FDA, USDA Sign MOU to Jointly Oversee Cell-Based Meat

USDA and FDA on Thursday released a formal agreement to jointly oversee foods made from cell-cultured meat, detailing a regulatory approach largely supported by cell meat companies, livestock producers and other stakeholders. The Memorandum of Understanding (MOU) essentially codifies an approach described by the two agencies last November. FDA will conduct premarket consultations, and oversee cell collection, development and production through the time of harvest. Oversight will shift to USDA's Food Safety and Inspection Service (FSIS) during the cell harvest stage and FSIS will then oversee the production and labeling of cell-based meat products. The MOU includes language detailing that both agencies will share information in order to ensure a smooth transfer of regulatory oversight. The agreement covers meat made from cells of livestock and poultry, and FDA retains sole oversight of cell-cultured seafood bar catfish. Under the MOU, companies would need to comply with FDA requirements, including facility registration, Current Good Manufacturing Practices and preventive controls regulations. As needed, FDA will develop requirements for cell bank and cell culturing facility conditions and take enforcement actions if these facilities are not in compliance. “HHS-FDA shall not inspect activities solely regulated by USDA-FSIS and shall rely on the USDA-FSIS regulatory process for information regarding such activities,” the MOU said. USDA plans to conduct inspections in establishments where cells cultured from livestock and poultry are harvested, processed, packaged or labeled that must meet HACCP and sanitation controls. Labels must be preapproved and then verified through inspections, as required by FSIS regulations, the MOU stated.