Loading...
This record has been deleted. Since it is linked to a published record, it is available here for reference purposes only.
Click here to view the deleted recordThis document has been updated. This is not the latest published version. Click here to view the latest version of the record.
Risk Assessment generated by a regulatory process
(RA)
published: 18 Sep 2008
last updated: 26 Mar 2025
Determination for the Safety Assessment of the Combined Trait Product Corn MON 810 x MON 863 for Direct Use as Food, Feed and for Processing
EN
16 Nov 2004
-
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,
-
MON-ØØ863-5 × MON-ØØ81Ø-6 - YieldGard™ Rootworm™ maize| Monsanto | Resistance to antibiotics (Kanamycin), Resistance to diseases and pests (Insects, Coleoptera (beetles), Lepidoptera (butterflies and moths), European corn borer (Ostrinia nubilalis))
- DA-BPI Biotechnology Office [ English ]
EN
Based on the different modes of action of Cry1Ab and Cry3Bb1, the likelihood of interaction or synergistic effects that would affect the biological activities of the individual proteins is considered highly unlikely.Bioefficacy results demonstrate that MON 810 x MON 863 is equivalent to MON 810 for corn borer efficacy and to MON 863 for corn rootworm efficacy. These results indicate that combining individual transformation events through traditional breeding does not alter their insecticidal efficacy or herbicide tolerance characteristics.
EN
There are no possible unexpected effects of the stacked genes on the plant metabolism when safety assessment was conducted. Results of the corn rootworm and corn borer efficacy data showed that there was a selective insecticidal action; no interactions were noted in the protein products.
EN
The combined trait product corn MON 810 x 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 or feed or for processing is as safe and substantially equivalent to its unmodified counterpart. There is no evidence of interaction of the two novel gene products leading to over expression/under expression and/or unintended effects.
EN
A biosafety notification for the combined trait product corn MON 810 x 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 or for processing, was issued to Monsanto Philippines, Inc. Corn MON 810 x MON 863 is found to be as safe as conventional counterpart and does not pose any significant risk to human and animal health.
EN
Corn MON 810 x MON 863 is found to be as safe as conventional counterpart and does not pose any significant risk to human and animal health.
EN
This application is not for propagation of the combined trait product corn MON 810 x MON 863. This LMO will be directly used for food, feed and for processing.
EN
For the individual events, MON 810 and MON 863, in the combined trait product MON 810 x MON 863, diagnostic lateral flow strips, ELISA and PCR for routine qualitative and semi-quantitative detection of transgenes. For higher sensitivity, real-time PCR methods can be used.
Methods and protocols for safety handling, storage, transport and use are all indicated in the implementing rules and regulations (IRRs), memo circulars supplementing Administrative Order No. 8 of the Department of Agriculture; also the general guidelines of the National Committee on Biosafety of the Philippines.
EN
Methods and protocols for safety handling, storage, transport and use are all indicated in the implementing rules and regulations (IRRs), memo circulars supplementing Administrative Order No. 8 of the Department of Agriculture; also the general guidelines of the National Committee on Biosafety of the Philippines.
Yes
Yes
Yes
Yes
Yes
The combined trait product corn MON 810 x 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 during the evaluation of this combined trait product.
All relevant references submitted by the technology developer in their application; other references requested by the Scientific and Technical Review Panel (STRP) members during the evaluation of this combined trait product.
EN
All relevant references submitted by the technology developer in their application; other references requested by the Scientific and Technical Review Panel (STRP) members during the evaluation of this combined trait product.
All relevant references submitted by the technology developer in their application; other references requested by the Scientific and Technical Review Panel (STRP) members during the evaluation of this combined trait product.
- OECD Consensus Document on Corn [ English ]
| Record type | Field | Record(s) | |
|---|---|---|---|
| Country's Decision or any other Communication | Risk assessment | 1 | |
