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Risk Assessment
Record information and status
Record ID
Date of creation
2021-06-11 01:19 UTC (lorelieu5@gmail.com)
Date of publication
2021-06-11 01:19 UTC (lorelieu5@gmail.com)

General Information
  • Philippines
Title of risk assessment
Determination for the Safety Assessment of RICE GR2E for Introduction into the Environment (Field Trial)
Date of the risk assessment
Date not available
Competent National Authority(ies) responsible for the risk assessment
Department of Agriculture
Elliptical Road, Diliman
Quezon City
Philippines, 1100
Phone:+632 920-3986,+632 924-1278 local 2802
Fax:+632 920-3986
Risk assessment details
Living modified organism
IR-ØØGR2E-5 - Provitamin A biofortified rice
Changes in quality and/or metabolite content - Vitamins Mannose tolerance Selectable marker genes and reporter genes
Scope of the risk assessment
Risk assessment report / Summary
Methodology and points to consider
Potential adverse effects identified in the risk assessment
Possibility for the seeds to be dispersed through seed shatter. Dormancy will be influenced by ecotype and is reinforced by rainy weather. Furthermore, insects/animals can also assist in seed dispersal.
Likelihood that the potential adverse effects will be realized
To mitigate the potential for any seed dispersal via foraging rodents or other animals, the proponent will erect an animal barrier surrounding the trial.  In addition, to prevent the possibility of any seed dispersal via water movement, water will be retained within the testing site using a levee that will surround the test plots and the overall test site.  Since cultivated rice dormancy is generally quite short, volunteers can be identified and destroyed during the period of post-harvest monitoring.
Possible consequences:
Interbreeding or genetic exchange with its conventional counterpart or with other species found at or near the trial sites of planned release.
Find scientific evidence that the novel proteins (ZmPSY1, CRT1, and PMI) that are expressed in the GR2E grains do not display significant amino acid sequence similarity with known allergens nor were there any primary sequence structural alerts for potential toxicity based on similar searches against existing databases of known and putative protein toxins. The beta-carotene that is expressed in GR2E is metabolized into vitamin A as needed by the organism and excess amounts resulting from the consumption of beta-carotene rich foods are easily flushed out of the body in the feces, urine and sweat.

RICE GR2E applied for field trial is safe to the environment and biodiversity. The potential impacts to the environment during the site preparation, planting, data gathering, harvesting, and monitoring could be handled, as indicated in the material management plan as part of the Environmental Management Plan

A biosafety permit for field trial can be issued for the said event.

Need(s) for further information on specific issues of concern
There is concern on the increase in the amount of beta-carotene produced by GR2E in time as compared to its conventional counterpart and how the GM rice will require changes in farm management to attain higher productivity.
Receiving environment(s) considered
The field trial of RICE GR2E will not cause any significant adverse effect on the environment (land and water) and biodiversity. The transgenic crop will not increase its weediness potential because the genetic modification resulting in the event GR2E is not intended to alter the reproductive biology of rice, with its seed germination rate, and pollen-mediated gene flow.

LMO detection and identification methods proposed
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
Additional Information
RICE GR2E is intended for field trial.

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.
Other relevant website address or attached documents