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Risk Assessment
Record information and status
Record ID
109790
Status
Published
Date of creation
2016-03-11 09:36 UTC (ralphklapps@gmail.com)
Date of publication
2016-03-14 02:17 UTC (estaciojulietafe@gmail.com)

General Information
Country
  • Philippines
Title of risk assessment
Determination of the Safety of Monsanto's Soybean MON 87769 for Direct use as Food, Feed, or Processing
Date of the risk assessment
2015-04-24
Institution 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-87769-7 - Soybean with modified fatty acid composition
Changes in quality and/or metabolite content - Lipid and fatty acids
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
Digestibility studies in SGF and SIF show that PjΔ6D and NcΔ15D proteins were rapidly digestible indicating that it is highly unlikely that these proteins will pose any safety concern to human and animal health.

Based on the weight of evidence, it is concluded that the PjΔ6D and NcΔ15D proteins expressed in MON 87769 is safe and poses no concerns for humans, animals and the environment.
Possible consequences:
Harvested soybean seeds contain several substances considered to be anti-nutrients (i.e. trypsin inhibitors, lectin, isoflavones (daidzein, genistein and glycitein) and phytic acid). Trypsin inhibitors and lectin are inactivated by proper processing of soybean protein products or soybean meal and their levels are similar to conventional control. The levels of stachyose, raffinose and phytic acid are also similar to conventional control. The mean and range values for three isoflavones, genistein, daidzein, and glycitein, were lower in MON 87769 harvested seed compared to the values in the conventional soybean control.  However, the range of values for these three analytes in MON 87769 were all within the 99% tolerance interval for the population of conventional reference varieties, and were also within the range of values found in the published literature and the ILSI Crop Composition Database. .  Therefore, these differences were not considered to be biologically meaningful from a food and feed safety and/or nutritional perspective.
Estimation of the overall risk
Soybean MON 87769 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 nutrition enhanced soybean MON 87769 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 87769 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 MON 87769 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 MON 87769. 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 MON 87769 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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