Scientific Opinion on the annual Post-Market Environmental Monitoring (PMEM) report from Monsanto Europe S.A. on the cultivation of genetically modified maize MON 810 in 2010

Following the 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 2010 growing season of maize MON810 provided by Monsanto Europe S.A. On 7 September 2011, the EFSA GMO Panel already adopted a scientifc opinion on the 2009 monitoring report of maize MON 810. The EFSA GMO Panel followed the same approach as for the assessment of the 2009 monitoring report and 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 MON 810 in 2010. 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. The EFSA GMO Panel notes similar shortcomings in the methodology for CSM and GS as in the 2009 monitoring report. Hence, the EFSA GMO Panel reiterates the same recommendations for improvement of the methodology for the post-market environmental monitoring of maize MON 810 as in its scientific opinion on the 2009 monitoring report of maize MON 810. However, from the data submitted by the applicant in its 2010 monitoring report, the EFSA GMO Panel does not identify adverse effects on the environment, human and animal health due to maize MON810 cultivation during the 2010 growing season. The outcomes of the 2010 monitoring report do not invalidate the previous EFSA GMO Panel’s scientific opinions on maize MON 810.