The stacked event LY038xMON810 maize confers resistance to lepidopteran insects and lysine high content to grain. Both parental events, LY038 and MON810, were stacked by conventional crossing (sexual). The stacked event has the cry1Ab gene from MON810 event and the gene cordapA from LY038 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 lepidopteran insects and the cDHDPS protein allows to raise the level of lysine in the grain.
After comparison of 85 analytes measured in grain and forage, in the compositional analysis study, it is concluded that maize LY038xMON810 is equivalent to conventional maize except for the intentional increase levels of free lysine and total lysine in grain and increase levels of lysine associated catabolites: saccharopine and α -aminoadipic acid. Also no unexpected effects were found in a 42 day feeding study conducted in broilers with maize grain LY038xMON810.
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.
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:
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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.