The Food Safety and Inspection Service (FSIS) of the U.S. Department of Agriculture (USDA) recently published an advanced notice of proposed rulemaking (ANPR) seeking public comment pertaining to the labeling of meat and poultry products “comprised of or containing cultured cells derived from animals,” also sometimes referred to as “clean meat.”
Creating cultured animal products involves cultivating cells drawn from the tissue of living animals in a controlled environment with nutrients and other factors to support growth and cellular multiplication. Additional nutrients and other inputs are added after the cells have multiplied, and the harvested cells are further processed, packaged, and marketed in the same or similar manner as slaughtered meat and poultry products.
FSIS regulates human food derived from cattle, sheep, swine, goats, and certain fish pursuant to the Federal Meat Inspection Act (FMIA) and human food from chickens, turkeys, ducks, geese, guineas, ratites, and squabs pursuant to the Poultry Products Inspection Act (PPIA). The U.S. Food and Drug Administration (FDA) regulates, among other things, food ingredients used during the production of meat and poultry under the Federal Food, Drug, and Cosmetic Act (FDCA) and other statutes. Under a formal agreement between FSIS and FDA, the two agencies share oversight of human food derived from cell lines of these USDA-amenable species. Essentially, FDA is responsible for overseeing the collection, growth and differentiation of livestock and poultry cells until cell harvest. FSIS is responsible for overseeing the processing, packaging, and labeling of the resulting meat and poultry products made using animal cell culture technology. Food products for human consumption (as well as food products for animal consumption) made from cells of species not subject to USDA jurisdiction will be regulated solely by FDA. Of note, FDA, in the Federal Register of October 7, 2020, published a request for information (similar to the USDA ANPR at issue) on the labeling of foods comprised of or containing cultured seafood cells.
Comments obtained on the ANPR are intended to inform future rulemaking by FSIS on labeling requirements to prevent misbranding. A meat or poultry product can be misbranded under the FMIA and PPIA for a number of reasons, for example, the product’s labeling is false or misleading, it fails to conform to a standard of identity that has been prescribed, it is offered for sale under the name of another food, or its label fails to include certain required information. The notice asks several questions related to the following topics:
- The nomenclature associated with cultured meat and poultry (as well as foods prepared with cultured meat and poultry);
- Whether and how to establish a standard of identity for foods comprised of or containing cultured animal cells;
- Whether to change any of the current regulatory definitions to include such products;
- How to regulate labeling claims for such products;
- Economic data on the costs and benefits of various labeling options; and
- Research on consumer perceptions of food made using this technology.
Any establishment that intends to distribute a cultured meat or poultry product prior to the completion of the labeling rulemaking is required to submit the proposed product label to FSIS for review. Other than new labeling regulations, FSIS “does not intend to issue any other new food safety regulations for the cell-cultured food products under its jurisdiction” and considers existing regulations requiring sanitation and Hazard Analysis and Critical Control Point (HACCP) systems as sufficient to ensure the safety of cultured meat and poultry products.
If interested in submitting comments, comments are due on or before November 2, 2021.
 Food Safety & Inspection Serv., Advanced Notice of Proposed Rulemaking, “Labeling of Meat or Poultry Products Comprised of or Containing Cultured Animal Cells,” 86 Fed. Reg. 49,491 (Sep. 3, 2021).
 Formal agreement between the U.S. Department of Health and Human Services Food and Drug Administration and U.S. Department of Agriculture Office of Food Safety Regarding Oversight of Human Food Produced Using Animal Cell Technology Derived from Cell Lines of USDA-amenable Species, March 7, 2019, available at: https://www.fsis.usda.gov/sites/default/files/media_file/2020-07/Formal-Agreement-FSIS-FDA.pdf.
 See Food & Drug Admin., Notice, Request for Information, “Labeling of Foods Comprised of or Containing Cultured Seafood Cells,” 85 Fed. Reg. 63,277 (Oct. 7, 2020).
 U.S. Dep’t of Agric., Press Release, “USDA Seeks Comments on the Labeling of Meat and Poultry Products Derived from Animal Cells” (Sep. 2, 2021), https://www.usda.gov/media/press-releases/2021/09/02/usda-seeks-comments-labeling-meat-and-poultry-products-derived.