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Risk Assessment generated by a regulatory process
(RA)
published: 13 Feb 2013
last updated: 25 Mar 2025
Determination of the Safety of Bayer's Soybean A5547-127 for Direct use as Food, Feed, and for Processing
EN
23 Jun 2011
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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,
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ACS-GMØØ6-4 - Liberty Link™ soybean| Bayer CropScience | Resistance to herbicides (Glufosinate)
- DA-BPI Biotechnology Office [ English ]
The inserted pat gene is present in Soybean A5547-127 and expresses phosphinothricin acetyltransferase. Streptomyces viridochromogenes, source of the pat gene, is not known to be pathogenic, toxic or allergenic for human or animals. Pat gene is composed of the same basic natural nucleic acids as found in any DNA from known food constituents consumed as part of human or animal diets. It undergoes the same breakdown process in the digestive system as typical food genes and poses no direct toxicity on human health.
EN
The Streptomyces viridochromogenes (source of gene) is non pathogenic and the pat gene as well as its encoded PAT protein is not toxic to mammals. PAT also does not possess characteristics associated with food allergens. There is a reasonable certainty that no harm will result from the inclusion of the PAT protein (encoded by the pat gene) in human food and in animal feed.
EN
The PAT protein lacks allergenic and toxic potential, it has no amino acid sequence homology to other known allergens or toxins as demonstrated by overall amino acid and epitope homology searches and it is rapidly and completely degraded in human Simulated Gastric Fluid (SGF) and Simulated Instestinal Fluid (SIF). This minimizes the likelihood that this protein could survive in the human digestive tract and be absorbed as intact protein.
EN
Soybean A5547-127 is as safe as its conventional counterpart based on compositional and nutritional analyses. Soybean A5547-27 is safe to humans, animals and as nutritious as conventional soybean.
EN
A biosafety permit for Soybean A5547-127 and all progenies from crosses of this product except when other biotech traits has undergone satisfactory assessment and found to be as safe as conventional soybean and can be a substitute for its traditional counterpart as food and feed or for processing was issued to Bayer CropScience, Inc.
EN
EN
This application is not for propagation of this event. This LMO will be directly used for food, feed and for processing.
EN
Quantitative diagnostic lateral flow strips, ELISA and PCR for routine quantitative and semi-quantitative detection of transgenes. For higher sensitivity, real-time PCR.
EN
Yes
Yes
Yes
Yes
Yes
Soybean 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 and DA Regulatory Agencies during the evaluation of Soybean A5547-127.
EN
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 A5547-127.
| Record type | Field | Record(s) | |
|---|---|---|---|
| Country's Decision or any other Communication | Risk assessment | 1 | |
