Date of creation
2021-02-19 07:21 UTC (firstname.lastname@example.org)
Date of publication
2021-02-19 07:21 UTC (email@example.com)
Determination for the Safety Assessment of Oilseed Rape (Canola)
MS11 for Direct Use as Food, Feed and for Processing
Department of Agriculture
Elliptical Road, Diliman
BCS-BNØ12-7 - Male Sterile/ Fertility Restored Herbicide Tolerant Canola
Changes in physiology and/or production - Reproduction - Male sterility
Resistance to herbicides - Glufosinate
- LMOs for direct use as feed
- LMOs for direct use as food
- LMOs for processing
Oilseed rape is also a source of a few anti-nutrients.
Glucsinolates, phenolic compounds like sinapine, phytic acid, and
tannins are considered anti-nutritional factors. However, these are
in very low amounts in current low erucic acid and low
glucosinolate rapeseed meal. Moreover, processing steps including
heat treatment eliminates or inactivates anti-nutritional factors.
Both the barnase and barstar genes were derived from Bacillus
amyloliquefaciens. Expression of the barnase gene in the anther
results in the absence of viable pollen and male sterility. Barstar
gene, on the other hand, encodes for the barstar protein, which is
a known inhibitor of the Barnase protein and was utilized in this
event to enhance the transformation frequency. Both genes are
non-allergenic and have no biologically relevant identities with
any toxic proteins from the Bayer's toxin database.
The bar gene, on the other hand, was isolated from Streptomyces
hygroscopicus, a common microbe in the soil. This gene encodes for
phosphinothricin acetyltransferase (PAT/bar) protein, which confers
tolerance to glufosinate ammonium. Bar and its homologues have no
record of being toxic or allergenic in humans or animals.
There are no in silico toxicological findings associated with the
PAT/bar protein from the toxin database. There was also an acute
oral gavage study for the PAT/bar protein which was done at a dose
level of 2000mg/kg body weight for 15 using 20 C57BL/6J, 10 females
and 10 males. No signs of systemic toxicity were noted.
Microbially-produced PAT/BAR protein and plant produced PAT/BAR
protein showed functional and structural equivalence.
An acute oral toxicity test with the Barnase protein was also done
at 2000 mg/kg body weight via the oral route. It did not produce
any signs of systemic toxicity in the male (10) and female (10)
C57BL/6J mice. Peptide mapping of the microbially-produced protein
demonstrated 100% coverage against the theoretical amino acid
sequence of the Barnase protein and was 100% identical to the amino
acid sequence predicted from the nucleotide sequence of the MS11
For MS11 canola, weight of evidence approach indicates the
substantial equivalence of the single event in terms of nutritional
composition and food safety, with the conventional canola other
than the tolerance to glufosinate-containing herbicides and male
The direct use of MS11 canola, whether for food, feed or for
processing will not cause any significant adverse effect on the
History of safe use is attributed on the host organism (Brassica
napus) and donor organisms (Bacillus amyloliquefaciens and
Streptomyces hygroscopicus) which is not known to be toxic or
allergenic to humans and animals. . The transgenic crop will not be
able to transfer its pollen grains to its wild relatives due to the
expression of Barnase-barstar system, which was due to the
insertion of the bar and barstar genes. Baxnase expression causes
the lack of viable pollen grains and male sterility in the
transgenic crop while barstar inhibits barnase expression causing
A biosafety permit for direct use can be issued for the said
Safety assessment based on the nutritional data is not applicable
since MS11 is male sterile. For MS11 canola, weight of
evidences approach indicates the substantial equivalence of the
single event in terms of nutritional composition and food safety,
with the conventional canola other than the tolerance to
glufosinate-containing herbicides and male sterility.
The application of oilseed rape/canola MS11 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.
Oilseed rape/canola MS11 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.