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Risk Assessment generated by a regulatory process
(RA)
published: 18 Sep 2008
last updated: 26 Mar 2025
Determination for the Safety Assessment of Combined Trait Product Corn: MON 810 x GA21 for Direct Use as Food, Feed and for Processing
EN
16 Nov 2004
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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-ØØØ21-9 × MON-ØØ81Ø-6 - Roundup Ready™ YieldGard™ maize| Monsanto | Resistance to antibiotics (Ampicillin), Resistance to diseases and pests (Insects, Lepidoptera (butterflies and moths), European corn borer (Ostrinia nubilalis)), Resistance to herbicides (Glyphosate)
- DA-BPI Biotechnology Office [ English ]
EN
Without stacking, both the insertion of cry1ab and cp4 epsps in corn did not result in the occurrence of a new allergen or a new toxin. The modes and sites of biological activity are significantly different for CP4 EPSPS and Cry1Ab and there is no known or conceivable mechanism of interaction between these proteins leading to adverse health effects in animals or man. Both Cry1Ab and CP4 EPSPS are non allergenic proteins because both these novel proteins could easily be digested by simulated gastric and intestinal fluids. Furthermore, using bioinformatics tools, both novel proteins do not share any significant homology or amino acid sequence.
EN
The mechanism and the target sites for Cry1Ab and mEPSPS are entirely different than the probability of protein-protein interaction that will lead to adverse health effects in non-target organisms such as animals and man is very low.
There are no possible unexpected effects of the stacked genes on the plant metabolism.
Based on mode of action of mEPSPS and Cry1Ab proteins and location of these proteins’ accumulation in the plant cells, the likelihood of interaction with one another is not considered to be significantly possible to affect stability and expression level of either one of the genes. This was confirmed macroscopically, by analysis of the agronomic properties with respect to the efficacy and selectivity of GA21 x MON810 corn in the field.
EN
There are no possible unexpected effects of the stacked genes on the plant metabolism.
Based on mode of action of mEPSPS and Cry1Ab proteins and location of these proteins’ accumulation in the plant cells, the likelihood of interaction with one another is not considered to be significantly possible to affect stability and expression level of either one of the genes. This was confirmed macroscopically, by analysis of the agronomic properties with respect to the efficacy and selectivity of GA21 x MON810 corn in the field.
MON 810 x GA21 corn 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. Monsanto’s combined trait product corn MON 810 x GA21 has no evidence of interaction leading to unintended effects and/or over expression/under expression of the two novel gene products and is therefore approved for direct use as food, or feed or for processing.
EN
A biosafety notification for combined trait product corn: MON 810 x GA21 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 were issued to Monsanto Philippines. Inc. MON 810 X GA21 corn is found to be as safe as its conventional counterpart and does not pose any significant risks to human and animal health.
EN
MON 810 X GA21 corn is found to be as safe as its conventional counterpart and does not pose any significant risks to human and animal health.
EN
This application is not for propagation of the combined trait product corn: MON 810 x GA21. This LMO will be directly used for food, feed and for processing.
EN
For the individual events, MON 810 and GA21, in the combined trait product MON 810 x NK 603, diagnostic lateral flow strips, ELISA and PCR for routine qualitative and semi-quantitative detection of transgenes. For higher sensitivity, real-time PCR.
Methods and protocols for safe 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 safe 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
MON 810 x GA 21 corn 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.
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.
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.
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.
- OECD Consensus Document on Corn [ English ]
| Record type | Field | Record(s) | |
|---|---|---|---|
| Country's Decision or any other Communication | Risk assessment | 1 | |
