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The Food Safety and Inspection Service (FSIS) is proposing to establish new requirements for the labeling of meat or poultry products made using animal cell-culture technology.

Statement of Need:

Many companies, both domestic and foreign, are currently developing cultured products derived from the cells of food animals amenable to the Federal Meat Inspection Act (FMIA; 21 U.S.C. 601 et. seq.) (cattle, sheep, swine, goats, and fish of the order Siluriformes, e.g., catfish) or the Poultry Products Inspection Act (PPIA; 21 U.S.C. 451 et seq.) (chickens, turkeys, ducks, geese, guineas, ratites, and squabs). Human food products derived from these species fall under FSIS jurisdiction.

Based on FSIS’ review of comments on the Advanced Notice of Proposed Rulemaking, the available literature, and the Agency’s ongoing interactions with the U.S. Food and Drug Administration (FDA) and industry, FSIS has determined that new regulatory requirements for labeling are necessary to ensure that cell-cultured meat and poultry products are truthfully and accurately labeled. Due to the novel method of production utilized to produce these products, the biological, chemical, nutritional, or organoleptic properties of some cell-cultured products may substantively differ from conventionally produced meat and poultry in a manner that is relevant to consumers. Moreover, these meat and poultry products, unlike any others on the U.S. market, are not derived from slaughter. It is imperative, therefore, that such products display unique labeling terminology that enables consumers to accurately identify the nature and source of such products.

Summary of the Legal Basis:

The Federal Meat Inspection Act (FMIA; 21 U.S.C. 601 et seq.) and the Poultry Products Inspection Act (PPIA; 21 U.S.C. 451 et seq.) require that meat and poultry products be truthfully and accurately labeled and that their labels be pre-approved by FSIS (21 U.S.C. 607(d) and 457(c), respectively), prior to movement in commerce. FSIS issues labeling regulations and reviews and approves meat and poultry product labels pursuant to these statutory labeling requirements. Food products made using animal cell culture technology and derived from the cells of livestock subject to the FMIA or the PPIA are subject to the labeling (and other applicable) requirements of these Acts and the regulations issued thereunder.

Alternatives:

In addition to the option proposed, the Agency would consider alternatives for the requirements for labeling of meat or poultry products made using animal cell culture technology.

Anticipated Costs and Benefits:

This proposed rule would benefit the public by providing truthful and accurate labeling of meat and poultry products produced using animal cell-culture technology. Consumers would be able to clearly differentiate cell-cultured products from other meat and poultry products to make better informed choices. The proposed rule would benefit industry because all producers would have consistent labels for their products made using animal cell-culture technology. It would also allow producers to design their labels with more certainty because producers would already be aware of FSIS labeling requirements for these products, reducing potential label modification costs.

FSIS expects its costs to be minimal and that current FSIS staffing would meet sketch approval needs.

Risks:

None.