Philippines | BCH-RA-PH-109748 | Risk Assessment generated by a regulatory process | Biosafety Clearing-House

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Risk Assessment generated by a regulatory process (RA)

last updated: 03 Mar 2016
General Information
Determination of the Safety of Monsanto's Soybean MON 87705 For Direct use as Food and Feed, and for Processing
EN
28 Nov 2014
Risk assessment details
Methodology and points to consider
EN
Digestive fat experiments conducted with the CP4 EPSPS protein demonstrate that the full-length protein is rapidly digested in simulated gastric fluid in vitro assay. In addition, the CP4 EPSPS protein represents no more than 0.031% of the total protein in the seed of MON 87705, a relatively low abundance for this protein compared to the rest of the seed protein content. These data support the conclusion that the CP4 EPSPS protein present in MON 87705 is not similar to known allergens and does not pose a significant allergenic risk to humans or animals and is unlikely to pose a human health concern.
EN
Soybean seed contains several well-described antinutritional factors which include: trypsin inhibitors, phytic acid, lectins, isoflavones (daidzen, glycitein and genistein), raffinose and stachyose. Combined site analysis of antinutrients showed no significant differences between MON 87705 and the conventional soybean control. Both trypsin inhibitors and lectins are inactivated during processing of soybean protein products or soybean meal and, when processed appropriately, the final edible soybean fractions should contain minimal levels of these nutrients.

No significant differences in isoflavone and raffinose levels were observed between MON 87705 and the conventional soybean control for the combined-site or individual-site analyses. Stachyose levels showed no differences between MON 87705 and the conventional soybean control in the combined-site analysis, but were significantly different at one site. This difference is not considered biologically relevant because it was observed only at one site and was not observed consistently
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Soybean MON87705 is found substantially equivalent to conventional counterpart and does not pose any significant risk to animal and human health.
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A biosafety permit for Soybean MON 87705 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 and feed and for processing was issued to Monsanto Philippines. Soybean MON87705 is found substantially equivalent to conventional counterpart and does not pose any significant risk to animal and human health.
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Soybean MON87705 is found substantially equivalent to conventional counterpart and does not pose any significant risk to animal and human health.
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This application is not for propagation of the Soybean MON87705. This LMO will be directly used for food, feed and for processing.
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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.
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Additional information
Soybean MON87705 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.
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