Philippines | BCH-RA-PH-105878 | Risk Assessment generated by a regulatory process | Biosafety Clearing-House

Loading...
Risk Assessment generated by a regulatory process (RA)
  |  
BCH-RA-PH-105878-1   |   PDF   |   Print   |  
last updated: 12 Sep 2014
General Information
Decision for the Safety Assessment of Monsanto and Dow AgroSciences' corn MON 89034 x TC 1507 x NK603, for Direct Use as food and feed or for processing
EN
10 Dec 2010
Risk assessment details
  • MON-89Ø34-3 × DAS-Ø15Ø7-1 × MON-ØØ6Ø3-6 - Power Core™ Maize
    | Resistance to diseases and pests (Insects, Lepidoptera (butterflies and moths)), Resistance to herbicides (Glufosinate, Glyphosate)
Methodology and points to consider
Based on the modes of action of the Cry1A.105, Cry2Ab2, Cry1F, PAT and CP4 EPSPS proteins
expressed in MON89034 x TC1507 x NK603, there is no known mechanism of interaction among/between
the gene products that could lead to adverse effects in human and animals.
EN
Each protein is not designed to alter the corn plant’s metabolism and has been shown in the evaluation of each single event (MON89034, TC1507, NK603) to be equivalent to conventional corn. Having different modes and/or mechanisms of action and binding sites involved for each protein, production of the Cry1A.105, Cry2Ab2, Cry1F, PAT and CP4 EPSPS proteins in the combined trait product does not produce any adverse effects (interactive or synergistic) on plant metabolism.
.
EN
There were no synergistic or antagonistic interactions identified in the combined trait product corn,  MON89034 x TC1507 x NK603, it is anticipated that there will be no biologically significant interactions in the dual event combinations that could occur in the grain derived from this combined trait product.
EN
After reviewing the scientific data and information relevant to the combined trait product corn MON89034 x TC1507 x NK603 application of Monsanto Philippines and Dow AgroSciences, it is concluded that no interaction found 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.
.
EN
A biosafety notification for combined trait product : corn MON89034 x TC1507 x NK603 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 and Dow
AgroSciences.
EN
MON89034 x TC1507 x NK603 is found to be as safe as its conventional counterpart and does not pose any significant risk to human and animal health.
EN
This LMO will be directly used for food, feed and processing.
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
Additional information
The combined trait product MON89034 X TC1507 X NK603 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 MON89034 X TC1507 X NK603.
EN
Records referencing this document Show in search
Record type Field Record(s)
Country's Decision or any other Communication Risk assessment 1