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Risk Assessment generated by a regulatory process
(RA)
last updated: 28 Apr 2026
Risk assessment of corn event Bt11xMIR162xMIR604xGA21 and MIR604 - Technical Opinion No. 4207/2014.
EN
04 Sep 2014
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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:Syngenta Seeds Ltda. ()Lilian Aguiar Saldanha Rodovia BR-452, Km 142 + 543m.Uberlândia, MG
38405-232, BrazilPhone: +55(11) 5643-6747,Fax: +55(11) 5643-6750 ; 5643-6750,Email: lilian.saldanha@syngenta.com,Website:
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SYN-BTØ11-1 × SYN-IR162-4 × SYN-IR6Ø4-5 × MON-ØØØ21-9 - Agrisure Viptera® 4 Maize| Resistance to diseases and pests (Insects, Coleoptera (beetles), Western corn rootworm (Diabrotica virgifera), Lepidoptera (butterflies and moths), European corn borer (Ostrinia nubilalis)), Resistance to herbicides (Glufosinate, Glyphosate), Selectable marker genes and reporter genes
- Commercial release 4207-2014 (2).pdf [ Portuguese ]
Bt11xMIR162xMIR604xGA21 corn was developed through classical genetic improvement, by sexual cross between genetically modified lines containing the combined event Bt11xMIR162xGA21, already approved for commercial release, and a line containing the event MIR604, also subject to evaluation for commercial approval in this process. Information regarding the number of inserted copies of the gene; nucleotide sequence of the transgene inserted in the GMO, indicating the regulatory elements present - promoters, regulatory elements in cis, polyadenylation sites, introns and exons and transcription termination region of the individual events Bt11, MIR162 and GA21, already approved, are in their respective commercial release request processes1, in which demonstrate: (1) only one copy of the genes inserted into their respective individual events. (2) absence of any structural sequence from the transformation plasmids. T-DNA sequence analyzes present in Events Bt11, MIR162, GA21 confirmed that the insert was intact and that the contiguity of the functional elements was maintained.
Based on the exposed results, no change in performance or physiological and/or morphological variation was verified in the animals tested when fed with MIR604 corn. Likewise, no adverse effect on animals is expected when fed with Bt11xMIR162xMIR604xGA21 corn, since the proteins are expressed at the same level as in the individual events that compose it and the compositional profile of the Combined maize does not differ from conventional maize.
The agronomic and phenotypic characteristics of Bt11xMIR162xMIR604xGA21 maize were evaluated in comparison to conventional isogenic maize and commercial conventional hybrids in order to identify any unintentional alteration that could turn the referred maize into a weed. Bt11xMIR162xMIR604xGA21 corn was compared with its conventional isogenic (control) and seven more conventional hybrids were also employed to provide a range of values common to commercial corn hybrids. The studies were conducted in field experiments, in 6 representative cultivation locations in Brazil: Cruz Alta-RS, Holambra-SP, Uberlândia-MG, Ituiutaba-MG, Formosa-GO and Lucas do Rio Verde-MT. Nine phenotypic and agronomic characteristics were evaluated during the experiment: male flowering, female flowering, foliar diseases, plant height, height of insertion of the ear, percentage of erect plants at harvest, grain texture, grain color and grain yield. The experiment was conducted in randomized blocks with 3 replications.
Bt11xMIR162xMIR604xGA21 corn is as safe as its conventional counterparts, and does not potentially cause significant degradation to the environment or human and animal health.
The concentration of Cry1Ab, PAT, Vip3Aa20, PMI, mCry3A and mEPSPS proteins present in Bt11xMIR162xMIR604xGA21 corn was determined by ELISA immunoassays in different tissues (leaf, root, whole plant, pollen and grain) and in two developmental stages (anthesis and maturity) of plants cultivated in Brazil. For most tissues analyzed at different stages of development, there was no difference. statistically significant difference between the expression of each of the proteins expressed in Bt11xMIR162xMIR604xGA21 maize and in maize containing the events alone. The expression of six proteins analyzed (Cry1Ab, PAT, Vip3Aa20, mCry3A, PMI and mEPSPS) for the five different tissue types (leaf, root, whole plant, pollen and grain) in maize Bt11xMIR162xMIR604xGA21 was consistently similar to the expression of events when resented individually in maize, ie, Bt11 maize, GA21 maize, MIR162 maize and MIR604 maize. In this way, the human, animal and environmental health risk assessments performed previously for these events can be applied to maize with these events combined. The only statistically significant differences found between the mean protein concentration in the Bt11xMIR162xMIR604xGA21 hybrid and their respective single-event hybrids were in whole plant and grain tissues for Vip3Aa20 protein and leaves for mCry3A. Even so, the expression of these proteins was lower in maize with the combined events.
Field studies for the evaluation of agronomic and phenotypic characteristics carried out in six locations in Brazil proved that the event Bt11xMIR162xMIR604xGA21 presents the same performance as the conventional isogenic, with the same genetic background, proving the absence of potential to become a weed. Additionally, insect efficacy assays were carried out in field plots that were infested with populations of Diabrotica speciosa and Spodotera fugiperda and proved the efficiency of Bt11xMIR162xMIR604xGA21 corn in controlling the main pests of corn. Likewise, this combined corn maintained tolerance to glufosinate ammonium herbicides and glyphosate, as expected.
Corn with the combination Bt11xMIR162xMIR604xGA21 does not have a significant impact on the environment. In addition, no botanical changes were found that could confer adaptive advantages to maize with the combination Bt11xMIR162xMIR604xGA21.
CTNBio considers that this activity does not potentially cause significant degradation of the environment or harm to human and animal health.
Molecular traddicional methods.
Yes
Yes
Yes
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Yes
EN
| Record type | Field | Record(s) | |
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| Country's Decision or any other Communication | Risk assessment | 1 | |
