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BCH-RA-PH-109747-1   |   PDF   |   Print   |  

Risk Assessment generated by a regulatory process (RA)

last updated: 03 Mar 2016
General Information
Philippines
Determination of the Safety of Monsanto's Herbicide (Dicamba) Tolerant Soybean MON 87708  For Direct Use as Food and Feed and for Processing
EN
05 May 2014
Risk assessment details
Methodology and points to consider
EN
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.
EN
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.
EN
Soybean MON87708 is found substantially equivalent to conventional counterpart and does not pose any significant risk to animal and human health.
EN
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.
EN
Soybean MON87708 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 Soybean MON87708. This LMO will be directly used for food, feed and for processing.
EN
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
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.
EN

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