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Risk Assessment
Record information and status
Record ID
Date of creation
2019-10-30 13:58 UTC (gutemberg.sousa@mctic.gov.br)
Date of publication
2019-10-30 14:57 UTC (dema@itamaraty.gov.br)

General Information
  • Brazil
Title of risk assessment
risk assessnt os maize MIR604 and Maize Bt11xMIR162xMIR604xGA21
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
Syngenta Seeds Ltda.
Syngenta Seeds Ltda.
Lilian Aguiar Saldanha

Rodovia BR-452, Km 142 + 543m.

Uberlândia, MG
Brazil, 38405-232
Phone:+55(11) 5643-6747
Fax:+55(11) 5643-6750 ; 5643-6750
Risk assessment details
Living modified organism
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
It has not been selected that the resources conferred by the introduction of genes present in MIR604 maize and Bt11xMIR162xMIR604xGA21 maize offer any competitive advantage or greater aggressiveness that results in an invasive species. Glyphosate and ammonium glufosinate tolerance confers competitive advantages to plants sprayed with these herbicides. While resistance in some insect species only provides an adaptive advantage in the environment in systems where insects are limiting agents for plant propagation, ie there is a strong selection pressure from pests. Thus, do not verify any competitive advantage of events under natural survival conditions.
No pleiotropic and epistatic effects caused by the presence of Bt11, MIR162, MIR604 and GA21 events or the combination of these non-Bt11xMIR162xMIR604xGA21 maize were observed.
Likelihood that the potential adverse effects will be realized
The dietary safety of mCry3A and PMI proteins present in MIR604 corn was evaluated in a rat oral toxicity study. Rats received a single dose of 2,377 mg / kg body weight for mCry3A protein and 2,072 mg / kg body weight of PMI protein and were observed for two weeks. No harmful effects were observed in the test animals. Tests were also performed on birds. The parameters evaluated were body weight, food consumption and clinical observations. Under the conditions of this study, the acute oral LD50 of mCry3A and PMI proteins in rats could only be estimated using higher amounts, ie greater than 2,377 mg / kg body weight for mCry3A and greater than 2,072mg / kg. body weight for PMI. In grains, the mCry3A concentration ranged from 0.07 to 0.17 µg / g fresh weight (0.08 to 0.24 µg / g dry weight) and the PMI concentration ranged from 1.25 to 1, 5 µg / g fresh weight (1.78 to 1.79 µg / g dry weight).
Similarly, no adverse effects on animals are expected when fed with Bt11xMIR162xMIR604xGA21 maize, since proteins are expressed at the same level as in the individual events that compose it and the compositional profile of combined maize does not differ from conventional maize.
Possible consequences:

As for Bt11xMIR162xMIR604xGA21 maize, it should be considered that the expression of each protein expressed in this combined maize does not differ from that in maize containing the events alone. Thus, the toxicological and pharmacological evaluations performed for individual events Bt11, MIR162 and GA21, presented in their respective commercial release processes, and evaluations of MIR604 maize described in this Process can be considered for Bt11xMIR162xMIR604xGA21 maize.
Estimation of the overall risk
No change in animal performance or physiological and / or morphological variation was observed in the animals tested when fed with MIR604 corn. Similarly, no adverse effects on animals are expected when fed with Bt11xMIR162xMIR604xGA21 maize, since proteins are expressed at the same level as in the individual events that compose it and the compositional profile of combined maize does not differ from conventional maize. Details are presented in the commercial release proposal for MIR 604 and Bt11xMIR162xMIR604xGA21 maize presented by Syngenta Seeds Ltda. Process No. 01200.004553 / 2012-90 in items 4.1 and 4.2.
In a combined analysis of data generated at different sites, no significant differences were detected between Bt11xMIR162xMIR604xGA21 maize and conventional isogenic maize for any of the phenotypic and agronomic characteristics evaluated.
Need(s) for further information on specific issues of concern
In a laboratory study, to assess the potential exposure of non-target organisms to mCry3A by cultivating MIR604 maize, it was considered the worst-case scenario using taxonomically related species to the target pest and species expected to have higher exposure. to mCry3A, such as birds (quail), fish (trout), non-aerial shoot arthropod (ladybug, flower bug), soil inhabitants (beetles and worms), pollinating insects (bee) and mammals (rat). According to the risk assessment presented, the results of this study indicated minimal risk of MIR604 maize to non-target organisms.
In conclusion, the results presented in this document prove the safety of the MIR604 event and Bt11xMIR162xMIR604xGA21 corn to the environment. In addition, the history of safe exposure of proteins present in the events supports the biosafety aspects.
Receiving environment(s) considered
The process rapporteurs concluded that MIR 604, classified as risk class 1, is as safe as its conventional counterparts, and is not potentially a cause of significant environmental or human and animal health degradation. In the evaluations, the internationally accepted criteria were used in the risk analysis process of genetically modified raw materials and the set of evidence obtained that demonstrated the safety for the cultivation of MIR604 corn.
LMO detection and identification methods proposed
molecular traditional methods

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