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Évaluation des risques générée par un processus de réglementation
(RA)
last updated: 28 avr. 2026
Risk assessment of cotton, event 281-24-236 & 3006-210-23, Technical Opinion 1757/2009.
EN
19 mars 2009
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Autorité nationale compétente :National Technical Biosafety Commission ()Setor Policial Sul -SPO Área 5 Quadra 3 Bloco B - Térreo Salas 10 à 14Brasília, DF
CEP - 70610-200,Téléphone : (5561) 3411-5516,Télécopieur : (5561) 3317-7475,E-mail : ctnbio@mct.gov.br,Site Web : http://www.ctnbio.gov.br,
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Organisation :Dow AgroSciences Industrial Ltda. ()Secteur privé (affaires et industrie)Rua Alexandre Dumas 1671 1º andar Ala ASao Paulo, SP
04717-903,Téléphone : +55 (16) 3690-1521; +55 (16) 3690-1500,Télécopieur : +55(16) 3690-1599,E-mail : mjvonzuben@dow.com,Site Web :
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DAS-24236-5 × DAS-21Ø23-5 - WideStrike™ cotton| Résistance aux maladies et aux parasites (Insectes, Chenille tisseuse (papillons et mites))
- Commercial release 1757-2009.pdf [ Portugais ]
WideStrike Cotton was obtained by backcrossing (“pyramiding”) between events 281-24-236, containing the synthetic gene cry1F, which encodes the synthetic protoxin Cry1F, and event 3006-210-23 containing the synthetic gene cry1Ac, which encodes the Cry1Ac synthetic protoxin. Both are crystallized insecticidal proteins also referred to as delta-endotoxins, obtained from Bacillus thuringiensis var aizawai strain PS811 and from Bacillus thuringiensis var. kurstaki strain HD73, respectively. In addition of insect resistance by the action of the genes cry1F and cry1Ac, the WideStrike event also presents resistance to the herbicide glufosinate ammonium due to the presence of two copies of the pat gene, which encodes the enzyme phosphinothricin acetyltransferase (PAT). The pat gene is a synthetic version based on the natural pat gene from Streptomyces viridochromogenes. Events Cry1F 281-24-236 and Cry1Ac 3006-210-23 were obtained through the transformation by
Agrobacterium tumefaciens from the cotton cultivar 'Germain's Acala GC510' (Gossypium hirsutum L.). Each event was later backcrossed to the PSC355 genotype (Phytogen Seed Company). The first generations (F1) of these crosses from each event were backcrossed by three additional generations to PSC355, to create a BC3F1 strain from each event. The two BC3F1 transgenic lines were crossed to obtain the Cry1F/Cry1Ac pyramided cotton line that was finally used in the final commercial product.
Agrobacterium tumefaciens from the cotton cultivar 'Germain's Acala GC510' (Gossypium hirsutum L.). Each event was later backcrossed to the PSC355 genotype (Phytogen Seed Company). The first generations (F1) of these crosses from each event were backcrossed by three additional generations to PSC355, to create a BC3F1 strain from each event. The two BC3F1 transgenic lines were crossed to obtain the Cry1F/Cry1Ac pyramided cotton line that was finally used in the final commercial product.
Information indicates that transgenic plants do not fundamentally differ from untransformed cotton genotypes, with the exception of insect resistance. Additionally, there is no evidence of adverse reactions to the use of Widestrike Cotton event 281-24-236/3006-210-23. For these reasons, there are no restrictions on the use of this cotton or its derivatives, whether for human or animal consumption.
Numerous experiments experimenting with Bt proteins demonstrate the absence of toxicity to man and vertebrate animals, absence of adverse effects to non-target organisms and the environment. The cotton pyramid events 281-24-236/3006-210-23 were field tested in 1999, 2000, 2001 and 2002, being evaluated until today in the main cotton growing regions in the United States, Costa Rica, Argentina, Australia , Mexico, Spain and China. An experiment in Brazil was carried out in the 2005/6 harvest. Data and information related to agronomic characteristics, pest and disease resistance were collected during these tests. Such reports inform that events 281-24-236/3006-210-23 do not exhibit plant pathogenic properties and are unlikely to harm other insects that are beneficial to the plant. agriculture. There is no evidence or indication that Bt proteins Cry1F and Cry1Ac increase the potential of the transformed cotton plant to act as an invasive plant, since its phenology, morphology, and several other agronomic aspects were not altered. Therefore, according to the results obtained and presented in the Cotton Biosafety report, it is unlikely that cotton events 281-24-236/3006-210-23 will become agricultural weeds or invasive of natural habitats; interbreed with wild relatives or create hybrid offspring that can become weeds or invasive despite the genetic compatibility between these species
Cotton event 281-24-236/3006-210-23 contributes to reducing the use of insecticides and, consequently, reduces the impacts of the use of these pesticides on the environment, human and animal health.
The Widestrike technology event 281-24-236/3006-210-23 proved to be capable of being used under all agricultural practices commonly used in different regions and conditions, whether
availability of inputs, labor, among others, used in cotton cultivation.
availability of inputs, labor, among others, used in cotton cultivation.
The data sent by the applicant proved that heterologous proteins are present in very low amounts in the most varied tissues, an excellent indication of the safety of the proteins. recombinants for humans as they are clearly distinct from those typically presented by allergenic proteins. Generally, allergenic proteins are reserve proteins from plant organs or tissues, proteins related to pathogens or stress and, in addition, are abundant proteins, being present in high levels in plant tissues. The experiments also proved that genetically modified cotton plants do not showed morphological, phenological or architectural changes and that there was no effect of gene insertion on fiber quality. With the exception of tolerance to target insects throughout the season, genetically modified cotton plants showed equivalence in all phenotypic and agronomic traits analyzed in relation to the pattern demonstrated by
untransformed parental line and by other varieties used in commercial production. The analysis of the documents presented allows us to conclude that the cultivation of cotton event 281-24- 236/3006-210-23 will not cause changes in the soil and its ecological and functional relationships different from those caused by conventional varieties. In addition, the studies carried out showed no changes in the main components and natural antinutrients present in cotton. The safety of transgenic cotton food products was determined by the equivalence in the composition of macro and micronutrients in
animal health studies. It was concluded that this product, as a component of animal feed and the recombinant proteins expressed in plant tissues, proved to be safe and with equivalent nutritional value for human and animal consumption. The quality and composition analyzes of cotton seed event 281-24-236/3006-210-23 showed that the properties of genetically modified cotton and its processed fractions were comparable to those of conventional cotton.
untransformed parental line and by other varieties used in commercial production. The analysis of the documents presented allows us to conclude that the cultivation of cotton event 281-24- 236/3006-210-23 will not cause changes in the soil and its ecological and functional relationships different from those caused by conventional varieties. In addition, the studies carried out showed no changes in the main components and natural antinutrients present in cotton. The safety of transgenic cotton food products was determined by the equivalence in the composition of macro and micronutrients in
animal health studies. It was concluded that this product, as a component of animal feed and the recombinant proteins expressed in plant tissues, proved to be safe and with equivalent nutritional value for human and animal consumption. The quality and composition analyzes of cotton seed event 281-24-236/3006-210-23 showed that the properties of genetically modified cotton and its processed fractions were comparable to those of conventional cotton.
Based on the data presented by the applicant, as well as independent studies consulted in the literature and considering the internationally accepted criteria in the process of risk analysis of genetically modified raw materials, based on the concept of substantial equivalence, it is possible to conclude that event 281- 24-236/3006-210-23 is as safe for human and animal consumption as its conventional equivalent.
Event Cotton 281-24-236/3006-210-23 is so safe for human and animal consumption
than its conventional equivalent. All possible interactions between Cry1F, Cry1Ac and PAT proteins were evaluated in order to estimate possible unpredictable interactions that could cause adverse effects to humans and animals and all results supported the initial evidence that stacked cotton is
safe from a food point of view. Cotton event 281-24-236/3006-210-23 contributes to reducing the use of insecticides and consequently, it reduces the impacts of the use of these pesticides on the environment, health and human and animal.
than its conventional equivalent. All possible interactions between Cry1F, Cry1Ac and PAT proteins were evaluated in order to estimate possible unpredictable interactions that could cause adverse effects to humans and animals and all results supported the initial evidence that stacked cotton is
safe from a food point of view. Cotton event 281-24-236/3006-210-23 contributes to reducing the use of insecticides and consequently, it reduces the impacts of the use of these pesticides on the environment, health and human and animal.
Molecular traddicional methods.
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Oui
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FR
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