| | english | español | français |
Go to record ID

  Home|Finding Information|Record details   Printer-friendly version

Risk Assessment
Record information and status
Record ID
113491
Status
Published
Date of creation
2016-06-23 12:57 UTC (gutemberg.sousa@mctic.gov.br)
Date of publication
2018-06-15 13:35 UTC (dema@itamaraty.gov.br)

General Information
Country
  • Brazil
Title of risk assessment
Risk Assessment fo genetically modified soybean named 'FG72' soybeans, tolerant to herbicides based on glyphosate and isoxaflutole
Date of the risk assessment
2015-10-08
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
Email:ctnbio@mct.gov.br
Url:National Technical Biosafety Comission
Contact details of the main responsible risk assessor
Dra Maria Sueli Felipe Soares
President
National Technical Biosafety Comission (CTNBio)
Setor Policial Sul -SPO Área 5 Quadra 3 Bloco B - Térreo Salas 08 à 10
Brasília, DF
Brazil, CEP - 70610-200
Phone:(5561) 3411-5151
Fax:(5561) 3317-7475
Email:msueliunb@gmail.com
Url:National Technical Biosafety Comission
Risk assessment details
Living modified organism
MST-FGØ72-2 - Soy modified for tolerance to glyphosate and HPPD inhibitors
Resistance to herbicides - Glyphosate
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 Introduction into the environment
    • Commercial production
    • Field trial
  • LMOs for processing
Risk assessment report / Summary
Methodology and points to consider
Potential adverse effects identified in the risk assessment
Regarding the studies of compositional analyses initially submitted by applicant, such
compositional analysis had been conducted in samples originated from cultivars in 10 different
locations within the United States. CTNBio requested this analysis to be also conducted in samples coming from Brazil and that the results were compared. The studies were conducted
by applicant with samples coming from three field essays that were selected in the 2012-2013
crops in Taquaravi, State of São Paulo; Poxoréu, State of Mato Grosso; and Água Santa, State of
Rio Grande do Sul. The analyses of samples produced in Brazil were conducted by Laboratório
TECAM, São Paulo, SP (analytical phase of the study and determination of centesimal
composition and fibers, minerals, Vitamin A, Vitamin B1, Vitamin B2, folic acid, tryptophan,
phytic acid, stachyose, raphynose and fat acids), by Centro de Ciências e Qualidade de
Alimentos, The Food Technology Institute - CCQA/ITAL (determination of lecithin, total
isoflavones and tocopherols) and by LABTEC - Laboratório de Análises Químicas, located in
Hortolândia, State of São Paulo (determination of total amino acids, except tryptophan).
Components selected for nutritional composition analyses represent important basic nutrients
of soybean, such as centesimal composition (including fibers), micronutrients, such as minerals
and vitamins, isoflavones, anti-nutrients such as raphynose, stachyose, phytic acid, trypsin
inhibitors, total amino acids, and fat acids.
- Centesimal Composition: Centesimal composition analyses of soybean seeds, both for
treated and untreated event FG72 soybean (application of herbicides IFT and
glyphosate) and for its conventional isoline, failed to display difference between them.
Averages remained within the range of values calculated from three commercial
varieties of soybean and of reference intervals widely known and reported in the
specialized literature for this culture.
- Minerals and Vitamins: Amounts of minerals and vitamins found in seeds of event
FG72 soybean, either treated or not with herbicides, and its conventional isoline were
equivalent between genotypes of the three commercial varieties and within referenceintervals described in the literature for this culture.
- Isoflavones and Anti-nutrients: Analyses of FG72 soybean seeds, either treated or not
with herbicides and seeds of its conventional isoline showed that the amounts of
isoflavones and non-nutrients failed to display significant differences between the
treatments, and all amounts were within the range of values described by the
literature for soybean seeds. When such analyses were conducted in toasted and
untoasted soybean meal, the content of anti-nutrients in genetically modified and
non-genetically modified samples was no different.
- Amino acids: The amount of amino acids found in soybean seeds and toasted and
untoasted soybean meal coming from FG72 soybean, either treated or untreated with
herbicides and from seeds of its conventional isoline failed to show significant
differences both between the treatments and the ranges of reference reported in the
literature.
- Fat Acids: The fat acid profile in samples of genetically modified seed and oils (both
plants treated and untreated with herbicides) and non-genetically modified ones,
were very similar. There were only small differences for oleic acid (C18:1) and linoleic
acid (C18:2); however, the values remained between their respective ranges of
reference.
- Phospholipids: The profile of phospholipids found in genetically modified soybean
(either treated of untreated with herbicides) and in its non-genetically modified isoline
is similar to each other and comparable to the levels found in conventional soybeans.
Therefore, these results taken as a whole, indicate that FG72 soybean displays substantial equivalence to the non-genetically modified soybean. The principle of substantial equivalence,
which is accepted by the United Nations Food and Agriculture Organization (FAO) and the
World Health Organization (WHO), is a concept that has contributed towards construction of a
robust framework to analyze alimentary safety of new food, including those coming from
transgenic plants (FAO/WHO, 2000).
Regarding nutritional assessment and animal performance, studies were conducted in boiler
chicken lineage ROSS 308 (Gallus gallus domesticus) using two-day birds, in a total of 420
individuals randomly selected (210 male and 210 female). In an experimental delineation, the
birds were also randomly selected for the three treatment groups, with 140 birds in each such
groups, accommodated in 14 replicates (seven male cages and seven female cages). The three
treatment consisted of ration containing: (A) toasted soymeal seeds from soybeans
conventional isoline; (B) toasted soymeal from FG72 soybean event; and (C) toasted soymeal
seeds from commercial non-GM soybeans. Birds were fed for 6 weeks (42 days) and health
effects, mortality, body weight, alimentary conversion efficiency, carcasses, muscles (breast,
thigh, foot, wing) and abdominal fat weight were assessed (STAFFORD, 2009).
The results failed to identify any change related to consumption of FG72 soybean, that is to
say, no adverse effect was recorded. For using animals that are very sensible to environmental
and nutritional changes, the experiment also evidences that genes 2mepsps and HPPD W336
do not produce toxins or other metabolites that may be hazardous to human or animal health.
Regarding digestibility of proteins 2mEPSPS and HPPD W336 expressed by FG72 soybean, it
shall be emphasized that one of the physicochemical characteristics of allergenic proteins is
resistance to proteolytic hydrolysis (AALBERSE, 2000) VERHOECK et al., 2015). Therefore,
resistance to digestibility of a protein has been used as a measure of its allergenic potential. Results obtained by applicant in gastric system and intestine simulation essays conducted
according to the methodology recommended by ILSI (International Life Science Institute)
(THOMAS et al., 2004) show that protein 2mEPSPS is rapidly degraded (<30 seconds) in a
medium with pH 1.2 in the presence of pepsin, or in a medium with pH 7.5 in the presence of
pancreatin (HEROUET-GUICHENEY et al., 2009). Similarly, protein HPPD W336 was promptly
degraded in a gastric simulation medium (pH 1.2 in a medium with enzyme pepsin) in thirty
seconds of incubation. In the presence of pancreatin and pH 7.5 (simulating the intestine
system), total degradation of HPPD W336 took place in less than 0.5 minutes. The results
indicated that the two proteins are promptly digested when exposed to media containing
digestive enzymes and under pH and temperature similar to the ones found in the
gastrointestinal systems of humans, failing therefore to display allergenic characteristics.
Likelihood that the potential adverse effects will be realized
Acute toxicity of proteins 2mEPSPS and HPPD W336 were assessed for 14 days in OF1 mice
through administration of highly concentrated proteins by oral (2000 mg/kg of the target
protein) and intravenous routes (up to 10 mg/kg). Clinical signs or individuals were
accompanied on a daily basis with the purpose of recording the onset, severity, reversibility
and duration of such symptoms. However, no change or mortality was found along the period
of assessment. Weight gain in animals treated with the target proteins was assessed on a
weekly basis and contrasted with that of animals treated with BSA (control), and no significant
difference was found. At the end of the experiment, the animals were necropsied and macroand
microscopic assessments were conducted in internal organs and cavities. Results showed
that the proteins 2mEPSPS and HPPD W336 failed to display any toxic effect on individuals
submitted to oral ingestion or intravenous administration of these polypeptides in high
concentration, indicating the safety of these compounds for the organisms. In silico studies were conducted to asses, in public databases, similarity of proteins HPPD W336
and 2mEPSPS against sequences of allergens and toxins. No homology of epitopes or putative
sites of n-glycosylation was found between the target-sequences and those sequences present
in different publicly assessed databanks and knowingly being allergenic or toxic.
Summarizing, results indicate that proteins 2mEPSPS and HPPD W336 expressed in FG72
soybean have no potential adverse effect on human and animal health
Possible consequences:
Other cultivars exist in Brazil of genetically modified soybean with the same characteristic of tolerance to herbicides (glyphosate, imidazolinones) that are commercially planted in millions
of hectares and, up to now, the technologies proved to be efficient, with no reference to
proven adverse effects when compared to cultivation of the conventional varieties.
Regarding Changes in the survival ability of the GMO in environments different from those
occupied by the parental, caused by new characteristics introduced, it shall be stressed that
the characteristics introduced in FG72 soybean is the selectiveness to herbicides glyphosate
and isoxaflutole as a result of the expressed proteins 2mEPSPS and HPPD W336. Given the
specificity of such enzymes, the long history of use of genetically modified soybean in the
country and the similarity of the phenotypic/agronomic characteristics of FG72 soybean as
against conventional varieties, there is no record of any fact that may corroborate the
hypothesis of changing the survival ability of Event FG72 in environments different from the
agricultural ecosystem.
SANVIDO et al. (2007), revising the literature resulting from 10 years of research in
experimental and commercial cultivation areas of genetically modified cultures report that
there is no evidence that an extensive cultivation of genetically modified canola with selectivity
to herbicides in the west of Canada had resulted in increased numbers of voluntary canola due
to its characteristics of tolerance to herbicides. Similarly, there is no evidence that the genetic
modification for such characteristics had increased the potential invasiveness of genetically
modified canola in natural environments.
In an extensive review of scientific publication on analysis of genetically modified products use
risk, LEMAUX (2008, 2009) concluded that though no human activity is able to reach a 100
safety level, genetically modified cultivars and their products commercially available are as safe
as those generated from conventional methods.
Estimation of the overall risk
1) Soybean species Glycine max is in the food chain for over 4,000 years with no record of
damage to humans, animals and the environment;
2) Over the relevant millennia, soybean failed to present characteristics of being a pest
plant;
3) There is not in Brazil sylvan species with which soybeans may intercross;
4) Genes inserted in one single locus of the plant genome, the characteristics of such
genes showed to be stable along generations and the segregation is mendelian;
5) Studies conducted in Brazil, Canada and United States of America showed that FG72
soybean is not different from the conventional variety in agronomic, morphologic,
reproductive characteristics, in survival characteristics and the form of dissemination of
plants, in the response to may pathogens and pests, except for the characteristics of
tolerance to herbicides glyphosate and isoxaflutole, granted by the presence and
expression of genes epsps of maize and hppd of bacterium Pseudomonas fluorescens,
respectively;
6) Chemical composition analysis, conducted in planned releases conducted in different
locations in Brazil and the United States of America, present similar results and show
that FG72 is substantially equivalent to conventional soybean;
7) Studies of nutritional assessment and animal performance conducted in broiler chicken
fail to reveal any change related to the consumption of FG72 soybean when compared
to conventional soybean and any adverse effect to the birds;
8) Proteins 2mEPSPS and HPPD W336 produced by the genetically modified soybean failed
to present any toxic or allergenic effect;
9) The change introduced failed to interfere in the ability to symbiotic association of
genetically modified plants with Bradyrhizobium japonicum with no impact, therefore,
in nitrogen fixation;
10) The event represents one additional available for farmers to manage populations of
weed in soybean cultures;
11) Biosafety analyses of FG72 soybean already conducted by regulatory agencies of
countries where the event had been analyzed and passed;
12) Information currently available in the scientific literature;
Recommendation(s)
One may conclude that FG72 soybean is as safe as its conventional equivalent. Therefore,
CTNBio opinion is favorable to the granting of the request for commercial release of this Event
Need(s) for further information on specific issues of concern
CTNBio analysis took into consideration the opinions issued by the Commission members;
documents supplied to the CTNBio Executive Secretary by the applicant; results from planned
releases into the environment and related texts. Also, consideration was given and
consultations made to studies and scientific independent publications of the applicant and
prepared by third persons, as well as the analyses already carried out in other countries by the
respective agencies of genetically modified organisms regulation.
Receiving environment(s) considered
Soybean (Glycine max) is the currently world leading oilseed culture in production and
consumption (WILCOX, 2004). Soybeans culture has its center of origin in the eastern region of
China (BORÉM, 1999) and is recognized as one of the first plants that were cultivated. The
species Glycine max belongs to the subgenus Soja, which includes Glycine soja and Glycine
gracilis. Glycine soja is a feral species that grows naturally in fields, roadsides, and ravines, but
only in some Asian countries. Cytological, morphologic and molecular analyses suggest that
Glycine soja is an ancestor species of Glycine max. Feral species are endemic in China, Korea,
Japan, Taiwan and the former Soviet Union. Glycine gracilis occurs only in northeastern China
and has a morphology described as intermediary between Glycine max and Glycine soja
(SKVORTZOV, 1927). Glycine gracilis is held to be a pest or semi-feral species of Glycine max,
featuring intermediary phenotypic characteristics between Glycine max and Glycinia soja
(OECD, 2000), or may be presented as a hybrid of Glycine max and Glycinia soja (OECD 2000).
Besides the subgenus Soja there are 12 perennial species belonging to the subgenus Glycine.
These species originated in Australia, South Pacific Islands, China, Papua New Guinea,
Philippines and Taiwan. Attempts to hybridization between annual and perennial species failed
to succeed in producing new individuals (HYMOWITZ, 1970). Evolution of soybean started with the appearance of plants formed by natural mating between
two species of feral soybean that were domesticated and improved by Chinese scientists. After
domesticated, soybean was introduced in other Western regions and countries, such as
Manchuria, Korea, Japan, Soviet Union and Southeastern Asian countries.
Soybean currently cultivated is typically herbaceous, annual and short days, with
characteristics quite distinct from the ancestor that originated it, which were creeping and
climbing species (SEDIYAMA et al., 2005). Feral species that belonged to the genus Glycine may
cross with cultivated soybean. However, according to VERNETTI (1983) and BORÉM (1999),
there is no native, sylvan or feral species in Brazil that may intercross with Glycine max. The
surveys conducted by HYMOWITZ (1970) and SINGH and HYMOWITZ (1999) prove that no
selvatic species of soybean occur naturally in Brazil.
Regarding the history of cultivation and use of a parental organism in terms of safety for the
environment, and human and animal consumption, informing on the likelihood of introgressive
hybridization with species sexually compatible and on the possible selective advantage of the
transgene it is important to stress that soybean (Glycine max) is a leguminous plant that is in
the alimentary chain for over 4000 years and has been an essential part of the Asian diet for
thousands of years. Currently cultivated soybean is quite different from its originating
ancestors: creeping plants that developed in the eastern coast of Asia, mainly along the Yellow
River in China. Its evolution started with the appearance of plants coming from natural
crossings between two species of feral soybean that were domesticated and improved by
scientists of ancient China. Its importance in the alimentary diet in the ancient Chinese
civilization was so large that soybean, jointly with wheat, rice, rye and millet were held to be
sacred grains, with right to ritualistic ceremonies at seeding and harvesting (EMBRAPA, 2004). Soybean is currently cultivated in over 35 countries. The first to process soybean were the
Chinese. Grains were crushed to obtain oil, which was used as food, and the soymeal initially
used as fertilizer and food to the animals and, later used in human feeding (TEIXEIRA et al.,
2009). Soybean was introduced to the West only in the twentieth century, arriving to the
United States of America in 1804 and to Brazil in 1882. Soybean was the main source of raw
material for extracting edible plant oil and of production of high protein bran used as human
food and animal ration, respectively (SEDIYAMA et al., 2009). The production of grain is
directed to different uses, such as oils (used in margarines, salads, cooking), alimentary
products such as tofu, soy sauce, soy milk, soy meat (texturized protein) among others.
Besides, soybean is used as alimentary supplement in animal rations. Industrial use of
soybeans is related to a range of products, since production of antibodies to the use in soaps
and disinfectants. (OECD, 2000).
Soybean arrived to Brazil, coming from the United States, in 1882. The first studies involving
assessments of cultivar introduced from that country were conducted by Gustavo Dutra,
professor of the State of Bahia School of Agronomy. In 1900 and 1901, the Agronomic Institute
of Campinas (IAC), State of São Paulo, promoted the first distribution of soybean seeds for
farmers of that State and, simultaneously, the first record of soybean farming was recorded in
the State of Rio Grande do Sul (EMBRAPA, 2004). Currently, Brazil is the second larger world
producer, with a planted area of 32.50 million hectares and a production of 97 million tons of
the grain in the 2015/2016 crop (USDA, 2015).
The crossing of a sylvan species of soybean with a cultivated soybean species may lead to the
creation of interspecific hybrid which, when successively recrossed with the cultivated species
and followed by selection, originate descendants similar to the cultivated parental, though enriched by some genes derived from the sylvan species. Through this process, named
introgressive hybridization, many cultivated plants developed to be intensely cultivated by the
human species (AZEVEDO et al., 2000).
Cultivated soybean (Glycine max) crossed naturally with the sylvan species Glycine soja,
although this has been recorded naturally only in China, Japan, Taiwan and Russia, and is not
found in the Brazilian environment. Therefore, the likely transfer of the selectivity
characteristics to glyphosate and isoxaflutole herbicides (introgression of genes 2mepsps and
hppd W336, respectively) to their parents or other species through genic flow in Brazil is close
to null.
Regarding analysis of the transgene selective advantage, it important to stress that, for being a
domesticated species, soybean depends highly on the human species for its survival and
scientific reasons would not exist to forecast the survival of soybean plants outside farming
environments. Besides, in the absence of a selective pressure (use of the herbicide), expression
of the inserted gene does not grant the plant any adaptive advantage.
The probability that soybean Event FG72 would present any selective advantage is very low,
since genes 2mepsps and hppd W336 are solely related with selectiveness to the glyphosate
and isoxaflutole herbicides. The study carried out in Brazil by applicant (MORAIS,
2011a - Annex 5) showed that the plants of FG72 soybean keep being sensitive to the active
ingredients Paraquat and Ammonium Gluphosinate, the same as any other soybean
conventional variety.
Data presented by applicant related to phenotypic assessments resulting from essays carried
out in Brazil (INOUE, 2011) and the United States of America ((KOWITE,2009), indicate that no
characteristic was recorded between GM FG72 soybean and non-GM soybean that could indicate any interference in of genes in the species adaptability. Therefore, the genetic change
failed to ascribe any selective advantage to FG72 soybean as against conventional soybean.
Regarding symbiont organisms, soybeans is one of the cultures that fix N2 existing in the
atmosphere due to the symbiotic association of its roots with bacteria of the Rhyzobium genus.
Inoculation of seeds with bacteria of the genus Rhyzobium is one of the practices adopted. The
association may also occur with some species of this bacterium naturally present in soils.
Therefore, Rhysobium may be held as a relevant symbiont organism to act as an indicator to
show whether the genetic modification introduced by FG72 soybean resulted in a product
offering greater environment risk than the commercial varieties of the plant. To answer this
question, applicant presented studies carried out in releases planned in the 2010-2011
harvests (Cascavel, State of Paraná; Palotina, State of Pará; Capão do Leão, State of Rio Grande
do Sul, and the 2012-2013 harvests (Paulínea, State of São Paulo; Trindade, State of Goiás;
Poxoréu, State of Mato Grosso; and Água Santa, State of Rio Grande do Sul) with the purpose
of assessing the association ability of Rhyzobium with plants of Event FG72 soybean, as against
its Jack conventional lineage (MORAIS, 2011b, MORAIS e ARAÚJO, 2014).
Results obtained show that the genetic change failed to affect the ability of symbiotic
association between Bradyrhisobium japonicum (lineages SEMIA 5079 and SEMIA 5080) and
soybean plants, with no impact on nitrogen fixation.
Regarding the entomofauna, data collected in the 2010-2011 crop indicate that there was not
significant modification in the population of natural enemies inhabiting the plots, while the
pests recorded did not present any differential preference either variety.
In what regards the GMO reproduction and propagation structures dispersion ability beyond the cultivation areas and the mechanisms for their dispersion in air, water and soil, supplying
information on the plant's pollen viability and indicating the potentially pollinizing and their
geographic distribution in Brazil, it is worth stressing that soybean is an essentially autogamous
plant, with perfect flowers, with both male and female organs protected within the corolla,
which favors autopollination (AHRENT and CAVINESS, 1994; MORSE and CARTTER, 1937;
RUBIS, 1970), being commercially propagated through seeds.
Insects, such as Trigona spinipes Fabricius (Hymenopera: Apidae) and, mainly, Aphis mellifera
(Hymenoptera: Apidae), are able to transport the pollen and provide for pollination of flowers
from different plants (ABUD et al., 2007). However, the soybean flower is little attractive to
bees, which are the most efficient pollinizers for soybean (THOMAS, 1989), notwithstanding
the natural soybean mating rate rarely reaching figures higher than one per cent for any
variety (ABUD et al.; NELSON and BERNARD, 1984). Studies conducted in greenhouse indicate
that there is no difference between these parameters between FG72 and the non-GM
soybean.
Regarding the likelihood of long term reproduction structures formation in the parental
organism, genes 2mepsps and hppd W336 are specific in attributing selectivity to herbicides
glyphosate and isoxaflutole (IFT) and fails do display any relation with the formation of
reproductive structures.
Post-harvesting monitoring assessments conducted in field essays in Brazil showed that FG72
soybean does not persist in the environment and failed to change into a more aggressive and
invasive species.
Soybean is a cultivated plant that underwent a domestication process and reproduces almost
exclusively by inbreeding, which limits the transfer of the inserted gene to other plants. Besides, soybean is not original in Brazil. Therefore, there are no plants kin of the species in our
environment, which eliminates the likelihood of transfer, in our conditions, of the introduced
gene (AZEVEDO et al., 2000).
There is a discrete fear that genes inserted in genetically modified plants may be transferred to
other species and cause damages, especially to soil microorganisms and microorganisms of the
digestive tract of humans and animals (DROGE et al., 1998). However, several studies
conducted to this purpose were unable to show the occurrence of transference, in normal
conditions of genes through horizontal flow between GM plants and bacteria (BERTOLLA and
SIMONET, 1999; GEBHARD and SMALLA, 1999; NELSEN et al., (1998). Essays conducted under
environment conditions with non-sterile soil failed to record occurrence of horizontal transfer
between plants and microorganisms, suggesting that soil conduction in itself inhibits the
transformation (THOMSON, 2001). A study with soil bacteria in an area that had been
cultivated for ten years with Bt maize evidenced that maize transgenic plants do not increase
the likelihood of acquisition of resistance to antibiotics by soil bacteria (GMO Safety, 2008).
Nevertheless, if we consider the remote hypothesis of transfer of cassettes containing genes
2mepsps and hppdPfw336 to some soil organism, the result would be an organism that
presents just tolerance to herbicides glyphosate and/or isoxaflutole. This characteristics does
not imply any adaptive advantage to microorganisms and fails to make possible for the
organisms a better reproduction ability and stability in the environment. Therefore, it could
not cause significant damage to the ecosystem.
Regarding possible negative and positive impacts to target and non-target organisms that
could take place with the release of the GMO into the environment, the listing of assessed
species, the reasons for the choice and the techniques used to show the impacts, it comes to surface that the use of FG72 soybean has the purpose of incrementing the management of
pest plants in post-emergence by using more than one herbicide featuring large range of
action. This characteristics of tolerance to herbicides described for Event FG72 does not result
in tolerance to any biotic element of the environment, and therefore there is no targetorganism
for the technology.
In field studies carried out in Brazil, United States of America, Canada and Argentina since
2002, the applicant reports that no adverse or unexpected effect was recorded as a result of
cultivation of FG72 soybean.
In 2007, a revision of works published up to the one regarding experimentation in areas of
research and commercial farming at global level, focusing on genetically modified cultures
already passed for commercial use and having relevant importance for agriculture in Central
and Western Europe (such as maize, canola and soybean) and more, considering the main
characteristics of tolerance to herbicides and resistance to insects, showed that the data then
available failed to show any scientific evidence that cultivation of GM assessed had caused
damages to the environment (SANVIDO, et al., 2007). The conclusion holds to date.
The assessment of changes in the ability of the plant to add or remove soil substances as a
result of the introduction of new characteristics, describing possible physical and chemical
changes of the soil and contamination of surrounding water bodies resulting from interactions
with the GMO, contrasted with conventional systems, according to data the only difference
between genetically modified soybean, event FG72 and conventional soybean varieties are
proteins 2mEPSPS and HPPD W336 expressed by FG72 soybean.
Event FG72 is substantially equivalent to conventional soybean and no difference was recorded
of phenotypic or agronomic difference in field tests carried out in Brazil and the United States between FG72 and conventional soybean. Each essay was conducted under the same
environment conditions, including soil fertility, an indication that Event FG72 soybean has no
differenced ability to use or remove components of soils.
Biodegradability of FG72 soybean refers to its susceptibility in suffering the action of soil
microorganisms, depending such action on: (i) physical characteristics of the plant; (ii) chemical
characteristics, and (iii) availability and activity of microorganisms. The expression of proteins
2mEPSPS and HPPD W336 is not expected to change either physical or chemical characteristics
of FG72 soybean, or capable to change the biodegradability of the plant by leading to the
production of composts displaying any toxicity to microorganisms, preventing or extending the
term for degradation or to differentiated expression of some molecule that could make
decomposition by microorganisms difficult.
Introduction of genes 2mepsps and hppdPfW336 in Event FG72 had the specific purpose of
making the Event specifically selective to group G and group F herbicides, glyphosate and
isoxaflutole, respectively. FG72 soybean remains sensitive to registered herbicides to the
control of pest plants both during soybean cultivation and in rotation of soybean with other
cultures. Voluntary soybean plants may be treated with pre-emergence or post-emergence
herbicides including 2,4D, atrazine, ammonium gluphosinate, mesotrione, acetochlor and
dicamba. It must be stressed that integrated management, with rotation of herbicides, is the
best way to reduce the resistance of weed to herbicides (BOEBOOM and OWEN, 2006).
FG72 soybean had been already PASSED in nine countries (Australia, Canada, South Korea,
United States of America, Japan, Malaysia, Mexico, New Zealand and Taiwan) either for human
food or animal ration.
LMO detection and identification methods proposed
Molecular traditional methods

Records referencing this document (1)
IDDescription
1record(s) found
Country's Decision or any other Communication1 record