The U.S. Department of Agriculture’s (USDA’s) Food Safety and Inspection Service (FSIS) and the Food and Drug Administration (FDA) announced today a formal-agreement coordinating joint jurisdiction over the production of products derived from cell lines of livestock and poultry. This agreement marks the next significant step in establishing the regulatory framework for these products and delineates the general roles that FSIS and FDA will play in regulating the developing of cell lines, culturing cells, harvesting cells, processing products from those cell cultures, labeling, and post-market enforcement. It builds on a November 2018 joint statement by USDA Secretary Perdue and FDA Commissioner Gottlieb last Fall, in which they announced that the agencies would establish a coordinated framework for regulating these products working within their existing statutory authorities. Although today’s formal agreement establishes a general regulatory framework, additional work remains, as both agencies will have to review and possibly update regulations, develop more specific regulatory guidance for these products, and resolve a number of important questions.
In general, the formal agreement adopts a “pre-harvest” and “post-harvest” approach, with FDA asserting oversight “through the time of harvest” and FSIS assuming jurisdiction over harvested cells that are intended for use in meat or poultry products. The agreement leaves jurisdiction at the point of “harvest” unresolved, with the agreement apparently contemplating both agencies having a role. The agreement calls for information sharing and coordination between FDA and FSIS, and the agencies have committed to a collaborative process for fleshing out the regulatory process moving forward.