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Risk Assessment generated by a regulatory process
(RA)
last updated: 17 Apr 2026
Risk assessment of cotton event DAS-21023-5 × DAS-24236-5 × SYN-IR102-7, Technical Opinion - 5955/2018.
EN
02 Aug 2018
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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,Phone: (5561) 3411-5516,Fax: (5561) 3317-7475,Email: ctnbio@mct.gov.br,Website: http://www.ctnbio.gov.br,
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Organization:Dow AgroSciences Industrial Ltda. ()Private sector (business and industry)Rua Alexandre Dumas 1671 1º andar Ala ASao Paulo, SP
04717-903,Phone: +55 (16) 3690-1521; +55 (16) 3690-1500,Fax: +55(16) 3690-1599,Email: mjvonzuben@dow.com,Website:
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DAS-21Ø23-5 × DAS-24236-5 × SYN-IR1Ø2-7 - Glufosinate-ammonium-tolerant, Insect-resistant cotton| Resistance to antibiotics (Hygromycin), Resistance to diseases and pests (Insects, Lepidoptera (butterflies and moths)), Resistance to herbicides (Glufosinate), Selectable marker genes and reporter genes
- Commercial release 5955 - 2018.pdf [ Portuguese ]
DAS-21023-5 x DAS-24236-5 x SYN-IR102-7 cotton is carrier of the cry1F, cry1Ac and vip3Aa19 genes, which encode, respectively, the Cry1F, Cry1Ac and Vip3Aa19 proteins, which confer resistance to lepidopteran pests of the aerial part of the plant; the pat gene, which encodes the PAT protein, which confers tolerance to the herbicide glufosinate ammonium (used as a selection marker); and the aph4 gene, which encodes the APH4 protein, which acts as a selection marker for transformed plants (hygromycin B phosphotransferase).
The presence of cry1Ac, cry1F, pat, vip3Aa19 and aph4 genes in DAS-21023-5 × DAS24236-5 × SYN-IR102-7 cotton, and the respective proteins encoded by them (Cry1Ac, Cry1F, PAT, Vip3Aa19 and APH4), does not cause changes in nutritional composition and does not have the potential to cause adverse effects on food from the use of cotton products DAS-21023-5 × DAS-24236-5 × SYN-IR102-7. All Cry1F, Cry1Ac, PAT, Vip3Aa19 and APH4 proteins present in DAS-21023-5 × DAS-24236-5 ×SYNIR102-7 cotton have very low risk potential.
Experiments were carried out in the cotton producing regions of the USA for DAS-21023-5, DAS-24236-5 and DAS-21023-5 cotton. × DAS-24236-5. Results were compared with the original PSC355 strain which was introgressed with transformed events. Field tests in 16 locations monitored the resistance to diseases and pests of the genetically modified cotton lines and the conventional cotton line (parent PSC355). There were no differences in the severity of disease symptoms or damage by non-target insects among the genetically modified cotton plants. SYN-IR 102-7 cotton was evaluated in 51 field trials conducted in 12 US states. Few significant differences were observed in the agronomic performance when SYNIR102-7 cotton was compared with its conventional parent counterpart, Coker 312 cotton. SYN-IR102-7 cotton produced a significant increase in plume yield resulting from high plant protection against insect pests. The evaluation of agronomic characteristics of cotton DAS-21023-5 × DAS-24236-5× SYN-IR102-7 in relation to conventional control cotton and commercial cotton (commercial reference) were carried out in cotton producing regions in Brazil (Montividiu (GO), Indianópolis (MG) and Conchal (SP)). According to the applicant, data were collected on 32 agronomic components compared with the commercial WideStrike (DAS-21023-5 × DAS24236-5), whose commercial release was approved in Brazil in 2009. Based on the result from this study, it is concluded that DAS-21023-5 × DAS-24236-5 × SYN-IR102-7 cotton is agronomically equivalent to the conventional cotton variety.
There is no evidence that DAS-21023-5 × DAS-24236-5 × SYN-IR102-7 cotton poses a risk of toxicity or allergenicity, resulting from the consumption of products derived from it, to human health or animal.
The experiments were carried out under laboratory and field conditions. Analysis of the effects of Cry1F and Cry1Ac proteins present in DAS-21023-5 × DAS-24236-5 cotton was shown on non-target organisms such as earthworm, Collembola (soil invertebrate), aquatic organisms, non-target arthropods (bee, lacewing, parasitic wasp, ladybird, monarch butterfly and others. Field experiments were carried out in Brazil. Studies regarding the Vip3Aa19 protein present in SYNIR102-7 cotton were also evaluated for the environmental safety of the protein in species such as birds, aquatic organisms, insects and soil invertebrate species, which demonstrated that the protein is a specific toxin of lepidopterans showing that available evidence indicates that no non-lepidopteran species will be directly impacted by cotton plants that express the Vip3Aa19 protein.
Risk assessments under Brazilian conditions were analyzed in the main cotton producing regions (Indianópolis-MG, Jardinópolis-SP, Mogi-Mirim-SP, Rio Verde-GO, Palotina-PR, Primavera do Leste-MT, Montevidiu-GO and Conchal -SP. The cotton growing regions do not have weeds that are sexually compatible with the cultivated Gossypium species. The possibility of gene flow with cotton would be very low due to the spatial isolation predicted for commercial crops. Considering the LPMA studies, there is no there was evidence of a risk effect to non-target organisms, the effect being effective on lepidopterans.
CTNBio considered that the proposed biosafety measures meet the norms and the pertinent legislation that aim to guarantee the biosafety of the environment, agriculture, human and animal health. As noted, the GMO will be planted under controlled experimental conditions, avoiding possible damage to the environment.
CTNBio considered that the proposed biosafety measures meet the norms and pertinent legislation that aim to guarantee the biosafety of the environment, agriculture, human and animal health. As noted, the GMO will be planted under controlled experimental conditions, avoiding possible damage to the environment. This activity is not potentially causing significant degradation of the environment or human health.
Molecular traddicional methods.
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EN
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| Country's Decision or any other Communication | Risk assessment | 1 | |
