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Risk Assessment
Record information and status
Record ID
46808
Status
Published
Date of creation
2008-09-18 01:10 UTC (estaciojulietafe@gmail.com)
Date of last update
2012-08-02 09:08 UTC (estaciojulietafe@gmail.com)
Date of publication
2012-08-02 09:08 UTC (estaciojulietafe@gmail.com)

General Information
Country
  • Philippines
Title of risk assessment
Determination for the Safety Assessment of Soybean MON 89788 for Direct Use as Food, Feed and for Processing
Date of the risk assessment
2007-11-16
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
MON-89788-1 - Roundup Ready2Yield™ soybean
Resistance to herbicides - Glyphosate
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
The level of protein, fiber, fat, ash and carbohydrates in forage and seed of MON 89788 were not significantly different from conventional variety. The composition of fatty acids in grain of MON 89788 was shown to be equivalent to the conventional soybean. The anti-nutrients (trypsin inhibitors, isoflavones [daidzein, genistein and glycitein]  raffinose, phytic acid and  stachyose) and toxicant (lectin) composition of MON 89788 is comparable to the conventional soybean.  Risk assessment also showed that MON 89788 has similar potential as the conventional soybean to be an allergen.
MON 89788 contains only one protein encoding   (cp4 epsps gene) sequences from the T-DNA insert. The results of the safety assessment indicated that the cp4 epsps in MON 89788 has no potential pathogenic or allergenic properties. The CP4 EPSPS protein represents only a small portion of approximately 0.037% of the total protein in MON 89788 which would have low probability to be absorbed and cause an allergenic response.  The rapid digestibility of the CP4 EPSPS protein indicated that it is not potentially allergenic. The presence of CP4 EPSPS does not alter the nutritional value of the food derived from MON 89788.  Furthermore, the pathway does not involve animals and there is no evidence that the metabolism in humans and animals will be affected.
In vitro studies done using simulated gastric fluid (SGF) and simulated intestinal fluid (SIF) demonstrated that the rapid digestibility (half life of 15 sec) of CP4 EPSPS protein indicated that the protein would not be potentially toxic.  Proteins that are rapidly digested would not stay in the digestive system for a long time and would not be able to be absorbed to cause potential toxicity.
Possible consequences:
Safety assessment proved that MON 89788 is compositionally and nutritionally equivalent  to conventional soybean currently in commerce.
Agrobacterium sp, the source of cp4 epsps gene is not known to be pathogenic to human and animal and the protein is not known to induce allergic reactions.
Estimation of the overall risk
Soybean MON 89788 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 soybean MON 89788 and all progenies derived from crosses of the product with any conventionally-bred soybean and soybean containing approved-biotech events for direct use as food, feed or for processing was issued to Monsanto Philippines Inc. Soybean MON 89788 is as safe as its conventional counterpart and does not pose any significant risk to animal and human health.  
Need(s) for further information on specific issues of concern
The raw and fully coated soybean seeds should be completely heat treated to deactivate the naturally present trypsin inhibitors found in all soybeans.
Receiving environment(s) considered
This application is not for propagation of this event. 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
Soybean MON 89788 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 Soybean MON 89788.
Other relevant website address or attached documents

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