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Risk Assessment generated by a regulatory process
(RA)
last updated: 02 Apr 2025
Determination for the Safety Assessment of Soybean DAS 68416-4 for Direct Use as Food, Feed and for Processing
EN
21 Mar 2019
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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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Organization:Bureau of Plant Industry (BPI)San Andres, MalateManila, Metro Manila
1004, PhilippinesPhone: 8524-9588 local 230,Fax:Email: bpibiotech@buplant.da.gov.ph,Website: https://biotech.buplant.da.com.ph/,
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DAS-68416-4 - Enlist™ Soybeans| Dow AgroSciences GmbH | Resistance to herbicides (Glufosinate), Tolerance to 2,4-Dichlorophenoxyacetic acid
- consolidated-report-das68416.pdf [ English ]
No evidence of potential toxic or allergenic attributes to soybean DAS 68416-4 for food, feed or for processing.
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EN
Comprehensive molecular analyses of soybean line 68416 indicate there is a single insertion site containing one complete copy of each of the two gene cassettes. The introduced genetic elements are stably inherited from one generation to the next. No known endogenous genes have been interrupted by insertion of the new genetic material.
In relation to potential toxicity and allergenicity, previous assessments of the PAT protein have shown it is inherently non-toxic to mammals and does not exhibit any potential to be allergenic to humans.
For the AAD-12 protein, bioinformatic studies confirmed the lack of any significant amino acid sequence similarity to known protein toxins or allergens; a digestibility study suggests the protein would be rapidly degraded in the stomach following ingestion; and a thermolability study showed that the protein is inactivated by heating. An acute oral toxicity study in mice also confirmed the absence of toxicity of AAD-12. Taken together, the evidence indicates that AAD-12 is unlikely to be toxic or allergenic to humans.
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EN
The soybean plant is not weedy in character. Cultivated soybean seeds rarely display dormancy and poorly survive in soil. Soybean volunteers are rare throughout the world and do not effectively compete with other cultivated plants or primary colonizers. In addition, volunteers are easily controlled mechanically or chemically.
Soybean is predominantly a self-pollinating species. The cross-pollination rate of soybean is less than 1%. The dispersal of pollen is limited because the anthers mature in the bud and directly pollinate the stigma of the same flower.
In the Philippines, hybridization with other species is not possible because there are no wild relatives of soybean.
A validated event-specific detection method for the quantification of DAS-68416-4 soybean event has been published by the European Union Reference Laboratory (EURL) of the Joint Research Centre (JRC).
The validated detection method is publicly available from the JRC-EURL website:
http://gmo-crl.jrc.ec.europa.eu/statusofdossiers.aspx
Yes
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| Record type | Field | Record(s) | |
|---|---|---|---|
| Country's Decision or any other Communication | Risk assessment | 1 | |
