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Risk Assessment generated by a regulatory process (RA)
  |  
BCH-RA-PH-46700-7   |   PDF   |   Print   |  
published: 15 Sep 2008 last updated: 26 Mar 2025
General Information
Determination for the Safety Assessment of Corn 1507 for Direct Use as Food, Feed and for Processing
EN
07 Oct 2008
Risk assessment details
  • DAS-Ø15Ø7-1 - Herculex™ I maize
    | Dow AgroSciences, Pioneer Hi-Bred International Inc. | Resistance to diseases and pests (Insects, Lepidoptera (butterflies and moths), European corn borer (Ostrinia nubilalis)), Resistance to herbicides (Glufosinate)
Methodology and points to consider
EN
The protein products of the inserted genes (cry1F and pat) are not, in any way, proteins that regulate the normal metabolic pathways of plants and therefore will not interfere with the plant’s normal growth and development.  No nucleic acid sequences that code for a protein toxic to humans or antibiotic resistance were introduced into 1507 maize.  Similarly, no significant homology was demonstrated for the cry1F and pat with known allergens and neither protein was stable in a simulated gastric fluid.  Both proteins have little probability of being allergenic.
The key nutrients present in TC1507 and non-transformed maize are comparable.  Two potential anti-nutrients, phytic acid and trypsin inhibitor were found to be within the acceptable range for both conventional and transformed maize grain.  Similarly, trypsin inhibitor levels in both 1507 maize and the isoline were below the limit of quantification.  This confirms that no unusually high levels of trypsin inhibitor are present in 1507 maize.
EN
Bacillus thuringiensis and Streptomyces viridochromogenes are non-pathogenic to human and animals. The CryIF and PAT protein also do not possess or exhibit any allergenic properties. Oral gavage studies of Cry1F and PAT proteins show no toxic proteins.
EN
1507 maize is comparable with its conventional counterpart and will not pose any significant risk through consumption by both animals (for feed) and humans (for food). 
EN
A biosafety permit for 1507 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. 1507 maize is found to be as safe as its conventional counterpart and does not pose any significant risk to human and animal health.
EN
1507 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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This application is not for propagation of 1507 maize. This LMO will be directly used for food, feed and for processing
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Quantitative diagnostic lateral flow strips, ELISA and PCR for routine quantitative and semi-quantitative detection of transgenes.  For higher sensitivity, real-time PCR.
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Information sharing with other databases
Yes
Yes
Yes
Yes
Yes
Additional information
1507 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 and DA Regulatory Agencies during the evaluation of 1507 maize.
EN
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