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Risk Assessment
Record information and status
Record ID
Date of creation
2008-06-26 11:11 UTC (pafca@mre.gov.br)
Date of last update
2013-03-27 19:45 UTC (gutemberg.sousa@mctic.gov.br)
Date of publication
2013-04-01 18:35 UTC (davi.bonavides@itamaraty.gov.br)

General Information
  • Brazil
Title of risk assessment
Risk Assessment for Insect Resistant Cotton
Date of the risk assessment
Date not available
Competent National Authority(ies) responsible for the risk assessment
National Technical Biosafety Commission
Setor Policial Sul -SPO Área 5 Quadra 3 Bloco B - Térreo Salas 10 à 14
Brasília, DF
Brazil, CEP - 70610-200
Phone:(5561) 3411-5516
Fax:(5561) 3317-7475
Url:National Technical Biosafety Comission
Risk assessment details
Living modified organism
MON-ØØ531-6 - Bollgard™ cotton
Resistance to antibiotics - Kanamycin, Streptomycin Resistance to diseases and pests - Insects - Lepidoptera (butterflies and moths)
Show detection method(s)
Scope of the risk assessment
  • LMOs for contained use
  • LMOs for direct use as feed
  • LMOs for direct use as food
  • LMOs for introduction into the environment
    • commercial production
    • field trial
  • LMOs for processing
Risk assessment report / Summary
Methodology and points to consider
Potential adverse effects identified in the risk assessment
The genetically modified cotton event 531 did not show morphologic, phenological or plant architecture alteration. The gene insertion caused no effect on fibers' quality. Except for the tolerance to target insects during the crop, the Bollgard Cotton event 531 plants showed equivalence in all phenotypical and agronomical features as regards the standard shown by the non-transformed parental lineage and other varieties used in commercial production. The analysis of the documents submitted allows us to conclude that the cultivation of the Bollgard cotton event 531 shall not cause alteration in the soil and in its ecologic and functional relationships, different from those caused by conventional varieties. Due to the specificity of the CrylAc protein action on some Lepidopteran species, a direct negative effect on the third trophic level (natural enemies) is not expected. Studies conducted in other countries have demonstrated that there is no adverse effect by the CrylAc protein on natural enemies. Even after almost 10 years of use of the Bollgard cotton event 531 in other countries, up to now there are no reports on the evolution of resistance from any plague to the B. thuringiensis toxins in the field. The NPTII protein is quickly degraded, as the other proteins found in vegetal tissues, and it is not toxic for living beings. The resistance to the canamycin and neomycin, granted by the gene nptII, is a ubiquitous presence in microorganisms, and there are no evidences of gene transfer from the plant to the bacteria
Likelihood that the potential adverse effects will be realized
The crossing rates in plantations with 10 and 15m of alley were 0%, and the gene flow of the Bollgard cotton event 531 for conventional cotton was 0.85% in borders of cotton genetically modified. Studies in other countries showed that the likelihood of gene transfer from a field with Bollgard cotton event 531 to a field with conventional or sylvan cotton is a very low one, and trends to zero in distances higher than 15m
Possible consequences:
Studies made do not show alterations in the main components and in natural anti-nutrients present in the cotton. The safety of feeding products from Bollgard cotton event 531 was determined by equivalence in the composition of macro and micronutrients in salubrity studies conducted with animals, and it was concluded that such product, as a component of animal ration, and proteins CrylAc and NPTII expressed in plant tissues, showed to be safe and with an equivalent nutrition value for human and animal consumption.
Estimation of the overall risk
not applicable
Further to respect the exclusion zones as regards the plantation of the genetically modified cotton for containing the gene flow, as proposed by Barroso e Freire (2004), the crop time for the Bollgard cotton event 531 in the different cotton producing regions, mainly in locations with safrinha cotton crops, should also be determined and limited, in order that the period of plagues' exposure to CrylAc is the shortest possible.

Need(s) for further information on specific issues of concern
not applicable
Receiving environment(s) considered
The field evaluations with the Bollgard Cotton event 531 conducted in cotton-producing regions in Brazil showed that there are no significant differences in morphologic features and in agronomic performance in relation to the Coker 312 non-transformed parental lineage. The following parameters were evaluated: effectiveness in the control of target-insects during the crop; plant growing and development morphologic features as germination, plant vigor, flowering, number and size of cotton bolls; susceptibility to plagues and diseases; yielding; fiber quality such as length, micronaire (fiber fineness and weaving capability), yarn resistance and elongation capability; and grain composition, where proteins, fats, fibers, carbohydrates, aminoacids, mineral residues, caloric contents, lipids, fatty acids, a -tocopherol, gossypol, and aflatoxins were evaluated.

The results of researches made in Brazil are similar to those observed in other countries. The levels of insect-laying plagues A. argillacea/P. gossypiella , and H. virescens in the Bollgard cotton event 531 were similar to those observed in the non-transformed parental lineage. The protein CrylAc expressed by plants of genetically modified cotton controlled and maintained the plague P. gossypiella within population satisfactory levels, even in high population pressure situations. The plagues A. argillacea and H. virescens had not a significant presence along the culture cycle of the Bollgard Cotton event 531 in evaluated experiments. The parasitism levels observed in eggs of A. argillacea and H. virescens species in the genetically modified lineage showed that parasitoids were not affected by the insecticide effect of protein CrylAc, compared with the non-transformed parental lineage.

LMO detection and identification methods proposed
Molecular traditional methods
Additional Information
Other relevant website address or attached documents

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