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Risk Assessment
Record information and status
Record ID
116097
Status
Published
Date of creation
2021-06-11 01:16 UTC (lorelieu5@gmail.com)
Date of publication
2021-06-11 01:16 UTC (lorelieu5@gmail.com)

General Information
Country
  • Philippines
Title of risk assessment
Determination for the Safety Assessment of SOYBEAN 2704-12 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
ACS-GMØØ5-3 - Herbicide-tolerant soybean
Resistance to herbicides - Glufosinate
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
Soybean contains anti-nutrients. These include phytic acid, protease inhibitors, hemagglutinins, stachyose, raffinose and isoflavones.

It also accounts for 90% of IgEmediated food allergies. Those allergenic proteins (such as glycinin and conglycinin) are associated with storage, enzymatic and protective functions. Depending on the degree of purity, soy lecithin may also contain allergenic proteins.
Likelihood that the potential adverse effects will be realized
Processing soybeans through heat treatment can inactivate or eliminate the harmful effects of these anti-nutrients.
The rapid degradation of the PAT proteins by human simulated gastric and intestinal fluids shows that these proteins cannot survive in the digestive tract. Therefore, it could not be absorbed into the body under normal conditions.
Possible consequences:
Fatal allergic reactions, such as anaphylactic shock and death, though, are reportedly rare.

PAT protein may cause toxicological risk to human health.
Recommendation(s)
No allergenic in silico findings associated with the PAT/pat protein. The molecular weight of PAT is about 21 kDa, hence within the 10-70 kDa range.

Bioinformatics analyses using FASTA sequence alignment tool showed that no relevant structural similarities were observed between PAT and known protein allergens upon evaluation using BLOSUM50 scoring matrix and an E-value threshold of 10 (Capt, 2009). An 8-mer search was also provided identifying any short sequences of 8 amino acids or longer that share 100% identity to an allergenic protein. The search was performed using SeqMatchAll from the EMBOSS suite, which compared the query sequence with all known allergens present in the allergen database. Analyses showed that there was no observed similarity of PAT to any known allergen.

Find scientific evidence that SOYBEAN A-2704-12 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
Data indicate that the protein is extremely labile in the digestive tract suggesting minimal to no systemic exposure anticipated in food. Results do not suggest further test such as serum screening.

Receiving environment(s) considered
The application of SOYBEAN A-2704-12 is not for propagation. This LMO will be directly used for food, feed and for processing.

The chances of unintended release or planting of SOYBEAN A-2704-12 is very minimal and will not cause any damaging and lasting effects because the receiving environment (areas near the port, roads, railways, etc.) is not conducive for plant growth. Also, soybeans generally are very highly domesticated and does not survive well without human intervention.

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
SOYBEAN A-2704-12 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