POLICY AND PRACTICE REVIEWS article
Front. Plant Sci.
Sec. Plant Biotechnology
Volume 16 - 2025 | doi: 10.3389/fpls.2025.1677066
This article is part of the Research TopicIntegrating CRISPR With AI: Challenges and Opportunities in the Global Regulatory Landscape for Gene-Edited CropsView all articles
Combining AI and new genomic techniques (NGTs) to 'fine-tune' plants: Challenges in risk assessment
Provisionally accepted- 1Testbiotech e.V. - Institute for Independent Impact Assessment of Biotechnology, Munich, Germany
- 2Aurelia Foundation, Berlin, Germany
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mber 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 not be classified as Category 1 NGT, and therefore treated as equivalent to conventionally-bred plants. Plants in this category would 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.
Keywords: New genomic techniques (NGT), Genome editing, Genetic Engineering, Genetically engineered plants, Risk Assessment, artificial intelligence, GMO regulation, Cis regulatory elements
Received: 31 Jul 2025; Accepted: 19 Sep 2025.
Copyright: © 2025 Juhas, Rodekohr, Bauer-Panskus and Then. This is an open-access article distributed under the terms of the Creative Commons Attribution License (CC BY). The use, distribution or reproduction in other forums is permitted, provided the original author(s) or licensor are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. No use, distribution or reproduction is permitted which does not comply with these terms.
* Correspondence: Matthias Juhas, matthias.juhas@testbiotech.de
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