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Risk Assessment generated by a regulatory process (RA)
  |  
BCH-RA-PH-46706-7   |   PDF   |   Print   |  
published: 15 Sep 2008 last updated: 25 Mar 2025
General Information
Determination for the Safety Assessment of Combined Trait Product Corn: 59122xNK603 or Direct Use as Food,  Feed and for Processing
EN
15 Dec 2006
Risk assessment details
  • DAS-59122-7 × MON-ØØ6Ø3-6 - Herculex™ RW Rootworm Protection Roundup Ready™ 2 maize
    | Pioneer Hi-Bred International Inc. | Resistance to diseases and pests (Insects, Coleoptera (beetles)), Resistance to herbicides (Glufosinate, Glyphosate)
Methodology and points to consider
EN
There is no known interaction between the cry34Ab1, cry35Ab1, pat, cp4epsps genes that would affect the stability and expression level of the individual genes. The Cry34Ab1, Cry35Ab1, PAT and CP4 EPSPS proteins expressed in 59122 x NK603 maize do not present the characteristics associated with allergenic proteins.  The gene products accumulate in different subcellular compartments of the plant parts. The mode of action of each gene product is different and the metabolic pathways of the products are different.
EN
Because of the different sites of accumulation and mode of action of the products, unexpected effects of the stacked genes, cry34 Ab1, cry35Ab1, pat and cp4 epsps, on the metabolism of the plant is less likely to occur. 59122xNK603 is unlikely to pose any significant allergenic risk or toxicity to humans and animals.
EN
59122xNK603 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. Stacked trait product corn: DAS59122 x NK603 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 59122xNK603 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 and Dow AgroScience in the Philippines. 59122xNK603 is found to be as safe as its conventional counterpart and does not pose any significant risk to human and animal health.
EN
59122xNK603 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 59122 x NK603 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
59122xNK603 is intended for direct use as food and 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 59122xNK603 maize
EN
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