August 31, 2015                           

 

Food safety evaluation completed for Arcadia Bioscience's HB4 soybean

 

 

 

Verdeca, a soybean technology joint venture between Arcadia Bioscience, Inc. and Bioceres S.A., received notification that the US Food and Drug Administration (FDA) had completed an Early Food Safety Evaluation (EFSE) process for HAHB4, the plant protein responsible for Verdeca's HB4 stress tolerance trait.

 

The completion of the review was considered 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.

 

Since 1992, the FDA has encouraged developers of new plant varieties, including varieties developed through biotechnology, to seek early consultation with the agency in the development process, discussing possible scientific and regulatory issues that might arise. The EFSE process accomplishes this objective by reviewing data and conclusions on the protein introduced to a variety and addressing potential allergic reactions and toxicity for humans or animals.

 

By conducting an early evaluation of a protein and discovering an absence of food safety concerns, the FDA would not expect an additional evaluation to be submitted if the same protein is introduced into another plant species.

 

"Soybean seed products based on the HB4 stress tolerance trait are in the latter stages of development, and completion of the EFSE process is a very positive signal about safety," said Eric Rey, the president and CEO of Arcadia Biosciences.

 

"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."

 

"FDA conclusions are of great significance to regulators around the globe and constitute a valuable reference for present and future submissions concerning HB4 seeds," said Federico Trucco, the CEO of Bioceres.

 

"As more regulatory agencies review the safety data and gain confidence in the safety of HB4 products, we hope to be able to expedite the pending regulatory processes required for the commercial launch of the technology."

 

Verdeca's HB4 soybeans have undergone extensive testing, including six seasons of multi-location field trials in Argentina and the US, along with three years of regulatory field trials. The results of these trials demonstrate that the HB4 trait can provide up to a 14% yield advantage under multiple stress conditions – including drought and low-water conditions - typically found in soybean production areas.

 

The FDA's evaluation follows an 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 commercialise Verdeca's HB4 stress tolerance trait in soybeans. 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.

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