Gene drive applications are likely to entail considerable ethical and ecological implications. Apart from societal issues, they pose challenges for environmental risk assessment (ERA), monitoring and risk management: 1) GDOs differ fundamentally from classical GMOs. Notably, GDOs are aimed at the modification, suppression or eradication of wild populations and have the potential to irreversibly spread novel traits in natural ecosystems. GDOs circumvent Mendelian inheritance and therefore evolutionary consequences are presently poorly understood. 2) Currently, applications with GDOs are still at experimental stage. Critical scientific uncertainties and knowledge gaps regarding their functionality, their containment, their environmental implications and the availability of reversal methods are evident. 3)Due to their persistence and autonomous propagation, environmental implications of GDOs include large-scale spread and potentially irreversible changes of ecosystems, in particular if suppression of populations or even species is the goal of a specific application with GDOs.  4)For many risk-related questions, the necessary knowledge and data to support ERA are not yet available. The current ERA tools and methods, together with monitoring provisions in the EU (and elsewhere), do not sufficiently address the specific risks GDOs pose for the environment and nature conservation. ERA tools and methods need to include a broader technology assessment. 5) The detection and identification of GDOs in the environment is a mandatory requirement for monitoring and traceability of harmful environmental effects.

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