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Risk Assessment generated by a regulatory process (RA)
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BCH-RA-PH-108088-2   |   PDF   |   Print   |  
published: 03 Jun 2015 last updated: 25 Mar 2025
General Information
Determination of the Safety of Monsanto's Combined Trait Product Corn: MON 87460 x MON 89034 x MON 88017 for Direct use as Food, Feed, and Processing
EN
26 Sep 2014
Risk assessment details
  • MON-8746Ø-4 × MON-89Ø34-3 × MON-88Ø17-3 - Maize Modified for drought and glyphosate tolerance and resistance to Lepidoptera and Coleoptera
    | Resistance to antibiotics (Kanamycin), Resistance to diseases and pests (Insects, Coleoptera (beetles), Lepidoptera (butterflies and moths)), Resistance to herbicides (Glyphosate), Tolerance to abiotic stress (Cold / Heat, Drought)
Methodology and points to consider
Based on the modes of action of drought tolerance protein (CSPB), the insect control proteins (Cry1A.105, Cry2Ab2 and Cry3Bb1) and the herbicide tolerance protein (CP4 EPSPS), and location of these proteins’ accumulation in the plant cells, any likelihood of interaction with one another is not considered to be significant to affect the stability and expression level of each gene nor could their interaction lead to production of a new allergen or toxin. Furthermore, there is no known mechanism of interaction among these proteins that could lead to adverse effects in humans or animals.
EN
The bioefficacy data demonstrate that the CSPB, NPTII, Cry1A.105, Cry2Ab2, Cry3Bb1 and CP4 EPSPS proteins in MON 87460 × MON 89034 × MON 88017 do not interact in the plant to produce synergistic or antagonistic effects.  There was no evidence of altered yield or altered insecticidal activity against key target insects or altered efficacy of the glyphosate tolerance traits in the combined trait product. 
EN
Each protein is not designed to alter the corn plant’s metabolism, and has been shown in the evaluation of each single event (MON 87460, MON 89034 and MON 88017) to be equivalent to conventional corn. Interactions between these previously approved events and proteins are not expected to affect food/feed safety, nor could a mechanism of such interaction affecting their safety be reasonably hypothesized. 
EN
The combined traits product MON 87460 × MON 89034 × MON 88017 was found to have no interaction between/among the combined traits, hence this plant product was found to be as safe as its conventional corn and can substitute for its traditional counterpart for direct use as food, feed and for processing and is therefore approved for direct use as food,  feed and for processing.
EN
A biosafety notification for combined trait product corn: MON87460 x MON89034 x MON88017 and all progenies derived from crosses of this product for direct use as food, feed and for processing was issued to Monsanto Philippines Inc.
EN
MON87460 x MON89034 x MON 88017 is safe for human food, livestock feed and for processing as its conventional counterparts.
EN
This LMO will be directly used for food, feed and processing. This does not include cultivation of combined trait product corn: MON 87460 x MON 89034 x MON 88017 in the Philippines.
EN
Quantitative diagnostic lateral flow strips, ELISA and PCR for routine quantitative 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
Information sharing with other databases
Yes
Yes
Yes
Yes
Yes
Additional information
The combined trait product corn MON 87460 x MON 89034 x MON 88017 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 MON 87460 x MON 89034 x mon 88017.
EN
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