The proteins present in NK 603 x MON89034 maize have a history of
safe use by the consumption of MON 89034 maize since 2008, and the
NK603 maize since 2000. The MON 89034 x NK 603 maize is approved in
Japan, North Korea, the Philippines, Taiwan, and the USA.
Concerning the proteins expressed by MON 89034 x NK 603 maize, it
is known that Cry proteins accumulate in the cytoplasm and which
have selective toxicity for some species of lepidopteran insects,
and their mechanism of action mediated by specific receptors on
target organisms. The Cry1A.105 protein and Cry2Ab2 protein bind to
these receptors located in the midgut of susceptible insects,
leading to form pores that cause insect death. The EPSPS protein,
accumulated in the chloroplast, catalyses a step in the shikimic
acid pathway for biosynthesis of aromatic amino acids, being so
essential to normal growth in plants and micro-organisms. The
mechanism for glyphosate action is by forming a complex with the
EPSPS enzyme, which regards to the natural substrate binding for
the enzyme, blocking the biosynthetic pathway. The CP4 EPSPS enzyme
is present in the MON 89034 x NK 603 maize, has low affinity for
glyphosate compared to wild EPSPS proteins. Thus, when the MON
89034 x NK603 maize is treated with glyphosate, the CP4 EPSPS
enzyme activity causes the plants to continue developing normally.
In summary, the proteins expressed by transgene cp4 epsps and cry
(and Cry1A.105 cry2Ab2) in MON 89034 x NK603 maize are accumulated
in different cellular compartments. They act in different pathways
and have different functions and not interactive functions. Studies
with the proteins Cry1A.105, Cry2Ab2, and CP4 EPSPS show that these
are rapidly digested in simulated gastric and intestinal fluids.
This contributes to a low allergenic potential of these proteins,
together with the fact they are present in MON 89034 x NK 603 maize
in low quantities. Tests for acute oral toxicity and for
sub-chronic oral toxicity indicated that the protein in question
does not produce adverse effects in mammals. Bioinformatics
analysis also demonstrated that the proteins Cry1A.105, Cry2Ab2,
and CP4 EPSPS show no similarity in amino acid sequence with known
allergenic and toxic proteins. The confirmation of presence and of
integrity for DNA sequence introduced into MON 89034 x NK603 maize
was carried out by using insert-specific identification by Southern
blot analysis. The expression of proteins Cry1A.105, Cry2Ab2, and
CP4 EPSPS occurs in all tissues of the plant because the promoters
used to promote constitutive expression of these proteins. The
expression levels of these proteins were determined in leaves,
grain, and fodder, tissues relevant to assess the safety of MON
89034 x NK603 maize as human food and animal feed. The results show
comparable levels of expression of proteins in the pyramided event
and in their parents, with a low expression of these proteins in
the grains and a higher expression in leaves, and were intermediate
in fodder. During the analysis of agronomic traits in the
phenotypic MON 89034 x NK 603 maize were not identified
statistically significant differences concerning control maize for
any parameter assessed. It was demonstrated also the effectiveness
in controlling target pests and the presence of the trait to
tolerate the herbicide glyphosate. Together, their results support
the conclusion that, except by the specific characteristics of each
introduced gene, the phenotype of GM maize has not changed and
therefore the MON 89034 x NK 603 maize has no greater potential
than conventional maize to become a weed. Chemical composition
analyses were performed in grains and fodder of MON 89034 x NK 603
maize, comparing it to conventional control variety, which has
similar genetic base, and seven varieties of conventional maize
referenda. The samples used were generated in three locations,
representative of the area of maize crop in Brazil, during the
2007/2008 harvest. All values of chemical composition on fodder and
MON 89034 x NK 603 maize grains were within the range of values for
isogenic control maize, or of commercial values found in the
database of the composition of the ILSI-CCD. With this, we can say
that the MON 89034 x NK 603 maize is substantially equivalent to
conventional maize and therefore as safe, healthy, and nutritious
as conventional maize. Besides the data provided by the company,
CTNBio consulted independent scientific literature to assess the
safety and the occurrence of any unexpected effect from the cross
between these events. Given the above, it is concluded that the
cultivation and consumption of MON 89034 x NK 603 maize is not
potentially causer of significant environmental degradation or risk
to human and animal health. For this reason, there are no
restrictions on the use of maize and its derivatives. CTNBio
determines that the monitoring post-commercial release should be
conducted in commercial fields and not in experimental fields. The
areas chosen to be monitored should not be isolated from the
others, have borders or any situation that is out of business
standard. Monitoring should be carried out in model comparison
between the conventional system of cultivation and cropping system
of GMOs, and the data collection done by sampling. Monitoring
should be conducted in representative biomes of the main areas of
cultivation of GMOs and, where possible, involve different types of
producers. The monitoring should be conducted for at least five
years. The reports presented should be detailed information about
all activities in the pre-planting and planting on their
implementation, with reports of activities conducted in the areas
of monitoring during the crop cycle, about the activities of
harvest and weather conditions. There should be monitoring of any
injuries to human and animal health systems through the official
notification of adverse effects, such as the SINEPS System (Adverse
Event Reporting Related to Health Products) regulated by ANVISA.
The analytical methods, results, and their interpretations must be
developed in accordance with the principles of independence and
transparency, subject to commercial confidentiality issues
previously defined and justified as such. With regard to the gene
cp4 epsps, which confers resistance to the herbicide, should be
monitored: the nutritional status and health of GM plants, the
chemical and physical attributes related to soil fertility and
other basic soil characteristics, soil microbial diversity; the
soil diaspore bank, the weed community, the development of
herbicide resistance in weeds, the herbicide residues in soil, in
grain and in aerial parts, and the gene flow. With respect to the
genes Cry1A.105 and cry2Ab2, which confer resistance to insects,
should be monitored: the impact on the target insects and on
non-target insects, the impact on soil invertebrates of indicators,
not belonging to the class Insecta, the residues of insecticidal
proteins in decomposing organic matter, soil and waterways near the
area of monitoring, the development of resistance among target
insects and the gene flow of the two inserted genes.
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