China's genetically engineered rice gets FDA approval
Huahui No.1, a new type of genetically engineered rice developed by Chinese scholars, has received approval from the U.S. Food &Drug Administration (FDA) and is expected to enter the American food market soon.
In an open letter released by the FDA on its official website, Huahui No.1 is described as a product that complies with the legal and regulatory requirements that fall within FDA’s jurisdiction. The letter also noted that human and animal foods from Huahui No.1 rice grain are not materially different in composition, safety, and other relevant parameters from rice-derived human and animal food currently on the market.
Developed by China’s Huazhong Agricultural University (HAU), Huahui No.1 contains a copy of the synthetic DNA sequence with two genes: cry1Ab and cry1Ac. These genes encode for the respective Bt toxins which, being lethal to Lepidoptera, make the plant resist to this group of insects.
According to the FDA, HAU should obtain all appropriate clearances, including those from the United States Environmental Protection Agency (EPA) and the United States Department of Agriculture (USDA), before marketing human or animal food derived from Huahui No.1 rice.
As of press time, HAU has already obtained a letter from the EPA stating that the Cry1Ab/Cry1Ac protein in Huahui No. 1 rice falls under the tolerance exemption for Cry1Ac in 40 CFR 174.510.
Huahui No.1 must be approved by the USDA if it wants to be planted on U.S. soil. But with approvals from both the EPA and the FDA, the genetically engineered rice has already gained access to the U.S. market and can be sold to American customers directly, according to Science and Technology Daily.
Created by Chinese scientists in 1999, Huahui No.1 was awarded a safety certification from China’s Ministry of Agriculture in 2009, and retained the certification upon reapplication when it expired in 2014.[ Editor: WPY ]