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Evaluación del riesgo generada por un proceso regulatorio
(RA)
last updated: 17 abr. 2026
Risk assessment of corn event MON89034 & NK603 - Technical Opinion No. 2725/2010.
EN
18 nov. 2010
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Autoridad Nacional Competente:National Technical Biosafety Commission ()Setor Policial Sul -SPO Área 5 Quadra 3 Bloco B - Térreo Salas 10 à 14Brasília, DF
CEP - 70610-200, BrasilTeléfono: (5561) 3411-5516,Fax: (5561) 3317-7475,Correo electrónico: ctnbio@mct.gov.br,Sitio web: http://www.ctnbio.gov.br,
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Organización:Monsanto do Brasil Ltda ()Sector privado (comercio e industria)Geraldo Ubirajara Berger Avenida das Nações Unidas, 12901 - Torre Norte - 7º andarSao Paulo, SP
04578-000, BrasilTeléfono: +55(11) 3383-8356,Fax: +55(11) 3383-8102 ; +55 (61) 3245-2523,Correo electrónico: geraldo.u.berger@monsanto.com,Sitio web:
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MON-89Ø34-3 × MON-ØØ6Ø3-6 - Genuity® VT Double Pro™ Maize| Resistencia a los antibióticos (Kanamicina), Resistencia a enfermedades y plagas (Insectos, Lepidoptera (mariposas y polillas)), Resistencia a herbicidas (Glifosato)
- Commercial release 2725-2010.pdf [ Portugués ]
MON89034 corn was produced through the methodology of genetic transformation mediated by Agrobacterium tumefaciens using the binary plasmid PVZMIR245. T-DNA I contains the cry1A.105 and cry2Ab2 genes, while T-DNA II contains the nptII gene, which confers resistance to the antibiotic kanamycin and was used in the initial selection process for transformed cells. Classic genetic improvement technique was used to isolate plants that contained only the genes of interest cry1A.105 and cry2Ab2, but that would be devoid of the nptII gene, thus producing plants free of the selection marker and only with the characteristic of resistance to some pest lepidopterans.
The safety of Cry proteins for animal and human nutrition has been confirmed by several authors. Xu et al.(53) observed that the Cry1Ab/Ac protein was rapidly degraded in gastric and intestinal fluids, and showed no adverse effects in mice submitted to an acute dose of 5 g (Cry1Ab/Ac protein)/kg of body weight. Again it was observed that this protein has no sequence homology with known allergens or toxins, nor N-glycosylation sites, confirming that no harm will result from the inclusion of the Cry1Ab/Ac protein in human food or animal feed.
The studies presented by the applicant demonstrate that there were no significant differences between the genetically modified corn and its conventional isoline with respect to agronomic characteristics, mode of reproduction, dissemination or ability to survive. All the evidence presented in the process and in the bibliographic references confirm the level of risk of the transgenic variety as equivalent to non-transgenic varieties against the soil microbiota, as well as other plants and human and animal health. Thus, the cultivation and consumption of MON 89034 x NK 603 corn are not potentially causing significant environmental degradation or risks to human and animal health.
The mode of action and biological activities of the CP4 EPSPS and Cry proteins expressed in MON 89034 x NK603 corn are distinct and do not have known mechanisms of interaction that could cause adverse effects on human and animal health, tbmnor to the environment.
The results of the experiments carried out in Brazil indicated that there was no substantial variation in the expression levels of Cry1A.105 and Cry2Ab2 proteins between MON 89034 x NK 603 corn and the single event MON 89034 in the evaluated tissues. Although the levels of the CP4 EPSPS protein have also been determined in experiments carried out in Brazil, the comparison of expression levels between the pyramid event MON 89034 x NK 603 and the individual event NK 603 was determined in experiments carried out in 5 locations in Argentina. In these assays, it was also demonstrated that there was no variation in the expression of the CP4 EPSPS protein between the stacked maize and the parental event NK 603. It is concluded from this set of analyzes that the expression levels of heterologous proteins in the genetically modified maize plant MON 89034 x NK 603 is comparable to that observed in the respective parents, with a low expression of these proteins in grains and a higher expression in leaves, being intermediate in forage.
Field studies were carried out in the 2007/2008 harvest in four locations (Rolândia/PR, Cachoeira Dourada/MG, Sorriso/MT and Não-Me-Toque/RS) with the objective of comparing MON 89034 × NK603 maize to conventional control maize. and to references
commercials regarding vigor, initial and final stand, 50% of plants with exposed tassel, 50% of plants with pollen, plant height, ear height, physiological maturity, stay green, grain yield, 1000 grain weight and hectoliter weight . In the same places,
in the 2008/2009 crop, the same agronomic and phenotypic traits were evaluated but now comparing MON 89034 corn, MON 89034 × NK603 corn without glyphosate application and MON 89034 × NK603 corn with glyphosate application to conventional control corn and commercial references . Significant statistical differences were not detected between MON 89034 × NK603 maize and control maize in the 2007/2008 season and between the tested maize (MON 89034 maize, MON 89034 × NK603 maize [without glyphosate] and MON 89034 × NK603 maize [with glyphosate] ]) and control corn in the 2008/2009 crop for none of the evaluated agronomic and phenotypic traits, indicating that the phenotypic traits of MON 89034 × NK603 maize were typical of maize grown in Brazil and, therefore, the potential for MON 89034 maize × NK603 has a plant behavior.
CTNBio considered that the request complies with the norms and legislation in force that aim to guarantee the biosafety of the environment, agriculture, human and animal health, and concluded that Corn MON 89034 x NK 603 is substantially equivalent to conventional corn, and its consumption is safe for human and animal health.
The consumption of MON 89034 x NK 603 corn does not potentially cause significant degradation of the environment, or risks to human and animal health. For this reason, there are no restrictions on the use of this corn or its derivatives.
Molecular traddicional methods.
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