Assessment of the 2018 post-market environmental monitoring report on the cultivation of genetically modified maize MON 810 in the EU.

Following a request from the European Commission, the EFSA assessed the 2018 post-market environmental monitoring (PMEM) report on the cultivation of Cry1Ab-expressing maize event MON 810. Like previous years, there was partial compliance with refuge requirements by Spanish farmers growing MON 810 varieties. European and Mediterranean corn borer populations collected from north-eastern Spain during the 2018 maize growing season and tested for Cry1Ab susceptibility show no symptoms of resistance to maize MON 810. The assessment of farmer questionnaires and relevant scientific publications does not indicate any unanticipated adverse effects on human and animal health or the environment arising from the cultivation of maize MON 810. The report does not provide information about the use of existing networks involved in environmental monitoring. Overall, EFSA concludes that the evidence reported in the 2018 PMEM report does not invalidate previous EFSA evaluations on the safety of maize MON 810. However, as in previous years, EFSA identifies shortcomings on resistance monitoring that need revision in future reports. In particular, the monitoring plan, as implemented in 2018, is not sufficiently sensitive to detect the recommended 3% resistance allele frequency. Consequently, EFSA strongly recommends the consent holder to: (1) achieve full compliance with refuge obligations in areas where adoption of maize MON 810 is high; (2) increase the sensitivity of the monitoring plan and address previously mentioned limitations for resistance monitoring; and (3) perform an F screen on corn borer populations from north-eastern Spain. A fit-for-purpose farmer alert system may help to detect unexpected adverse effects associated with the cultivation of MON 810 varieties and be an alternative to the current farmer survey system. Moreover, relevant stakeholders should implement a methodological framework to enable making the best use of existing networks involved in environmental monitoring for the general surveillance of genetically modified plants.