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Risk Assessment generated by a regulatory process
(RA)
last updated: 04 Jul 2025
Safety Assessment of Soybean MON87751 × MON87701 × MON87708 × MON89788 for Direct Use as Food and Feed, or for Processing
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Date not available
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Competent National Authority:Department of Agriculture ()Elliptical Road, DilimanQuezon City,
1100, PhilippinesPhone: (02) 8928-8741 to 64 local 2118, 2214, 2215, 2240,Fax:Website: http://www.da.gov.ph,
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Organization:Bureau of Plant Industry (BPI)San Andres, MalateManila, Metro Manila
1004, PhilippinesPhone: 8524-9588 local 230,Fax:Email: bpibiotech@buplant.da.gov.ph,Website: https://biotech.buplant.da.com.ph/,
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MON-87751-7 × MON-877Ø1-2 × MON-877Ø8-9 × MON-89788-1 - Herbicide tolerant insect resistant soybean| Monsanto | Resistance to Diacamba, Resistance to diseases and pests (Insects, Coleoptera (beetles), Lepidoptera (butterflies and moths)), Resistance to herbicides (Glyphosate)
After reviewing the technical dossier provided by the applicant, the Scientific and Technical Review Panel (STRP), Bureau of Plant Industry Plant Products Safety Services Division (BPI-PPSSD), Bureau of Animal Industry (BAI), Department of Environment and Natural Resources Biosafety Committee (DENR-BC), and the Department of Health Biosafety Committee (DOH-BC) concurred that Soybean MON87751 × MON87701 × MON87708 × MON89788 is as safe as its conventional counterpart and shall not pose any significant risks to human and animal health and to the environment.
The gene products, Cry1A.105, Cry2Ab2, Cry1Ac, DMO, and CP4 EPSPS, expressed by the multi-stack soybean line may pose allergenic or toxic risks. These novel proteins may also interact in the same metabolic pathway such that an unintended adverse effect is created.
Cry1A.105, Cry2Ab2, Cry1Ac, DMO, and CP4 EPSPS proteins would not act on the same metabolic pathways and do not share any intermediate metabolites in the biochemical pathways that the proteins act on or interfere with. Due to lack of interaction, unexpected adverse effects are highly unlikely.
Based on the provided data, the novel proteins showed no amino acid sequence homology to known protein toxins, and are rapidly degraded with loss of functional activity under conditions that simulate mammalian digestion. There were also no indications of toxicity as measured by treatment-related adverse effects in mice by oral gavage. Hence, the assessors concluded that the novel proteins expressed in the multi-stack soybean line are not allergenic nor toxic.
Considering the unlikely probability of interaction among the novel proteins and the absence of allergenic or toxic characteristics, the assessors concluded that Soybean MON87751 × MON87701 × MON87708 × MON89788 does not pose risks to humans, animals, and the environment.
Based on the evidences presented, the risk assessors concurred that Soybean MON87751 × MON87701 × MON87708 × MON89788 is as safe as its conventional counterpart and shall not pose any significant risks to human and animal health and to the environment. Therefore, the approval and issuance of a biosafety permit for direct use as food and feed, or for processing was recommended.
Assessors recommended the strict monitoring of the regulated article from the port of entry to the traders/importers storage/warehouse.
Based on the evaluation and review of literature cited, the DENR-BC considered Soybean MON87751 × MON87701 × MON87708 × MON89788, safe to the environment and biodiversity.
The quantitative event-specific PCR detection methods are those individually validated for genetically modified soybean MON87751, MON87701, MON87708, MON89788 and further verified on soybean stack MON87751 × MON87701 × MON87708 × MON89788.
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| Record type | Field | Record(s) | |
|---|---|---|---|
| Country's Decision or any other Communication | Risk assessment | 1 | |
