The final determination1 comes in advance of a broader reassessment of the Agency’s Salmonella policy anticipated through its Salmonella Framework. The announcement finalizes the Agency’s proposed determination published in April 2023 and previews how FSIS might approach Salmonella in other raw poultry products. The determination will go into effect May 1, 2025. FSIS has issued FSIS Notice 15-24 to inspectors, instructing them to implement the final determination on its effective date.

FSIS’s Final Determination

FSIS’s final determination is largely consistent with its 2023 proposed determination and declares that NRTE breaded stuffed chicken products that contain Salmonella at levels of 1 colony forming unit (CFU)/g or higher are adulterated within the meaning of the Poultry Products Inspection Act (PPIA). FSIS made one primary change from its proposed determination: instead of collecting samples after the establishment has completed all processes needed to prepare the chicken component to be stuffed and breaded to produce a final NRTE breaded stuffed chicken product, FSIS will collect verification samples on raw incoming chicken components.

Key components of the final determination are below:

• Products Affected: The new standard will apply to the specific and narrow category of NRTE breaded stuffed chicken products, such as chicken Kiev or chicken cordon bleu. FSIS clarified that the standard will not apply to breaded products that are not stuffed, such as chicken nuggets, or to stuffed products that have not had their breading set such that they could appear RTE (e.g., a retail-prepared chicken cordon bleu product with breading but that has not been par-cooked to set the breading). 
• Adulteration Standard: FSIS will consider affected products adulterated if they contain 1 CFU/g Salmonella or higher. The standard will apply to the entire finished product, although FSIS plans to conduct verification sampling by testing only the chicken component. FSIS clarified, however, that samples from finished product (e.g., collected at retail) would still be evaluated against the 1 CFU/g standard.
• Sampling and Verification: FSIS’s sampling and verification testing would begin from May 1, 2025. FSIS will collect one pound of chicken as a raw material to analyze a 325 grams per test for Salmonella. As discussed in the proposed determination, FSIS estimates negative results will routinely be available within 48 hours of the samples’ shipment to the laboratory, assuming the laboratory receives and is able to enrich the sample overnight. FSIS estimates it will take another three days to confirm a positive result and return the enumeration result. Establishments would be permitted to divert lots that test positive for Salmonella above the 1 CFU/g threshold for use in fully cooked applications or other raw products where consumer cooking practices are more likely to mitigate risk.
• Lotting: FSIS will expect establishments to develop microbiologically independent lotting practices for incoming raw product and maintain control of the tested product until FSIS receives its results. Establishments may incorporate the chicken that has been sampled into finished NRTE breaded stuffed chicken products so long as these remain under the establishment’s control until the test results become available. FSIS refers companies to its existing lotting guidance, which the Agency says it will update to reflect the requirements of the final determination.2
• HACCP Reassessment: Consistent with FSIS regulations that require establishments to reassess adequacy of their Hazard Analysis and Critical Control Point (HACCP) plans annually and whenever changes occur that could affect their underlying hazard analysis, establishments that manufacture these products will be required to reassess their HACCP plans before the determination’s effective date.3 If the establishment makes changes to its production process as a result of this reevaluation, the establishment will need to revalidate its HACCP plan. Establishments must complete their reevaluation and revalidate their HACCP plan (if necessary) by May 1, 2025.

States that have their own poultry inspection programs for products produced for purely intrastate commerce will need to adopt sampling procedures and testing methods that align with the final determination’s standard. Although FSIS says no foreign country exports NRTE breaded stuffed chicken products to the United States, if one did, it would need to apply inspection, sanitation, and other standards equivalent to those of FSIS, including alignment with the final determination.

FSIS notes that while it typically performs baseline studies to estimate the national prevalence of bacteria of public health concern, such a study was not warranted for the breaded stuffed NRTE chicken product category because there are only six federally regulated establishments that produce these products.

The scope of the determination remains narrow—the NRTE but appears RTE chicken category includes only breaded and stuffed raw chicken products, such as frozen chicken cordon bleu and chicken Kiev, that are not visibly raw. However, the determination is significant in that it could indicate how FSIS could move to treat Salmonella in other meat or poultry products in the future. FSIS is currently evaluating its approach to Salmonella control in raw poultry through its proposed Salmonella Framework. That proposed framework referenced FSIS’s plan for NRTE but appears RTE breaded and stuff chicken products, and the proposed framework also draws heavily on FSIS’s policy for certain strains of E. coli in raw non-intact beef. In the final determination, FSIS states it “has not made a determination about whether Salmonella is an added substance in any other raw poultry products,” and it will address this issue in a subsequent rulemaking after proper notice and comment.4 Nonetheless, the approach taken in the final determination is highly suggestive of how FSIS might proceed with addressing Salmonella in raw poultry more broadly.

Justification for the Final Determination

Historically, FSIS has not considered Salmonella an adulterant in raw poultry products because proper cooking destroys the pathogen. In its determination, FSIS reiterates that even though industry has worked to update labeling of NRTE breaded stuffed chicken products to better inform consumers that the products are raw and provide appropriate cooking instructions on safe preparation, the products continue to be associated with foodborne illness outbreaks. FSIS points to numerous Salmonella illness outbreaks associated with consumption of NRTE breaded stuffed chicken products dating back to 1998 (note that most of these outbreaks occurred prior to 2015). The Agency concludes that based on this historical precedent, the product labeling and improved consumer education efforts will not effectively prevent future illnesses associated with the NRTE breaded stuffed chicken product category, and the final determination’s product standard is a needed preventive measure to protect public health.

In the final determination, FSIS responds to concerns about the Agency’s legal justification for the rule. As in the proposed determination, the Agency relies on its authority to declare Salmonella an adulterant in NRTE breaded stuffed chicken products under two separate provisions of the PPIA:

• Section 453(g)(1): Added poisonous or deleterious substances are adulterants if they “may” render product injurious to health.
• Section 453(g)(3): Products are adulterated if they are unsound, unwholesome, or otherwise unfit for food.

FSIS classifies Salmonella as an “added substance” in this product category: The final determination signals a change in FSIS’s longstanding interpretation that Salmonella is “naturally occurring” in broilers, which subjects it to a different standard under the PPIA.5 Responding to comments arguing the product is not “added” because Salmonella is present in the gastrointestinal tract of live birds and in poultry skin, livers, bones, bone marrow, and even muscle tissue before processing, FSIS reiterates Salmonella is not ordinarily found in chicken muscle tissue, and because previously uncontaminated chicken components can be introduced to Salmonella-contaminated chicken components during processing, the Salmonella is an added substance. FSIS focused specifically on the potential for Salmonella present on skin to become incorporated into muscle tissue through the comminution process. FSIS also rebutted studies offered by commenters showing the presence of Salmonella in muscle tissue.

As in its earlier proposal, FSIS continues to draw parallels to its approach to E. coli O157:H7 and other Shiga toxin-producing E. coli in raw nonintact ground beef. FSIS looks to factors such as severity of illness and infectious dose to support its determination.

FSIS states it also believes Salmonella at 1 CFU/g in NRTE breaded stuffed chicken products meets the more stringent standard for non-added substances, which are considered adulterants only when they render the product “ordinarily injurious to health.” FSIS notes that consumers do not reliably prepare these products properly, even with proper labeling and cooking instructions.

FSIS finds Salmonella renders these products unsound, unwholesome, and otherwise unfit for food: The Agency also points to a second standard for adulteration, that these products are unsound, unwholesome, or otherwise unfit for food, because the products present a “sufficiently serious risk of causing Salmonella illness” given the prevalence and severity of human illnesses associated with Salmonella, Salmonella’s infectious dose, and consumer preparation practices associated with the NRTE breaded stuffed product category.6 FSIS concludes, “[b]ecause Salmonella can survive ordinary handling and cooking practices for NRTE breaded stuffed chicken products, FSIS has determined that the appropriate response to protect public health is to ensure that products contaminated with Salmonella at levels more likely to cause human illness are excluded from commerce.”7

Cost Benefit Analysis

FSIS updated its cost-benefit analysis as part of the final determination, assessing the total estimated industry cost of the determination at $5.29 million annually over a ten-year period (up from $4.33 million annually in the Agency’s initial cost-benefit analysis). FSIS expects the determination to impact six domestic establishments. The costs considered in the assessment include the need for establishments to hold the relevant products while waiting for the results of FSIS’s verification testing, reassessing establishment HACCP plans to reflect the new policy, and implementing a Salmonella sampling and testing program. The analysis recognizes that establishments may incur additional expenses not calculated in the cost-benefit analysis, such as HACCP plan validation, training, formula changes, process changes, and label changes.

FSIS assesses the estimated quantified benefit of one prevented outbreak-related recall being $34.99 million (up from $25.85 million in the proposed determination), concluding that the policy will “break even” if it helps avoid 1,134 illnesses annually.

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Please contact us with any questions you may have regarding the final determination.