Concerns about planned deregulation backed by new research
9 November 2023 / Two recent scientific studies have reported surprising effects caused by CRISPR/Cas gene scissors applications in plants. The new findings are also important for the risk assessment of plants obtained from new genetic engineering (New GE, also known as new genomic techniques, NGT), and increase concerns about EU plans for deregulation.
According to the current legislative proposal put forward by the Commission, mandatory risk assessment would no longer be required for most plants obtained from New GE (NGT plants). However, the new studies show that the EU Commission proposal is not in line with current scientific findings.
A recent study published in Nature Communications shows that CRISPR/Cas applications in plants often lead to gene segments which are cut out of the genome (deletions) actually being reinserted in the opposite direction (inversions). The scientists have introduced a new term to describe this type of genetic modification, i. e. ‘delinvers’. They emphasise that this effect plays a role specifically in the use of gene scissors, and are calling for more detailed studies to identify the undesirable genetic changes. Even though these effects occur very frequently in some NGT plants, they have until now been overlooked. This is the first time they have been described.
The effects of ‘delinvers’ can vary from case to case, including, for example, the unintentional alteration of gene functions in the plants. Nevertheless, according to the EU Commission proposal, such inversions and deletions would be explicitly excluded from risk assessment.
Another study published in Science shows that the effect of genetic modifications in plants not only depends on the engineered gene sequence itself, but can also be influenced by interactions with other genes. Corresponding effects are known as 'epistasis', i. e. interactions between a gene and its genetic background. Applications in tomatoes are a good example of just how unpredictable the effects of epistasis can be, as it was found that changes to the same gene - depending on the tomato variety – resulted in different effects. The site of the genetic change, the affected gene function and the type of genetic alteration all play an important role in this respect. These can differ significantly in NGT plants in comparison to conventionally-bred plants.
In terms of risks, these unintended interactions are by no means harmless. For example, they can influence the composition of the ingredients of plants and their interactions with the environment. However, the EU Commission assumes that in most cases such unintended effects would not need to be examined for risks. The Commission believes that, within a virtual gene pool, all genes can be changed, transferred and combined by NGT without risks, ignoring the effects caused by the genetic background.
An earlier scientific publication in Frontiers showed in detail why the EU Commission's approach is not sufficient to make statements about the safety of NGT plants. These results have now been confirmed in the new studies.
The EU Commission wants to introduce purely formal criteria to decide whether plants obtained from new genetic engineering can be treated in the same way as conventionally-bred plants, and thus allow NGT plants to be exempt from risk assessment. The Commission has proposed that only the number of genetic modifications should be taken into account, but not their biological effects or possible unintended consequences.
Testbiotech is calling for the EU Commission proposal to be rejected. All genetically engineered plants must continue to be assessed for both intended and unintended genetic changes and their associated risks.
Testbiotech is warning against a hasty adoption of the EU Commission proposal, because the EU Parliament has extremely short deadlines for discussing the legislative proposal. All relevant facts must first be brought to the table and evaluated in detail before a decision can be made.
Christoph Then, email@example.com, Tel + 49 151 54638040