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Risk Assessment
Record information and status
Record ID
114766
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 Bayer's Stacked trait product soybean: FG72 x A5547-127 for direct use as food and feed, or for 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
MST-FGØ72-2 x ACS-GMØØ6-4 - Soybean modified for herbicide tolerance
Resistance to herbicides - Glufosinate, 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
Methodology and points to consider
Potential adverse effects identified in the risk assessment
It is concluded that no interaction was found between/among the combined traits, hence this plant product was found to be as safe as its conventional soybean and can substitute for its traditional counterpart for direct use as food, feed, for processing
Likelihood that the potential adverse effects will be realized
The Assessments of the maize (Zea mays L.) source organism, the 2mepsps gene, and the 2mEPSPS protein indicate that they are not pathogenic, allergenic, or toxic to mammals, which is the same for hppd (hppdf) gene for the genetic modification described for soybean. FG72 was initially isolated and cloned from the bacterium Pseudomonas fluorescens A32. The substitution of glycine (G) with tryptophan (W) at position 336 in the expressed HPPDF protein resulted in the hppdfPf W336 gene.

A safety evaluation for the phosphinothricin acetyltransferase (PAT) proteins encoded by the pat and bar sequences that confer tolerance to glufosinate-ammonium herbicide in transgenic plants was conducted based on the recommendations provided by different international organizations and authorities, i.e., the United Nations Food and Agricultural Organization and the World Health Organization, the US Food and Drug Administration, the Organization for Economic Co-operation and Development, Health Canada, the European Commission, the Codex Alimentarius, etc. No safety concerns with the PAT protein had been envisaged.
Possible consequences:
Anti-nutrients, including isoflavones, raffinose, stachyose, phytic acid, trypsin inhibitors and lectins in seeds and toasted meal were analyzed and compared with those of commercial soybean varieties. The amount of anti-nutrients present in FG72 and A5547-127 fell within the range found in non-transgenic soybean.
Estimation of the overall risk
Stacked trait Soybean FG72 x A5547-127 is found substantially equivalent to conventional counterpart and does not pose any significant risk to animal and human health.
Recommendation(s)
After reviewing the scientific data and information relevant to the combined traits product soybean FG72 x A5547-127 application of Bayer CropScience Inc., it is concluded that no interaction was found between/among the combined traits, hence this plant product was found to be as safe as its conventional soybean and can substitute for its traditional counterpart for direct use as food, feed, for processing, and is therefore approved for direct use as food, feed, for processing.  Bayer CropScience Inc. is hereby notified that it may proceed with the activities for the above product for direct use as food and feed or for processing following all existing rules and regulations consistent with JDC 1 s2016.
Need(s) for further information on specific issues of concern
Stacked trait Soybean FG72 x A5547-127 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 Stacked trait Soybean FG72 x A5547-127. 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
Stacked trait Soybean FG72 x A5547-127 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