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FSIS is proposing a new regulatory framework targeted at reducing Salmonella illnesses associated with poultry products. First, FSIS is proposing final product standards that would define whether certain raw poultry products contaminated with certain Salmonella levels and serotypes are adulterated and thus prohibited from entering commerce. FSIS is also proposing to revise the regulations that require that all poultry slaughter establishments develop, implement, and maintain written procedures to prevent contamination by enteric pathogens throughout the entire slaughter and dressing operation, by establishing new requirements pertaining to how establishments monitor and document whether their processes for preventing microbial contamination are in control. The proposal also focuses on a non-regulatory approach for controlling Salmonella on incoming flocks.

Statement of Need:

While the results of FSIS’ Salmonella verification sampling show that the Agency’s current prevalence-based performance standards approach has been effective in reducing the proportion of poultry products contaminated with Salmonella , these measures have not had an observable impact on human illness rates, estimated to be over 1 million annual Salmonella illnesses from all sources. Poultry is the leading source of Salmonella foodborne illness acquired domestically in the United States. Therefore, in October 2021, FSIS announced that it was mobilizing a stronger, and more comprehensive effort to reduce Salmonella illnesses associated with poultry products. As part of this effort, FSIS initiated several activities designed to gather data and information to inform and support future actions related to this new effort. FSIS also held a public meeting in November 2022 to solicit stakeholder input on a draft regulatory framework that the Agency was considering for a new strategy to control Salmonella in poultry products and provided an opportunity for stakeholders to submit written comments. After carefully evaluating the written comments and other stakeholder input, along with studies and information that have become available after FSIS made the framework under consideration available to the public, FSIS is proposing a new regulatory framework targeted at reducing Salmonella illnesses associated with poultry products.

Summary of the Legal Basis:

FSIS regulates the production of poultry prepared for distribution in interstate commerce under the authority of the Poultry Products Inspection Act (PPIA) (21 U.S.C. 451 et seq.). 21 U.S.C. 455(b) provides that the Secretary shall cause to be made by inspector's post-mortem inspection of the carcass of each bird processed, and at any time reinspection as he deems necessary of poultry and poultry products capable of use as human food. 21 U.S.C. 455(c) requires that all poultry carcasses and other poultry products found to be adulterated be condemned. Under the PPIA, a poultry product is adulterated, among other circumstances, if it bears or contains any poisonous or deleterious substance that may render it injurious to health; it is unhealthful, unwholesome, or otherwise unfit for human consumption; or it was prepared, packaged, or held under unsanitary conditions whereby it may have been rendered injurious to health (21 U.S.C. 453(g)(1), (3), and (4)). Finally, 21 U.S.C. 463(b) provides that the Secretary shall promulgate such other rules and regulations as are necessary to carry out the provisions of the PPIA.

Alternatives:

In addition to the proposed option, FSIS considered an alternative that would keep the current Salmonella performance standards. The Agency also considered alternatives for various Salmonella levels and serotypes for the proposed final product standards.

Anticipated Costs and Benefits:

FSIS estimates this proposal would benefit society by preventing Salmonella illnesses associated with poultry products. The proposal is also estimated to benefit industry by reducing the risk of illness outbreak-related recalls. The main cost associated with this proposal is the cost to industry associated with maintaining control of products sampled by FSIS for adulterants pending test results.

Risks:

FSIS estimates this proposal would benefit society by preventing Salmonella illnesses associated with poultry products. The proposal is also estimated to benefit industry by reducing the risk of out-break-related recalls. The main cost associated with this proposal is the cost to industry associated with maintaining control of products sampled by FSIS for adulterants pending test results.