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Risk Assessment
Record information and status
Record ID
Date of creation
2017-12-27 17:59 UTC (gutemberg.sousa@mctic.gov.br)
Date of publication
2018-06-15 13:39 UTC (dema@itamaraty.gov.br)

General Information
  • Brazil
Title of risk assessment
Risk assessment of maize hybrids selected by conventional crossing resulting from the combination of events technically approved by CTNBio - TC15Ø7 x MON81Ø x MIR162 x MON6Ø3 - Technical Report 4409/2015
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-Ø15Ø7-1 x MON-ØØ81Ø-6 x SYN-IR162-4 x MON-ØØ6Ø3-6 - Herbicide tolerant, insect resistant corn
Mannose tolerance Resistance to diseases and pests - Insects - Lepidoptera (butterflies and moths) Resistance to herbicides - Glufosinate, Glyphosate Selectable marker genes and reporter genes
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
CTNBio reviewed the reports submitted by the applicant as well as independent scientific literature. Scientific studies conducted to evaluate biosafety, agronomic and phenotypic characteristics, as part of the risk assessment of this GMO, included representative regions for maize culture in Brazilian territory. After analyzing the data, CTNBio concluded that there are no restrictions on the use of quadruple corn and subcombinations cited, considering also their derivatives.
Likelihood that the potential adverse effects will be realized
The double and triple combinations of the cited events have also been submitted to the CTNBio risk assessment, which concludes in their opinions that "genetic modification events are substantially equivalent to conventional corn" and "that these events are not potentially causing significant degradation of the environment ".
Possible consequences:
The analysis of the risk assessment of the combined event TC1507 x MON810 x MIR162 x NK603 occurred on a case-by-case basis and considered, according to Art. 3 of RN 5/2008, the information previously presented for the individual events, which contain the same genetic construct , and the information of the present proposal for commercial release of the combined event, aiming to verify if the information presented and evaluated by CIBio of the applicant corroborate the hypothesis that there is no interaction between the inserts present in the combined event.
Estimation of the overall risk
All the individual events of the combined event have already been analyzed by CTNBio and released commercially and all the information on the risk assessment of these events is found in the aforementioned opinions.
In addition to the literature data demonstrating the different modes of action of the Cry1Ab, Cry1F and Vip3Aa proteins that confer insect resistance, laboratory analyzes and field tests evidence the absence of unexpected effects corroborating the hypothesis that there is no interaction between proteins Cry1F, Cry1Ab, Vip3Aa, PAT, CP4 EPSPS and PMI, according to the results presented according to the tests performed
Need(s) for further information on specific issues of concern
Considering the substantial equivalence of the TC1507 x MON810 x MIR162 x NK603 event demonstrated in the composition analysis studies and considering that there is no evidence that the combination of the four individual events resulted in a new product, according to studies, it is concluded that all the experiments that demonstrated the safety of individual events are applicable to the combined event.
Receiving environment(s) considered
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 Areas of Environmental Protection"
LMO detection and identification methods proposed
Molecular Traditional Methods

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