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Risk Assessment
Record information and status
Record ID
112305
Status
Published
Date of creation
2017-06-15 14:45 UTC (gutemberg.sousa@mctic.gov.br)
Date of publication
2017-08-01 20:15 UTC (dema@itamaraty.gov.br)

General Information
Country
  • Brazil
Title of risk assessment
Risk Assessment of genetically modified soybean tolerant 2,4-D and ammonium glufosinate
Date of the risk assessment
2015-04-15
Competent National Authority(ies) responsible for the risk assessment
National Technical Biosafety Commission
Setor Policial Sul -SPO Área 5 Quadra 3 Bloco B - Térreo Salas 10 à 14
Brasília, DF
Brazil, CEP - 70610-200
Phone:(5561) 3411-5516
Fax:(5561) 3317-7475
Email:ctnbio@mct.gov.br
Url:National Technical Biosafety Comission
Contact details of the main responsible risk assessor
Dr. Edivaldo Domingues Velini
President
National Technical Biosafety Comission (CTNBio)
Setor Policial Sul -SPO Área 5 Quadra 3 Bloco B - Térreo Salas 08 à 10
Brasília, DF
Brazil, CEP - 70610-200
Phone:(5561) 3411-5151
Fax:(5561) 3317-7475
Email:secretariactnbio@mct.gov.br
Url:National Technical Biosafety Comission
Risk assessment details
Living modified organism
DAS-68416-4 - Enlist™ Soybeans
Dow AgroSciences GmbH Resistance to herbicides - Glufosinate
Scope of the risk assessment
  • LMOs for Contained use
  • LMOs for direct use as feed
  • LMOs for direct use as food
  • LMOs for processing
Risk assessment report / Summary
Methodology and points to consider
Potential adverse effects identified in the risk assessment
The environmental security of the event was analyzed in studies carried out in Brazil, in the United States and Canada that demonstrated that soy DAS-68416-4 does not differ from soybeans In agronomic, morphological and reproductive characteristics, as well as Equivalent in chemical and nutritional composition with the exception of the characteristics of Tolerance to glufosinate ammonium herbicides by expression of the pat gene and the Herbicides based on 2,4-D by the presence of the aad-12 gene. The plant phenotype The genes described is similar to the phenotype of the original plant in Refers to the reproductive organs, the duration of the plant's development period, its Method of propagation. In addition, the soybean containing said transformation event, Like conventional soybeans, does not tend to proliferate as weeds And is not an invasive species in natural ecosystems.
Likelihood that the potential adverse effects will be realized
Studies in Brazil, the United States and Canada have shown that DAS-
68416-4 does not differ from conventional soybean in agronomic, morphological,
Reproduction, demonstrating their equivalence in chemical and nutritional composition (with
Except for herbicide tolerance characteristics based on glufosinate ammonium
By expression of the pat gene and 2,4-D-based herbicides by the presence of the aad-12 gene.
Possible consequences:
No adverse effects caused by soybean cultivation DAS-68416-4 were found Relevant indicator organisms when compared to conventional soy based on Studies conducted in Brazil, the United States and Canada.
Estimation of the overall risk
The phenotype of the transformed plants containing the aad-12 and pat genes is similar to the
Reproductive organs, the duration of the
Development of the plant, to its method of propagation. In addition, soybeans containing
Aad-12 and pat genes, like conventional soybeans, do not show a tendency to proliferate
A weed, and is not an invasive species in natural ecosystems.
Recommendation(s)
As established in art. 1 of Law No. 11,460, of March 21, 2007, "are prohibited the research and cultivation of GMOs in indigenous lands and areas of conservation units,
Except in the Environmental Protection Areas
Receiving environment(s) considered
With regard to the environment, it was concluded that soybean DAS-68416-4 is not potentially
Significant degradation of the environment or damage to human health and
Animal, keeping with the biota identical relation to conventional soy.
LMO detection and identification methods proposed
molecular traditional methods

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