” in the requirements for the certification of new products.

The 1st BIOVEGEN Congress also unveiled two innovative public-private projects: Patafest, a consortium of European companies and research centres that offers biosolutions to combat serious potato crop diseases, such as the so-called 'Zebra chip' (caused by the Candidatus Liberi-bacter solanacearum bacteria) as well as other common post-harvest problems in this tuber (Fusarium sambu-cinum, Colletothricum coccodes, Helminthosporium solani); and the company Agrícola 2000 and its 'Campo Demo' programme, dedicated to offering companies plots where they can physically present the advantages of their products, or to consumers, to evaluate first-hand the desired characteristics of the varieties or products being tested.

As usual in other previous conferences, BIOVEGEN also wanted to leave a space to present the tools available to finance this type of project. This was when Antonio Santa Cruz, from the company Vector Horizonte -specialized in offering this service- reviewed the existing alternatives in terms of national and European subsidies, tax deductions, bonuses for research staff or the so-called 'patent box' (a tax incentive that allows reducing the tax rate on the transfer or transfer between entities of intangible assets that lead to R&D&I activities). Along these same lines, Alejandro Marín from the Inventium fund, from the ABANCA Group, specialized in connecting private investors with disruptive initiatives of this type, intervened. The Congress was closed by the general director of the CDTI himself, José Moisés Martín.

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Program and presentations

11:45 a.m. Registration and collection of accreditations
 
12:00 p.m. Welcome and introduction

• María José Sánchez. Director FRUIT ATTRACTION
• José Pellicer. President BIOVEGEN

12:15 p.m. Unlocking the potential of CRISPR CAS in plants

• Diego Orzaez. IBMCP-Institute of Plant Molecular and Cellular Biology

12:45 h. Legislation in agrobiotechnology: advances and opportunities in plant breeding and biostimulants 

• News in plant breeding. Leire Escajedo. UNIVERSITY OF THE BASQUE COUNTRY

• Legislation on biostimulants: status and perspectives. Stephanie Hinajeros. ALGAENERGY

13:15 h. Innovative public-private projects

• PATAFEST: biosolutions in potato cultivation and post-harvest. Christian Ghidelli. FUNDITEC

• DEMO FIELD: variety and bioinput trials. Giacomo Scatolino. AGRICULTURAL 2000

1:45 p.m. Tools to stimulate R&D&i

• Overview of R&D financing tools. Antonio Santa Cruz. VECTOR HORIZON

• Private investment in agrobiotechnology. Alejandro Marin. INVENTIUM 

2:15 p.m. Conclusions and closing. José Moisés Martín. Managing Director. CDTI

2:30 p.m. Cocktail and networking