Philippines | BCH-RA-PH-116100 | Risk Assessment generated by a regulatory process | Biosafety Clearing-House

BCH-RA-PH-116100-1   |   PDF   |   Print   |  

Risk Assessment generated by a regulatory process (RA)

last updated: 11 Jun 2021
General Information
Determination for the Safety Assessment of RICE GR2E for Direct Use as Food, Feed and for Processing
Risk assessment details
  • IR-ØØGR2E-5 - Provitamin A biofortified rice
    | International Rice Research Institute | Changes in quality and/or metabolite content (Vitamins)
Methodology and points to consider
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 organism.

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 health.
A biosafety permit for direct use can be issued for the said event.
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 to alcoholics.
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 wit:
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 crop

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.
Additional information
RICE GR2E is intended for direct use as food, feed and for processing.

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.