Determination for the Safety Assessment of Soybean MON 89788 for Direct Use as Food, Feed and for Processing

The level of protein, fiber, fat, ash and carbohydrates in forage and seed of MON 89788 were not significantly different from conventional variety. The composition of fatty acids in grain of MON 89788 was shown to be equivalent to the conventional soybean. The anti-nutrients (trypsin inhibitors, isoflavones [daidzein, genistein and glycitein]  raffinose, phytic acid and  stachyose) and toxicant (lectin) composition of MON 89788 is comparable to the conventional soybean.  Risk assessment also showed that MON 89788 has similar potential as the conventional soybean to be an allergen.
MON 89788 contains only one protein encoding   (cp4 epsps gene) sequences from the T-DNA insert. The results of the safety assessment indicated that the cp4 epsps in MON 89788 has no potential pathogenic or allergenic properties. The CP4 EPSPS protein represents only a small portion of approximately 0.037% of the total protein in MON 89788 which would have low probability to be absorbed and cause an allergenic response.  The rapid digestibility of the CP4 EPSPS protein indicated that it is not potentially allergenic. The presence of CP4 EPSPS does not alter the nutritional value of the food derived from MON 89788.  Furthermore, the pathway does not involve animals and there is no evidence that the metabolism in humans and animals will be affected.
In vitro studies done using simulated gastric fluid (SGF) and simulated intestinal fluid (SIF) demonstrated that the rapid digestibility (half life of 15 sec) of CP4 EPSPS protein indicated that the protein would not be potentially toxic.  Proteins that are rapidly digested would not stay in the digestive system for a long time and would not be able to be absorbed to cause potential toxicity.

Safety assessment proved that MON 89788 is compositionally and nutritionally equivalent  to conventional soybean currently in commerce.
Agrobacterium sp, the source of cp4 epsps gene is not known to be pathogenic to human and animal and the protein is not known to induce allergic reactions.

Soybean MON 89788 is as safe as its conventional counterpart and does not pose any significant risk to animal and human health.

A biosafety permit for soybean MON 89788 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 89788 is as safe as its conventional counterpart and does not pose any significant risk to animal and human health.  

The raw and fully coated soybean seeds should be completely heat treated to deactivate the naturally present trypsin inhibitors found in all soybeans.

This application is not for propagation of this event. 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.

Soybean MON 89788 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 Soybean MON 89788.