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Risk Assessment
Record information and status
Record ID
Date of creation
2017-06-15 19:39 UTC (gutemberg.sousa@mctic.gov.br)
Date of publication
2017-08-01 20:13 UTC (dema@itamaraty.gov.br)

General Information
  • Brazil
Title of risk assessment
Risk assessment of soybean DAS-44406-6
Date of the risk assessment
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
Url:National Technical Biosafety Comission
Contact details of the main responsible risk assessor
Dr. Edivaldo Domingues Velini
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
Url:National Technical Biosafety Comission
Risk assessment details
Living modified organism
DAS-444Ø6-6 - Enlist E3™ Soybean
Resistance to herbicides - Glufosinate, Glyphosate
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
Studies conducted in the USA and Brazil involved the analysis of phenotypic characters, Agronomic characteristics (items 2.2.1 to 2.2.5, ANNEX IV of the process), nutrient composition (item 3.1 to 3.2, Annex III to the file), the effect of DAS-44406-6 soybean on chemical and Physical properties of the soil (item 9, Annex IV of the process), the organic matter degradability of Plants (item 10, Annex IV of the process) and the effect of the transgenic plants in the state Nutritional value of plants (item 9.2., Annex IV of the process). In all these studies, no No statistically significant difference was detected between soybean DAS-44406-6 and its Conventional control of the same genetic background, which could indicate the occurrence of Interactions of genes inserted in soybean DAS-44406-6 and other genes of the genome with Of detectable pleiotropic and epistatic effects, with genetically modified soya remaining
With the same phenotype as the conventional one, except for the inserted characteristic.
The various studies that represent this risk analysis, associated to the large number of
Of evaluated characteristics, allows to conclude that no evidence of pleiotropic effect or
Associated with the inserted genes was observed.
Likelihood that the potential adverse effects will be realized
The PAT proteins, AAD-12 and 2mEPSPS, present in the gene construct of the event
DAS-44406-6, have specific action under their respective substrates. The observations in
Several generations of soybean DAS-44406-6 show that the presence of the aad-12, 2mepsps and
Pat did not produce changes in host plant characteristics, including characteristics Agronomic and reproductive, indicating the absence of interactions between these genes
Possible consequences:
The studies carried out in Brazil and the United States showed that soybean DAS-
44406-6 does not differ from conventional soybean in agronomic, morphological,
Reproductive characteristics, survival characteristics and the dissemination of
Response to major pathogens and pests, with the exception of Herbicide tolerance characteristics; Thus, there is no additional risk to the use of this soybean in relation to conventional soybeans
Estimation of the overall risk
The phenotypic and plant growth characteristics that respond to the
Stress, response to insect pressure and disease in
And the characteristics of soybean germination and dormancy DAS-44406-6 were not
Were altered relative to conventional soybean control. Therefore, these data
Conclusion that agronomic characteristics, and susceptibility to soybean diseases and pests
DAS-44406-6 are not significantly different from those of control soybeans and nothing indicates that soybeans DAS-44406-6 may pose a significant risk to the environment other than the risks May occur with the conventional soybean itself.
There is no experimental evidence that soybean DAS-44406-6 is lower or has any
Toxicological or nutritional risk to animals which is distinct from the conventional variety
Widely used. Therefore, the modification introduced by genetic manipulation,
Simply conferred resistance to the herbicides glufosinate ammonium, glyphosate and 2,4-D,
Providing agronomic, economic and ecological advantages
Need(s) for further information on specific issues of concern
As established in art. 1 of Law 11,460, of March 21, 2007, "are prohibited the research and the cultivation of genetically modified organisms in the indigenous lands and
conseration unidts ", except in the areas of environmental protection
Receiving environment(s) considered
Soy is not native to Brazil and there is no native, wild or feral species in the country that can cross-link with Glycine max. Therefore, there are no additional risks for the environment
Environment with soybean planting DAS-44406-6 in addition to those already caused for the different conventional soybean varieties in use in the country
LMO detection and identification methods proposed
molecular traditional methods

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