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Risk Assessment
Record information and status
Record ID
Date of creation
2017-09-12 20:34 UTC (gutemberg.sousa@mctic.gov.br)
Date of publication
2018-06-15 13:36 UTC (dema@itamaraty.gov.br)

General Information
  • Brazil
Title of risk assessment
risk assessment of genetically modified maize 5307 and Maize Bt11xMIR162xMIR604xTC1507x5307xGA21 - Technical Report 4764
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
SYN-Ø53Ø7-1 x SYN-IR6Ø4-5 x SYN-BTØ11-1 x DAS-Ø15Ø7-1 x MON-ØØØ21-9 x SYN-IR162-4 - Agrisure® Duracade™ 5222
Mannose tolerance Resistance to diseases and pests - Insects - Coleoptera (beetles) - Western corn rootworm (Diabrotica virgifera), Northern corn rootworm (Diabrotica barberi), 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 introduction into the environment
  • LMOs for processing
Risk assessment report / Summary
Methodology and points to consider
Potential adverse effects identified in the risk assessment
The history of safe use of Cry, Vip3, EPSPS, PAT and PMI proteins in plantations
which for some of these genes have been used for more than 19 years in several
countries, including Brazil, and based on data and evidence
the current scientific literature available for the proteins described in the application in
discussion, we consider that GM events are as safe as their equivalents
their food and environmental security
Likelihood that the potential adverse effects will be realized
Microbial formulations of B. thuringiensis have been used for decades as
biopesticides in an organic production system or under conventional agricultural conditions,
to date, no impact on human, animal and environmental health has been related to the
their use. GM plants expressing Cry proteins have already been grown in several countries
for more than 19 years. The gene constructs requested in this process for commercial release
have already been released in Brazil (except for Milho 5307) and in several countries, both for consumption
cultivation, with no adverse effects on human, animal,
environment and non-target organisms. The overwhelming majority of the scientific literature on
health and environmental safety attests that there are no observable risks in the introduction of these
cultures containing Cry proteins.
Possible consequences:
All GM corn present in this commercial release proposal, classified as risk class 1, are as safe as their conventional equivalents, and not potentially cause significant degradation of the environment or health
human and animal. In the evaluations submitted to the CTNBio, criteria internationally accepted in the process of risk analysis of genetically and a set of evidences that demonstrated the safety for the cultivation of 5307, Bt11 x MIR162 x MIR604 x TC1507 x 5307 x GA21 and Bt11xMIR162.
Estimation of the overall risk
There is no difference between the agronomic performance of transgenic and conventional plants, as well as how there is substantial equivalence between them. Thus, information indicates that transgenic maize plants do not differ fundamentally from untransformed maize genotypes,
In Brazil, there are no related species of maize in natural distribution.
Need(s) for further information on specific issues of concern
Maize (Zea mays) is not native to Brazil and there are no native, wild or feral species in the country that can interbreed with Zea mays. Therefore, there are no additional risks to the environment with the planting of maize 5307, Bt11xMIR162xMIR604xTC1507x5307xGA21 and Bt11xMIR162 in addition to those already caused for the different varieties of conventional maize in use in the country
Receiving environment(s) considered
As established in art. 1 of Law 11,460, of March 21, 2007, "are prohibited the research and the cultivation of genetically modified organisms in the indigenous lands and areas of conservation units".
LMO detection and identification methods proposed
Molecular Traditional Methods

Records referencing this document (3)
3record(s) found
Country's Decision or any other Communication3 records