With this agreement, FDA oversees cell collection, growth, and differentiation of cells. FDA will transfer oversight at the cell harvest stage to FSIS. FSIS will then oversee the cell harvest, processing, packaging, and labeling of products. FDA and FSIS also agreed to collaborate to develop joint principles for the labeling of products made using cell culture technology under their respective labeling jurisdictions. Seafood, other than Siluriformes fish, falls under FDA’s jurisdiction, whereas meat, including Siluriformes fish, and poultry are under the jurisdiction of FSIS. 

FSIS does not intend to issue any other new food safety regulations for the cell-cultured food products under its jurisdiction, with the exception of new labeling regulations concerning these products. Current FSIS regulations requiring sanitation and Hazard Analysis and Critical Control Points systems are immediately applicable and sufficient to ensure the safety of products cultured from the cells of livestock and poultry.

FSIS already has received thousands of comments on the topic, in response to a 2018 joint public meeting with FDA and regarding two petitions for rulemaking (from the United States Cattlemen’s Association and Harvard Law School Animal Law and Policy Clinic). However, FSIS needs specific types of comments and information that will inform the process of developing labeling regulations for meat and poultry products made using animal cell culture technology.

The ANPR is requesting comment on specific topics to be considered during rulemaking related to statutory and regulatory requirements for the labeling of these meat and poultry products. These include:

• Consumer expectations about the labeling of these products, especially in light of the nutritional composition and organoleptic qualities (taste, color, odor, or texture) of the products
• Names for these products that would be neither false nor misleading
• Economic data
• Any consumer research related to labeling nomenclature for products made using animal cell culture technology

The ANPR also discusses how FSIS will generally evaluate labels for these products if they are submitted before the agency completes rulemaking.

The ANPR is allowing a 60-day period for comment. To view the ANPR and information on how to comment or submit information, visit the FSIS website here.