An empirical approach is given for specifying coexistence requirements for genetically modified (GM) maize (Zea mays L.) production, to ensure compliance with the 0.9% labeling threshold for food and feed in the European Union. Field data were considered in which pollen-mediated gene flow (PMGF) was measured within maize receptor fields at a series of distances from source fields having a marker. An empirical model is presented that fits the observed decrease of gene flow with distance. The model was parameterized to provide both reasonable worst case and expected case predictions of gene flow for various combinations of isolation distance, use of non-GM border rows in the GM field and/or separately harvested border rows in the receptor field. Based on the data assessed, the model is used to show that the effect of scale is minimal for source fields of surface area 4 ha and greater. Combinations of isolation distance and border rows of 20 m or more are predicted to result in gene flow of less than 0.9%, as a blended average for receptor fields 1 ha or larger. Lesser requirements are necessary when the source field is much smaller than the receptor, and an extension to the model is provided to estimate such effects.

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In European regulations for the deliberate release into the environment of genetically modified organisms (GMO), the objective of General Surveillance in Post-Market Environmental Monitoring is defined as the identification of the occurrence of adverse effects of the GMO or its use which were not anticipated in the environmental risk assessment (ERA). Accompanying the commercial cultivation in the EU of maize event MON 810, General Surveillance was implemented by Monsanto, the authorization holder, on a voluntary basis. We carried out a statistical analysis on the pooled results of ten years of farmer questionnaires, which were a part of this General Surveillance, amounting to 2,627 farmer fields in eight European countries in the period 2006-2015. This analysis did not reveal any unexpected adverse effects associated with the cultivation of MON 810. Results from farmer questionnaires confirmed that the cultivation of MON 810 resulted in a significant reduction in the use of pesticides, efficient protection against the target pests, and healthier, higher yielding crops compared to conventional maize. MON 810 also had reduced susceptibility to disease and pests when compared to conventional maize. Monitoring characteristics related to environment and wildlife revealed no significant differences between MON 810 and conventional maize. Literature searches, that were also conducted as part of General Surveillance, identified a comprehensive set of publications addressing environmental safety as well as food and feed safety aspects of MON 810. None of the publications indicated any adverse effect of MON 810 that was not anticipated in the initial ERA, nor did they lead to a change in the conclusions of the initial risk assessment that demonstrated the safety of MON 810. The development of resistance by the target pests (Ostrinia nubilalis, ECB and Sesamia nonagrioides, MCB) was the only potential adverse effect identified in the ERA of MON 810 cultivation in the EU. The extensive safety data package for MON 810, the robust weight of evidence demonstrating both its safety and benefits, and the history of safe use of MON 810 for 15 years in the EU, indicates that focussing the General Surveillance of MON 810 on literature searches and farmer complaint systems would be appropriately protective. This will

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