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Risk Assessment
Record information and status
Record ID
112295
Status
Published
Date of creation
2017-06-28 18:08 UTC (gutemberg.sousa@mctic.gov.br)
Date of publication
2017-08-01 20:02 UTC (dema@itamaraty.gov.br)

General Information
Country
  • Brazil
Title of risk assessment
Risk assessment of MIR604 maize and Bt11xMIR162xMIR604xGA21 maize - Technical Report 4207/14
Date of the risk assessment
2014-09-04
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
SYN-BTØ11-1 x SYN-IR162-4 x SYN-IR6Ø4-5 x MON-ØØØ21-9 - Agrisure Viptera® 4 Maize
Mannose tolerance Resistance to diseases and pests - Insects - Coleoptera (beetles) - Western corn rootworm (Diabrotica virgifera), Lepidoptera (butterflies and moths) Resistance to herbicides - Glufosinate, Glyphosate Selectable marker genes and reporter genes
Show detection method(s)
SYN-IR6Ø4-5 - Agrisure™ RW Rootworm-Protected maize
Mannose tolerance Resistance to diseases and pests - Insects - Coleoptera (beetles) - Western corn rootworm (Diabrotica virgifera) 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
Field studies for the evaluation of the agronomic and phenotypic characteristics performed at six sites in Brazil have shown that the Bt11xMIR162xMIR604xGA21 event presents the same performance of the conventional isogenic, with the same genetic background, proving the absence of potential to become a weed. In addition, insect efficacy assays were performed on field plots that were infested with populations of Diabrotica speciosa and Spodotera fugiperda and demonstrated the efficiency of Bt11xMIR162xMIR604xGA21 maize to control the main pests of maize crop. Likewise, this combined corn maintained tolerance to the herbicides glufosinate of ammonia and glyphosate, as expected.
Likelihood that the potential adverse effects will be realized
It was not verified that the characteristics conferred by the introduction of the genes present in MIR604 maize and Bt11xMIR162xMIR604xGA21 maize provide any competitive advantage or greater aggressiveness, which would result in an invasive species. Tolerance to glyphosate and glufosinate of ammonium only confers a competitive advantage to plants submitted to spraying with these herbicides. While resistance to some insect species would only confer an adaptive advantage on the environment in systems where insects were the limiting agents for plant propagation, that is, if there was a strong selection pressure from pests. Thus, there is no competitive advantage of these events under natural conditions of survival
Possible consequences:
No pleiotropic and epistatic effects caused by the presence of Bt11, MIR162, MIR604 and GA21 events or by the combination of these in Bt11xMIR162xMIR604xGA21 maize
Estimation of the overall risk
Bt11xMIR162xMIR604xGA21 maize was developed through classical genetic improvement, by crossbreeding between genetically modified lines. Comparative molecular analysis demonstrated that the genes of the Bt11, MIR162, MIR604 and GA21 events are independent. These are distinct pathways and therefore one should not expect that the presence of genes has any different effect from that expected for each characteristic when present independently. Information from comparative molecular analysis, protein expression analysis, compositional profile and agronomic evaluations corroborate the fact that the genes present in these events act independently.
Recommendation(s)
Field experiments carried out in Brazil, the United States and Argentina have shown that the results obtained from the phenotypic and agronomic characteristics of Bt11xMIR162xMIR604xGA21 maize were within the range of responses that are expected for the maize crop. Therefore, the potential of corn Bt11xMIR162xMIR604xGA21 in becoming a weed is no different from conventional maize. Likewise, no phenotypic and agronomic changes are expected between MIR604 maize in relation to its conventional isogenic, since this event is aimed at resistance to beetles Prague
Need(s) for further information on specific issues of concern
It was not verified that the characteristics conferred by the introduction of the genes present in the maize MIR604 and Bt11xMIR162xMIR604xGA21 maize provide any competitive advantage or a greater aggressiveness, that would result in an invasive species
Receiving environment(s) considered
Bt11xMIR162xMIR604xGA21 maize was developed through classical genetic improvement, by crossbreeding between genetically modified lines. Comparative molecular analysis demonstrated that the genes of the Bt11, MIR162, MIR604 and GA21 events are independent. These are distinct pathways and therefore one should not expect that the presence of genes has any effect different from that expected for each characteristic when present independently
LMO detection and identification methods proposed
molecular traditional methods

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