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Arcadia Biosciences, Bioceres Verdeca JV gets FDA approval for HB4 soybeans

15 Aug 2017

Arcadia Biosciences and Bioceres have announced that their joint venture, Verdeca, received notification from the FDA that allows products derived from HB4 soybeans to be used commercially in human food and animal feed.

Arcadia Biosciences and Bioceres have announced that their joint venture, Verdeca, received notification that the U.S. Food and Drug Administration (FDA) has completed its full review of the company’s safety evaluation for HB4 soybeans. The FDA’s notice to Verdeca allows products derived from HB4 soybeans to be used commercially in human food and animal feed. This, said the companies, is a major milestone in the development of commercial soybean seed products based on the HB4 stress tolerance trait.

The 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.

Verdeca’s HB4 soybeans are said to have undergone extensive testing, including multi-location field trials in Argentina and the United States and multiple regulatory field trials. The results of these trials are claimed to 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,” said 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,” said Federico Trucco, CEO of Bioceres. “In a way, this FDA clearance testifies to the quality standards implementented in HB4 product development and safety evaluations. We hope this decision will help expedite international regulatory clearences 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.

Verdeca has also submitted an environmental safety data petition to the US Department of Agriculture (USDA), and this submission is currently under review. Upon completion, the USDA is expected to issue a Determination on Nonregulated Status, which will complete the approval processes in the US and allow for commercial production of HB4 soybeans.

The companies note that soybeans are the world’s fourth-largest crop, grown on 110 million hectares worldwide. Global demand is projected to increase over the next decade as a result of population growth and the expanding middle class in highly populated countries such as India and China. South America is the world’s largest exporter of soybeans to both developed and developing countries, and more than 45% of the world’s soybeans are grown in Argentina and Brazil. Verdeca is developing multiple agronomic performance and product quality traits in soybeans to give farmers new options to help increase productivity and total value.