Here are answers to common questions on Golden Rice and the Golden Rice project status and updates coordinated by IRRI.
For more information, please send an email to info@irri.org.
Have regulators assessed the risks concerning the application for the proposed Golden Rice field trials in the Philippines?
The Department of Agriculture-Bureau of Plant Industry (DA-BPI) in the Philippines released a consolidated risk assessment report on the application submitted by PhilRice for the proposed field trials of Golden Rice. The report indicates positive assessments from the DA-BPI Scientific and Technical Review panel,biosafety committees of the Department of Environment and Natural Resources and Department of Health, and a socio-economic ethical and cultural expert, which resulted in a recommendation to grant a biosafety permit for the field trial.
Transparency and public participation are key components of biosafety regulatory approval under the Joint Department Circular No. 1 series of 2016. In addition to the consolidated risk assessment report, local government resolutions that emanate from the public consultations and a report summarizing feedback gathered during the public comment period will be assessed as part of the decision-making process.
There have been reports that Golden Rice field trials resulted in stunted plants and reduced grain yield. Is this true?
In 2014, we shared an update on the results of the multilocation trials (MLTs) conducted in 2012-2013 that used the most advanced event of Golden Rice at that time, GR2R. Results from these MLTs showed that while the target level of beta-carotene in the grain was attained, average yield was lower than that of comparable local varieties preferred by farmers. Hence, a decision has been reached to use more promising events such as GR2E to advance the development of Golden Rice.
Research and development of Golden Rice using GR2E are ongoing and moving toward deployment. From October 2014 to July 2017, a series of confined field tests (CFTs) were successfully conducted at IRRI and PhilRice in the Philippines and at five different locations within Bangladesh to assess the agronomic performance of GR2E introgression lines in comparison with their respective recipient parents. The results from the CFTs were also helpful in selecting a subset of lines with suitable agronomic and product performance for advancement.
The results from the CFTs confirmed there are no unintended effects of the GR2E event on agronomic performance, yield, and grain quality. Moreover, there were no observed differences for their pest and disease reactions. Except for the intended production of beta-carotene, all other nutritional components of the rice have been maintained.
A number of GR2E introgression lines with acceptable agronomic, yield and grain quality traits, and having a significant concentration of carotenoids in the milled rice as measured two months post-harvest, were selected for further evaluation in MLTs in 2017.
What is the status of the Golden Rice project?
Regulatory updates in the Philippines
In accordance with the Joint Department Circular No. 1 series of 2016, the Department of Agriculture-Bureau of Plant Industry (DA-BPI) has instructed PhilRice to proceed with the public consultation process in the localities identified in the application for a biosafety permit for the conduct of GR2E Golden Rice field trials submitted by PhilRice to the DA-BPI in February 2017.
The consultation process is comprised of Public Information Sheet postings in accessible community locations, a 30-day public comment period, and the public hearing, which will take place on 18 July 2018 in Munoz, Nueva Ecija, and on 20 July 2018 in San Mateo, Isabela. (Update as of 16 July 2018: Following Executive Order No. 17 Series of 2018 of the Office of the Governor of the Isabela, which declares 20 July 2018 as a non-working holiday, the San Mateo public hearing has been moved to 19 July 2018).
PhilRice, in coordination with IRRI, led a series of briefings from July to 2017 in Quezon City, Nueva Ecija, Isabela, Ilocos Norte, Agusan del Norte, Albay, Camarines Sur, and Tagaytay City. Different stakeholders, such as farmers, policy makers, students and teachers, research and development professionals, medical and health practitioners, and media and public information officers, including those from women’s groups and the religious sectors attended these briefings, which were held during the 60-day public comment period for the joint PhilRice-IRRI application for a biosafety permit for the direct use in food, feed, or for processing, of GR2E Golden Rice. The application was submitted in March 2017 and the PIS was published on 26 July 2017.
Regulatory updates in Bangladesh
Meanwhile in Bangladesh, the application for environmental and food safety assessment of GR2E BRRI dhan29 Golden Rice was lodged with the Ministry of Agriculture on 26 November 2017 and the Ministry of Environment and Forest on 04 December 2017.
Global Regulatory updates
Outside of the Philippines and Bangladesh, applications for food or food and feed safety review of GR2E Golden Rice have been submitted to the US Food and Drug Administration, Food Standards Australia New Zealand, and to Health Canada. Collectively, the data presented in these application submissions have not identified potential health and safety concerns, and support the conclusion that food and/or livestock animal feed derived from provitamin A biofortified GR2E rice is as safe and nutritious as food or feed derived from conventional rice varieties. Detailed information on the product safety studies can be found here.
On 7 August 2017, FSANZ published a call for submission of comments on the Golden Rice application and noted that “FSANZ has conducted a thorough safety assessment, including a dietary intake assessment (DIA), and has determined there are no public health or safety concerns.” The regulatory process under FSANZ was completed on 22 February 2018 with the publication of the Food Standards variance in the Commonwealth of Australia Gazette.
In its notice of decision dated 16 March 2018, Health Canada declared that “changes made in this rice variety did not pose a greater risk to human health than rice varieties currently available on the Canadian market”, further noting that “GR2E would have no impact on allergies”, and that there were no differences in the nutritional value of GR2E compared to other traditional rice varieties available for consumption except for increased levels of provitamin A.
Golden Rice completed a third positive food safety evaluation on 24 May 2018, this time from the United States Food and Drug Administration (US FDA). In an official letter, the US FDA concurred with IRRI’s assessment regarding the safety and nutrition of Golden Rice.