Scientific Opinion on application (EFSA‐GMO‐CZ‐2008‐54) for placing on the market of genetically modified insect resistant and herbicide tolerant maize MON 88017 for cultivation under Regulation (EC) No 1829/2003 from Monsanto

Andersson, Hans; Arpaia, Salvatore; Bartsch, Detlef K.; Casacuberta, Josep; Davies, Howard V.; Jardin, Patrick du; Flachowsky, Gerhard; Herman, Lieve; Jones, Huw; Kärenlampi, Sirpa; Kiss, J.; Kleter, Gijs; Kuiper, H.A.; Messéan, Antoine; Nielsen, Kaare Magne; Perry, J. N.; Pöting, Annette; Sweet, Jeremy; Tebbe, Christoph C.; Wal, J.-M.

doi:10.2903/j.efsa.2011.2428

Cited by 10 publications

(5 citation statements)

References 676 publications

(902 reference statements)

Supporting

Mentioning

Contrasting

Order By: Relevance

“…The Cry3Bb1 protein has been previously assessed by the GMO Panel (e.g. EFSA GMO Panel 2009, 2011c and no safety concerns for humans and animals were identified. Updated bioinformatics analysis did not reveal similarities of the Cry3Bb1 protein to known toxins causing toxicity to humans and animals (except for Coleoptera).…”

Section: Testing Of the Newly Expressed Proteinsmentioning

confidence: 99%

“…The GMO Panel has previously evaluated the safety of the Cry3Bb1 and CP4 EPSPS proteins in the context of other applications and no concerns on allergenicity were identified (e.g. EFSA GMO Panel, 2009, 2011c.…”

Section: Assessment Of Allergenicity Of the Newly Expressed Proteins 49mentioning

confidence: 99%

“…Vazquez et al, 1999). The GMO Panel has previously evaluated the safety of the Cry3Bb1 protein and no concerns on adjuvanticity in the context of the applications assessed were identified (EFSA GMO Panel, 2009, 2011c. From the limited experimental evidence available, the GMO Panel did not find indications that the presence of the Bt protein at the levels expressed in maize MON 87411 might act as adjuvants with the potential to enhance a specific immunoglobulin E (IgE) response and to favour the development of an allergic reaction.…”

Section: Assessment Of Allergenicity Of the Newly Expressed Proteins 49mentioning

confidence: 99%

See 2 more Smart Citations

Assessment of genetically modified maize MON 87411 for food and feed uses, import and processing, under Regulation (EC) No 1829/2003 (application EFSA‐GMO‐NL‐2015‐124)

Naegeli¹,

Birch²,

Casacuberta³

et al. 2018

EFS2

View full text Add to dashboard Cite

Maize MON 87411 was developed to confer resistance to corn rootworms (Diabrotica spp.) by the expression of a modified version of the Bacillus thuringiensis cry3Bb1 gene and a DvSnf7 dsRNA expression cassette, and tolerance to glyphosate‐containing herbicides by the expression of a CP4 5‐enolpyruvylshikimate‐3‐phosphate synthase (cp4 epsps) gene. The molecular characterisation data and bioinformatics analyses did not identify issues requiring assessment for food and feed safety. No statistically significant differences in the agronomic and phenotypic characteristics tested between maize MON 87411 and its conventional counterpart were identified. The compositional analysis of maize MON 87411 did not identify differences that required further assessment except for palmitic acid levels in grains from not treated maize MON 87411. The GMO Panel did not identify safety concerns regarding the toxicity and allergenicity of the Cry3Bb1 and CP4 EPSPS proteins, as expressed in maize MON 87411 and found no evidence that the genetic modification might significantly change the overall allergenicity of maize MON 87411. The nutritional impact of maize MON 87411‐derived food and feed is expected to be the same as those derived from the conventional counterpart and non‐GM commercial reference varieties. The GMO Panel concludes that maize MON 87411, as described in this application, is nutritionally equivalent to and as safe as the conventional counterpart and the non‐GM maize reference varieties tested, and no post‐market monitoring of food/feed is considered necessary. In the case of accidental release of viable maize MON 87411 grains into the environment, maize MON 87411 would not raise environmental safety concerns. The post‐market environmental monitoring plan and reporting intervals are in line with the intended uses of maize MON 87411. The GMO Panel concludes that maize MON 87411, as described in this application, is as safe as its conventional counterpart and the tested non‐GM maize reference varieties with respect to potential effects on human and animal health and the environment.

show abstract

Section: Testing Of the Newly Expressed Proteinsmentioning

confidence: 99%

Section: Assessment Of Allergenicity Of the Newly Expressed Proteins 49mentioning

confidence: 99%

Section: Assessment Of Allergenicity Of the Newly Expressed Proteins 49mentioning

confidence: 99%

See 1 more Smart Citation

Assessment of genetically modified maize MON 87411 for food and feed uses, import and processing, under Regulation (EC) No 1829/2003 (application EFSA‐GMO‐NL‐2015‐124)

Naegeli¹,

Birch²,

Casacuberta³

et al. 2018

EFS2

View full text Add to dashboard Cite

show abstract

“…The lack of statistically significant differences in turn, however, is then deemed by the EFSA panel sufficient to declare the new GM plant comparatively as safe as the non-GM counterparts. But even if significant differences between the measured biochemical compounds are reported that also regularly exceed even historical ranges, these differences are interpreted away as being biologically irrelevant (e.g., see case examples [70][71][72][73]).…”

Section: Including Unrelated Reference 'Controls'mentioning

confidence: 99%

“…The EFSA panel has subsequently used this 'comparative (safety) assessment' step for GM plants and GM food and feed, as an opportunity to declare the many reported statistically significant differences found among the chemical analytical data (called 'compositional analyses' or 'comparative analyses of the composition') to be 'not biological relevant' , so long as the reported values fall within the 'natural variation' of 'traditionally cultivated crops' , i.e., data derived from any non-GM varieties ever analyzed in history as long as they may share common pedigree (e.g., [70][71][72]): "The potential variability in the degree of genetic similarity between the GM plant and its comparator(s) does not necessarily compromise the reliability of the safety assessment, provided that the comparator is genetically "as close as possible" to the GM plant with regard to its breeding pedigree. " [17].…”

Section: Re-introducing the Concept Of 'Substantial Equivalence' Into Eu Risk Assessment By Renaming It A 'Comparative Safety Assessment'mentioning

confidence: 99%

GMO regulations and their interpretation: how EFSA’s guidance on risk assessments of GMOs is bound to fail

Hilbeck¹,

Meyer²,

Wynne

et al. 2020

Environ Sci Eur

View full text Add to dashboard Cite

We identify the origins, and key characteristics, of the current regulatory framework for genetically modified organisms (GMOs) in the European Union (EU). We focus on the approach of the European Food Safety Authority (EFSA) to assessing GMO risks to public and environmental health. An historical account informs our critical appraisal of the current practices of EFSA’s GMO panel, and helps to explain how and why it fails to satisfy the objectives of the EU’s GMO legislation. While those legislative texts set appropriate objectives, their concrete implementation has fallen far short of the legislative goals. EFSA’s prevailing approach to GM crop and food risk assessment starts from what it terms a ‘comparative safety assessment’. Those comparisons require the scrutiny of sets of molecular, chemical and phenotypic data from GM plants and non-GM varieties (many of which may be only remotely related to the GM variety). Those data are, however, inadequate for predicting adverse biological, toxicological and ecological effects. EFSA’s ‘comparative safety assessments’ draw over-optimistic conclusions from too little data from too few studies. When GM products are deemed to have passed a ‘comparative safety assessment’, EFSA has interpreted that as grounds for conducting only very narrowly circumscribed risk assessments, which have not required meaningful data from studies of ecological or eco-toxicological impacts. This is a reductionist approach to risk assessment, when a more inclusive and comprehensive approach, which we outline, is scientifically available, and also more likely to meet the specified legislative aims. Instead, however, the reductionist choice is systematically applied, but never justified nor acknowledged as such. Indeed, it is concealed, by EFSA and by its main policy client the European Commission, as if it were only for specialist expert scientific deliberation. Thus, key questions that sound scientific assessments should ask about potential harm are not even posed, let alone answered—or at least, they are ‘answered’ only by default, given that the implicit burden of proof requires harm to be demonstrated. Furthermore, and a key point of this paper, we show how the problematic features of EFSA’s approach have been premised on a set of evaluative policy judgements, rather than purely scientific considerations. Responsibility for selecting how EFSA frames its scientific approach should however lie with European Commission risk managers, and not with EFSA. These problems might have been and could be avoided if explicit commitments entered into by the EU at the Codex Alimentarius Commission were implemented by the European Commission and EFSA were instructed accordingly.

show abstract

Resistance evolution to the first generation of genetically modified Diabrotica-active Bt-maize events by western corn rootworm: management and monitoring considerations

et al. 2012

View full text Add to dashboard Cite

Western corn rootworm (Diabrotica virgifera virgifera; WCR) is a major coleopteran maize pest in North America and the EU, and has traditionally been managed through crop rotation and broad-spectrum soil insecticides. Genetically modified Bt-maize offers an additional management tool for WCR and has been valuable in reducing insecticide use and increasing farm income. A concern is that the widespread, repeated, and exclusive deployment of the same Bt-maize transformation event will result in the rapid evolution of resistance in WCR. This publication explores the potential of WCR to evolve resistance to plant-produced Bt-toxins from the first generation of Diabrotica-active Bt-maize events (MON 863 and MON 88017, DAS-59122-7 and MIR604), and whether currently implemented risk management strategies to delay and monitor resistance evolution are appropriate. In twelve of the twelve artificial selection experiments reported, resistant WCR populations were yielded rapidly. Field-selected resistance of WCR to Cry3Bb1 is documented in some US maize growing areas, where an increasing number of cases of unexpected damage of WCR larvae to Bt-maize MON 88017 has been reported. Currently implemented insect resistance management measures for Bt-crops usually rely on the high dose/refuge (HDR) strategy. Evidence (including laboratory, greenhouse and field data) indicates that several conditions contributing to the success of the HDR strategy may not be met for the first generation of Bt-maize events and WCR: (1) the Bt-toxins are expressed heterogeneously at a low-to-moderate dose in roots; (2) resistance alleles may be present at a higher frequency than initially assumed; (3) WCR may mate in a non-random manner; (4) resistance traits could have non-recessive inheritance; and (5) fitness costs may not necessarily be associated with resistance evolution. However, caution must be exercised when extrapolating laboratory and greenhouse results to field conditions. Model predictions suggest that a 20 % refuge of non-Diabrotica-active Bt-maize can delay resistance evolution in WCR under certain conditions. This publication concludes that further research is needed to resolve the remaining scientific uncertainty related to the appropriateness of the HDR in delaying resistance evolution in WCR, resistance monitoring is essential to detect early warning signs indicating resistance evolution in the field, and that integrated pest management reliant on multiple tactics should be deployed to ensure effective long-term corn rootworm management and sustainable use of Bt-maize.

show abstract

Scientific Opinion on application (EFSA‐GMO‐CZ‐2008‐54) for placing on the market of genetically modified insect resistant and herbicide tolerant maize MON 88017 for cultivation under Regulation (EC) No 1829/2003 from Monsanto

Cited by 10 publications

References 676 publications

Assessment of genetically modified maize MON 87411 for food and feed uses, import and processing, under Regulation (EC) No 1829/2003 (application EFSA‐GMO‐NL‐2015‐124)

Assessment of genetically modified maize MON 87411 for food and feed uses, import and processing, under Regulation (EC) No 1829/2003 (application EFSA‐GMO‐NL‐2015‐124)

GMO regulations and their interpretation: how EFSA’s guidance on risk assessments of GMOs is bound to fail

Resistance evolution to the first generation of genetically modified Diabrotica-active Bt-maize events by western corn rootworm: management and monitoring considerations

Contact Info

Product

Resources

About