Relevance of a new scientific publication (Hofmann et al., 2016) for previous environmental risk assessment conclusions and risk management recommendations on the cultivation of Bt‐maize events MON810, Bt11 and 1507

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doi:10.2903/sp.efsa.2016.en-1070

EFSA Supporting Publications

2016

DOI: 10.2903/sp.efsa.2016.en-1070

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Relevance of a new scientific publication (Hofmann et al., 2016) for previous environmental risk assessment conclusions and risk management recommendations on the cultivation of Bt‐maize events MON810, Bt11 and 1507

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Annual post‐market environmental monitoring (PMEM) report on the cultivation of genetically modified maize MON 810 in 2015 from Monsanto Europe S.A.

Naegeli

Birch²,

Casacuberta³

et al. 2017

EFS2

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Following a request from the European Commission, the Panel on Genetically Modified Organisms of the European Food Safety Authority (GMO Panel) assessed the annual post-market environmental monitoring (PMEM) report for the 2015 growing season of the Cry1Ab-expressing maize event MON 810 provided by Monsanto Europe S.A. The GMO Panel concludes that the insect resistance monitoring data submitted to EFSA do not indicate a decrease in susceptibility of field Iberian populations of corn borers to the Cry1Ab protein during the 2015 season. However, since the methodology for insect resistance monitoring remained unchanged compared to previous PMEM reports, the GMO Panel reiterates its previous recommendations on resistance monitoring to provide sufficient detection sensitivity. Although the farmer alert system to report complaints about product performance could complement the information obtained from the laboratory bioassays, the GMO Panel is currently not in a position to appraise its usefulness, and therefore encourages the consent holder to provide more information on this complementary resistance monitoring tool. The data on general surveillance (GS) do not indicate any unanticipated adverse effects on human and animal health or the environment arising from the cultivation of maize MON 810. The GMO Panel reiterates its previous recommendations on the analysis of farmer questionnaires, and advises the consent holder to provide more detailed information on the conducting and reporting of the literature search in future annual PMEM reports. Moreover, the GMO Panel encourages relevant parties to continue developing a methodological framework to use existing networks in the broader context of environmental monitoring. The GMO Panel concludes that the case-specific monitoring (CSM) and GS activities of maize MON 810 as carried out by the consent holder do not provide evidence that would invalidate previous GMO Panel evaluations on the safety of maize MON 810.

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Annual post‐market environmental monitoring (PMEM) report on the cultivation of genetically modified maize MON 810 in 2015 from Monsanto Europe S.A.

Naegeli

Birch²,

Casacuberta³

et al. 2017

EFS2

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Potential Risk of Pollen from Genetically Modified MON 810 Maize Containing Cry1Ab Toxin to Protected Lepidopteran Larvae in the Pannonian Biogeographical Region—A Retrospective View

Darvas

Gyurcsó

Takács

et al. 2022

Insects

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A credible risk analysis of maize pollen containing Cry1Ab toxin must include the assessment of (i) pollen production and its Cry1 toxin content; (ii) distribution of the pollen grains in the surroundings; (iii) pollen-catching capacity of the weeds on field edges; (iv) the lifestyle of protected lepidopteran larvae living on weeds; (v) Cry1 toxin sensitivity of non-target caterpillars; and (vi) Cry1 toxin resistance of individual non-target populations. The concentration range of 5–4300 ng Cry1Ab toxin/g dry pollen determined in MON 810 pollen batches is too diverse for handling it as a single set in any mathematical modeling. Within the work carried out mainly with the DK-440 BTY cultivar, the seed samples officially received from the variety owner produced significantly different (250–470 vs. 5–15 ng/g) Cry1Ab toxin concentrations in the pollen. Nymphalis io L1-L3 larvae were nearly six times more sensitive for Dipel than Nymphalis c-album. Feeding on the back side and in a leaf nest, Vanessa atalanta may be subject to lower pollen exposures. N. io larvae may actively attempt to avoid patches with high pollen contamination. Cry1Ab toxin resistance also partially emerged in N. io populations reared in the Pannonian Biogeographical Region (Hungary).

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Relevance of a new scientific publication (Hofmann et al., 2016) for previous environmental risk assessment conclusions and risk management recommendations on the cultivation of Bt‐maize events MON810, Bt11 and 1507

Cited by 2 publications

References 18 publications

Annual post‐market environmental monitoring (PMEM) report on the cultivation of genetically modified maize MON 810 in 2015 from Monsanto Europe S.A.

Annual post‐market environmental monitoring (PMEM) report on the cultivation of genetically modified maize MON 810 in 2015 from Monsanto Europe S.A.

Potential Risk of Pollen from Genetically Modified MON 810 Maize Containing Cry1Ab Toxin to Protected Lepidopteran Larvae in the Pannonian Biogeographical Region—A Retrospective View

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