Number of mutations cannot determine safety of new GM plants
Testbiotech has published a new backgrounder summarising recent research showing clear evidence that the EU Commission proposal for the future regulation of plants obtained from new genetic engineering (new genomic techniques, NGT) is inadequate. It would be outdated before the new regulation could be implemented. The proposal is based on the fundamental misconception that there is a threshold of 20 mutations for NGT effects that would not require risk assessment. However, recent scientific publications have found undeniable evidence that there is no such thing as a "magic threshold".
According to proponents of the technology, an unprecedented wave of technically "fine-tuned" genetically engineered (GE) plants is about to become a reality. The most relevant targets in this respect are small but powerful regulatory units in the genome of plants, which influence gene expression. This strategy benefits from artificial intelligence (AI) and new variants of gene scissors.
The intended genomic changes are meant to enable scalable but also extreme effects. These would target plant characteristics, e.g. plant components, plant architecture, or response to stressors. All these traits may be associated with unintended effects. Studies show that the effects do not depend on the number of mutations, but on their position within the genome and their combinations.
In most cases, the genetic changes have not been described in the existing gene pool and could not be obtained from conventional breeding. In addition, many of the targeted DNA sequences are located in highly conserved regions that only have a very low frequency of spontaneous mutations. Some of the technically induced genetic changes are very unlikely to ever emerge from non-targeted mutations, e.g. specific combinations of genetic changes within very small regions of the genome.
All in all, these technically "fine-tuned" NGT plants show that there is no "magic threshold" of a specific number of mutations which would enable to conclude that the NGT plants are safe. Neither does this enable conclusions on the equivalence of the NGT plants to those obtained from conventional breeding. Because these changes in NGT plants go beyond what is known from conventional breeding, their environmental risks need to be examined. However, this need is completely ignored under the EU Commission’s proposal.
Furthermore, the Commission proposal does not consider recent technical developments, such as the use of new gene scissors, new processes to deliver gene scissors into the cells, e.g. viral vectors, or the use of artificial intelligence (AI) to generate new gene variants. These techniques and processes would all require case-specific consideration, while the proposed new regulation for NGT plants would simply ignore them.
If the EU Commission proposal was to be implemented, within the coming decades, hundreds of plants with "technically tuned" characteristics might be released in the environment, which exceed the spectrum of characteristics of plants obtained from conventional breeding by far. They could all be introduced into the environment or brought to market without mandatory risk assessment, traceability, or monitoring.
Testbiotech demands that the EU Commission should withdraw its outdated proposal from 2023 and instead use the flexibility of the current GMO Regulation to adapt to the latest progress in this area.
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Source: Testbiotech