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Risk Assessment generated by a regulatory process
(RA)
last updated: 01 Sep 2022
Risk assessment of cotton, event MON531, Technical Opinion - No. 513/2005.
EN
17 Mar 2005
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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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Organization:Monsanto do Brasil Ltda ()Private sector (business and industry)Geraldo Ubirajara Berger Avenida das Nações Unidas, 12901 - Torre Norte - 7º andarSao Paulo, SP
04578-000, BrazilPhone: +55(11) 3383-8356,Fax: +55(11) 3383-8102 ; +55 (61) 3245-2523,Email: geraldo.u.berger@monsanto.com,Website:
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MON-ØØ531-6 - Bollgard™ cotton| Monsanto | Resistance to antibiotics (Kanamycin, Streptomycin), Resistance to diseases and pests (Insects, Lepidoptera (butterflies and moths))
- Commercial release 513 - 2005.pdf [ Portuguese ]
The genetically modified cotton developed by Monsanto do Brasil Ltda., designated Bollgard Cotton Event 531, was generated by using the transformation technique indirect via Agrobacterium tumefaciens, a well-established technique and one of the most used in obtaining genetically modified plants. A. tumefaciens is a gram-positive bacterium, found in soil and causing tumor in plants. The mechanism of insertion of A. tumefaciens genes into the host plant is practically all known. In wild A. tumefaciens, the existence of the Ti plasmid allows the bacterium to insert part of its genome (T-DNA region) into the plant genome. To unravel this mechanism, scientists, using molecular biology techniques, removed the tumor-inducing genes from the T-DNA region of the Ti plasmid and replaced them by genes of interest. The specificity of the mechanism in transferring only the sequences between the right edge and the left edge of the T-DNA region makes the quite safe transformation in the sense that other bacterial sequences mediator of the process are not transferred.
The security of Bollgard cotton food products event 531 was determined by the equivalence in the composition of macro and micronutrients in health studies with animals and it was concluded that this product, as a component of animal feed and the proteins Cry1Ac and NPTII expressed in plant tissues proved to be safe and nutritious equivalent for human and animal consumption.
Research for the evaluation of agronomic efficacy and performance with Cotton Bollgard in Brazil were carried out in the 1997/1998 and 1999/2000 harvests, in the regions of Goiatuba and Edéia (GO), Ituverava and Santa Cruz das Palmeiras (SP), Rondonópolis (MT) and Capinopolis (MG). Other studies to evaluate the effectiveness of Bollgard Cotton against some pest species were carried out in a greenhouse. The studies proved the effectiveness of Bollgard Cotton in the control of the cotton curuquerê (Alabama argillacea), the apple bollworm (Heliothis virescens) and the pink bollworm.
(Pectinophora gossypiella). Bollgard Cotton is an advanced technology of great interest
to Brazil, where lepidopteran pests cause large production losses and to their control, huge amounts of insecticides are applied. The adoption of this technology can reduce the use of about one million liters of insecticides in the country each year, raise productivity and reduce production costs.
(Pectinophora gossypiella). Bollgard Cotton is an advanced technology of great interest
to Brazil, where lepidopteran pests cause large production losses and to their control, huge amounts of insecticides are applied. The adoption of this technology can reduce the use of about one million liters of insecticides in the country each year, raise productivity and reduce production costs.
Despite the absence of proteins in food products, the way of action, specificity and exposure history, lack of similarity with allergenic and toxic proteins, rapid digestion in gastric and intestinal fluids
simulated, as well as the lack of acute oral toxicity in animals, Bollgard cotton event 531 expressing Cry1Ac and NPTII proteins demonstrates safety for consumption human and animal equivalent to conventional cotton.
simulated, as well as the lack of acute oral toxicity in animals, Bollgard cotton event 531 expressing Cry1Ac and NPTII proteins demonstrates safety for consumption human and animal equivalent to conventional cotton.
Field evaluations with the Bollgard Cotton event 531 carried out in the regions cotton producers in Brazil, showed that there are no significant differences in the morphological characteristics and agronomic performance in relation to the parental line untransformed Coker 312. The following parameters were evaluated: efficacy in control of target insects throughout the season; morphological characteristics of growth and plant development such as germination, plant vigor, flowering, number and boll size; susceptibility to pests and diseases; Yield; fiber quality such as length, micronaire (fineness and weaveability of the fiber), strength and elongation of the yarn; and grain composition, in which proteins, fats, fibers, carbohydrates, amino acids, mineral residues, caloric content, lipids, fatty acids, - tocopherol, gossypol and aflatoxins. The results of research carried out in Brazil are similar to those observed in other countries. Laying levels of insect pests A. argillacea, P. gossypiella and H. virescens in Bollgard event 531 cotton were similar to those observed in the non- transformed. The Cry1Ac protein expressed by genetically modified cotton plants modified controlled and maintained the pest P. gossypiella within population levels satisfactory, even in situations of high population pressure. The pests A. argillacea and H. virescens did not present a significant presence throughout the crop cycle of Bollgard event 531 cotton in the evaluated experiments. The levels of parasitism observed in the eggs of the species A. argillacea and H. virescens in the genetically modified showed that the parasitoids were not affected by the insecticidal effect of the Cry1Ac protein, compared to the untransformed parental line. The fiber qualities were also evaluated and did not show any effect of
gene insertion. Length data, length uniformity, index micronaire, the strength and elongation of the yarn obtained from Bollgard Cotton event 531 in commercial production in other countries demonstrate equivalence or superior quality to fibers produced by the parental variety Coker 312 and by the conventional varieties commercialized. The composition of the genetically modified cotton grains showed equivalence in the pattern of grain composition of the parental and commercial varieties.
gene insertion. Length data, length uniformity, index micronaire, the strength and elongation of the yarn obtained from Bollgard Cotton event 531 in commercial production in other countries demonstrate equivalence or superior quality to fibers produced by the parental variety Coker 312 and by the conventional varieties commercialized. The composition of the genetically modified cotton grains showed equivalence in the pattern of grain composition of the parental and commercial varieties.
The genetically modified cotton event 531 did not show any morphological, phenological or plant architecture changes. There was no effect of gene insertion on fiber quality. With the exception of tolerance to target insects throughout the season, the Bollgard Cotton event 531 plants showed equivalence in all phenotypic and agronomic traits in relation to the pattern demonstrated by the untransformed parental line and by other varieties used in commercial production. The analysis of the documents presented allows us to conclude that the cultivation of Bollgard event 531 cotton will not cause changes in the soil and its ecological and functional relationships different from those caused by conventional varieties.
CTNBio considered that the experimental protocol and the other proposed biosecurity measures meet the standards and relevant legislation that aim to guarantee the biosafety of the environment, agriculture, human and animal health.
The safety of Bollgard event 531 cotton food products was determined by the equivalence in the composition of macro and micronutrients in animal health studies and it was concluded that this product, as a component of animal feed and the proteins Cry1Ac and NPTII expressed in plant tissues proved to be safe and with equivalent nutritional value for human and animal consumption. the National Technical Commission on Biosafety – CTNBio after analyzing the biosafety of Bollgard cotton event 531, process 01200.001471/2003-01, decides in favor of its release for commercial planting and human and animal consumption.
Molecular traddicional methods.
Yes
Yes
Yes
Yes
Yes
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