FDA Issues Guidance for Gene-Edited Crops

This article is taken from the March 1, 2024 NGFA Newsletter

The U.S. Food and Drug Administration (FDA) last week issued a 22-page guidance document providing recommendations for biotech companies and plant breeders that want to bring new geneedited crop traits to market.

For crops that pose no food safety questions, FDA says a voluntary premarket meeting with the agency is enough. For other crops, FDA recommends a premarket consultation process similar to the current standard practice for new biotech traits. Under current provisions, the public is not mandatorily required to be notified by the FDA, Environmental Protection Agency, or U.S. Department of Agriculture if a company has formally submitted an application for a new product.

In 2023, NGFA, the North American Grain Export Association and several other industry trade groups said in comments to the White House Office of Science and Technology Policy (OSTP) that the government should require companies commercializing new biotechnology products to notify the FDA and that this information should be made public.

FDA is accepting comments on the guidance document.