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Risk Assessment
Record information and status
Record ID
114767
Status
Published
Date of creation
2019-05-30 03:46 UTC (estaciojulietafe@gmail.com)
Date of publication
2019-05-30 03:46 UTC (estaciojulietafe@gmail.com)

General Information
Country
  • Philippines
Title of risk assessment
Determination of the Safety of Monsanto's Soybean MON87701 for Direct use as Food, Feed, or Processing
Date of the risk assessment
2018-06-22
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
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-877Ø1-2 - Insect resistant soybean
Resistance to diseases and pests - Insects - Lepidoptera (butterflies and moths)
Show detection method(s)
Scope of the risk assessment
  • LMOs for direct use as feed
  • LMOs for direct use as food
  • LMOs for processing
Methodology and points to consider
Likelihood that the potential adverse effects will be realized
The CryAc protein represents no more than 0.0012% of the total protein in the seed of MON 87701.  Therefore, the CryAc protein would constitute a very small portion of the total protein present in feed and food derived from MON 87701.  Bioinformatics analyses demonstrated that the CryAc protein do not share structurally or immunologically relevant amino acid sequence similarities with known allergens.  Thus, it is highly unlikely that the CryAc protein contains immunologically cross-reactive allergenic epitopes.   Digestive fate experiments conducted with E. coli-produced CryAc demonstrated that the protein is rapidly digested in simulated digestive fluids, a characteristic shared among proteins with a history of safe consumption.  Taken together, these data support the conclusion that the CryAc protein presents in MON 87701 is not similar to known allergens and does not pose a significant allergenic risk to humans or animals.
Possible consequences:
The levels of anti-nutrient in MON 87701 are compositionally equivalent to that of the conventional soybean.  In addition, MON 87701 is intended to provide insect protection; therefore, no changes should be anticipated on amount of material consumed, the characteristics of the edible parts of the plant or in the use pattern and processing procedure of MON 87701, compared to conventional soybean.  

In general, soybean processing for food use includes various procedures such as steam cooking, baking, drying and cooling, fermenting, roller milling, grinding and etc. Some degree of heating, mechanical and chemical disruption may accompany those processes, which may or may not affect the level of anti-nutrients. Nevertheless, the level of anti-nutrients in processed products of MON 87701 and the conventional control would be expected to be similar, as there was no difference in the levels of anti-nutrients in MON 87701 compared to control soybean.
Estimation of the overall risk
Soybean MON87701  is found substantially equivalent to conventional counterpart and does not pose any significant risk to animal and human health.
Recommendation(s)
Based on the results of the risk evaluation of the submitted scientific data and other information relevant to the application of Monsanto Philippines Inc., it is concluded that soybean MON87701, 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,  is as safe and substantially equivalent to its unmodified counterpart, and is therefore approved for direct use as food, feed or for processing
Need(s) for further information on specific issues of concern
Soybean MON87701 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 MON87701. 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 MON87701 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, BAI, PPSSD, DENR, DOH and SEC Expert during the evaluation of this event.
Other relevant website address or attached documents