Combining AI and new genomic techniques to 'fine-tune' plants: challenges in risk assessment.

Using new genomic techniques (NGTs) to 'fine-tune' plants typically involves changing just a small number of nucleotides. These small interventions can, nevertheless, lead to effects that go beyond the known plant characteristics, caused by genotypes previously unknown in the breeders' gene pool. The EU is currently discussing a proposal for the future regulation of NGT plants. In essence, the European Commission is proposing that NGT plants with less than 20 deletions, insertions or substitutions should in future no longer undergo mandatory risk assessment. NGT plants up to this threshold would be classified as Category 1 NGT, and therefore treated as equivalent to conventionally-bred plants. Plants in this category would not be subject to mandatory environmental risk assessment. The question thus arises of whether any of these Category1 NGT plants considered, in fact, have novel environmentally hazardous characteristics. Based on our findings from horizon scanning and to exemplify regulatory challenges, we used publicly available generative AI with the aim to design 'fine-tuned' NGT plants that would very likely require environmental risk assessment, but would nevertheless meet the specific the criteria for Category 1 NGT plants. As a proof of principle, we designed a genetic blueprint for an insecticidal maize plant, which could subsequently be developed using NGTs. There are several reasons why these insecticidal NGT plants should be subject to environmental risk assessment prior to being approved for cultivation. For example, they could be toxic to non-target species, cause resistance in pest insects, or show unintended genetic and phenotypic changes. In summary, there is no scientifically justifiable threshold of a certain number of mutations up to which NGT effects could be assumed to be of the same category as conventionally bred plants. Therefore, it is essential that the future regulatory concept is not based on such thresholds. On the contrary, future regulation should be science based and include case-by-case and step-by-step risk assessment, traceability and monitoring requirements to secure the future of food production and to protect biodiversity.