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Risk Assessment
Record information and status
Record ID
114763
Status
Published
Date of creation
2019-05-30 03:44 UTC (estaciojulietafe@gmail.com)
Date of publication
2019-05-30 03:44 UTC (estaciojulietafe@gmail.com)

General Information
Country
  • Philippines
Title of risk assessment
Determination of the Safety of BASF's Cotton GHB614 for Direct use as Food, Feed, or Processing
Date of the risk assessment
2018-10-22
Institution responsible for the risk assessment
Department of Agriculture
Elliptical Road, Diliman
Quezon City
Philippines, 1100
Phone:+632 920-3986,+632 924-1278 local 2802
Fax:+632 920-3986
Email:osec.da@gmail.com
Url:DA
Department of Environment and Natural Resources
Visayas Avenue
Quezon City
Philippines, 1100
Phone:+632 925-2329, +632 920-4352
Fax:+632 920-4301
Email:osec@denr.gov.ph
Url:DENR,PAWB
Department of Health
San Lazaro Compound, Sta. Cruz
Manila
Philippines
Phone:+632 651 7801; +623 651 7800
Fax:+632 743 1829
Email:etona@co.doh.gov.ph
Url:DOH Website
Contact details of the main responsible risk assessor
Ms. Ma. Lorelei U. Agbagala
Supervising Agriculturist
Post Entry Quarantine
Bureau of Plant Industry (BPI)
Economic Garden
Los Banos, Laguna
Philippines, 4030
Phone:+63 49 536 1678
Fax:+63 49 536 1678
Email:lorelieu5@gmail.com
Url:Bureau of Plant Industry
Risk assessment details
Living modified organism
BCS-GHØØ2-5 - GlyTol™ Cotton GHB614
Bayer CropScience Resistance to herbicides - Glyphosate
Show detection method(s)
Scope of the risk assessment
  • LMOs for direct use as feed
  • LMOs for direct use as food
  • LMOs for processing
Methodology and points to consider
Likelihood that the potential adverse effects will be realized
Safety assessments conducted on GHB614 cotton demonstrate no potential effects on human and animal health and the environment. Findings from a comprehensive safety assessment of GHB614 demonstrate that the host cottonseed products are safely consumed by humans and animals, the 2mepsps gene is expected to present negligible safety concerns, the 2mEPSPS protein is deemed to be as safe as the wild type EPSPS proteins, and a reasonable certainty of no harm can be derived on GHB614 when compared to its parental line Coker 312. The 2mEPSPS protein does not possess properties that contribute to its toxic and allergenic potentials (e.g. no sequence homology to known toxins and allergens; rapid degradation in simulated gastric and intestinal fluids; no alteration in the N-glycosylation status; and no harm to animals when administered orally at a high dose). The wild type epsps gene is derived from Zea mays, a crop widely consumed as food and feed with no known pathogenic, toxic, or allergenic effects. The endogenous EPSPS proteins are ubiquitous in nature, and have been consumed safely for a long period of human history.
Possible consequences:
Statistical significant differences were detected for a number of fatty acids, amongst them the anti-nutritional cyclopropenoid fatty acids.  The statistical findings have no nutritional relevance since the absolute differences in the fatty acid contents are minimal, the amounts of cyclopropenoid fatty acid are lower in the transgenic samples, and all mean values are inside the reference ranges reported from literature.
Estimation of the overall risk
Cotton GHB614 is found substantially equivalent to conventional counterpart and does not pose any significant risk to animal and human health.
Recommendation(s)
Based on the results of the risk evaluation of the submitted scientific data and other information relevant to the application of BASF Philippines Inc., it is concluded that cotton GHB614, and all progenies derived from crosses of the product with any conventionally-bred cotton, and cotton containing approved-biotech events for direct use as food, feed or for processing,  is as safe and substantially equivalent to its unmodified counterpart, and is therefore approved for direct use as food, feed or for processing
Need(s) for further information on specific issues of concern
Cotton GHB614 is found substantially equivalent to conventional counterpart and does not pose any significant risk to animal and human health.
Receiving environment(s) considered
This application is not for propagation of the Cotton GHB614. This LMO will be directly used for food, feed and for processing.
LMO detection and identification methods proposed
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.
Additional Information
Additional Information
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.
Other relevant website address or attached documents