Date of creation
2019-10-30 13:58 UTC (email@example.com)
Date of publication
2019-10-30 14:57 UTC (firstname.lastname@example.org)
risk assessnt os maize MIR604 and Maize Bt11xMIR162xMIR604xGA21
National Technical Biosafety Commission
Setor Policial Sul -SPO Área 5 Quadra 3 Bloco B - Térreo Salas 10 à
Brazil, CEP - 70610-200
Syngenta Seeds Ltda.
Syngenta Seeds Ltda.
Lilian Aguiar Saldanha
Rodovia BR-452, Km 142 + 543m.
SYN-IR6Ø4-5 - Agrisure™ RW Rootworm-Protected maize
Resistance to diseases and pests - Insects - Coleoptera (beetles) - Western corn rootworm (Diabrotica virgifera)
Selectable marker genes and reporter genes
Show detection method(s)
- LMOs for contained use
- LMOs for direct use as feed
- LMOs for direct use as food
- LMOs for introduction into the environment
- commercial production
- field trial
- LMOs for processing
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.
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
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
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.
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
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.
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.
molecular traditional methods
Records referencing this document (1)
|Country's Decision or any other Communication||1 record||