Arcadia Biosciences’ nitrogen use efficiency trait completes FDA evaluation

Davis, California-based Arcadia Biosciences Inc. recently announced that the U.S. Food and Drug Administration (FDA) had completed the Early Food Safety Evaluation (EFSE) process for the plant protein responsible for the company’s Nitrogen Use Efficiency (NUE) trait.

This is significant because Arcadia is developing 13 nitrogen use efficient crops -- four of which are in the final stages of production.

“Completion of the EFSE process provides our seed company partners with assurance of gene safety," Arcadia Biosciences Chief Executive Officer and President Eric Rey said. "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.”

The FDA's EFSE review proved alanine aminotransferase is safe for ingestion by humans and animals and would not be a safety issue in the food supply.

“Seed products based on the NUE trait are in development for most major global crops,” Rey said.

Arcadia, along with its commercial partners, is conducting tests on crops with the NUE trait worldwide.

“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.

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FDA Office of Medical Products and Tobacco

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