Applications (EFSA‐GMO‐RX‐MON810) for renewal of authorisation for the continued marketing of (1) existing food and food ingredients produced from genetically modified insect resistant maize MON810; (2) feed consisting of and/or containing maize MON810, including the use of seed for cultivation; and of (3) food and feed additives, and feed materials produced from maize MON810, all under Regulation (EC) No 1829/2003 from Monsanto

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doi:10.2903/j.efsa.2009.1149

Cited by 16 publications

(10 citation statements)

References 265 publications

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“…In addition, the GMO Panel advised that resistance management strategies continue to be employed and that the evolution of resistance in lepidopteran target pests continues to be monitored, in order to detect potential changes in resistance levels in pest populations (EFSA, 2009 Since 2010, the European Commission requested the GMO Panel to assess the annual PMEM reports on the cultivation of maize MON 810 submitted by the consent holder. The GMO Panel therefore adopted scientific opinions on the 2009, 2010, 2013and revised 2013annual PMEM reports (EFSA GMO Panel, 2011a, 2012a, 2013, 2014a, 2015a. From the data provided in the previous annual PMEM reports, the GMO Panel did not identify adverse effects on human and animal health and the environment resulting from the cultivation of maize MON 810.…”

Section: Discussionmentioning

confidence: 99%

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

Birch¹,

Casacuberta²,

Schrijver³

et al. 2016

EFS2

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However, as the methodology for insect resistance monitoring remained unchanged compared to previous PMEM reports, the GMO Panel reiterates its previous recommendations for improvement of the insect resistance management plan. The GMO Panel considers that the farmer alert system to report complaints regarding product performance could complement the information obtained from the laboratory bioassays, but encourages the consent holder to provide more information in order to be in a position to appraise its usefulness. The data on general surveillance activities 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 2014. The GMO Panel reiterates its previous recommendations to improve the methodology for the analysis of farmer questionnaires and conduct of the literature review in future annual PMEM reports on maize MON 810. The GMO Panel urges the consent holder to consider how to make best use of the information recorded in national registers to optimise sampling for farmer questionnaires, and requests to continue reviewing and discussing relevant scientific publications on possible adverse effects of maize MON 810 on rove beetles. Also, the GMO Panel encourages relevant parties to continue developing a methodological framework to use existing networks in the broader context of environmental monitoring. DOI: https://doi.org/10. 2903/j.efsa.2016.4446 Posted at the Zurich Open Repository and Archive, University of Zurich ZORA URL: https://doi.org/10.5167/uzh-134226 Veröffentlichte VersionOriginally published at: Birch, Nicholas; Casacuberta, Josep; De Schrijver, Adinda; Gathmann, Achim; Gralak, Mikolaj Antoni; Guerche, Philippe; Jones, Huw; Manachini, Barbara; Messéan, Antoine; Naegeli, Hanspeter; Ebbesen Nielsen, Elsa; Nogué, Fabien; Robaglia, Christophe; Rostoks, Nils; Sweet, Jeremy; Tebbe, Christoph; Visioli, Francesco; Wal, Jean-Michel (2016 This is an open access article under the terms of the Creative Commons Attribution-NoDerivs License, which permits use and distribution in any medium, provided the original work is properly cited and no modifications or adaptations are made.The EFSA Journal is a publication of the European Food Safety Authority, an agency of the European Union. The 2014 case-specific monitoring (CSM) dataset on maize MON 810 consists of a survey on compliance with non-Bacillus thuringiensis (non-Bt) refugia in Spain and Portugal, and dose-response and diagnostic dose bioassays to monitor for changes in susceptibility to Cry1Ab in target pests (European and Mediterranean corn borer) collected from Iberian populations. The 2014 PMEM report shows partial non-compliance with the implementation of non-Bt refugia in Spain as observed in previous years. Therefore, the GMO Panel recommends that the consent holder consolidates its efforts to increase the level of compliance, especially in regions of high maize MON 810 uptake, where such compliance is crucial to ensure the effectiveness of the ...

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Section: Discussionmentioning

confidence: 99%

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

Birch¹,

Casacuberta²,

Schrijver³

et al. 2016

EFS2

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“…Also, in-field mitigation measures aim to limit temporal exposure to the potential stressor. To reduce exposure to NTOs, possibly including endangered species, risk mitigation might include the planting of non-GM plants as border rows (EFSA GMO Panel, 2009) or, where feasible, detasseling of GM maize plants in border rows in order to limit Bt maize pollen dispersal outside the field (EFSA GMO Panel, 2010).…”

Section: 2mentioning

confidence: 99%

Coverage of endangered species in environmental risk assessments at EFSA

2016

EFS2

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The EFSA performs environmental risk assessment (ERA) for single potential stressors such as plant protection products, genetically modified organisms and feed additives, and for invasive alien species that are harmful to plant health. This ERA focusses primarily on the use or spread of such potential stressors in an agricultural context, but also considers the impact on the wider environment. It is important to realise that the above potential stressors in most cases contribute a minor proportion of the total integrated pressure that ecosystems experience. The World Wildlife Fund listed the relative attribution of threats contributing to the declines in animal populations as follows: 37% from exploitation (fishing, hunting, etc.), 31% habitat degradation and change, 13% from habitat loss, 7% from climate change, and only 5% from invasive species, 4% from pollution and 2% from disease. In this scientific opinion, the Scientific Committee gathered scientific knowledge on the extent of coverage of endangered species in current ERA schemes that fall under the remit of EFSA. The legal basis and the relevant ecological and biological features used to classify a species as endangered are investigated. The characteristics that determine vulnerability of endangered species are reviewed. Whether endangered species are more at risk from exposure to potential stressors than other nontarget species is discussed, but specific protection goals for endangered species are not given. Due to a lack of effect and exposure data for the vast majority of endangered species, the reliability of using data from other species is a key issue for their ERA. This issue and other uncertainties are discussed when reviewing the coverage of endangered species in current ERA schemes. Potential tools, such as population and landscape modelling and trait‐based approaches, for extending the coverage of endangered species in current ERA schemes, are explored and reported.

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“…According to the available literature, the dose potentially ingested by larvae is assumed to be linearly related to the number of pollen grains present per unit area of leaves of their host plant. Previous risk management recommendations (EFSA, 2009(EFSA, , 2011a(EFSA, ,b, 2012a have focussed on the nettle (Urtica dioica) since it is the host plant of some iconic species of butterflies such as the Peacock (Inachis io) and the Red Admiral (Vanessa atalanta).…”

Section: Scientific Backgroundmentioning

confidence: 99%

“…It is generally agreed that pollen deposition declines with increasing distance from the nearest pollen source, but proposed relationships governing this decline differ (see review by Perry et al, 2013). In particular, for the GMO Panel Scientific Opinions published prior to 2014 (EFSA, 2009(EFSA, , 2011a(EFSA, ,b, 2012a the assumed dose of pollen on host plants within the Bt-maize source crop was almost seven times greater than that assumed under the relationship for mechanical samplers published by Hofmann et al (2014). Furthermore, outside the source crop, the assumed dose was greater than that assumed by Hofmann et al (2014) up to 9 m from the crop edge.…”

Section: Scientific Backgroundmentioning

confidence: 99%

“…EFSA assessed whether the publication contains new information that would change or invalidate its previous risk management recommendations on limiting the exposure of non-target (NT) Lepidoptera of conservation concern potentially occurring in protected habitats, as defined under Directive 2004/35/EC, to maize MON810, Bt11 and 1507 pollen. has quantified the risk to NT Lepidoptera associated with the ingestion of Bt-maize pollen deposited on their host plants through estimates of larval mortality (EFSA, 2009(EFSA, , 2011a(EFSA, ,b, 2012a(EFSA, ,b, 2015 based on mathematical models developed by Perry et al (2010Perry et al ( , 2011Perry et al ( , 2012Perry et al ( , 2013. Based on these model predictions, the GMO Panel provided risk managers with a set of risk mitigation measures (e.g., non-Bt-maize border rows around a Bt-maize crop, isolation distances from protected habitats to nearest Bt-maize field) to limit the exposure of NT lepidopteran larvae to Bt-maize pollen.…”

Section: Introductionmentioning

confidence: 99%

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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

2016

EFSA Supporting Publications

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Cited by 16 publications

References 265 publications

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

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

Coverage of endangered species in environmental risk assessments at EFSA

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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