Date of creation
2021-06-11 01:36 UTC (firstname.lastname@example.org)
Date of publication
2021-06-11 01:36 UTC (email@example.com)
Determination for the Safety Assessment of RICE GR2E for Direct Use
as Food, Feed and for Processing
Department of Agriculture
Elliptical Road, Diliman
IR-ØØGR2E-5 - Provitamin A biofortified rice
Changes in quality and/or metabolite content - Vitamins
Selectable marker genes and reporter genes
- LMOs for direct use as feed
- LMOs for direct use as food
- LMOs for processing
Pantoea ananatis, source of crtI gene, is found in a wide range of
natural environments. Strains of P. ananatis have been reported to
cause pathogenicity to plants and humans. History of safe use of P.
ananatis in association with food uses has not yet been
established. However, the crtI gene isolated from this organism is
not associated with pathogenicity or virulence of the donor
Due to the non-food source of the crtI gene, acute oral toxicity
testing of CRTI protein in mice was conducted as a further
assurance of safety and demonstrated a lack of any observable
adverse effects at a dose of 100 mg/kg body.
Pantoea ananatis was the source of the crtI gene. Although strains
of P. ananatis have been found to be pathogenic on a broad range of
plant hosts as well as humans, a recent analysis of the P. ananatis
genome to identify potential molecular determinants of its
underlying pathogenicity revealed the absence of many of the
factors that are central to the pathogenicity and virulence arsenal
of related plant and animal pathogens, including animal toxins,
hemolysins, phytotoxins, and their associated effectors.
Provitamin A Biofortified Rice Event GR2E is substantially
equivalent to the conventional counterpart in terms of nutritional
composition and food safety.
The chances of unintended release or planting of the regulated
article is very minimal and will not cause any damaging and lasting
effects to the environment.
All of the three proteins are expressed independently of each other
and the functional activities of each are maintained. Both ZmPSY1
and CRTI are expressed in the plastid while PMI is in the
cytoplasm. No interactions were found.
For the Provitamin A Biofortified Rice Event GR2E, enough evidence
was considered to support the substantial equivalence of the
genetically modified crop in terms of nutritional composition and
food safety, with the conventional rice other than the
biofortification with β-carotene.
Find scientific evidence that RICE GR2E 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
A biosafety permit for direct use can be issued for the said
Concerns had been included in the assessment such as the other
carotenoids found in GR2E rice, safety of β-carotene degradation
products, conversion of β-carotene to vitamin A, effect of
β-carotene supplementation to smokers and the effect of β-carotene
The application of RICE GR2E is not for propagation. This LMO will
be directly used for food, feed and for processing.
The direct use of RICE GR2E whether for food, feed and/or for
processing will not cause any significant adverse effect on the
environment (land, air, and water) and non-target organisms, to
1. The genetic stability in the transgenic crop is ensured both
under contained use and in previous multi-location confined testing
(conducted year 2015 and 2016) such that no unintended horizontal
gene transfer to unrelated species occurs;
2. The protein product produced by the transgenic crop will degrade
upon exposure to the natural environment and general conditions
(i.e. high temperature (60 degrees and above), varying pH, enzyme
digestion, etc.); and
3. The protein product will not increase the weediness potential
and will not confer selective advantage to the transgenic
The data submitted support the conclusion that RICE GR2E is a s
safe as its conventional counterpart.
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.
RICE GR2E is intended for direct use as food, feed and for
All relevant references were 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 were provided.