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Risk Assessment generated by a regulatory process
(RA)
last updated: 03 Apr 2025
Safety Assessment of Soybean DP305423 x GTS 40-3-2 for Direct Use as Food and Feed, or for Processing
EN
30 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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DP-3Ø5423-1 × MON-Ø4Ø32-6 - Modified fatty acid, herbicide-tolerant soybean| Pioneer Hi-Bred | Resistance to herbicides (Glyphosate, Sulfonylurea)
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-BT), the Department of Environment and Natural Resources Biosafety Committee (DENR-BC), and the Department of Health Biosafety Committee (DOH-BC)- concurred that Soybean DP305423 x GTS 40-3-2 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, GM-HRA, and fad2-1 transcript— interacting in an unexpected metabolic pathway.
The assessors concurred, based on a review of the technical dossier, that the gene products will not produce a novel or known allergen or toxin. The novel proteins cp4EPSPS and GM-HRA are unlikely to interact due to the differences in their modes of action and their localization. Whereas cp4EPSPS accumulates in the chloroplast, GM-HRA is localized at the cytoplasm.
A review of the biochemical pathways of the novel proteins has shown that the novel proteins have different substrates and modes of biological action. Each protein, thus, functions differently and independently of each other and are not expected to interact and affect the metabolism of the plant.
Gene expression and gene stability studies, particularly the enzyme-linked immunosorbent assay (ELISA), also show that the novel proteins are expressed in similar levels compared to the single events DP305423 and GTS 40-3-2.
Gene expression and gene stability studies, particularly the enzyme-linked immunosorbent assay (ELISA), also show that the novel proteins are expressed in similar levels compared to the single events DP305423 and GTS 40-3-2.
Based on these findings, the assessors concluded that the stacked Soybean DP305423 x GTS 40-3-2 has no evidence of unintended interaction in its gene products and, therefore, is as safe as its conventional counterpart.
The assessors recommended for the issuance of a biosafety permit for the direct use as food and feed, or for processing of Soybean DP305423 x GTS 40-3-2. A specified management plan, indicating the possible harm to the environment and biodiversity and the corresponding mitigating measures and contingency plans, is provided in the application.
EN
The scope of the application covers only the direct use of the regulated article, which shall not be propagated domestically. The possible receiving environments are therefore those that are along the transport route of the regulated article. These include ports, roads, and railways, which are not conducive for plant growth. The assessors further noted that soybean is a highly domesticated crop and is unlikely to persist without human intervention. Therefore, the unintended release of the regulated article is highly unlikely.
Soybean DP305423 x GTS 40-3-2 can be detected via event-specific 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 | |
