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Risk Assessment generated by a regulatory process
(RA)
last updated: 17 Apr 2026
Risk assessment of corn event MON89034 x MON88017 - Technical Opinion No. 3045/2011.
EN
15 Sep 2011
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Competent National Authority:National Technical Biosafety Commission ()Setor Policial Sul -SPO Área 5 Quadra 3 Bloco B - Térreo Salas 10 à 14Brasília, DF
CEP - 70610-200, BrazilPhone: (5561) 3411-5516,Fax: (5561) 3317-7475,Email: ctnbio@mct.gov.br,Website: http://www.ctnbio.gov.br,
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Organization:Monsanto do Brasil Ltda ()Private sector (business and industry)Geraldo Ubirajara Berger Avenida das Nações Unidas, 12901 - Torre Norte - 7º andarSao Paulo, SP
04578-000, BrazilPhone: +55(11) 3383-8356,Fax: +55(11) 3383-8102 ; +55 (61) 3245-2523,Email: geraldo.u.berger@monsanto.com,Website:
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MON-89Ø34-3 × DAS-Ø15Ø7-1 × MON-88Ø17-3 - Insect resistant, herbicide tolerant maize| Monsanto | Resistance to diseases and pests (Insects, Coleoptera (beetles), Lepidoptera (butterflies and moths)), Resistance to herbicides (Glufosinate, Glyphosate)
- Commercial release 3045-2011.pdf [ Portuguese ]
MON 89034 × MON 88017 maize is the result of a conventional cross between MON 89034 maize and MON 88017 maize using classical genetic improvement techniques. MON 89034 corn was approved by CTNBio in October/2009 (EPT 2052/2009) and MON 88017 corn was approved in December/2010 (EPT 2764/2010). Abroad, the combination of the two individual events is approved in the United States, Argentina (2010), Japan (2008), Mexico (2010), South Korea (2009), the Philippines (2009) and Taiwan (2009). It also received approval from the European Food Safety Authority (EFSA) for use in the European Union in March 2010. MON 89034 corn produces Cry1A.105 and Cry2Ab2 proteins derived from B. thuringiensis, which are active against lepidopteran pests that are important in this culture. MON 88017 corn produces the enzyme 5-enolpyruvylshikimate-3-phosphate synthase from Agrobacterium sp. strain CP4 (CP4 EPSPS), distinct from the other EPSPS of plants because it does not is inhibited by the herbicide glyphosate, thereby conferring tolerance to glyphosate. This event also produces the modified Cry3Bb1 protein from Bacillus thuringiensis subsp. kumamotoensis that selectively controls target beetles, such as the larvae of Coleoptera of the genus Diabrotica, which are soil pests in corn.
The CP4 EPSPS protein, in turn, belongs to the family of 5 enolpyruvylshikimate-3-phosphate (EPSP) synthases, which are enzymes involved in the shikimate biochemical pathway. This pathway produces aromatic amino acids in the chloroplasts of plants and microorganisms. The modes and sites of biological activity are different for Cry and CP4 EPSPS proteins. The Cry proteins act in the cytoplasm and the CP4 EPSPS protein is targeted to the chloroplast. There is no known or possible mechanism for interaction between these proteins that could lead to an adverse effect on animal and human health.
The results obtained indicated that the resistance characteristic does not interfere with the visitation of non-target organisms in MON 89034 × MON 88017 corn. The data presented also confirm the numerous results obtained so far, in more than a decade, which demonstrate that the transgenic crops Insect resistant insects do not adversely affect the diversity of non-target insects including predators, parasitoids and other ecologically important non-target insects.
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 MON 89034 × MON 88017 corn is substantially equivalent to conventional corn, and its consumption is safe for human and animal health.
Studies were carried out to characterize the potential for interaction between Cry proteins. In a first study, the purified proteins Cry1A.105 and Cry2Ab2 were tested alone and in combination, in bioassays with incorporation of the same in the diet, against two species of sensitive lepidopterans, the European corn borer (Ostrinia nubilalis) and the caterpillar of the cob (Helicoverpa zea). The data were consistent with those of a previous study, showing additive insecticidal activity and no interaction. A second study was carried out to characterize the potential for interaction between the proteins Cry1A.105 and Cry2Ab2 active against lepidopterans and the protein Cry3Bb1 active against coleopterans. The combined activity of Cry1A.105 and Cry2Ab2 proteins tested in bioassays using an artificial diet against the European corn borer and the caterpillar of the spike, was not significantly altered by the presence of Cry3Bb1 protein. Likewise, the activity of the Cry3Bb1 protein tested in bioassays using diet artificial against the Colorado potato beetle (Leptinotarsa decemlineata), was not altered by the presence of Cry1A.105 and/or Cry2Ab2 proteins. Based on these results, it is concluded that there is no interaction between Cry1A.105/Cry2Ab2 and Cry3Bb1 proteins that could result in changes in their activities. functional.
The applicant presented the results of a study carried out in Santo Antonio do Leste, MT and in São Desidério, BA (FREIRE, 2012), where no statistical differences were detected between the phenological, morphological and productive components between unmodified cotton, the individual GlyTol and LibertyLink events, and the combined GTxLL event. The evaluated parameters indicated that the combination of individual events, by crossing and selection, did not change the specificity of the genes and did not result in pleiotropic or epistatic effects. The parameters of moisture, crude protein, lipids, ash, carbohydrates, fibers, minerals, vitamins and antinutrients were analyzed, comparing samples of GTxLL cotton with the parental and with unmodified cotton. Comparing the GTxLL cotton data in relation to the parents GHB614 and LLCotton25, the results showed that there are some differences between the means for the compounds of ash, calcium, α-tocopherol, free gossypol, total gossypol, phytic acid, dihydrosterculic acid and potassium.
The cultivation and consumption of MON 89034 × MON 88017 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.
The phenotypic and agronomic observations carried out allowed us to conclude that MON 89034 × MON 88017 corn, with the exception of the characteristics determined by genetic modification, does not differ from control corn and, therefore, does not present environmental risks, greater potential as a weed or increase in gene flow for conventional maize or sexually compatible species.
Molecular traddiciional methods.
Yes
Yes
Yes
EN
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| Country's Decision or any other Communication | Risk assessment | 1 | |
