Loading...
You are viewing a DELETED record.
This record information is displayed for reference purpose only and should be not used.
This document has been updated. This is not the latest published version. Click here to view the latest version of the record.
Risk Assessment generated by a regulatory process (RA)
last updated: 06 Jan 2022
Determination for the Safety Assessment of Soybean DAS81419-2 for Direct Use as Food, Feed and for Processing
EN
Date not available
-
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,
-
DAS-81419-2 - Conkesta™ Soybean| Resistance to diseases and pests (Insects, Lepidoptera (butterflies and moths)), Resistance to herbicides (Glufosinate)
- http://biotech.da.gov.ph/ [ English ]
Glufosinate herbicide tolerance - eliminates herbicidal activity of glufosinate (phosphinothricin) herbicides by acetylation
Lepidopteran insect resistance - confers resistance to lepidopteran insects by selectively damaging their midgut lining
Soybean contains Selenium which could be toxic when taken at high dosage. Food allergens have also been noted in soybean which may cause IgE-mediated reaction. It also contains antinutrients which are heat-inactivated during processing.
Soybeans are commonly consumed in processed form and primary source of oil and protein. Heat processing eliminates the anti-nutritional factors in soybean.
Compositional analysis of the nutritional data of DAS-81419-2 in comparison with the non-transgenic soybean, range of commercial varieties and range of literature values (DAS, 2016) indicated that there is no differences in the proximate, fiber, mineral, amino acid, fatty acid, vitamins, anti-nutrient and secondary metabolite levels of DAS-81419-2 and the non-transgenic soybean that can be considered biologically relevant.
Cry1Ac, Cry1F, and PAT proteins have a long history of safe use. The proteins are not known to possess potential pathogenic or allergenic properties. The proteins have specific modes of action and have no significant sequence similarity to known allergens or toxins.
For the transgenic DAS-81419-2 soybean, enough evidence is provided to support the equivalence of the genetically modified crop, in terms of the nutritional composition and food safety, with the conventional soybean other than the resistance to certain lepidopteran insects and glufosinate ammonium-containing herbicides. It is therefore concluded that DAS-81419-2 soybean is as safe as its conventional counterpart.
Bacillus thuringiensis is a donor of cry1Ac and cry1F genes. Streptomyces viridochromogenes is a donor organism of pat gene. Donor organisms of genetic elements including promoters, terminators and border sequences include Arabidopsis thaliana, Agrobacterium tumefaciens, and Cassava vein mosaic virus. All donor organisms are not known to be toxic and allergenic and has been used in Agrobacterium-mediated transformation of several genetically modified crops. History of safe use was attributed to all donor organisms.
The application of DAS-81419-2 soybean is not for propagation. This LMO will be directly used for food, feed and for processing.
Diagnostic lateral flow strips, ELISA and PCR for routine qualitative and semi-quantitative detection of transgenes. For higher sensitivity, real-time PCR methods may be used.
No
DAS-81419-2 soybean has been reviewed and approved for food and/or feed use in many countries including United States (Food and Feed, 2014), Canada (Food and Feed, 2014), Australia & New Zealand (Food and Feed, 2014), Argentina (Food and Feed, 2016), Brazil (Food and Feed, 2016), Colombia (Food and Feed, 2016), Japan (Food and Feed, 2014), Korea (Food and Feed, 2016), Mexico (Food and Feed, 2015), South Africa (Food and Feed, 2016), Taiwan (Food and Feed, 2015) (ISAAA, 2017).
- http://biotech.da.gov.ph/ [ English ]
Loading...
