Genetically engineered bacteria could soon be introduced into to the digestive tracts of cattle, pigs and poultry, added to food, sprayed into the environment as pesticides, or used on farmland as fertilisers. Applications for use in humans are also currently being developed. Many of these uses carry a significant risk potential. Nevertheless, the European Commission intends to substantially lower safety standards. In a statement to the German Federal Ministry of Agriculture (BMLEH), Testbiotech expressed its opposition to these plans.
The Commission proposal aims to create a special category of genetically engineered microorganisms, and thus facilitate accelerated market access. The exemption from the environmental risk assessment is applied to microorganisms such as algae, bacteria, fungi, yeasts and viruses that meet the criteria for a ‘Qualified Presumption of Safety’ (QPS).
QPS is a system for categorizing risks, which has so far been used to simplify risk assessment in food production. The current QPS list, which is steadily expanded, includes more than 120 microorganisms. These are considered as being safe, if they do not contain any ‘problematic genes’. This refers in particular to new resistance genes against antibiotics.
All authorisations would be valid indefinitely instead of being limited to ten years, and methods of identification would no longer be required in each and every case. In addition, the Commission would also have extensive powers to change the respective criteria in future.
According to Testbiotech, these plans should be rejected. In recent years, the use of new genetic engineering techniques (or new genomic techniques, NGTs) has substantially expanded the ways in which microorganisms can be engineered. Also, the convergence of these developments with artificial intelligence is expected to further expand the range of applications. Safety standards should therefore be raised, not lowered. It is not sufficient to take decisions based on presumptions.
Knowledge about microorganisms has increased significantly in recent years. Their characteristics cannot be viewed independently of interactions with other species or the environment. For example, a recent publication shows that bacteria can spread specific resistance genes across the globe and throughout various ecosystems, thus leading to their simultaneous presence in wastewater, estuaries, lakes, terrestrial ecosystems and the human gut.
The risks associated with genetically engineered microbes particularly affect microbiomes, i.e. the complex communities of microorganisms inhabiting the intestines of humans and animals as well as the roots of plants. Even though the European Food Safety Authority (EFSA) has recognised risks and significant uncertainties in this context, it has nevertheless mostly omitted these from its risk assessment guidelines. EFSA has also not developed any guidance for the risk assessment of mixtures of different genetically engineered microbes, even though some companies are already planning the release of such products. An EFSA guidance would however be crucial for the implementation of the new directive.
Furthermore, there are procedural concerns. The Commission has neither conducted a consultation nor an impact assessment, arguing with “urgency” without sufficient justification. Moreover, it has bundled the future regulation of GMOs into a joint directive on the processing of organs. There appears to be no technical reason for combining these very different topics. Testbiotech is demanding that these issues are separated for the consultation process and an impact assessment to be conducted to ensure a proper legislative procedure.
Contact:
Christoph Then, info@testbiotech.org, Tel + 49 151 54638040
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