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Risk Assessment generated by an independent or non-regulatory process
(IRA)
last updated: 30 May 2019
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
EN
22 Jun 2018
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Competent National Authority:Department of Agriculture ()Elliptical Road, DilimanQuezon City,
1100, PhilippinesPhone: (02) 8928-8741 to 64 local 2118, 2214, 2215, 2240,Fax:Website: http://www.da.gov.ph, -
Competent National Authority:Department of Environment and Natural Resources ()Visayas Avenue, DilimanQuezon City, Metro Manila
1100, PhilippinesPhone: (02) 8925-8277,Fax:Email: actioncenter@denr.gov.ph, osec@denr.gov.ph,Website: http://www.denr.gov.ph, -
Competent National Authority:Department of Health ()Tayuman, Sta. CruzManila, Metro Manila
1003, PhilippinesPhone: (632) 8651-7800,Fax:Email: callcenter@doh.gov.ph,Website: http://www.doh.gov.ph,
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Person:Ms. Ma. Lorelei U. AgbagalaSupervising Agriculturist, Post Entry QuarantineEconomic GardenLos Banos, Laguna
4030, PhilippinesPhone: +63 49 536 1678,Fax: +63 49 536 1678,Email: lorelieu5@gmail.com,Website: http://bpi.da.gov.ph,Related OrganizationBureau of Plant Industry (BPI)Economic GardenLos Banos, Laguna
4030, PhilippinesPhone: +63 49 536 1678,Fax: +63 49 536 1678,Email: lorelieu5@gmail.com,Website: http://bpi.da.gov.ph,
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MST-FGØ72-2 × ACS-GMØØ6-4 - Soybean modified for herbicide tolerance| Bayer CropScience | HPPD Herbicides, Resistance to herbicides (Glufosinate, Glyphosate)
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
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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.
EN
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.
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.
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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.
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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.
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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.
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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.
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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.
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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.
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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.
