Potential risks of synthetic genes drive systems and monitoring requirements

The application of gene drives (GD) in wild organisms (disease vectors; pests; invasive species) has come within reach with the rapid development of new molecular biology methods. The rapidly increasing number of publications shows that work is being carried out vigorously in the laboratories on this technique. Due to the potential environmental impact of global GDs (in particular a collapse of populations or even species), concepts for limiting the spread of GDs in time and space are also being worked on. GDs have not yet been developed to market maturity or tested under field conditions. Gene drive-organisms (GDO) in the EU are covered by genetic engineering law since transgenes are integrated in their genome with biotechnological methods. However, it is unclear whether the current methods and guidelines for the risk assessment of GMOs are applicable and sufficient for GDOs. GDOs differ in a number of properties from classical GMOs. In view of these differences, the current guidelines for the risk assessment of GMOs are considered to be inadequate to be able to reliably determine the effects of GDOs after release. The current R & D project contributes to supporting the scientific basis for risk assessment and monitoring for GDO.