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Risk Assessment generated by a regulatory process
(RA)
last updated: 01 Sep 2022
Risk assessment of genetically modified herbicide tolerant cotton - DAS-81910-7
EN
04 Oct 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-8191Ø-7 - Cotton modified for herbicide tolerance| DOW Chemical Company | Resistance to herbicides (Glufosinate), Tolerance to 2,4-Dichlorophenoxyacetic acid
- commercial release 6107 - 2018.pdf [ Portuguese ]
DAS-81910-7 cotton falls into Risk Class 1 (low individual risk and low risk to the community), in accordance with Article 8 of the Normative Resolution Nº 2 of November 27, 2006, of the National Technical Commission on Biosafety. The cotton DAS-81910-7 event was developed through transformation genetics mediated by Agrobacterium tumefaciens, strain EHA101, using the plasmid pDAB4468. The DAS-81910-7 cotton presents inserted in its genome the aad-12 gene from the bacterium Delftia acidovorans encodes the protein AAD-12, which confers tolerance to the 2,4-D herbicide, and the pat gene from of Streptomyces viridochromogenes, which encodes the PAT protein, which confers glufosinate ammonium herbicide tolerance.
As for the impacts on non-target organisms, the applicant concluded that the specificity of the enzyme aryloxyalkanoate dioxygenase-12 (AAD-12) and the biological activity of the protein
PAT, and the high exposure of these proteins in the environment, no adverse effects on non-target organisms present in the DAS81910-7 cotton ecosystem are expected with the commercial release of the product.
PAT, and the high exposure of these proteins in the environment, no adverse effects on non-target organisms present in the DAS81910-7 cotton ecosystem are expected with the commercial release of the product.
Results presented in the lawsuit (pages 212 to 216) show that no significant identity was observed between the PAT and AAD-12 proteins with respect to proteins known to be toxic or allergenic, indicating a lack of potential for DAS-81910-7 cotton to produce toxins. , allergens or metabolites that cause adverse effects in organisms that, by chance, consume products derived from DAS-81910-7 cotton.
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 DAS-81910-7 cotton is substantially equivalent to conventional cotton, being its consumption safe for human and animal health.
Regarding the environmental aspects, considering the extensive literature on the subject and the fact that DAS-81910-7 cotton did not show differences in relation to conventional cotton in terms of agronomic, morphological, reproductive, biodegradability, chemical and nutritional composition, the applicant classified it as very The possibility of horizontal transfer of genes from plants to soil biota is remote, not representing a significant risk for the possibility of transfer of aad-12 and pat genes from DAS-81910-7 cotton to soil organisms. As for the impacts on non-target organisms, the applicant concluded that the specificity of the enzyme aryloxyalkanoate dioxygenase-12 (AAD-12) and the biological activity of the PAT protein, and the large exposure of these proteins in the environment, had no adverse effect on non-target organisms. -targets present in the cotton ecosystem DAS-81910-7 is expected with the commercial release of the product. However, although there are previous studies showing that the commercial release of this product in other countries has not shown an effect on soil biota and non-target organisms and that there are no differences between GM and conventional cotton in many evaluated traits, there is a need to carry out experimental studies in environments in our country to make sure that the event is safe in terms of effects on soil biota and non-target organisms.
The applicant company must present a strategy to eliminate ratoon and control the regrowth of GM cotton. This request is based on the fact that there is an environmental biosafety issue arising from the fact that the cotton event is 2,4-D tolerant. This issue is provided for in Item 8 of Annex 4 of RN 5. - “Inform: the negative and positive impacts to target and non-target organisms that may occur with the release of the GMO, listing the species evaluated, the reasons for the choice and the techniques used to demonstrate impacts.”
Field studies conducted with authorization from the National Technical Commission on Biosafety (CTNBio) demonstrated the effectiveness, agronomic feasibility and biosafety of using DAS-81910-7 cotton for cultivation in different regions that are representative of cotton cultivation in the countr.
DAS81910-7 cotton are as safe for the environment and human and animal health as conventional cotton.
Molecular traddicional methods.
Yes
Yes
Yes
Yes
Yes
EN
| Record type | Field | Record(s) | |
|---|---|---|---|
| Country's Decision or any other Communication | Risk assessment | 1 | |
