Biotech Updates

FDA Completes Early Food Safety Evaluation for Soybean Stress Tolerance Trait

September 2, 2015

Arcadia Biosciences Inc. and Bioceres S.A. have announced that Verdeca, their soybean technology joint venture, received notification that the US 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.

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.

Eric Rey, Arcadia Biosciences President and CEO said "The completion of the EFSE process is a very strong and positive signal about safety. The core safety data used in the EFSE process will facilitate international regulatory approvals for HB4 stress-tolerant soybeans, and for the use of the HB4 trait in other crops as well."

The FDA's evaluation follows the April regulatory approval from Argentina's National Advisory Commission on Agricultural Biotechnology (CONABIA) and the Biotechnology Directorate of the Ministry of Agriculture, Livestock and Fisheries of Argentina. The Argentinean 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.

For more information, read the news release at the Arcadia Biosciences website.