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Risk Assessment
Record information and status
Record ID
111737
Status
Published
Date of creation
2017-03-01 01:57 UTC (estaciojulietafe@gmail.com)
Date of publication
2017-03-01 01:57 UTC (estaciojulietafe@gmail.com)

General Information
Country
  • Philippines
Title of risk assessment
Determination of Safety of Monsanto's Stacked Trait Product Soybean: MON87708 x MON89788 for Direct Use as Food and Feed or Processing
Date of the risk assessment
2017-02-01
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
Department of Environment and Natural Resources
Visayas Avenue
Quezon City
Philippines, 1100
Phone:+632 925-2329, +632 920-4352
Fax:+632 920-4301
Email:osec@denr.gov.ph
Url:DENR,PAWB
Department of Health
San Lazaro Compound, Sta. Cruz
Manila
Philippines
Phone:+632 651 7801; +623 651 7800
Fax:+632 743 1829
Email:etona@co.doh.gov.ph
Url:DOH Website
Contact details of the main responsible risk assessor
Mr. Ariel J. Bayot
Officer-In-Charge Chief
National Plant Quarantine Services Division
Bureau of Plant Industry (BPI)
San Andres
Malate, Manila
Philippines
Phone:+63 2 404-0409
Fax:+63 2 404-0409
Email:ajbayot@yahoo.com
Ms. Ma. Lorelei U. Agbagala
Supervising Agriculturist
Post Entry Quarantine
Bureau of Plant Industry (BPI)
Economic Garden
Los Banos, Laguna
Philippines, 4030
Phone:+63 49 536 1678
Fax:+63 49 536 1678
Email:lorelieu5@gmail.com
Url:Bureau of Plant Industry
Risk assessment details
Living modified organism
MON-877Ø8-9 x MON-89788-1 - Herbicide tolerant 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
  • Environmental Assessment
  • Socio-Economic and Cultural Considerations
Risk assessment report / Summary
Methodology and points to consider
Likelihood that the potential adverse effects will be realized
The protein levels of the two protein products in MON87708 x MON89788 are equivalent to the protein levels expressed in both single events that were previously approved as validated by enzyme-linked immunosorbent assay (ELISA). DMO, in average was expressed in 41 ug/g of seed dry weight while CP4 EPSPS was expressed in 93 ug/g of seed dry weight. 

In addition, the expressed proteins are not involved in the same metabolic pathway. DMO is a Rieske nonheme oxygenase which catalyzes the oxidative demethylation of dicamba to 3,6 dichlorosalicylic acid and formaldehyde.  On the other hand, CP4 EPSPS is involved in the shikimic pathway of aromatic amino acid biosynthesis. 

Lastly, occurrence of unexpected effects of the stacked genes is unlikely based on the compositional analysis of MON87708 x MON89788 seeds wherein there was no significant variation compared to the conventional variety of soybean (A3525).
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
The Stacked Trait Soybean MON87707 x MON89788 is found substantially equivalent to conventional counterpart and does not pose any significant risk to animal, human health and the environment.
Recommendation(s)
After reviewing the scientific data and information relevant to the combined traits product Soybean MON87708 x MON89788 application of Monsanto Philippines Inc., it is concluded that no interaction was found between/among the combined traits as well as serious socio-economic, ethical and cultural issues. Hence this plant product was found to be as safe as its conventional soybean and can substitute for its traditional counterpart for direct use, and is therefore approved.  Monsanto is hereby notified that it may proceed with the activities for the above product for direct use following all existing rules and regulations consistent with JDC No.1 Series of 2016.
Need(s) for further information on specific issues of concern
The Stacked Trait Soybean MON87707 x MON89788 is found substantially equivalent to conventional counterpart and does not pose any significant risk to animal, human health, environment, and no socio-economic, ethical and cultural concerns.
Receiving environment(s) considered
This application is not for propagation of the Soybean MON87707 x MON89788. 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 x MON89788 is intended for direct use as food, feed and for processing.

All relevant documents and references in support of their application were submitted by the technology developer to the Scientific and Technical Review Panel (STRP) members, DA, DOH, and DENR during the evaluation of this event. Socio-economic, Ethical and Cultural Considerations (SEECC) were taken into account during the review process.
Other relevant website address or attached documents