Cultivation of maize line MON89034 x MON88017
This notification concerns the cultivation of genetically modified maize line MON89034 x MON88017. This maize line expresses the genes cry1A.105, cry2Ab2, cry3Bb1 and cp4epsps conferring resistance to certain lepidopteran and coleopteran insects and tolerance to glyphosate containing herbicides.
Previously, COGEM advised positively on the import of both parental maize lines MON88034 and MON88017 and on the import of hybrid maize line MON88034 x MON88017. COGEM advised negatively on the cultivation of parental maize line MON88017 because the studies provided were insufficient to conclude there are no adverse effects to be expected on NTOs.
In Europe, no wild relatives of maize are present and establishment of maize plants in the wild
has never been observed. There are no reasons to assume that the inserted traits will increase the potential of the maize line to establish feral populations. In addition, in Europe the appearance of volunteers is very rare.
COGEM is of the opinion that the molecular characterization of MON89034xMON88017 is adequately performed. With regard to potential adverse effects of MON89034xMON88017 on non-target organisms (NTOs), the applicant refers to laboratory, greenhouse and field studies. None of the laboratory experiments have been carried out with MON89034 x MON88017. In most cases either Cry1Ab.105, Cry2Ab2 or Cry3Bb1 pure protein was used. In other cases a different maize line was used, for example MON863 which expresses a cry3Bb1 protein which differs by one amino acid from cry3Bb1 in MON88017. COGEM is of the opinion that the applicant did not sufficiently demonstrate that the Cry1A.105, Cry2Ab2 and Cry3Bb1 proteins do not interact. Furthermore, most of the NTOs that were studied do not occur in the European Union and the applicant did not explain why these organisms are relevant to European maize fields. The laboratory experiments also exhibit other shortcomings: the statistical power of the experiments and the obtained P value are not given, the choice for the statistical test is not explained and the applicant did not provide an explanation for the high mortality (over 15%) in certain control groups.
The applicant presented two studies that describe MON89034xMON88017 field trials. However, these field trials investigate the effect of MON89034xMON88017 on target and pest organisms. None of the field trial studies investigates the effect of ecologically relevant NTO’s in Europe. COGEM is of the opinion that the data provided are insufficient to allow a conclusion that cultivation of MON89034xMON88017 exerts negligible effects on NTOs. In conclusion, COGEM cannot advise positively on cultivation of maize line MON89034xMON88017. COGEM is of the opinion that additional data from laboratory experiments and field trials have to be supplied to be able to make a reliable environmental risk analysis on cultivation of maize line MON89034xMON88017.