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Risk Assessment generated by a regulatory process (RA)
  |  
BCH-RA-PH-46806-8   |   PDF   |   Print   |  
published: 17 Sep 2008 last updated: 25 Mar 2025
General Information
Determination for the Safety Assessment of Corn DBT 418 for Direct Use as Food, Feed and for Processing
EN
22 Oct 2008
Risk assessment details
  • DKB-89614-9 - Bt Xtra™ maize
    | Resistance to diseases and pests (Insects, Lepidoptera (butterflies and moths)), Resistance to herbicides (Glufosinate)
Methodology and points to consider
EN
Given the lack of sequence homology to known allergens, sensitivity to simulated gastric digestion and lack of glycosylation, Cry1A(c) and PAT do not pose any significant allergenic risk associated with consumption of products generated from DBT 418 corn.  Furthermore, it is likely that all Cry1Ac or PAT protein that is ingested by an animal will be rapidly degraded and therefore the exposure of the human or animal would be minimal.
EN
Cry1A(c) and PAT do not pose any significant allergenic risk associated with consumption of products generated from DBT 418 corn.
EN
Corn DBT 418 is as safe as its conventional counterpart and does not pose any significant risk to animal and human health.
EN
A biosafety permit for Corn DBT418 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 Philippines Inc.Corn DBT 418 is as safe as its conventional counterpart and does not pose any significant risk to animal and human health.
EN
Corn DBT 418 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.  This application is not for propagation of Corn DBT 418
EN
Quantitative diagnostic lateral flow strips, ELISA and PCR for routine quantitative 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
Corn DBT 418 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 Corn DBT 418.
EN
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