Annual post‐market environmental monitoring (PMEM) report on the cultivation of genetically modified maize MON 810 in 2015 from Monsanto Europe S.A.

Abstract

Following a request from the European Commission, the Panel on Genetically Modified Organisms of the European Food Safety Authority (GMO Panel) assessed the annual post-market environmental monitoring (PMEM) report for the 2015 growing season of the Cry1Ab-expressing maize event MON 810 provided by Monsanto Europe S.A. The GMO Panel concludes that the insect resistance monitoring data submitted to EFSA do not indicate a decrease in susceptibility of field Iberian populations of corn borers to the Cry1Ab protein during the 2015 season. However, since the methodology for insect resistance monitoring remained unchanged compared to previous PMEM reports, the GMO Panel reiterates its previous recommendations on resistance monitoring to provide sufficient detection sensitivity. Although the farmer alert system to report complaints about product performance could complement the information obtained from the laboratory bioassays, the GMO Panel is currently not in a position to appraise its usefulness, and therefore encourages the consent holder to provide more information on this complementary resistance monitoring tool. The data on general surveillance (GS) do not indicate any unanticipated adverse effects on human and animal health or the environment arising from the cultivation of maize MON 810. The GMO Panel reiterates its previous recommendations on the analysis of farmer questionnaires, and advises the consent holder to provide more detailed information on the conducting and reporting of the literature search in future annual PMEM reports. Moreover, the GMO Panel encourages relevant parties to continue developing a methodological framework to use existing networks in the broader context of environmental monitoring. The GMO Panel concludes that the case-specific monitoring (CSM) and GS activities of maize MON 810 as carried out by the consent holder do not provide evidence that would invalidate previous GMO Panel evaluations on the safety of maize MON 810.

Annual post‐market environmental monitoring report on the cultivation of genetically modified maize MON 810 in 2016

“…The selected concentration corresponds to the 99% moulting inhibition concentration (MIC 99 ) estimated with data pooled from ECB populations collected in the Czech Republic, France, Germany, Hungary, Italy, Poland, Portugal, Romania and Spain between 2005 and 2012 . This diagnostic concentration was validated by testing several ECB populations collected in Spain in 2013, 2014 and 2015 (EFSA GMO Panel, , , ).…”

“…EFSA notes that the study with MCB did not include a negative control, as recommended by the GMO Panel (EFSA GMO Panel, ). The inclusion of a suitable negative control is a key element in the design of laboratory studies and adds certainty to the suitability of the test system and increases the reliability of the obtained results (Romeis et al., ).…”

“…Since 2005, the results of the IRM and monitoring activities on the cultivation of maize MON 810 in the EU (hereafter referred to as case‐specific monitoring which focuses on resistance and refuge compliance monitoring to allow the periodic evaluation of the adequacy and efficacy of the IRM strategy), along with the results of general surveillance, have been reported to the European Commission and the EU Member States on an annual basis by the consent holder. These PMEM reports on maize MON 810 have been assessed by EFSA since 2010 (EFSA GMO Panel, , , , , ,b, , ). From the data provided in the previous annual PMEM reports, the GMO Panel did not identify adverse effects on human and animal health and the environment resulting from the cultivation of maize MON 810.…”

Annual report of the EFSA Scientific Network for Risk Assessment of GMOs for 2017

“…Yann Devos, scientific officer of the GMO Unit, presented the explanatory note to the guidance on literature searching (EFSA, 2017 Specific recommendations for: (1) identifying review questions and clarifying their purpose; (2) searching for/identifying relevant studies; (3) selecting studies; (4) extracting high level data from the relevant studies, where appropriate; and (5) summarising and reporting the data, and considering the implications of the findings, were presented.…”

“…Fernando Álvarez, scientific officer of the GMO Unit, presented the EFSA GMO Panel scientific opinion on the annual PMEM report on the cultivation of GM maize MON810, corresponding to the cultivation season 2015 (EFSA GMO Panel, 2017). During his presentation, Fernando Álvarez informed participants on the status of the cultivation of maize MON810 in the EU, gave an overview of the casespecific monitoring (CSM) and general surveillance activities (GS) performed by the consent holder, and summarised the conclusions and recommendations made by the GMO Panel in its scientific opinion.…”