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Risk Assessment generated by a regulatory process (RA)
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BCH-RA-BR-294106-1   |   PDF   |   Print   |  
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last updated: 17 Apr 2026
General Information
Brazil
Risk assessment f corn event MON89034 x TC1507 x NK603 - Technical Opinion 2753/2010.
EN
16 Jun 2011
Risk assessment details
The maize MON 89034 × TC1507 × NK603 was formed from the combination of maize containing the event MON 89034 that had the genes cry1A.105 and cry2Ab2 inserted in its genome, which encode the proteins Cry1A.105 and Cry2Ab2, respectively. Proteins Cry1A.105 and Cry2Ab2 are active against lepidopteran insects considered corn pests. The second component of MON 89034 × TC1507 × NK603 maize is the corn containing event TC1507 that had the cry1F and pat genes inserted into its genome. The cry1F gene encodes the Cry1F protein that is active against lepidopteran insects considered corn pests. The pat gene, in turn, encodes the PAT protein, which gives corn plants tolerance to herbicides containing the active principle glufosinate ammonium. Finally, the third component of corn MON 89034 × TC1507 × NK603 is the corn containing the NK603 event, which had the cp4 epsps gene inserted into its genome and expresses the CP4 EPSPS protein. The CP4 EPSPS protein gives corn plants tolerance to the herbicide glyphosate.
EN
Methodology and points to consider
The authors demonstrated that the PAT protein is rapidly degraded in gastric and intestinal fluid simulation experiments with pancreatin and pepsin. Additionally, they did not observe mortality or toxicity when they administered 1 or 10 mg of PAT protein/kg body weight by intravenous injection. in mice, confirming that the PAT protein does not show acute toxicity (safety factor >1000) and does not cause adverse effects in mice after intravenous administration of high doses for a period longer than two weeks.
EN
Experiments carried out in Brazil to evaluate the effect of corn MON 89034, TC1507 and NK603 on non-target arthropods did not detect differences in visitation of the orders and morphospecies of arthropods studied, compared to conventional maize. In other ecotoxicity studies carried out with parasitoids, beneficial arthropods, bees, earthworms, Collembola and Daphnia among others, it was shown that Cry proteins do not cause adverse effects to the non-target organisms studied.
EN
CTNBio approved several corn containing events with the protein Cry and that to date there is no report of any effect on human/animal health or the environment.
EN
Agronomic and efficacy evaluations of MON 89034 x TC 1507 x NK603 corn indicated that the combination of these events by classical genetic improvement methods (sexual crosses) did not lead to the expression of any traits other than resistance to certain insects and herbicide tolerance. glyphosate and herbicides in which glufosinate ammonium is the active ingredient; No morphophysiological changes were observed in MON 89034 x NK 603 maize that could confer adaptive advantages.
EN
Data submitted by the applicant showed that there was no significant difference between corn hybrids derived from unmodified lines and corn 89034 × TC1507 × NK603 with respect to agronomic traits, mode of reproduction, dissemination or survivability. All evidence presented in the process and in bibliographic references confirm the level of risk of the transgenic variety as equivalent to non-transgenic varieties in terms of soil microflora, as well as other plants and human and animal health. Thus, the cultivation and consumption of MON 89034 × TC1507 × NK603 corn do not potentially cause significant environmental degradation or risks to human and animal health.
EN
The corn MON 89034 × TC1507 × NK603 it is as safe as the conventional versions.
EN
The cultivation and consumption of MON 89034 × TC1507 × NK603 corn are not potentially causing significant environmental degradation or risks to human and animal health.
EN
Molecular traddicional methods. 
EN
Information sharing with other databases
Yes
Yes
Yes
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Yes
Additional information
EN
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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