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Risk Assessment generated by a regulatory process
(RA)
published: 03 Aug 2012
last updated: 16 Aug 2012
Determination of the Safety of Pioneer's Soybean DP356043 (Herbicide tolerant) for Direct use as Food, Feed, and for Processing
EN
26 Nov 2009
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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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DP-356Ø43-5 - Optimum™ GAT™ soybean| Pioneer Hi-Bred International, Inc. | Resistance to herbicides (Glyphosate, Sulfonylurea)
- DA-BPI Biotech Website [ English ]
Soybean 356043 contains two inserted protein encoding sequences such as 1) gat4601; and 2) gmhra gene. gat 4601 is derived from common soil bacterium Bacillus licheniformis which has no known pathogenic properties. B. licheniformis is a spore-forming bacteria commonly found in the soil and well known for being an industrial source of proteases, amylases, antibiotics and specialty chemical products. It is widespread in the environment where humans and animals are exposed without known adverse effects to this organism and its components, such as the GAT protein.
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356043 soybean will have no adverse effects on the nutritional quality of soybeans or food safety and therefore, no adverse effects to human or animal
health are expected. Since it contains no toxin, 356043 soybean is not expected to cause any harm to the environment.
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health are expected. Since it contains no toxin, 356043 soybean is not expected to cause any harm to the environment.
The levels of GAT4601 and GM-HRA proteins expressed in 356043 soybean tissues were also measured to determine the exposure levels of these proteins to humans and animals in the grain. The exposure levels were found to be exponentially lower than the doses tested in the mouse acute oral
study and becomes negligible when heat lability of the two proteins during processing is taken into consideration.
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study and becomes negligible when heat lability of the two proteins during processing is taken into consideration.
Soybean DP356043 is as safe as the conventional soybean taking into account dietary impact of any changes in nutritional content or value. Soybean DP356043 is safe to humans, animals and as nutritious as ordinary soybean.
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Biosafety permit for Soybean DP356043 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, feed or for processing was issued to Pioneer Hi-Bred Philippines.
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This application is not for propagation of this event. 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.
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Soybean DP356043 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 DP356043.
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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 DP356043.
- OECD Consensus Document on soybean [ English ]
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