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Risk Assessment generated by a regulatory process
(RA)
last updated: 17 Apr 2026
Risk assessment of cotton, event GHB614, Technical Opinion No. 2754/2010.
EN
09 Dec 2010
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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 - GlyTol™ Cotton GHB614| Bayer CropScience | Resistance to herbicides (Glyphosate)
- Commercial release 2754-2010.pdf [ Portuguese ]
GlyTol® cotton - Event GHB614 - was genetically modified by inserting the 2mepsps gene, responsible for the expression of the enzyme 5-enolpyruvyl shikimato-3-phosphate synthase (2mEPSPS) with a mutation in 2 amino acids. This modified enzyme gives GlyTol® cotton selectivity to the herbicidal effect of the active ingredient glyphosate, thus allowing the control of weeds in post-emergence of the crop without causing damage to the cotton crop. Event GHB614 was obtained by inserting the gene of interest and the regulatory elements into the genome of the Coker 312 cotton variety. The genetic modification in the Event occurred through the system mediated by Agrobacterium tumefasciens containing the pTEM2 vector.
The experimental results in Brazil generated in tests authorized by CTNBio and MAPA demonstrate a significant reduction in the use of herbicides in crops, which simplifies the system of
weed control when compared to conventional cotton. A good example of the high penetration of the product are the rates of adherence to the technology in the United States and Australia: in 2006, nine years after the first commercial plantation of glyphosate-tolerant cotton (Event MON1445) in American crops, 65% of the planted area of cotton in the country was already with the
respective Event. In Australia, the first commercial area was in 2000 and in just six years the area planted with the product already represented 75% of the cotton planted area in the country. In these
Therefore, in countries that already have a long history of use in the environment, there is no reference regarding adverse effects or environmental degradation as a result of this technology that allows the management of weeds with glyphosate
weed control when compared to conventional cotton. A good example of the high penetration of the product are the rates of adherence to the technology in the United States and Australia: in 2006, nine years after the first commercial plantation of glyphosate-tolerant cotton (Event MON1445) in American crops, 65% of the planted area of cotton in the country was already with the
respective Event. In Australia, the first commercial area was in 2000 and in just six years the area planted with the product already represented 75% of the cotton planted area in the country. In these
Therefore, in countries that already have a long history of use in the environment, there is no reference regarding adverse effects or environmental degradation as a result of this technology that allows the management of weeds with glyphosate
According to data collected by ABRAPA (Brazilian Association of Cotton Producers), Brazil cultivated 1.07 million hectares in the 2008/09 harvest, of which 300 thousand hectares were planted with
genetically modified cotton (SILVEIRA et al., 2009). Abrapa's expectation for the 2009/10 harvest is a reduction of around 23%, to 850 thousand hectares, with production of 1.2 million tons of lint. The experimental results in Brazil generated in trials authorized by CTNBio and MAPA demonstrate a significant reduction in the use of herbicides in crops, which simplifies the weed control system when compared to conventional cotton. A good example of high penetration of the product are the rates of adherence to the technology in the United States and Australia: in 2006, nine years after the first commercial plantation of glyphosate-tolerant cotton (Event MON1445) in American crops, 65% of the cotton planted area in the country was already covered by the respective Event. In Australia, the first commercial area was in 2000 and in just six years the area planted with the product already represented 75% of the cotton planted area in the country. In these countries, which therefore already have a long history of use in the environment, there is no no reference to adverse effects or environmental degradation as a result of this technology that allows the management of weeds with glyphosate.
genetically modified cotton (SILVEIRA et al., 2009). Abrapa's expectation for the 2009/10 harvest is a reduction of around 23%, to 850 thousand hectares, with production of 1.2 million tons of lint. The experimental results in Brazil generated in trials authorized by CTNBio and MAPA demonstrate a significant reduction in the use of herbicides in crops, which simplifies the weed control system when compared to conventional cotton. A good example of high penetration of the product are the rates of adherence to the technology in the United States and Australia: in 2006, nine years after the first commercial plantation of glyphosate-tolerant cotton (Event MON1445) in American crops, 65% of the cotton planted area in the country was already covered by the respective Event. In Australia, the first commercial area was in 2000 and in just six years the area planted with the product already represented 75% of the cotton planted area in the country. In these countries, which therefore already have a long history of use in the environment, there is no no reference to adverse effects or environmental degradation as a result of this technology that allows the management of weeds with glyphosate.
The data presented by the applicant support the conclusion that the 2mEPSPS protein, under the conditions found in GlyTol cotton derivatives, does not present greater risks of allergenicity for humans and animals than the non-transgenic varieties.
The data showed that for most components analyzed, no significant difference was identified between GlyTol cotton and its iso-line. In cases of variation, they did not represent a nutritional impact for the following reasons:
- the values found for the GHB614 and Coker 312 samples were within the range reported for commercial products, especially for cyclopropenoids (malvalic, sterculic and dihydrosterculic fatty acids);
- there was no trend in the variation found. In the fiber analysis (neutral), for example, in some fabrics higher values were found in GHB614 and in others lower, compared to the
Coker 312;
- differences in nutrient levels were observed in only one product. The values measured for myristic fatty acid (C14:0) showed a difference between the genotypes only when analyzed in refined oil, which was not observed in ginned seeds, delinted seeds and crude oil;
- differences in nutrient levels were so small as to have no nutritional relevance (0.1% variation for fatty acids measured in husk and fiber between genotypes).
- the values found for the GHB614 and Coker 312 samples were within the range reported for commercial products, especially for cyclopropenoids (malvalic, sterculic and dihydrosterculic fatty acids);
- there was no trend in the variation found. In the fiber analysis (neutral), for example, in some fabrics higher values were found in GHB614 and in others lower, compared to the
Coker 312;
- differences in nutrient levels were observed in only one product. The values measured for myristic fatty acid (C14:0) showed a difference between the genotypes only when analyzed in refined oil, which was not observed in ginned seeds, delinted seeds and crude oil;
- differences in nutrient levels were so small as to have no nutritional relevance (0.1% variation for fatty acids measured in husk and fiber between genotypes).
The results obtained by analyzing the phenological data indicated that the plants derived from Event GHB614 were tolerant to glyphosate, even at high doses of the herbicide, since the parameters evaluated did not differ statistically from the data analyzed in plants managed without the herbicide. This indicates that the 2mEPSPS protein was expressed at a level sufficient for the proper protection of the plant, allowing the maintenance of its normal growth and development. When the plants were subjected to applications of the herbicide Ammonium Glufosinate in order to evaluate the Event specificity for selectivity only to the active ingredient glyphosate, both VGM (cotton GlyTol) and NM plants were highly sensitive, leading to total injury. of plants at 14 days after application, demonstrating that the 2mepsps gene acts solely on tolerance to glyphosate, without any additional attribute of survival or adaptive advantage to GlyTol cotton. This test also demonstrated that, if there is a need to eradicate plants derived from the GlyTol Event, the use of other non-selective herbicides to the crop remains efficient for this purpose. of eradication of plants derived from the GlyTol Event, the use of other non-selective herbicides to the crop remains efficient for this purpose. Cotton growing regions do not have any weeds that are sexually compatible with the cultivated Gossypium species. Apparently, the possibilities of interbreeding between cotton species and other cultivated Malvaceae (such as okra, Hibiscus esculentus, or Hibiscus cannabinus and the vinegar plant Hibiscus sabdariffa) are very remote.
The use of cotton and its derivatives produced from GlyTol® cotton (Event GHB614) implies the same safety for human/animal health and the environment as conventional commercial lines, or even genetically modified varieties already approved and made available on the market containing selectivity to glyphosate.
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 GHB614 Cotton (Glytol®) is substantially equivalent to conventional cotton, and its consumption is safe for human and animal health. Regarding the environment, CTNBio concluded that GHB614 Cotton (Glytol®) does not potentially cause significant degradation of the environment, keeping with the biota the same relationship as conventional cotton.
Molecular traddicional methods.
Yes
Yes
Yes
Yes
Yes
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