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Risk Assessment generated by a regulatory process
(RA)
last updated: 01 Sep 2022
Requests exemption from COT102 × MON 15985 × MON 88913 cotton post-commercial release monitoring plan.
EN
28 Jul 2016
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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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SYN-IR1Ø2-7 × MON-15985-7 × MON-88913-8 - Insect resistant, Herbicide tolerant Cotton| Monsanto | Resistance to antibiotics (Hygromycin, Kanamycin, Streptomycin), Resistance to diseases and pests (Insects, Lepidoptera (butterflies and moths)), Resistance to herbicides (Glyphosate)
- commercial release 5155 - 2016.pdf [ Portuguese ]
COT102 × MON 15985 × MON 88913 cotton is the result of a cross between COT102 cotton (licensed from the Syngenta company), MON 15985 cotton and MON cotton. 88913 through classical genetic improvement techniques. MON 15985 cotton was approved in Brazil by CTNBio in May/2009 (Technical Opinion No. 1,832/2009), MON 88913 cotton was approved in June/2011 (Technical Opinion No. 2,956/2011) and COT 102 cotton has not yet been approved in Brazil , having already been approved in other countries. The COT102 event expresses the protein Vip3A that confers resistance to certain lepidopteran insects (cotton curuquerê), (Alabama argillacea), false medideira (Chrysodeixis includens), pink caterpillar (Pectinophora gossypiella), apple bollworm (Heliothis virescens, Helicoverpa zea and H. armigera), fall armyworm (Spodoptera frugiperda), pod bollworm (Spodoptera eridania) and black bollworm (Spodoptera cosmioides)) and expresses the APH4 protein, used as a marker, which confers resistance to the antibiotic hygromycin. Event MON 15985 expresses Cry1Ac and Cry2Ab2 proteins that confer resistance to certain lepidopteran insects (cotton curuquerê (Alabama claycea), apple worms (Heliothis virescens and Helicoverpa zea), pink worm (Pectinophora gossypiella) and armyworm (Spodoptera frugiperda)) and the selection markers GUS and NPTII. Event MON 88913 expresses the CP4 EPSPS protein that confers tolerance to the herbicide glyphosate.
Events MON 15985 and MON 88913 have already been analyzed by CTNBio and commercially released and all information on the risk assessment of these events can be found in the aforementioned
opinions.
opinions.
Agronomic and phenotypic evaluation data were collected in field experiments in the United States and Brazil. In the USA, data were collected in experiments conducted in the 2011 harvest at ten locations in cotton-producing regions in the United States. A total of 26 phenotypic and agronomic traits were evaluated for COT102 × MON 15985 × MON 88913 cotton. These included nine growth and development traits, seven plant mapping traits (number of nodes on the main branch, final plant height (at harvest), number of nodes up to the first branch with fruits, number of first-rate bolls position per plant, total amount of bolls per plant and total amount of vegetative bolls per plant), four seed characteristics and six boll and fiber quality. In addition, twelve unique commercial references were included to generate ranges of comparative values that were representative of existing cotton varieties. In the analysis of the data, the applicant informs that no statistically significant differences were found for most of the parameters tested and, if differences were found in the mean values, they were compared and were within the range of variability of commercial references.
The commercial release of this genetically modified cotton is not potentially causing significant environmental degradation or harm to human and animal health.
The applicant presents in its risk assessment a review of the distinct modes of action of the proteins expressed in the combined event and states that the absence of interaction of the Bt and CP4 EPSPS proteins in COT102 × MON 15985 × MON 88913 cotton can be justified by the following
evidence:
- the expression levels of these proteins in COT102 × MON 15985 × MON 88913 cotton are low, but sufficient to confer the respective characteristics of resistance to lepidopteran pests and
of tolerance to glyphosate; - the modes of action and safety of these proteins are well known and are detailed in this document. Bt proteins, such as Vip3A, Cry1Ac and Cry2Ab, have different metabolic pathways from the CP4 EPSPS enzyme;
- the sites of biological activity of these proteins in COT102 × MON 15985 × MON 88913 cotton are distinct. Bt proteins, such as Cry1Ac, Cry2Ab2 and Vip3A, are synthesized and maintained in the cytoplasm of the plant cell, exerting their insecticidal biological activity by binding to receptors of midgut epithelial cells of the target insects, after solubilization and activation. by enzymatic cleavage. On the other hand, the CP4 EPSPS enzyme is directed to the chloroplast after
translation, acting in situ in the plant;
- the history of safe use of Bt and CP4 EPSPS proteins in other combination products that express these proteins simultaneously shows that, to date,
evidence:
- the expression levels of these proteins in COT102 × MON 15985 × MON 88913 cotton are low, but sufficient to confer the respective characteristics of resistance to lepidopteran pests and
of tolerance to glyphosate; - the modes of action and safety of these proteins are well known and are detailed in this document. Bt proteins, such as Vip3A, Cry1Ac and Cry2Ab, have different metabolic pathways from the CP4 EPSPS enzyme;
- the sites of biological activity of these proteins in COT102 × MON 15985 × MON 88913 cotton are distinct. Bt proteins, such as Cry1Ac, Cry2Ab2 and Vip3A, are synthesized and maintained in the cytoplasm of the plant cell, exerting their insecticidal biological activity by binding to receptors of midgut epithelial cells of the target insects, after solubilization and activation. by enzymatic cleavage. On the other hand, the CP4 EPSPS enzyme is directed to the chloroplast after
translation, acting in situ in the plant;
- the history of safe use of Bt and CP4 EPSPS proteins in other combination products that express these proteins simultaneously shows that, to date,
According to data presented in the applicant's proposal, the phenotype of the transformed plants containing the combined event COT102 × MON 15985 × MON 88913 is equivalent to the phenotype of
original plant, with regard to reproductive organs, duration of the plant's development and growth period, dormancy and germination, survival and persistence in the field, among others features. Furthermore, COT102 × MON 15985 × MON 88913 cotton, like conventional cotton, is not considered an invasive species in natural ecosystems and does not tend to proliferate as a weed. The genetic modifications included in cotton COT102 × MON 15985 × MON 88913 do not have any action or relationship with the natural processes of reproduction, dissemination and survival of the recipient species, concluding that no competitive advantage was provided. The assessment of the impact on usual agronomic practices also indicates that COT102 × MON 15985 × MON 88913 cotton does not have an impact on cultivation and rotation practices, or on the management of insects or diseases that are more likely to establish themselves in the environment as a weed than conventional cotton
original plant, with regard to reproductive organs, duration of the plant's development and growth period, dormancy and germination, survival and persistence in the field, among others features. Furthermore, COT102 × MON 15985 × MON 88913 cotton, like conventional cotton, is not considered an invasive species in natural ecosystems and does not tend to proliferate as a weed. The genetic modifications included in cotton COT102 × MON 15985 × MON 88913 do not have any action or relationship with the natural processes of reproduction, dissemination and survival of the recipient species, concluding that no competitive advantage was provided. The assessment of the impact on usual agronomic practices also indicates that COT102 × MON 15985 × MON 88913 cotton does not have an impact on cultivation and rotation practices, or on the management of insects or diseases that are more likely to establish themselves in the environment as a weed than conventional cotton
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. Thus, this activity is not potentially causing significant degradation of the environment or human health.
The commercial release of this genetically modified cotton is not potentially causing significant environmental degradation or harm to human and animal health.
Molecular traddicional methods.
Yes
Yes
Yes
Yes
Yes
EN
| Record type | Field | Record(s) | |
|---|---|---|---|
| Country's Decision or any other Communication | Risk assessment | 1 | |
