Dr. Antonio A. Alfonso

To conduct proper breeding trials under field conditions allowing for the selection of agronomically desirable and highly adoptable plants/lines of pro-vitamin A enriched 'Golden Rice' Event GR2-E PSB Rc82.

To produce the grains and other plant materials that will be used for the event-specific biosafety tests required by the regulators to complete the FFP biosafety data dossier for event GR2-E in the Philippines.

The site is within experimental stations that are under total control of PhilRice

Access to the site will be for a limited number of personnel and for DOST-BC approved visitors. Only one entry point will be provided and be locked at all times. Movement of people within the sites will be restricted and only authorized personnel will be allowed to enter. A log book will be maintained to record the entry of any person.

Plant material movements will strictly follow the relevant biosafety and phytosanitary requirements of the Philippine Government.

Temporal and spatial isolations and physical barriers will be used to prevent integration of the introduced plant in the local environment.

Any unplanned activity will be monitored and reported. There will be a log book and other monitoring systems. Accidental release will be taken care by cleaning the site of accidental release. A thorough investigation of accidental release will be conducted to prevent similar incident from happening in the future. In the extreme case that an accident arises in the field site, all plant materials in the experimental plots will be ploughed back in the soil. Any case of sabotage will be immediately reported to the appropriate authorities.

After harvest, all rice straws/stubbles will be ploughed back in the soil. The trial site will be left fallow for 30-45 days after harvest and volunteer plants will also be ploughed.

a) Before commencing with the activities, the DOST-BC and the Post Entry Quarantine Station, Bureau of Plant Industry (PEQS-BPI) shall inspect and approve the proposed site for the confined test (CT) located at Philippine Rice Research Institute, Brgy. Maligaya, Science City of Munoz, Nueva Ecija.

b) Prior to the initiation of the activities, the proponent/s shall discuss the monitoring schedule with the DOST-BC and the PEQS-BPI to identify the activities that will require their presence. The proponent/s shall furnish the DOST-BC and the PEQS-BPI with a copy of the agreed monitoring schedule.

c) The DOST-BC approved Project Information Sheet (PIS) shall be posted for three (3) consecutive weeks in at least three (3) conspicuous places in the barangay and/or City/Municipal halls where the proposed activities will be conducted. The PIS should be posted at least fifteen (15) days before the actual transplanting of seeded transgenic rice in the confined test site. Proof of posting of the PIS, which may either be a certification from the duly authorized Barangay leader(s) or an affidavit executed by the Proponent, should be submitted to the DOST-BC within ten (10) days from the last day of posting.

d) The proponent shall adhere as closely as possible to the schedule of implementation and monitoring activities for this activity.

e) Modifications in the planting schedule and other activities may be made only with the concurrence of the IBC and DOST-BC.

f) At least 150 meters physical or temporal reproductive isolation of the GMO shall be observed at all times.

g) All confinement measures should be in place before the actual transplanting of rice seedlings.

h) The proponent shall ensure that only authorized personnel are allowed inside the test site.

i) The DOST-BC and the PEQS-BPI shall be informed in advance of any visitations by unauthorized personnel.

j) The DOST-BC and the PEQS-BPI shall be informed immediately of any intrusion by unauthorized persons.

k) The proponent shall ensure that rodent control measures are in place and that stray animals are excluded from the test site while trials are being conducted.

l) The proponent shall ensure the security of the trial, the field workers and the monitors.

m) In case of undue destruction of the experimental materials resulting from unauthorized entry of personnel or breach of containment of the Confined test facility, the proponent should implement measures to prevent the inadvertent escape of any viable material within the site.

n) The proponent and the supervising IBC shall be held accountable for the undue destruction of the experimental materials and the consequences that its inadvertent escape may cause to the surrounding environment.

o) The rice grains or any plant part shall not be eaten or fed to humans, wildlife and livestock.

p) The proponent shall provide a space within the test site for disposal of the used plant materials.

q) The harvested grains shall be properly labeled and stored at the designated Seed Storage Facility where transgenic seeds are kept, while plant materials and other plant debris used within the test site should be buried in a pit within the test site or plowed under.

r) The proponent shall leave the test site fallow for at least 30 days. During the fallow period, the proponent shall strictly monitor emergence of volunteer plants and plant pests/diseases within the site for two (2) consecutive weeks after harvest. Furthermore, the proponent shall coordinate with the PEQS-BPI personnel during this period for the monitoring of the fallow site. If necessary, the proponent may irrigate the test site to induce germination of seeds. Any volunteer plants that will emerge, or any ratoon residues shall be uprooted and disposed either by plowing under or by burying in the pit intended for transgenic plant biomass from this confined field test.

s) The proponent shall comply with additional requirements that the DOST-BC may impose, as necessary, during the experiment period.

t) The proponent shall submit through the IBC a completion report ninety (90) days after the official completion of the experiment which shall be determined by the PEQS-BPI monitors after completion of all post-harvest monitoring of volunteers.

u) The IBC shall report on all its monitoring activities upon completion of this project.

Vitamin A deficiency (VAD) is a major nutritional problem affecting millions of people particularly children and women in the developing world. Rice is the major staple food crop for more than half of the world's populations but is a poor supplier of essential micronutrients and does not contain any beta-carotene, a source of vitamin A. Dependence on rice as the predominant food source, therefore, necessarily leads to VAD, most severely affecting children and pregnant women.

Golden Rice is a new type of rice that contains beta-carotene. Leading nutrition and agricultural research organizations are working together to evaluate Golden Rice as a potential tool to reduce VAD in the Philippines and in other rice-consuming countries.

In 2009, the Golden Rice Humanitarian Board selected one of the Golden rice events in development, GR2-R, as the lead Golden rice event that will be advanced into the Philippine biosafety regulatory approvals. The Board also selected GR2-E as a back-up event just in case a problem in the development process of the lead event is encountered.

In 2010, DOST-BC granted IRRI the Certificate of Completion of a Confined Test for GR2-R allowing IRRI and PhilRice to submit an application to DA-BPI for a multi-location field trial (MLT) for GR2-R. The application was granted in February 2012 and three seasons of MLTs were conducted in 2012-2013 to assess the agronomic performance of the GR2-R lines and produce the plant materials needed to complete the required biosafety tests. The key findings from these MLTs were the following:

• The target level of beta-carotene in the Golden Rice grains was attained and this level is consistent through multi-seasons and multi-locations.
• No negative results were generated from the toxicity and allergenicity tests conducted so far on Golden Rice.
• No lines will be acceptable to farmers based on the poor agronomic results of the GR2-R lines tested in the field trials.

An important goal of the MLT was to test whether the agronomic performance of the new rice variety would be acceptable to farmers. The initial results indicate that more research is needed, with greater focus on increasing yield. Based on these results, a decision has been reached to move forward from work solely focused on GR2-R to also include other versions of Golden Rice, such as GR2-E and others.

The development of Gr2-E has been carried out so far only the screenhouse conditions at IRRI. Plants closely similar to recipient parents have been identified. Even though the screenhouse data are useful for pre-screening of the lines, a thorough plant selection in the final segregating generations under field conditions and their further advancement by field evaluations, preferably in multi-environments, is highly essential. This is especially critical in choosing the GR2-E derived lines for advancement into MLTs to support the commercial approval process in the Philippines and elsewhere.

We propose to conduct two-seasons of confined field tests at the PhilRice Central Experiment Station in Muñoz, Nueva Ecija. The main objective of the CFT is to conduct proper breeding trials under field conditions allowing for the selection of agronomically desirable and highly adoptable plants/lines of pro-vitamin A enriched 'Golden Rice' Event GR2-E in the backgroun of PSB Rc82. The following breeding materials will be teste:

CFT2 and CFT3

~ 70 lines of Oryza sativa PSB Rc82-GR2-E BC₅F₃ lines, corresponding isogenic null segregants, PSB Rc82 wild type, Kaybonnet-GR2-E, and Kaybonnet wild type.

In addition to the breeding activities, we also want to advance the biosafety data assessment of Golden Rice by the Philippine regulators. Accordingly, we propose to produce the grains and other plant materials that will be used for the event-specific biosafety tests required by the regulators to complete the FFP biosafety data dossier for event GR2-E in the Philippines.