Golden Rice receives U.S. FDA approval

01.06.2018

GR2E Golden Rice, a provitamin-A biofortified rice variety, completed its third positive food safety evaluation, from the U.S. Food and Drug Administration (FDA). In an official response received by the International Rice Research Institute (IRRI) on May 24, the FDA concurred with IRRI’s assessment regarding the safety and nutrition of Golden Rice.

The U.S. FDA statement comes on the heels of the safety and nutrition approvals from Food Standards Australia New Zealand (FSANZ) and Health Canada in February and March 2018, respectively. 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 Co-operation 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 Matthew Morell, IRRI director general. “The rigorous safety standards observed by the U.S. FDA and other agencies provide a model for decision-making in all countries wishing to reap the benefits of Golden Rice.”

For those who struggle with vitamin A deficiency (VAD), including an estimated 250 million preschool-age children, the announcement represents one more step forward to making the rice available to them, the IRRI said. 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 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; South and Southeast Asia rank high among the regions where VAD is prevalent.

According to IRRI, 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% to 50% 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 said.

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

In Bangladesh and the Philippines, the Bangladesh Rice Research Institute (BRRI) and Philippine Rice Research Institute (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 logged in 2017.

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

“Regulatory approval enables organizations such as IRRI to conduct further trials and nutrition assessments that can assure the public that our healthier rice varieties meet their needs,” Reinke said.

Alongside the continuing work on the GR2E Golden Rice variety, IRRI is developing high-iron and zinc rice and stacked beta-carotene, iron and zinc varieties to address other micronutrient deficiencies among impoverished communities.

“Each component of IRRI’s efforts to improve the nutritional content of rice responds to critical and enduring global nutrition security concerns,” Morell said.


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