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Risk Assessment
Record information and status
Record ID
109884
Status
Published
Date of creation
2016-03-20 11:49 UTC (ralphklapps@gmail.com)
Date of last update
2016-03-23 02:51 UTC (estaciojulietafe@gmail.com)
Date of publication
2016-03-23 02:51 UTC (estaciojulietafe@gmail.com)

General Information
Country
  • Philippines
Title of risk assessment
Determination of the Safety of Syngenta's Cotton COT102 For Direct use as Food, Feed, or for Processing
Date of the risk assessment
2015-09-09
Institution responsible for the risk assessment
Department of Agriculture
Elliptical Road, Diliman
Quezon City
Philippines, 1100
Phone:+632 920-3986,+632 924-1278 local 2802
Fax:+632 920-3986
Email:osec.da@gmail.com
Url:DA
Contact details of the main responsible risk assessor
Ms. Merle B. Palacpac
Chief
Post Entry Quarantine Station
Bureau of Plant Industry (BPI)
Economic Garden
Los Banos, Laguna
Philippines, 4030
Phone:+63 49 536 1678
Fax:+63 49 536 1678
Email:merle.palacpac@gmail.com
Url:http://bpi.da.gov.ph
Risk assessment details
Living modified organism
SYN-IR1Ø2-7 - VIPCOT™ Cotton
Resistance to antibiotics - Hygromycin Resistance to diseases and pests - Insects - Lepidoptera (butterflies and moths) Selectable marker genes and reporter genes
Show detection method(s)
Scope of the risk assessment
  • LMOs for direct use as feed
  • LMOs for direct use as food
  • LMOs for processing
Risk assessment report / Summary
Methodology and points to consider
Likelihood that the potential adverse effects will be realized
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.
Possible consequences:
The cyclopropenoid fatty acids (CPFA) including sterculic, malvalic, and dihydrosterculic are unique fatty acids in cotton that are considered undesirable, anti-nutrients (OECD, 2008)
Estimation of the overall risk
Cotton COT102 is found substantially equivalent to conventional counterpart and does not pose any significant risk to animal and human health.
Recommendation(s)
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.
Need(s) for further information on specific issues of concern
Cotton COT102 is found substantially equivalent to conventional counterpart and does not pose any significant risk to animal and human health.
Receiving environment(s) considered
This application is not for propagation of the Cotton COT102. This LMO will be directly used for food, feed and for processing.
LMO detection and identification methods proposed
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.
Additional Information
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.
Other relevant website address or attached documents

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