On August 7, 2024, the U.S. Department of Agriculture’s (USDA) Food Safety and Inspection Service (FSIS) published its proposed Salmonella Framework for Raw Poultry Products. The proposed framework would create final product standards for certain raw poultry products contaminated with Salmonella. Specifically, it would declare products adulterated when contaminated with certain levels or distinguishable strains, also called serotypes, of Salmonella. Additionally, the rule proposes revisions to the regulations for poultry slaughter establishments slaughter and dressing processes. FSIS is inviting interested people and organizations to submit comments on the proposed framework. The comments will be taken into consideration as FSIS drafts the final rule.
Background on FSIS regulation of Salmonella
Salmonella is a bacterium which often causes an illness called salmonellosis. A Salmonella infection usually results from eating food or drinking water that is contaminated with the bacteria. The Centers for Disease Control and Prevention (CDC) estimates that 1.3 million illnesses and 420 deaths each year in the U.S. result from non-typhoidal Salmonella. Specifically, FSIS estimates Salmonella causes 125,115 chicken-associated and 42,669 turkey-associated foodborne illnesses per year.
Deriving authority from the Poultry Products Inspection Act (PPIA), FSIS has jurisdiction over the inspection of poultry products. FSIS splits authority over the regulation of food with the Food and Drug Administration (FDA), but FSIS specifically has jurisdiction over meat, poultry, catfish, and unshelled egg products. Through the PPIA, FSIS is tasked with ensuring poultry products are “wholesome, not adulterated, and properly marked, labeled, and packaged.” 21 U.S.C. § 451. A poultry product is deemed adulterated if “it bears or contains any poisonous or deleterious substance which may render it injurious to health.” 21 U.S.C. § 453. To learn more about FSIS’ regulation of adulterated food generally, click here to read NALC article “The Adulterating Foodborne Pathogens: Meat, Poultry, and Some Egg Products.”
Despite the large number of illnesses that result from its presence in food, Salmonella, like most foodborne pathogens, has not historically been considered an adulterant in raw and other not ready-to-eat (NRTE) meat and poultry products. This is because there is an assumption that ordinary cooking will destroy the pathogen. The exception to the assumption is for E. coli O157:H:7 and certain non-O157 Shiga toxin-producing Escherichia coli (STEC) in raw, non-intact beef products and intact cuts that are to be further processed into non-intact products before being distributed for consumption. The exception exists because these pathogens remain “injurious to health” on what many consumers believe to be properly cooked non-intact beef products. For example, many consumers would believe a hamburger patty that is “medium rare” is properly cooked even though the meat was not cooked to a temperature hot enough to destroy all pathogens present.
Unlike STEC pathogens in beef products, Salmonella in poultry has not been considered an adulterant until this year. One of the main reasons for this is because it was believed that ordinary consumer cooking and preparation practices of poultry products would kill pathogens. However, a number of consumer behavior research studies suggest that the actual practices consumers use do not adequately ensure the products will not be contaminated when consumed. For example, FSIS recommends cooking poultry products until the center of the meat reaches a minimum internal temperature of 165° F as measured by a meat thermometer. However, instead of using a meat thermometer to check that the meat has reached the proper temperature, many consumers will rely on visual cues, such as color or juice clarity, which does not ensure that all pathogens have been destroyed. In light of these studies, in May 2024, Salmonella was officially declared an adulterant for the first time. This final rule declared that not ready-to-eat (NRTE) breaded stuffed chicken products that contain Salmonella at levels of 1 Colony Forming Unit per gram (cfu/g) or higher are adulterated. This rule was a part of a larger FSIS effort to decrease the occurrence of Salmonella in raw poultry products.
2021 Salmonella Comprehensive Effort
In 1996, FSIS established its current regulatory scheme for Salmonella. The Salmonella verification testing program established Salmonella pathogen reduction performance standards for certain poultry slaughter establishments. The purpose of the Salmonella performance standards for raw products is to allow FSIS to verify whether slaughter establishments have effective process controls to address Salmonella. The current performance standards are expressed as a fraction of the maximum number of allowable Salmonella-positive results over a targeted number of samples collected and analyzed in a 52-week window. However, since Salmonella is not considered an adulterant, using solely the establishment’s performance standard results, FSIS does not have the ability to withdraw its mark of inspection or prevent products produced in the establishment that fail performance standards from entering commerce.
While FSIS sampling data indicates that the occurrence of Salmonella in raw poultry products has decreased since FSIS implemented its performance standards, there has not been a corresponding observed reduction in Salmonella illness in the United States. In fact, the estimated rate of human Salmonella infections has remained consistent over the past two decades. After a number of petitions to FSIS requesting action to declare Salmonella an adulterant, in 2021 FSIS announced it was mobilizing a stronger, and more comprehensive effort to reduce Salmonella illness associated with poultry products by 25%. The final rule declaring Salmonella an adulterant in raw breaded stuffed chicken products was one piece of the comprehensive effort. Additionally, FSIS released a preliminary draft of this framework in 2022 highlighting three components of its effort:
- Component One. Requiring that establishments characterize Salmonella as a hazard reasonably likely to occur at receiving and requiring that incoming flocks be tested for Salmonella before entering an establishment.
- Component Two. Enhancing establishment process control monitoring and FSIS verification.
- Component Three. Implementing an enforceable final product standard that would define whether certain raw poultry products contaminated with certain levels and/or serotypes of Salmonella are adulterated.
FSIS received stakeholder comments on the draft and held public meetings to gather feedback. The proposed rule includes Component Three and Component Two but leaves out Component One. People and organizations interested in the rule may submit formal comments here until October 7, 2024.
Proposed Rule
Component Three
The proposed rule includes the final product standards introduced in Component Three of the 2022 draft. The rule proposes to classify raw chicken carcasses, chicken parts, comminuted chicken, and comminuted turkey as adulterated if they contain any type of Salmonella at or above 10 cfu/g or contain any detectable level of at least one of the Salmonella serotypes of public health significance identified for that commodity. At the time of the proposed rules publication, the proposed serotypes of public health significance for chicken are Enteritidis, Typhimurium, and I 4,[5], 12:i:-, and for turkey are Hadar, Typhimurium, and Muenchen. Selected serotypes are considered of “public health significance” because they are the distinguishable strains of Salmonella more frequently associated with illness. However, FSIS intends to reevaluate the serotypes of public health significance every 3-5 years at a minimum and whenever new information on Salmonella serotypes becomes available. FSIS claims that implementing Component Three will help achieve its goal of reducing Salmonella illness by 25% because it is setting an enforceable final product standard. By declaring Salmonella an adulterant, FSIS will have the ability to prevent raw poultry products with certain levels and serotypes of Salmonella contamination from entering the stream of commerce.
Component two
The second component of the proposed framework creates enhanced process control monitoring for poultry slaughter establishments. This will introduce new requirements for the establishments to monitor and document their process for preventing microbial contamination in the slaughter and dressing operation. The proposed rule would mandate establishments incorporate statistical process control (SPC) monitoring principles for their microbial monitoring program (MMP). SPC monitoring uses statistical methods to compare quantitative results against predefined benchmarks to determine whether a process is operating within expected parameters. Additionally, the proposed rule would require microbial organism sampling to occur at rehang and post-chill locations, and it would require more frequent sampling based on the size of the slaughter establishment. For example, under the proposed rule, an establishment that annually slaughters between 440,001 and 1,100,000 chickens must weekly conduct microbial organism sampling. However, an establishment that annually slaughters more than 1,100,000 chickens must conduct microbial organism sampling on one chicken for every 22,000 chickens.
The proposed rule also requires that poultry slaughter establishments maintain daily records that sufficiently document its implementation and monitoring procedures. The microbial sampling results must be electronically submitted to FSIS every month.
Component one
Component One of the 2022 framework draft considered whether poultry slaughter establishments should characterize Salmonella as a hazard reasonably likely to occur at receiving and considered whether to require incoming flocks be tested for Salmonella before entering an establishment. This would have required an incoming flock to meet a predetermined target level of Salmonella at receiving. Under the proposed rule, FSIS determined that current research does not show that testing for a predetermined Salmonella level at receiving eliminates contamination in raw poultry products. Additionally, stakeholder comments indicated that these measures would impose an overwhelming burden on small producers and processors.
Conclusion
FSIS published the proposed Salmonella Framework for Raw Poultry Products. This long-awaited rule incorporates two of the three components included in the prior 2022 draft framework. Component Three would declare Salmonella an adulterant in raw chicken carcasses, chicken parts, comminuted chicken, and comminuted turkey products contaminated with certain Salmonella levels and serotypes. Component Two creates enhanced process control monitoring for poultry slaughter establishments. FSIS is receiving public comments on the proposed framework until October 7, 2024.
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