As previously reported on this blog, the United States Department of Agriculture (USDA) and the Food and Drug Administration (FDA) have both claimed regulatory oversight of cell-cultured meat, a product that some say could be available for marketing in as early as three years.  Federal law grants regulatory authority over meat products, poultry, catfish, and egg products to USDA.  FDA has regulatory authority over all other food in interstate commerce.  Jurisdictional issues impact cell-cultured meat from early decisions on premarket approval and labeling through daily operations going forward.  For example, USDA Food Safety Inspection Service (FSIS) inspectors are in federally inspected meat and poultry slaughter plants during all hours of operation and in meat, poultry, catfish and egg processing plants for at least a brief period each shift, whereas FDA inspections are on a periodic basis of one year or more between inspections.

FDA and USDA invited public input on the oversight of cell-cultured meat in a joint meeting on October 23-24, 2018.  Subsequently, in a November 16, 2018 joint press release, USDA and FDA announced an agreement on a joint regulatory framework (although the framework itself was not released) wherein FDA will oversee cell collection, cell banks, and cell growth and differentiation.  USDA oversight would begin during the cell harvest stage and continue through the production and labeling of food products derived from the cells of livestock and poultry.  Since cell-cultured products do not necessarily have the same food safety concerns as meat and poultry harvested from animals, it is unclear if USDA jurisdiction from the cell harvest stage forward means that daily in-plant inspect will be required.

Regarding speculation that Congress may have to settle the USDA-FDA jurisdictional issue, the joint press release asserts no new legislation is needed to regulate cell-cultured food products derived from livestock and poultry.  However, no statutory authority was cited.  In this regard, the definition of “meat food product” in the Federal Meat Inspection Act as “any product capable of use as human food which is made wholly or in part from any meat or other portion of the carcass,” does not clearly encompass food from tissue cultured cells.  See 21 USC 601(j) (emphasis added).  Although not mentioned in the press release, cell-cultured fish (other than catfish) and seafood would be under FDA’s sole jurisdiction.

As USDA and FDA actively work on the numerous technical details of the joint regulatory framework, the period for public comment has been extended and will remain open through December 26, 2018.