The U.S. Department of Agriculture’s (USDA) Food Safety and Inspection Service (FSIS) published an advance notice of proposed rulemaking (ANPR) to solicit comments and information regarding the labeling of meat and poultry products made using cultured cells derived from animals under FSIS jurisdiction.

FSIS will use these comments to inform future regulatory requirements for the labeling of such food products.

“This ANPR is an important step forward in ensuring the appropriate labeling of meat and poultry products made using animal cell culture technology,” USDA Deputy Undersecretary for Food Safety Sandra Eskin said. “We want to hear from stakeholders and will consider their comments as we work on a proposed regulation for labeling these products.”

On March 7, 2019, USDA and FDA announced a formal agreement to jointly oversee the production of human food products made using animal cell culture technology and derived from the cells of livestock and poultry to ensure that such products brought to market are safe, unadulterated and truthfully labeled.

Under the agreement, FDA will oversee 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 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 FSIS’ jurisdiction.

Other than new labeling regulations concerning this product, FSIS does not intend to issue any other new food safety regulations for the cell-cultured food products under its jurisdiction. Current FSIS regulations requiring sanitation and Hazard Analysis and Critical Control Point (HACCP) systems are immediately applicable and sufficient to ensure the safety of products cultured from the cells of livestock and poultry.

FSIS 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). The agency, however, 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:

  • 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; and
  • 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.

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