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Salmonella Framework for Raw Poultry Products

Salmonella Framework for Raw Poultry Products

by Dionne S. Meehan, EAS Consulting Group Independent Consultant

On August 7, 2024, the United States Department of Agriculture’s (USDA) Food Safety and Inspection Service (FSIS) published its updated “Salmonella Framework for Raw Poultry Products” consisting of a proposed rule and proposed determination that would declare Salmonella an adulterant in raw poultry under certain circumstances.

FSIS is proposing to declare Salmonella an adulterant in raw poultry when Salmonella is present at greater than 10 CFR/g or ml 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.

Background

In October 2022, FSIS published a Salmonella Framework document, a precursor to a proposed rule and determination, which shared the agency’s thinking on an alternative approach to reducing Salmonella contamination in raw poultry and related illnesses.

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.

Major Impact Highlight:

The draft regulatory framework is comprised of three key components and would apply to raw chicken carcasses, chicken parts, comminuted chicken, and comminuted turkey.

Component 1: Focuses on non-regulatory approach for mitigating the risk of introducing Salmonella into the processing establishment (pre-harvest measures), thereby requiring that incoming flocks be tested for Salmonella before entering an establishment.

Component 2: Establishments would be required to incorporate statistical process control (SPS) monitoring into their microbial monitoring programs (MMPs) with FSIS verification. Would revise 9 CFR 381.65(g) and (h).

Component 3: Implements an enforceable final product standard 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 is present. *Serotypes of public health impact would be subject to updating over time and vary by species.

Proposed Regulatory Framework:

  1. Pre-Harvest Measures – This marks a significant shift in that FSIS considered setting incoming Salmonella thresholds and requiring establishments to treat Salmonella as a hazard reasonably likely to occur.
  2. Establishment Microbial Process Control Monitoring/Statistical Process Control Programs – FSIS proposes establishments test and analyze microbial indicators at the rehang and post chill steps. FSIS proposes the following specific requirements:
  1. Utilize only validated and fit for purpose microbial sampling and analysis procedures to generate and record statistically meaningful microbial monitoring data.
  2. Establish benchmarks utilized to evaluate microbial monitoring data.
  3. Define statistical methods the establishment will utilize to evaluate the data against the predetermined limits.
  4. Establish a sample frequency [1 per 22,000 birds (chicken) or 1 per 3,000 birds (turkey)]. Low and very low volume would be required to collect a minimum of 13 weekly pairs per year.
  5. Require establishments to implement written corrective actions, including root cause assessment when microbial monito0ring results deviate from the predetermined limits or the process determination made for the HACCP program.
  6. 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 selected 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
  1. 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 monthly via a web portal that is currently in development (the agency would also provide a data template).
  2. Very small plants and low volume establishments would have access to laboratory services provided by FSIS at no charge.
  3. 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.
Salmonella Framework for Raw Poultry Products

It is important to note that implementation of this regulation is currently frozen and is now subject to review by the administration. This does not mean however that it will be discarded or rescinded.

Regulatory Reference:

Posted in Foods, Issue of the Month.