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Risk Assessment
Record information and status
Record ID
112293
Status
Published
Date of creation
2017-06-28 19:08 UTC (gutemberg.sousa@mctic.gov.br)
Date of publication
2017-08-01 19:57 UTC (dema@itamaraty.gov.br)

General Information
Country
  • Brazil
Title of risk assessment
Risk assessment of maize DAS-40278-9 - Technical Report 4406/15
Date of the risk assessment
2015-03-05
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-4Ø278-9 - Enlist™ Maize
Dow AgroSciences GmbH Resistance to herbicides Tolerance to 2,4-Dichlorophenoxyacetic acid Tolerance to aryloxyphenoxypropionate
Show detection method(s)
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 studies conducted in Brazil as in the United States and Canada have shown that GM maize DAS-40278-9 does not differ from conventional maize in morphological, agronomic and reproductive characteristics. The only difference is its characteristic herbicide tolerance based on 2,4-D and haloxyfop-R, which is conferred by the presence and functional expression of the aad-1 gene of the soil bacterium Sphingobium herbicidorovans.
Likelihood that the potential adverse effects will be realized
The phenotype of the transformed plants is equivalent to the original plant phenotype with respect to the reproductive organs, the duration of the development period and the propagation method, which shows the absence of adverse genetic interactions resulting from the transformation process. Genetic modifications introduced into the GMO do not alter their ability to reproduce, survive, disseminate or transfer genes inserted into other organisms. Transfer of the transgene to other maize crops can be avoided provided that the measures described in the current legislation on coexistence between GM crops and conventional crops are adopted.
Possible consequences:
The studies carried out in Brazil have shown that DAS-40278-9 maize is as safe as conventional maize, it is not expected adverse effects of its introduction on the different organisms present in the environment different from those caused by conventional maize. Thus, no effect different from that of conventional maize is expected for relevant indicator organisms, symbionts, predators, pollinators, parasites or competitors with maize cultivation DAS-40278-9.
Estimation of the overall risk
in the present case, the presence of the aad-1 gene of the soil bacterium Sphingobium herbicidovorans gives GM maize DAS-40278-9 only tolerance to 2,4-D herbicides and herbicides of the aryloxyphenoxypropionate (AOPPs) group. Aside from this characteristic, studies have shown that GM maize DAS-40278-9 does not differ from conventional maize in agronomic, morphological and reproductive characteristics, as it is equivalent in chemical and nutritional composition to conventional corn, being as safe as the same. The AAD-1 protein produced by GM maize DAS-40278-9 is an enzyme that has no insecticidal, nematicidal, fungicidal, bactericidal or other effects than inactivating the 2,4-D herbicides and certain herbicides of the aryloxyphenoxypropionates group .
Recommendation(s)
As DAS-40278-9 has been shown to be as safe as conventional maize, adverse effects of its introduction on different organisms present in the environment are not expected to be different from those caused by conventional maize. Thus, no effect different from that of conventional maize is expected for relevant indicator organisms, symbionts, predators, pollinators, parasites or competitors with maize cultivation DAS-40278-9.
Need(s) for further information on specific issues of concern
DAS-40278-9 corn, like conventional maize, has no invasive species characteristics or weed properties, exhibiting only the novel tolerance characteristic for some herbicides.
Receiving environment(s) considered
The studies carried out consider the particularities of the different regions of Brazil as established in Paragraph 4 of Article XXIII of Law 11,105 of March 24, 2005.
LMO detection and identification methods proposed
molecular traditional methods

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