As we previously reported, the United States Department of Agriculture (USDA) Food Safety and Inspection Service (FSIS) and the Food and Drug Administration (FDA) in a November 16, 2018 joint press release, announced an agreement on joint regulation of cell-cultured meat.  Though the framework was not released at the time, the press release indicated that under the agreement, FDA will oversee “cell collection, cell banks, and cell growth and differentiation. A transition from FDA to USDA oversight will occur during the cell harvest stage. USDA will then oversee the production and labeling of food products derived from the cells of livestock and poultry”.  As we noted at the time, the scope of USDA inspection was not addressed and the Agencies agreed that no legislation would be necessary to effectuate the joint agreement.

On March 7, 2019, USDA and FDA published a “Formal Agreement Between FDA and USDA Regarding Oversight of Human Food Produced Using Animal Cell Technology Derived from Cell Lines of USDA-amenable Species” (the press release can be found here).  The agreement provides some indication of expected inspectional burdens on industry – the agreement includes a provision that USDA will “require each establishment that harvests cells cultured from livestock or poultry . . . for the purpose of producing human food required to bear the USDA mark of inspection, processes those cells into such human food products, or packages and labels such products, to obtain a grant of inspection, as required by the FSIS regulations.” In addition, USDA will conduct “inspection in establishments where cells cultured from livestock and poultry subject to the FMIA and PPIA are harvested, processed, packaged or labeled, in accordance with applicable FSIS regulations (including sanitation and physical product inspection, Hazard Analysis and Critical Control Point (HACCP) verification, product testing, and records review), to ensure that resulting products are safe, unadulterated, wholesome and properly labeled.” As FDA will oversee cell collection and the development/maintenance of cell banks up and until the harvesting stage, FDA also will conduct inspections at those facilities to ensure compliance with FDA laws and regulations.

In contrast, the formal agreement provides no clarity on the statutory basis for USDA regulation.  As opposed to the press release in November, which indicated that no legislation would be necessary, the formal agreement indicates that FDA and USDA “will undertake a joint process to identify any changes needed to statutory or regulatory authorities to effectuate” the agreement.