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Risk Assessment
Record information and status
Record ID
116098
Status
Published
Date of creation
2021-06-11 01:18 UTC (lorelieu5@gmail.com)
Date of publication
2021-06-11 01:18 UTC (lorelieu5@gmail.com)

General Information
Country
  • Philippines
Title of risk assessment
Determination for the Safety Assessment of COTTON COT102 for Direct Use as Food, Feed and for Processing
Date of the risk assessment
Date not available
Competent National Authority(ies) 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
Risk assessment details
Living modified organism
SYN-IR1Ø2-7 - VIPCOT™ Cotton
Resistance to antibiotics - Hygromycin Resistance to diseases and pests - Insects - Lepidoptera (butterflies and moths) Selectable marker genes and reporter genes
Show detection method(s)
Scope of the risk assessment
  • LMOs for direct use as feed
  • LMOs for direct use as food
  • LMOs for processing
Risk assessment report / Summary
Methodology and points to consider
Potential adverse effects identified in the risk assessment
Certain fatty acid forms like sterculic, malvalic and dihydrosterculic acids are found in cotton. These are classified as anti-nutrients.

Gossypol is a toxic substance in cottonseed and its by-product meal.
Likelihood that the potential adverse effects will be realized
Using BLASTP program, the vip3Aa19 protein was compared to sequences in two databases (NCBI) and Syngenta Toxin Database. The comparison would determine its significant similarity to known and putative toxins. Results confirm that vip3Aa19 is not a toxic protein to humans or other mammals, nor does vip3Aa19 share significant sequence similarity with other known or putative protein toxins.
Possible consequences:
A comparison of APH4 protein to sequences in two databases was performed using the Basic Local Alignment Search Tool (BLASTP) program. Results from both database comparisons confirm that APH4 is not a toxic protein, and an acute oral gavage was done using a mouse oral toxicity study. A single gavage dose of APH-0102 test material at 1,828mg/kg BW was administered to male and female mouse. This amounted to 779mg APH4 protein/kg BW. No mortalities occurred during the study. No clinical signs of toxicity were observed in both test and control groups.
Recommendation(s)
A comparison of the Vip3Aa19 protein to sequences in a database was performed using the Basic Local Alignment Search Tool for Proteins (BLASTP) program. The comparisons were used to determine whether the Vip3Aa19 protein (Vip3Aa19) amino acid sequence showed significant similarity to known and putative toxins. The protein Vip3Aa19 is 99.9% identical in amino acid sequence to the native Vip3Aa1 protein identified in Bacillus thuringiensis strain AB88.

Based on the submitted results of proximate analysis done in 2001 (Moisture, Fat, Protein, Crude Fiber and Ash) and in 2002 (Moisture, Fat, Protein, Total Dietary Fiber, Acid Detergent Fiber, Neutral Detergent Fiber, Ash, and Carbohydrates), there were no statistical differences between the COT 102 and Coker 312 (non-transgenic comparator).

The submitted data indicated that COTTON COT102 applied for human food and animal feed use is as safe as its conventional counterpart and shall not pose any significant risk to human and animal health.
A biosafety permit for direct use can be issued for the said event.
Need(s) for further information on specific issues of concern
Based on the statistical analyses, there were no statistical differences between gossypol, sterculic acid, malvalic acid and dihydrosterculic acid content of COT102 cotton and non- transgenic cotton that can be considered biologically relevant.
Receiving environment(s) considered
The application of COTTON COT102 is not for propagation. This LMO will be directly used for food, feed and for processing.

The regulated article is considered as safe for direct use as food, feed or for processing and is less likely to pose a threat to the environment, particularly on biodiversity and non-target organisms. The genetically modified crop is substantially similar to its conventional counterpart except for the novel insect resistance trait.
LMO detection and identification methods proposed
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.
Additional Information
Additional Information
COTTON COT102 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.

Other relevant website address or attached documents