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Risk Assessment generated by a regulatory process
(RA)
last updated: 04 Apr 2025
Safety Assessment of Cotton MON88702 for Direct Use as Food and Feed, or for Processing
EN
16 Jul 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-887Ø2-4 - Insect-protected cotton| Monsanto | Resistance to diseases and pests (Insects)
After reviewing the technical dossier, 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) found that Cotton MON88702 is as safe for food and feed as its conventional counterpart and will not cause any adverse effect to the environment.
The novel protein expressed in Cotton MON88702, mCry51Aa2, may be an allergen or toxin.
EN
The potential allergenicity and toxicity of mCry31Aa2 was investigated via in silico analysis of sequence similarity to known allergens and toxins, digestibility assay, heat stability study, and oral gavage study. The similarity search turned up no structural or functional similarity with known allergens or toxins. When incubated in pepsin and pancreatin, mCry31Aa2 was digested within 2 minutes and 0.5 minutes, respectively. Meanwhile, when subjected to heat, mCry31Aa2 was denatured and lost biological function at 15 minutes incubation at 55°C. Lastly, acute oral gavage using mice models showed that there were no treatment-related effects on survival, clinical observations, body weight gain, feed intake, and gross pathology. A thorough scientific review of the results of these tests led the assessors to conclude that mCry31Aa2 expressed in Cotton MON88702 is not toxic or allergenic.
Given the results of the toxicological and allergenicity assessments of mCry31Aa2, the assessors deemed that the overall risk for Cotton MON88702 is negligible.
Considering the evidences presented, the risk assessors concurred that Cotton MON88702 is as safe as its conventional counterpart and does not pose any significant risk to human and animal health and the environment. The assessors, therefore, recommended for the approval and issuance of a biosafety permit for direct use as food and feed or for processing for Cotton MON88702.
The assessors set clear instructions to the applicant that the regulated article shall not be used as planting materials.
The assessors set clear instructions to the applicant that the regulated article shall not be used as planting materials.
EN
EN
Event-specific Method for the Quantification of Cotton MON 88702 Using Real-time PCR
Yes
Yes
Yes
Yes
Yes
EN
| Record type | Field | Record(s) | |
|---|---|---|---|
| Country's Decision or any other Communication | Risk assessment | 1 | |
