Philippines | BCH-RA-PH-46708 | Risk Assessment generated by a regulatory process | Biosafety Clearing-House

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Risk Assessment generated by a regulatory process (RA)
  |  
BCH-RA-PH-46708-6   |   PDF   |   Print   |  
published: 15 Sep 2008 last updated: 01 Jun 2012
General Information
Determination for the Safety  Assessment of Combined Trait Product Corn; 1507x NK603 for Direct Use as Food, Feed and for Processing
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Risk assessment details
  • DAS-Ø15Ø7-1 × MON-ØØ6Ø3-6 - Herculex™ I Roundup Ready™ 2 maize
    | Dow AgroSciences, Pioneer Hi-Bred International Inc. | Resistance to diseases and pests (Insects, Lepidoptera (butterflies and moths)), Resistance to herbicides (Glufosinate, Glyphosate)
Methodology and points to consider
EN
There is no known interaction between the cry1F, pat and cp4epsps genes as observed in the western blots. The Cry1F, PAT and CP4EPSPS proteins expressed in 1507x NK603 maize do not present the characteristics associated with allergenic proteins.  Therefore, 1507x NK603 maize is unlikely to pose any significant allergenic risk or toxicity to humans and animals. The mode of action of each gene product is different the possibility of unexpected effects of the genes on the metabolism of the plant is very minimal. The expression levels of the proteins in grain from 1507x NK603 maize are comparable. 
EN
There are no unexpected effects of the stacked genes on the metabolism of the plant since the 1507xNK603 maize has been obtained from traditional breeding methods between progeny of two genetically modified maize. All proteins within the combined trait product are expressed in the individual 1507 and NK603 maize hybrids. There is no known interaction between the cry1F, pat and cp4epsps genes that would affect the stability and expression level of the individual genes.
EN
1507 x NK603 maize 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. Gene product in 1507 x NK603 exhibited no evidence of  interaction leading to unintended effects and/or over expression/under expression and is therefore approved for direct use as food, feed and for processing.
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A biosafety notification for 1507x NK603 maize 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 Pioneer Hi-Bred and Dow AgroSciences in the Philippines. 1507 x NK603 maize is found to be as safe as its conventional counterpart and does not pose any significant risk to human and animal health.
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1507 x NK603 maize is found to be as safe as its conventional counterpart and does not pose any significant risk to human and animal health.
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The LMO will be directly used for food, feed and for processing.  This application is not for propagation of 1507x NK603
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Qualitative diagnostic lateral flow strips, ELISA and   PCR for routine qualitative and semi-quantitative detection of transgenes. For higher sensitivity,   real-time PCR.
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Additional information
1507 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 during the evaluation of 1507 x NK603 maize.

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 1507 x NK603 maize.
EN
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Country's Decision or any other Communication Risk assessment 1