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Risk Assessment generated by a regulatory process
(RA)
last updated: 01 Sep 2022
Risk assessment of genetically modified cotton tolerant to herbicides and resistant to insects called GlyTol x TwinLink – Event GHB 614 x T304-40 x GHB119- Technical Opinion - 3286/2012.
EN
18 Apr 2012
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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 × BCS-GHØØ4-7 × BCS-GHØØ5-8 - GlyTol™ x TwinLink™ Cotton| Bayer Schering Pharma | Resistance to diseases and pests (Insects, Lepidoptera (butterflies and moths), Cotton bollworm (Helicoverpa spp.), Fall armyworm (Spodoptera frugiperda)), Resistance to herbicides (Glufosinate, Glyphosate)
- Commercial release 3286 - 2012.pdf [ Portuguese ]
The cotton GlyTol x TwinLink – Event GHB 614 x T304-40 x GHB119 was obtained by breeding classical genetics, by crossing and selection between individuals containing the T304-40 events (Cry1Ab, Cry2A genes) and GHB119 (gene bar) to obtain the TwinLink cotton and later, the crossing with individuals of event GHB614 (GlyTol, gene 2mEPSPS). In this way, the cotton GlyTol x TwinLink – Event GHB 614 x T304-40 x GHB119 displays the Cry1Ab, Cry2Ae, 2mEPSPS and bar (PAT protein) genes. Event GHB614 (GlyTol®) was genetically modified by the insertion of the 2mepsps gene, responsible for the expression of the enzyme 5-enolpyruvyl shikimate-3-phosphate synthase (2mEPSPS) with mutation in 2 amino acids. It is modified enzyme gives GlyTol® cotton selectivity to the herbicidal effect whose active ingredient is the glyphosate, thus allowing the control of weeds in post-emergence, without causing injuries to crops of cotton.
Analysis of data on food and environmental biosecurity of cotton GlyTol x TwinLink – Event GHB 614
x T304-40 x GHB119 showed that cotton is equivalent to conventional cotton and commercial references. Additionally, there is no evidence of adverse reactions to the use of GlyTol x TwinLink cotton – Event GHB 614 x T304-40 x GHB119. For these reasons, there are no restrictions on the use of this cotton or its derivatives either for human or animal food.
x T304-40 x GHB119 showed that cotton is equivalent to conventional cotton and commercial references. Additionally, there is no evidence of adverse reactions to the use of GlyTol x TwinLink cotton – Event GHB 614 x T304-40 x GHB119. For these reasons, there are no restrictions on the use of this cotton or its derivatives either for human or animal food.
Animal feeding studies were carried out (birds treated with cotton cake), such as: protein in simulated gastric and intestinal system; acute toxicity by oral and intravenous application and homology of the protein with toxic/allergenic compounds. The results, in all cases, according to the company, indicate that cotton containing 2mEPSPS is substantially equivalent to other cotton varieties; the inserted DNA as well as the protein expressed 2mEPSPS do not pose any risk to human/animal health, compared to use of conventional cotton and its by-products in food.
CTNBio considers that this activity does not potentially cause significant degradation of the environment
environment or harm to human and animal health.
environment or harm to human and animal health.
The safety of Cry1Ab, Cry2Ae, 2mEPSPS and PAT proteins for human and animal consumption, as well as for the use in the environment has already been evaluated when analyzing the isolated events GlyTol and TwinLink, both in Brazil as in several other countries, obtaining commercial approval in all those that completed the evaluation of biosafety for GlyTol cotton and for TwinLink. In these analyses, the proteins were evaluated for their similarity with toxic/allergenic compounds, stability in the gastrointestinal system, acute and adverse effects when present in animal feed. In none of the studies was there any evidence significant risk to the environment or to human and animal health.
The proximate composition data did not show significant differences between the cotton variety genetically modified GlyTol x TwinLink – Event GHB 614 x T304-40 x GHB119 and the conventional ones, indicating the nutritional equivalence between them; The use of seeds or by-products derived from the GlyTol x TwinLink Event – GHB Event 614 x T304-40 x GHB119, meeting the same recommendations and safety criteria already usual for cotton varieties commercial, does not represent greater exposure to any risk situation.
Biosafety analysis of individual events (GlyTol x TwinLink – GHB Event 614 x T304-40 x GHB119) has shown that genetically modified cotton does not pose any significant risk to human/animal health, or the environment.
The CTNB adequate consumption that the request meets in accordance with the environmental guarantee of the environment, the CTNB safe consumption for the animal, and surely the safe consumption for animals, is equivalent to an agreement in its human and animal health environment. In terms of media, CTNBio concluded that the cultivation of GlyTol x TwinLink cotton does not cause environmental degradation, biologically correct, it does not cause environmental degradation, the environment can be used with conventional cotton.
Molecular traddicional methods.
Yes
Yes
Yes
Yes
Yes
EN
| Record type | Field | Record(s) | |
|---|---|---|---|
| Country's Decision or any other Communication | Risk assessment | 1 | |
