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Risk Assessment
Record information and status
Record ID
104691
Status
Published
Date of creation
2013-02-14 06:50 UTC (tluzaransoriano@yahoo.com)
Date of publication
2013-02-14 11:09 UTC (estaciojulietafe@gmail.com)

General Information
Country
  • Philippines
Title of risk assessment
Determination of the Safety of Soybean MON87701 for Direct use as Food, Feed, and for Processing
Date of the risk assessment
2012-05-16
Competent National Authority(ies) 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
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
Risk assessment report / Summary
Methodology and points to consider
Potential adverse effects identified in the risk assessment
A detailed characterization and safety evaluation of the newly expressed Cry1Ac protein confirm that it is safe for human and animal consumption. Bioinformatics assessments showed that Cry1Ac does not share amino acid sequence similarities with known allergens, gliadins, glutenins, or protein toxins that have adverse effects on mammals.
Likelihood that the potential adverse effects will be realized
Cry1Ac is a member of the family of Bt Cry proteins that have been used in agriculture as microbial pesticides for over 50 years with no evidence of adverse effects to human or animal health.Since 1996, a number of insect-resistant biotechnology crops expressing Bt Cry proteins have been commercialized. The data indicate that food and feed derived from MON 87701 containing Cry1Ac protein are as safe for consumption as the food and feed derived from conventional soybean.
Possible consequences:
The safety of Cry1Ac is further confirmed by history of safe use, low toxicity potential, and no anticipated risk to humans and animals from its presence in the diet.
Estimation of the overall risk
MON 87701 soybean is as safe as its conventional counterpart taking into its dietary source and nutritional impact of any changes in nutritional value.  MON 87701 soybean is safe to humans, animals and as nutritious as conventional soybean.
Recommendation(s)
A biosafety permit for Soybean MON 87701 (No: 12-057) and all progenies from crosses of the product except when stacked with other biotech traits was issued to Monsanto Philippines, Inc.  The permit was valid for five years, subject to the terms and conditions set forth in DA Administrative Order No. 8, Series of 2002 as amended by DA Administrative Order No. 22, Series of 2007.
Receiving environment(s) considered
This application is not for propagation of this event. 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.
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 and DA Regulatory Agencies during the evaluation of  Soybean MON87701.

Records referencing this document (1)
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1record(s) found
Country's Decision or any other Communication1 record