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Risk Assessment
Record information and status
Record ID
Date of creation
2018-01-31 19:24 UTC (gutemberg.sousa@mctic.gov.br)
Date of publication
2018-06-15 13:41 UTC (dema@itamaraty.gov.br)

General Information
  • Brazil
Title of risk assessment
Risk assessment of corn TC1507 x MON810 x MIR162 - Thecnical Report 4465/15
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 - Herbicide tolerant, insect resistant corn
Mannose tolerance Resistance to diseases and pests - Insects - Lepidoptera (butterflies and moths) Resistance to herbicides - Glufosinate 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 combined genetic modification event of maize expressing insect resistance and tolerance to glufosinate ammonium herbicide was obtained by conventional crossing between the events TC1507 (DAS- Ø15Ø7-1), MON810 (MONØØ810-6) and MIR162 (SYNIR162- 4). The corn event TC1507 expresses the Cry1F and PAT proteins, the corn event MON810 expresses the Cry1Ab protein and the MIR162 maize expresses the proteins Vip3Aa20 and PMI. The PAT protein renders the plant tolerant to herbicides formulated with ammonium glufosinate and the proteins Cry1F, Cry1Ab and Vip3Aa20 are responsible for conferring the resistance characteristic to lepidopteran maize crop pests. PMI (phosphomannose isomerase enzyme) is used as a selection marker. The individual events that make up the combined event object of the present analysis have already had their risk assessment by CTNBio, which concluded for the safety of these events
Likelihood that the potential adverse effects will be realized
In order to verify if the transgenes are stable in VHY maize and had Southern blot assays were performed that demonstrated that in VHY maize there is an unequivocal presence of the transgenes originating from the 3 original events and that these present genomic stability. In addition, it is possible to interpret from these results that the transgenes are not located in the same genomic loci, since all segregate independently as shown
Possible consequences:
Another analysis performed by the company on VHY maize was the quantification of recombinant protein levels in individual hybrids and VHY maize by the ELISA technique. The analysis of each of the recombinant proteins comparing the presence in VHY
in individual hybrids showed that levels in VHY maize are statistically similar for the Cry1F, PAT, Cry1Ab, Vip3Aa20 and PMI (p> 0.05) proteins. This in all samples
analyzed as leaves, pollen, whole plant, forage and grains
Estimation of the overall risk
studies were carried out regarding the control of target lepidoptera both in the laboratory and in containment conditions and in the field.
In the laboratory conditions, leaf consumption of hybrid maize plants was verified
individual, VHY maize and non GM GM maize by larvae of Ostrinia nubilalis and Spodoptera frugiperda. It was possible to determine that the control efficacy of the TC1507xMON810xMIR162 combination present in VHY corn is similar to the best found in the events
in the control of these target species. In the contention test, exposing the plants from the individual or
pyramids, it was verified that the VHY corn presented less attack to the leaves by the S. frugiperda caterpillars than the control maize with infestation and the corns TC1507 and TC1507xMON810, which attests the greater effectiveness of the VHY maize on S.frugiperda infestation. In the field trial, a visual evaluation was made of the damage caused by the natural infestation of the Maize Cartridge (S. frugiperda) and the Sugar Cane Broca (Diatraea saccharalis) pests. Statistical differences were observed between the control and TC1507 plants in relation to VHY maize, which also confirms the greater efficacy of this hybrid on the caterpillars in the field conditions where the experiment was performed
it has been shown that the inserts do not interact
that the recombinant proteins are produced under conditions similar to the cultivars with the individual characteristics and that there is no difference in the nutritional composition, it is evident, in the light of this advice, that VHY maize should not present higher risks than the individual cultivars already known, analyzed and approved for marketing by the
Need(s) for further information on specific issues of concern
In addition to the analysis and approval of CTNBio that concluded for the security of said events and their subcombinations, the corn event MON810, event TC1507 and maize MIR162 event have already been evaluated and approved in different countries
Receiving environment(s) considered
As established in art. 1 of Law 11,460, dated March 21, 2007, "are prohibited the research and the cultivation of energetically modified organisms in the indigenous lands and areas of conservation units".
LMO detection and identification methods proposed
molecular traditional methods

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