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Risk Assessment
Record information and status
Record ID
Date of creation
2017-06-20 14:35 UTC (gutemberg.sousa@mctic.gov.br)
Date of publication
2017-08-01 20:10 UTC (dema@itamaraty.gov.br)

General Information
  • Brazil
Title of risk assessment
Risk Assessment of insect resistant and tolerant to glufosinate ammonium soybean DAS-81419-2
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
Dra Maria Sueli Felipe Soares
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-81419-2 - Conkesta™ Soybean
Resistance to diseases and pests - Insects - Lepidoptera (butterflies and moths) 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
Studies in the USA and Brazil involved the analysis of phenotypic, agronomic traits, nutrient composition, plant effect on soil chemical and physical characteristics, soil organic matter degradability and nutritional status of plants, among others. In all of these studies, no significant difference was detected between soybean DAS-81419-2 and its conventional control of the same genetic background, which otherwise could indicate presence of interactions between the inserted genes cry1Ac and cry1F and other genes of the genome, Resulting in detectable pleiotropic and epistatic effects.
Likelihood that the potential adverse effects will be realized
All the agronomic characteristics of soybean DAS-81419-2 evaluated in field trials in several crops in Brazil (processes 01200.003138 / 2011-38 and 01200.004683 / 2010-61) and in the USA were statistically indistinguishable from the control soybean where the results were within the Range of non-GM soybeans. The results of this study demonstrated agronomic equivalence between the soybean event DAS-81419-2 and the non-transgenic soybean.
Possible consequences:
Studies conducted in Brazil and the United States have shown that soybean DAS-81419-2 does not differ from conventional soybeans in agronomic, morphological and reproductive characteristics, as well as being equivalent in chemical and nutritional composition, except for herbicide tolerance characteristics Glufosinate ammonium base, for the expression of the pat gene and resistance to some insects, by the expression of the cry1Ac and cry1F genes, thus not identifying additional risks compared to conventional soybeans
Estimation of the overall risk
Soy is extensively cultivated and consumed in Brazil and has a wide history of safe use for humans and animals. Brazil is not a center of diversity for this species, since there is no native, wild or feral species that can interbreed with Glycine max
The restrictions on the use of the GMO under analysis and its derivatives are conditioned to the provisions of Law 11,460 of March 21, 2007.
Need(s) for further information on specific issues of concern
After analyzing the data presented by the company and available in the world scientific literature, it is possible to verify that soy DAS-81419-2 does not differ significantly from conventional soy in its chemical and nutritional composition, except for the presence and expression of genes cry1Ac, cry1F and pat , Which confer resistance to some insect pest of soybean and tolerance to the herbicide glufosinate ammonium
Receiving environment(s) considered
Soybean DAS-81419-2, like conventional soya, does not exhibit a tendency to proliferate as a weed and is not invasive in natural ecosystems. No competitive advantage, outside crop culture conditions, will be provided by the cry1Ac, cry1F and pat genes introduced in soybean DAS-81419-2, when compared to conventional soya.
LMO detection and identification methods proposed
Molecular traditional methods

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