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Risk Assessment generated by a regulatory process
(RA)
last updated: 17 Apr 2026
Risk assessment of corn event Bt11 x GA21, Technical Opinion - 2040/2009.
EN
17 Sep 2009
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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 × MON-ØØØ21-9 - YieldGard™ Roundup Ready™ maize| Resistance to diseases and pests (Insects, Lepidoptera (butterflies and moths), European corn borer (Ostrinia nubilalis)), Resistance to herbicides (Glufosinate, Glyphosate)
- Commercial release 2040-2009.pdf [ Portuguese ]
Maize containing the Bt11 event was obtained by direct DNA transfer into protoplasts of the H8540 maize lineage by inserting the pZO1502 plasmid containing the cry1Ab and pat genes. The expression product of the Cry1Ab gene is the Cry1Ab protein, which exerts insecticidal activity on target pests, protecting plants from damage caused by them. The cry1Ab gene was isolated from the bacterium B. thuringiensis subspecies kurstaki strain HD-1. The pat gene is derived from Streptomyces viridochromogenes strain Tu494 and is responsible for encoding the enzyme phosphinothricin N-acetyltransferase (PAT). This enzyme is capable of chemically inactivating herbicides derived from phosphinothricin, such as glufosinate ammonium, making cells and plants that contain them resistant. The PAT enzyme has described and well-known activity.
The mode of action and the biological activities of the mEPSPS and Cry1Ab proteins expressed in Bt11 x GA21 maize are distinct and do not have known mechanisms of interaction that could cause adverse effects on human and animal health, nor on tenvironment.
Studies presented by the applicant showed that there was no significant difference between corn hybrids derived from unmodified lines and Bt11 x GA21 corn with respect to agronomic characteristics, mode of reproduction, dissemination or survival capacity. All the evidence presented in the process and in 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 Bt11 x GA21 corn are not potentially causing significant environmental degradation or risks to human and animal health.
In the process of risk analysis of genetically modified raw materials, it is possible to conclude that Bt11 x GA21 corn is as safe as its conventional equivalents. within the scope of powers conferred on it by art. 14 of Law 11,105/05, CTNBio considered that the request complies with the current rules and legislation that aim to guarantee the biosafety of the environment, agriculture, human and animal health and concluded that Bt11 x GA21 is substantially equivalent to conventional corn, and its consumption is safe for human and animal health. Regarding the environment, CTNBio concluded that the cultivation of Bt11 x GA21 corn is not potentially a cause of significant degradation. of the environment, keeping with the biota the same relationship as that of conventional cotton.
The safety of proteins Cry1Ab and EPSPS were duly evaluated by CTNBio and the mode of action of protein Cry1Ab is well explained in the scientific literature (5, 6). In vitro experiments were used to evaluate the increase in digestibility of foods containing Cry1Ab and mEPSPS proteins after preheating. This study demonstrated that preheating increases the digestibility of the protein in simulated gastric and intestinal fluids, suggesting that the probability of an eventual allergenicity potential of the Cry1Ab protein is extremely low, due to the ease of digestion (12). Additionally, in vivo and in vitro studies confirmed that Cry1Ab proteins expressed in B. thuringiensis and Bt11 x GA21 maize are highly selective and do not act on mammals.
The agronomic parameters in pest control of Bt11 corn hybrids were compared with agronomic assay lines in 5 locations: Uberlândia-MG, Ituiuta-MG, Iraí de Minas-MG and Pinhalzinho-SC, in the 2005/06 crop. Plant height, ear insertion height, date of male and female cement flowers, degree of erect plants, grain type, grain color, moisture content, yield and burnt grains were the parameters studied in agronomic estimates. For the diligence study of the Bt11 event in the control of lepidopteran pests, the fall armyworm (S. frugiperda) was damaged; of corn stalk borer (D. saccharalis) and earworm (H. zea).
The cultivation and consumption of Bt11 x GA21 maize are not potentially causing significant environmental degradation or risks to human and animal health.
CTNBio considered that the request complies with the current rules and legislation that aim to guarantee the biosafety of the environment, agriculture, human and animal health and concluded that Bt11 x GA21 is substantially equivalent to conventional corn, and its consumption is safe for human and animal health.
Molecular traddicional methods.
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EN
| Record type | Field | Record(s) | |
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| Country's Decision or any other Communication | Risk assessment | 1 | |
