Ministry of Science and Technology-MCT
National Technical Biosafety Commission-CTNBio

TECHNICAL OPINION No.1.100/2007.

Process No: 01200.002995/1999-54
Petitioner: Monsanto do Brasil Ltda.
CNPJ: 64.858.525/0001-45
Address: Av. das Nações Unidas, 12901 Torre Norte – 7 e 8
andares CEP: 04578-000 – São Paulo – SP.
Subject: Commercial Release of Genetically Modified Corn
Previous Extract: Communication No. 91/1999 published on
DOU of October 14th, 1999.
Meeting: 105th Ordinary Meeting of CTNBio that took place
on August 16th, 2007.
Decision: GRANTED

After appreciation of request for Technical Opinion for
commercial release of genetically modified corn resistant
to insects of the Lepidoptera order (Guardian Corn, Event
MON810), as well as all the progenies coming from the
transformation event MON180, and its derivatives of
crossing of lineages, and non—transgenic populations of
corn with lineages bearing event MON810, CTNBio decided to
GRANT it, on the terms of this conclusive technical
opinion.
Monsanto do Brasil Ltda. requested from CTNBio a Technical
Opinion for the free registration, use, essays, tests,
seeding, transportation, storage, commercialization,
consume, importation, release and discard of corn (Zea
mays, L.) resistant to insects of the Lepidoptera order –
Guardian Corn - Event MON810. Integrated to its genome,
Guardian corn that derives from lineage MON810, presents
gene cry1Ab, that comes from Bacillus thuringiensis subsp.
kurstaki, which codifies protein Cry1Ab with toxic effect
over insects of Lepidoptera order (Spodoptera frugiperda,
earworm and Meromyza Americana). The transformation process
consisted of the bombarding of vegetal material with
particles coated with the genetic material of interest,
generating the corn lineage MON810 that contains gene
cry1Ab of B. thuringiensis (classified as organism of risk
class I of biosafety). The expression levels of protein Cry
1AB (also called Bt, from Bacillus thuringiensis) of
lineage MON810 were evaluated on young leaves, grains,
whole plant and pollen. The results showed the highest
levels of expression on leaves (9.35 μg/g of dry weight),
followed by the whole plant (4.31 μ/g of dry weight),
grains (0.31 μg/g of dry weight) and pollen (0.09 μg/g of
dry weight). The protein is toxic only for the mentioned
target insects, specifically to lepidopteron (worms) that
exclusively have in their intestines specific receptors for
this protein. Mammals do not have these receptors, or
connection places, and, therefore, human beings, animals,
and other organisms that are not target are not affected by
protein Bt, including other arthropods and also natural
enemies of target-plagues. The protein sequence was
compared to data banks of protein with allergenic
properties, and no biologically meaningful homology was
demonstrated between protein Cry1Ab as a whole and
sequences of proteins with these properties. Due to
digestibility characteristics of protein Cry1Ab on gastric
and intestinal fluids, the probability that it presents
allergenic action is extremely low. It is improbable that
exogenous DNA may integrate itself to human genome, for DNA
molecule is disintegrated during the digestion process, and
would hardly stay intact to be used by the human or animal
body cells. The introduction of gene cry1Ab did not result
on apparent alteration of nutritional importance, for the
profiles of the main nutrients were similar to those
normally observed in other varieties, or under distinct
conditions of cultivation. Thus, the results about chemical
and centesimal composition of MON810 corn are in accordance
with the Principle of Substantial Equivalence. Due to the
smaller infestation by insects in relation to the
traditional varieties of corn, there is less growth of
associated fungus, micotoxins producers of pathologic
importance for human beings and animals, and, consequently,
considerably reducing the contamination and the presence of
these toxins, contributing to improve the quality and food
safety of grains. The possibility of transgenic plant, or
progenies coming from the crossing of lineage MON810 with
other corn plants, to become weed species is minimum due to
biological characteristics of the species, and to the fact
that corn does not survive well without human intervention.
Corn is an entirely domesticated plant, and needs the men
to survive. Since the event introduced into corn does not
have relation to the reproduction of the plant, or with its
interaction with the environment, it is expected that the
transgenic corn Bt have environmental behavior similar to
the common corn, having, therefore, no possibility of this
corn to become an invasive plant or weed. B. thuringiensis
is a soil microorganisms and the exposition of live
organisms, and of the environment to this bacteria, or to
any element extracted from it, is an event that occurs
abundantly in nature, not resulting in meaningful risk for
the soil micro biota. Agriculturists, including those that
prefer the so- called organic agriculture, have been
spreading this bacteria for a long time over plants to
avoid lepidopteron from destroying them. Various studies
results have shown that corn MON810 does not cause negative
impact over the community of non-targeted evaluated
organisms. Information indicate that transgenic plants do
not fundamentally differ from genotypes of untransformed
corn, except for the resistance to insects of Lepidopteron
order. The background of ten years of safe use of this
transgenic variety in the world points to great
accumulation of trustworthy scientific information that
indicate that this variety is as safe for the environment,
and for human and animal’s health as the hybrid corns
varieties that have been being used. Additionally, there is
no evidence of adverse reactions to the use of Guardian
corn. For these reasons, there are no restrictions to the
use of this corn, or of its derivatives for human or animal
feeding. The coexistence among conventional corns crops
(improved or creoles) and transgenic corn crops is possible
from the agronomic point of view (10, 29), and should
follow the disposition on Normative Resolution No. 4 of
CTNBio. According to what is established on art. 1 of law
11.460, of March 21st, 2007, “it is vetoed the research and
cultivation of genetically modified organisms on indigenous
lands and areas of conservation units”. In the ambit of
competences of art.14 of law 11.105/05, CTNBio considered
that the request fulfills the pertinent norms and the
legislation that aims at guaranteeing biosafety for the
environment, agriculture, human and animal’s health.

CTNBio TECHNICAL OPINION

I. GMO Identification
Designation of GMO: Guardian Corn, Event MON810
Petitioner: Monsanto do Brasil Ltda.
Species: Zea mays – Corn
Inserted Characteristics: Resistance to insects of
Lepidoptera order
Method of characteristic introduction: Bombarding of
particles method
Proposed Use: Silage and grains Production for human and
animal consume of GMO and its derivatives.
II. General Information
Zea mays L., the corn, is a species that belongs to Maydae
tribe that is included in the sub-family Panicoideae,
Gramineae family (Poaceae). The genders belonging to Maydae
tribe include Zea and Tripsacum in the Western Hemisphere.
Corn is a separate species within Zea sub-gender, with
chromosome number 2n = 20,21,22,24 (15). The sylvan species
closer to corn is teosinte, found in Mexico and in some
places in Central America, where it can be crossed with
corn cultivated in production fields. The corn produced can
also be crossed with the most distant genre Tripsacum. This
crossing, however, occurs with great difficulty and results
on sterile-male progeny.
Corn history is over eight thousand years old in the
Americas. Out of all the cultivated plants, it is probably
the one that has the greatest genetic variety. Today, there
are around 300 races of corn, and within each race,
thousands of crops. Corn is nowadays, the cultivated
species that reached the highest degree of domestication
and only survives in nature when it is cultivated by
men(6). The maintenance of this genetic variability has
been usually made through individualized storage, in
germoplasm banks, with controlled conditions of humidity
and temperature. There are many germoplasm banks in
Brazil, and in the world. Embrapa has two germoplasm banks,
one at Embrapa Genetic Resources and Biotechnology, in
Brasília-DF, and another one at Embrapa Corn and Sorghum,
in Sete Lagoas-MG. Corn is commercially cultivated in over
100 countries, with a total production estimated in 705
million tons/year.
Corn is one of the most important sources of food in the
world, and is raw material for the production of a wide
range of products. In the productive chain of swine and
poultry, approximately 70 to 80% of the corn produced in
Brazil is consumed.
Brazil is the third biggest corn producer in the world with
a production of approximately 35 million tons in 2005,
behind only of the United states of America (282 million
tons), and China (139 million tons)(19). In Brazil, corn is
basically planted in two crops (summer plantation, and
small crop), and it is cultivated practically all over the
national territory, being 92% of the production in the
South (47% of production), Southeast (21% of production)
and Center-West (24% of production)(12).
In the last years, insects have become plagues that limit
the corn culture in Brazil, especially insects of
Lepidoptera order (Spodoptera frugiperda, earworm and
Meromyza Americana). It is estimated that they may cause
damages of up to 34% on the production of corn grains. With
the increase of the area cultivated with corn during the
so-called “small crop” (three million hectares), closing
the cycle of various plagues and diseases, the problem
became bigger. In some areas of the Brazilian Center-West,
it is necessary dozens of pulverizations with insecticides
in only one cycle of cultivation.
Brazil is the third biggest consumer of agricultural
defensives in the world. Nowadays, we have 142 registered
agro toxics for corn, 107 only for worms. There are already
many cases of resistance for the constant and
indiscriminate use of insecticides in corn culture in
Brazil. What’s more, one of the factors that mostly affects
agriculturists’ health in Brazil is the use of agricultural
defensives, which are responsible for the intoxication of a
million people every year (2).
Guardian corn, event MON810, consists of an alternative
proposal for the control of worms, plagues of corn culture.
It is based on the use of corn hybrids that derive from
lineage MON810, genetically modified to be resistant to
these worms attack. For this purpose, gene cry1Ab of
Bacillus thuringiensis subsp. kurstaki (Bt), lineage HD-1
was inserted. The same lineage was used in commercial
formulations of B. thuringiensis of wide use in
agriculture. Transgenic corn MON810 – Guardian Corn is
already cultivated, or commercialized in 14 countries
(Argentina, Australia, Canada, China, European Union,
Japan, Korea, Philippines, Mexico, South Africa,
Switzerland, Taiwan, Uruguay and The United States of
America). The event was developed with the introduction of
gene cry1Ab of Bt in one corn lineage, through biobalistics
process. The event expresses protein Cry1Ab, responsible
for the death of worms during the whole vegetable cycle.
This protein is specific for lepidopteron (worms), and does
not have toxic effect over dipterous (flies, bees, and
others) or coleopterons (beetles, ladybugs and others)(1).
The protein produced on Bt corn is identical to the one
found in nature, or in formulations for pulverizations
available in the market for over 40 years. It is important
to highlight that corn varieties containing this protein
have been used in many countries in the world, and there is
no information that hybrids of corn containing cry genes
have caused damage to the environment, or to human or other
animal’s health.
In Brazil, many releases in the environment of Guardian
corn, were conducted after approval by CTNBio in regions
that represent the corn culture, including the states of
São Paulo, Minas Gerais, Mato Grosso, Mato Grosso do Sul,
Paraná, Goiás, Rio Grande do Sul, Distrito Federal, Santa
Catarina and Bahia.
III. Description of GMO and Expressed Proteins
The corn lineage MON810 was obtained through the genetic
transformation, particles acceleration methodology or
biobalistics(26), of plants of hybrid corn HI-II, resulting
form the crossing of public lineages of corn A188 and B73,
developed in the United States of America by the University
of Minnesota, and by the University of the State of Iowa,
respectively. According to the company’s information, the
genotypes represent around 50% of each material. These
plants were transformed into vectors PV-ZMBK07 and PVZMGT10,
generating the corn lineage MON810 that contains
gene cry1Ab of B. thuringiensis (classified as organism of
risk class I of biosafety).
B. thuringiensis is a soil bacteria, gram-positive,
initially isolated in Japan by Ishiata, and formally
described by Berliner in 1915. This microorganism forms
crystals of endotoxins, proteins with insecticide action
that act before and during the sporulation phase of its
life cycle. Nowadays, there are many collections in the
world that contain thousands of isolated B. thuringiensis,
being many races classified based on their spectrum of
action, their crystalline toxins and their genetic
similarities (14).
Vector PV-ZMBK07 contains the gene that codifies endotoxin
Cry1Ab, and vector PV-ZMGT10 contains genes cp4-epsps and
gox. Gene cry 1Ab present in vector PV-ZMBK07 was put under
control of transcriptional promoter E35S (around 0.6 kb).
An intron of 0.8kb deriving from gene hsp70 of corn was
also inserted between the promoter and the gene cry1Ab.
This insertion was made in order to increase the levels of
transgenic expression. To the reflux of the gene cry1Ab was
put the sequence 3’-UTR (transcribed, but not translated)
of 0.26 kb of nopaline synthase, which contains the signal
of polyadenylation. The sequence of gene cry1Ab is composed
by 3468 nucleotides, and codifies one protein of B.
thuringiensis sbsp. kurstaki HD-1 (Cry1Ab) of 1156 amino
acids. To allow adequate levels of expression in corn, the
sequence of gene was modified to adjust the use of codons
and proportion A + T. Thus, the proteic sequence did not
differ from the one obtained from B. thuringiensis.
The molecular characterization was executed to identify the
presence of vectors PV-ZMBK07 and PV-ZMGT10 on the genome
of transformed corn plants, besides the number of copies
integrated to the genome. The molecular characterization of
lineage MON810 was made by Southern Blot, indicating the
integration of a sole copy of gene cry1Ab with the promoter
35S and the intron of corn hsp70 without any residue of
sequences of the vector or of the gene nptll, of resistance
to neomycin. Also, it was noticed the absence of genes gox
and cp4-epsps of the construction on vector PV-ZMGT10. The
absence o additional sequences on lineage MON810 restricts
the evaluation of safety to the implications of the
presence of gene cry1Ab.
The genetic stability of elements present on vector PVZMBK07
was characterized from the execution of crossings,
and evaluation of segregation of progenies derived from
lineage MON810. The results indicate the occurrence of a
sole functional insertion, in accordance with the
Mendeliane Genetic. According to information present on the
process, gene cry1Ab showed to be stable for seven
generations of crossings with one of its recurrent parent
(B73), and for six generations of crossings with a nonparental
lineage (Mo17). These data were also confirmed
from the hybridizations with a probe formed by part of gene
cry1Ab.
The mechanism of action of toxins Cry have been extensively
studied in lepidopteron, dipterous, and coleopterons (25).
On the alkaline pH of insects’ intestines, proteins
crystals ingested are dissolved, and the pro-toxins are
activated by digestive proteinases of insects(30). The
mechanism of action of proteins Cry revealed by Broderick
and collaborators(9) indicates that the toxin Cry makes the
intestinal epitheliums permeable, allowing bacteria of the
digestive treat to contaminate hemolynpha, leading to a
septicemia picture and death of the worm.
The expression levels of protein cry1Ab on the lineage
MON810 were evaluated in young leaves, grains, whole plant
and pollen. Materials were collected in six places in the
United States of America, and the levels o expression of
the protein were evaluated by ELISA and Western blot. The
results showed the highest levels of expression on leaves
(9.35 μg/g of dry weight), followed by the whole plant
(4.31 μg/g of dry weight), grains (0.31 μg/g of dry
weight), and pollen (0.09 μg/g of dry weight). Later on,
the transfer of the cassette of expression containing the
gene cry1Ab for tropical germoplasm of corn was executed.
The first introductions of more adapted materials, or
materials in phase of adaptation, were made in Brazil in
1998. According to the petitioner, these requests aimed at
experimenting lineages derived from MON810 in Brazil and
proceed to the introgression of the gene in improvement
programs. To confirm the introgression of the cassette of
expression on tropical lineages, an experiment of Southern
blot was executed, and it identified the presence of the
transgene on the sample genotypes.
IV. Aspects Related to Human and Animals’ Health
The evaluation of safety of foods derived from genetically
modified raw material is based on risk analysis, scientific
methodology that encompass the phases of evaluation,
management and risk communication. On the risk evaluation
phase one looks for the qualitative and quantitative
characterization of potential adverse effects, having as
base the concept of substantial equivalence, for the
identification of eventual differences between the new
food, and its conventional correspondent.
To evaluate safety of genetically modified food raw
material, or its equivalence to conventional food, it is
recommended that four main elements are analyzed, more
specifically: (1) parental variety, that is, the plant that
originated the new genetically modified raw material; (2)
the transformation process, including the characterization
of the construction used, and of the resulting event; (3)
the inserted gene product and the potential toxicity and
allergenicity, and; (4) the composition of the new variety
deriving from the genetic transformation. The group of data
of this analysis should allow for the identification and
characterization of the potential adverse effects
associated to the consume of the new raw-material,
subsidizing the phases of management and risk
communication.
Z. mays is a well characterized species, having solid
background of safety for human consume. During the process
a considerable volume of information is presented,
including the origin, domestication, identity, taxonomy,
morphology, genetics hybridization and crossing, that
reflect the profound degree of knowledge around this
species.
Cultures of B. thuringiensis are registered at the National
Health Surveillance Agency – ANVISA under different
formulations for application in 30 kinds of vegetable
cultures for food use. They are included on the
toxicological classification of group IV, and there is no
determined maximum limit of residues and safety interval
(3).
In the process, it is mentioned that the sequence of gene
cry1ab of B. thuringiensis was modified to provide high
expression on corn, without, however, modifying the amino
acids sequence. This alteration does not imply on increased
risk, due to the variation on the repertoire of common
bases to the genetic code of organisms.
The transformation process consisted of the bombarding of
vegetal material with particles coated with genetic
material of interest. Once this is a physical process of
DNA molecules transfer, that does not count with
intermediation of any biological agent, and is executed
with asepsis conditions, it is practically little the
chances of having DNA molecules, other than those of the
genic construction present on particles, transferred to
vegetable cells.
Protein Cry1Ab is a á-endotoxin, produced by B.
thuringiensis that presents specific activity over the
digestive system of some family of insects. For its
activity, the protein should be ingested by insects, whose
stomach pH is capable of solubilizing protein. Under the
proteases action, the protein is transformed on the
activated form that is linked to specific receptors of high
affinity present in insects and absent in mammals.
The protein is only toxic for the mentioned target insects,
more specifically to lepidopteron (worms), who have in
their intestines, specific receptors for this protein.
Mammals do not have such places of linkage, and, therefore,
human beings, animals and other untargeted organisms are
not affected by protein Bt, including other arthropods and
also natural enemies of target-plagues (11, 18, 33, 38,
42).
Studies were conducted to evaluate the toxicity of corn
MON810, and of protein Cry1Ab. Quails were fed with grains
of corn of lineage MON810 with up to 10% of weight of bran
of corn whole grains on the diet, and adverse or toxic
effects have not been observed. Sanden and collaborators
(37) concluded that corn MON810, added to 12% of fish food,
are as safe as non-transgenic varieties, evaluating
parameters of the intestinal treat of Atlantic salmon.
Studies of food safety for mammals were carried out with
the protein expressed in E. coli that turned out to be
chemical and functionally equivalent to the one expressed
on lineage MON810, as well as in a formulation of microbial
plaguecide (DIPEL) containing B. thuringiensis. Studies of
acute oral toxicity for rats showed that the level reached,
without noted effects, was 4000 mg/Kg of body weight being
proposed a DL50 over this value. A recent published study
that evaluated the sub-chronic toxicity (90 days) of
Guardian corn in rats demonstrated that adding corn MON810
on levels of 11% and 33% to balanced diets did not bring
any alterations to animals fed with the genetically
modified variety, when compared to the non-modified
lineage(24). Shimada and collaborators(39) demonstrated the
absence of toxicity of protein Cry1Ab over culture of
isolated hepatocites of bovine suggesting that the protein
has low acute toxicity for mammal’s cells.
Protein Cry1Ab does not present allergenicity
characteristics, besides being degraded in the gastrointestinal
system of mammals. Data available in
literature(41) have indicated normal digestibility for the
varieties of transgenic corn released for human consume.
Okunuki and collaborators(34) argue that the protein
allergenicity, if any, should be meaningless due to the
digestibility characteristics of protein Cry1Ab in gastric
and intestinal fluids. These authors demonstrate also that
after being heated, the degradation is faster, what
suggests a smaller concentration of protein in foods based
on corn that are heated during the processing.
The protein sequence was compared to data banks of proteins
with allergenic properties. Meaningful biologically
homology was not demonstrated between the complete protein
Cry1Ab and sequences of proteins with these known proteins
at the time of this process presentation.
To check the allergenic potential of proteins extracted
from the transgenic corn MON810, and of protein Cry1Ab,
Batista and collaborators(7) evaluated two sensitive
populations of individuals, through skin tests: children
with inhaling allergy, and allergy to foods, and
individuals with asthma-rhinitis. Besides, they also
evaluated IgE levels in serum of individuals allergic to
corn and pure transgenic proteins (Cry1Ab). Authors
concluded that the transgenic evaluated regarding the
allergenic potential are safe. Similar results were
observed by Nakajima and collaborators(31) in patients with
allergy to foods. In these patients, no meaningful levels
of specific IgE against Cry1Ab in serum were found.
The analysis of chemical composition of the variety
obtained through transgene, mainly the levels of its
nutrients and of eventual toxic compositions naturally
present, aims at guaranteeing that this new variety is as
nutritive and safe as its conventional equivalent. Thus, it
serves to confirm that intentional effects of modification
did not compromise its safety, nor resulted in non-intended
effects. International data presented on the process
include the centesimal composition, profile of amino acids
and fatty acids of genetically modified variety, and of
cultivated parental varieties, under the same conditions,
in the United States (1994), Italy, France (1995). In
general, for all the analyzed parameters, there was no
meaningful difference between the genetically modified
variety, and its respective conventional counter-part, or
the differences were within the variety normally noted in
corn. Thus, it is possible to consider that the
introduction of gene cry1Ab has not resulted on apparent
alteration of nutritional importance, for the profiles of
the main nutrients were similar to those normally conserved
in other varieties, or under different conditions of
cultivation.
In Brazil, there were analysis of centesimal composition of
two hybrids derived from the lineage MON810, C806-guardian,
cultivated in the municipalities of Campo Novo dos Parecis
(MT), Uberaba (MG), and Pirassununga (SP) on the 1998-1999
crop. Similarly to what was observed for corn samples of
lineage MON810 cultivated abroad, there was no meaningful
difference in relation to the conventional variety, or the
differences were within the variability normally found in
corn. Data suggest that, also on plants cultivated in
Brazil, the introduction of gene cry1Ab has not resulted on
apparent nutritional alteration. Thus, results about
chemical and centesimal composition of corn 810 are in
accordance with the Principle of Substantial Equivalence
that affirms that, if food is modified by any technique and
has the same chemical and physical composition, texture,
nutritional value, and does not present toxic substance
different from the original food, these foods are
substantially equivalent, and, therefore, should not be
differentiated or segregated. According to Codex
Alimentarius, the Principle of Substantial Equivalence is a
key element on the process of innocuousness evaluation of
new food in relation to its conventional homologous(17).
It is relevant to consider that the protection given to
grains by toxin Bt against damages of worms on the spike
drastically reduces the incidence of rancid grains. The
presence of rancid grains is associated to production of
micotoxins, and it is a serious problem on corn. Thus, the
smaller observed infestation by insects brings as
consequence a smaller growth of fungus that produce
micotoxins of pathologic importance for humans and animals,
considerably reducing contamination, and consequently, the
presence of such toxins (22,23,28,35,43,44), contributing
to improve the quality and level of food safety of grains.
V. Environmental Aspects
Corn is a monoic plant: a sole individual contains male and
female flowers located separately. Corn plants are plants
of crossed fecundation, and widely pollinated with the help
of the wind, insects, gravity and others. The introduction
of genic elements previously described has not altered the
reproductive characteristics of the plant. Therefore, the
same chances of crossed fecundation that occur between
hybrids and conventional corn lineages - not genetically
modified - will occur between plants of event MON810 and
other corn plants.
Corn genic flow may occur through pollen transfer and seeds
dispersion. Seeds dispersion is easily controlled, once
corn domestication eliminated the ancient mechanisms of
seeds dispersion, and pollen movement is the only effective
mean of corn plants genes escape.
Studies about corn pollen dispersion have been conducted,
and some of them show that corn pollen may travel long
distances. However, most pollen that is released is
deposited near the culture, with very low translocation
rate outside the source culture. The predominant
pollination agent for corn is the wind, and the distance
that viable pollen may travel depends on wind patterns,
humidity and temperature. Luna and collaborators (27) have
evaluated the distance of isolation and control of pollen,
and have demonstrated that crossed pollination occurs in a
maximum distance of 200m, and no crossed pollination
happened in the same distances, or over 300 meters in
relation to pollen sources, in non detasseling condition.
The results indicate that the viability of pollen is kept
for 2h, and that crossed pollination was not observed in
300 meters distances from the pollen source.
Comparing the concentrations at 1 m of source culture,
under low to moderate winds, it was estimated that
approximately 2% of pollen is annotated at 60m, 1.1% at
200m and 0.75-0.5% at 500m of distance. At 10m from a
field, in average, the number of pollen grains per area
unit is ten times smaller than the one observed at 1m from
the border. Therefore, if the established distances of
separation developed for corn seed production are observed,
it is expected that the pollen transfer to the adjacent
varieties is minimized, and the presence of any genetic
materials resistant to insects is improbable.
Corn is an allogamous and annual plant, the predominant
pollination agent for corn is the wind and the distance
that pollen may travel depends on wind patterns, humidity
and temperature. Corn pollen is dispersed freely around the
area cultivated with this gramineae, and it may reach the
stigma-style of the same genotype, or of different
genotypes, and in adequate conditions, it starts its
germination, originating the pollinic tube that promotes
fecundation of the ovule within the average period of 24
hours.
The possibility of the transgenic plant to become a weed,
as well as the lineage crossing MON810 with other corn
plants, to originate a weed is very low, due to the
biological characteristics of the species, and to the fact
that corn does not survive without men intervention, result
of the selection made during its evolution. Corn is the
species that reached the highest degree of domestication
among cultivated plants, having lost its survival
characteristics in nature, such as, for example, degrana
elimination. Thus, corn is a plant that is incapable of
surviving in natural conditions, when not technically
assisted. So, it is expected that transgenic Bt corn has an
environmental behavior similar to the common corn,
therefore, there is no possibility that corn is transformed
into an invasive plant or weed.
The possibility of gene cry1Ab of the transgenic plant pass
to other organisms, as for example, soil microorganisms is
practically null (32, 40). Once B. thuringiensis is a soil
microorganisms, the expositions of live organisms, and of
the environment to this bacteria, or to any element
extracted from it, is an event that occurs abundantly in
nature, not resulting in meaningful risk for the soil micro
biota.
Another remote possibility is the transfer of exogenous DNA
to the human being that would consume corn MON810.
Depending on the composition of the ingested food, the
amount of DNA ingested by a person varies between 0.1 and
1.0 per day. The gene inserted into corn MON810 represents
a quantity 20,000 times smaller than this. Besides, DNA
molecule is disintegrated during the digestion impeding it
to be absorbed as a whole by intestine cells, likewise, men
and animal do not absorb DNA of billions of bacteria that
live in the intestine, or of any non-transgenic food.
Additionally, commercial formulations of B. thuringiensis
containing these proteins have been being used in Brazil
and in other countries for the control of some agricultural
plagues for 40 years. Due to its insecticides properties,
spray products based on Bt are the most efficacious
commercial bio-insecticides used for protecting crops, and
forests, and they start to substitute the measures of
conventional control that present practical
limitations(14). Nowadays, bio-pesticides based on toxin Bt
represent around 90% of the world market of bio-pesticides,
being widely used as an alternative to chemical
insecticides in terms of safety to untargeted organisms,
and when there is the development of resistance to chemical
insecticides (36).
Cry1Ab protein safety was tested for the following
organisms: bees (Apis melifera L.) in larvae and adults,
benefic pollinizer; crisopideo (Cryperla carnea) benefic
predator; a hymenoptera (Brachymeria intermedia),
parasitoid benefic insect of the domestic fly; ladybug
(Hippodamia convergens) benefic predator insect; worms
(Esenia fétida); micro-crustaceous of aquatic environments,
Daphnia magna. Field studies carried out in Brazil, about
insect populations present in transgenic corn plantations
derived from the lineage MON810, showed that the presence
of natural enemies, and of non-target insects in these
fields is similar. Field essays made for the evaluation of
insects population dynamics, such as beetles, ladybugs
(Coleopteran), syrphidae (Dipteral), bugs (Hemiptera) have
not demonstrated meaningful impacts on entomofauna of the
studied regions.
Corn MON810 has not present effect over the population
dynamics of the predominant species of spiders and benefic
insects of different trophic guilds either, including nontarget
plagues and benefic insects (Carabidae,
Coccinellidae, Chrysopidae, Hemerobiidae, Syrphidae,
Tachinidae and Apidae). The bees’ population, A. mellifera,
was bigger in the evaluated areas. This result may be
explained this way: (1) protein Cry1Ab does not act in the
digestive system of the bees, for it is specific only for
some lepidopteron species; (2) bees freely feed from the
pollen for the smaller use of insecticides on corn MON810
plantations.
Two doctorate theses(20,21) analyze the possible impacts
caused by corn MON810 over the different taxonomic groups
that represent biodiversity of Brazilian agro-system where
corn plantation is carried out. The main conclusion was
that corn MON810 does not have negative impact over the
evaluated insects’ community.
Data available in literature (4,5,8, 13) corroborate to the
results found, and are also evidence that among the
advantages of use of cry gene, in relation to other control
methods of lepidopteron, is the absence of negative effects
in non-target insects, mammals and human beings, the high
specificity and efficiency against target-insects, the
environmental degradability, and the safety of manipulation
and use.
One should highlight that any insects control measure that
allow for the reduction on the use of chemical defensives
should be considered as a priority under the point of view
of environmental and nutritional safety.
VI. Restriction to the use of GMO and its derivatives:
Technical opinions regarding the agronomic performance came
to the conclusion that there is equivalence between
transgenic and conventional plants. Thus, information
indicates that transgenic plants do not fundamentally
differ from non transformed corn genotypes, except for
resistance to insects of Lepidoptera order. Additionally,
there is no evidence of adverse reactions to the use of
Guardian corn. Thus, there is no restriction to the use of
this corn, or of its derivatives to human or animal
feeding.
The vertical gene flow for local varieties (called creoles
corn) of open pollination is possible, and presents the
same risk caused by commercial genotypes available in the
market (80% of planted conventional corn in Brazil comes
from commercial seeds that went through a genetic
improvement process). The coexistence between conventional
corns cultivation (improved or creoles), and transgenic
cultivations of corns is possible from the agronomic point
of view (10, 29), and should follow the disposition on
Normative Resolution No. 4 of CTNBio.
VII. Considerations about particularities of different
regions of the Country (subsidies to the inspections
organs):
In accordance with what is established on art. 1 of Law
11.460, of March 21st, 2007, “it is vetoed the research and
cultivation of organisms genetically modified on indigenous
lands and areas of conservation units”.
VIII. Conclusion
Considering that Guardian variety of corn (Zea mays)
belongs to a well characterized species, and with solid
safety background for human and animal consume, and that
gene cry1Ab introduced into this variety codifies toxic
protein exclusively for larvae of insects of Lepidoptera
order, being innocuous to human beings.
Considering that the genic construction used to insert this
gene into corn resulted on the stable insertion of a
functional copy of cry1Ab, what provided resistance of
plants to worms attack.
Considering that data of centesimal composition, resulting
from plants analysis cultivated in the United States of
America, Italy, France, and Brazil, do not point out
meaningful differences between the genetically modified
varieties, and the conventional ones, suggesting the
nutritional equivalence between them.
Considering also that:
1. Corn is the species that reached the highest degree of
domestication among cultivated plants, being able to
survive in nature without human intervention.
2. There is no sylvan species in Brazil with which corn can
be crossed, since the closer sylvan species to corn is
teosinte, found in Mexico and in some places in Central
America, where it can be crossed with corn cultivated in
production fields.
3. Protein Cry1Ab was detected in low levels of analyzed
tissues, and presented great susceptibility to digestion in
simulations of gastric fluids, not demonstrating acute
toxicity in mammals, or similarity with known allergenic.
4. The smallest infestation of Helicoverpa zea noted on
transgenic cultures results on a smaller number of damaged
gains, and, consequently, in a smaller growth of fungus
that produce micotoxins of pathological importance for
human beings and animals, considerably reducing the
contamination and, consequently, the presence of these
toxins , contributing for the improvement of the quality,
and of the level of food safety of the grains.
5. The genetic modification introduced on event MON810 has
not resulted in important differences of chemical
composition regarding nutrients, being within the normal
variation scope among the conventional varieties.
6. DNA molecule in a natural component of food, not
presenting any evidence that such molecule may have adverse
molecule effect to men when ingested in food in acceptable
quantities (no direct toxic effect).
7. There is no evidence that intact genes of plants may be
transferred and functionally integrated to human genome, or
to other mammals exposed to this DNA, or foods manufactured
with these elements(16).
8. The petitioner answered to all the questionings
postulated on Normative Instruction No. 20 of CTNBio, and
none of the questions indicate that this corn may present
adverse effects on human and animal food.
9. The possibility of the transgenic plant become a weed,
as well as the crossing of lineage MON810 with other corn
plants originate a weed is too small.
10. B. thuringiensis is a soil microorganisms, and the
expositions of live organisms, and of the environment to
this bacteria, or to any element extracted from it, is an
event that occurs abundantly in nature, not resulting in
meaningful risk for soil micro biota.
11. B. thuringiensis cultures are registered in the
National Health Surveillance Agency – ANVISA under
different formulations for the application in 30 kinds of
vegetable cultures for food use.
12. Bio-pesticides based on toxin are widely used as an
alternative to chemical insecticides in terms of safety to
untargeted organisms, and when the development of
resistance to chemical insecticides occurs.
13. Field studies carried out in Brazil about populations
of insects present in transgenic corn plantations derived
from MON810 lineage, showed that the presence of natural
enemies of untargeted insects in these fields is similar.
14. MON810 corn did not present effect over the population
dynamics of predominant species of spiders, and benefic
insects of different trophic guilds, including untargeted
plagues and benefic insects.
15. Among the advantages of use of cry gene in relation to
other control methods of lepidopteron, we have the lack of
negative effects in untargeted insects, mammals and human
beings, high specificity, and efficiency against target
insects, the environmental degradability, and safety of
manipulation and use.
16. Any control measure of insects that allow the reduction
on the use of chemical defensives should be considered,
mainly under the environmental, safety and economical point
of view.
17. The coexistence between cultivations of conventional
corns (improved or creoles), and transgenic cultivations of
corns is possible from the agronomic point of view, and one
should observe the disposition on Normative Resolution No.
4 of CTNBio.
18. Criticism, questionings and allegations entered in
protocol by people, or by organizations that discuss the
release of this transgenic variety are, mostly, based on
news from newspapers, or electronic addresses of nonscientific
organizations, not presenting scientific
foundation.
19. Some documents that were entered in a protocol
presented many conceptually wrong statements, or
superficial ones, showing profound lack of knowledge of
molecular biology, and inducing the reader to wrong
conclusions.
20. Attachment III of Cartagena Protocol about Biosafety
(Decree 5.705, of February 16th, 2006) says that risks
associated to modified live organisms, or to products
derived from them, to wit, benefited materials that have as
origin a modified live organism, containing new detectable
combinations of replicable genetic material obtained
through the use of modern biotechnology, should be
considered on the context of risks presented by the nonmodified
receptors or parental organisms in the probable
receptor environment.
21. The historical use of this transgenic variety in the
world appoints to a great accumulation of trustworthy
scientific information that indicate that this variety is
as safe for the environment, and for human and animal’s
health, as the varieties of hybrid corns that have been
being used.
22. After ten years of use in different countries, no
problem was detected for human, and animal’s health or to
the environment that may be attributed to transgenic corns.
It is necessary to emphasize that the lack of negative
effects resulting of corn transgenic plants does not mean
that they may not happen. Zero risk and absolute safety
does not exist in the biologic world, although an
accumulation of trustworthy scientific information already
exists, and a safe background of ten years of use allows us
to declare that corn MON810 is as safe as conventional
versions. Thus, the petitioner should conduct monitoring of
post-commercial release on the terms Normative Resolution
No. 3 of CTNBio.
Before the foregoing, and considering the international
criteria accepted on the process of risk analysis of
genetically modified raw-material, it is possible to
conclude that Guardian corn, derived from MON810 lineage,
is as safe as it conventional equivalent.
CTNBio thinks that this activity is not potentially causing
meaningful degradation to the environment, or aggravations
to human and animal’s health. The use restrictions of the
GMO in analysis, and its derivatives are conditioned to
disposition on Normative Resolution No. 03 and Normative
Resolution No. 04 of CTNBio.
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Walter Colli
President of CTNBio
Divergent Vote
The reporter Dr.Rubens Onofre Nodari (Environmental
Permanent Sector Sub-commission) issued contrary opinion to
this product approval based on:
1. The doctrine of substantial equivalence does to have
legal or scientific support to be granted.
2. The sequence of nucleotides inserted on lineages MON810
is not available;
3. Absence of risk analysis composed of studies about
possible adverse effects to the environment in Brazilian
ecosystems with descendent Brazilian varieties of MON810.
4. Absence of studies with the insecticide nucleus of toxin
Cry1Ab extracted from plants MON810.
5. Lack of expression data of insecticide toxin cry1Ab in
different organs and tissues of transgenic plants of
Brazilian varieties (except leaves).
6. Most of the studies with untargeted organisms are not
scientifically robust enough.
7.CTNBio demands were not fulfilled by the petitioner
company.
8. The scientific literature available was partially used.
9. There was an attempt of considering equal the use of
biological insecticides based on Bacillus thuringiensis and
MON810, without considering that GMO contains non-active
and partially synthetic genes expressed all the time, and
in every tissue of the plant.
10. An effective and efficacious coexistence plan with
other cultivation systems, and varieties without
contamination does not exist.
11. Law 11.105/2005, particularly the observance of the
Precaution Principle, and the Cartagena Protocol about
Biosafety, particularly the policies and principles of Risk
Analysis, stipulated in its Attachment III, were not
fulfilled.
12. Risk evaluation should be executed, including studies
of environmental impact in Brazilian ecosystems, and
studies on regions of corn cultivation in Brazil to
evaluate the possibility of coexistence without
contamination.
13. A public hearing specifically about MON810 should be
executed.

Executive Secretariat of CTNBio
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