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Risk Assessment
Record information and status
Record ID
46701
Status
Published
Date of creation
2008-09-15 02:55 UTC (estaciojulietafe@gmail.com)
Date of last update
2012-07-19 05:34 UTC (tluzaransoriano@yahoo.com)
Date of publication
2012-07-20 06:00 UTC (estaciojulietafe@gmail.com)

General Information
Country
  • Philippines
Title of risk assessment
Determination for the Safety Assessment of Bt11 Corn for Direct Use as Food, Feed and for Processing
Date of the risk assessment
Date not available
Competent National Authority(ies) 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
Risk assessment details
Living modified organism
SYN-BTØ11-1 - YieldGard™ maize
Resistance to diseases and pests - Insects - Lepidoptera (butterflies and moths) Resistance to herbicides - Glufosinate
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
No significant adverse effects were noted on key nutrients and major composition.  Toxicity and allergenicity studies show that both Btk and PAT proteins are readily degradable in gastric conditions and have no similarity with any known toxins or allergens.  Toxicity studies have shown that Btk and PAT protein did not exhibit adverse effects in laboratory animals.  Btk and PAT protein have not been found to be immunogenic. Biochemical analysis of the protein structures did not show features characteristic of allergen. Animal feeding studies further supported the absence of pleiotropic effects.
Review and assessment on acute oral toxicity, inhalation, dermal, toxicological and other biological effects of protein delta endotoxin of Bacillus thuringiensis in Bt11 maize revealed that no adverse effects were recorded in in vivo toxicity testing in laboratory animals with cry1A(b). DIMBOA, a metabolic by-product, maybe a potential toxicant. However, submitted studies reported that DIMBOA levels declined rapidly as plants grow older and that DIMBOA production is not related to Bt 11 transformation event.  
Numerous compositional analyses were conducted in grains of Bt 11 maize in order to check for the occurrence of unintended pleitropic effects. No such effects were found. Furthermore, in the safety evaluation of transgenic plant for human food, the following facts were considered:-proteins were usually acutely nontoxic and there are no known proteins that exhibit chronic toxicities such as mutagenesis or carcinogenesis.- proteins are usually degraded by digestion in the alimentary tract of mammals.-proteins do not appear to be bioaccumulated as are some chemicals.; and-proteins are not usually absorbed in the intestine in their intact form, but rather as their amino acid components and small peptides.Exposure to Btk protein through inhalation and dermal routes is not likely to happen because Btk protein is a product of high molecular weight of approximately 65 kd. As such, it is not volatile and cannot be absorbed through the skin.Genetic modification of maize plants does not alter the nutritional composition of the corn maize grain.
Possible consequences:
The comparison of Btk and PAT proteins to known allergens shows the unlikeliness of Btk and PAT proteins having an allergenic potential. Results of the investigations reveal that both Btk and PAT proteins showed no acute toxicity.
Estimation of the overall risk
Corn Bt11 is as safe as its conventional counterpart and does not pose any significant risk to animal and human health.
Recommendation(s)
A biosafety permit for Corn Bt11 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 Syngenta  Philippines, Inc. Corn Bt11 is found to be as safe as its conventional counterpart and does not pose any significant risk to human and animal health.
Need(s) for further information on specific issues of concern
Corn Bt11 is found to be as safe as its conventional counterpart and does not pose any significant risk to human and animal health.
Receiving environment(s) considered
This application is also for propagation of Corn Bt 11. 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.
Additional Information
Additional Information
Corn Bt11 is intended for direct use as food,   feed and for processing. This application is also intended for propagation.

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 Bt 11.
Other relevant website address or attached documents

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