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Risk Assessment generated by a regulatory process
(RA)
last updated: 04 Apr 2025
Safety Assessment of Soybean MON87701 x MON89788 for Direct Use as Food and Feed, or for Processing
EN
10 Oct 2018
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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-877Ø1-2 × MON-89788-1 - Intacta™ Roundup Ready™ 2 Pro soybean| Resistance to diseases and pests (Insects, Lepidoptera (butterflies and moths)), Resistance to herbicides (Glyphosate)
- MON87701 X MON89788.pdf [ English ]
After reviewing the risk assessment report and the attached technical dossier, the assessors- the Scientific and Technical Review Panel (STRP), the Bureau of Plant Industry Plant Products Safety Services Division (BPI-PPSSD), the Bureau of Animal Industry Biotech Team (BAI), the Department of Environment and Natural Resources Biosafety Committee (DENR-BC), and the Department of Health Biosafety Committee (DOH-BC)- concurred that Soybean MON87701 x MON89788 is as safe for human food and animal feed as its conventional counterpart and will not pose any significant risk to health and the environment.
The assessors considered the possibility of the gene products— Cry1Ac and cp4EPSPS— interacting in an unexpected metabolic pathway.
The assessors find that there is sufficient information to support the conclusion that the novel proteins will not interact to produce any new allergen or toxin. This is primarily due to the different modes of action of each novel protein. Additionally, there has been no documented instance of Cry1Ac and cp4EPSPS interaction.
The assessors noted that Cry1Ac and cp4EPSPS interaction is highly unlikely since each protein has a different substrate and is localized at different parts of the cell.
The levels of expression of the novel proteins in Soybean MON87701 x MON89788 were similar with that of the single-event soybean lines, based on enzyme-linked immunosorbent assay (ELISA). The assessors concurred that no possible interaction between the novel proteins could affect the stability and expression level of each responsible gene.
The levels of expression of the novel proteins in Soybean MON87701 x MON89788 were similar with that of the single-event soybean lines, based on enzyme-linked immunosorbent assay (ELISA). The assessors concurred that no possible interaction between the novel proteins could affect the stability and expression level of each responsible gene.
Based on these findings, the assessors concluded that the stacked Soybean MON87701 x MON89788 has no evidence of unintended interaction in its gene products and, therefore, is as safe as its conventional counterpart.
The assessors recommended for the approval and issuance of a biosafety permit for the direct use as food and feed, or for processing of Soybean MON87701 x MON89788. A specified environmental management plan, indicating the possible harm to the environment and biodiversity as well as the mitigating measures and contingency plan, is provided in the application.
EN
The chances of unintended release or planting of the regulated article is very minimal and will not cause any lasting effect. The receiving environments, which coincide with the route of transport— ports, roads, railways, etc.— are not conducive for plant growth, especially for soybean which is a highly domesticated crop.
Soybean MON87701 x MON89788 can be detected via quantitative real-time PCR.
Yes
Yes
Yes
Yes
Yes
EN
| Record type | Field | Record(s) | |
|---|---|---|---|
| Country's Decision or any other Communication | Risk assessment | 1 | |
