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Scientific Opinion on the annual Post-Market Environmental Monitoring (PMEM) report from Monsanto Europe S.A. on the cultivation of genetically modified maize MON 810 in 2010

EFSA Journal 2012;10(4):2610 [35 pp.]. doi:10.2903/j.efsa.2012.2610
  EFSA Panel on Genetically Modified Organisms (GMO) Panel Members Hans Christer Andersson, Salvatore Arpaia, Detlef Bartsch, Josep Casacuberta, Howard Davies, Patrick du Jardin, Gerhard Flachowsky, Lieve Herman, Huw Jones, Sirpa Kärenlampi, Jozsef Kiss, Gijs Kleter, Harry Kuiper, Antoine Messéan, Kaare Magne Nielsen, Joe Perry, Annette Pöting, Jeremy Sweet, Christoph Tebbe, Atte Johannes von Wright and Jean-Michel Wal. Acknowledgment The Panel wishes to thank the members of the Standing Working Group on annual PMEM reports: Salvatore Arpaia, Jozsef Kiss, Antoine Messéan, Joe Perry, Jeremy Sweet for the preparation of this Scientific Opinion; members of the Standing Working Groups on Food & Feed: Ilona Kryspin-Sorensen, Christer Andersson; and EFSA staff: Saghir Bashir, Sylvie Mestdagh and Jane Richardson for the support provided to this Scientific Opinion. Possible conflict of interest One member of the Panel did not participate in the discussion on the subject referred to above because of potential conflict of interest identified in accordance with the EFSA policy on declarations of interests. Contact gmo@efsa.europa.eu
Type: Opinion of the Scientific Committee/Scientific Panel On request from: European Commission Question number: EFSA-Q-2011-01161 Adopted: 07 March 2012 Published: 11 April 2012 Affiliation: European Food Safety Authority (EFSA), Parma, Italy
Abstract

Following the request from the European Commission, the Panel on Genetically Modified Organisms of the European Food Safety Authority (EFSA GMO Panel) assessed the monitoring report for the 2010 growing season of maize MON810 provided by Monsanto Europe S.A. On 7 September 2011, the EFSA GMO Panel already adopted a scientifc opinion on the 2009 monitoring report of maize MON 810. The EFSA GMO Panel followed the same approach as for the assessment of the 2009 monitoring report and assessed, in close collaboration with the EFSA Unit for Scientific Assessment Support, the methodology applied by the applicant for the Case-Specific Monitoring and General Surveillance of maize MON 810 in 2010. Concerning the Case- Specific Monitoring (CSM), the EFSA GMO Panel considered the plan for Insect-Resistant Management mainly based on the “high dose/refuge strategy”, monitoring of target pest resistance and education of farmers. Concerning General Surveillance (GS), the EFSA GMO Panel paid particular attention to the design and analysis of the farmer questionnaires. The EFSA GMO Panel notes similar shortcomings in the methodology for CSM and GS as in the 2009 monitoring report. Hence, the EFSA GMO Panel reiterates the same recommendations for improvement of the methodology for the post-market environmental monitoring of maize MON 810 as in its scientific opinion on the 2009 monitoring report of maize MON 810. However, from the data submitted by the applicant in its 2010 monitoring report, the EFSA GMO Panel does not identify adverse effects on the environment, human and animal health due to maize MON810 cultivation during the 2010 growing season. The outcomes of the 2010 monitoring report do not invalidate the previous EFSA GMO Panel’s scientific opinions on maize MON 810.

© European Food Safety Authority, 2012

Summary

On 7 September 2011, in response to a request from the European Commission, the Panel on Genetically Modified Organisms of the European Food Safety Authority (EFSA GMO Panel) adopted a scientific opinion on the monitoring report of maize MON 810 for the 2009 growing season provided by Monsanto Europe S.A.. During its assessment of the 2009 monitoring report, the EFSA GMO Panel identified shortcomings in the methodology for both Case-Specific Monitoring (CSM) and General Surveillance (GS) of maize MON 810 and hence provided recommendations for improvement of the Post-Market Environmental Monitoring (PMEM) of maize MON 810.

Following a similar request from the European Commission to assess the monitoring report of the same maize MON 810 for the 2010 growing season, the EFSA GMO Panel firstly noted that the applicant followed the same approach as in its 2009 monitoring report.

The EFSA GMO Panel assessed, in close collaboration with the EFSA Unit for Scientific Assessment Support, the methodology applied by the applicant for the CSM and GS of maize MON 810 in 2010. The methodology used for the monitoring of maize MON 810 in 2010 is similar to what was done in 2009. Therefore, the EFSA GMO Panel mostly focused on the new 2010 datasets, i.e., data from farmer questionnaires, from a survey in Spain on refugia compliance and from monitoring resistance development in target pests.

The EFSA GMO Panel notes similar shortcomings in the methodology for CSM and GS as in the 2009 monitoring report. Hence, the EFSA GMO Panel reiterates the same recommendations for improvement of the methodology for the PMEM of maize MON 810 as in its scientific opinion on the 2009 monitoring report of maize MON 810.

However, from the data submitted by the applicant in its 2010 monitoring report, the EFSA GMO Panel does not identify adverse effects on the environment, human and animal health due to maize MON810 cultivation during the 2010 growing season. The outcomes of this 2010 monitoring report do not invalidate the previous EFSA GMO Panel’s scientific opinions on maize MON 810.

Keywords

GMO, PMEM, annual report, cultivation, case-specific monitoring, general surveillance, insect-resistance management, maize, MON 810