The stacked event Bt11 x GA21 maize confers tolerance to lepidopteran insects, especially to Diatraea saccharalis, and tolerance to herbicides which active principle is glyphosate and glufosinate ammonium.
Both parental events, Bt11 and GA21, were stacked by conventional crossing (sexual). The stacked event has the mepsps gene from the GA21 event and the genes cry1Ab and pat from the Bt11 event. The transgenes are inherited in independent form, since it presents mendelian segregation. Moreover, the applicant proved the gene stability and the effective levels of the expressed proteins.
The protein Cry1Ab confers resistance to certain lepideroptean insects, and proteins PAT and mEPSPS allows tolerate herbicides ammonium glufosinate and glyphosate respectively.
After comparison of 65 analytes measured in grain and forage, in the compositional analysis study, it is concluded that maize Bt11 x GA21 is equivalent to commercial maize and the parental lines.
The allergenicity and toxicity assessment of the new expression proteins were carried out previously in both single events.
Taking into account the assessment of genetic stability, molecular characterization, products and levels of expression, compositional analyses and morphoagronomic studies, no metabolic interaction is expected that might impact on the food safety when single events are stacked in a conventional way.
The Bt11xGA21 event is substantial and nutritionally equivalent to its non transgenic counterpart.
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:
Please see decision document weblinks
Where detection method protocols and appropriate reference material (non-viable, or in certain circumstances, viable) suitable for low-level situation may be obtained:
Relevant links to documents and information prepared by the competent authority responsible for the safety assessment:
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The food risk assessment process of transformation events, as the result of modern biotechnology, is carried out by the National Service for Agrifood Health and Quality (Senasa), regulatory agency depending on the Ministery of Agriculture, Livestock and Fisheries.
The Agrifood Quality Directorate of Senasa, is the area responsible for carrying out this task. It has an specific scientific team and the advise of a Technical Advisory Committee composed of experts from different scientific disciplines representing different sectors involved in the production, industrialization, consumption, research and development of genetically modified organisms.