This piece is written by three experts who are part of the heads of two European associations, the WGG (Wissenschaftlerkreis Grüne Gentechnik e.V) in Germany and the AFBV (Association Française des Biotechnologies Végétales) in France, who work together to disseminate scientific information on genomic editing, one of the technologies referred to as NBT (New Breeding Techniques). They offer their vision and recommendations for adapting current legislation to issues of genomic editing.
Agriculture is facing many challenges, the most important of which are a growing world population (9-10 billion people in 2050), the scarcity of arable land and the risks related to climate change and biodiversity loss1. Agricultural production must increase its sustainability by using less land, fewer inputs and by reducing its environmental impacts. The Farm to Fork strategy which is at the heart of the European Green Deal aims to make our food system more sustainable and resilient2.
To meet these challenges, all stakeholders must accelerate the development of innovative and efficient agriculture in Europe. Among the innovations which are required at all steps from seed to fork, those related to plant genetics play a strategic role. It is thus essential that all technologies available for the creation of new plant varieties may be used without exclusion in principle.
Technologies to improve plant genetics have been constantly evolving with scientific progress. This article focuses on genome editing, a set of technologies enabling the targeted modification of genetic information by addition, deletion, or exchange (replacement) of nucleotides at a specific site of the genome sequence of a recipient organism. In the case of plants these technologies can deliver desirable traits to the production chain, from the farmer to the consumer, faster than older methods. These remarkably diverse traits include (i) resistance to biotic stresses, pathogens and aggressors, (ii) increased tolerance to abiotic stress such as drought or temperature variations, and (iii) improved sanitary, technological and nutritional qualities of harvested products. The first edited plants have been introduced in North America3 and a limited distribution of an edited tomato has been launched in Japan4.
Why genome-edited plants need a different regulation
Many analyses and evaluations of these technologies undertaken by the French High Council of Biotechnologies5, EFSA6 and the Scientific Advice Mechanism7 in Europe have concluded that plants developed with the use of such technologies are no different in their effects on health or the environment from those obtained from traditional breeding methods.
In its decision of 25 July 2018, holding that organisms resulting from genome editing technologies were subject to Directive 2001/18/EC, the Court of Justice of the European Union determined that they did not benefit from the exclusion provided for in the Annex IB of this Directive, blocking, de facto, their use for commercial purposes in the EU.
How to enable commercialization of plants resulting from genomic editing
Given the potential of these technologies to enable the EU to reach its sustainability goals, it seems timely and essential for the EU to review and adapt the regulatory framework for plants derived from genome editing technologies, taking into account the above-mentioned scientific evaluations. This need for revision and adaptation has been confirmed by the recent ethical recommendations of the European Group on Ethics in Science and New Technologies8.
As genome-editing technologies can be used to obtain a broad range of modifications in the genome, going from a change in one nucleotide up to the incorporation of whole genes, we are proposing to establish different regulatory categories based on the type of edited plant that has been obtained. At this stage, we are proposing four categories of edited plants which should be excluded from the scope of Directive 2001/18/CE (Table 1). As scientific knowledge and technical advances progress, new categories may be added. These four categories were established taking into account the approaches of traditional breeding methods.
*The terms ‘Editing’ or ‘edited’ refer to the application of ‘genome editing’ techniques.
**The term ‘natural gene pool’ refers to the gene pool of a plant species defined as all of the genes and alleles (i.e., different versions of the same gene) obtained from plants which can exchange genes by sexual crossing as well as from distantly related plant species with which genes can be exchanged by sexual crosses using methods of conventional breeding.
To benefit from the exclusion, the developer must validate with a competent authority that the edited plant belongs to one of the four categories described above. In its request, the notifier must provide information on the recipient plant, the technique used and the edited allele or the inserted gene. In the case an intermediate GMO was produced in the editing process, any inserted recombinant nucleic acid sequence should be eliminated, and confirmation of the elimination should be provided. The exclusion of an edited plant will apply to all varieties obtained from that edited plant with the same modification and will apply to all Member States. The review time should not exceed 60 days. Once confirmation of exclusion has been obtained, the variety (ies) obtained using the edited plant would be subject to seed and plant variety regulations applicable to relevant crop species in the same manner as any variety obtained through traditional breeding techniques, including registration in the common catalogues of varieties of agricultural plant and vegetable species which can be marketed in the EU.
Europe has all the assets to succeed, provided it has confidence in its research and innovation
In conclusion, our proposal would bring benefits to farmers and consumers in Europe, in three ways:
- Accelerating genetic improvement through widespread use: genome editing tools are already widely accessible to public and private sectors as well as large and small businesses. An adapted regulation will further encourage the use of genome editing in all crops and in all countries, with the possibility of improving old varieties directly to enable them to remain competitive, protecting crop diversity and the biodiversity. These tools will save costs for all plant breeders and enable access to genetic improvement in meaningful timeframes considering today’s climate challenges.
- Maintaining stakeholder confidence through transparency: competent authorities will validate the excluded status of a genome edited plant but the latter will continue to be subject to seed and plant variety regulations that apply to conventional varieties. Any claims related to new traits will be subject to applicable regulations. Any unexpected or adverse effects will be subject to the same reporting requirements as any agricultural products marketed in the EU today.
- Achieving EU sustainability goals: through their ability to enable rapid adaptation of crops, genome editing technologies will help to strengthen sustainability and biodiversity and maintain the competitiveness of all European crops.
The fate of the regulatory treatment to be decided by Europe for genome editing in plants will largely dictate the future of its innovation in plant genetics and, therefore, the future of its agriculture and of its food sovereignty.
9. Wang et al., 2014 – doi:10.1038/nbt.2969
10. Haverkort et al., 2016 – doi:10.1007/s11540-015-9312-6