Annual post‐market environmental monitoring (PMEM) report on the cultivation of genetically modified maize MON 810 in 2014 from Monsanto Europe S.A.

Birch, Andrew Nicholas; Casacuberta, Josep; Schrijver, Adinda De; Gathmann, Achim; Gralak, Mikołaj Antoni; Guerche, Philippe; Jones, Huw; Manachini, Barbara; Messéan, Antoine; Naegeli, Hanspeter; Nielsen, Elsa; Nogué, Fabien; Robaglia, Christophe; Rostoks, Nils; Sweet, Jeremy; Tebbe, Christoph C.; Visioli, Francesco; Wal, Jean‐Michel

doi:10.2903/j.efsa.2016.4446

Cited by 9 publications

(15 citation statements)

References 36 publications

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“…Guerrero et al, 2004;Adel-Patient et al, 2011) and the GMO Panel identified no indications of safety concern in the context of the applications assessed (EFSA GMO Panel, 2012, 2016a. 28 Sprayed once with glufosinate-ammonium-based herbicides and twice with glyphosate.…”

Section: Assessment Of Allergenicity Of the Newly Expressed Proteins 30mentioning

confidence: 99%

Assessment of genetically modified cotton GHB614 × LLCotton25 × MON 15985 for food and feed uses, under Regulation (EC) No 1829/2003 (application EFSA‐GMO‐NL‐2011‐94)

Naegeli¹,

Birch²,

Casacuberta³

et al. 2018

EFS2

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The three‐event stack cotton GHB614 × LLCotton25 × MON 15985 was produced by conventional crossing to combine three single cotton events, GHB614, LLCotton25 and MON 15985. The EFSA GMO Panel previously assessed the three single events and did not identify safety concerns. No new data on the single events that could lead to modification of the original conclusions on their safety were identified. Based on the molecular, agronomic, phenotypic and compositional characteristics, the combination of the single events and of the newly expressed proteins in the three‐event stack cotton did not give rise to food and feed safety or nutritional issues. Food and feed derived from cotton GHB614 × LLCotton25 × MON 15985 are expected to have the same nutritional impact as those derived from the non‐GM comparator. In the case of accidental release of viable GHB614 × LLCotton25 × MON 15985 cottonseeds into the environment, this three‐event stack cotton would not raise environmental safety concerns. The post‐market environmental monitoring plan and reporting intervals are in line with the intended uses of cotton GHB614 × LLCotton25 × MON 15985. In conclusion, the GMO Panel considers that cotton GHB614 × LLCotton25 × MON 15985, as described in this application, is as safe as the non‐GM comparator with respect to potential effects on human and animal health and the environment.

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Section: Assessment Of Allergenicity Of the Newly Expressed Proteins 30mentioning

confidence: 99%

Assessment of genetically modified cotton GHB614 × LLCotton25 × MON 15985 for food and feed uses, under Regulation (EC) No 1829/2003 (application EFSA‐GMO‐NL‐2011‐94)

Naegeli¹,

Birch²,

Casacuberta³

et al. 2018

EFS2

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“…Consistent with its previous recommendations, the GMO Panel acknowledges that the consent holder has provided further details on the laboratory rearing of corn borers, the reference laboratory strains and the methodology of the bioassays (EFSA GMO Panel, 2016). To evaluate and verify data quality, and to be in a position to fully assess the analysis of the laboratory assays performed with the progeny of the corn borers sampled, the consent holder should provide the raw data in future PMEM reports.…”

Section: Gmo Panel Assessmentmentioning

confidence: 99%

“…However, the GMO Panel notes that efforts have been made to develop a methodological framework to facilitate the use of existing networks in the broader context of environmental monitoring (Centre for Ecology and Hydrology, Perseus et al, 2014;EFSA GMO Panel, 2014b;Smets et al, 2014). The GMO Panel encourages that these efforts are continued by relevant parties (EFSA GMO Panel, 2011b The search strategy 29 used for the literature search was similar to that applied in the search reported in the previous annual PMEM report (for further details see EFSA GMO Panel, 2016).…”

Section: Existing Monitoring Networkmentioning

confidence: 99%

“…Five publications were relevant for the food and feed (FF) safety assessment (in terms of toxicity and allergenicity), 13 publications pertained to the ERA or the IRM of maize MON 810 (most studies assessed the interaction of maize MON 810 with target organisms and non-target organisms). Three of the 18 publications, B € ottger et al (2015), Holderbaum et al (2015) and Xu et al (2015), have already been assessed by EFSA (EFSA, 2016b) or the GMO Panel (EFSA GMO Panel, 2016), and have concluded that no environmental safety concerns owing to maize MON 810 and Cry1Ab were identified.…”

Section: Existing Monitoring Networkmentioning

confidence: 99%

“…report the dates of the search, use of a second database, report the eligibility/inclusion criteria for relevance, and provide the full list of retrieved publications) (EFSA GMO Panel, 2016). However, the GMO Panel still considers that the consent holder should: (i) better define the review question, including its key elements, and its purpose; (ii) better report the results of the literature search; in particular, the number of scientific publications retrieved from each database, the number and list of publications remaining after removing duplicates, and the number of publications that were considered not relevant based on title and abstract on each of the steps of the searching process; and (iii) detail how the selection of relevant publications was conducted, provide the reason(s) for categorising each publication as not relevant, and report which of the relevant publications were previously risk assessed by EFSA.…”

Section: Gmo Panel Assessmentmentioning

confidence: 99%

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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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Results from ten years of post-market environmental monitoring of genetically modified MON 810 maize in the European Union

Bertho

Schmidt²,

Schmidtke³

et al. 2020

PLoS ONE

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In European regulations for the deliberate release into the environment of genetically modified organisms (GMO), the objective of General Surveillance in Post-Market Environmental Monitoring is defined as the identification of the occurrence of adverse effects of the GMO or its use which were not anticipated in the environmental risk assessment (ERA). Accompanying the commercial cultivation in the EU of maize event MON 810, General Surveillance was implemented by Monsanto, the authorization holder, on a voluntary basis. We carried out a statistical analysis on the pooled results of ten years of farmer questionnaires, which were a part of this General Surveillance, amounting to 2,627 farmer fields in eight European countries in the period 2006-2015. This analysis did not reveal any unexpected adverse effects associated with the cultivation of MON 810. Results from farmer questionnaires confirmed that the cultivation of MON 810 resulted in a significant reduction in the use of pesticides, efficient protection against the target pests, and healthier, higher yielding crops compared to conventional maize. MON 810 also had reduced susceptibility to disease and pests when compared to conventional maize. Monitoring characteristics related to environment and wildlife revealed no significant differences between MON 810 and conventional maize. Literature searches, that were also conducted as part of General Surveillance, identified a comprehensive set of publications addressing environmental safety as well as food and feed safety aspects of MON 810. None of the publications indicated any adverse effect of MON 810 that was not anticipated in the initial ERA, nor did they lead to a change in the conclusions of the initial risk assessment that demonstrated the safety of MON 810. The development of resistance by the target pests (Ostrinia nubilalis, ECB and Sesamia nonagrioides, MCB) was the only potential adverse effect identified in the ERA of MON 810 cultivation in the EU. The extensive safety data package for MON 810, the robust weight of evidence demonstrating both its safety and benefits, and the history of safe use of MON 810 for 15 years in the EU, indicates that focussing the General Surveillance of MON 810 on literature searches and farmer complaint systems would be appropriately protective. This will

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Annual post‐market environmental monitoring (PMEM) report on the cultivation of genetically modified maize MON 810 in 2014 from Monsanto Europe S.A.

Cited by 9 publications

References 36 publications

Assessment of genetically modified cotton GHB614 × LLCotton25 × MON 15985 for food and feed uses, under Regulation (EC) No 1829/2003 (application EFSA‐GMO‐NL‐2011‐94)

Assessment of genetically modified cotton GHB614 × LLCotton25 × MON 15985 for food and feed uses, under Regulation (EC) No 1829/2003 (application EFSA‐GMO‐NL‐2011‐94)

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

Results from ten years of post-market environmental monitoring of genetically modified MON 810 maize in the European Union

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