Arcadia Biosciences’ NUE trait completes FDA evaluation

Arcadia Biosciences, Inc., an agricultural technology company, announced that the U.S. Food and Drug Administration (FDA) has completed the Early Food Safety Evaluation (EFSE) process for the plant protein responsible for the company’s Nitrogen Use Efficiency (NUE) trait. Completion of this review is a critical milestone in the development of Arcadia’s pipeline of 13 nitrogen use efficient crops, four of which are in the latter phases of product development.

The FDA EFSE review supported the conclusion that the functional protein for the NUE trait, alanine aminotransferase, is safe for consumption by humans and animals and would not raise safety concerns if present in the food supply. The EFSE is applicable to all plant species utilizing Arcadia’s NUE trait.

"Seed products based on the NUE trait are in development for most major global crops,” said Eric Rey, president and CEO of Arcadia Biosciences. “Completion of the EFSE process provides our seed company partners with assurance of gene safety. The core safety data used in the EFSE process will facilitate regulatory approvals for all crops that ultimately will bring this yield-enhancing trait to farmers worldwide.”

Conventional crops use only about half of applied nitrogen fertilizer. Much of the remainder moves through the soil and enters ground and surface water systems, or volatilizes into the air as a greenhouse gas 300 times more potent than carbon dioxide. Arcadia’s NUE trait was developed to help farmers increase yields while reducing costly fertilizer usage and improving the environmental footprint of agriculture.

Arcadia and its commercial partners are testing crops with the NUE trait at 16 field trials worldwide in 2015. The trait’s efficacy has been demonstrated in major crops including rice, wheat, barley, sugarcane and canola. To date, three years of independent field trials of NUE in rice have demonstrated an average yield increase of 27 percent in multiple environments. Field trials of NUE wheat lines over multiple locations and crop seasons demonstrated an average yield increase of 10 percent for the leading lines across a range of nitrogen application rates.

"Coupled with the recent regulatory approval of drought tolerant soybeans in Argentina for our joint venture Verdeca, completion of the EFSE process validates Arcadia’s significant capabilities to manage the regulatory framework for new crop traits,” Rey said.

The data provided by Arcadia to the FDA in support of the EFSE for the NUE trait is consistent with international regulatory requirements for genetically modified crops and will be utilized by Arcadia and its global partners for future regulatory submissions. Arcadia is currently pursuing an additional EFSE for the HB4 drought tolerance trait being utilized in multiple crops in conjunction with Bioceres SA.