Philippines | BCH-RA-PH-116099 | Risk Assessment generated by a regulatory process | Biosafety Clearing-House

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BCH-RA-PH-116099-1   |   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 Introduction into the Environment (Field Trial)
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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
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.
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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.
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Interbreeding or genetic exchange with its conventional counterpart or with other species found at or near the trial sites of planned release.
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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.

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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.
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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.

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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.

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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.
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