Rice variety meets standards of US FDA

By Madelaine B. Miraflor

GR2E Golden Rice, a provitamin-A biofortified rice variety, completed its third positive food safety evaluation, this time from the United States Food and Drug Administration (US FDA), Philippine-based International Rice Research Institute (IRRI) said.

The regulatory approval could eventually pave the way for the commercialization of what could be the first nutritionally enhanced genetically modified rice in the world.

In the Philippines, the Philippine Rice Research Institute (PhilRice) is now developing high-yielding inbred local rice varieties with the beta-carotene producing GR2E Golden Rice trait.

There is now a Joint Department Circular in the Department of Agriculture on Rules and Regulations for the Research and Development, Handling and Use, Transboundary Movement, Release into the Environment, and Management of Genetically-Modified Plant and Plant Products Derived from the Use of Modern Biotechnology.

This regulation governs the safe and responsible use of the products of modern biotechnology, which includes Golden Rice.

In an official response received by IRRI last week, the US FDA concurred with the agency’s assessment regarding the safety and nutrition of Golden Rice.

The US FDA statement came just a few months after Food Standards Australia New Zealand (FSANZ) and Health Canada also gave their safety and nutrition approvals on Golden Rice.

These three national regulatory agencies carry out their assessments based on concepts and principles developed over more than two decades by international organizations such as the World Health Organization (WHO), the Food and Agriculture Organization (FAO) of the United Nations, the Organization for Economic Cooperation and Development (OECD) and the Codex Alimentarius Commission.

“Each regulatory application that Golden Rice completes with national regulatory agencies takes us one step closer to bringing Golden Rice to the people who need it the most,” said IRRI Director General Matthew Morell.

“The rigorous safety standards observed by the US FDA and other agencies provide a model for decision-making in all countries wishing to reap the benefits of Golden Rice,” he added.

Once Golden Rice receives all necessary national approvals, a sustainable deployment program will ensure that Golden Rice is acceptable and accessible to its target communities.

Vitamin A deficiency (VAD) remains a pervasive public health problem worldwide.

WHO estimates that alongside children under 5 years of age, a substantial number of pregnant and lactating women are afflicted with VAD, while South and Southeast Asia rank high among the regions where VAD is prevalent.

Golden Rice is intended as a complementary, food-based solution to existing nutritional interventions, such as diet diversification and oral supplementation. It achieves this by providing 30 percent to 50 percent of the estimated average requirement for Vitamin A of women and children.

GR2E Golden Rice is the first nutritionally enhanced genetically modified rice to receive regulatory approval for use in food.

IRRI is working with national research partners in the development and deployment of healthier rice varieties that have more iron, zinc, and beta-carotene content to improve the nutritional status of vulnerable populations with limited access to diverse diets.

Because rice is already widely grown and eaten, these bio-fortified rice varieties have the potential to reach many people, IRRI said.

Bangladesh Rice Research Institute (BRRI) and PhilRice are developing high-yielding inbred local rice varieties with the beta-carotene producing GR2E Golden Rice trait.

Golden Rice applications with the appropriate national regulatory agencies have been made by BRRI in Bangladesh, and a joint IRRI/PhilRice application has been submitted in the Philippines. Both were lodged in 2017.

Russell Reinke, Healthier Rice program lead at IRRI, regulatory applications are a necessary step in the research and development process.