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Évaluation des risques générée par un processus de réglementation
(RA)
published: 17 déc. 2008
last updated: 27 mars 2013
Risk assessment for herbicide tolerant maize (Roundup Ready 2)
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Autorité nationale compétente :National Technical Biosafety Commission ()Setor Policial Sul -SPO Área 5 Quadra 3 Bloco B - Térreo Salas 10 à 14Brasília, DF
CEP - 70610-200,Téléphone : (5561) 3411-5516,Télécopieur : (5561) 3317-7475,E-mail : ctnbio@mct.gov.br,Site Web : http://www.ctnbio.gov.br,
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MON-ØØ6Ø3-6 - Roundup Ready™ maize| Monsanto | Résistance aux herbicides (Glyphosate)
- National Biosafety Commitiee [ English ]
- Comissão Técnica Nacional de Biossegurança [ Portugais ]
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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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
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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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).
molecular traditional methods
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- Comissão Técnica Nacional de Biossegurança [ Portugais ]
- National Technical Biosafety Comission [ English ]
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