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Risk Assessment generated by a regulatory process (RA)
last updated: 19 Feb 2021
Determination for the Safety Assessment of Cotton GHB614 x T304-40 x GHB119 x COT102 for Direct Use as Food, Feed and for Processing
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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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BCS-GHØØ2-5 × BCS-GHØØ4-7 × BCS-GHØØ5-8 × SYN-IR1Ø2-7 - Glytol™ x Twinlink™ x VIPCOT™ Cotton| Bayer CropScience | Resistance to diseases and pests (Insects, Lepidoptera (butterflies and moths)), Resistance to herbicides (Glufosinate, Glyphosate), Selectable marker genes and reporter genes
Cotton is widely cultivated and has a history of safe use. Cotton is not considered harmful or pathogenic to humans; however, the plant does produce gossypol and cyclopropenoid fatty acids (CPFA), which are anti-nutrients. All of the anti-nutritional factors are subject to neutralization during processing. Free gossypol binds to lysine and other products, and then becomes unavailable to animals. Cyclopropenoid fatty acids are deactivated or removed from the oil by hydrogenation or during deodorization at 230-235°C.
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There is no plausible interaction of the resulting novel protein products, in which a new allergen or a new toxin could be produced. Cry1Ab, Cry2Ae, Vip3Aa19, PAT/bar, 2mEPSPS, and APH4 proteins indeed do not act on the same metabolic pathways and do not share any intermediate metabolites in the biochemical pathways that the proteins act on or interfere with. Without the lack of interaction, there is no expected adverse effect on the target trait that the transgenes confer, more so, no new allergen nor toxin will be produced.
The resulting novel protein products will accumulate in the cytoplasm of the transgenic plant cells. Despite this co-localization, Cry1Ab, Cry2Ae, Vip3Aa19, PAT/bar, 2mEPSPS, and APH4 proteins indeed would not act on the same metabolic pathways and do not share any intermediate metabolites in the biochemical pathways that the proteins act on or interfere with.
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The resulting novel protein products will accumulate in the cytoplasm of the transgenic plant cells. Despite this co-localization, Cry1Ab, Cry2Ae, Vip3Aa19, PAT/bar, 2mEPSPS, and APH4 proteins indeed would not act on the same metabolic pathways and do not share any intermediate metabolites in the biochemical pathways that the proteins act on or interfere with.
The expression levels of the novel proteins were not biologically different between the stacked transgenic plant under evaluation and its parental genotypes. The measurements done by the proponents using ELISA and subsequent statistical analysis clearly demonstrated that there is indeed no significant difference among the expression levels of the novel proteins. Even though there are five statistically significantly difference found, it is indeed acceptable because it does not imply biological significance when viewed in the box-plot perspective.
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The individual events of the gene stacked Cotton GHB614 x T304-40 x GHB 119 x COT 102 has undergone rigorous safety assessment, and is considered safe to humans, animals and is less likely to pose any significant adverse effect on the environment.
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The individual events of the gene stacked Cotton GHB614 x T304-40 x GHB 119 x COT 102 have biosafety permits for direct use, which were previously issued. Therefore, each event has undergone rigorous safety assessment, and is considered safe to the environment, biodiversity, and non-target organisms. A biosafety permit for direct use can be issued for the said event.
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The incorporation of gene stacked event is through conventional breeding, which is regarded as innocuous for its long history of safe use. Furthermore, the method of crossing individual transgenic parents is similar with that of non-transgenic parents. This method does not introduce any greater variation in the genome beyond what is obtained.
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The application of cotton GHB614 x T304-40 x GHB 119 x COT 102 is not for propagation. This LMO will be directly used for food, feed and for processing.
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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.
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Cotton GHB614 x T304-40 x GHB 119 x COT 102 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 during the evaluation of this combined trait product.
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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 during the evaluation of this combined trait product.
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