HB4 stress tolerance trait of Verdeca completed FDA early food safety evaluation

Arcadia Biosciences, Inc. and Bioceres S.A. Recently announced that Verdeca, their soybean technology joint venture, received notification that the U.S. Food and Drug Administration (FDA) has completed the Early Food Safety Evaluation (EFSE) process for HAHB4, the plant protein responsible for Verdeca’s HB4 stress tolerance trait. Completion of this review is a major milestone in the development of commercial soybean seed products based on the HB4 stress tolerance trait, as well as the development of HB4-based products in other crops.

 

In the EFSE process, the FDA reviewed safety data provided by Verdeca and supported the conclusion that the inadvertent presence of low levels of the HAHB4 protein would not raise food safety concerns. 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 FDA’s evaluation follows the April regulatory approval from Argentina’s National Advisory Commission on Agricultural Biotechnology (CONABIA) and the Biotechnology Directorate from the Ministry of Agriculture, Livestock and Fisheries of Argentina. The Argentinian approval was the first regulatory approval for the HB4 trait, and the world’s first regulatory approval of an abiotic stress tolerance trait in soybeans.

 

Along with this key regulatory milestone, Verdeca recently announced significant partnerships that will advance the development of high-value traits in soybeans. In July, Bioceres, Arcadia, and Tropical Melhoramento e Genética Ltda. (TMG) announced a collaboration to develop and commercialize Verdeca’s HB4 stress tolerance trait in soybeans. And earlier this year, Verdeca announced a collaboration with Dow AgroSciences to develop soybean trait stacks that combine Verdeca’s agronomic performance and product quality traits with Dow AgroSciences’ herbicide tolerance and insect resistance traits.