Plant breeding in the EU at a regulatory impasse

Date:03-18-2024

By David Spencer and Jana Gäbert

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.

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