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Risk Assessment generated by a regulatory process
(RA)
last updated: 02 Apr 2025
Determination for the Safety Assessment of Cotton T304-40 for Direct Use as Food, Feed and for Processing
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07 Dec 2016
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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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BCS-GHØØ4-7 - Herbicide-tolerant, insect-resistant cotton| Bayer Crop Science K.K | Resistance to diseases and pests (Insects, Lepidoptera (butterflies and moths), European corn borer (Ostrinia nubilalis)), Resistance to herbicides (Glufosinate)
No evidence of potential toxic or allergenic attributes to cotton T304-30 for food, feed or for processing.
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EN
Bioinformatic analyses and genetic stability studies did not raise safety issues. Levels of the Cry1Ab and PAT proteins in cotton T304-40 have been sufficiently analyzed. Based on the information available, there is no evidence that the genetic modification might significantly change the overall allergenicity of cotton T304-40.
Nutritional equivalence of cotton T304-40 to its conventional counterparts was indicated by compositional data. No biologically relevant differences were identified in the compositional analysis when the seed of T304-40 was compared with its conventional counterpart and non-GM cotton varieties. The safety assessment identified no concerns regarding the potential toxicity and allergenicity of the newly introduced Cry1Ab and PAT proteins. The assessors conclude that cotton T304-40 is as safe and nutritious as its conventional counterpart and that it is unlikely that the overall allergenicity of the whole plant is changed.
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EN
In the Philippines, no wild relatives of cotton are present. Modern cotton cultivars do not possess any of the attributes commonly associated with problematic weeds. The Assessors does not know of reasons to assume that the introduced traits will increase the potential of cotton to establish feral populations.
Considering its intended use as food and feed, interactions with the biotic and abiotic environment were not considered to be an issue. Risks associated with an unlikely but theoretically possible horizontal gene transfer from cotton T304-40 to bacteria have not been identified.
PCR for routine qualitative and semi-quantitative detection of transgenes.
Yes
Yes
Yes
Yes
Yes
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| Record type | Field | Record(s) | |
|---|---|---|---|
| Country's Decision or any other Communication | Risk assessment | 1 | |