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Risk Assessment generated by a regulatory process (RA)
last updated: 11 Jun 2021
Determination for the Safety Assessment of SOYBEAN 2704-12 for Direct Use as Food, Feed and for Processing
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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,
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ACS-GMØØ5-3 - Herbicide-tolerant soybean| Bayer CropScience | Resistance to herbicides (Glufosinate)
- http://biotech.da.gov.ph/ [ English ]
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.
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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.
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.
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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.
Fatal allergic reactions, such as anaphylactic shock and death, though, are reportedly rare.
PAT protein may cause toxicological risk to human health.
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PAT protein may cause toxicological risk to human health.
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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.
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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.
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.
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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.
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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.
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.
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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.
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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 during the evaluation of this combined trait product.
- http://biotech.da.gov.ph/ [ English ]
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