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Historical Determination Makes Salmonella an Adulterant in a Raw Chicken Product

Salmonella illness levels have not really decreased over the last 20 years despite huge efforts by the regulatory agencies, especially USDA FSIS, to drive down Salmonella risks in poultry.  Although its prevalence has fallen in raw poultry, this has not translated to a reduction in human illness levels due to Salmonella. Because of this, FSIS has made it clear that it seeks to have an impact on Salmonella illness, and has, thus, initially targeted breaded chicken. However, we all should anticipate that this will expand to other poultry products over time.

Breaded chicken products have a history of linkage to Salmonella illness which is attributed to the way the product appears to be cooked even though it is raw. Thanks to changes in labeling, the frequency of outbreaks from breaded chicken is much less than in the past.  Nevertheless, it is an understandable initial target of FSIS.

That initial target is the naming of Salmonella as an adulterant in not ready-to-eat (NRTE) breaded stuffed chicken products (effective May 1, 2025). Undercooking of the product has been an issue for years with 14 associated Salmonella outbreaks and approximately 200 illnesses since 1998. By 2022, the USDA had decided that a broad initiative was needed to reduce Salmonella illnesses associated with poultry in the U.S., and in August 2022 announced that it would be taking action to declare Salmonella as an adulterant in the raw breaded stuffed chicken products.

In 2023, USDA FSIS released a proposed determination, and on May 1, 2024, it became law with the Federal Register publication of the final determination. Effective one year from that date, the determination sets down in history the first declaration of Salmonella as an adulterant in a raw poultry product.

Specifically, Salmonella will be considered an adulterant in raw breaded stuffed chicken products if the product tests positive for Salmonella at 1 colony forming unit per gram (1 CFU/g) or higher. To ensure producers are implementing controls, the FSIS intends to carry out verification procedures, including sampling and testing of the raw incoming chicken components used in the NRTE products prior to product stuffing and breading. We also would expect there to be a reassessment of a firm’s HACCP plans for these products to ensure that all critical controls related to the new requirements are in place.

This NRTE stuffed chicken product has been specifically called out because it is pre-browned and often appears to the consumer to be cooked, but the chicken is raw. Significant changes have been made to the labels to better inform consumers that the product is raw and to provide safe preparation instructions (specifically warning against microwave use, as this does not always ensure the frozen product reaches a safe internal temperature). However, labeling alone has not been able to eliminate consumer illnesses.

Thus, by declaring Salmonella to be an adulterant in these products, contaminated products will be kept off the market more often, and the safety of the product will not be so reliant on safe cooking practices by the consumer. However, even at less than 1 cfu per gram, if the product is temperature abused and the levels of Salmonella grow, it would pose a risk if the product is not cooked. So, this should be seen as an extra control not a total control.

FSIS made only one change in the final determination from that which was proposed in 2023. That is, based on public comments, FSIS modified the verification sampling location to provide greater flexibility and reduce costs to industry. Specifically, instead of collecting samples the producer’s completion of all processes needed to prepare the chicken to be stuffed and breaded, FSIS will collect verification samples on the raw incoming chicken components.

Additionally:

  • The final determination clarifies that the raw chicken components sampled by FSIS may be incorporated into the finished product as long as the products remain under the establishment’s control pending test results.
  • FSIS does not intend to begin the sampling and verification testing until May 1, 2025.
  • FSIS also reconsidered the economic effects in response and updated the final Cost Benefit Analysis (CBA).

With this one in the books, FSIS also plans to address Salmonella contamination in other raw poultry products later this year as a part of its overall effort to reduce Salmonella illnesses associated with raw poultry supply.

The full May 1 Final Determination of the Salmonella Not Ready-To-Eat Breaded Stuffed Chicken Products is available in the Federal Register.

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