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OECD Unique Identifier details

DAS-Ø15Ø7-1 x SYN-IR162-4
Commodity: Corn / Maize
Traits: Herbicide tolerance,Insect resistance
Brazil
Name of product applicant: Du Pont do Brasil
Summary of application:

Commercial release of maize TC1507xMIR162

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Date of authorization: 09/04/2015
Scope of authorization: Food and feed
Links to the information on the same product in other databases maintained by relevant international organizations, as appropriate. (We recommend providing links to only those databases to which your country has officially contributed.): ISAAA
Summary of the safety assessment (food safety):
Du Pont do Brasil S. A - Pioneer Seeds Division, requested CTNBio's opinion on the biosafety of hybrid corn selected by conventional crossing resulting from the combination of TC15Ø7 x MON81Ø x MIR162 x MON6Ø3 events, for the purpose of their release into the environment, Marketing, consumption and any other activities related to that GMO and its progenies. Event TC15Ø7 x MON81Ø x MIR162 x MON6Ø3 and its subcombinations are produced by conventional crosses between individual genetically modified events that have already been evaluated for risk by CTNBio. TC1507 maize contains the cry1F gene and the pat gene. The insecticidal protein present in TC1507 maize is a truncated Cry1F protein derived from strain PS81I from Bacillus thuringiensis var. Aizawai. The pat gene, from Streptomice viridrochromogenes, confers tolerance to the herbicide glufosinate ammonium. The MON810 maize line contains the B. thuringiensis cry1Ab gene. The MIR162 event, which contains the Vip3Aa protein is a Bacillus thurigiensis protein, but unlike the crystal proteins (Cry) of Bacillus thuringiensis, Vip proteins (Vegetative Insecticidal Proteins) are produced during bacterial growth. The NK603 event contains the cp4 epsps gene encoding a glyphosate-tolerant form of the enzyme 5-enolpyruvlyshikimate-3-phosphate synthase (EPSPS) was isolated from the bacterium Agrobacterium tumefaciens CP4 strain. The applicant also requested authorization for the subcombinations: DAS-Ø15Ø7-1 (TC1507) x SYN-IR162-4 (MIR162) x MON-ØØ603-6 (NK603); DAS-Ø15Ø7-1 (TC1507) x SYN-IR162-4 (MIR162); SYN-IR162-4 (MIR162) x MON-ØØ603-6 (NK603) and MON-Ø810-6 (MON810) x SYN-IR162-4 (MIR162). The analysis of the risk assessment of the combined event TC1507 x MON810 x MIR162 x NK603 occurred on a case-by-case basis and considered, according to Art. 3 of RN 5/2008, the information previously presented for the individual events that contain the same genetic construct and The information of the present commercial release proposal, aiming to verify if the data presented by the applicant corroborate the hypothesis that there is no interaction between the inserts present in the combined event. In the proposed commercial release of the event TC1507 x MON810 x MIR162 x NK603 the information presented included the molecular characterization of the event; Evaluation of protein expression; The composition analysis of different plant tissues, insect studies and the results of experiments for agronomic and phenotypic evaluations of the combined event. CTNBio evaluated combined event data for molecular characterization (PCR and Southern Blot), grain and forage composition, expression of heterologous proteins, control of target insects and herbicide tolerance, and no evidence of interactions was found between the four events that indicated The need for additional risk analyzes to those already carried out for individualized events, both in human and animal health as well as in the environment. According to article 2 of RN no. 15/2015, which amends Art. 22 of RN no. 5/2008, the company submitted a request for commercial release of the subcombinations of this event: DAS-Ø15Ø7-1 (TC1507) x SYN-IR162 -4 (MIR162) x MON-Ø603-6 (NK603); DAS-Ø15Ø7-1 (TC1507) x SYN-IR162-4 (MIR162); SYN-IR162-4 (MIR162) x MON-Ø603-6 (NK603); MON-Ø810-6 (MON810) x SYN-IR162-4 (MIR162) and were also deferred by CTNBio. CTNBio reviewed the reports submitted by the applicant as well as independent scientific literature. Scientific studies carried out to evaluate biosafety, agronomic and phenotypic characteristics, as part of the risk assessment of this GMO, included representative regions for corn cultivation in Brazilian territory. CTNBio concluded that the event TC15Ø7 x MON81Ø x MIR162 x MON6Ø3 and said subcombinations keep with the biota the same ratio as conventional maize. The restrictions on the use of the GMO under analysis and its derivatives are conditioned to the provisions of Law 11,460 of March 21, 2007.
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Where detection method protocols and appropriate reference material (non-viable, or in certain circumstances, viable) suitable for low-level situation may be obtained:
molecular traditional methods
Relevant links to documents and information prepared by the competent authority responsible for the safety assessment: National Biosafety Commission
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Authorization expiration date (a blank field means there is no expiration date) Not Applicable
E-mail:
Organization/agency name (Full name):
National Biosafety Technical Commission
Contact person name:
Maria Sueli Felipe Soares
Website:
Physical full address:
SPO Area 5 Qd 3 Bl B S 10.1 Brasilia DF
Phone number:
556134115516
Fax number:
556133177475
Country introduction:

Brazil had the first biosafety law approved in 1995. After the identification of the need to improve the biosafety system of Brazilian genetically modified organisms, a new law was published. The Law 11.105 / 05 establishes a technical committee dedicated to the analysis of the safety aspects of genetically modified organisms and a council of ministers that is dedicated to the analysis of the socioeconomic aspects of the commercial release of genetically modified organisms. In this context, Brazil already has several commercial products that involve genetically modified organisms (plants, human and veterinary vaccines, microorganisms for fuel production) and products derived from new genetic modification techniques.

Useful links
Relevant documents
Stacked events:

At the discretion of, and upon consultation with, CTNBio, a new analysis and issuance of technical opinion may be released on GMOs containing more than one event, combined through classic genetic improvement and which have been previously approved for commercial release by CTNBio

Contact details of the competent authority(s) responsible for the safety assessment and the product applicant:

Dr. Edivaldo Domingues Velini (President of national Biosafety Commission)