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Risk Assessment generated by a regulatory process
(RA)
last updated: 05 Apr 2025
Safety Assessment of Soybean FG72 for Direct Use as Food and Feed, or for Processing
EN
05 Dec 2019
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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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MST-FGØ72-2 - Soy modified for tolerance to glyphosate and HPPD inhibitors| Bayer CropScience LP | HPPD Herbicides, Resistance to herbicides (Glyphosate)
- FG72-FFP.pdf [ English ]
The novel proteins expressed in Soybean FG72— Zea mays 2mEPSPS and Pseudomonas fluorescens HPPD W336, may be new allergens or toxins.
EN
Allergenicity and toxicological assessment were conducted to determine the potential harm of the regulated article. HPPD W336 and 2mEPSPS do not have homology nor sequence similarity with any known allergen or toxin, are rapidly degraded in simulated gastric and intestinal fluids (SGF and/or SIF), inactivated by heat, and do not elicit adverse effects when administered to mice during oral gavage study. It was therefore concluded that HPPD W336 and 2mEPSPS do not pose allergenic or toxic risks to human and animal health.
The assessors find sufficient scientific evidence that Soybean FG72 is as safe as its conventional counterpart and shall not pose any significant risk to human and animal health.
The assessors agreed to recommend for the issuance of a biosafety permit for direct use as food and feed or for processing for Soybean FG72.
A project description report is provided, detailing the mitigating measures and contingency plan for possible risk and harm to the environment, particularly to biodiversity.
A project description report is provided, detailing the mitigating measures and contingency plan for possible risk and harm to the environment, particularly to biodiversity.
EN
The assessors concluded that there is low possibility of the regulated article becoming invasive or weedy since soybean cannot survive in unmanaged habitats.
Event-specific method for detection and quatnification of soybean event FG72.
Yes
Yes
Yes
Yes
Yes
EN
| Record type | Field | Record(s) | |
|---|---|---|---|
| Country's Decision or any other Communication | Risk assessment | 1 | |
