Date of creation
2021-02-18 07:53 UTC (email@example.com)
Date of publication
2021-02-18 07:53 UTC (firstname.lastname@example.org)
Determination for the Safety Assessment of Corn DAS 40278-9 for
Direct Use as Food, Feed and for Processing
Department of Agriculture
Elliptical Road, Diliman
DAS-4Ø278-9 - Enlist™ Maize
Dow AgroSciences GmbH
Resistance to herbicides
Tolerance to 2,4-Dichlorophenoxyacetic acid
Tolerance to aryloxyphenoxypropionate Show detection method(s)
- LMOs for direct use as feed
- LMOs for direct use as food
- LMOs for processing
Corn is not known to be a toxicant, except for improperly stored
grain that can be infested by insects and toxin-producing molds.
Corn grain is not a source of allergen. However, the pollen of the
corn plant is known to be allergenic to hypersensitive individuals.
The potential pollen allergens known are Zea m1 and Clone C13. The
pollen specific cDNAs of these are similar to those found in rye
(Lol P1 sequence) and olives (ole e1). Pollen is shed at specific
time points in the growing season. Since the subject of this
application is corn grain, then pollen is not expected to be
included in the importation.
The transgene insert in DAS-40278-9 corn occurred as a single
integration of a single intact copy of aad-1 expression cassette
from plasmid pDAS 1740. The insert is stably integrated and
inherited across and within the breeding generations. No plasmid
backbone sequences are present in DAS-40278-9 corn. here was no
indication of truncations in the Southern blots. The number and
expected sizes of the specific hybridizing bands were consistently
observed were consistently observed. There was also no indication
of deletions in the Southern blots.
Southern blot analyses were conducted with five (5) distinct
generations (T3, T4, BC3S3, and BC3S2) of DAS-40278-9 corn. Results
across all DAS-40278-9 corn samples indicated stable inheritance of
the intact single copy insert across multiple generations of
DAS040278-9 corn. Segregation in T1, T2, BC1, BC2 BC3 and BC3S1 of
DAS-40278- 9 corn were performed on leaf tissues through Southern
blotting and immunoassay for the expressed AAD-1. The typical
Mendelian inheritance ratio of 3:1 was observed. From the BC3S1
line for example, 65 tested positive for AAD-1 protein expression
and 20 were null segregants. The aad-1 probe hybridized to each of
the 65 plants that tested positive for AAD-1. The 20 null
segregants did not show this hybridization band, indicating the
absence or non-inheritance of the inserted aad-1.
Corn DAS 40278-9 applied for Direct Use for food, feed and/or for
processing will not cause any significant adverse effect on both
humans and animals and the environment, including non-target
For the transgenic DAS-40278-9 corn, enough evidence is provided to
support the equivalence of the genetically modified crop, in terms
of the nutritional composition and food safety, with the
conventional corn other than tolerance to 2,4-dichlorophenoxyacetic
acid (2,4-D) and aryloxyphenoxypropionate (AOPP) acetyl coenzyme A
carboxylase (ACCase) inhibitors ("fop" herbicides. A biosafety
permit for direct use can be issued for the said event.
The digestibility of AAD-1 protein was tested in vitro using
simulated gastric fluid (SGF). Samples were analyzed via SDS-PAGE
and Western blot. The results demonstrated that AAD-1 protein was
readily digested or inactivated (not detected at 30 seconds in
SGF). Heat inactivation tests were also done, the lowest
temperature used was 50oC for 30 min. These conditions already
inactivated 97 % of the enzyme activity. The common cooking
conditions applied to corn processing covers this and with the
average field expression level of the AAD-1 present at 4.81 ng/mg
tissue, processed products from DAS-40278-9 corn can be expected to
be inactivated. Human consumption of raw corn is not the norm.
The application of corn DAS40278-9 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.
Corn DAS40278-9 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.