When it comes to the cutting-edge technology of gene editing, the USDA and the Food and Drug Administration (FDA) came to very different conclusions.
In January 2017, the FDA released Draft Guidance for Industry #187 (GFI#187). The document outlined that food animals produced using gene editing, or the offspring of such animals, are to be regulated under the Federal Food, Drug, and Cosmetic (FD&C) Act. Specifically, the edited DNA of the animals counts as a drug, according to the FD&C Act.
However, on March 28, 2018, the Secretary of Agriculture Sonny Perdue announced that the USDA has does not regulate, nor has any intention to regulate, “innovative new breeding techniques” including gene editing in plants.
“With this approach, USDA seeks to allow innovation when there is no risk present,” said Perdue.
The announcement of the decision noted that gene editing is “increasingly being used by plant breeders to produce new plant varieties that are indistinguishable from those developed through traditional breeding methods.”
WLJ reached out to the FDA on the apparent conflict of the new announcement.
“USDA’s statement has no bearing on FDA’s or EPA’s requirements, guidance, or actions related to products under their jurisdictions,” Anne Norris, Health Communications Specialist, told WLJ in an emailed correspondence.
“FDA and USDA operate under different statutes and, as such, focus on different types of risks. The focus of USDA’s authority in this space is on plant health. By contrast, FDA’s focus is on the safety of plant-derived food intended for humans or animals.”
The USDA announcement noted that it, the FDA, and the Environmental Protection Agency (EPA) regulate food and agricultural technology under the Coordinated Framework for the Regulation of Biotechnology.
“USDA’s regulations focus on protecting plant health; FDA oversees food and feed safety; and EPA regulates the sale, distribution, and testing of pesticides in order to protect human health and the environment,” the announcement detailed.
Norris also cited the Coordinated Framework.
“While FDA, USDA, and EPA will continue to coordinate responsibilities under the Coordinated Framework for the Regulation of Biotechnology, FDA’s actions under the Food, Drug, and Cosmetic Act are separate and distinct from APHIS’ authority,” she said.
“These key differences may lead us to take different approaches with respect to the regulation of genome editing technologies.” — Kerry Halladay, WLJ editor
