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Risk Assessment generated by a regulatory process
(RA)
last updated: 30 May 2013
Determination for the Safety Assessment of Soybean A2704-12 for Direct Use as Food, Feed and for Processing
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- Competent National Authority: | BCH-CNA-PH-46524-5 This document has been updated. This is not the latest published version. Click here to view the latest version of the record.Competent National Authority:Department of Agriculture ()Elliptical Road, DilimanQuezon City,
1100, PhilippinesPhone: +632 920-3986, +632 924-1278 local 2802,Fax: +632 920-3986,Email: osec.da@gmail.com,Website: http://www.da.gov.ph,
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ACS-GMØØ5-3 - Herbicide-tolerant soybean| Bayer CropScience | Resistance to herbicides (Glufosinate)
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The concentration levels of total isoflavones (phytoestrogens, including total daidzein, total genistein, and total glycitein) were all inside the Literature range and not statistically different between samples from non-transgenic and transgenic nonsprayed soybeans.
The low potential for allergenicity of the PAT protein has previously been established through amino acid sequence comparisons with known protein allergens and digestibility studies using simulated gastric and intestinal fluids.
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The low potential for allergenicity of the PAT protein has previously been established through amino acid sequence comparisons with known protein allergens and digestibility studies using simulated gastric and intestinal fluids.
Soybean seed extracts from line A2704-12 and from non-transgenic control plants were screened against a panel of sera from 16 soy-allergic individuals using the radioallergosorbent test (RAST). The results of this study did not reveal any qualitative or quantitative difference in endogenous soybean allergen content between transgenic and non-transgenic soybean.
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Soybean A2704-12 is as safe as its conventional counterpart and does not pose any significant risk to animal and human health.
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A biosafety permit for Soybean A2704-12 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 and feed or for processing was issued to Bayer CropScience. Soybean A2704-12 is found to be as safe as its conventional counterpart and does not pose any significant risk to human and animal health.
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This LMO will be directly used for food, feed and for processing. This application is not for propagation of this event.
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Qualitative diagnostic lateral flow strips, ELISA and PCR for routine quantitative and semi-quantitative detection of transgenes. For higher sensitivity, real-time PCR.
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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 and DA regulatory agencies during the evaluation of Soybean A2704-12.
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