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Country's Decision or any other Communication (DEC)
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BCH-DEC-PH-279603-1   |   PDF   |   Print   |  
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last updated: 04 Jul 2025
Amendment
No
General Information
Decision for the Safety Assessment of RICE GR2E for Introduction into the Environment (Field Trial)
EN
20 May 2019
No
Subject of the decision, notification, communication or declaration
  • Decision on LMOs for intentional introduction into the environment (according to Article 10 or domestic regulatory framework)
LMOs for intentional introduction into the environment
No
Yes
Yes
No
Yes
Result of the decision
Approval of the import and/or use of the LMO(s) with conditions
1. The proponent shall submit to the BPI the duly accomplished Oath of Undertaking before commencing with the field trial (The Oath of Undertaking shall contain the objectives of the field test); 
2. The proponent has the option to consult with the National Seed Industry Council (NSIC) regarding Rice National Cooperative Testing if there is an intention to register the variety; 
3. The proponent shall submit to the BPI and inform the designated monitors of the detailed schedule of planting, planting plan, cultural management practices, monitoring activities and pest damage assessment;
4. The proponent shall adhere as closely as possible to the planting schedules for these sites. Modification in the planting schedule and other activities could be made only with the concurrence of BPI; 
5. The proponent shall strictly observe the 100m physical isolation and/or 30-day temporal isolation at all times, from rice fields outside the enclosed experimental area; regular monitoring/inspection of the surrounding 100m radius isolation shall be done; 
6. The proponent shall ensure that three (3) rows of corn plants will be grown around the site to further prevent pollen dispersal; 
7. The proponent shall ensure the security of the experiment, and safety of the field workers and the monitors;
8. The proponent shall ensure that the workers and monitors have access to health facilities as the need arises;
9. The proponent shall be held accountable/responsible for any inadvertent release of the regulated plant material into the surrounding environment and shall undertake the necessary mitigating measures to address the incident;
10. The proponent shall ensure that only authorized persons are allowed inside the trial sites; 
11. The proponent shall ensure that access to the site is limited. Visitors, staff and personnel are strictly monitored (physically search) during the maturity of the grain; 
12. The proponent shall ensure that stray animals, birds and rodents are excluded from the trial sites while tests are being conducted;
13. The proponent shall ensure that all materials saved for other studies are well accounted for; 
14. Immediately after harvest, the proponent shall ensure that all viable plant parts are heat killed (incineration is not allowed) and the emerged seedlings will be uprooted, chopped and buried at a designated spot in the site;
15. Immediately after harvest, the proponent shall ensure that the area shall be flooded after which volunteer plants will be monitored; 
16. The proponent shall ensure that the area may be re-used for the second season planting only if no volunteer plants are observed after successive ten (10) day monitoring interval; 
17. The permit holder shall notify the Director of BPI, within the time periods and in the manner specified below, in case of any of the following occurrences:
a. Immediately upon discovery, not exceeding twenty-four (24) hours, through verifiable means of communication (email, text message, etc.), in the event that new information becomes available indicating that the regulated article could pose greater risks to biodiversity, human and animal health than its conventional counterpart; 
b. In writing, as soon as possible, but not to exceed three (3) working days, if the regulated article or associated host organism is found to have characteristics substantially different from those listed in the application, or suffers from any unusual occurrence (e.g., excessive mortality or morbidity, unanticipated effect on non-target organisms); 
18. The proponent shall strictly comply with the additional requirements that the BPI may impose, as necessary, during the trial period; 
19. The proponent shall strictly adhere to the provisions of DA MC No. 02 Series of 2000 t. "Guidelines on the conduct of field test of plants derived from modem biotechnology"; and
20. The proponent shall comply with the reportorial requirements as discussed in Section 38 Item A and B of the DOST-DA-DENR-DOH-DILG Joint Department Circular No. 1 series of 2016.    
EN
The permit is valid for a period of two (2) years from the time of issuance subject to extension as maybe necessary to complete the field trial, unless sooner revoked for any of the reasons set forth in Article V Section 11 Item L of the DOST-DA-DENR-DOH-DILG Joint Department Circular No. 1 series of 2016.
EN
Information sharing with other databases
Yes
Yes
Yes
Yes
Yes
LMO identification & risk assessment
  • BCH-LMO-SCBD-112997-1 Living Modified Organism IR-ØØGR2E-5 - Provitamin A biofortified rice
    International Rice Research Institute | Changes in quality and/or metabolite content (Vitamins)
  • BCH-RA-PH-116099-2 Risk Assessment generated by a regulatory process Determination for the Safety Assessment of RICE GR2E for Introduction into the Environment (Field Trial)
    IR-ØØGR2E-5 - Provitamin A biofortified rice | Changes in quality and/or metabolite content
Document on the decision, communication, notification or declaration
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. 
EN
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