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Risk Assessment generated by a regulatory process
(RA)
last updated: 04 Apr 2025
Safety Assessment of Canola MON88302 for Direct Use as Food and Feed, or for Processing
EN
29 Apr 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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MON-883Ø2-9 - TruFlex Roundup Ready™ Canola| Monsanto | Resistance to herbicides (Glyphosate)
After conducting a thorough review and assessment, 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 Canola MON88302 will not pose any significant risk to the health and environment. Further, any hazards could be managed by measures set by the assessors.
The novel protein expressed by Canola MON88302, cp4EPSPS, could potentially be a new allergen or toxin.
The likelihood of harm being realized was assessed in the context of dietary exposure to the regulated article. The key considerations were the concentration of cp4EPSPS in the plant part from which the commercial product is derived and the processing conditions through which the commercial product will be subjected. The assessors agreed that cp4EPSPS is expressed minimally in canola seeds and represent a small percentage in the total protein of the seed. Further, proteins are rapidly degraded once subjected to the strenuous processing conditions to produce canola oil and other consumed products. Hence, the likelihood of potential adverse effects being realized is very low.
The novel protein cp4EPSPS may elicit allergenic or toxic reactions when ingested, so a review of its potential allergenicity or toxicity was conducted. Data from in silico analysis of sequence similarity to known allergens and toxins, digestibility assay, heat stability study, and oral gavage study substantiated the conclusion that cp4EPSPS does not have allergenic nor toxic properties as it is rapidly degraded under heat incubation, rapidly digested with simulated gastric or intestinal fluids (SGF and SIF), and did not cause any treatment-related adverse effect when fed to mice at a 1000-fold level.
Since there is highly unlikely exposure to cp4EPSPS and there is marginal hazard due to absence of evidence on the allergenicity or toxicity of the same protein, the overall estimated risk of Canola MON88302 is negligible.
In view of the above conclusions, the assessors recommended for the issuance of a biosafety permit for the direct use of Canola MON88302 as food and feed, or for processing. The assessors requested the BPI to issue clear instructions to the applicant that the regulated article is not to be used as planting materials.
EN
The scope of the risk assessment covered only the direct use of the regulated article, hence, it did not focus on the receiving environments. However, assessors noted that canola is sensitive to weather changes and seedbed conditions during its early growing stages. These strict conditions are unlikely to be satisfied in the potential receiving environments such as areas near the port, roads, and railways. Therefore, the chances of the unintended release is very low.
Canola MON88302 can be detected via event-specific quantitative real-time PCR.
Yes
Yes
Yes
Yes
Yes
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