Assessment of the 2018 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 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 northeastern 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 2 screen on corn borer populations from northeastern 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.

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

“…Moult inhibition values for both ECB populations were as well below > 99% (95.09% and 84.12%). In line with previous assessments (EFSA, 2020, 2021), EFSA strongly recommends the consent holder to include a reference population as a negative control in the diagnostic concentration assays with ECB. This would allow to evaluate whether moult inhibition values below > 99% in field‐collected populations could indicate a decrease of susceptibility to Cry1Ab or could be associated to other factors, such as a low efficacy of the toxin batch used in the assays or the use of an inadequate diagnostic Cry1Ab concentration.…”

“…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.…”

“…The same observations were made in the previous EFSA statements. For further details, we would like to refer to EFSA (2020, 2021). •The questionnaire provides a list of the GM and non‐GM varieties grown by each farmer, but it is unclear which conventional and GM fields have been actually compared.…”

“…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.…”

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

“…A pooled analysis of farmer questionnaires covering the years 2006–2015 was provided in the PMEM report of 2018 and evaluated by EFSA (EFSA, 2020).…”