The European Commission is proposing fast-track approvals of genetically engineered viruses. The proposal would apply to several hundred species which, in their natural forms, pose a significant risk to plants and insects. In future, environmental releases of viruses could be considered ‘low risk’, even if they are genetically engineered. Risk assessment could be reduced, authorisations no longer time-limited and methods for identification and monitoring would no longer be mandatory in all cases.
As explained in a new Testbiotech backgrounder, releases of genetically engineered viruses cannot be considered as ‘low-risk’. There can be no justification for lowering environmental risk assessment standards, as expected in the new regulatory framework. Testbiotech is therefore urging the EU Parliament to reject the Commission proposal.
Many current research projects are aiming to genetically engineer viruses for potential releases into the environment. Such viruses might also be used to genetically transform plants and animals directly in the environment, outside of laboratories.
As recently demonstrated, the creation of viruses with the help of artificial intelligence (AI) involves an unprecedented level of complexity of genetic changes and poses serious risks to health and the environment. The convergence of AI and new genetic engineering allows whole virus genomes to be re-designed, re-organised and synthesised. This may unintentionally increase the pathogenicity of these engineered viruses.
The Testbiotech backgrounder shows that genetically engineered viruses must undergo full case-by-case risk assessment prior to approval for any potential releases. Approvals must be rejected if there are safety data gaps. Authorisations must be time-limited. Requirements for identification methods and monitoring must also be mandatory. In summary, the EU regulations have to ensure the highest safety standards for environmental releases.
Contact:
Christoph Then, info@testbiotech.org, Tel +49 151 54638040
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