Assessment of the 2019 post‐market environmental monitoring report on the cultivation of genetically modified maize MON 810 in the EU

Abstract

Following a request from the European Commission, the EFSA assessed the 2019 post-market environmental monitoring (PMEM) report on the cultivation of Cry1Ab-expressing maize event MON 810. Like previous years, there was full compliance with refuge requirement in Portugal and 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 2019 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. Overall, EFSA concludes that the evidence reported in the 2019 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 2019, is not sufficiently sensitive to detect the recommended 3% resistance allele frequency. Consequently, EFSA strongly recommends the consent holder to achieve full compliance with refuge obligations in areas where adoption of maize MON 810 is high and increase the sensitivity of the monitoring plan by performing periodic F 2 screens on corn borer populations from north-eastern Spain. EFSA recommends revising the farmer questionnaires when new characteristics of the receiving environment emerge which are relevant for the environmental risk assessment of MON 810 such as the emergence of teosinte. EFSA encourages the Competent authorities of concerned EU Member States, the consent holder and environmental networks to engage in a dialogue to develop a framework on how to best identify and report unexpected adverse effects from the cultivation of Bt maize varieties.

Assessment of the 2020 post‐market environmental monitoring report on the cultivation of genetically modified maize MON 810 in the EU

“…Since the 2016 growing season, the consent holder conducts diagnostic bioassays with F 1 larvae from the field‐collected individuals to assess the susceptibility of target pests to the Cry1Ab protein, instead of concentration–response assays. EFSA already agreed with the principles driving the revision of the testing approach previously proposed by the consent holder but expressed reservations on the actual implementation and made considerations regarding the design of the diagnostic bioassays, the selection of the diagnostic concentrations and the confirmatory studies performed with suspected‐resistant individuals (EFSA, 2018, 2019a, 2020, 2021). EFSA has also encouraged the consent holder to improve the IRM plan and consider alternative testing methods continuously.…”

“…Selection of diagnostic concentrations: Moult inhibition values observed in the susceptible reference MCB populations are repeatedly below the expected 99% (Appendix C). Besides, the consent holder has not provided sufficient evidence to underpin the appropriateness of the diagnostic concentration selected for this target pest species (EFSA, 2021). Thus, uncertainty remains on whether the diagnostic concentration for MCB is able to reliably discriminate between homozygous resistant and susceptible individuals.…”

“…Since 2005, the consent holder has reported to the European Commission and the EU Member States 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 monitoring resistance evolution and refuge compliance), along with the results of general surveillance. EFSA has evaluated the annual PMEM reports on maize MON 810 corresponding to the 2009–2019 growing seasons (EFSA, 2018, 2019a, 2020, 2021; EFSA GMO Panel, 2011a, 2012a, 2013, 2014a, 2015a,b 2016, 2017). Based on the data provided in those reports, EFSA and its GMO Panel did not identify adverse effects on human and animal health and the environment resulting from the cultivation of maize MON 810.…”

Update of environmental risk assessment conclusions and risk management recommendations of EFSA (2016) on EU teosinte

“…Genetically modified (GM) maize event MON810 is currently the only GM crop approved for cultivation in the EU. In recent years, maize MON810 has been grown mainly in ES and to a lesser extent in Portugal (PT) (Camargo et al, 2018 ; EFSA, 2021 ; Álvarez‐Alfageme et al, 2022 ). In 2019, maize MON810 represented approximately 35% of ES’s total maize area and less than 10% in PT (Álvarez‐Alfageme et al, 2022 ).…”

“…In April 2021, the European Commission (Directorate‐General for Health and Food Safety (DG SANTE)) requested EFSA to assess whether, based on the evidence supplied by the ES/FR Competent Authorities, existing scientific literature and any other pertinent evidence, there is a need to update: (1) the post‐market environmental monitoring (PMEM) plan for maize MON810; and (2) the EFSA (2016) technical report on teosinte. Following the request of the European Commission, in May 2021, EFSA recommended: (1) the consent holder to put more emphasis on ES teosinte in the annual PMEM reports on the cultivation of maize MON810 (see also EFSA, 2021 ); and (2) to update EFSA ( 2016 ) to integrate and report the most recent and relevant evidence on EU teosinte for the ERA and RM of maize MON810, Bt11, 1507 and GA21. 2…”