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Risk Assessment generated by a regulatory process
(RA)
last updated: 04 Apr 2025
Safety Assessment of Soybean MON87701 × 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)
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 (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 × 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— cp4EPSPS and Cry1Ac— interacting in an unexpected metabolic pathway.
The applicant provided sufficient information to support the conclusion that cp4EPSPS and Cry1Ac will not interact to produce any new allergen or toxin. The biochemical pathways on which the novel proteins are involved were closely studied and the assessors noted that these proteins have different modes of action and localization of function. To illustrate, cp4EPSPS is responsible for the penultimate step in the shikimate pathway of aromatic acid biosynthesis in the chloroplast while Cry1Ac elicits the insecticidal effect by binding to the midgut of susceptible insect species.
Cry1Ac and cp4EPSPS function differently and independently of each other and are not expected to interact and affect the metabolism of the plant. Additionally, the expression levels of Cry1Ac and cp4EPSPS in the stacked soybean line were similar to the corresponding single-event lines as shown by enzyme-linked immunosorbent assay (ELISA).
In consideration of the provided results, the assessors concluded that the stacking of soybean events MON87701 and MON89788 through conventional breeding is not expected to cause unintended effects, and is as safe as conventional soybean.
The assessors recommended for the issuance of a biosafety permit for the direct use as food and feed, or for processing of Soybean MON87701 × MON89788.
EN
The assessors noted that the application is strictly for direct use of the regulated article and, therefore, the possible receiving environments will be restricted to the transport route of the regulated article. These areas, such as ports, roads, and railways, are generally not conducive for plant growth. Therefore, the chances of unintended release of the regulated article is very minimal and will not cause any damaging and lasting effects.
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No
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