Determination of the Safety of Syngenta's Corn MIR604 for Direct use as Food, Feed, or Processing

Results of the digestibility, heat inactivation, amino acid sequence comparison and acute oral toxicity studies indicates that mCry3A and PMI proteins being expressed in MIR604 corn are not toxic or allergenic to humans (Syngenta, n.d.).

Anti-nutrients, including ferulic acid, p-coumaric acid, furfural, inositol, phytic acid, raffinose and trypsin inhibitor in grain were analyzed and compared with those of commercial corn varieties. Statistically significant differences are noted for both ferulic acid and p-coumaric acid, with lower levels of both in the transgenic samples as compared to the control samples. Other antinutrients analyzed have no statistically significant differences between the transgenic and the control

Therefore, based on the above statements, there is no safety issue related to the consumption of MIR604 seed, since the contents of all anti-nutrients were comparable to the contents in seeds from other commercial corn lines. The relevance of the statistically significant differences found between the non-transgenic and transgenic control and the transgenic event MIR604 was negligible from a biological and nutritional standpoint.

Corn MIR604 is found substantially equivalent to conventional counterpart and does not pose any significant risk to animal and human health.

Based on the results of the risk evaluation of the submitted scientific data and other information relevant to the application of Syngenta Philippines Inc., it is concluded that corn MIR604, 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,  is as safe and substantially equivalent to its unmodified counterpart, and is therefore approved for direct use as food, feed or for processing.

Corn MIR604 is found substantially equivalent to conventional counterpart and does not pose any significant risk to animal and human health.

This application is not for propagation of the Corn MIR604. This LMO will be directly used for food, feed and for processing.

Quantitative diagnostic lateral flow strips, ELISA and PCR for routine quantitative and semi-quantitative detection of transgenes.  For higher sensitivity, real-time PCR may be used.

corn MIR604 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, BAI, PPSSD, DENR, DOH and SEC Expert during the evaluation of this event.