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Risk Assessment generated by a regulatory process (RA)
last updated: 06 Jan 2022
Determination for the Safety Assessment of LLCotton25 for Direct Use as Food, Feed and for Processing
EN
Date not available
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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-GHØØ1-3 - Liberty Link™ cotton| Bayer CropScience | Resistance to herbicides (Glufosinate)
- http://biotech.da.gov.ph/ [ English ]
Cotton contains gossypol and it is toxic to non-ruminants and has male sterility properties. The free gossypol is the toxic form with toxicity of 24 mg per head per day.
Raw cottonseed is not used for food. It needs to be processed first before it becomes available for consumption of both human and livestock.
For raw agricultural products, more than 99% of the PAT protein was found in the kernel fractions of cottonseeds. Seed cotton and delinted cottonseed contain an average of 32.1 ug/g and 114 ug/g of PAT protein, respectively. The maximum amount of gossypol that should be fed to dairy cows should be 18 mg.
The only new protein encoded by the bar gene from S. hygroscopicusis PAT. Several in silico findings showed that the protein associated with the pat/bar protein is neither toxic nor allergenic.
LLCotton25 has been approved for feed use in the USA, Taiwan, Canada, Japan, South Korea, Mexico, Australia/New Zealand, European Union, Colombia, China, South Africa and Brazil. Consumption patterns are not expected to change as a result of the introduction of the novel trait as cottonseed derived from GHB119 Cotton is nutritionally and substantially equivalent to cotton derived from conventional breeding practices.
There were no significant differences between the modified product and the conventional product and were more pronounced for protein and crude fiber. The developer provided information on the comparison between the parent line Coker 312 and the GM LLCotton25. Treatments were grown in the same environmental conditions. Comparisons with ranges of commercial varieties were within the range.
The application of LL25COTTON 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
LL25COTTON is intended for direct use as food, feed and for processing.
During the long history of use, no adverse effects to human and animal have been attributed to the residual toxicant (gossypol) in properly processed, refined, bleached and deodorized cottonseed oil, hence no health risk.
During the long history of use, no adverse effects to human and animal have been attributed to the residual toxicant (gossypol) in properly processed, refined, bleached and deodorized cottonseed oil, hence no health risk.
- http://biotech.da.gov.ph/ [ English ]
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