Results from ten years of post-market environmental monitoring of genetically modified MON 810 maize in the European Union

Abstract

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

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

“…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. Concerning the analysis of the pooled data (2006-2015 maize growing seasons) from Bertho et al (2020), EFSA cannot comment on the results and conclusions presented in this publication since the statistical model used is not considered appropriate.…”

“…The general surveillance data set consists of a farmer survey based on 250 farmer questionnaires and relevant scientific publications published between June 2018 and May 2019 that were identified through a systematic literature search. Besides, the consent holder has published the results of the pooled analysis of the questionnaires completed between 2006 and 2015 in a peer-reviewed publication (Bertho et al, 2020).…”

“…field and environmental and wildlife aspects were collected and analysed, including an analysis of trends within the data. For characteristics, the estimated 99% confidence intervals (CIs) for the model proportions for the 'As usual', 'Plus or changed' or 'Minus' responses (for more details, see Bertho et al, 2020) excluded the predefined threshold values (10% or 10%) for an effect (Table 6). Bertho et al (2020) concluded that the analysis of the 2006-2015 data did not reveal any unexpected adverse effects associated with the cultivation of maize MON 810 in the EU.…”

“…For characteristics, the estimated 99% confidence intervals (CIs) for the model proportions for the 'As usual', 'Plus or changed' or 'Minus' responses (for more details, see Bertho et al, 2020) excluded the predefined threshold values (10% or 10%) for an effect (Table 6). Bertho et al (2020) concluded that the analysis of the 2006-2015 data did not reveal any unexpected adverse effects associated with the cultivation of maize MON 810 in the EU. Besides, they proposed replacing annual surveys of farmers by the farmer complaint systems implemented by companies marketing maize MON 810 seeds (see Section 3.1.2.1).…”

“…In the assessment that follows, EFSA makes several observations and comments on the pooled analysis of the farmer questionnaires data published in Bertho et al (2020). For the full explanations, see the analysis report in Annex 2 of supporting information of this statement.…”