Specifically, FSIS is proposing to declare Salmonella an adulterant in raw poultry when Salmonella is present at great than 10 colony forming units (CFU) per gram or milliliter and certain serotypes of public health concern are present. In addition, FSIS is proposing to revise regulations in 9 CFR 381.65(g) and (h) to require that poultry slaughter establishments incorporate statistical process control (SPC) monitoring principles into their microbial monitoring programs (MMPs) and submit microbial monitoring sampling results to FSIS electronically and to require additional sampling at certain processing steps. Comments on this proposed framework are due on October 7, 2024.

Background

The proposed framework¹ is the culmination of a three-year effort to reevaluate FSIS’s strategy to control Salmonella in poultry products. FSIS initiated several activities in October 2021 designed to gather information that would inform and support future actions related to reducing Salmonella illnesses. These activities included (1) conducting a risk profile of pathogenic Salmonella subtypes in poultry and developing one quantitative risk assessment for chicken and one for turkey;2 (2) charging the National Committee on Microbiological Criteria for Food (NACMCF) to provide guidance on the types of microbiological criteria FSIS might use to better prevent Salmonella illnesses from poultry products; and (3) beginning an exploratory sampling program for young chicken carcasses to generate data that will inform future policies.³ In addition, FSIS published a final determination earlier this year declaring Salmonella an adulterant in certain raw breaded stuffed chicken products.⁴

On October 17, 2022, FSIS published a draft regulatory framework to control Salmonella in poultry comprised of three components⁵:

Component 1: Requiring that incoming flocks be tested for Salmonella before entering an establishment.

Component 2: Enhancing establishment process control monitoring and FSIS verification.

Component 3: Implementing an enforceable final product standard.

The draft framework also addressed cross-cutting issues associated with testing for Salmonella, considerations for small and very small establishments, and data sharing. FSIS subsequently hosted a virtual public meeting to discuss the framework and later accepted stakeholder comments. The current proposed framework incorporates stakeholder input provided on the October 2022 draft framework, and makes several changes, including the following important points: 1) FSIS declined to require that establishments characterize Salmonella as a hazard reasonably likely to occur and test incoming flocks for Salmonella; 2) FSIS proposes revising regulations in 9 CFR 381.65(g) and (h) to require that all poultry slaughter establishments develop and maintain written SPC procedures to prevent contamination throughout the entire operation and maintain records documenting those procedures; and 3) FSIS is proposing enforceable final product standards that would consider certain raw poultry products to be adulterated if they contain Salmonella at or above a 10 CFU/g or mL threshold level and a serotype of public health significance is present. The serotypes of public health significance would vary by species and be subject to updating over time.

We briefly summarize the relevant portions of the framework below.

The Proposed Framework

The proposed framework continues the “three component” approach introduced in the 2022 Draft Framework, although it has de-emphasized parts. We provide a summary of the proposed framework below.  

Component 1: Pre-Harvest Measures

FSIS proposed to focus on non-regulatory approaches, such as guidance documents, to drive reductions in incoming Salmonella loads on poultry flocks. This marks a change from the draft framework, in which FSIS considered setting incoming Salmonella thresholds and requiring establishments to treat Salmonella as a hazard reasonably likely to occur.⁶

Component 2: Proposed Regulation – Enhanced Establishment Process Control Monitoring

FSIS is proposing to require that poultry slaughter establishments implement SPC programs to test for and analyze microbial indicators at the rehang and post-chill steps.  Specifically, FSIS is proposing to revise the regulations in 9 CFR 381.65(g) and (h) to require all poultry slaughter establishments to develop, implement, and maintain written procedures to prevent contamination by enteric pathogens throughout the entire slaughter and dressing operation and maintain records documenting those procedures. The following is a brief summary of the key elements of Component Two as proposed in the current framework.

• SPC requirements. Under the new proposal, establishments would be required to incorporate SPC monitoring principles into their microbial monitoring programs (MMPs). FSIS proposes three specific requirements. Establishments must:

  1. Use only validated and fit for purpose microbial sampling and analysis procedures to generate and record statistically meaningful microbial monitoring data,

  2. Set benchmarks used to evaluate microbial monitoring data, and

  3. Define the statistical methods the establishment will use to evaluate the recorded data against the predefined limits.

• Sample frequency. Establishments would have to collect paired samples at a rate of 1 per 22,000 birds (chicken) or 1 per 3,000 birds (turkey). Low and very low volume establishments would have to collect at least 13 weekly pairs per year.
• Corrective actions. FSIS proposes requiring establishments to implement written corrective actions, including a root cause assessment, when microbial monitoring results deviate from the predefined criteria in the MMP, process control monitoring results, or the process control determination made for the HACCP program.

• Guidance. FSIS is developing guidance to help establishments meet the proposed updated sampling and analysis requirements under 9 CFR 381.65(g). The guidance includes several key elements.

  1. Establishments would implement an SPC sampling plan based on paired sampling for aerobic plate count (APC) at rehang and post-chill locations. This includes a one-sided process control statistical model that charts and calculates against minimum monitoring criteria at the minimum required frequency.

  2. Establishments that follow the guidance would not have to provide the Agency with additional information to support their chosen statistical methods.

  3. FSIS would make available to all poultry slaughter establishments an electronic spreadsheet that calculates monitoring measures for the guidance sampling plan as results are entered.

• Electronic submission of results. FSIS is proposing to amend the recordkeeping requirements under 9 CFR 381.65(h) to require that establishments submit their microbial monitoring sampling results to FSIS electronically. The Agency is developing a web portal that would allow establishments to upload sampling information directly to FSIS. Further, FSIS would provide a template that establishments can use to record monthly results before submitting the template directly to the portal. Establishments that do not choose to use the template would need to manually enter their data each month.
• Small plants. Eligible very small and very low volume establishments would have access to laboratory services provided by FSIS at no charge.

Component 3: Proposed Determination for Final Product Standards

FSIS is proposing an enforceable final product standard by which the agency would consider certain raw poultry products to be adulterated if they contain Salmonella at or above a 10 CFU threshold level and any detectable amount of a Salmonella serotype of public health significance.

The proposed standards for chicken carcasses and chicken parts, comminuted chicken, and comminuted turkey are summarized in the following table. Specifically, for parts, FSIS focuses its proposed determination on legs, thighs, breasts, wings, quarters, and halves.

FSIS addresses several additional aspects of its proposed determination:

• Updating serotypes. FSIS plans to re-evaluate the levels and serotypes listed above every 3-5 years at a minimum and whenever new information on Salmonella serotypes becomes available. FSIS would consider, among other things, outbreak illness data, foodborne illness surveillance data, product testing data, and animal testing data when evaluating serotypes in the future.
• Verification testing. FSIS plans to implement a routine sampling and verification testing program for Salmonella.⁷ FSIS in For chicken carcasses and parts, FSIS intends to collect a rinsate sample from the establishment to analyze 30 mL per test for Salmonella. FSIS would collect 1 lb. of comminuted chicken or turkey from an establishment to analyze 325 g per test for Salmonella. Establishments would be required to hold any affected lots pending the results of FSIS’s verification testing. FSIS suggests that it may be able to obtain actionable results within 5 days of sampling.
• Defining independent lots. Because test results will be attributed to the production lot in question, lot definition will become especially important. The proposed determination provides limited guidance, indicating that production lots should be defined such that they are microbiologically independent, which is documented by separation (physical, temporal, or by sanitation intervention) that clearly delineates the end of one production lot and the beginning of the next. FSIS recommends that establishments develop and implement in-plant sampling plans that define production lots or sub-lots that are microbiologically independent of other production lots or sub-lots. FSIS proposes updating its lot control guidance to cover Salmonella sampling of raw poultry products.⁸
• Phasing out the performance standards. FSIS plans to phase out all current Salmonella performance standards for poultry in favor of the new proposed framework, which would result in performance standards no longer being published on FSIS’s website.

Rationale for Salmonella as an Adulterant

FSIS’s proposed determination would reflect a tremendous shift in how FSIS regulates pathogens in raw products. To support its proposed determination, FSIS relied on its prior determination that Salmonella is an adulterant in not ready to eat (NRTE) breaded stuffed chicken products. Historically, Salmonella and other foodborne pathogens were not considered adulterants in raw and NRTE meat and poultry products based on the premise that ordinary cooking is sufficient to destroy the pathogens. The one exception to this rule was certain E. coli strains, which are considered adulterants raw nonintact beef because they are added “render injurious to health” beef products consumers believe to be properly cooked. In reviewing its approach to E. coli in raw non-intact beef, FSIS characterized its decision as being based on E. coli in raw non-intact beef: (1) having been associated with illness and outbreaks, (2) having a relatively low infectious dose, (3) being able to cause serious illness in humans, and (4) being able to survive what many consumers consider ordinary preparation and cooking practices.

After finding that these characteristics also apply to Salmonella in NRTE stuffed chicken products, FSIS made a similar finding here. FSIS evaluated the available information on Salmonella in chicken carcasses, chicken parts, comminuted chicken, and comminuted turkey using the same four factors discussed above:

• First, FSIS found that the serotypes identified in this proposed framework were more likely to cause illness than other Salmonella serotypes.

• Second, FSIS considered multiple peer-reviewed studies and previous outbreaks, finding that Salmonella can cause illness from 10 or fewer organisms per person.

• Third, a FSIS 2023 risk profile found that Salmonella can cause severe and debilitating health outcomes.

• Fourth, FSIS viewed several consumer behavior studies as indicating that ordinary consumer preparation and cooking practices–including handling of raw poultry and proper thermometer use–do not adequately protect against Salmonella contamination in consumed products.

Based on this evaluation, the Agency tentatively determined that raw chicken carcasses, chicken parts, comminuted chicken, and comminuted turkey products that contain Salmonella levels and serotypes identified in the final product standard are adulterated because they contain a “poisonous or deleterious substance” that renders them “injurious to health.”⁹ Furthermore, the elevated risk of illness associated with these Salmonella serotypes and levels makes them “unhealthful, unwholesome, or otherwise unfit for human food.”¹⁰

Next Steps

Comments on the proposed framework are due on October 7, 2024. We will continue to stay apprised of FSIS’s efforts regarding Salmonella in poultry. Please contact us if you have any questions.