Date of creation
2021-02-19 08:07 UTC (firstname.lastname@example.org)
Date of publication
2021-02-19 08:07 UTC (email@example.com)
Determination for the Safety Assessment of Soybean SYHTOH2 for
Direct Use as Food, Feed and for Processing
Department of Agriculture
Elliptical Road, Diliman
SYN-ØØØH2-5 - Soy modified for tolerance to Mesotrione and Glufosinate
Resistance to herbicides - Glufosinate
- LMOs for direct use as feed
- LMOs for direct use as food
- LMOs for processing
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
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
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.
SOYBEAN SYHT0H2 is intended for direct use as food, feed and for
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.