cDHDPS has a low likelihood of adverse effects based on an assessment of its allergenic and toxicological potential.  The donor organism for cDHDPS, Corynebacterium glutamicum is not known to cause human pathogenicity or allergenicity.  The results of bioinformatics analyses indicate that cDHDPS is not similar to known allergens, toxins or other pharmacologically active proteins relevant to animal or human health.  cDHDPS is rapidly digested in simulated digestive tract matrices.  Absence of both structural and immunological similarities of cDHDPS with known allergens indicate that cDHDPS is unlikely to be an allergen.  Increased levels of lysine and its two major catbolites, sacharropine and alpha-aminoadipic acid pose no threat, are commonly found in nature, are rapidly degraded and have a history of safe use.cDHDPS produced no adverse effects at a high dose in an acute oral rodent toxicity study.  The NOEL was found to be 800 mg/kg, the highest dose level tested.These results show that the cDHDPS protein produced in LY038 will not cause adverse effects to human and animal health.