Chapter 6: Maize with Increased Lysine (Lysine Maize—LY038)

Abstract

ABSTRACT: Data and information provided in this case study relate to a crop derived by modern biotechnology, in which a specific nutrient (lysine) has been increased in maize grain.Lysine maize is a feed ingredient with enhanced nutritional characteristics for poultry and swine and provides an alternative to adding supplemental lysine to diets for these animals. Lysine maize is in an advanced state of development; therefore, extensive unpublished data and information are presented to demonstrate that (1) Lysine maize,and the feeds and foods derived from it,are as safe as those derived from conventional maize,and (2) the increased lysine in Lysine maize grain produces the intended nutritional benefit for broiler chickens when compared to a diet containing conventional maize grain and a crystalline lysine supplement.These conclusions are based on a detailed molecular characterization of Lysine maize,a safety assessment of the introduced protein,a safety and nutritional assessment of the LY038 crop,and a comparison of the agronomic and phenotypic properties of maize hybrids with and without the Lysine maize trait.Although Lysine maize is a specialty crop for use in animal feed,its safety for both animals and humans must be demonstrated. Free lysine is significantly increased in Lysine maize by the introduction of the dapA gene (cordapA) from Corynebacterium glutamicum that encodes a form of dihydrodipicolinate synthase (cDHDPS) that is insensitive to lysine feedback inhibition.Analysis of lysine anabolic and catabolic pathways in maize identified 6 metabolites that might change as a consequence of the introduction of cDHDPS insensitive to lysine‐feedback inhibition.The results of compositional analysis demonstrated that Lysine maize grain is comparable to conventional maize, with the exception of the intended increase in lysine and a corresponding increase in 2 products of lysine catabolism,saccha‐ropine and ‐aminoadipic acid. Therefore, the safety and/or nutritional implication of these 3 compounds under the conditions of use were the focus of additional assessments and found to not present either a safety or nutritional problem.