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Risk Assessment generated by a regulatory process (RA)
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last updated: 28 Jun 2017
General Information
Brazil
Risk assessment of maize DAS-40278-9 - Technical Report 4406/15
EN
05 Mar 2015
Risk assessment details
Methodology and points to consider
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.
EN
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.
EN
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.
EN
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 .
EN
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.
EN
DAS-40278-9 corn, like conventional maize, has no invasive species characteristics or weed properties, exhibiting only the novel tolerance characteristic for some herbicides.
EN
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.
EN
molecular traditional methods
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Additional information
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Records referencing this document Show in search
Record type Field Record(s)
Country's Decision or any other Communication Risk assessment 1

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