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Évaluation des risques générée par un processus de réglementation (RA)
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last updated: 28 avr. 2026
Informations générales
Risk assessment of soybean event A2704-12 - Technical Opinion 2286/2009.
EN
11 févr. 2010
Détails de l’évaluation des risques
Event A2704-12, called LibertyLink Soybean, presents the pat gene, derived from the non-pathogenic soil bacterium (Wohlleben et al., 1992; Hérouet et al., 2005), Streptomyces viridochromogenes, which confers tolerance to the herbicide glufosinate of ammonium. This exogenous gene codifies the enzyme phosphinothricin-N-acetyltransferase (PAT protein) which promotes herbicide inactivation. The nucleotide sequence of the pat gene introduced in soybean was modified, via site-directed mutagenesis, in order to reduce the content of G:C bases (frequent in bacterial genomes, but atypical in plant genomes), ensuring high expression of the PAT protein. . The modifications made did not result in changes in the original amino acid sequence of the PAT protein.
EN
Méthode et points à examiner
Event A2704-12, or produced from this event, do not have any adverse effects on human or animal health, as well as on the environment.
EN
Studies presented by the applicant showed that there was no significant difference between the genetically modified soybean and its conventional isoline with respect to agronomic characteristics, mode of reproduction, dissemination or ability to survive. All the evidence presented in the process and in the bibliographic references confirm the level of risk of the transgenic variety as equivalent to non-transgenic varieties against the soil microbiota, as well as other plants and human and animal health. Thus, the cultivation and consumption of A2704-12 soybeans do not potentially cause significant degradation of the environment or risks to human and animal health.
EN
Agronomic and efficacy evaluations of A2704-12 soybean indicated that the insertion did not lead to the expression of any other characteristics than that expected, that is, tolerance to the herbicide glufosinate ammonium (GA), and that it presents the same agronomic behavior. and adaptability than the conventional lineage, without changing the characters that regulate the survival and reproduction of the species.
EN
It has no homology to any allergenic protein, toxin or nutrients; It does not present any glycosylation site (present in several allergenic products); It is structurally unstable in acidic environments; Rapidly degrades and denatures in the gastric and intestinal fluid of humans and domestic animals; It has substrate-specific activity (acts exclusively on the GA compound and has no activity on the glutamate amino acid); It did not show any adverse effects in mammals even when administered in high doses intravenously; Protein accumulation occurs mostly in the seed, but its levels are very low, ranging from 0.003% to 0.029% of the total protein. Protein levels were not affected when the crop was sprayed with the herbicide glufosinate ammonium.
EN
According to the proponent, experiments conducted in the United States and Puerto Rico, with visual observations throughout the evolutionary cycle to assess the occurrence of atypical plants or plants that respond differently to biotic pressure, indicated that the insertion of the pat gene did not influence susceptibility / resistance to pests and diseases of lines derived from event A2704-12, even when subjected to different environmental conditions. Studies carried out in Paulínia/SP and São Gabriel do Oeste/MS did not indicate any anomalies in terms of the occurrence of insects, fungi or even in relation to plant physiology.
EN
Environmental safety aspects were analyzed in local field studies, showing that event A2704-12 does not adversely affect the survival of other plants or animals.
EN
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 Liberty Link Soybean (Event A2704-12) is substantially equivalent to conventional soy, being its consumption safe for human and animal health.
EN
Molecular traddicional methods. 
EN
Partage d’informations avec d’autres bases de données
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Information supplémentaire
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