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Risk Assessment generated by an independent or non-regulatory process
(IRA)
last updated: 30 May 2019
CONSOLIDATED REPORT OF COTTON GHB119 FOR DIRECT USE AS FOOD AND FEED, OR FOR PROCESSING
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19 Nov 2018
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- Competent National Authority: | BCH-CNA-PH-46524-5 This document has been updated. This is not the latest published version. Click here to view the latest version of the record.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, -
Competent National Authority:Department of Environment and Natural Resources ()Visayas AvenueQuezon City,
1100, PhilippinesPhone: +632 925-2329, +632 920-4352,Fax: +632 920-4301,Email: osec@denr.gov.ph,Website: http://www.denr.gov.ph, http://www.pawb.gov.ph, -
Competent National Authority:Department of Health ()San Lazaro Compound, Sta. CruzManila,
, PhilippinesPhone: +632 651 7801; +623 651 7800,Fax: +632 743 1829,Email: etona@co.doh.gov.ph,Website: http://www.doh.gov.ph,
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Person:Ms. Ma. Lorelei U. AgbagalaSupervising Agriculturist, Post Entry QuarantineEconomic GardenLos Banos, Laguna
4030, PhilippinesPhone: +63 49 536 1678,Fax: +63 49 536 1678,Email: lorelieu5@gmail.com,Website: http://bpi.da.gov.ph,Related OrganizationBureau of Plant Industry (BPI)Government agency (National/Federal)Economic GardenLos Banos, Laguna
4030, PhilippinesPhone: +63 49 536 1678,Fax: +63 49 536 1678,Email: lorelieu5@gmail.com,Website: http://bpi.da.gov.ph,
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BCS-GHØØ5-8 - Herbicide-tolerant and lepidoptera-resistant cotton| Bayer BioScience N.V. | Changes in quality and/or metabolite content (Pigmentation / Coloration), Resistance to diseases and pests (Insects, Lepidoptera (butterflies and moths), Cotton bollworm (Helicoverpa spp.), Fall armyworm (Spodoptera frugiperda)), Resistance to herbicides (Glufosinate)
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The assessors confirmed that acute oral gavage is performed in mice with 2000 mg/kg body weight showing no mortalities, no-treatment related clinical signs, no effect on body weight parameters, no effect on food consumptions, no macroscopic changes at necropsy were observed in mice treated with Cry2Ae and PAT.
Furthermore, bioinformatics analysis indicated that Cry2Ae and PAT protein in GHB119 cotton has no homology to any known toxins and based on FASTA algorithm and BLOSUM50 scoring matrix.
Exposure potential of both proteins was also estimated. Cotton seed oil is the main dietary product obtained from cotton. The Cry2Ae and PAT is not detected in products derived from cotton event GHB119 seeds thus; the intake will be significantly lower.
In terms of the interaction among the two novel proteins, no likelihood of interaction among the novel proteins, Cry2Ae and PAT since they are expressed independently of each other and their mode of actions and metabolic pathways are different from one another.
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Furthermore, bioinformatics analysis indicated that Cry2Ae and PAT protein in GHB119 cotton has no homology to any known toxins and based on FASTA algorithm and BLOSUM50 scoring matrix.
Exposure potential of both proteins was also estimated. Cotton seed oil is the main dietary product obtained from cotton. The Cry2Ae and PAT is not detected in products derived from cotton event GHB119 seeds thus; the intake will be significantly lower.
In terms of the interaction among the two novel proteins, no likelihood of interaction among the novel proteins, Cry2Ae and PAT since they are expressed independently of each other and their mode of actions and metabolic pathways are different from one another.
The compositional equivalence of GHB119 to conventional cotton was assessed through comparison with commercial cotton varieties, and comparison with range of literature values of commercial cotton varieties.
Most of the promixates, key nutrients (minerals, vitamins, amino acids and fatty acids) and anti-nutrients levels in GHB119 seeds were not significantly different from non-transgenic cotton. Values obtained from GHB119 seeds were within the range of reported values from cotton literatures. This indicates that there is no statistical differences in the composition of GHB119 seeds that can be considered as biologically relevant.
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Most of the promixates, key nutrients (minerals, vitamins, amino acids and fatty acids) and anti-nutrients levels in GHB119 seeds were not significantly different from non-transgenic cotton. Values obtained from GHB119 seeds were within the range of reported values from cotton literatures. This indicates that there is no statistical differences in the composition of GHB119 seeds that can be considered as biologically relevant.
The regulated article applied for direct use as food and feed or processing is safe as its conventional counterpart and is not expected to pose any significant risk to human and animal health and environment.
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DENR Recommendations:
1. The effect of the regulated article on the environment depends largely on the viability of the product to be utilized for direct use. lf the article is transported in a non-viable form, there is no danger to the environment;
2. Due to the absence of a specified Environmental Management Plan (EMP) by the traders/importers, the Committee would like to recommend that it be added to the requirements for the issuance of an import permit by the Bureau of Plant Industry (BPI) (Article VIII, Section 26 of JDC No,1 s.2016);
3. It is suggested that BPI ensure the following:
a) Development of guidelines on the EMP in coordination with DENR;
b) implementation of the EMP by the traders/importers involved in the import, handling, processing and transport of viable COTTON GHB 119 commodity products; and
c) Strict monitoring of the regulated article from port of entry to the trader's/importer's storage/warehouse (Section 32 of the JDC No. 1 s.2016).
DOH Recommendations:
1. Find that the regulated article applied for Direct Use for Food, Feed and for Processing does not require changes in the usual practices in unloading, and loading, hauling, transport and storage and processing. As such, the regulated article is as safe as its conventional counterpart and is not expected to pose any
significant risk to human and animal health and environment while in transit, storage and processing;
2. Scientific pieces of evidences from provided references i.e., literatures show that Regulated article applied for Direct Use for Food, Feed and or for Processing (FFP) is as safe as its conventional counterpart and shall not pose any significant risk to human and animal health and on the environment.
3. It is suggested that the Bureau of Plant Industry (BPI) ensure the following:
a. Strict monitoring of the regulated article from port of entry to the trader’s/ importers storage/warehouse as stated in Section 32 of the JDC No. 1 series, 2016.
b. The BPI to include in the issuance of permit for the release of this product the following conditions:
b. 1. Any spillage (during unloading and loading/hauling and transport unloading and storage) shall be collected and cleaned up immediately.
b. 2. Transportation of the consignment from the port of entry to any destination within the country shall be in closed containers.
b. 3. There shall be a clear labeling of the product from importation down to all levels of marketing stating that it is only for the purpose of direct use as food and feed or processing and is not to be used as planting
materials.
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1. The effect of the regulated article on the environment depends largely on the viability of the product to be utilized for direct use. lf the article is transported in a non-viable form, there is no danger to the environment;
2. Due to the absence of a specified Environmental Management Plan (EMP) by the traders/importers, the Committee would like to recommend that it be added to the requirements for the issuance of an import permit by the Bureau of Plant Industry (BPI) (Article VIII, Section 26 of JDC No,1 s.2016);
3. It is suggested that BPI ensure the following:
a) Development of guidelines on the EMP in coordination with DENR;
b) implementation of the EMP by the traders/importers involved in the import, handling, processing and transport of viable COTTON GHB 119 commodity products; and
c) Strict monitoring of the regulated article from port of entry to the trader's/importer's storage/warehouse (Section 32 of the JDC No. 1 s.2016).
DOH Recommendations:
1. Find that the regulated article applied for Direct Use for Food, Feed and for Processing does not require changes in the usual practices in unloading, and loading, hauling, transport and storage and processing. As such, the regulated article is as safe as its conventional counterpart and is not expected to pose any
significant risk to human and animal health and environment while in transit, storage and processing;
2. Scientific pieces of evidences from provided references i.e., literatures show that Regulated article applied for Direct Use for Food, Feed and or for Processing (FFP) is as safe as its conventional counterpart and shall not pose any significant risk to human and animal health and on the environment.
3. It is suggested that the Bureau of Plant Industry (BPI) ensure the following:
a. Strict monitoring of the regulated article from port of entry to the trader’s/ importers storage/warehouse as stated in Section 32 of the JDC No. 1 series, 2016.
b. The BPI to include in the issuance of permit for the release of this product the following conditions:
b. 1. Any spillage (during unloading and loading/hauling and transport unloading and storage) shall be collected and cleaned up immediately.
b. 2. Transportation of the consignment from the port of entry to any destination within the country shall be in closed containers.
b. 3. There shall be a clear labeling of the product from importation down to all levels of marketing stating that it is only for the purpose of direct use as food and feed or processing and is not to be used as planting
materials.
Cotton GHB119 is found to be as safe as its conventional counterpart and does not pose any significant risk to human and animal health.
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This application is not for propagation of the Cotton GHB119. This LMO will be directly used for food, feed and for processing.
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Quantitative diagnostic lateral flow strips, ELISA and PCR for routine quantitative and semi-quantitative detection of transgenes. For higher sensitivity, real-time PCR may be used.
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Cotton GHB119 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, BAI, PPSSD, DENR, DOH and SEC Expert during the evaluation of this event.
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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, BAI, PPSSD, DENR, DOH and SEC Expert during the evaluation of this event.
- ISAAA [ English ]
