Determination of the Safety of Syngenta's Cotton COT102 For Direct use as Food, Feed, or for Processing | BCH-IRA-SCBD-109884 | Risk Assessment generated by an independent or non-regulatory process | Biosafety Clearing-House

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Risk Assessment generated by an independent or non-regulatory process (IRA)
  |  
BCH-IRA-PH-109884-2   |   PDF   |   Print   |  
published: 20 Mar 2016 last updated: 23 Mar 2016
General Information
Determination of the Safety of Syngenta's Cotton COT102 For Direct use as Food, Feed, or for Processing
EN
09 Sep 2015
Risk assessment details
  • SYN-IR1Ø2-7 - VIPCOT™ Cotton
    | Resistance to antibiotics (Hygromycin), Resistance to diseases and pests (Insects, Lepidoptera (butterflies and moths))
Methodology and points to consider
EN
APH4 protein expressed in transgenic plants was readily digested as conventional dietary protein under typical mammalian gastric condition (SGF) as determined by Western Blot analysis.  Therefore, APH protein will not cause adverse effects on human and animal health.
EN
The cyclopropenoid fatty acids (CPFA) including sterculic, malvalic, and dihydrosterculic are unique fatty acids in cotton that are considered undesirable, anti-nutrients (OECD, 2008)
EN
Cotton COT102 is found substantially equivalent to conventional counterpart and does not pose any significant risk to animal and human health.
EN
A biosafety permit for Cotton COT102 and all progenies derived from crosses of the product with any conventionally-bred cotton and cotton containing approved-biotech events for direct use as food, feed or for processing was issued to Syngenta Philippines Inc. Cotton COT102 is found substantially equivalent to conventional counterpart and does not pose any significant risk to animal and human health.
EN
Cotton COT102 is found substantially equivalent to conventional counterpart and does not pose any significant risk to animal and human health.
EN
This application is not for propagation of the Cotton COT102. 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 may be used.
EN
Additional information
Cotton COT102  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 this event.
EN
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