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Risk Assessment generated by a regulatory process (RA)
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BCH-RA-BR-294014-1   |   PDF   |   Print   |  
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last updated: 14 Apr 2026
General Information
Risk assessment of cotton, event LLCotton25 - Technical Opinion No. 1521/2008.
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21 Aug 2021
Risk assessment details
  • ACS-GHØØ1-3 - Liberty Link™ cotton
    | Bayer CropScience | Resistance to herbicides (Glufosinate)
LibertyLink Cotton has the bar gene in its composition, derived from Streptomyces hygroscopicus strain ATCC-21705 (55), a ubiquitous gram-positive actinobacterium in the soil, non-pathogenic to plants, humans and animals (74, 58). This gene encodes the enzyme PAT – phosphinothricin N-acetyltransferase, responsible for the acetylation of phosphinothricin, also called glyphosinate or glufosinate ammonium (GA). The inactivation of phosphinothricin by PAT allows the selective use of herbicides that have glufosinate ammonium as an active ingredient. The commercial event LLCotton25 was obtained by transforming cotton tissues from the region between the hypocotyl and the radicle, collected at 3 days after emergence and submitted to cultivation in culture with Agrobacterium tumefaciens using the binary transformation system with the Ti plasmids pGV3000 and the vector pGSV71 binary. Explants were regenerated in appropriate medium in the presence of 500 mg/L Claforan. The bar gene expression was used as a selection marker. The regenerated tissues formed T0 seedlings, which were transferred to soil cultivation in a greenhouse until flowering and seed production by self-pollination.
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Methodology and points to consider
Additionally, the proponent carried out sampling over two years of cultivation, where interaction with several pathogens was observed, such as those that cause Ramulose, Fusarium wilt, Angular leaf spot, Alternaria leaf spot, Blue Disease and Common Mosaic, and no difference was found. significant in relation to non-genetically modified plants. In this way, literature data and field experiments suggest that the LLCotton25 event does not cause impacts against non-target organisms beyond those already inherent to the cotton crop.
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In practice, plants containing the PAT protein have been widely cultivated in the United States of America and Canada for almost a decade, without any reports of adverse effects when used in human and animal nutrition. Thus, the inclusion of PAT protein in human and animal food does not cause harm. The action of this protein is well known and there is no evidence in the literature that it has a biocidal action against non-target organisms. The trait conferred by the bar gene - herbicide tolerance - is recognized as not being able to endow the receptor genotypes with any adaptive advantage outside agricultural areas, since outside these areas, the potential wild receptor genotypes are not affected by the selective pressure of the glufosinate ammonium herbicide and, therefore, the eventual pollination of these genotypes would not result in gene introgression. It is extremely unlikely that the bar transgene from Event LLCotton25 will be transferred to weeds making them more invasive. The agronomic tests carried out attached to the process and the reports of the planned releases in the environment did not identify differences between the LLCotton25 cotton plant and its isoline in terms of susceptibility to diseases and pests. The possibility of the herbaceous cotton plant LLCotton25 becoming a weed is considered negligible. The analysis of the biochemical composition of LibertyLink Cotton demonstrates that the LLCotton25 event presents substantial equivalence to non-genetically modified varieties, strongly suggesting that the event in question does not present undesirable pleiotropic effects. None of the phenotypic characteristics of the genetically modified cotton plants suffered any alteration due to the insertion and expression of the bar gene in relation to the unmodified cultivars.
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The commercial release of LibertyLink Cotton is potentially not causing damage to human and animal health, or significant degradation of the environment.
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The analysis of the biochemical composition of LibertyLink Cotton demonstrates that the LLCotton25 event presents substantial equivalence to non-genetically modified varieties, strongly suggesting that the event in question does not present undesirable pleiotropic effects. none of the features phenotypic characteristics of genetically modified cotton plants suffered any alteration as a function of the insertion and expression of the bar gene in relation to non-modified cultivars.
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The results of agronomic behavior of genetically modified cotton plants, both in terms of quantitative and qualitative traits, were equivalent to cotton plants conventional herbicides in the absence and presence of glufosinate-ammonium-derived herbicides. The experiments were conducted mainly between 2001 and 2003 (two agricultural years) and conducted by technicians from Bayer CropScience Ltd. and by researchers from the Federal University of Uberlândia and the University of São Paulo in regions of the states of São Paulo and Minas Gerais. Among the characters evaluated are: plant height, cotton production in branches and in plumes, flowering pattern throughout development, plant glandulation and presence of leaf nectaries, size and shape of leaves, hairiness of stems and leaves, color of flowers, stems and pollen grains, plant density, number of vegetative and reproductive branches, feather retention and fruit shape and pattern of development (apples). As conclusions of the analysis of this series of genotype descriptors used for the registration and protection of cultivars (among others) and the behavior of genetically modified and non-genetically modified plants modified in response to environmental factors, including crop pests, none of the phenotypic characteristics of genetically modified cotton plants underwent any change as a function of the insertion and expression of the bar gene in relation to unmodified cultivars. No difference was observed by the authors even when the vegetables were submitted to different methods of controlling invasive plants or in the absence of the use of herbicides.
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CTNBio considered that the request complies with the relevant rules and legislation that aim to guarantee the biosafety of the environment, agriculture, human and animal health.
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The applicant responded to all the questions postulated in Normative Instruction No. 20 of CTNBio (in force at the time of submission of the process) and that none of the questions indicate that
this cotton may have adverse effects on human or animal nutrition.
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Molecular traddicional methods. 
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Information sharing with other databases
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Additional information
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