EPA, FDA, and USDA will overhaul biotech regulations

The three federal agencies that share jurisdiction over genetically engineered plants and animals said on Wednesday that they would update and streamline biotechnology regulations in five areas, including modified food animals. The United States is a worldwide leader in agricultural biotechnology.

In an announcement, the Environmental Protection Agency, the Food and Drug Administration, and the Agriculture Department said the modernization project would focus on modified plants; modified animals; modified microorganisms; human drugs, biologics, and medical devices; and “cross-cutting issues.” The FDA and USDA said they would clarify and provide guidance on cultivated meat, also known as cell-cultured meat, which is now being sold in small amounts.

“In calendar year 2024, USDA will propose new regulations pertaining to the labeling of meat and poultry products comprised of or containing cultured cells derived from animals,” said the outline. “USDA will also issue labeling guidance for establishments producing these cell-cultured meat and poultry products.”

The Biotechnology Innovation Organization (BIO) said it was pleased to see a joint plan to update the Coordinated Framework for the Regulation of Biotechnology. “Developers of plant, animal, and microbial biotechnology are innovating rapidly to meet the challenges we face, from addressing climate change to ensuring we can feed a growing world. We need a regulatory process that works at the speed of today’s innovation,” said BIO.

To read the 16-page plan for regulatory reform, click here.

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