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Évaluation des risques générée par un processus de réglementation (RA)
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BCH-RA-BR-47840-3   |   PDF   |   Imprimer   |  
published: 17 déc. 2008 last updated: 27 mars 2013
Informations générales
Risk assessment for herbicide tolerant maize (Roundup Ready 2)
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Détails de l’évaluation des risques
Méthode et points à examiner
Toxicity tests  were conducted with EPSPS-synthase enzyme  isolated from transformed  plants. Ingestion through gastric gavage of the protein molecule in doses  1000 times above the figure for modified seeds failed to cause any physiologic change in animals tested. Results of in vitro proteolysis also verified rapid digestion and innocuousness of the engineered protein, removing any suspicions of allergenicity.  CP4 EPSPS protein is atoxic, as demonstrated by a oral acute toxicity  stud, when CP4 EPSPS was administered to mice in one single high dose. The protein, produced and purified from Escherichia coli, was characterized and showed to be equivalent  to the CP4 EPSPS produced in the corn. The purified  protein was orally administered to mice for assessing its acute toxicity. Acute administration was deemed as  appropriate in assessing  the safety of CP4 EPSPS, since toxic proteins act by means of acute mechanisms. The no-observed-effect-level (NOEL)  for oral toxicity in mice was 572  mg/kg, the highest tested dose. The result represented a safety margin of about 260,000 times,  based on the average daily consumption of corn in the United States and average expression of the protein in the glyphosate tolerant genetically modified corn (assuming that there is no  loss of CP4 EPSPS  throughout processing). There were no statistically different differences in body weight, aggregate body weight or food  consumption between control  groups (with the  vehicle or bovine albumin  serum) and groups treated with the purified CP4 EPSPS protein. EPSPS proteins are ubiquitous in nature and  are  naturally present in foods derived from plant and microbial sources and do not  show significant homology of  amino acids with proteins known to be toxic  or allergenic to mammals.
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Technical opinions related  to agronomic  performance reached a  conclusion that there  is equivalence between transgenic  and  conventional  plants. Thus, this information suggest  that transgenic  plants are not fundamentally different from the non-transformed corn genotypes, except  for  the  tolerance to glyphosate. Besides, there is no evidence of adverse reactions to the use of NK603 corn. For this reason, there are  no restrictions to the use of this corn or its derivatives, either for human  or animal feeding.
The vertical  genic  flow to  local varieties (the  so-called  Creole corns)  of  open pollination is possible and carries the  same  risk caused by the commercial genotypes  available in the market (80% of the conventional corn farmed in Brazil come from commercial seeds that underwent a process of genetic improvement). Coexistence among cultivars of conventional (either cultivated of local varieties) and transgenic cultivars is possible  from the agronomic viewpoint
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not applicable
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not applicable
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not applicable
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Zea mays L., corn, is a species of the Maydae tribe, included in the subfamily Panicoidae, family Graminea (Poacea). Genera belonging to the Maydae tribe  include Zea and Tripsacum in the Western Hemisphere.  Corn is a separate species within the Zea subgenus, with a chromosome number 2n = 20,21,22,24(9). The wild  species closest to corn  is teosinte, found in Mexico and  some other places of Central America, where it may cross with cultivated corn in production fields. Cultivated corn may also cross with a more  distant genus, the  Tripsacum.  The crossing seldom happens and results in a sterile male progeny.
Corn has  a history of eight  thousand  years in the Americas. Out of all cultivated plants, corn is probably the  one possessing the largest genetic variability.  Today, about three hundred races of corn are identified and, within each such race, there are thousands of cultivars. Corn is currently the cultivated species that reached the highest degree of domestication and it may only survive in nature when raised by man(4). Normally, the maintenance of  this genetic variability has been achieved through individualized storage, in germplasm banks, under  controlled humidity and temperature. There are several germplasm banks,  in Brazil and all over the world. Embrapa, the Brazilian Agricultural Research Agency, has two germplasm banks,  one at Embrapa Recursos Genéticos e Biotecnologia, Embrapa Genetic Resources and Biotechnology, in Brasília, Federal District, Brazil, and another  at Embrapa Milho e Sorgo, Embrapa Maize and Sorghum, in Sete Lagoas, Brazil. Corn is farmed in over 100 countries, with a total estimated production of 705  million tons per year.
Corn is one of the most important food  sources in the world and  is the raw material  for a large range  of products. From 70% to 80% of corn produced in Brazil is consumed by the swine and poultry productive chain.
Brazil is the world third largest corn producer, with  an output of about 35 million tons  in 2005, behind the United States of America (282 million tons) and China (139 million tons)(11).In Brazil, corn is planted basically in two different crops (summer and safrinha, or  small  crop) and is cultivated in practically all the domestic territory, with 92% concentrated in the Southern Region (47% of production), Southeastern Region (21% of production) and Center Western Region (24% of production)(8).
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molecular traditional methods
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Information supplémentaire
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Décision de pays ou tout autre communication Évaluation des risques 1