Determination for the Safety Assessment of Corn LY038 for Direct Use as Food, Feed and for Processing

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.

The cDHDPS protein will not cause significant adverse effects in man or animals.

Corn LY038 is as safe as its conventional counterpart and does not pose any significant risk to animal and human health.

A biosafety permit for Corn LY038 and all progenies derived from crosses of the product with any conventionally-bred corn and corn containing approved-biotech events for direct use as food, feed and for processing was issued to Monsanto Philippines, Inc. Corn LY038 is found to be as safe as its conventional counterpart and does not pose any significant risk to human and animal health.

Corn LY038 is found to be as safe as its conventional counterpart and does not pose any significant risk to human and animal health.

This application is not for propagation of Corn LY038.  This LMO will be directly used as food, feed and processing. 

Diagnostic lateral flow strips, ELISA and PCR for routine qualitative and semi-quantitative detection of transgenes. For higher sensitivity, real-time PCR.

Corn LY038 is intended for direct use as food,   feed and for processing.

All relevant references submitted by the technology developer in their application; other references requested by the Scientific and Technical Review Panel (STRP) members and DA Regulatory Agencies during the evaluation of Corn LY038.