US FDA approves Golden Rice

By Mark Lynas

May 25, 2018

The United States Food and Drug Administration (FDA) has approved Golden Rice, marking the third positive international assessment for the genetically engineered biofortified crop.

Previously, Food Standards Australia, New Zealand and Health Canada gave Golden Rice the stamp of approval in February and March 2018 respectively.

In an official letter to the developers of Golden Rice, the International Rice Research Institute (IRRI), the FDA concurred that the new rice was safe for consumers.

“Based on the information IRRI has presented to FDA, we have no further questions concerning human or animal food derived from GR2E rice at this time,” the FDA’s letter to IRRI concludes.

The FDA’s assessment concerns Golden Rice event GR2E, which contains genes encoding phytoene synthase and carotene desaturase, components of the carotenoid biosynthetic pathway.

These genes allow Golden Rice to produce the Vitamin A precursor beta-carotene, giving it a rich yellow colour.

The rice is intended to address Vitamin A deficiency (VAD), a serious disease which is estimated to affect 250 million preschool-age children around the world. VAD can cause blindness and early death in young children who are affected.

“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.”

Although target consumers for Golden Rice are rice-dependent populations in developing countries in Asia, IRRI has applied for approvals in rich countries in order to avoid trade disruptions should small amounts of genetically engineered rice be present in the traded commodity.

Two target countries are Bangladesh and the Philippines, where IRRI is working in collaboration with the Bangladesh Rice Research Institute and the Philippine Rice Research Institute, respectively, in order to develop high-yielding inbred local rice varieties with the beta-carotene producing GR2E Golden Rice trait.

Golden Rice applications with the national regulatory agencies of both countries were lodged in 2017 by IRRI and its local partners.

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 30-50% of the estimated average requirement for Vitamin A of women and children.

Alongside the continuing work on the GR2E Golden Rice variety, IRRI is also 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 asserts.