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Risk Assessment generated by a regulatory process
(RA)
last updated: 01 Sep 2022
Risk assessment of cotton GHB614 x LLCotton25 - TECHNICAL OPINION No. 3290/2012
EN
21 Jun 2011
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Competent National Authority:National Technical Biosafety Commission ()Setor Policial Sul -SPO Área 5 Quadra 3 Bloco B - Térreo Salas 10 à 14Brasília, DF
CEP - 70610-200, BrazilPhone: (5561) 3411-5516,Fax: (5561) 3317-7475,Email: ctnbio@mct.gov.br,Website: http://www.ctnbio.gov.br,
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Person:Bayer S.ARua Domingos Jorge, 1100, Prédio 9504, 3º Andar Bairro SocorroSão Paulo, SP
04779-900, BrazilPhone: +55 (11) 2165-7803,Fax: +55 (11) 2165-7711,Website: http://www.bayerscheringpharma.com.br,Related OrganizationBayer Schering Pharma ()Private sector (business and industry)Rua Domingos Jorge, 1100, Prédio 9504, 3º Andar Bairro SocorroSão Paulo, SP
04779-900, BrazilPhone: +55 (11) 2165-7803,Fax: +55 (11) 2165-7711,Website: http://www.bayerscheringpharma.com.br,
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BCS-GHØØ2-5 × ACS-GHØØ1-3 - GlyTol™ Liberty Link™ cotton| Resistance to herbicides (Glufosinate, Glyphosate)
- Commercial release 3290-2012.pdf [ Portuguese ]
The combined event GHB614 x LLCotton25 was obtained by the applicant through classical genetic improvement by crossing between GHB614 cotton, in the FM958 genetic background, and LLCotton25 cotton, in the FM981 background. Combined cotton GHB614xLLCotton25 (GTxLL) is the F3 offspring of crossing them and selecting individuals with the desired traits.
GlyTol x LibertyLink cotton can be classified as Risk Class I (low individual risk and low risk to the community), as the DNA sequences of the donor and recipient organisms do not cause harm to human and animal health and adverse effects to plants and the environment. environment.
Regarding the PAT protein, in the analysis of the risk assessment (process no. 01200.001894/2004-01) it was identified that: (i) it has no homology with any allergenic protein, toxin or antinutrients; (ii) they do not present any glycosylation site (present in several allergenic components); (iii) they are structurally unstable in acidic environments; (iv) are rapidly degraded and denatured in the gastric and intestinal fluid of mammals; (v) it has substrate-specific activity and (vi) it did not show any adverse effects in mammals, even when administered the pure protein and in high doses intravenously. Thus, there is no evidence that PAT protein can cause adverse effects on human or animal health.
CTNBio considered that the request complies with the norms and legislation in force that aim to guarantee the biosafety of the environment, agriculture, human and animal health, and concluded that the cotton GlyTol x LibertyLink (GTxLL) – event GHB614 x LLCotton25, is substantially equivalent to the conventional cotton, and its consumption is safe for human and animal health. Regarding the environment, CTNBio concluded that the cotton GlyTol x LibertyLink (GTxLL) – event GHB614 x LLCotton25 is not potentially causing significant degradation of the environment, keeping with the biota an identical relationship to conventional cotton.
According to the process sent by Bayer, it is possible to affirm that the hypothesis of interaction between the PAT and 2mEPSPS proteins is practically null, since the expression of both proteins occurs by the combination by conventional crossing between the parents and not by the insertion of recombinant DNA. Furthermore, the metabolic pathways in which proteins are involved are distinct. This statement is based on tests whose results for PAT and 2mEPSPS protein contents in leaves, grains and flower buds performed on GlyTol x LibertyLink cotton and on their genetically modified parents were essentially the same. The applicant states that the data obtained demonstrate that the PAT and 2mEPSPS proteins do not depend on or are affected by the presence of each other, do not compete for substrate and there is no inhibition by the final product of the compounds. Also, according to the applicant company, the safety of GlyTol x LibertyLink cotton has already been demonstrated in the isolated events GlyTol and LibertyLink. Western blot analysis showed that the protein profile, after
cleavage with the same restriction enzymes used in the cleavage of the parents, does not differ when comparing the stacked cotton and its parents, which makes us believe that there were no changes in the genetic modification due to the crossing and conventional improvement of the genetically modified parents.
cleavage with the same restriction enzymes used in the cleavage of the parents, does not differ when comparing the stacked cotton and its parents, which makes us believe that there were no changes in the genetic modification due to the crossing and conventional improvement of the genetically modified parents.
The applicant presented the results of a study carried out in Santo Antonio do Leste, MT and in São Desidério, BA (FREIRE, 2012), where no statistical differences were detected between the phenological, morphological and production components between the unmodified cotton , the individual events GlyTol and LibertyLink, and the combined event GTxLL. The parameters evaluated indicated that the combination of individual events, by crossing and selection, did not change the specificity of the genes and did not result in pleiotropic or epistatic effects. The parameters of moisture, crude protein, lipids, ash, carbohydrates, fiber, minerals, vitamins and antinutrients were analyzed, comparing samples of GTxLL cotton with the parent and with unmodified cotton. Comparing data from GTxLL cotton in relation to the parents GHB614 and LLCotton25, the results showed that there are some differences between the means for the ash compounds, calcium, α-tocopherol, free gossypol, total gossypol, phytic acid, dihydrosterculic acid and potassium.
Considering that studies carried out in the planned releases showed that the presence of bar and 2mepsps genes in GTxLL cotton did not significantly alter any phenotypic characteristics, related to phenological stages throughout the cycle or growth parameters, and considering the literature data on flux gene and introgression of genes in cotton, there is no evidence that could make GM cotton more invasive than conventional strains.
CTNBio considered that the request complies with the norms and legislation in force that aim to guarantee the biosafety of the environment, agriculture, human and animal health, and concluded that the cotton GlyTol x LibertyLink (GTxLL) - event GHB614 x LLCotton25, is substantially equivalent to the conventional cotton, and its consumption is safe for human and animal health. Regarding the environment, CTNBio concluded that the cotton GlyTol x LibertyLink (GTxLL) – event GHB614 x LLCotton25 is not potentially causing significant degradation of the environment, keeping with the biota an identical relationship to conventional cotton.
Molecular traddicional methods.
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Yes
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Yes
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