CBD /

 

Loading...
Risk Assessment generated by a regulatory process (RA)
  |  
BCH-RA-BR-105000-2   |   PDF   |   Print   |  
| 
|  Close
published: 31 Jul 2013 last updated: 12 Mar 2015
General Information
Brazil
Risk Assessment of insect resistant and herbicide tolerant maize containing events TC1507x DAS-59122-7
ES
13 Jun 2013
Risk assessment details
  • BCH-LMO-SCBD-15186-6
    DAS-Ø15Ø7-1 × DAS-59122-7 - Herculex XTRA™ maize
    | Pioneer Hi-Bred International Inc. | Resistance to diseases and pests (Insects, Coleoptera (beetles), Lepidoptera (butterflies and moths)), Resistance to herbicides (Glufosinate)
    Show detection method(s)
Methodology and points to consider
The Du Pont in Brazil SA - Pioneer Seeds , holds the Certified Biosafety Quality 13/97 and Dow AgroSciences Seeds & Biotechnology Brazil Ltda., Holder of the Certificate of Quality in Biosafety 107/97, requested the CTNBio Technical Opinion about genetically modified maize insect resistant and tolerant to glufosinate ammonium, event TC1507 x DAS-59122-7, to effect their release into the environment, marketing, consumption, and any other activities related to this GMO and progeny derived from it. The event TC1507 x DAS-59122-7 was generated by crossing the maize TC1507 and DAS-59122-7, for classical genetic crosses, being possessed of genes and Cry1F/pat Cry34Ab1/Cry35Ab1/pat, and are responsible for the production of proteins Cry1F / phosphinothricin acetyltransferase (PAT) and Cry34Ab1/Cry35Ab1/PAT. Proteins Cry34Ab1 and Cry35Ab1 are directed to the protection of plants against insect pests of the order Coleoptera root while. Cry1F have specific action against insect pests of the order Lepidoptera. Additionally, maize TC1507 × DAS-59122-7 PAT protein expressed in both events parenting, responsible for tolerance to the herbicide glufosinate ammonium. The PAT protein is an enzyme that acts on glufosinate ammonium, being able to modify it, rendering it inactive, phosphinothricin by acetylation of the free amine in its grouping. Protein expression studies were carried out in Brazil with events TC1507, DAS-59122-7 and the combined event TC1507 x DAS-59122-7. For analysis of protein expression corn TC1507 x DAS-59122-7 protein Cry1F, PAT and Cry34Ab1 Cry35Ab1 were measured using the quantitative method of Enzyme Linked Immunosorbent Assay (ELISA) in tissues of leaf, pollen, root, whole plant, forage and grains, resulting in the combined event, compared with simple events, similarity of values​​, corroborating the results obtained for phenotypic, agronomic, compositional and reproductive, indicating absence of gene interaction arising from sexual reproduction.

ES
Corn TC1507 × DAS-59122-7 shows Mendelian inheritance expected for independent loci. The phenotypic stability of the event TC1507 x DAS-59122-7 was observed for more than 10 generations during the conversion of production lines and hybrids. In every generation there is the characteristic of tolerance to the herbicide glufosinate ammonium, which is inherited stably. Likewise, the characteristic of resistance to coleopteran and lepidopteran insects pests also remained stable and was transferred as expected for all successive generations of progeny during the conversion process. The expression results also confirm these observations, showing stability of expression levels of proteins Cry1F, Cry34Ab1, Cry35Ab1 and PAT maize TC1507 x DAS-59122-7. Substantial equivalence combined corn compared to conventional corn, and rapid denaturation and degradation of proteins Cry1F Cry34Ab1, Cry35Ab1 and PAT during processing, attest to the safety of the consumption of genetically modified maize and products derived from it. Analysis of the nutritional composition of maize TC1507 x DAS-59122-7 opposite to conventional corn show similarity between the two products with respect to the content of protein, fiber, carbohydrates, oils, ash, minerals, fatty acids, amino acids, vitamins, metabolites and anti-nutrients . This similarity confirms data published in scientific-technical literature on maize TC1507 x DAS-59122-7 that the presence of cry genes that confer control of insect pests and the pat gene which determines tolerance to the herbicide glufosinate ammonium does not cause changes the nutritional composition of the GMO, as well as those that may be caused by biotic to abiotic.

ES
not applicable
ES
Proteins Cry1F, Cry34Ab1, Cry35Ab1 and PAT  no have homology with allergenic proteins considered, either with known toxins. These proteins were tested for acute oral toxicity study in mice to evaluate the potential toxicity to humans and animals. No acute effect, chronic or subchronic was detected due to the consumption of these proteins. Research conducted in Brazil showed that maize TC1507 x DAS-59122-7 did not differ from conventional maize on agronomic, morphological, reproductive, as well as the chemical and nutritional composition, with the exception only of the characteristics of tolerance to the herbicide glufosinate-based ammonium and the characteristics of insect resistance. The agronomic traits for the comparative study of the effect of the event TC1507 x DAS-59122-7 used as a reference control corn with the same genetic background combined event. The comparative analysis of treatments indicated that no statistically significant difference was observed between transgenic maize TC1507 x DAS-59122-7 with respect to conventional corn
ES
The agronomic data, botanic and reproductive behaviors of combined event TC1507 x DAS-59122-7 and its simple events (TC1507 and DAS-59122-7), compared to their conventional hybrids in different germplasm, demonstrated the similarity of the TC1507 × maize DAS-59122-7 and its components with conventional maize. Data from studies of the environmental assessment shows that the introduction of simple event TC1507 and DAS-59122-7 in combined event TC1507 x DAS-59122-7 in maize adapted to the abiotic and biotic Brazilian caused no adverse effect on the morphology, physiology, reproductive characteristics, type of dissemination of plant response to major pathogens, survival characteristics, except for changing the response of plants to control insect pests of shoots and roots of maize. Given the above CTNBio concludes that the cultivation and consumption of maize TC1507 x DAS-59122-7 is not potentially cause significant degradation of the environment, or risks to human and animal health. For this reason, there are no restrictions on the use of this corn and its derivatives. The monitoring shall be submitted by the company in accordance with the standards contained in the Normative Resolution No. 9 of December 2, 2011 CTNBio
ES
not applicable
ES
CTNBio examined the reports submitted by the applicants and independent scientific literature.

Under the powers conferred by Art. 14 of the Low 11. 105/05, CTNBio considered that the application meets the standards and legislation to ensure the biosafety of the environment, agriculture, human and animal health and concluded that maize TC1507 x DAS-59122-7
is substantially equivalent to conventional maize consumption being safe for human and animal health. Regarding the environment, CTNBio concluded that cultivation of maize TC1507 x DAS-59122-7 is not potentially cause significant degradation of the environment, biota keeping with the identical relation to conventional corn.

ES
molecular traditional methods
ES
Additional information
EN
Records referencing this document Show in search
Record type Field Record(s)
Country's Decision or any other Communication Risk assessment 1

Quick links

About the BCH About the Cartagena Protocol Supplementary Protocol

Sign in Search records Submit records
Registries: LMO-Organism-Gene Country Profiles
National Report Analyzer

Forums BCH Announcements

Need help?

Knowledge Base FAQs UNEP eLearning Training Site

Contact us at: bch@cbd.int
BCH Biosafety Clearing-House
Subscribe to e-mail notifications
Subscribe to our newsletter