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Évaluation des risques générée par un processus de réglementation
(RA)
last updated: 16 juin 2026
Risk assessment of cotton event MON 88701 - Technical Opinion No. 5429/2017.
EN
09 mars 2017
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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 :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,Téléphone : +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-887Ø1-3 - Dicamba- and Glufosinate-tolerant cotton| Monsanto | Résistance aux herbicides (Glufosinate)
- commercial release 5429 - 2017.pdf [ Portugais ]
The MON 88701 cotton was developed by the transformation method mediated by Agrobacterium tumefaciens using the plasmid PV-GHHT6997 in the cotton variety Coker 130, which served as a comparison control between the transgenic event and the conventional one. Plasmid PV-GHHT6997 is approximately 9.4 kb and contains a T-DNA that is delimited by left and right border regions. T-DNA contains the dmo and bar gene expression cassettes. The dmo gene expression cassette is regulated by the PC1SV promoter, the 5' TEV leader sequence and the 3' UTR E6 region (CTP2 chloroplast UTR directs the transport of the MON 88701 DMO protein to this organelle and is derived from the sequence CTP2 target of the Arabidopsis thaliana shkG gene. The dmo gene in MON88701 is identical to that of S. maltophilia, except that the codons were modified to optimize expression in plants without altering the amino acid sequence, and an additional codon for leucine was inserted after the codon for methionine. The bar gene is regulated by the 35S promoter, the leader sequence Hsp70 and the 3' UTR region we. After transformation, self-pollination and segregation were performed to select those plants containing a single homozygous copy of the T-DNA, including the dmo and bar gene expression cassettes The remaining sequence of the vector excluded the T-DNA sequence was not detected.
MON 88701 genetically modified cotton is substantially equivalent to conventional cotton, and its consumption is safe for human and animal health.
Field experiments were carried out to evaluate the agronomic, phenotypic characteristics and environmental interactions of MON 88710 cotton compared to COKER 130 cotton and commercial references in 5 localities (as described in the process). Phenotypic and agronomic characteristics, abundance of non-target organisms, pollen morphology and viability, evaluation of volunteer plants, vigor and germination were considered. The results obtained indicate that MON 88710 cotton did not present different results than conventional or COKER 130 cottons. The data from environmental interactions also indicate that MONO 88710 cotton does not confer differences in susceptibility or greater tolerance to diseases, abiotic stresses or arthropods when compared to other conventional varieties or COKER 130. The data on morphology and pollen viability, as well as those on germination and vigor, also indicate equivalence with conventional or COKER 130 cottons. Thus, MON 88710 should not pose a greater risk to the environment. environment when compared to conventional cottons or its parent COKER 130.
MON88710 has been approved for use in the United States, Canada, Colombia, Japan, South Korea, Mexico, Australia, Taiwan, and New Zealand. Within the scope of the powers of art. 14. MON 88701 genetically modified cotton is as safe as its conventional equivalent and the order complies with current norms and legislation that aim to guarantee the biosafety of the environment, agriculture, human and animal health.
The MON88701 event had its molecular characterization defined, the analysis of protein expression, compositional analysis and agronomic and phenotypic evaluations showed no evidence of risk to human and animal health; The history of use of other plants into which these genes have been introduced does not record any risk to man or animals that are greater than those of the same plants that have not had heterologous genes introduced; The data presented show that the addition of these genes does not alter the performance of the animals used in tests and also does not introduce physiological or morphological variation; The history of the use of plants expressing the proteins encoded by the genes in question shows that there is no adverse effect on relevant indicator organisms and no significant environmental impact.
The results obtained indicate that MON 88710 cotton did not present different results than conventional or COKER 130 cottons. The data from environmental interactions also indicate that MONO 88710 cotton does not confer differences in susceptibility or greater tolerance to diseases, abiotic stresses or arthropods when compared other conventional varieties or COKER 130. The data on morphology and pollen viability, as well as those on germination and vigor, also indicate equivalence with conventional or COKER 130 cottons. Thus, MON 88710 should not pose a greater risk to the environment when compared to conventional cottons or its parental COKER 130.
The MON88701 event had its molecular characterization defined, the analysis of protein expression, compositional analysis and agronomic and phenotypic evaluations did not demonstrate
evidence of risk to human and animal health.
evidence of risk to human and animal health.
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 MON 88701 cotton is substantially equivalent to conventional cotton, and its consumption is safe for health human and animal.
Molecular traddicional methods.
Oui
Oui
Oui
Oui
Oui
FR
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