The USDA’s Food Safety and Inspection Service (FSIS) and the U.S. Department of Health and Human Services’ (HHS) Food and Drug Administration (FDA) announced a formal agreement to jointly oversee the production of human food products derived from the cells of livestock and poultry on Thursday.
The agreement between FSIS and FDA addresses the regulatory oversight of human food produced using this new technology and recognizes the important role each party bears.
“The National Pork Producers Council (NPPC) has consistently called for a level playing field when it comes to regulatory oversight of laboratory-produced cultured protein,” says Jim Monroe, senior director of public relations with the National Pork Producers Council. “By placing labeling and inspection oversight for these products with the USDA, the framework announced today by the Trump administration does just that. We are very pleased with this outcome.”
According to the USDA, the agreement explains the oversight roles and responsibilities for both agencies and how the agencies will collaborate to regulate the development and entry of these products into commerce. This shared regulatory approach will ensure that cell-cultured products derived from the cell lines of livestock and poultry are produced safely and are accurately labeled.
“Consumers trust the USDA mark of inspection to ensure safe, wholesome and accurately labeled products," says USDA Deputy Under Secretary for Food Safety Mindy Brashears. "We look forward to continued collaboration with FDA and our stakeholders to safely regulate these new products and ensure parity in labeling.”
Stakeholders want clarity when it comes to this issue. How will the industry ensure safety and proper labeling of these cell-cultured human food products?
“Collaboration between USDA and FDA will allow us to draw upon the unique expertise of each agency in addressing the many important technical and regulatory considerations that can arise with the development of animal cell-cultured food products for human consumption,” says Frank Yiannas, FDA Deputy Commissioner for Food Policy and Response.
The agreement says the agencies agree upon a joint regulatory framework where FDA oversees cell collection, cell banks and cell growth and differentiation. FDA oversight will transition to FSIS oversight during the cell harvest stage. FSIS will oversee the production and labeling of human food products derived from the cells of livestock and poultry.
NPPC now turns its attention to establishing the right regulatory framework for gene edited livestock. Currently stalled at the FDA, NPPC believes USDA regulatory oversight of gene edited livestock gives U.S. agriculture the best hope of realizing its incredible potential.
“In addition to dramatic animal health gains and reduced financial risk for farmers, gene editing’s promise includes less need to use antibiotics to care for livestock and reduced environmental impact from more efficient farm operations,” Monroe says.