The U.S. Department of Agriculture’s Food Safety and Inspection Service (USDA’s FSIS) is continuing its efforts to reduce incidences of Salmonella infections from poultry products with the proposal of a new regulatory framework. FSIS is seeking stakeholder input on the framework, and will be hosting a virtual public meeting on November 3, 2022, from 10 A.M–5 P.M. ET via Zoom.
The framework, designed to reduce the prevalence of Salmonella contamination in poultry products, is based on discussions with stakeholders, researchers, and scientists, as well as information that has been gathered over months. In addition to addressing cross-cutting issues of testing for Salmonella, the impact on small and very small establishments, and data sharing, three key components comprise the framework:
- Requiring that incoming flocks be tested for Salmonella before entering an establishment
- Enhancing establishment process control monitoring and FSIS verification
- Implementing an enforceable final product standard.
Component 1: Required Salmonella Testing for Incoming Flocks
The first key component of the framework would require establishments to characterize Salmonella as a hazard that is reasonably likely to occur at receiving as part of their Hazard Analysis and Critical Control Point (HACCP) plans, and that incoming flocks be tested for Salmonella before entering an establishment. Flocks would have to meet a predetermined target for Salmonella at receiving, which may be industry-wide or establishment-specific, and establishments must demonstrate that their subsequent processes would be effective in reducing Salmonella so that products would meet the final product standard.
FSIS is contemplating a requirement that all establishments monitor Salmonella levels or serotypes in incoming flocks. Establishments would be expected to have procedures in place to address incoming Salmonella levels. Component 1 of the framework would also require that each flock received at an establishment is accompanied with documentation demonstrating that the birds were tested for Salmonella before slaughter, and for the specific Salmonella levels or serotypes. FSIS would use periodic Salmonella testing at rehang to verify such documentation. Additionally, the agency is considering that if a flock’s documented Salmonella load does not meet the predetermined target at receiving, then the establishment could implement corrective actions necessary to reduce the Salmonella load and meet the final product standard, which could be based on the historical ability of an establishment to consistently decrease Salmonella loads.
Component 2: Enhanced Establishment Process Control Monitoring and FSIS Verification
To ensure that poultry slaughter establishments are effectively controlling Salmonella throughout their operations, FSIS may modify its current regulations to include enhanced establishment monitoring procedures, such as revised locations for multipoint sampling and the use of a statistical approach to process control. Additionally, considering production volume to determine the frequency at which establishments must collect samples, FSIS may modify the existing requirements for indicator organism testing for process control and establish additional parameters to better define the required analysis of the data.
Regarding changes in location for multipoint sampling, FSIS may require that the pre-chill location at which establishments must conduct sampling for indicator organisms should be at rehang, which would standardize the paired microbial data generated by establishments and enable FSIS to improve process control verification instructions for FSIS in-plant personnel.
FSIS may also require that establishments use a standardized statistical approach to process control, therefore standardizing the microbial data definition of process control at a particular establishment and ensuring that establishments generate and monitor data that lead to supportable results. A standard definition of process control would also enable FSIS in-plant personnel to identify and take consistent action if an establishment fails to identify or respond to loss of process control.
Component 3: Enforceable Final Product Standard
Finally, FSIS is considering implementing a final product standard to ensure that product contaminated with Salmonella that is likely to cause illness is not sold to consumers. FSIS would make an enforceable final product standard possible by declaring Salmonella an adulterant, and would rely on criteria that were applied to Shiga toxin-producing Escherichia coli (STEC). These criteria are: consideration of serotypes associated with human illnesses, low infectious dose, severity of human illnesses, and typical consumer cooking practices.
FSIS is considering whether there are specific pairs of Salmonella and raw poultry products that have distinguishing characteristics, such that Salmonella at certain levels and types of Salmonella should be considered as adulterants when present in a specific raw poultry product. For example, FSIS has already discussed a proposal for Salmonella to be considered an adulterant in not-ready-to-eat (NRTE), breaded and stuffed raw chicken products.
At the same time, FSIS is also exploring if a single product standard for Salmonella in all raw poultry products may be appropriate. In developing a final product standard, FSIS would evaluate existing scientific support, stakeholder feedback, and access to test results to support timely identification of Salmonella serotypes or pathogenicity factors. FSIS could also take into account documentation presented with a flock and make a regulatory distinction between vaccinated flocks and non-vaccinated flocks in the context of a final product standard. In light of existing testing technology, FSIS is considering the initial development of an enforceable final product standard based on quantification rather than a “zero- tolerance” standard for Salmonella.
FSIS is authorized to use any enforcement tools, up to and including retention, to control product and suspension of inspection services, to address continued failures of the food safety system. Establishments would be able to further process the adulterated product to render it safe and wholesome or send it to another inspected establishment for further processing.
If an enforceable final product standard is ultimately finalized and implemented, FSIS is considering retiring its current Salmonella performance standards, including the moving-window approach to sampling and categorization of establishments.
FSIS is considering cross-cutting in its proposed regulatory framework. Regarding testing for Salmonella, the agency may target Salmonella serotypes found in poultry that are most likely to cause human illness. After analyzing recent data on human illness and sampling results from chicken and turkey products, FSIS has decided to focus at this time on three serotypes: Enteritidis, Typhimurium, and Infantis, which together cause 33 percent of all Salmonella illnesses. By advancing science and testing technology, the agency’s ultimate goal is to identify the specific pathogenicity factors that make certain Salmonella within the same or different serotypes more likely to cause human illness.
Acknowledging that small and very small establishments have more limited resources than larger-volume, vertically integrated poultry establishments, FSIS is considering how to account for production volume and other additional options, as appropriate, to factor establishment size into its proposal. Additionally, FSIS will also evaluate if small and very small establishments require more time to meet regulatory requirements, necessitating a phased rollout of new requirements. Ultimately, FSIS standards and regulatory requirements will apply to all establishments, regardless of size.
Finally, in addition to the current requirement of establishments providing sampling data to FSIS in-plant personnel for review, FSIS is may develop a process for establishments that are performing their own sampling and testing for Salmonella and indicator organisms at rehang and post-chill to regularly share their data with FSIS electronically. Data-sharing would allow FSIS scientists to develop tools and processes that aid FSIS in-plant personnel and establishments in monitoring trends and identifying food safety issues, allow for prioritization of FSIS resources, enhance the continual evaluation and refinement of FSIS systems and procedures, and support future policy development.
FSIS will publish a proposed notice of determination to declare Salmonella as an adulterant in NRTE breaded and stuffed chicken products in 2022, and intends to publish additional proposed rules and policies implementing the strategy in 2023, with the goal of finalizing any rules by mid-2024. Additionally, the following work is underway:
- The National Advisory Committee on Microbiological Criteria for Foods (NACMCF) has been charged with providing guidance on what types of microbiological criteria FSIS might use to better prevent Salmonella infections associated with poultry products
- FSIS is completing a risk profile for pathogenic Salmonella subtypes in poultry and is collaborating on quantitative risk assessments for Salmonella in chicken and turkey that will address key risk management questions associated with the framework
- Expansion of FSIS’ exploratory sampling program for young chicken carcasses to generate microbial data to help inform future policies
- FSIS is transitioning from using presence-based tests to tests that quantify the amount of all Salmonella cells.
FSIS will continue to seek stakeholder input on the proposed framework, and aims to be methodical and transparent in its approach while moving toward implementing a final strategy.
FSIS is seeking feedback from stakeholders on the proposed framework, both at the public meeting and in written comments submitted to the meeting docket published in the Federal Register. Stakeholders who wish to speak at the public meeting must notify FSIS during registration and must register by October 24, 2022. Specifically, FSIS would appreciate comments and input on the following questions:
- What factors should FSIS consider relative to the approaches outlined in each of the components of the framework?
- How can each component be strengthened?
- Where are the gaps in the framework?
Update, October 31, 2022: Edits were made to reflect changes that USDA made to the time at which its webinar on the regulatory framework will take place.