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Évaluation des risques générée par un processus de réglementation (RA)
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last updated: 28 avr. 2026
Informations générales
Risk assessment of corn event MON97411 - Technical Opinion No. 5162/2016.
EN
01 sept. 2016
Détails de l’évaluation des risques
  • MON-87411-9 - Herbicide-tolerant and insect-resistant maize
    | Monsanto | Résistance aux maladies et aux parasites (Insectes, Coléoptères, Chrysomèle occidentale des racines du maïs (Diabrotica virgifera), Chrysomèle des racines du maïs (Diabrotica barberi)), Résistance aux herbicides (Glyphosate)
MON 87411 corn was developed by transformation with Agrobacterium tumefaciens and has protection against Diabrotica spceciosa (Coleoptera: Chrysomelidae), a root system pest, and tolerance to the herbicide glyphosate. In one of the expression cassettes, in tandem repeated sequences homologous to the Snf7 gene of Diabrotica virgifera virgifera (DvSnf7) were inserted, which leads to the formation of a 240 bp dsRNA of the DvSnf7 gene, leading to the suppression of gene expression by RNAi in the target pest. Another cassette contains the cry3Bb1 gene from Bacillus thuringiensis, which encodes the Cry3Bb1 protein, which confers protection against root pests. The third cassette promotes the expression of the cp4epsps gene from Agrobacterium sp, conferring resistance to glyphosate. Therefore, MON 87411 corn presents resistance to Diabrotica speciosa larvae and tolerance to glyphosate.
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Méthode et points à examiner
Studies were carried out investigating the food safety of MON87411 maize, the proteins Cry3Bb1 and CP4 EPSPS, and the repeated sequence dsRNA DvSnf7. There is a large volume of information accumulated in recent years on the food safety of donor organisms of genes cry3Bb1 and cp4 epsps, Bacillus thuringiensis and Agrobacterium sp strain CP4. Furthermore, these two microorganisms are widely found in nature and human and animal exposure to them has no potential to cause adverse effects.
EN
Acute toxicity studies were performed in mice with proteins Cry3Bb1 and CP4 EPSPS, which showed no adverse effects even at higher doses. Another relevant fact is the fact that both proteins are rapidly digested in gastric fluids or in drastic pH conditions (they lose more than 95% of their activity in 15 seconds of incubation). Proteins also lose activity by heat treatment – ​​a condition used in cooking food. There is a history of safe consumption of RNAi molecules in plants, including those with homology to genes in humans and animals. Furthermore, there is no evidence that the consumption of nucleic acid molecules is associated with toxicity, including those associated with dsRNA-mediated gene regulation. Considering the studies on the expression level of DvSnf7 dsRNA, the highest level being 73x107 ug/g of dry mass, the potential dietary incorporation by the consumption of foods derived from MON 87411 corn would be 3300 times lower than the Toxicological Threshold value (TTC – Threshold of Toxicological Concern) for compounds that do not raise structural concerns for toxicity. Data indicate negligible levels of exposure to the product and that these are non-toxic. In addition, physiological barriers to RNA would limit the risk to human and animal health from the consumption of DvSnf7 dsRNA present in food products derived from MON87411 maize.
EN
Observations of the abundance of non-target arthropods in an area experimentally planted with MON 87411 maize demonstrate that it does not consistently differ from conventional control maize and the significant differences found were punctual and do not represent characteristics that constitute potential environmental risks, a potential increase in the persistence of the culture as a weed or, even, risk of transference of this characteristic to the conventional population or sexually compatible species.
EN
Food security evaluated by analyzing the proximate composition of ashes, fats, proteins and carbohydrates by calcium of grains and forages of MON87411 corn produced in the 2013/2014 harvest in 6 different locations proved to be equivalent to conventional corns, not impacting food security . In addition, MON87411 corn treated with glyphosate was analyzed in relation to conventional corn for 60 components considered key nutrients. Of these, 12 components showed differences, but these were within the 99% confidence interval of the commercial reference values, i.e., they confirmed the equivalence of corn 87411 in relation to the conventional control.
EN
The results of the analysis of samples from the areas of Dourados (MS) and Campo Verde (MT) regarding the frequency of flow of the cry1Ab gene from MON 810 corn to conventional corn, as a function of the distances between plants, show that the gene flow was decreasing as a function of distance from the pollen source. The occurrence of corn grains expressing the Cry1Ab protein was higher in the Dourados area, reaching 3.03% at 10 meters and 2.00% at 20 meters. At distances of 50 and 100 meters, no corn grains expressing the Cry1Ab protein were found. In the Campo Verde area, it was found 0.25% of grains expressing Cry1Ab at the distance of 10 meters and no grains expressing the protein at the other distances. The results obtained in the 2008/2009 crop are consistent with the literature, as they show a significant reduction in the frequency of gene flow between corn plants at distances above 20 meters from the pollen source, which results in a low frequency of dissemination of the cry1Ab gene.
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CTNBio concluded that MON87411 corn does not potentially cause significant degradation of the environment, keeping the same relationship with the biota as that of conventional corn.
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CTNBio considered that the request complies with the rules and current legislation that aims to guarantee the biosafety of the environment, agriculture, human and animal health, and concluded that MON87411 corn is substantially equivalent to conventional corn, and its consumption is safe for human and animal health.
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Molecular traddicional methods. 
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Partage d’informations avec d’autres bases de données
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