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Évaluation des risques générée par un processus de réglementation (RA)
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BCH-RA-BR-47842-4   |   PDF   |   Imprimer   |  
published: 17 déc. 2008 last updated: 28 mars 2013
Informations générales
Risk Assessment for herbicide tolerant maize (GA21)
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Détails de l’évaluation des risques
Méthode et points à examiner
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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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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Information supplémentaire
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