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Risk Assessment generated by a regulatory process
(RA)
last updated: 16 Jun 2026
Risk assessment of cotton event T304-40 & GHB119 - Technical Opinion No. 2795/2011.
EN
17 Feb 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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Person:Bayer S.ARua Domingos Jorge, 1100, Prédio 9504, 3º Andar Bairro SocorroSão Paulo, SP
04779-900, BrazilPhone: +55 (11) 2165-7803,Fax: +55 (11) 2165-7711,Website: http://www.bayerscheringpharma.com.br,Related OrganizationBayer Schering Pharma ()Private sector (business and industry)Rua Domingos Jorge, 1100, Prédio 9504, 3º Andar Bairro SocorroSão Paulo, SP
04779-900, BrazilPhone: +55 (11) 2165-7803,Fax: +55 (11) 2165-7711,Website: http://www.bayerscheringpharma.com.br,
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BCS-GHØØ4-7 × BCS-GHØØ5-8 - TwinLink™ Cotton| Bayer Schering Pharma | Resistance to diseases and pests (Insects, Lepidoptera (butterflies and moths), Cotton bollworm (Helicoverpa spp.), European corn borer (Ostrinia nubilalis), Fall armyworm (Spodoptera frugiperda)), Resistance to herbicides (Glufosinate)
- Commercial release 2795-2011.pdf [ Portuguese ]
The T304-40 x GHB119 cotton, or TwinLink, is the result of the crossing, through classical genetic improvement, of the genetically modified parents T304-40 and GHB119, resulting in a strain that expresses the cry1Ab, cry2Ae and bar genes and, consequently, the crystals proteins Cry1Ab, Cry2Ae and the PAT enzyme. Proteins Cry1Ab and Cry2Ae, derived from the soil bacterium Bacillus thuringiensis (Bt), have biological action on certain insects, allowing plants derived from TwinLink cotton to express the characteristic of self-defense against certain lepidopteran pests, such as curuquerê (Alabama argillacea), earworm (Helicoverpa zea), apple bollworm (Heliothis virenscens), military caterpillar (Spodoptera spp), pink bollworm (Pectinophora gossypiella) and false midge (Pseudoplusia includens). The PAT protein confers tolerance to the herbicide glufosinate ammonium, so that it can be used in doses of agronomic utility in the control of weeds in post-emergence.
The cultivation and consumption of TwinLink cotton, event T304-40 x GHB119, is not potentially causing significant degradation of the environment, or risks to human and animal health.
Events T304-40 and GHB119, as well as their combination (TwinLink Cotton), are substantially equivalent to other cotton varieties, and the inserted DNA or expressed proteins (Cry1Ab, Cry2Ae and PAT) do not pose any significant health risk. human/animal compared to the use of conventional cotton and its by-products in food. Environmental safety aspects were analyzed in a series of studies carried out in Brazil and abroad. Experiments carried out in regions with favorable and representative soil and climate conditions for the cotton crop in Brazil evaluated aspects of reproduction, survival and agronomic aspects compared between genetically modified cotton lines and the conventional variety. The results showed regularity of occurrence of the phenological stages throughout the cycle and similarity of the parameters of growth, development and phenotypic characters between the genetically modified lines and the unmodified isogenic cultivar, so that no additional characteristic was observed that could regulate survival. of genetically modified cotton in the environment, ruling out the possibility of epistatic and pleiotropic effects of the introduced genes.
TwinLink cotton does not potentially cause significant degradation of the environment, keeping a relationship with the biota identical to conventional cotton.
Agronomic evaluations showed no changes in growth parameters, development, reproductive capacity and phenotypic characters between genetically modified cotton plants and the conventional cultivar. Genetically modified plants have been shown to be equally sensitive to biotic stress, so there is no evidence of change in their ability to survive and invasiveness. No direct effect on non-target pests and natural enemies was observed from the cultivation of genetically modified cotton events. No evidence of toxicity of Cry proteins was observed on selected non-target species after incorporation of purified proteins in the diet. Degradability analyzes of Cry proteins show that both reach undetectable values, although at different times, not posing a risk to microbiological and biochemical processes in the soil. Several parameters related to soil microbiota, such as protozoan population, mycorrhizal fungus, carbon and nitrogen biomass and soil respiration rate were not affected. The biodegradability of the roots and shoots of the TwinLink cotton plants was the same compared to the conventional strain. TwinLink cotton sheets showed greater degradability, which does not represent a change in their safety for the soil biota.
Studies carried out in Brazil with events T304-40, GHB119 and TwinLink cotton, grown in regions currently traditional for cotton cultivation (States of Mato Grosso and Bahia) evaluated the parameters of growth, development and phenotypic characters compared to genetically modified lines. (VGM) and the unmodified isogenic cultivar (48) . The results demonstrated the regularity of occurrence of the phenological stages throughout the cycle and the similarity of the parameters of growth, development and phenotypic characters between the VGM and the isogenic unmodified cultivar, which indicates that the attributes that guarantee resistance on some lepidopteran pests and tolerance to the glufosinate ammonium herbicide must not be related to any alteration in metabolic pathways, morphological aspects or in the phenology of the cotton plant, consequently there is no additional characteristic that could regulate the survival of genetically modified events in the environment, ruling out the possibility of occurrence of pleiotropic and epistatic effects of the introduced genes.
TwinLink cotton is substantially equivalent to cotton conventional, and its consumption is safe for human and animal health. Regarding the environment, CTNBio concluded that TwinLink cotton does not potentially cause significant degradation of the environment, keeping with the biota a relationship identical to conventional cotton.
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 TwinLink cotton is substantially equivalent to cotton conventional, and its consumption is safe for human and animal health.
Molecular traddicional methods.
Yes
Yes
Yes
Yes
Yes
EN
| Record type | Field | Record(s) | |
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| Country's Decision or any other Communication | Risk assessment | 1 | |