Revised annual post-market environmental monitoring (PMEM) report on the cultivation of genetically modified maize MON 810 in 2013 from Monsanto Europe S.A.

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Article
Panel on Genetically Modified Organisms
EFSA Journal
EFSA Journal 2015;13(11):4295 [37 pp.].
doi
10.2903/j.efsa.2015.4295
Panel members at the time of adoption
Andrew Nicholas Birch, Josep Casacuberta, Adinda De Schrijver, Achim Gathmann, Mikolaj Gralak, Philippe Guerche, Huw Jones, Barbara Manachini, Antoine Messéan, Hanspeter Naegeli, Elsa Ebbesen Nielsen, Fabien Nogué, Christophe Robaglia, Nils Rostoks, Jeremy Sweet, Christoph Tebbe, Francesco Visioli, Jean-Michel Wal.
Acknowledgements

The Panel wishes to thank the members of the Working Group on annual PMEM reports, Salvatore Arpaia, Barbara Manachini, Antoine Messéan and Jeremy Sweet, for the preparatory work on this scientific and EFSA staff members, Fernando Álvarez, Michele Ardizzone, Yann Devos, Marios Georgiadis, Ana Gomes, Anna Lanzoni and Jane Richardson, for the support provided to this scientific output.

Contact
Type
Opinion of the Scientific Committee/Scientific Panel
On request from
European Commission
Question Number
EFSA-Q-2015-00432
Adopted
28 October 2015
Published
17 November 2015
Affiliation
European Food Safety Authority (EFSA), Parma, Italy
Note
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Abstract

Following a request from the European Commission, the Panel on Genetically Modified Organisms of the European Food Safety Authority (EFSA GMO Panel) assessed the results of the general surveillance activities contained in the revised annual post-market environmental monitoring (PMEM) report for the 2013 growing season of maize MON 810 provided by Monsanto Europe S.A. The supplied data do not indicate any unanticipated adverse effects on human and animal health or the environment arising from the cultivation of maize MON 810 cultivation in 2013. Similar methodological shortcomings to those observed in previous annual PMEM reports were identified in the analysis of farmer questionnaires and the conduct of the literature review. The EFSA GMO Panel therefore strongly reiterates its previous recommendations to improve the methodology of future annual PMEM reports on maize MON 810. The EFSA GMO Panel urges the applicant to consider how to make best use of the information recorded in national registers in order to optimise sampling for farmer questionnaires, reiterates its previous recommendations on insect resistance monitoring and continued screening, and requests to continue reviewing and discussing relevant scientific publications on possible adverse effects of maize MON 810 on rove beetles. Also, the EFSA GMO Panel encourages relevant parties to continue developing a methodological framework to use existing networks in the broader context of environmental monitoring.

Summary

Following a request from the European Commission, the Panel on Genetically Modified Organisms of the European Food Safety Authority (EFSA GMO Panel) assessed the results of the general surveillance (GS) activities contained in the revised annual post-market environmental monitoring report on the cultivation of maize MON 810 during the 2013 growing season provided by Monsanto Europe S.A.

The EFSA GMO Panel assessed the 2013 GS dataset on maize MON 810, which consists of a survey based on 256 questionnaires received from farmers in four European countries, peer-reviewed publications relevant to the risk assessment and/or management of maize MON 810 (published between June 2013 and the beginning of June 2014), and alerts on environmental issues issued by regulatory authorities and existing surveillance networks. To identify relevant publications not reported by the applicant, the EFSA GMO Panel performed a literature search and assessed the relevance of retrieved scientific publications for the safety of maize MON 810. The available data do not indicate any unanticipated adverse effects on human and animal health or the environment arising from the cultivation of maize MON 810 during the 2013 growing season. Therefore, the EFSA GMO Panel considers that its previous conclusions on the safety of maize MON 810 remain valid and applicable.

Similar methodological shortcomings to those found in previous annual PMEM reports on maize MON 810 were identified by the EFSA GMO Panel in the analysis of farmer questionnaires and conduct of the literature review. The EFSA GMO Panel therefore strongly reiterates its recommendations to provide more detailed information on the sampling methodology and to reduce the possibility of selection bias in farmer questionnaires, and to ensure that all relevant scientific publications are identified. In order to improve the sampling frame of the farmer survey, the EFSA GMO Panel reiterates the importance of national GMO cultivation registers; and its recommendations to applicants to consider how they may make best use of the information recorded in national registers and foster dialogue with those responsible for the administration of these registers where maize MON 810 is cultivated.

No information collected from existing monitoring networks in the EU was provided by the applicant. However, the EFSA GMO Panel notes that initiatives have been taken to develop a methodological framework to use existing networks in the broader context of environmental monitoring, and encourages relevant parties to continue to use these.

The outcome of the literature review reinforces previous recommendations on insect resistance monitoring as part of the insect resistance management plan, and to use farmer questionnaires as a tool to capture early warning signs indicating increases in tolerance in populations of non-target lepidopteran pests in the field.

With regard to rove beetles (Coleoptera: Staphylinidae), the applicant is requested to continue screening, reviewing and discussing relevant scientific publications on possible adverse effects of maize MON 810 on rove beetles.

Keywords
Cry1Ab, farmer questionnaires, general surveillance, literature searches, risk assessment, Zea mays
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Number of Pages
37