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Risk Assessment
Record information and status
Record ID
109747
Status
Published
Date of creation
2016-03-03 08:03 UTC (lorelieu5@gmail.com)
Date of publication
2016-03-03 08:54 UTC (estaciojulietafe@gmail.com)

General Information
Country
  • Philippines
Title of risk assessment
Determination of the Safety of Monsanto's Herbicide (Dicamba) Tolerant Soybean MON 87708  For Direct Use as Food and Feed and for Processing
Date of the risk assessment
2014-05-05
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
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
MON-877Ø8-9 - Dicamba Tolerant Soybean
Resistance to herbicides
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
Data confirmed that MON 87708 is unlikely to be a toxin or allergen based on extensive information collected. MON 87708 was readily digestible in simulated gastric and simulated intestinal fluids, inactivated when exposed to heat and showed no oral toxicity or cause any adverse effects on mice.
Possible consequences:
MON 87708 was compared to conventional soybean in eight anti-nutrient components. Statistically significant differences were observed in four namely, phytic acid, raffinose, stachyose, and daidzein.  The levels of these antinutrients in seed of MON 87708 were within the range of natural variability of conventional commercial reference soybean varieties. The results further showed no health risk concern with the consumption of MON 87708 soybean.

Soybean meal produced from MON 87708 compared to meal produced from conventional soybean through a broiler study showed no biologically meaningful differences in broiler performance, carcass yield or meat composition between the two groups.  There was a comparable  nutritional wholesomeness of the two diets.
Estimation of the overall risk
Soybean MON87708 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 Herbicide (Dicamba) Tolerant MON 87708 and all progenies derived from crosses of the product with any conventional soybean containing approved-biotech events for direct use was issued to Monsanto Philippines Inc. Soybean MON87708 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
Soybean MON87708 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 Soybean MON87708. 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
Soybean MON87708 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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