Assessment of the 2017 post‐market environmental monitoring report on the cultivation of genetically modified maize MON 810

Abstract

Following a request from the European Commission, EFSA assessed the 2017 post‐market environmental monitoring (PMEM) report on the cultivation of Cry1Ab‐expressing maize event MON 810. Like previous years, partial compliance with refuge requirements is reported for Spain. European and Mediterranean corn borer populations collected from North‐eastern Spain during the 2017 maize growing season and tested for Cry1Ab susceptibility show no symptoms of resistance to maize MON 810. No complaints about unexpected field damage caused by corn borers were received through the farmer complaint system. 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. No information about the use of existing networks involved in environmental monitoring is provided. Overall, EFSA concludes that the evidence reported in the 2017 PMEM report does not invalidate previous EFSA and GMO Panel evaluations on the safety of maize MON 810. As in previous years, EFSA identifies methodological and reporting shortcomings pertaining to resistance monitoring that need revision in future PMEM reports. In particular, the monitoring plan, as implemented in 2017, 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 requirements in areas where maize MON 810 adoption is high (i.e. North‐eastern Spain); (2) increase the sensitivity of the resistance monitoring plan and address previously mentioned methodological, analytical and/or reporting limitations for resistance monitoring and farmer questionnaires; and (3) perform a F2‐screen on European and Mediterranean corn borer populations from North‐eastern Spain. Moreover, relevant stakeholders should implement a methodological framework to enable making 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

“…The evidence from the 2020 PMEM report does not indicate any adverse effects on human and animal health or the environment arising from the cultivation of maize MON 810 during the 2019 growing season. Consequently, previous evaluations on the safety of maize MON 810 (EFSA, 2019a,b; EFSA GMO Panel, 2012b,c) remain valid.…”

“…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.…”

“…A description of the information sources searched is provided with limited discussion on the reasons for their selection. Additional information submitted by the consent holder upon EFSA's request, clarified that other information sources were not considered necessary, because the SciSearch and CABA databases allow for a wide‐ranging coverage for literature searching, meeting the minimum requirement in accordance to EFSA (2019a,b). A discussion on what might be the impact of non‐inclusion of other databases is lacking.…”

“…According to EFSA (2019a,b), details on the criteria to appraise the reliability of the studies identified in the review should be provided. Some further information was provided in the additional information but more details on the individual reliability criteria applied should be provided in future searches.…”

“…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.…”