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Évaluation des risques générée par un processus de réglementation
(RA)
last updated: 17 avr. 2026
Risk assessment of cotton event MON88913, Technical Opinion 2956/2011.
EN
16 juin 2011
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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, BrésilTéléphone : (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 :Monsanto do Brasil Ltda ()Secteur privé (affaires et industrie)Geraldo Ubirajara Berger Avenida das Nações Unidas, 12901 - Torre Norte - 7º andarSao Paulo, SP
04578-000, BrésilTéléphone : +55(11) 3383-8356,Télécopieur : +55(11) 3383-8102 ; +55 (61) 3245-2523,E-mail : geraldo.u.berger@monsanto.com,Site Web :
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MON-88913-8 - Roundup Ready™ Flex™ cotton| Monsanto | Résistance aux herbicides (Glyphosate)
- Commercial release 2956-2011.pdf [ Portugais ]
MON 88913 cotton was produced using Agrobacterium tumefaciens-mediated transformation system. The Agrobacterium strain ABI, which carries the plasmid PV-GHGT35, was
co-cultured with cotton seedling hypocotyl explants in vitro, which were then used to produce cotton somatic embryogenic callus containing the transferred T-DNA sequence. Calli were selected in vitro for the traits of interest by incorporating glyphosate into the culture medium. MON 88913 cotton was selected in vitro using glyphosate as a selective agent in the culture medium, while MON 1445 cotton was selected in vitro using the antibiotic kanamycin as a selective agent in the culture medium. The glyphosate-tolerant calluses generated somatic embryos that germinated and developed into plants that were subsequently tested in growth chambers, greenhouses and field experiments, until the definition of the lead event that would be regulated. MON 88913 cotton (MON 88913 event) comes from a single cell transformed by Agrobacterium that was later regenerated in a plant and selected for the trait of interest (glyphosate tolerance).
co-cultured with cotton seedling hypocotyl explants in vitro, which were then used to produce cotton somatic embryogenic callus containing the transferred T-DNA sequence. Calli were selected in vitro for the traits of interest by incorporating glyphosate into the culture medium. MON 88913 cotton was selected in vitro using glyphosate as a selective agent in the culture medium, while MON 1445 cotton was selected in vitro using the antibiotic kanamycin as a selective agent in the culture medium. The glyphosate-tolerant calluses generated somatic embryos that germinated and developed into plants that were subsequently tested in growth chambers, greenhouses and field experiments, until the definition of the lead event that would be regulated. MON 88913 cotton (MON 88913 event) comes from a single cell transformed by Agrobacterium that was later regenerated in a plant and selected for the trait of interest (glyphosate tolerance).
The safety of the CP4 EPSPS protein was evaluated for potential toxicity to humans and animals. The potential toxicity assessment of the CP4 EPSPS protein in MON 88913 cotton was based on the premise that a protein is not toxic if: (a) it has a history of safe use, (b) there is no structural similarity to known toxins or other biologically active proteins. that may cause adverse effects in humans or animals and (c) have no acute toxic effects on mammals.
In terms of environmental safety, the results of the phenotypic and agronomic evaluations carried out in Brazil corroborated the data generated in the United States, indicating that cotton MON 88913 does not have characteristics that could confer a significantly altered risk of becoming a weed or causing an ecological impact different from conventional cotton. In addition Furthermore, ecological interaction data presented also indicated that MON 88913 cotton does not confer any susceptibility or greater tolerance to diseases and abiotic or insect stresses. It was also verified that MON 88913 cotton has no potential to cause adverse effects to beneficial organisms, plants or non-target organisms. Taken together, the food and environmental safety data for MON 88913 cotton showed that MON 88913 cotton does not pose a risk to human, animal and environmental health when compared to conventional cotton.
In Brazil, the evaluation of colony forming units (CFU) of bacteria, fungi and actinomycetes was carried out in soil samples collected in the 2008/2009 harvest in Cachoeira Dourada/MG and Sorriso/MT. Significant differences were not observed in the comparisons between MON 88913 cotton and control cotton, concluding that the genetic modification in MON 88913 cotton does not cause effects on the soil microbiota. The biodegradability of MON 88913 cotton was evaluated in a study carried out in Brazil. The purpose of this study was to obtain information on the degradation of plant residues collected after physiological maturation, kept on the soil surface for 180 days. The data of the present study, therefore, suggest that the MON 88913 cotton biomass does not present significant changes in terms of its biodegradability when compared to the conventional control cotton biomass, thus not contributing to any environmental change as a consequence of the new characteristic introduced in cotton. (glyphosate tolerance).
In Brazil, cotton cultivation is highly developed in the Center-West and Southeast regions, which represent approximately 61.4% of the planted area, with Mato Grosso currently the main producer of seed cotton with an area of approximately 420 thousand ha and production of approximately 1,580 thousand tons, according to CONAB's 2009/2010 harvest estimate. The first generation of glyphosate-tolerant genetically modified cotton was the cotton variety MON 1445 that has been widely used by cotton growers and has become a significant portion of American cotton production. Glyphosate is used as a herbicide non-selective in foliar applications and provides more effective weed control during the season, with reduced risks of plant damage, as it is a highly effective herbicide, effective against most annual and perennial weeds that can cause problems during the later stages of crop development. MON 88913 cotton represents the second generation of glyphosate tolerant cotton that shows greater tolerance to glyphosate during critical growth phases when compared to MON 1445 cotton. The increased levels of glyphosate tolerance in MON 88913 cotton were achieved by the use of improved promoter sequences, which regulate the expression of the cp4 epsps gene encoding sequences, which encode the expression of the CP4 EPSPS protein, which confers the characteristic of tolerance to glyphosate.
In Brazil, studies on the centesimal composition of MON 88913 cotton were carried out with grains collected from experiments carried out in Cachoeira Dourada/MG and Sorriso/MT. O MON 88913 cotton was compared with conventional control cotton (of similar genetic background to MON 88913) and commercial references. Grain analyzes measured the following proximate components: ash, fat, moisture, proteins and carbohydrates by calculation and gossypol (free and total). Statistical analyses, in this case the averages of the repetitions for each location and the ranges of values were generated for each analyzed component. The results from each site were analyzed separately, with the references of the two sites used to generate the averages and ranges of proximate component values determined for these materials. For each local, all average levels of centesimal components and gossypol determined in MON 88913 cotton grains were comparable to the average values of the control and were at or within the ranges of controls, or references, or both, as well as falling within ranges found in the ILSI composition database. It can be concluded that the composition of the MON 88913 cotton was equivalent to the composition of commercial references of conventional cotton. The results collected in the United States and Brazil showed that the grains of the MON 88913 cotton had a composition equivalent to that of commercially cultivated conventional cotton varieties.
The analysis of data on food and environmental biosecurity of MON 88913 cotton, carried out in Brazil and the United States, showed that MON 88913 cotton is equivalent to conventional cotton and commercial references. Additionally, there is no evidence of adverse reactions to the use of MON 88913 cotton. For these reasons, there are no restrictions on the use of this cotton or its derivatives either for human or animal consumption.
CTNBio concluded that MON 88913 cotton is as safe as its conventional equivalent. Within the scope of the powers assigned to it by Art. 14 of Law 11,105/05, CTNBio considered that the request complies with the rules and legislation in force that aim to guarantee the biosafety of the environment, agriculture, human and animal health, and concluded that MON 88913 cotton is substantially equivalent to conventional cotton, and its consumption is safe for human and animal health. Regarding the environment, CTNBio concluded that MON 88913 cotton does not potentially cause significant environmental degradation, keeping with the biota an identical relationship to conventional cotton.
Molecular traddicional methods.
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FR
