Plant breeding in the EU at a regulatory impasse
🇩🇪 Eine deutschsprachige Version von diesem Text ist im Progressive Agrarwende Blog erschienen.
Regulation of New Genomic Techniques: Please read the fine print!
On February 7, 2024, a majority in the European Parliament voted in favor of the re-regulation of plants produced using New Genomic Techniques (NGTs). What meant a setback for many environmental organizations in terms of freedom of choice was seen by others as a long-awaited reform based on scientific consensus. However, the European Commission’s legislative proposal was not adopted without amendments. On the contrary, through numerous modifications, the once progressive text could morph into a “Genetic Engineering Act 2.0”.
The Amendments: A new bureaucratic monster?
In the original version of the Commission’s proposal, the extensive facilitations regarding the approval procedure were explicitly only drafted for plants in the NGT-1 category. This category includes all plants that could also be achieved using conventional techniques. The law text describes as “equivalent to conventional”, for example, the alteration of up to 20 DNA “letters” (nucleotides), the deletion of any number of nucleotides, or the insertion of DNA elements that already exist in the breeder’s gene pool of the respective species. All other plants automatically fall into the NGT-2 category and continue to be treated and regulated as GMOs. Furthermore, due to the rejection of new breeding techniques within the sector, the use of NGT-1 plants was banned for organic farming.
However, this was not enough for some members of Parliament: In total, more than 300 amendment proposals were submitted 1 (over 90 of which were adopted), mainly concerning labeling up to the final product and traceability. The Commission should also report after seven years on a possible market introduction of NGT plants, on how the “perception of consumers and producers has developed”2. There was agreement on the non-patentability, which should apply to all NGT plants.
It already seems somewhat of a paradox: Shouldn’t the progressive legislative proposal reduce bureaucracy for NGT plants of a certain type? Shouldn’t they leave their status as “dangerous GM crops” and be classified as the conventional breeds with whom they are on all fours? Now, there may lurk an even bigger bureaucratic monster in the shadow of the plenary election, noticed only by those who have summoned it in the shape of trial-blocking amendments. In the end, a self-fulfilling prophecy could lead to the law achieving the opposite of what it was intended for: only the largest and most financially sound companies would benefit.
Spokes in the wheel of SMEs
Small and medium-sized enterprises (SMEs) are eagerly waiting to apply the new breeding methods in practice. In this respect, the adoption in the EU Parliament is a “significant step in the right direction”, says Jon Falk, CEO of Saaten-Union Biotec GmbH, Germany. However, the amendments adopted in Parliament could ultimately mean extensive requirements for the newly assessed plants, which would be similar to strict genetic engineering laws.
The associated effort and stigmatization of such plants (…) undermine the intention of the EU Commission’s draft regulation.
– Dr. Jon Falk, Saaten-Union Biotec GmbH, statement on behalf of 8 SMEs
This would include, for example, “continuous labeling for plants and products containing such plants, monitoring requirements, and the introduction of traceability systems.” These plants would be treated more like classical genetically modified organisms than conventionally bred plants, Falk says. The associated effort and stigmatization of such plants and products thus undermine the intention of the EU Commission’s draft regulation, which aims to enable the application of new breeding methods in plant breeding. Falk sees the Parliament’s addressing of the issue of “protection of intellectual property” and the strengthening of plant variety protection as the primary protective law in plant breeding. Thus, for small and medium sized breeding companies, adjusting patentability could be a helpful addition to the Commission’s proposal.
Anja Matzk (KWS Saat SE & Co. KGaA, Germany) also evaluates the recent vote in the EU Parliament as a “positive signal and (…) milestone on the way to enabling the use of NGTs in European agriculture.” However, the plant breeder and Head of Regulatory Affairs at the growing breeding company KWS also sees room for improvement: “Some of the proposed requirements do not correspond to the basic intention with which the EU Commission initiated the legislative project. In particular, we question the labeling of end products that goes beyond the listing of varieties and seeds.”
Thus, the new law would allow the use of certain NGTs, but they would still not find application in practice.
– Dr. Anja Matzk, KWS Saat SE & Co. KGaA
Labeling products that cannot be distinguished from products of conventionally bred plants is incomprehensible and suggests an “unfounded warning for consumers, which would most likely lead to rejection of the products,” Matzk wrote in a statement to the Eco-Progressive Network. Her conclusion: “Thus, the new law would allow the use of certain NGTs, but they would still not find application in practice.” Unless…
…consumers are open to NGT products and recognize their advantages or their equivalence to previously available products. Assumed consumer fears need not be an argument from an eco-progressive perspective. On the contrary, freedom of choice and coexistence are important values in agricultural production, which are addressed by some of the amendments. However, why these buzzwords are overestimated in the NGT debate can be read in Robert Hoffie’s recently published text.
In the upcoming trilogues between the Commission, Parliament and Council, German plant breeding hopes for a speedy agreement leading to evidence-based legislation for new genomic techniques in the EU. But what happens if the unspeakable amendments are waved through unchecked?
Better no law than a bad law?
It is becoming clear that regulating NGT plants in the light of the adopted amendments would not increase the usability of the technology – on the contrary: through extensive, costly, and years-long approval procedures, the benefits of “new genetic engineering” would not become apparent. From the perspective of proponents, a bad new law would not be a partial victory but a worst-case scenario. Innovation in plant breeding using technologies like CRISPR/Cas would once again be put on hold for the foreseeable future, and the much-touted practical examples would again fail to materialize.
Furthermore, the obfuscation of the legislative process hinders the process of lawmaking. The trilogues between Parliament, Commission and Council can only begin once the latter has reached an internal agreement. So, the ministers are currently diligently working on an endless set of rules for innovation-friendly plant breeding. When they will reach a result is unknown.
The Council’s Homework
In the trilogue lies the opportunity for a compromise that addresses the patent issue while foregoing mandatory labeling for category 1 NGT plants. This could potentially generate a majority in both chambers. If the Council of the European Union can reach an agreement before the last plenary session (week of April 22), a law could be passed before the European elections. If not, the trilogue process will be postponed until after the elections.
However, if the Council cannot reach an internal agreement, the expected re-regulation will be delayed by several years: the (current) Belgian Council Presidency will pass the file to the next in line – which are Hungary (second half of 2024) and Poland (first half of 2025). Both nations categorically reject the EU Commission’s legislative proposal. Only with Denmark (second half of 2025) will a country hold the presidency that is interested in bringing forward the evidence-based regulation of NGT plants.
The breeding of new plant varieties in the EU, which meet current challenges in agriculture such as the climate crisis, disease, and pest pressure, thus lies in the hands of the Council members. It remains to be seen which version of the draft proposal they want to push forward.
Whether bureaucratic monster or not: There is not much time left to adapt plant breeding to the pace of global challenges – because species extinction and global warming do not wait for paperwork.
Graduate farmer who enjoys bringing science and practice together at an agricultural cooperative in Brandenburg and is convinced that modern agriculture and biodiversity conservation go together perfectly.
Dear authors and dear members and activists in the “Öko-Progressives Netzwerk”,
I think it is good and welcome that you are thinking about environmentally friendly, sustainable agriculture. This is a basis that we have in common. 🙂 You have discussed several approaches to this, and I agree with some of them (e.g. agroforestry, more biodiversity in agriculture).
However, what I think is the wrong approach, is to modify living beings genetically.
The EU draft of July 5, 2023 for the deregulation of “New Genetic Engineering”/ “New Genomic Techniques” (NGT) should have been rejected in the EU Parliament because it would be highly problematic. It and variants based on it must be rejected and the entire process stopped.
In my opinion, the “most serious error” in the current EU draft is that it would apply to all NGT plants, and not just to agricultural crops. Also NGT wild plants and NGT trees, which would be very long-lived and have key positions in many ecosystems, and e.g. NGT algae would be deregulated and completely removed from the current EU genetic engineering law, without any risk assessments, without monitoring and without traceability and retrievability measures. Genetic engineers could produce NGT trees and NGT wild plants and release them, and those could find their way into natural areas, spread uncontrollably and irreversibly change ecosystems, possibly without being known or regulated (!), and that would be irreversible. That would be unacceptable from a nature conservation perspective and would clearly violate core principles such as the precautionary principle, “preservation of creation” and “respect for life” that we as humans should always respect.
If the EU draft were to be pushed further or even decided upon, in my opinion, environmental authorities such as the BfN and nature conservation organizations or associated bodies entitled to sue would not only have the right, but also the obligation to sue against it, so that our wonderful nature remains to be protected from GMOs (see also the current “Policy Brief #02/2024” from the BfN: https://www.bfn.de/sites/default/files/2024-02/24_02_07_BfN_policy_brief_NGT-7.pdf). For probably most EU citizens and me, it is a matter close to our hearts and we want our nature to remain protected from GMOs today and in the future.
Your umbrella organization “WePlanet” is also in favor of protecting nature, and nature conservation also includes protection against GMO entries into natural areas. So, in my opinion, you should all actually take a position against such an EU draft.
If “new genomic techniques” were to be deregulated at EU level, then this should only apply to certain agricultural crops – ideally only annual species – which cannot cross with wild forms and cannot spread in our natural environment. A possible deregulation of “new genetic engineering” should only occur moderately and within the framework of existing EU genetic engineering law.
Many scientists who not only take into account the possible potential of “new genetic engineering”, but also “look outside the box” and also take ecology and social issues into account, warn of the problems associated with “new genetic engineering” (on-/off-target Effects, patenting, protection of GMO-free and organic agriculture, …) and speak out against the EU draft for deregulation or generally against deregulation of GMOs from the “new genetic engineering”, see e.g.:
https://www.srf.ch/news/schweiz/kritik-an-genom-editierung-agraroekologin-die-dna-ist-kein-computercode,
https://www.mdpi.com/2223-7747/12/9/1764,
https://ensser.org/publications/2023/ensser-stellungnahme-der-vorschlag-der-eu-kommission-zu-neuen-gv-pflanzen-ist-unwissenschaftlich-und-verschleiert-deren-risiken/,
https://newgmo.org/2023/11/19/open-letter-serious-concerns-about-the-eu-commission-proposal-on-new-genomic-techniques/,
https://www.testbiotech.org/aktuelles/neue-gentechnik-wissenschaftlerinnen-gegen-vorschlag-der-eu-kommission.
All NGT plants would be regulated by patent law (https://www.euractiv.com/section/agriculture-food/news/europe-patent-office-gene-edited-plants-will-be-patented-under-gmo-rules/), which means that in the medium term, control over the seed market and plant breeding would increasingly fall into the hands of corporations and other patent holders (see situation in the USA!). That would be very problematic for all farmers and us consumers. In my opinion, it is very strange when biotech companies and scientists claim to own patents on living beings and their descendants.
The EU draft would grant the EU Commission extensive powers in the future to adapt genetic engineering regulation independently if necessary and to largely remove it from parliamentary-democratic influence. The EU Parliament would hardly have any say in the future.
The narrative that “new genomic techniques” would only selectively change the DNA and that there would only be “small, precise interventions at precisely defined DNA sites that would be indistinguishable from natural mutations and would be natural” must be questioned: The CRISPR/ Cas system comes from bacteria and is used in cells of higher plants. It cuts the DNA at all sites that match the respective guide RNA template, which in reality can be multiple DNA sites. These are the frequently cited “off-target effects”, and there may be other unexpected effects (see, for example, the scientific publication at https://www.biorxiv.org/content/10.1101/2023.05.22.541757v1). Many genes occur as multiple copies, and the CRISPR/Cas system cuts all of those copies – this could hardly happen “naturally”, e.g. because of UV rays. In the case of multiplexing, several guide RNAs are used for several DNA sites, which would increase the problem. Different NGT plants could also be crossed with each other in the medium to long term, and over time more and more DNA changes could become established, so that one could soon no longer speak of “just a small point mutation”. The DNA repair mechanisms at the DNA interfaces cannot be influenced. In many cases, there is no point mutation but rather a deletion of a DNA base, which shifts the reading frame of the gene and “knocks out” the entire gene. But most genes code for not just one but for several characteristics and have complex interactions with other genes. It is likely that NGT plants not only possess a particular desired new trait, but also other, possibly unexpected, traits.
The narrative that the “new genomic techniques” would be “significantly faster and cheaper” than classic breeding must also be questioned, considering that expensive, complicated laboratory equipment and highly qualified personnel are needed and that the genomes have to be sequenced, the genes have to be assigned to certain functions and there are many failed attempts. In addition, in the end you have to outcross the CRISPR/Cas system (usually introduced into the genome with “old genetic engineering”, i.e. via Agrobacterium or “gene cannon”…), and you should also screen the genome for off-target effects and carry out extensive experiments with NGT plants.
Several environmental and food authorities in several countries of the European Union have come to the conclusion that the EU draft or variants based on it are incompatible with the precautionary principle and cannot be scientifically justified, and they reject it or the deregulation of “new genetic engineering” under such conditions , e.g.:
– the GfÖ (The Ecological Society of Germany, Austria and Switzerland, direct link to the pdf-document: https://gfoe.org/sites/default/files/ngt_gfoe_final.pdf) and
– the French food authority ANSES (direct link to a translation in English: https://www.anses.fr/en/system/files/BIOT2023AUTO0189EN.pdf) and
– the German Federal Agency for Nature Conservation (direct link to the pdf-document: https://www.bfn.de/sites/default/files/2024-02/24_02_07_BfN_policy_brief_NGT-7.pdf).
Another critical statement from the French authority ANSES from the end of January 2024 (please see https://www.anses.fr/fr/content/actu-nouvelles-techniques-genomiques) was probably only released after the EU Parliament had voted on the EU draft (please see https://www.euractiv.com/section/agriculture-food/news/french-health-agency-report-challenges-proposed-eu-rules-on-gene-edited-plants/). Such an approach is unacceptable.
More than 420,000 EU citizens have signed with their signature that they are against deregulation of “new genetic engineering” (see e.g. https://demeter.net/more-than-420-000-citizens-oppose-deregulation-of-new-gmos/).
The vast majority of us EU citizens are skeptical about genetically modified organisms (GMOs), do not want GMO labeling and freedom of choice to be abolished, and would like to see risk assessments and labeling of all GMOs and the products manufactured out of them (please see e.g. https://www.ohnegentechnik.org/en/news/article/survey-almost-everyone-wants-labelling-and-risk-assessment-for-new-genetic-engineering).
I ask you and all politicians to respect the wishes of the vast majority of us EU citizens. Democracy is the best form of government and we live in a democracy and not in a technocracy.
Also the “European Committee of the Regions” was also very critical of the EU draft (please see https://cor.europa.eu/en/news/Pages/21-nat-meeting.aspx).
Dear authors and dear members and activists in the “Öko-Progressives Netzwerk”,
we do not have to – and in my opinion we should not – manipulate living beings genetically in order to meet current challenges (climate change, world nutrition, …). That would be the wrong approach and would be associated with numerous unresolved problems (on-/off-target effects, patenting of seeds, increasing control of patent holders over the seed market, no protection of GMO-free and organic agriculture, …).
Please let us use sensible environmentally and socially responsible measures that are in harmony with life and nature, especially:
– Organic farming
– Organic plant breeding
– Use of plant genetic resources in gene banks for conventional breeding programs with modern varieties: Let’s liberate diversity! 🙂
– Agroecology
– Agroforestry systems
– Avoiding food loss and food waste
– Reducing the consumption of animal products.
Please let us all work together on this!
Please let us use our energy and our knowledge and skills in these areas!
These measures are completely unproblematic from a social and ecological point of view and bring a lot! 🙂
This is how we ensure a good future for ourselves and the world. 🙂
With kind regards
Matthias Henneberger
(Dipl.-Ing. agr., volunteer at BUND, in nature conservation and in the social sector)