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Risk Assessment generated by a regulatory process
(RA)
published: 18 Sep 2008
last updated: 25 Mar 2025
Determination for the Safety Assessment of Corn MON863 for Direct Use as Food, Feed and for Processing
EN
07 Oct 2008
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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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MON-ØØ863-5 - YieldGard™ Rootworm™ maize| Monsanto | Resistance to antibiotics (Kanamycin), Resistance to diseases and pests (Insects, Coleoptera (beetles))
- DA-BPI Biotechnology Office [ English ]
EN
The Cry3Bb1 protein has a low likelihood of adverse effects based on an assessment of its allergenic and toxicological potential. The donor organism, Bacillus thuringiensis, has a history of safe use as a microbial insecticide since 1958. .Since there are no receptors for Cry proteins in mammals, Cry proteins do not show toxic effects to mammals. The results of bioinformatics analyses indicate that Cry3Bb1 is not similar to known allergens, toxins or other pharmacologically active proteins relevant to animal or human health. Cry3Bb1 is rapidly digested in simulated digestive tract matrices. Absence of both structural and immunological similarities of Cry3Bb1 with known allergens indicates that Cry3Bb1 is unlikely to be an allergen.. . Cry3Bb1 produced no adverse effects at high dose in an acute oral rodent toxicity study. The NOEL was found to be 3,200 mg/kg, the highest dose level tested. These results show that the Cry3Bb1 protein produced in MON 863 will not cause adverse effects to human and animal health.
EN
Bioinformatics assessment shows that no structural similarities were noted with known toxins or allergens indicating that Cry3Bb1 protein is not a potential allergen or toxic to mammals.
EN
Corn MON 863 applied for direct use is safe for human food, livestock feed and for processing as its conventional counterparts.
EN
A biosafety permit for Corn MON 863 and all progenies derived from crosses of the product with any conventionally-bred corn and corn containing approved-biotech events for direct use as food, feed and for processing was issued to Monsanto Philippines Inc. Corn MON 863 is found to be as safe as its conventional counterpart and does not pose any significant risk to human and animal health.
EN
Corn MON 863 is found to be as safe as its conventional counterpart and does not pose any significant risk to human and animal health.
EN
This application is not for propagation of Corn MON 863. This LMO will be directly used for food, feed and for processing.
EN
Diagnostic lateral flow strips, ELISA and PCR for routine semi-quantitative and quantitative and detection of transgenes. For higher sensitivity, real-time PCR.
EN
Yes
Yes
Yes
Yes
Yes
Corn MON 863 is intended for direct use as food, feed and for processing.
All relevant references submitted by the technology developer in their application; other references requested by the Scientific and Technical Review Panel (STRP) members and DA Regulatory Agencies during the evaluation of Corn MON 863.
EN
All relevant references submitted by the technology developer in their application; other references requested by the Scientific and Technical Review Panel (STRP) members and DA Regulatory Agencies during the evaluation of Corn MON 863.
- OECD Consensus Document on Corn [ English ]
| Record type | Field | Record(s) | |
|---|---|---|---|
| Country's Decision or any other Communication | Risk assessment | 1 | |
