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Risk Assessment generated by a regulatory process (RA)
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BCH-RA-PH-46815-6   |   PDF   |   Print   |  
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published: 18 Sep 2008 last updated: 28 Mar 2025
General Information
Determination for the Safety Assessment of Combined Trait Product Corn: 59122x1507xNK603 for Direct Use as Food,   Feed and for Processing
EN
30 Oct 2019
Risk assessment details
  • DAS-59122-7 × DAS-Ø15Ø7-1 × MON-ØØ6Ø3-6 - Herculex XTRA™ Roundup Ready™ 2 maize
    | Pioneer Hi-Bred International Inc. | Resistance to diseases and pests (Insects, Coleoptera (beetles), Lepidoptera (butterflies and moths)), Resistance to herbicides (Glufosinate, Glyphosate)
Methodology and points to consider
EN
There is no evident interaction between the proteins expressed by the 5 transgenes (cry34Ab1, cry35Ab1, cry1F, pat and cp4epsps) as observed in the western blots.  The Cry34Ab1, Cry35Ab1, Cry1F, PAT and CP4EPSPS proteins expressed in 59122x1507xNK603 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 triple genes on the metabolism of the plant is very minimal.  The expression levels of the proteins in grain from triple stacked maize are comparable.
EN
There is no observed gene interaction or new protein formation between the Cry34Ab1, Cry35Ab1, Cry1F, PAT and CP4EPSPS. The expression levels are the same for all the proteins in the leaf tissues and grains which can be seen from the western blots of the five proteins.
EN
59122x1507xNK603 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. 59122x1507xNK603 maize has no evidence of interaction leading to unintended effects and/or over expression/under expression of the novel gene products and is therefore approved for direct use as food, or feed or for processing.
EN
A biosafety notification for 59122x1507xNK603 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 or for processing was issued to Pioneer Hi-Bred Philippines. 59122x1507xNK603 maize is found to be as safe as its conventional counterpart and does not pose any significant risk to human and animal health.
EN
59122x1507xNK603 maize is found to be as safe as its conventional counterpart and does not pose any significant risk to human and animal health.
EN
This application is not for propagation of 59122x1507xNK603 maize. This LMO will be directly used for food, feed and for processing. 
EN
Qualitative diagnostic lateral flow strips, ELISA and PCR for routine qualitative and semi-quantitative detection of transgenes. For higher sensitivity, real-time PCR.      
EN
Information sharing with other databases
Yes
Yes
Yes
Yes
Yes
Additional information
59122x1507xNK603 maize 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 59122x1507xNK603.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  59122x1507xNK603.maize.
EN
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