CONSOLIDATED REPORT OF MONSANTO'S SOYBEAN MON87751 APPLICATION FOR DIRECT USE AS FOOD AND FEED, OR FOR PROCESSING

soybean is not a source of toxicants. Although, soybean contains recognized allergenic protein, but relevant estimate of its allergenic potential is not complete. There is no significant level of amino acid homology exists between the pat gene and any protein allergens.

The donor organism, Bacillus thuringensis is not known to be toxic or allergenic or pathogenic to humans, animals or plants. Bioinformatics analyses showed that the CryA.105 and Cry2Ab2 proteins do not share structurally or immunologically relevant amino acid sequence similarities with known allergens and pathogens.

Further, as shown in simulated digestion experiments using simulated digestive fluids, CryA.105 and Cry2Ab2 are rapidly digested. Thus, these cry proteins are not similar to known allergens and do not pose significant allergenic risk to humans or animals.

No significant differences were observed for lectin, trypsin inhibitors, phyticacid, and stachyose. A statistically significant difference (p<0.05) was observed for raffinose. The mean difference in raffinose values between MON 87751 and the conventional control was less than the range of the conventional control values, indicating that MON 87751 does not impact levels of raffinose more than natural variation within the conventional control grown at multiple locations.

MON 87751 soybean is as safe as its conventional counterpart and shall not pose any
significant risk to human and animal health and environment.

Upon evaluation of the project description report (PDR) and environmental risk assessment (ERA) submitted by the applicant, the Committee found that the effect of the regulated article on the environment depends largely on the viability of the product to be utilized for direct use. If the article is transported in a non-viable form, there is no danger to the environment. The DENR BC recommended the approval and issuance of a biosafety permit for FFP for MON 87751 soybean provided that strict monitoring of the regulated article will be conducted from the port of entry to the traders/importers storage/warehouse in accordance with Section32 of the JDC 1 s.2016.

The DOH BC recommended the approval of the regulated article with the following conditions:
1. Strict monitoring of the regulated article from port of entry to the trader's/ importers
storage/warehouse as stated in Section 32 of the JDC No. 1 series, 2016.
2. The BPI to include in the issuance of permit for the release of this product the following
conditions:
a) Any spillage (during unloading and loading/hauling and transport unloading and
storage) shall be collected and cleaned up immediately.
b) Transportation of the consignment from the port of entry to any destination within
the country shall be in closed containers.
c) It is recommended that the BPI ensure the following:
Clear instructions that the product is only for the purpose of direct use as food, feed
or for processing, and is not to be used as planting material.

MON 87751 soybean 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 MON 87751. 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 MON87751 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.