Table 1.

New challenges in the ERA of GE gene drive organisms in comparison to experience with GE crop plants

Assumptions in the risk assessment of GE crop plants	New challenges in ERA of GE gene drive organisms
The majority of crop plants are cultivated for a single growing period. These plants are not meant to reproduce outside cultivation.	Next generations will emerge spontaneously; the process of genetic engineering is a self‐organized process replicating in each generation.
Due to previous breeding processes, plant varieties used for genetic engineering are relatively stable and have defined characteristics, as well as a reduced genetic diversity. Seed quality can be controlled by breeders (or farmers) before and during cultivation.	Wild populations very often contain a broad spectrum of genetic backgrounds. As a result, GE gene drive organisms introduce their new genetic information into heterogeneous genetic backgrounds without additional controls in place, such as those used in the laboratory or by the breeder.
Crop plants are often grown in a managed agricultural environment with reduced biodiversity.	Wild populations very often interact with complex ecosystems.
Crop plants of the same species are often cultivated under similar environmental conditions.	Wild populations, e.g., insects are often exposed to a wider range of environmental conditions due to their mobility. Further impact factors include, e.g., seasonal changes.

ERA = environmental risk assessment; GE = genetically engineered.