Determination for the Safety Assessment of the Combined Trait Product Corn: MON 810 x NK 603 for Direct Use as Food, Feed and  for Processing

The modes and sites of biological activity are significantly different for CP4 EPSPS and Cry1Ab and there is no known or conceivable mechanism of interaction between these proteins leading to adverse health effects in animals or man. Both Cry1Ab and CP4 EPSPS are non allergenic proteins because both these novel proteins could easily be digested by simulated gastric and intestinal fluids. Furthermore, using bioinformatics tools, both novel proteins do not share any significant homology or amino acid sequence.
Bioefficacy results demonstrate that MON 810 x NK 603 is equivalent to MON 810 for corn borer efficacy and to NK 603 for Roundup®tolerance. These results indicate that combining individual transformation events through traditional breeding does not alter their insecticidal efficacy or herbicide tolerance characteristics.

The modes and sites of biological activity are significantly different for mEPSPS and Cry1Ab and there is no known or conceivable mechanism of interaction between these proteins leading to adverse health effects in animals or man.

The combined trait product corn: MON 810 x NK 603 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 or feed or for processing is as safe and substantially equivalent to its unmodified counterpart. Monsanto's stacked trait product corn, MON 810 and NK 603 has no evidence of interaction leading to unintended effects and/or over expression/under expression of the two novel gene products and is therefore approved for direct use as food, feed or for processing and for propagation.

A biosafety notification for the combined trait product corn: MON 810 x NK 603 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 or for processing and for propagation was issued to Monsanto Philippines, Inc. Corn MON 810 x NK 603 is found to be as safe as its conventional counterpart and does not pose any significant risks to human and animal health and the environment.

Corn MON 810 x NK 603 is found to be as safe as its conventional counterpart and does not pose any significant risks to human and animal health and the environment.

This application is also for propagation of the combined trait product corn: MON 810 x NK 603. This LMO will be directly used for food, feed and for processing. 

For the individual events, MON 810 and NK603, in the combined trait product MON 810 x NK 603, diagnostic lateral flow strips, ELISA and PCR for routine qualitative and semi-quantitative detection of transgenes. For higher sensitivity, real-time PCR.
Methods and protocols for safety handling, storage, transport and use are all indicated in the implementing rules and regulations (IRRs), memo circulars supplementing Administrative Order No. 8 of the Department of Agriculture; also the general guidelines of the National Committee on Biosafety of the Philippines.

The combined trait product corn MON 810 x NK 603 is intended for direct use as food and feed and for processing and for propagation.

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 this combined trait product.