Determination of the Safety of Monsanto's Soybean MON 87769 for Direct use as Food, Feed, or Processing

Digestibility studies in SGF and SIF show that PjΔ6D and NcΔ15D proteins were rapidly digestible indicating that it is highly unlikely that these proteins will pose any safety concern to human and animal health.

Based on the weight of evidence, it is concluded that the PjΔ6D and NcΔ15D proteins expressed in MON 87769 is safe and poses no concerns for humans, animals and the environment.

Harvested soybean seeds contain several substances considered to be anti-nutrients (i.e. trypsin inhibitors, lectin, isoflavones (daidzein, genistein and glycitein) and phytic acid). Trypsin inhibitors and lectin are inactivated by proper processing of soybean protein products or soybean meal and their levels are similar to conventional control. The levels of stachyose, raffinose and phytic acid are also similar to conventional control. The mean and range values for three isoflavones, genistein, daidzein, and glycitein, were lower in MON 87769 harvested seed compared to the values in the conventional soybean control.  However, the range of values for these three analytes in MON 87769 were all within the 99% tolerance interval for the population of conventional reference varieties, and were also within the range of values found in the published literature and the ILSI Crop Composition Database. .  Therefore, these differences were not considered to be biologically meaningful from a food and feed safety and/or nutritional perspective.

Soybean MON 87769 is found substantially equivalent to conventional counterpart and does not pose any significant risk to animal and human health.

A biosafety permit for nutrition enhanced soybean MON 87769 and all progenies derived from crosses of the product with any conventionally bred soybean and soybean containing approved-biotech events for direct use as food, feed or for processing, was issued to Monsanto Philippines Inc. Soybean MON 87769 is found substantially equivalent to conventional counterpart and does not pose any significant risk to animal and human health.

Soybean MON 87769 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 Soybean MON 87769. 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.

Soybean MON 87769 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 this event.