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  6. FDA Regulated Meats and Meat Products for Human Consumption
  1. Meat Guidance Documents & Regulatory Information

FDA Regulated Meats and Meat Products for Human Consumption

Meat and meat products are regulated by both the U.S. Food and Drug administration (FDA) and the United States Department of Agriculture (USDA). The USDA Food Safety and Inspection Service (FSIS) has primary responsibility for regulating meat from the species of animals listed in the Federal Meat Inspection Act and the Poultry Products Inspection Act. These animals are considered “amenable species” and include cattle, sheep, swine, goats, domestic poultry (chickens, turkeys, ducks, geese, and guinea), ratites, and squab.

The FDA regulates game meats and game meat products, referred to as “non-amenable” meats. These animals include antelope, bison, deer, elk, reindeer, muskrat, non-aquatic reptiles, opossum, rabbit, raccoon, squirrel, water buffalo, grouse, pheasant, quail, wild turkey, wild geese, and wild ducks.

Information for Industry

Non-amenable meats and meat products are from animals and birds that are reared, slaughtered, and commercially sold for food. The 2022 Food Code (3-201.17) generally provides for food establishments to use game meat that is processed under a voluntary inspection program or through a regular inspection program, as allowed by law. All non-amenable meat and meat products must meet the FDA’s requirements, including the FDA’s labeling requirements for packaged foods.

The USDA Food Safety Inspection Service can perform voluntary inspections (fee for service) for certain non-amenable species, under the Agricultural Marketing Act of 1946. More information can be found at Voluntary and Other Reimbursable Inspection Services. FDA-regulated, or non-amenable, meats that are slaughtered under voluntary inspection of USDA FSIS may receive a USDA FSIS voluntary mark of inspection.

Meat and meat products from animals diagnosed with a disease may be considered adulterated under the Federal Food, Drug, and Cosmetic Act (FD&C Act) and, if so, may not be sold in interstate commerce.

Import Requirements

FDA-regulated, or non-amenable, meats and meat products imported to the US from other countries must meet the same FDA safety standards applied to all foods domestically produced and offered for entry into U.S. interstate commerce. Companies exporting FDA-regulated meat to the U.S. must comply with all applicable FDA regulations, including registration and prior notice requirements. Any imported food under FDA jurisdiction must be safe, wholesome, properly labelled and fully compliant with all applicable FDA requirements.  Domestic and international food shipments found not to comply with the provisions of the Federal Food, Drug, and Cosmetic Act (FD&C Act) must be brought into compliance, destroyed, or if from other countries, may be re-exported.

The FDA does not require a license to import food. However, as mentioned above, the FDA requires the registration of food facilities that export foods to the U.S., and prior notification of food (including animal feed) that is imported or offered for import into the United States. The FDA may inspect foreign facilities, and the FD&C Act provides that the FDA shall refuse admission of a food from a foreign establishment of which the owner, operator, or agent in charge, or the government of the foreign country, refuses to permit entry of FDA investigators.  In addition, shipments are evaluated at entry by U.S. Customs and Border Protection on behalf of the FDA and are subject to examination at entry by the FDA.

The United States Department of Agriculture (USDA) Animal and Plant Health Inspection Service (APHIS) may have additional requirements for meat offered for import into the United States. APHIS monitors the importation into the U.S. of meat and poultry to prevent infectious disease spread by animals. Additionally, some U.S. states may have specific requirements for importation into their jurisdiction. The importer or U.S. agent for the firm may be able to provide additional information regarding specific U.S. state requirements and/or APHIS requirements.

Relevant Regulations and References

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