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Statement of Need: Over the years, FSIS has made decisions about the jurisdiction under which food products containing meat or poultry ingredients are produced based on the amount of meat or poultry in the product; whether the product is represented as a meat or poultry product (that is, whether a term that refers to meat or poultry is used on labeling); whether the product is perceived by consumers as a product of the meat or poultry industries; and whether the product contains poultry or meat from an accepted source. With regard to the consumer perception factor, FSIS made decisions on a case-by-case basis, mostly in response to situations involving determinations for compliance and enforcement. Although this case-by-case approach resulted in decisions that made sense at the time that they were made, a review in 2004 to 2005 by a working group of FSIS and FDA representatives showed that some of the decisions do not appear to be fully consistent with other product decisions and that the reasoning behind various determinations was not fully articulated or supported.

Summary of the Legal Basis: Under the Federal Meat Inspection Act (FMIA) (21 U.S.C. 601 to 695), the Poultry Products Inspection Act (PPIA) (21 U.S.C. 451 to 470), and the Egg Products Inspection Act (EPIA) (21 U.S.C. 1032), and the regulations that implement these Acts, FSIS has authority over all meat food and poultry products and processed egg products. Under the Federal Food, Drug, and Cosmetic Act (FFDCA) and the regulations that implement it, FDA has authority over all foods not under FSIS’ jurisdiction, including dairy, bread and other grain products, vegetables and other produce, and other products, such as seafood. According to the provisions of the FMIA and PPIA, the Secretary has the authority to exempt certain human food products from the definition of a meat food product (21 U.S.C. 601(j)) or a poultry product (20 U.S.C. 454(f)) based on either of two factors: (1) The product contains only a relatively small proportion of livestock ingredients or poultry ingredients, or (2) the product historically has not been considered by consumers as a product of the meat food or poultry industry, and under such conditions as he or she may prescribe to ensure that the livestock or poultry ingredients are not adulterated and that the products are not represented as meat food or poultry products.

Alternatives: FSIS has considered over the years a number of variations to clarify the confusion regarding jurisdiction for these various products. Alternative 1: Maintain the status quo. Although FSIS has considered taking no action at this time, the Agency does not recommend this option because of the continued confusion that exists among industry and consumers as to jurisdictional coverage for nine categories of products. Alternative 2: Reassess the statutory factors for making jurisdiction decision and recommend an amendment. The amendment of the statute would be from the historical perception factor because that is the factor, of the two statutory factors, that the working group identified as leading to the state of confusion about the jurisdiction of certain products containing meat or poultry. Alternative 3: Adopt some of the FDA/FSIS working group’s suggested approach to making clear and transparent jurisdiction decisions by proposing changes to regulations to codify the current policies on exempted products.

Anticipated Costs and Benefits: FSIS estimates that the initial and recurring costs of the rule to industry would be approximately $5 million and $7 million, respectively. These costs would be attributable to new Sanitation SOP and HACCP plan development, as well as to labeling changes and training. FSIS would incur $7 million in annual recurring costs (salaries and benefits). Establishments coming under FSIS jurisdiction also would incur costs for recordkeeping, monitoring, testing, and annual HACCP plan reassessment. Benefits to industry would accrue from reduced confusion over Agency jurisdiction, which may affect labeling and recordkeeping costs. There may be spill-over benefits accruing from changes in consumer behavior. Also, there would be improvement in efficiency in use of FDA and FSIS resources.

Risks: None