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Évaluation des risques générée par un processus de réglementation
(RA)
last updated: 28 avr. 2026
Risk assessment of soybean event MON 87708 × MON 89788 - Technical Opinion 5392/2017.
EN
09 févr. 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, 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 ()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-877Ø8-9 × MON-89788-1 - Herbicide tolerant soybean| Monsanto | Resistance to Dicamba, Résistance aux herbicides (Glyphosate)
- commercial release 5392 - 2017.pdf [ Portugais ]
The soybean tolerant to the herbicide dicamba MON 87708 was developed using the transformation methodology mediated by Agrobacterium sp. and plasmid PV-GMHT4355 (described in detail in the dossier). After transformation, 1) the sequences of the right border (42pb) and left border (53pb) from Agrobacterium tumefaciens were introduced into the soybean genome, which are essential for the transfer of T-DNA; 2) P-PC1SV, which is the promoter of the full-length transcript (FLt) of the peanut chlorotic spot caulimovirus (PC1SV) (Maiti and Shepherd, 1998), which directs transcription in plant cells; 3) L-TEV that is a 5' untranslated region of the tobacco Etch virus (TEV) genome (Niepel and Gallie, 1999), involved in the regulation of gene expression; 4) TS-RbcS: encodes the chloroplast transit peptide, as well as the first 24 amino acids, of the mature protein of the pea RbcS gene (Pisum sativum) (Fluhr et al.,
1986), which directs the transport of the DMO protein to the chloroplast; 5) CS-dmo: modified coding region of the enzyme dicamba monooxygenase from Stenotrophomonas maltophilia, strain DI-6 (Herman et al., 2005; Wang et al., 1997); 6) T-E9: a 3' untranslated region of the pea RbcS2 gene, which originally encodes the small subunit of Rubisco, which provides the signals for transcription termination and mRNA polyadenylation (Coruzzi et al., 1984), in addition to of intermediate sequences used in DNA cloning. The absence of other sequences present in the original plasmid was confirmed by DNA hybridization (Southern) and sequencing techniques. The region of the soybean genome that flanks the insert was also mapped and identified.
1986), which directs the transport of the DMO protein to the chloroplast; 5) CS-dmo: modified coding region of the enzyme dicamba monooxygenase from Stenotrophomonas maltophilia, strain DI-6 (Herman et al., 2005; Wang et al., 1997); 6) T-E9: a 3' untranslated region of the pea RbcS2 gene, which originally encodes the small subunit of Rubisco, which provides the signals for transcription termination and mRNA polyadenylation (Coruzzi et al., 1984), in addition to of intermediate sequences used in DNA cloning. The absence of other sequences present in the original plasmid was confirmed by DNA hybridization (Southern) and sequencing techniques. The region of the soybean genome that flanks the insert was also mapped and identified.
A thorough safety assessment of the DMO and CP4 EPSPS proteins has determined that they are very unlikely to cause any adverse effects on human or animal health.
Regarding the BMD protein encoded by the Stenotrophomonas maltophilia dmo gene, an acute oral toxicity study with mice to estimate the intake of exogenous protein through the diet showed that the BMD protein does not present acute toxicity and does not cause any adverse effects, even at the highest dose. test high, which was 140 mg/kg body weight. BMD protein is rapidly digested in simulated gastric fluid (100% in 30 seconds). Proteins that are rapidly digested in the gastrointestinal systems of mammals have a negligible probability of causing allergies when
consumed. In addition, through bioinformatics tools (search using a window of eight amino acids), it was observed that the DMO protein does not share any amino acid sequence similarity with known allergens or toxic proteins that cause adverse effects in mammals.
consumed. In addition, through bioinformatics tools (search using a window of eight amino acids), it was observed that the DMO protein does not share any amino acid sequence similarity with known allergens or toxic proteins that cause adverse effects in mammals.
The DMO and CP4 EPSPS proteins were evaluated for their potential for toxicity to humans and animals according to recommendations from the Codex Alimentarius Commission (Codex, 2003). These proteins have a history of safe use, lack of structural similarity to known toxins or proteins. biologically active that cause effects in mammals, do not cause acute oral toxicity in mice, and constitute a very small portion of the total protein present in feed and foods derived from MON 87708 × MON 89788 soy, leading to the conclusion that it is unlikely and unexpected that proteins DMO and CP4 EPSPS cause any toxic effects in humans and animals.
The CP4 EPSPS protein, which is encoded by the cp4 epsps gene from Agrobacterium sp. strain CP4, is structurally and functionally similar to the endogenous EPSPS enzymes of plants and microorganisms, a larger family of related EPSPS proteins. EPSPS are ubiquitous in nature and have no known toxicity, are not associated with pathogenicity, and do not confer a selective advantage on organisms that infect them. produce. Furthermore, cultures expressing this CP4 EPSPS protein have been cultivated for over 18 years in several countries without any reports of allergy or toxicity. The food safety of the CP4 EPSPS protein present in foods and feeds derived from soy MON 87708 × MON 89788 was evaluated for risks to humans and animals. Acute oral toxicity studies with mice to estimate the intake of exogenous protein through the diet showed that the CP4 EPSPS protein does not present acute toxicity and does not cause any adverse effects even at the highest test dose, which was 572 mg/kg body weight. The CP4 EPSPS protein is rapidly digested in simulated gastric fluid (more than 95% of the CP4 EPSPS protein in 15 seconds). Proteins that are rapidly digested in the gastrointestinal systems of mammals have a negligible probability of causing allergies when consumed. Furthermore, by means of bioinformatics tools (search using an eight amino acid window), it was observed that the CP4 EPSPS protein does not share any sequence similarity of amino acids with known allergens, gliadins, glutenins or toxic proteins that cause adverse effects in mammals.
The phenotypic and agronomic analyzes performed with MON 87708 × MON 89788 soybean in Brazil in the 2013/2014 crop did not show the occurrence of pleiotropic and epistatic effects. The agronomic and phenotypic traits of MON 87708 × MON 89788 soybeans were not altered in relation to commercial varieties, except for the expression of dicamba and glyphosate tolerance traits, which was the objective of the introduction of the dmo and cp4 epsps genes in the soybean genome. .
Analyzes of ecological interactions with arthropods, diseases and with the bacterium Bradyrhizobium japonicum, as well as vigor, dormancy and germination of seeds, response to biotic and abiotic stress carried out in Brazil and in the USA, showed that MON 87708 × MON 89788 soybean does not differ significantly from conventional varieties. These results demonstrate that the expression of the genes of interest does not alter the interaction patterns of this plant in the environment, reducing the risk of change in the potential to become a weed.
CTNBio considered that the proposed biosafety measures meet the norms and pertinent legislation that aim to guarantee the biosafety of the environment, agriculture, human and animal health.
Molecular traddicional methods.
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