Philippines | BCH-RA-PH-115901 | Risk Assessment generated by a regulatory process | Biosafety Clearing-House


Risk Assessment generated by a regulatory process (RA)

last updated: 19 Feb 2021
General information
Determination for the Safety Assessment of Soybean SYHTOH2 for Direct Use as Food, Feed and for Processing
  • - Competent National Authority: BCH-CNA-PH-46524-5 | BCH-CNA-PH-46524-5
    Competent National Authority
    Department of Agriculture ()
    Elliptical Road, Diliman
    Quezon City,
    1100, Philippines
    Phone: +632 920-3986, +632 924-1278 local 2802,
    Fax: +632 920-3986,
Risk assessment details
  • SYN-ØØØH2-5 - Soy modified for tolerance to Mesotrione and Glufosinate
    | Bayer CropScience LP | Resistance to herbicides (Glufosinate), Resistance to Mesotrione
Methodology and points to consider
The antinutrients present in soybean such as trypsin inhibitors and lectins, stachyrose, raffinose oligosaccharides and phytic acids are degraded during processing. 
Soybean contains recognized allergenic proteins, but the relevant estimate of its allergenic potential is not complete. No significant level of amino acid homology exists between the PAT gene and any protein allergens.
Southern blot analysis and nucleotide sequencing were done for the extensive characterization of the DNA inserted in SYHT0H2 soybean. In addition, the soybean genome sequence flanking the SYHT0H2 inserted were identified and characterized. Results showed that the SYHT0H2 inserted did not disrupt the function of any known soybean gene. These data collectively demonstrate that no deleterious changes occurred in the SYHT0H2 soybean genome as a result of the DNA insertion.

The PAT regulatory enzymes are reportedly not associated with food toxins and allergens backed up by the absence of a sequence homology with known allergens or toxins.

The enzyme AvHPPD expressed by avhppd-03 gene confers tolerance to commercial application rates of HPPD-inhibiting herbicides such as mesotrione. It is not known to be homologous to known toxin or allergen as supported by analyses provided by developer. PAT expressed by pat-09 genes is an enzyme involved in the inactivation of glufosinate ammonium through acetylation. History of safe use was attributed to PAT proteins which are not associated with any known toxins or allergens. The developer provided sufficient information that there is no possibility of any interaction of AvHPPD and PAT in a metabolic pathway.
No safety concerns for the environment from the import and processing of soybean SYHT0H2 were identified. The safety assessment identified no concerns regarding the potential toxicity and allergenicity of the newly expressed proteins and found no evidence that the genetic modification might significantly change the overall allergenicity of soybean SYHT0H2.
No unintended, adverse consequences of the transformation process or expression of the transgenes in SYHT0H2 were evident that will affect human health and no possible risk in animal health. A biosafety permit for direct use can be issued for the said event.
The protein used in the assessment of toxicity was microbially produced AvHPPD-03 from Eschericia coli and is reportedly non-toxic to mice as evidenced by the absence of mortality during two and 14-day observation. Sufficient data and analyses were provided by the developer indicating that the microbially produced AvHPPD-03 is biochemically and functionally equivalent to AvHPPD-03 produced in SYHT0H2 soybean and therefore is a suitable surrogate to evaluate the safety of AvHPPD-03 produced in SYHT0H2 soybean.
Safety evaluation supports the innocuousness of the PAT gene which does not possess characteristics of a toxin or allergen, no N-glycosylation sites, easily degraded by gastric and intestinal fluids and devoid of adverse effects in mice after IV injection of a high dose. Utilizing the NCBI Entrez Protein Database in search of the similarity of the PAT amino acid sequences shows that it has no homologies with known toxins.

Acute Oral Gavage tests were performed, and reasonable certainty of safety is expected from the inclusion of PAT proteins in human food and animal feed. 
The application of soybean SYHT0H2   is not for propagation. This LMO will be directly used for food, feed and for processing.
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.
Information sharing with other databases
Additional Information
SOYBEAN SYHT0H2 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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