Additional advice on cultivation of maize MON88017

 This advice concerns the application for cultivation, import and processing of genetically modified MON88017 maize. This maize line expresses the cp4 epsps and cry3Bb1 genes conferring tolerance to glyphosate containing herbicides and resistance to coleopteran insects such as the Western corn rootworm and the Colorado potato beetle. These insects belong to the Chrysomelidae family.

In its previous advice on this application, COGEM concluded that the provided data were insufficient to conclude that cultivation of MON88017 would not pose a risk to non-target organisms. The majority of the data in the original application was obtained using other maize lines or Cry3Bb1 protein variants that were not identical to the MON88017 Cry3Bb1 protein. COGEM was of the opinion that additional data from laboratory experiments and field trials had to be provided. These laboratory experiments should be carried out with the Cry3Bb1 protein that is present in maize line MON88017 or with the maize line itself.

Recently, EFSA published its opinion on cultivation of MON88017. The Dutch Ministry of Infrastructure and the Environment (IenM) asked COGEM whether the opinion of the EFSA GMO panel and the additional information that is provided by the applicant gives reason to reconsider its previous advice.

The applicant performed an additional laboratory experiment on the effect of MON88017 pollen on honeybee, but did not prove that active Cry3Bb1 protein was still present in the pollen.
In addition, the applicant provided new data on the LC50 values of the different Cry3Bb1 protein variants using the Colorado potato beetle (a target insect). The applicant did not compare the effect of the Cry3Bb1 protein variants on non-target organisms. As the different protein variants could affect a different range of organisms and data is lacking on the effect of the protein variants on non-target organisms, such as non-target coleopteran insects, COGEM is of the opinion that the functional equivalence of the two Cry3Bb1 protein variants was not sufficiently proven.
In addition, the applicant used a theoretical exposure analysis to assess whether non-target chrysomelid insects could be affected by MON88017 maize pollen and concluded that MON88017 does not pose a risk to these insects. The applicant also reviewed the available scientific literature on the effect of Cry3Bb1 protein or Cry3Bb1 expressing maize on non-target organisms. In the opinion of COGEM the evidence is insufficient to proof the functional equivalence of the Cry3Bb1 protein variants that are present in other maize lines and the MON88017 Cry3Bb1 protein. Therefore, COGEM only took those studies into consideration that used MON88017 or the Cry3Bb1 protein that is present in MON88017. The available literature indicates that MON88017 does not adversely affect a range of non-target organisms (a predatory spider, spider mite, plant bug, leaf hopper, lacewing and two ladybird species). However, COGEM is of the opinion that sufficient data on the absence of an effect on ground beetles (Coleoptera: Carabidae) is lacking. Predatory ground beetles are present in agricultural fields and may be indirectly exposed to Cry3Bb1 protein via its prey. COGEM is of the opinion that in case of maize line MON88017 which is resistant to certain coleopteran insects, an assessment of the effect of this maize line on ground beetles is necessary.
In conclusion, sufficient data on the absence of an effect on ground beetles is lacking and the study on the effect of MON88017 pollen on honeybees did not contain the proper control experiments. Therefore, COGEM cannot advise positively on cultivation of MON88017 maize.