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Évaluation des risques générée par un processus de réglementation
(RA)
published: 25 juin 2008
last updated: 27 mars 2013
Risk Assessment for Herbicide Tolerant Soybean
EN
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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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MON-Ø4Ø32-6 - Roundup Ready™ soybean| Monsanto | Résistance aux herbicides (Glyphosate)
- National Biosafety Commitiee [ English ]
Soybean is a predominant self-pollinated plant species with an outcrossing rate of about 1.0%. Soybean is an exotic species without wild relatives that are sexually compatible in Brazil. Therefore, cross-pollination with wild species in the natural environment is not possible in the national territory.
EN
Soybean is a domesticated species and highly dependent on the human intervention for survival. Thus, there is no scientific reason to predict that the soybean lines derived from GTS 40-3-2 will survive outside the agricultural environment. Furthermore, without the selective pressure (glyphosate use) the expression of the inserted gene does not provide any adaptive advantage (increased fitness).
EN
CTNBio concluded that the introduction of the transgene does not alter the chemical composition of the soybean, with the exception of the transgenic protein CP4 EPSPS. This conclusion in the equivalence of the chemical composition is based on evaluations conducted by scientific methodologies, published in international scientific referee journals. The safety of the protein CP4 EPSPS regarding the toxicological and allergenic aspects were also proved. It is important to mention that the utilization of the transgenic soybean and products thereof in South, Central and North America, Europe, and Asia there is not even one case of allergic reaction of any human person that is not allergic to the conventional soybean. Also, it is important to consider that individuals sensible to conventional soybean will continue to be sensible to the transgenic soybean; therefore, they should not use this product.
EN
not applicable
EN
The interested party (Monsanto) must make available areas for conducting and be responsible for the scientific monitoring to generate the complementary information, which will be supervised by technical experts nominated by the CTNBio. The information must be obtained in parallel to the commercial production of the crop. The areas, dimensions, location will be established in regions representative of the soybean growing areas in mutual agreement between CTNBio and Monsanto.
B.3. The monitoring must include the following:
B.3.1. Variation of the specific composition of the weed species community in the area, including the composition and magnitude of the seed reserve in the soil, as part of the evaluation;
B.3.2. Incidence of escapes of weed species determining if this was a consequence of the transfer of the transgene.
B.3.3. Periodic evaluation of the population dynamics of the organisms "indicadors": insects, pathogens, nitrogen fixing and phosphate solubilizing microorganisms
B.3.4. Provide an annual technical report to the executive secretary of the CTNBio by June 15th, following the crop season
EN
B.3. The monitoring must include the following:
B.3.1. Variation of the specific composition of the weed species community in the area, including the composition and magnitude of the seed reserve in the soil, as part of the evaluation;
B.3.2. Incidence of escapes of weed species determining if this was a consequence of the transfer of the transgene.
B.3.3. Periodic evaluation of the population dynamics of the organisms "indicadors": insects, pathogens, nitrogen fixing and phosphate solubilizing microorganisms
B.3.4. Provide an annual technical report to the executive secretary of the CTNBio by June 15th, following the crop season
Not applicable
EN
Soybean is an exotic species in Brazil.
EN
Traditional Molecular methods, or fenotypic marker (gliphosathe application)
EN
FR
| Type de fichier | Champs | Fichier(s) : | |
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| Décision de pays ou tout autre communication | Évaluation des risques | 4 | |
