Turning point in EU law for genetic engineering in agriculture – liability situation in Germany in urgent need of adjustment
After green genetic engineering had been practically dead in the EU for almost 15 years due to the strict regulatory framework, there are now signs of a fundamental change of dogma at EU level. If we look at it closely, the proposal for an NGT regulation (Regulation on plants obtained by certain new genomic techniques and their food and feed, and amending Regulation (EU) 2017/625, COM(2023) 411 final) recently presented by the EU Commission is tantamount to a revolution. Its potential for economic and socio-economic change for agriculture and food security and supply in times of global climate change is immense. At the same time, however, the issue still has considerable social and political explosive power. Hardly any discussion on the regulatory framework for a new technology has been as emotional and confrontational as that on green genetic engineering. The outcome of this discourse, which began almost 20 years ago, is well known: Due to strict regulatory approval conditions and an eventual moratorium and escalating liability, no significant cultivation of genetically modified plants is currently taking place in Europe – in stark contrast to the rest of the world, where genetically modified plants have long made up the vast majority of cultivated land in individual areas.
What does the EU intend to do with the draft NGT regulation? In the last 20 years, a lot has changed fundamentally in genetic research, especially with regard to how genetic modifications are brought about. Today, for example, the so-called “CRISPR technology” is available and highly developed, as well as other methods that implement changes to the genome of plants with less risk than earlier methods. The generic term for this is “NGT” (New Genomic Techniques). The aim of the NGT methods, which have already been tried and tested in practice, is in particular to improve climate and pest resistance in a more targeted, efficient and faster way than with classical breeding. It is precisely these NGT methods that are now to be specifically regulated.
According to the draft submitted on 5 July 2023, there will be two categories of NGT plants:
- NGT plants that could also occur in nature or conventionally bred will have to undergo a testing procedure based on the criteria set out in the proposal. NGT plants that pass this procedure are treated as conventional plants and are therefore exempted from the requirements of GMO legislation (in particular Directive 2001/18/EC). This means that no risk assessment needs to be carried out for these plants and they can be labelled and placed on the market in the same way as conventional plants.
- For all other NGT plants, the existing GMO legislation continues to apply. This means that they must be approved in particular before being placed on the market. Various detection methods and control mechanisms are to apply to these plants.
All NGT plants are to be recorded in a public database. Furthermore, their seeds and other plant propagation material will be labelled accordingly to ensure transparency and choice. Similar to GMOs, Member States are to establish mandatory coexistence measures at national level. Specifically, Member States must take measures to allow different types of cultivation to coexist, e.g. by establishing distances between fields.
The proposed regulation does NOT deal with liability for the cultivation of NGT plants. As with GMOs, this is the responsibility of the Member States and is subject to the liability provisions existing there. In Germany, the then red-green federal government created an extremely controversial, extremely strict liability regime in 2005 with § 36a GenTG, which is linked to the neighbourhood defence and compensation claims of § 906 BGB and is still valid today. The result of § 36a GenTG is that users of genetically modified plants are threatened with escalating liability risks, which – when cultivation was still possible in principle – practically meant that conventional cultivation never took place in Germany on a significant scale, except for experimental purposes. The author accompanied the legislative process at the time and comprehensively analysed the liability situation, noting a “suffocating effect” and postulating fundamental adjustments and mitigations (see Hartmannsberger, Gentechnik in der Landwirtschaft: Die Entwicklung der Haftung für den Einsatz gentechnisch veränderter Pflanzen, zugl. Diss. 2007, p. 266 et seq.).
If the draft of the NGT regulation is adopted with even the rudimentary content planned, the legislature will be compelled to fundamentally amend the liability situation. Otherwise, it can undoubtedly be assumed that genetic engineering in agriculture will continue to find no practical application in Germany despite liberalised regulatory framework conditions.