Application for cultivation of MON89034 maize

The present application concerns the cultivation of the genetically modified maize line MON89034. This maize line expresses the genes cry1A.105 and cry2Ab2 conferring resistance to certain lepidopteran insects. In the past, COGEM advised positively on the import of maize line MON89034. Two applications for cultivation of the stacked lines MON89034xNK603 and MON89034xMON88017 were assessed by COGEM. COGEM concluded for both stacked lines that the data on the effects of non-target organisms (NTOs) were insufficient to draw conclusions.
There are no wild relatives of maize in Europe and the appearance of volunteers is rare. Furthermore, there are no reasons to assume that the inserted traits will increase the now absent potential of maize to establish feral populations. COGEM is of the opinion that the molecular characterisation is adequate.
The applicant conducted several laboratory and field studies and refers to these studies in order to demonstrate the absence of potential adverse effects of MON89034 on NTOs. COGEM is of the opinion that the applicant did not sufficiently demonstrate that interaction between the Cry1A.105 and Cry2Ab2 proteins is absent in MON89034, since no studies were done on synergistic effects in non-target organisms. Therefore, a study in which honey bees were exposed to the Cry1A.105 and Cry2Ab2 proteins separately does not suffice to conclude that MON89034 cultivation will not affect honey bees. In a study on the NTO Orius insidiosus, the potential exposure of this anthocorid bug to Cry1A.105 via prey and plant material other than pollen is not taken into account. In the field trials, differences in Coccinellidae numbers between years and differences in numbers between collection methods were not addressed by the applicant. In addition, the theoretical exposure analysis for non-target lepidopteran species did not take into account that the LC50 value in the field may vary up to a factor of ten.
COGEM is therefore of the opinion that the data provided are not sufficient to conclude that cultivation of MON89034 exerts negligible adverse effects on NTOs. Furthermore, the General Surveillance plan should be improved on several points. As a result of these concerns, COGEM cannot issue a positive advice on the cultivation of maize line MON89034.