Although Friday’s announcement provides only an overarching proposed framework—with many details to be filled in—the proposal would address Salmonella control at live receiving (i.e., when birds enter the establishment), change testing requirements during raw poultry processing, and implement an enforceable standard for Salmonella in finished products.¹ The proposed framework outlines a general regulatory approach. It does not provide specific details on how the framework would be implemented, and it is not a proposed regulation. FSIS likely plans to issue more specific policy proposals after receiving input on its proposed framework.  FSIS plans to hold a public meeting on November 3 to solicit input on its proposed framework, and written comments are due by November 16. 

FSIS’s proposed Salmonella framework comes amidst a number of ongoing agency actions focused on Salmonella in raw poultry. For example, FSIS earlier indicated its plans to propose declaring Salmonella an adulterant in raw breaded and stuffed not ready to eat chicken products,² and, in conjunction with its proposed Salmonella framework, FSIS has solicited input from its advisory committees and is conducting a risk assessment for Salmonella in raw poultry.

Proposed Framework

The proposed framework would impose significant changes to Salmonella control at three specific points in the raw poultry production process. The proposed framework is presented generally and without many supporting details about how the agency would implement the contemplated requirements.  

• Live Receiving Controls
  • FSIS is considering requiring establishments to treat Salmonella as a hazard reasonably likely to occur at the live receiving step. Doing so would require establishments to implement a Critical Control Point to control the hazard under their HACCP plans. 
  • FSIS is considering requiring that incoming flocks entering an establishment to come with records showing the birds were tested for Salmonella. FSIS would then periodically verify the records through testing during processing. FSIS has suggested testing would have to identify the level of Salmonella present, and the agency has suggested it might expand the requirement to focus on specific serotypes. FSIS has not specified when in the grow-out process testing would have to occur. 
  • The proposed framework contemplates that if a flock’s documented Salmonella load does not meet a predetermined target before entering the establishment, the establishment would be required to implement corrective actions and take follow up steps to reduce the load and meet the final product standard.
• Enhanced In-Process Control
  • FSIS would adjust in-process testing to require indicator organism testing at the rehang and post-chill sampling locations.  
  • FSIS is considering requiring establishments to use a standardized statistical process control to monitor process control during production and to allow for comparison across establishments. 
• Final Product Standard
  • FSIS is considering implementing an enforceable final product standard for Salmonella in raw poultry. FSIS has suggested it would set a tolerance level rather than pursue a zero-tolerance approach, although FSIS also floated the idea of future standards being based on serotypes or pathogenicity factors. FSIS indicated it is exploring setting a single standard for all raw poultry products. The final product standard contemplated in the proposed framework is similar but procedurally separate from FSIS’s previously announced plans to declare Salmonella an adulterant in breaded and stuffed not ready to eat raw chicken products. 
  • If FSIS implements an enforceable final product standard, the agency would consider eliminating the Salmonella performance standards for raw poultry. 
  • FSIS did not detail the basis it would use to declare that Salmonella above certain levels would adulterate raw product, but the agency indicated it would follow a similar approach as when FSIS declared certain strains of E. coli an adulterant in raw non-intact beef.  

Cross Cutting Considerations

The proposed framework identifies several items FSIS is considering throughout the proposal as a whole:

• Specific serotypes: Although the proposed framework focuses mostly on using quantifiable levels of Salmonella to evaluate compliance, FSIS also expresses an interest in focusing on specific serotypes of greatest concern. In particular, FSIS is interested in the three serotypes that together cause 33% of all Salmonella illness (Enteritidis, Typhimurium, and Infantis), and, looking further ahead, the agency indicates its “ultimate goal is to identify the specific pathogenicity factors” that make certain Salmonella strains more likely to cause human illness. FSIS appears to seek input on whether it should follow a serotype-based approach now or in the future. 
• Small and very small establishments: The proposed framework contemplates flexibility in testing and compliance deadlines for small and very small establishments with lower production volume but ultimately would hold these plants to the same overall standards.
• Data sharing: FSIS is contemplating developing a data sharing program wherein establishments performing their own sampling and testing may share the data with FSIS electronically. It is unclear whether FSIS views this as a voluntary or mandatory program.

FSIS indicates it is gathering scientific data to better inform its approach. In particular, FSIS advised it is obtaining guidance from the National Advisory Committee on Microbiological Criteria for Foods (NACMCF) on microbiological criteria that can be used to prevent Salmonella infections related to poultry products, conducting a risk profile for pathogenic Salmonella and quantitative risk assessments for Salmonella in chicken and turkey, and using expanded sampling for young chicken carcasses to develop microbial data.

Next steps

FSIS is hosting a virtual public meeting on November 3, 2022 to obtain input from stakeholders on the proposal. Written comments may be submitted on the proposed framework to the meeting docket at regulations.gov by November 16, 2022.³

Separately, the agency plans to publish in 2022 a proposed notice of determination to declare Salmonella an adulterant in NRTE breaded and stuffed chicken products and  additional proposed rules implementing the proposed framework in 2023 (with the goal of finalizing any proposed rules in 2024).

Authored by Brian D. Eyink and Connie Potter.

References

1 USDA, Proposed Regulatory Framework to Reduce Salmonella Illnesses Attributable to Poultry (Oct. 14, 2022).

2 See Hogan Lovells, FSIS plans to make Salmonella an adulterant in certain raw poultry products; previews other policies (Aug. 2, 2022).

3 Meetings: Proposed Framework for Controlling Salmonella in Poultry, Docket No. FSIS_FRDOC_0001  (Oct. 17, 2022).