ABSTRACT:

Following a request from the European Commission, the Panel on Genetically Modified Organisms of  the European Food Safety Authority (EFSA GMO Panel) assessed the monitoring report for the 2009  cultivation season of maize MON810 provided by Monsanto Europe S.A. The EFSA GMO Panel  assessed, in close collaboration with the EFSA  Unit for Scientific Assessment Support, the  methodology applied by the applicant for the Case-Specific Monitoring and General Surveillance of  maize MON810 in 2009. Concerning the Case-Specific monitoring (CSM), the EFSA GMO Panel considered the plan for Insect-Resistant Management mainly based on the ‘high dose/refuge strategy’, monitoring of target pest resistance and education of farmers. Concerning General Surveillance (GS),  the EFSA GMO Panel paid particular attention to the design and analysis of the farmer questionnaires.  From the data submitted by the applicant in its 2009 MON810 report, the EFSA GMO Panel did not  identify adverse effects on the environment, human and animal health due to maize MON810  cultivation during the 2009 growing season. The outcomes of the 2009 MON810 report do not invalidate the previous risk assessment conclusions on maize MON810. However, the EFSA GMO Panel notes a number of shortcomings in the methodology for CSM and GS. Hence, this scientific opinion gives specific recommendations for improvement of the strategy, methodology and reporting for the post-market environmental monitoring of  maize MON810. The applicant should take into  account the guidance on Post-Market Environmental Monitoring (PMEM) of genetically modified  plants as outlined in the recent scientific opinion of the EFSA GMO Panel. The recommendations of  the EFSA GMO Panel in this opinion supplement the previous recommendations on PMEM of maize MON810 in the 2009 scientific opinion for the renewal of the authorisation for continued marketing of maize MON810.