Parma, Italy
July 2, 2015
European Food Safety Authority
Question number: EFSA-Q-2015-00235
Report
Abstract
Following a request of the European Commission, the European Food Safety Authority (EFSA) assessed the concerns raised by Monsanto on the previous EFSA GMO Panel’s recommendations on its insect resistance management (IRM) plan for maize MON 810. EFSA specifically considered the feasibility of its recommendations for sampling target pests in order to optimise the sampling protocols. EFSA recommends the identification of large geographical areas (e.g. Ebro valley in Spain) where maize MON 810 adoption rate and target pest pressure are high. EFSA suggests focusing the collection of the target pest larvae in three ‘sampling zones’ instead of sampling extensively over entire ‘geographical areas’. In response to Monsanto’s concerns, EFSA also re-used the same resistance evolution model as before to assess whether the IRM approach of Monsanto enables the early detection of resistance so that alternative management measures can be adopted to prevent field resistance. Notwithstanding the difficulty to estimate the density-dependent (DD) mortality of target pests, EFSA considered a range of DD values in the new simulations performed with the same resistance evolution model as before. Based on the results of the new model simulations, EFSA concludes that the previous conclusions and recommendations of the EFSA GMO Panel remain valid. EFSA therefore advocates setting the detection limit for resistance allele frequency at 1 % or 3 % depending on the adoption rate of maize MON 810. Moreover, EFSA recommends to annually sample bi-/multi-voltine target pest populations in areas where maize MON 810 adoption rate is at least 60 % of the total cultivated maize.
Summary
Following a request of the European Commission, the European Food Safety Authority (EFSA) discusses the concerns raised by Monsanto on EFSA GMO Panel’s recommendations on its insect resistance management (IRM) plan for maize MON 810. EFSA considers the relevance and assesses the implications of these concerns on previous EFSA GMO Panel recommendations.
EFSA considers the feasibility of its recommendations for sampling target pests and acknowledges Monsanto’s view to maintain the correct balance between the sampling efforts and the objective to detect resistance in target pests at an early stage.
To optimise the sampling protocol of target pests, EFSA recommends the identification of large geographical areas (e.g. Ebro valley in Spain) where maize MON 810 adoption rate and target pest pressure are high. EFSA also suggests focusing the collection of the target pest larvae in three ‘sampling zones’ instead of sampling extensively over entire ‘geographical areas’.
In response to Monsanto’s concerns, EFSA re-uses the same resistance evolution model as before to assess whether the IRM approach followed by Monsanto enables the early detection of resistance so that alternative management measures can be adopted to prevent field resistance. EFSA highlights the difficulty to set a unique value to estimate the density-dependent (DD) mortality of target pests for the model calculations, owing to the lack of information available on the occurrence and density of their natural enemies in maize agro-ecosystems and due to their high variability over time and space. Nevertheless, for the new model simulations, EFSA considers a range of DD mortality values. The newly obtained results presented here only slightly differ from those derived from the previous EFSA GMO Panel model simulations.
EFSA concludes that the previous conclusions and recommendations on Monsanto’s IRM plan made by the EFSA GMO Panel remain valid. EFSA therefore advocates setting the detection limit for resistance allele frequency at 1 % for areas with 80 % maize MON 810 adoption rate or 3 % for areas with 60 % maize MON 810 adoption rate, instead of 5 % as proposed by Monsanto. In addition, EFSA recommends to annually sample bi-/multi-voltine target pest populations in areas where maize MON 810 adoption rate is at least 60 % of the total cultivated maize.
Finally, owing to limitations inherent to all models, EFSA recommends that new data are gathered from literature or monitoring to help fine-tuning the model predictions.
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