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This notice of proposed rulemaking seeks public comments to inform future Food Safety and Inspection Service (FSIS) regulations for the labeling of meat and 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.

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:

FSIS will consider at least three alternatives for the rule:1) Adopting a naming convention that is preferred by cellular agriculture industry; 2) Adopting a naming convention that is preferred by traditional agriculture industry; 3) Adopting a naming convention that is preferred by consumers groups.

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.

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

Risks:

None.