Abstract
Genetically modified maize event DP-915635-4 expressing the IPD079Ea protein was developed to control corn rootworm damage to maize plants. Utilizing a modernized safety assessment model published by CropLife International (CLI), the safety of DP-915635-4 maize was assessed. The CLI core studies included were molecular characterization of the inserted DNA, expression and characterization of the expressed IPD079Ea protein, and its safety for both food and feed use and the environment. No hazards were identified for human or animal consumption of DP-915635-4 maize containing the IPD079Ea protein, indicating that supplementary studies were not necessary. An environmental risk assessment was performed to characterize any potential impacts to non-target organisms, the results of which established that DP-915635-4 maize is unlikely to result in unreasonable adverse effects to non-target organisms. This case study shows that the modernized safety assessment is effective at demonstrating the safety of genetically modified crop plants.