US FDA grants clearance for the use of Verdeca’s HB4 stress-tolerant soybeans in human food

11 Aug 2017 --- Arcadia Biosciences Inc. and Bioceres S.A. have announced that the US Food and Drug Administration (FDA) has completed its full review of the safety evaluation for HB4 soybeans, produced by their joint venture, Verdeca. The FDA’s notice to Verdeca allows products derived from HB4 soybeans to be used commercially in human food and animal feed.

The US FDA uses its Biotechnology Notice process to review and assess safety data provided by companies developing new plant varieties using advanced breeding technologies. The data provided to the FDA is consistent with international regulatory requirements for genetically modified crops and will be used by Verdeca and its global partners for future regulatory submissions, the companies report.

Verdeca’s HB4 soybeans have undergone extensive testing, including multi-location field trials in Argentina and the US and multiple regulatory field trials. The results of these trials demonstrate that the HB4 trait can provide yield advantages under stress conditions – including drought and low-water conditions – found in several soybean production areas.

“The HB4 gene holds great promise for bringing better yield stability to agriculture in areas that experience chronic water stress problems,” says Raj Ketkar, President and CEO of Arcadia Biosciences. “Our combined efforts aim to create significant value for soybean growers by increasing the productivity and sustainability of this important protein crop in the face of global climate challenges.”

“The FDA is one of the most prestigious regulatory agencies in the world, and its opinions are of reference to regulators everywhere,” says Federico Trucco, CEO of Bioceres. “In a way, this FDA clearance testifies to the quality standards implemented in HB4 product development and safety evaluations. We hope this decision will help expedite international regulatory clearances for HB4 soybeans, and bring us closer to the much-anticipated launch of this unique technology.”

Completion of the FDA’s review is another key regulatory achievement in the approval process for Verdeca’s HB4 drought stress tolerance trait. The trait has already been approved in Argentina by the Ministry of Agriculture, Livestock and Fisheries.