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Risk Assessment generated by a regulatory process
(RA)
published: 09 Jan 2025
last updated: 10 Jan 2025
Safety Assessment of Cotton GHB614 for Direct Use as Food, Feed, or for Processing
EN
22 Nov 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:Department of Agriculture (DA)Government agency (National/Federal)Elliptical Road, Diliman, Quezon City PhilippinesQuezon City, Quezon City
1100, PhilippinesPhone: +632 920-3896, +632 924-1278 local 2802, +632 920-3986,Fax:Email: osec.da@gmail.com,Website: https://www.da.gov.ph,
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BCS-GHØØ2-5 - GlyTol™ Cotton GHB614| Bayer CropScience | Resistance to herbicides (Glyphosate)
The assessors— the Scientific and Technical Review Panel (STRP), the Bureau of Plant Industry Plant Products Safety Services Division (BPI-PPSSD), the Bureau of Animal Industry Biotech Team (BAI-BT), the Department of Environment and Natural Resources Biosafety Committee (DENR-BC), and the Department of Health Biosafety Committee (DOST-BC)— after a thorough review of the technical dossier provided in the application, concurred that Cotton GHB614 is (1) as safe for human food and animal feed as its conventional counterpart and (2) will not pose any significant risk to health and the environment.
Since cotton can be a source of food products such as flours and oils, the assessors considered the potential adverse effects of Cotton GHB614 and its derivatives in the event that the regulated article enters the food chain. In particular, the novel protein 2mEPSPS— a modified form of the 5-enol-pyruvylshikimate-3-phosphate synthase from corn— may pose allergenic or toxic risks.
The likelihood of the potential adverse effects being realized was analyzed with respect to the pathway of exposure to the novel protein via ingestion. Cottonseed oil, the main cotton product consumed by humans, was the basis for the assessment. The assessors— in noting that (1) the concentration of 2mEPSPS in the delinted cottonseed is at low levels (102 + 2 μg/g across four growth stages) relative to the total crude protein and that (2) the novel protein is not likely to withstand processing into cottonseed oil— concurred that the exposure to 2mEPSPS in Cotton GHB614 is highly unlikely. Additionally, 2mEPSPS was not detected in lint, linters, toasted meal, and oil samples from Cotton GHB614.
The possible consequences of the potential adverse effects of Cotton GHB614 were assessed in terms of the potential allergenicity and toxicity of the novel protein 2mEPSPS. Data generated through in silico analysis of sequence similarity to known allergens and toxins, digestibility assay, heat stability study, and oral gavage study were therefore considered in the assessment. The assessors, through the weight-of-evidence approach, concluded that the 2mEPSPS expressed in Cotton GHB614 is not allergenic nor toxic.
The overall risk for Cotton GHB614 was assessed by considering the likelihood of exposure to the regulated article, its potential for being allergenic or toxic, and its substantial equivalence with its conventional counterpart.
The assessors concurred that the likelihood of exposure to 2mEPSPS in Cotton GHB614 is highly unlikely due to its limited expression in the cottonseed (the plant part used to produce the plant product intended for consumption).
The potential for allergenicity and toxicity was assessed via in silico analysis of sequence similarity to known allergens and toxins, digestibility assay, heat stability study, and oral gavage study. Homology search across protein databases (e.g. NCBI non-redundant protein database, Bayer Toxin Database, and FASTA) showed that 2mEPSPS shares homology with other enzymes in the EPSPS family in different plants. However, no similarity with known allergens or toxins were recorded. Digestibility assays showed that 2mEPSPS was rapidly degraded within 0.5 minutes of incubation for both simulated human gastric fluid and simulated intestinal fluid. The heat stability study, on the other hand, indicated that the primary structure of 2mEPSPS remained stable across incubation at 4°C, 25°C, 37°C, 55°C, 75°C, and 95°C for 30 minutes. Only minor degradation was recorded starting at 55°C. Finally, acute oral gavage study demonstrated that there were no observed mortalities, treatment-related clinical signs, effect on body weight parameters, effect on food consumption, nor macroscopic changes at necropsy for mice treated with 2000 mg/kg body weight of 2mEPSPS.
Compositional analysis, in turn, showed that the levels of most proximates, key nutrients, and anti-nutrients in Cotton GHB614 are comparable to those in Coker 312, the non-GM cotton comparator. Some of the levels of the components of Cotton GHB614 deviate from literature values, but fall within the range of those observed in Coker 312. Therefore, there are no biologically relevant statistical differences in the composition of GHB614. Assessors agree that there is enough evidence to support the substantial equivalence of Cotton GHB614 with conventional cotton.
Accounting for these lines of evidence, the assessors concurred that the overall risk for Cotton GHB614 is negligible.
The assessors concurred that the likelihood of exposure to 2mEPSPS in Cotton GHB614 is highly unlikely due to its limited expression in the cottonseed (the plant part used to produce the plant product intended for consumption).
The potential for allergenicity and toxicity was assessed via in silico analysis of sequence similarity to known allergens and toxins, digestibility assay, heat stability study, and oral gavage study. Homology search across protein databases (e.g. NCBI non-redundant protein database, Bayer Toxin Database, and FASTA) showed that 2mEPSPS shares homology with other enzymes in the EPSPS family in different plants. However, no similarity with known allergens or toxins were recorded. Digestibility assays showed that 2mEPSPS was rapidly degraded within 0.5 minutes of incubation for both simulated human gastric fluid and simulated intestinal fluid. The heat stability study, on the other hand, indicated that the primary structure of 2mEPSPS remained stable across incubation at 4°C, 25°C, 37°C, 55°C, 75°C, and 95°C for 30 minutes. Only minor degradation was recorded starting at 55°C. Finally, acute oral gavage study demonstrated that there were no observed mortalities, treatment-related clinical signs, effect on body weight parameters, effect on food consumption, nor macroscopic changes at necropsy for mice treated with 2000 mg/kg body weight of 2mEPSPS.
Compositional analysis, in turn, showed that the levels of most proximates, key nutrients, and anti-nutrients in Cotton GHB614 are comparable to those in Coker 312, the non-GM cotton comparator. Some of the levels of the components of Cotton GHB614 deviate from literature values, but fall within the range of those observed in Coker 312. Therefore, there are no biologically relevant statistical differences in the composition of GHB614. Assessors agree that there is enough evidence to support the substantial equivalence of Cotton GHB614 with conventional cotton.
Accounting for these lines of evidence, the assessors concurred that the overall risk for Cotton GHB614 is negligible.
The assessors— after finding that there is enough evidence that the regulated article is as safe as its conventional counterpart and shall not pose any significant risk to human and animal health— recommended for the issuance of a biosafety permit for direct use as food and feed, or for processing, for Cotton GHB614.
The DENR-BC recommended that a specified environmental management plan (EMP) be accomplished by the importer(s) of the regulated article. Additionally, the DENR-BC and the DOH-BC recommended that a strict monitoring of the regulated article from the port of entry to the importers storage/warehouse be followed.
The scope of this application only covers the importation and use for food and feed, or for processing of Cotton GHB614 and its derived products in the Philippines. Therefore, propagation or planting of the regulated article shall not occur or be allowed to occur.
Cotton GHB614 can be detected via event-specific quantitative real-time quantitative PCR.
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| Record type | Field | Record(s) | |
|---|---|---|---|
| Country's Decision or any other Communication | Risk assessment | 1 | |
