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OECD Unique Identifier details

BCS-GHØØ2-5xACS-GHØØ1-3
Commodity: Cotton
Traits: Glufosinate tolerance,Glyphosate tolerance
Brazil
Name of product applicant: Bayer S.A
Summary of application:
Commercial release of genetically modified cotton tolerant to the gluphosinate ammonium herbicide and to the glyphosate herbicide, named GlyTol x Liberty Link (GTxLL)
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Date of authorization: 21/06/2011
Scope of authorization: Food and feed
Links to the information on the same product in other databases maintained by relevant international organizations, as appropriate. (We recommend providing links to only those databases to which your country has officially contributed.): Center for Environmental Risk Assessment
Summary of the safety assessment:
The organism analyzed displays tolerance to glyphosate and gluphosinate ammonium herbicides, granted by genes 2mepsps and bar, respectively. Both events have already been commercially released by CTNBio by Technical Opinion nº 1521/2008 (published in the Federal Official Gazette of 09.04.2008), related to commercial release of genetically modified cotton tolerant to gluphosinate ammonium herbicide (LibertyLink cotton, Event LLCotton24) and Technical Opinion nº 2754 (published in the Federal Official Gazette nº 241, of 12.27.2010, related to commercial release of genetically modified cotton tolerant to the glyphosate herbicide (GlyTol cotton, Event GHB614). Assessment of the results for all tests indicated that GlyTol x LibertyLink is held as substantially equivalent to other cotton varieties. Restricted zones for tilling of genetically modified cotton (Annex of the Ministry of Agriculture and Supply (MAPA) Directive nº 21/2005) of this event GlyTol x LibertyLink (GTxLL) and other transformations shall be strictly followed by monitoring bodies, both in the marketing of seeds in such areas and in technical guidance and monitoring of the interested company. CTNBio, along the assessment phases of this process, examined the reports submitted by applicant as well as the independent scientific literature. TECHNICAL OPINION. I. Identification of GMO Name: Genetically modified cotton tolerant to the gluphosinate ammonium herbicide and to the glyphosate herbicide, named GlyTol x LibertyLink (GTxLL – event GHB614 X LLCotton25. Applicant: Bayer S.A. Species: Gossypium hirsutum L. Inserted Characteristics: Tolerance to glyphosate and gluphosinate ammonium herbicides Insertion Method: Classical genetic improvement, by crossing and selection among individuals containing events GlyTol x LibertyLink (GTxLL) Proposed use: Production of fibers for the textile industry; and grains for human and animal consumption, and its derivatives. II. General Information Cotton belongs to genus Gossypium, tribe Gossypieae, family Malvaceae, order Malvales (Fryxell, P.A., 1979; Munro, J.M., 1987).L This genus is further divided into four subgenera (Gossypium, Sturtia, Houzingenia and Karpas) which, in turn, are divided into nine sections and several subsections (Fryxell, P.A., Craven, L.A., and Stewart, J.MCD, 1992). The Gossypium genus is made of 52 species distributed in the Asian, African, Australian and American continents, of which only 4 are farmed. Especially, three species belonging to such genus are found in Brazil: Gossypium hirsutum L., var. latifolium; Gossypium hirsutum L. r. marie galante; Gossypium mustelinum; and Gossypium barbadense (Embrapa, Algodão, 2004). In the production chain, about 90% of the world cotton population is Gossypium hirsutum L., and 8% is Gossypium barbadense L. (Lee, 1984). Brazil is the original center of G. mustelinum and an important center of diversity for G. barbadense and G. hirsutum r. marie galante. According to Freire et al. (1990), the species G. mustelinum was never improved nor commercially explored, despite evidences of allele introgression of G. hirsutum in its genome (Wendell et. al., 1994). Its original center is the Brazilian Northeast, where there are some populations in the Municipalities of Caicó, RN; Macurerê, BA; and Caraíba, BA (Freire, 2000). Two varieties are found in Brazil, both in a semi-domesticated state: Rim-de-Boi (G. barbadiense var. brasiliense) having linterless seeds, strongly attached to each other, resembling an ox kidney. The other variety (G. barbadense var. barbadense), known as Quebradinho or Maranhão, has linterless, detached seeds. This variety comes from the north of Peru and south of Ecuador, and is likely to have been introduced in Brazil by indigenous populations, the descendants of which still today use the fibers in handmade fabrics, as a medicinal plant and oil lamp wicks. Both varieties are arboreal and perennial. They are widely distributed in Brazil and preserved by farmers for generations. They may be found in the Amazonian region, in the lowlands of Maranhão and Piauí, in cities of the mining cycle of the State of Mato Grosso, in the Mato Grosso Marsh surrounding areas and in the Atlantic Forest, from Rio Grande do Norte to Espírito Santo. Dispersion of the two varieties of G. barbadense in different locations was due to farming practices (Boulanger & Pinheiro, 1972; Smith & Cothren, 1999). The species Gossypium hirsutum, also known as herbaceous cotton plant, is largely farmed in Brazil (Craven et al., 1994) and is the main species cultivated in the world for production of cotton fiber (Penna, J.C.V., 2005). Cotton tilling in Brazil ranks among the main ten agricultural cultures in the country, and is the sixth most cultivated plant in the world as far as cultivated surface is concerned. III. Description of GMO and Expressed Proteins The combined event GHB614 x LLCotton25 was obtained by applicant through classical genetic improvement by crossing GHB614 cotton, genetic background FM958, and LLCotton25, genetic background FM981. Combined cotton GHB614 x LLCotton25 is the F3 descendant of the crossing between them and the selection of individuals with the desired features. Both events have already been separately released by CTNBio through Technical Opinion 1521/2008 (published in the Federal Official Gazette nº 171, of 09.04.2008), regarding commercial release of genetically modified cotton tolerant to the herbicide gluphosinate ammonium (LibertyLink, Event LLCotton25, cotton) and Technical Opinion nº 2754 (published in the Federal Official Gazette nº 241, of12.17.2010), related to the commercial release of genetically modified cotton tolerant to the herbicide glyphosate (GlyTol, Event GHB614, cotton). LibertyLink, Event LLCotton25, Cotton Gene bar, obtained from bacteria Streptomyces hygroscopicus, is expressed in LLCotton25. The bar gene expresses enzyme PAT (phosphinothricin N-acetyl transferase) that catalyzes the acetylation reaction of phosphinothricin, producing the inactive compost N-acetil phosphinothricin, which is later metabolized in the plant cells. The synthetic phosphinothricin is named gluphosinate ammonium, which controls invading plants for being an inhibitor of the glutamine synthase enzyme (GS), responsible for incorporating of ammonia to the glutamic acid, forming the glutamine. GS inhibition results in a deficit of glutamine and accumulation of ammonia until it reaches toxic levels in the plant cells, leading to desiccation of the plant. Gluphosinate has a large action spectrum, controlling both dicotyledons and monocotyledons. Tolerance to the herbicide gluphosinate ammonium is a resulting feature of Cotton event LLCotton25. Event LLCotton25 contains the chymeric gene p35S::bar::Nos3’, with one intact copy in the cassette. The event was obtained through genetic transformation of Coker 312 cotton mediated by Agrobacterium tumefasciens containing the binary vector pGSV71. Regarding the PAT protein, when the risk was being analyzed (proceedings nº 01200.001894/2004-01) it became clear that: (i) it has no homology with any allergenic protein, toxin, or antinutrients; (ii) it has no glycosilation site (present in several allergenic components); (iii) it is structurally unstable in acid environments; (iv) it degrades and denatures quickly in the gastric and intestinal fluids of mammals; (v) it has substratum-specific activity; and (vi) it has no adverse effects in mammals, even when the pure protein is intravenously administered in high doses. Therefore, there is no evidence that the PAT protein may cause adverse effects to human and animal health. GlyTol Cotton, Event GHB614 Gene 2mepsps, originated from corn gene epsps (Zea mayz) changed through a site mutation directed in two amino acids of the original peptide sequence, altering positions 103 (isoleucin substituted by threonine) and 107 (serine substituted by proline). Enzyme EPSPS (5-enolpyruvylshikimate-3-phosphate synthase, E.C. 2.5.1.19) is basic in the pathway responsible for synthesizing aromatic amino acids in plants and different microorganisms (Gruys & Sikorski, 1999). Enzyme 2mEPSPS has high similarity with corn EPSPS (>99.5%), yet it displays lower affinity by the glyphosate molecule (Lebrun et al.), granting GHB614 cotton selectivity to the herbicide effect of the active ingredient, enabling GHB614 cotton to have sufficient enzyme activity even under the presence of the glyphosate herbicide. Event GHB614 contains the chimerical gene Ph4a748At-intron1h3At-TPotpC::2mepsps::3’histonAt, and there is one intact copy of the cassette. This event was obtained through genetic transformation of Coker 312 cotton variety, mediated by Agrobacterium tumefasciens, containing the binary vector pTEM2. According to a risk analysis performed by CTNBio (proceedings nº 01200.000800/2010-17) there is no evidence that protein 2mEPSPS may offer risk to human/animal health as against the use of conventional cotton and its byproducts in food. Protein 2mEPSPS was obtained from a corn native protein and its safety is shown by studies in animal feeding (birds treated with cottonseed cake); digestibility analysis of the protein in simulated gastric and intestinal tracts; tests of acute toxicity through oral and intravenous application; and absence of homology of the 2mEPSPS with toxic and allergenic compounds. Individual events LLCotton25 and GHB614 are approved in different countries. Event LLCotton25 was first approved in the United States in 2003 and is currently approved in eleven countries. Event GHB614 was first approved for planting in the United States in 2009 and is currently approved in nine countries (source: http://www.cera-gmc.org; http://wwwbiotradestatus,com/results.cfm). At this moment, there are ten events combined in cotton approved in different parts of the world featuring tolerance to herbicides and/or resistance to insects. Combined cotton GTxLL is approved in Japan, Mexico, Australia, Canada, and, in the USA, for planting. In Brazil, CTNBio approvals of genetic modification events granting tolerance to the glyphosate herbicide include four cotton events (GHB614 cotton, MON1445 cotton, MON531xMON1445 cotton, MON88913 cotton); two soybean events (GTS-40-3-2 soy, MON87701Xmon89788) and eleven maize events (NK603 maize, GA21 maize, MON810Xnk603 maize, BT11xGA21 maize, TC150xNK603 maize, BT11xMIRxGA21 maize, MON89034xNJK603 maize, MON88017 maize, MON89034xNK602 maize, MON810xTC1507xNK603 maize, and MON89034xMON88017 maize). In case of genetic modification that grant tolerance to the gluphosinate ammonium herbicide, CTNBio approved, in addition to LLCotton25: A2704-12 soybean, A5547-127 soybean TG25 corn, BT11 maize and TC1507 maize. Considering that the EPSPS acts in the metabolism of aromatic amino acids, more specifically in the shikimate pathway, in the synthesis of the Chorismate compound and that the PAT enzyme has no vital function, acting solely in the acetylation of the gluphosinate ammonium herbicide, there is no indication that such proteins may interact, since they are independent from each other, there is no competition for substrates, and there is not inhibition by the final product. IV. Aspects Related to Human and Animal Health GlyTol x LibertyLink cotton may be classified as Risk Class I (low individual risk and low risk for the collectivity), since the DNA sequences of donor and receiving organisms cause no harm to human and animal health nor adverse effects to plants and the environment. According to the records forwarded by Bayer, one may state that the hypothesis of interaction between the proteins PAT and 2mEPSPS is practically none, since expression of both proteins is given through combination by conventional crossing of the parent plants and not by insertion of recombinant DNA. Besides, the metabolic pathways involving the proteins are different. This averment is based in tests conducted on GlyTol x LibertyLink cotton and its genetically modified parents resulted tenors of PAT and 2mEPSPS in leaves, corns and buds practically identical. Applicant represents that the data obtained show that PAT and 2mEPSPS proteins do not depend nor are affected by each other presence, fail to compete for substrate and there is no inhibition by the final product of compounds. Applicant additionally represents that safety of GlyTol x LibertyLink cotton has already been shown by the separate events GlyTol and LivbertyLink. Western Blot analyses evidenced that the protein profile, after cleavage with the same restriction enzymes used in the cleavage of the parental plants, is not different when compared the stacked effect and the related parents, leading to the belief that there are no changes in the genetic modification resulting from the crossing and conventional improvement of the genetically modified parents. Applicant informs that the insert flank region was maintained after combination of the genetically modified parents after crossing for classical genetic improvement. The in-silico analysis, using bioinformatic tolls, was conducted to assess the presence of genes and open reading frames (ORF) at the junction regions, as well as to assess the presence of new coding sequences. The results showed presence of two ORFs, but the results of the insilico analysis for these regions showed that there was no full presence of promoters, therefore there is no possibility of generating messenger RNA. For event LLCotton25 (LibertyLink) flank region, determination of the insertion locus of the insert was possible. It was ascertained, by homology, that the flank regions of the insert LL25 correspond to the sequence existing in the conventional cotton genome (non modified parent). In-silico analyses were conducted to assess whether there was any functional gene of ORF change due to the insertion of the bar cassette. The analysis identified a total of twelve interrupted ORFs and one gene that traverses the deleted region, yet no homology was found with any protein of the databanks, indicated as very improbable that the gene found may be expressed in the cotton. Applicant states that all ORFs were analyzed and none displayed similarity or identity to unwanted sequences. Cotton use in food chain is limited to animals, which are fed with cottonseed meal and cake. Only cotton oil extracted from seeds is used for human consumption. This oil is normally purified, that is to say, becomes exempt from the GMO (DNA, proteins) and other GMO derivatives. Marketed cotton has antinutritional and toxic factors, such as gossypol, cyclopenoid fatty acids and phytic acid, which prevent its use as food. With processing, the level of such elements drops considerably. Applicant informs that the combination of events GlyTol and LLCotton25 through classical genetic improvement fails to result in any new product or organism that may threaten alimentary safety, including safety in the separate events. Substantial equivalence comparison analyses were conducted between the combined cotton and its conventional FM958 isoline, both with and without the use of herbicides, and studies with their parents GlyTol and LibertyLink. According to applicant, the analyses showed that there is no statistically significant difference between the treatments. The variables in which significant differences were recorded were due to different localities analyzed, and in some of the components that are not biologically relevant, since they are within the limits of the species natural variation. Toxicologic and pharmacologic assessment studies in animals were conducted when the requests for commercial release of events GlyTol and LibertyLink were submitted. Similarity verification studies of products of expression of GlyTol x LibertyLink cotton with known allergens were submitted for the individual events and, according to applicant, proteins 2mEPSPS and PAT failed to display homology with toxic and allergenic compounds. V. Environmental Aspects Genus Gossypium, to which the cotton plant belongs, comprises 52 species out of which only four are cultivated in the world. Among such species (Gossypium arboretum L., Gossypium hirsutum L., and Gossypium barbadense L.) production of G. hirsutum represents around 90% of the cotton marketed all over the world (Lee, 1984). As mentioned above, Brazil is the original center of some species of the genus Gossypium. G. barbadense is widely distributed, and its occurrence takes place mainly as a backyard plant, while G. hirsutum of the marie galante race was largely cultivated in the Northeast during the seventies and later resumed its wild features after its tillage was abandoned. According to a risk assessment conducted by the applicant (Freire, 2012), regarding pollen flow, the rates of transgenic cotton to conventional cotton shall not be different from that measured in conventional cultivars, since there is no morphological characteristic differentiating the genetically modified cotton plant from conventional cultivars. Combined event cotton plants, through classical genetic improvement, failed to originate any new product or organism able to change the gene flow rate measured for the species. Regarding sylvan cotton, the likelihood of gene flow with genetically modified cotton is remote due to the isolation foreseen for commercial planting (distributed in the high technology cerrado crops) in areas recognizably exempt from sylvan types (Freire, 2000). Though there is total sexual compatibility between the tetraploid cotton species (G. hirsutum and G. barbadense), the greater hindrance to crossing between perennial (sylvan) and annual (cultivated) species is the difference in cycle and lack of coincidence in flowering periods. In case gene flow does take place, it fails to affect the genome of the receiving plant, since the alleles received by cross fecundation are inserted solely in the progeny (that is to say, in seeds that are harvested with the lint cotton) and there will be no adaptive advantage against other varieties, since farming practices of the sylvan cotton include hand weeding, with cultivation of small areas. Applicant additionally argues that the change in the distribution pattern of sylvan varieties in a given environment, following a genetic transfer, shall be analyzed considering several features that may be incorporated. Many features that are present in modern varieties of conventional cotton, such as resistance to diseases, high productivity and production of fructiferous branches, may favor adaptive ability and survival of sylvan species and lead to their widespread in some regions, since the selection factor does not depend from a man controllable factor. Regarding characteristics of selectivity to herbicides, these shall not be seen as fundamental selection factors enabling adaptive advantages of the genetically modified variety as against other varieties. Regarding the crossing with weed, under Brazilian conditions the regions cultivated with cotton fail to exhibit any weed that may be sexually compatible with the cultivated Gossypium species. Considering the studies conducted in planned releases, they showed that the presence of bar and 2mepsps genes in cotton GTxLL failed to change in a significant amount any phenotypic characteristic, related to phonological studies during the cycle or the growth parameters and, considering in addition the literature data on gene flow and gene introgression in cotton plants, there is no evidence that any characteristic could make the GM cotton to be more invasive than the conventional cotton lineages. Southern blot analyzes showed that there is the same band standard in the combined cotton GTxLL and the individual events GHB614 and LLCotton25. Analyzes conducted showed that the structure of the insert, its location and stability were not changed by the combination. Both sizes and numbers of fragments observed in DNA hybridation analyzes corresponded to the expected results (Moens, 2010). Expression of proteins 2mEPSPS and PAT in leaves, seeds (corn) and flower buds in cotton GTxLL was assessed against their parents. The plants were greenhouse cultivated and the material was collected, and proteins PAT and 2mEPSPS extracted and quantified by ELISA (Thompson, 2009). Considering that the analysis conducted revealed difference in the expression of proteins in the combined event when contrasted with the parental line, a review was requested for analysis and criticism of potential biosafety risks, considering that assessment of the proteins expression was a study intended to show inexistence of interaction between the proteins expressed in the combined event. Answering to the request, applicant offered the following arguments: • Variations in gene expression and consequently in content of expressed proteins are highly dependent of several factors such as age and sanity of the tissue examined, and environmental conditions such as (temperature, radiation, humidity) (Floris et. al, 2009); • Potential expression level differences may be expected between combined and individual events, since it also happens in conventional crossings between non-GM, as a consequence of the difference in germplasm (genetic background). By the same token, expression of transgenes may also change when inserted in different genetic backgrounds (EFSA, 2007; De Schrijver et. al., 2007). GTxLL cotton stems from genetic crossing between varieties FM958 and FM981, that have different genetic bases that, consequently may explain a possible change in the expression pattern of proteins 2mEPSPS and PAT when compared with the parents; • The hypothesis of interaction between the inserts may not be analyzed based on a sole parameter. This analysis shall be conducted in a wider way, taking other data into consideration, such as phenotypic analyses; • In another study performed by applicant for quantification of protein 2mEPSPS in flower tissues of different ages (Robinson, 2011), the results showed large superposition in amplitude of measured values, comparing GTxLL cotton and its parents. Applicant submitted the result of a study conducted in the cities of Santo Antonio do Leste, State of Mato Grosso and São Desidério, State of Bahia (Freire, 2012) were no statistic differences were recorded between phenologic, morphologic characteristics, and production components between the non modified cotton plant and individual events GlyTol and LibertyLink and the combined event GTxLL. The parameters assessed indicate that the combination of individual events, by crossing and selection, was unable to change gene specificity and failed to exhibit both pleiotropic and epistatic effects. Humidity, gross protein, lipids, ashes, carbohydrates, fiber, minerals, vitamins and antinutrients parameters were studied, comparing samples of GTxLL cotton with the non modified parent. When comparing data of cotton GTxLL with the parents GHB614 and LLCotton25, the results showed some differences between averages for the compounds such as ashes, calcium, α-tocopherol, free gossypol, total gossypol, phytic acid, dihydro-sterculic acid, and potassium. Estimated average differences are within the variation range for the commercial cotton varieties described in the literature (OECD, 2004); ILSI Crop Composition database). VI. Restrictions to the Use of the GMO and Derivatives Analysis of alimentary and environmental biosafety of cotton Glytol x LibertyLink (GTxLL), event GHB614 x LLCotton25 showed that this cotton is equivalent to conventional cotton and commercial references. Besides, there is no evidence of adverse reactions related to the use of GlyTol x LibertyLink (GTxLL), event GHB614 x LLCotton25. Therefore, there are no restrictions to the use of this cotton or any of its derivatives for both human and animal consumption. VII. Considerations on Particulars of Different Regions of the Country (information to monitoring bodies) Zones where farming of this genetically modified cotton, GlyTol x LibertyLink) GTxLL event GHB614 x LLCotton25 and other transformations are restricted (Annex to the Ministry of Agriculture Directive nº 21/2005) shall be rigorously observed by monitoring bodies, both regarding the trade of seeds in such areas and technical guidance and monitoring of the applicant. VIII. Conclusion Whereas: • Cotton (Gossypium hirsutum) variety event GHB614 x LLCotton25 belongs to a well characterized species with a solid history of safety for human consumption; • Proteins PAT and 2mEPSPS granting tolerance to the herbicide gluphosinate ammonium and glyphosate, respectively, are expressed in several events of different agricultural cultures already submitted to risk assessment and approved for commercial use in numerous countries; • Parents, event GHB614 and LLCotton25, were submitted to risk assessment by CTNBio and were granted a favorable opinion for their commercial release; CTNBio reached the conclusion, expressed by the majority of its members, that this activity is not potentially a cause of significant degradation of the environment nor harmful to human and animal health. Restrictions to the use of this GMO and its derivatives are mentioned in the provisions of the Ministry of Agriculture Directive nº 21/05. In the context of the competences vested in it by Article 14 of Law nº 11105/2005, CTNBio finds that the request is under current regulations and legislation in effect, aiming and securing environmental, agricultural, human and animal health biosafety, and concluded that cotton GlyTol x LibertyLink (GTxLL) event GHB614 x LLCotton25 is substantially equivalent to conventional cotton and that its consume is safe for human and animal health. Regarding the environment, CTNBio concluded that cotton GlyTol x LibertyLink (GTxLL) event GHB614 x LLCotton25 is not potentially a cause of significant degradation of the environment, keeping with the biota a relation identical to that of the conventional cotton. Regarding the post-commercial release monitoring plan, CTNBio determines that the instructions be followed and technical monitoring actions be conducted as mentioned by CTNBio Ruling Resolution nº 09, of December 02, 2011. IX. Referências Bibliográficas BARROSO, P. A. V.; FREIRE, E. C.; AMARAL, J. A. B. do; SILVA, M. T. 2005. Zonas de exclusão de algodoeiros transgênicos para preservação de espécies de Gossypium Nativas ou naturalizadas. Campina Grande: Embrapa Algodão, 7 p. (Comunicado Técnico, 242). BETZ FS, HAMMOND BG, FUCHS RL (2000) Safety and advantages of Bacillus thuringiensiprotected plants to control insect pests. Regul. Toxicol. Pharmacol. 32:156-173. Biotechnology Industry Organization (http://www.biotradestatus.com). BOULANGER J.; PINHEIRO D. 1972. Conseqüências genéticas da evolução da cultura algodoeira do Nordeste do Brasil. Pesquisas Agropecuárias no Nordeste, v.4, n.1, p.5-52. CRAVEN, L.A.; STEWART, J. MCD; BROWN, A.H.D.; GRACE, J.P. The Australian wild species of Gossypium. In: Proceedings of the world cotton research conference, 1. Brisbane, Australia. Challenging the future. P. 278-281. 1994. Comissão Técnica Nacional de Biossegurança – CTNBio. Parecer Técnico nº 2754/2010 - Liberação Comercial de Algodão Geneticamente Modificado Tolerante a Herbicidas Denominado GHB614 (Algodão GlyTol®). Publicado no D.O.U de 27/12/2010, Seção 1, página 46. Comissão Técnica Nacional de Biossegurança – CTNBio. Parecer Técnico nº 1521/2008 - Liberação Comercial de Algodão Geneticamente Modificado Tolerante a Herbicida Evento 105/2013 16 19 LLCotton25. Publicado no D.O.U de 04/09/2008, Seção 1, página 6. De SCHRIJVER, A.; DEVOS, Y.; Van de BULCKE, M.; CADOT, P.; De LOOSE, M.; REHEUL, D.; SNEYERS, M. Risk assessment of GM stacked events obtained from crosses between GM events. Trends in Food Science & Technology, v.18, p.101-109, 2007. EFSA. European Food Safety Authority. Guidance document of the Scientific Panel on Genetically Modified Organisms for the risk assessment of genetically modified plants containing stacked transformation events, the EFSA Journal v.512, p.1-5. 2007. FLORIS,M. MAHGOUB, H. LANET, E.; ROBAGLIA,C.; MENAND, B.; Post-transcriptional Regulation of Gene Expression in Plants during Abiotic Stress. Int. J. Mol. Sci., v.10, p.3168-3185. 2009. FREIRE, E.C. Distribuição, coleta, uso e preservação das espécies silvestres de algodão no Brasil. Embrapa- CNPA. Documentos, 78. Campina Grande. 22p. 2000. FREIRE, E.C.; MOREIRA, J.A.N.; MIRANDA, A.R.; PERCIVAL, A.E. E STEWART, J.M. Identificação de novos sítios de ocorrência de Gossypium mustelinum no Brasil. Pesquisa em Andamento, 10, 7p. 1990. FREIRE, E. Avaliação dos aspectos reprodutivos e de sobrevivência dos Eventos combinados GlyTol x LibertyLink efetuadas no cerrado do Brasil durante a safra 2010/11. Bayer CropScience. Relatório Interno, 24p, 2012. FRYXELL, P.A. 1979. The natural history of the cotton Tribe Malvaceae (Tribe Gossypieae). Texas A&M University Press, College Station. FRYXELL, P.A., CRAVEN, L.A. E STEWART, J.MCD. 1992. A revision of Gossypium Sect. Grandicalyx (Malvaceae) including the description of six new species. Systematic Botany, v.17, n.1, p.91-114. GRUYS, K. J.; SIKORSKI, J. A.; Inhibitors of Tryptophan, Phenylalanine and Tyrosine Biosynthesis as Herbicides, Dekker: New York, 1999. ILSI (International Life Sciences Institute). http://cera-gmc.org/index.php?action=gm_crop_database) IBGE 2012. http://www.ibge.gov.br/home/presidencia/noticias/noticia_visualiza.php?id_noticia=2065&id_pagina=1 Japan: Assessment report of GHB614xLLCotton 25 for Importing and Processing. (http://www.bch.biodic.go.jp/download/en_lmo/GHB614_LLCotton25enRi.pdf) KOWITE, W.J. Comparative assessment of agronomic characteristics of combined transgenic event GlyTolxLibertyLink cotton from multiple field trials. USA. Bayer CropScience, Internal Report, 57p, 2009. LEBRUN M., SAILLAND A., Freyssinet G. 1997. Mutant 5-enol pyruvylshikimate-3-phosphate synthase, gene encoding for said protein and transformed plants containing said gene. International patent publication W0 97/04103-A2. 06.02.97. 25 pages. LEE, J.A Cotton as a world crop. In: RHOEL, R.J.; LEWIS, C.F. (eds). Cotton. Madison: American Society of Agronomy p.1-16. 1984. LEITE, D. S.; SILVA, I.T.G.; ALMEIDA, D.A.; RIBEIRO, P.G.; CIAMPI;A.Y.; AZEVEDO; V.C.R. Fluxo Gênico Entre Gossypium Barbadense E Gossypium Hirsutum Da Região Do Distrito Federal E Entorno. IN: CONGRESSO BRASILEIRO DO ALGODÃO, 7., 2009, Foz do Iguaçu. Sustentabilidade da cotonicultura Brasileira e Expansão dos Mercados: Anais... Campina Grande: Embrapa Algodão, 2009. p. 1704-1708. MOENS, S. Stability analysis of cotton combined events GHB614xLLCotton 25. USA. Bayer CropScience, Internal Report, 18p, 2010. OECD. (Organization for Economic Co-operation and Development). CONSENSUS DOCUMENT ON THE BIOLOGY OF COTTON (Gossypium spp.) ENV/JM/FOOD(2008)33. France. 64p. 2008. OECD. (Organization for Economic Co-operation and Development). CONSENSUS DOCUMENT ON COMPOSITIONAL CONSIDERATIONS FOR NEW VARIETIES OF COTTON (Gossypium hirsutum and Gossypium barbadense): KEY FOOD AND FEED NUTRIENTS AND ANTI-NUTRIENTS. ENV/JM/FOOD(2004)16. France. 32p. 2004. OECD. (Organization for Economic Co-operation and Development). CONSENSUS DOCUMENT ON GENERAL INFORMATION CONCERNING THE GENES AND THEIR ENZYMES THAT CONFER TOLERANCE TO PHOSPHINOTHRICIN HERBICIDE. ENV/JM/MONO(99)13. France. 26p.1999. OECD. (Organization for Economic Co-operation and Development). CONSENSUS DOCUMENT ON GENERAL INFORMATION CONCERNING THE GENES AND THEIR ENZYMES THAT CONFER TOLERANCE TO GLYPHOSATE HERBICIDE. ENV/JM/MONO(99)9. France. 26p.1999. PENNA, J.C.V. Melhoramento de algodão. Inc: Melhoramento de espécies cultivadas. Borém, A (Ed.) Viçosa; Ed. UFV.p. 15-53.2005.969p. ROBINSON, T.D. Expression of 2mEPSPS protein in young and mature leaves from GlyTolTM and GlyTolTMxLLCotton25 grown in the greenhouse. USA. Bayer CropScience, Internal Report, 29p, 2011. SMITH, C.W.; COTHREN, J. T., eds. Cotton: Origin, History, Technology, and Production, p. 175- 206. John Wiley and Sons, Inc., 1999. THOMPSON, D.M. Protein expression analysis for the combined cotton event GlyTolxLLCotton25 and its parents GlyTol and LLCotton25. USA. Bayer CropScience, Internal Report, 45p, 2009. WENDEL, J.F.; ROWLEY, R.; STEWART, J.M. Genetic diversity in and phylogenetic relationships of the Brazilian endemic cotton, Gossypium mustelinum (malvaceae). Plant Systematics and Evolution, v.192, p,49-59, 1994.
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Where detection method protocols and appropriate reference material (non-viable, or in certain circumstances, viable) suitable for low-level situation may be obtained:
molecular traditional methods
Relevant links to documents and information prepared by the competent authority responsible for the safety assessment: National Biosafety Commission
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E-mail:
gutemberg.sousa@mct.gov.br
Organization/agency name (Full name):
National Biosafety Technical Commission
Contact person name:
Flavio Finardi
Website:
Physical full address:
SPO Area 5 Qd 3 Bl B S 10.1 Brasilia DF
Phone number:
556134115516
Fax number:
556133177475
Country introduction:
The Brazilian National Biosafety Commission – CTNBio , is responsible to the technical decision on biological risk as a response to a request from the proponent. The technical decision is given on a definitive basis. Only the National Biosafety Council (CNBS) can revoke the decision (in case of commercial release), based on social-economical reasons and not on biosafety reasons. Once a decision is taken by CTNBio favorable to the commercial release of a new GMO (being it a plant or any other organism), CNBS has 30 days to issue a revoke. After these steps, the new product must be evaluated for conformity to the Brazilian standards by the registration and enforcement agencies (ANVISA – Ministry of Health, Ministry of Agriculture, Ministry of Environment and Ministry of Fisheries, according to the intended use of the product). If it conforms to the standards, it may be offered to the market. Every institution dealing with GMOs (including universities and public research institutes) has to have an Internal Biosafety Commission (CIBio), which is legally responsible of everything that may happen to be done or caused by the GMO
Useful links
Relevant documents
Stacked events:
At the discretion of, and upon consultation with, CTNBio, a new analysis and issuance of technical opinion may be released on GMOs containing more than one event, combined through classic genetic improvement and which have been previously approved for commercial release by CTNBio
Contact details of the competent authority(s) responsible for the safety assessment and the product applicant:
Dr. Edivaldo Domingues Velini (President of national Biosafety Commission)