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Évaluation des risques générée par un processus de réglementation
(RA)
published: 17 déc. 2008
last updated: 28 mars 2013
Risk Assessment for herbicide tolerant maize (GA21)
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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-ØØØ21-9 - Roundup Ready™ maize| Monsanto | Résistance aux herbicides (Glyphosate)
- National Biosafety Commitiee [ English ]
- http://www.ctnbio.gov.br/index.php/content/view/14178.html [ Portugais ]
The genic construct used to insert the mepsps gene in corn resulted from stable insertion of a functional copy of such gene, which granted plants tolerance to the glyphosate herbicide. The mEPSPS enzyme amino acid sequence expressed in GA21 corn is 99.3% identical to the conventional corn endogenous enzyme sequence , which is expressed in a concentration significantly lower than mEPSPS protein of GA21 event. Quantifiable concentration of mEPSPS protein has been detected in most part of tissues of plants derived from GA21. No sequence introduced in event GA21 or of its donors is known to be pathogenic to humans or animals. EPSPS proteins are ubiquitous in nature and are naturally present in food derived from plant and microbial sources, included in the everyday diet of humans and animals. Bromatology tests and procedures for quantification of corn kernel different nutritional components have been conducted. The analyses suggest that the level of measured components have not changed beyond corn natural variation. No consistent pattern emerged suggesting that biologically significant changes in composition or nutritive value of the kernel or forage took place following the transformation or expression of the mepsps transgene. Analysis of amino acids inserted in mEPSPS enzyme reveals no homology with toxic proteins for mammals and toxic potential for humans is not expected. Absence of toxicity was also verified in studies with animals using high doses of purified protein. The mEPSPS enzyme expressed in corn with the GA21 event has no typical characteristics of known allergens. There is no homology regions when the introduced sequence is compared with sequences of known allergens. The data submitted indicate an extremely low likelihood that the intact protein may be absorbed through the intestine mucosa during consumption and establish immunochemical affinity to antibodies, including IgE antibodies, primarily responsible for allergic reactions. In addition, mEPSPS enzyme is promptly degraded by acid and enzymatic hydrolysis when exposed to fluids similar to gastric and intestinal fluids. According to data on nutritional and compositional equivalence of GA21 corn with its conventional isogenic version, no GA21 corn metabolite has potential to concentrate in the food chain, in addition to what may be expected from the widely cultivated conventional corn
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Considering that the corn (Zea mays) GA21 belongs to a well characterized species with a solid background of safety for human consumption and that the mepsps gene introduced in this variety codifies a protein that is ubiquitous in nature, present in plants, fungi and microorganisms participating in the alimentary diet of humans and animals.
Considering that the genic construct used to insert the gene in corn resulted from the stable insertion of a functional copy of mepsps, which granted tolerance to the glyphosate herbicide.
Considering that centesimal composition data failed to identify significant differences between the genetically modified and conventional varieties, suggesting nutritional equivalence between them.
Considering, in addition, that:
1. Corn is the species that reached the highest domestication level among cultivated plants, and is unable to survive in nature with no human intervention.
2. In Brazil, there are no wild species with which corn may intercross, since the closest wild corn species is teosinte, found only in Mexico and in some Central America locations, where it may cross with corn cultivated in production fields.
3. The mEPSPS protein was detected in low levels in tissues analyzed and displayed great susceptibility to digestion in simulated gastric fluids, lacking acute toxicity in mammals and similarity with known allergens.
4. The genetic modification introduced in GA21 event did not result in important differences of chemical composition regarding nutrients, which are within the normal variation range found between conventional varieties.
5 The DNA molecule is a natural food component and there is no evidence that this molecule may have adverse effect to humans when ingested in food in acceptable amounts (no direct toxic effect).
6. There is no evidence that intact plant genes may be transferred and functionally integrated to the genome of human or other mammals exposed to this DNA or to food produced with such elements(15).
7. The applicant answered all questions stipulated by CTNBio Regulatory Instruction no. 20 and that no topic indicated that this corn may have adverse effect in human and animal food.
8. The likelihood of a transgenic plant to change into a weed species, as well as the crossing of GA21 corn with other corn plants originating a pest is negligible.
9. The mEPSPS protein is common to plants, fungi and microorganisms and the exposure of living organisms and the environment to this protein is an event that occurs abundantly in nature without resulting significant risk to soil microbiota.
10. The coexistence between cultivars of conventional corn (either cultivated or creole) and transgenic corn cultivars is possible from the agronomic viewpoint, under the provisions of CTNBio Regulatory Resolution no. 4.
11. Annex III of the Cartagena Protocol on Biosafety (Decree no. 5,705, of February 16, 2006) provides that risks associated to modified living organisms or to products derived therefrom, to wit, improved materials originated from a modified living organism containing new detectable combinations of replicable genetic material obtained by modern biotechnology shall be considered in the context of the risks posed by the unmodified receptors in kindred organisms in the probable receiving environment.
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Considering that the genic construct used to insert the gene in corn resulted from the stable insertion of a functional copy of mepsps, which granted tolerance to the glyphosate herbicide.
Considering that centesimal composition data failed to identify significant differences between the genetically modified and conventional varieties, suggesting nutritional equivalence between them.
Considering, in addition, that:
1. Corn is the species that reached the highest domestication level among cultivated plants, and is unable to survive in nature with no human intervention.
2. In Brazil, there are no wild species with which corn may intercross, since the closest wild corn species is teosinte, found only in Mexico and in some Central America locations, where it may cross with corn cultivated in production fields.
3. The mEPSPS protein was detected in low levels in tissues analyzed and displayed great susceptibility to digestion in simulated gastric fluids, lacking acute toxicity in mammals and similarity with known allergens.
4. The genetic modification introduced in GA21 event did not result in important differences of chemical composition regarding nutrients, which are within the normal variation range found between conventional varieties.
5 The DNA molecule is a natural food component and there is no evidence that this molecule may have adverse effect to humans when ingested in food in acceptable amounts (no direct toxic effect).
6. There is no evidence that intact plant genes may be transferred and functionally integrated to the genome of human or other mammals exposed to this DNA or to food produced with such elements(15).
7. The applicant answered all questions stipulated by CTNBio Regulatory Instruction no. 20 and that no topic indicated that this corn may have adverse effect in human and animal food.
8. The likelihood of a transgenic plant to change into a weed species, as well as the crossing of GA21 corn with other corn plants originating a pest is negligible.
9. The mEPSPS protein is common to plants, fungi and microorganisms and the exposure of living organisms and the environment to this protein is an event that occurs abundantly in nature without resulting significant risk to soil microbiota.
10. The coexistence between cultivars of conventional corn (either cultivated or creole) and transgenic corn cultivars is possible from the agronomic viewpoint, under the provisions of CTNBio Regulatory Resolution no. 4.
11. Annex III of the Cartagena Protocol on Biosafety (Decree no. 5,705, of February 16, 2006) provides that risks associated to modified living organisms or to products derived therefrom, to wit, improved materials originated from a modified living organism containing new detectable combinations of replicable genetic material obtained by modern biotechnology shall be considered in the context of the risks posed by the unmodified receptors in kindred organisms in the probable receiving environment.
not applicable
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not applicable
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In Brazil, there are no kindred species of corn distributed in nature. However, genic flow for local open pollination varieties is possible, however this flow is as risky as the one caused by commercial genotypes available in the market. Coexistence of cultivars is possible between conventional corn (improved or local varieties) and transgenic from the agronomic viewpoint. The likelihood of a transgenic plant changing into a weed, as well as of originating a weed by crossing GA21 corn with other corn plants is negligible, due to the biologic characteristics of the species and the fact that corn does not survive well without human intervention. Therefore, it is expected that GA21 corn has an environmental behavior similar to that of common corn
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Tradicional molecular methods or phenotypic marker
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- Comissão Técnica Nacional de Biossegurança [ Portugais ]
- National Technical Biosafety Comission [ English ]
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| Décision de pays ou tout autre communication | Évaluation des risques | 1 | |