Food safety and quality
| share
 

OECD Unique Identifier details

DP-32138-1
Commodity: Corn / Maize
Traits: Fertility restoration
Brazil
Name of product applicant: DuPont do Brasil S.A. - Div. Pioneer Sementes
Summary of application:

The present proposal dealt with the specific case monitoring plan of the SPT process using the transgenic corn DP-32138-1, approved for commercial release in December 2015 (Technical Opinion 4,865/2015). In March 2017, through Technical Opinion 5399/2017, CTNBio approved the exemption from the general post-commercial release monitoring plan for this GM, however, it requested that the applicant submit a “... allows meeting the requirement determined in the commercial approval of event DP-32138-1, which is to monitor the efficiency and genetic stability of the SPT process, specifically at the stage in which event DP-32138-1 is used”. The proposed case-specific monitoring plan is focused on color sorting steps to monitor the ongoing efficiency of the SPT process. This will provide evidence that the SPT process is running as expected and described in Process No. 01200.001761/2013-18. Use will be limited to the applicant's internal operations in Brazil for the production of hybrid corn seeds. The applicant reported that the maintainer SPT 32138 is used as a pollinator to propagate the seeds of male-sterile female lines. The SPT process was developed in such a way that the female lineage seeds produced using the SPT maintainer do not contain the insertion of event 32138 and, consequently, the F1 hybrid seeds produced using these male-sterile female parental lines, as well as the commercial grains. produced in the fields do not contain an insert derived from event 32138 and therefore are not transgenic for SPT. As such, the SPT process will be used internally by DuPont Pioneer for the production of hybrid corn seed, and the SPT 32138 maintainer is not a commercial product per se, nor part of a commercial product; and there is no intention to introduce the transgenic seed of the maintainer SPT 32138 into commercial grain channels.

Upload:
Date of authorization: 04/10/2018
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.):
Summary of the safety assessment (food safety):
Within the scope of Art. 14 of Law 11,105/05, CTNBio considered that the general post-commercial release monitoring plan, specific to the DP-32138-1 corn event, complies with the relevant rules and legislation that aim to guarantee the biosafety of the environment, agriculture, human and animal health. Thus, provided the conditions described in the process and in this technical opinion are met, this activity is not potentially causing significant degradation of the environment or human healt
Upload:
Where detection method protocols and appropriate reference material (non-viable, or in certain circumstances, viable) suitable for low-level situation may be obtained:
Molecular traddicional methods.
Relevant links to documents and information prepared by the competent authority responsible for the safety assessment:
Upload:
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:
Paulo Augusto Viana Barroso
Website:
Physical full address:
SPO Area 5 Qd 3 Bl B S 10.1 Brasilia DF
Phone number:
556120335087
Fax number:
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. Paulo Augusto Viana Barroso (President of national Biosafety Commission)