Additional information concerning the application for cultivation of MON89034xNK603 maize
This advice concerns the application for cultivation, import and processing of genetically modified MON89034xNK603 maize. This maize line expresses the cp4 epsps, cp4 epsps L214P, cry1A.105 and cry2Ab2 genes conferring tolerance to glyphosate containing herbicides and resistance to certain lepidopteran insects.
In its previous advice on this application, COGEM concluded that insufficient data were provided to allow conclusions on the effect of MON89034xNK603 on non-target organisms. COGEM was of the opinion that additional data from laboratory experiments and field trials had to be provided.
Based on COGEM’s previous advice the applicant was asked for additional information. The applicant provided more information on the Cry1A.105 and Cry2Ab2 proteins that were used in the laboratory experiments and on the statistical analysis of the obtained data. In addition, a Spanish field trial that examined the effect of MON89034xNK603 on NTOs was provided. Although some of COGEM’s questions are answered by the provided information, some new questions arose and other questions were not sufficiently answered.
COGEM is of the opinion that the applicant should justify the extrapolation of the results from the interaction study to non-target organisms, and should provide more information on the statistical analysis of the obtained data and the protein concentrations used in the laboratory study. In addition, the applicant should elaborate on the observed effect on the anthocorid bug Orius insidiosus. Furthermore, COGEM is of the opinion that the applicant should provide more information on the use of “maintenance” pesticides in the Spanish field trial. In addition, the effect of MON89034xNK603 on butterflies was not examined in laboratory experiments or the Spanish field trial. Instead the applicant estimated whether butterflies would be affected. COGEM strongly prefers the use of laboratory experiments to examine the presence of an effect of MON89034xNK603 on non-target lepidopteran species over theoretical exposure analysis as in the latter case flaws can be introduced by the use of assumptions, estimations and extrapolations. In addition, laboratory experiments allow the examination of sublethal effects on population growth.
In conclusion, COGEM is of the opinion that the above mentioned questions need to be addressed to allow conclusions on the effect of cultivation of MON89034xNK603 on non-target organisms.
In addition, in response to COGEM’s previous questions the applicant still has to provide a revised general surveillance plan.