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Risk Assessment generated by a regulatory process
(RA)
last updated: 04 Apr 2025
Safety Assessment of Soybean MON87769 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-87769-7 - Soybean with modified fatty acid composition| Monsanto | Changes in quality and/or metabolite content (Lipid and fatty acids)
The Scientific and Technical Review Panel (STRP), the Bureau of Plant Industry Plant Products Safety Services Division (BPI-PPSSD), the Bureau of Animal Industry (BAI), the Department of Environment and Natural Resources Biosafety Committee (DENR-BC), and the Department of Health Biosafety Committee (DOST-BC)- concurred that (1) Soybean MON87769 is as safe for human food and animal feed as its conventional counterpart and (2) will not pose any significant risk to health and the environment.
The novel proteins— Primula juliae delta 6 desaturase (PjΔ 6D) enzyme and Neurospora crassa delta 15 desaturase (NcΔ15D) enzyme— can potentially be new allergens or toxins, or share biologically significant similarity with known allergens or toxins.
The potential adverse effects will be realized primarily if there is human exposure to the novel protein. As such, the expression of the novel proteins were assessed. Both PjΔ 6D and NcΔ15D enzymes are under the control of seed-specific promoters. The computation for the percentage of the novel protein was therefore derived from data obtained from the mature seed. The total amount of PjΔ 6D in the mature seed constitutes only 0.00043% of the total protein in the mature seed. Meanwhile, the percent NcΔ15D protein in the mature seed is only 0.00239%. Therefore, the exposure to humans via consumption is highly unlikely and the likelihood of the potential adverse effects of these novel proteins is negligible.
The potential allergenicity and toxicity of the novel proteins PjΔ 6D and NcΔ15D were determined via digestibility assay, heat stability study, amino acid sequence similarity search, and oral gavage study. SDS-PAGE and western blotting after simulated gastric fluid (SGF) digestion indicated the rapid digestion of the novel proteins. Heat stability study also showed that the novel proteins are below the limit of detection after subjection to 189.1°C (mimicking the conditions of soybean flour processing), indicating significant loss of the proteins. Finally, similarity search with non-redundant protein sequences using BLASTp showed no homology of the novel proteins with known allergens or toxins. These results led the assessors to conclude that the PjΔ 6D and NcΔ15D enzymes expressed in Soybean MON87769are not toxic or allergenic.
Considering the unlikely outcome of the PjΔ 6D and NcΔ15D enzymes entering the food chain and that these do not have allergenic nor toxic properties, the assessors find that Soybean MON87769 does not pose risks to human and animal health, and to the environment.
The assessors recommended for the issuance of a biosafety permit for the direct use of Soybean MON87769. The assessors emphasized that there are clear instructions to the applicant that the regulated article shall not be used as planting materials.
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The scope of the risk assessment is limited only to the direct use of the regulated article. In any case, the assessors noted that soybean is a highly domesticated crop and cannot survive without human intervention.
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Yes
Yes
Yes
Yes
Yes
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| Record type | Field | Record(s) | |
|---|---|---|---|
| Country's Decision or any other Communication | Risk assessment | 1 | |
