Proposed Regulatory 

Framework to Reduce 

Salmonella Illnesses 

Attributable to Poultry
The Food Safety and Inspection Service (FSIS) is considering a regulatory framework for a new strategy to control Salmonella

in poultry products and more effectively reduce foodborne Salmonella infections linked to these products. The framework 

under consideration has been shaped by months of information-gathering and discussions with a wide range of stakeholders, 

researchers, and scientists.

At the same time, FSIS is gathering scientific evidence relevant to the approaches presented in this framework. 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 also 

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 this framework. FSIS 

also expanded its exploratory sampling program for young chicken carcasses to generate microbial data to help inform future 

policies and is transitioning from using presence-based tests to tests that quantify the amount of all Salmonella cells.

While awaiting results from these activities, FSIS is sharing this framework to identify the key elements that the Agency is 

currently considering as part of a new regulatory strategy. FSIS is soliciting feedback from stakeholders on all of the elements 

of the framework—both at a public meeting and in written comments submitted to the meeting docket in the Federal Register—

before moving forward with any proposed changes to regulations or other actions.

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Introduction

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Introduction/Background
FSIS is the public health agency in U.S. Department of Agriculture (USDA) whose mission is to ensure that meat, poultry, and egg 

products are safe, wholesome, and properly labeled. As a public health agency, we continually review and optimize our policies 

and practices to best protect consumers from foodborne illness. For example, past illness outbreaks, such as those caused by 

Shiga toxin-producing E. coli (STEC) in beef and Listeria monocytogenes in ready-to-eat products, have prompted the Agency to 

respond with regulations and policies that resulted in substantial decreases in human illnesses due to those pathogens.

However, while FSIS has had a goal of reducing Salmonella infections linked to poultry products for some time, we have not 

seen the same level of success with our current approach. FSIS has used the U.S. Department of Health and Human Services’ 

Healthy People1 target to set pathogen reduction goals over the past few decades, but the 2010 and 2020 Healthy People 

targets for a reduction in Salmonella infections from all sources were not met.2 The Healthy People 2030 target is to reduce 

Salmonella infections to national case rate of no more than 11.5 per 100,000 consumers per year. To reach the 2030 target, 

illnesses must be reduced by 25%. Although this target is for Salmonella infections from all sources, FSIS has adopted the same 

target and aims to reduce Salmonella infections linked to FSIS-regulated products by 25%.

Despite FSIS sampling data showing reductions in Salmonella contamination in poultry products, our current approach to 

Salmonella has not led to a demonstrable reduction in Salmonella infections. For example, during the five-year period from 

2017 to 2021, the number of chicken samples in which FSIS detected Salmonella decreased by more than 50%. However, the 

estimated rate of human Salmonella infections from all sources has remained consistent over the last two decades, with an 

estimated 1.35 million infections in the U.S. each year. The most recent report from the Interagency Food Safety Analytics 

Collaboration estimates that over 23% of foodborne Salmonella illnesses are attributable to poultry consumption—almost 

17% from chicken and over 6% from turkey. 

1

The Healthy People initiative guides national health promotion and disease prevention efforts to improve the health of the nation. Led by the U.S. Department of Health and Human Services (HHS), 

Healthy People has identified, for every decade since 1980, science-based objectives with targets to monitor progress and motivate and focus action.

2

The Healthy People 2010 and 2020 targets were 6.8 and 11.4 Salmonella infections per 100,000 population, respectively. Between 2010 and 2017, infection rates averaged 15.8 Salmonella infections per 

100,000 population.

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Background

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This document outlines the regulatory framework under consideration for a new strategy that we anticipate should reduce the 

number of Salmonella infections linked to poultry consumption. The framework consists of three components that, together, 

support a comprehensive approach to controlling Salmonella in poultry. 

The three components are:

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FSIS’ Proposed Framework

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Introduction/Background

*Under this proposed framework, testing for Salmonella would also occur during the same steps in production as testing for 

indicator organisms.

Requiring incoming flocks be 

tested for Salmonella before 

entering an establishment

COMPONENT 1

Implementing an enforceable 

final product standard

COMPONENT 3

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Salmonella

Indicator 

organisms

Testing For:

Enhancing establishment 

process control monitoring 

and FSIS verification

COMPONENT 2 *
FSIS is considering requiring establishments to characterize Salmonella as a hazard reasonably likely to occur at 

receiving and that incoming flocks be tested for Salmonella before entering an establishment. Under this approach, 

the flock would have to meet a predetermined target for Salmonella at receiving, which may be industry-wide or 

establishment-specific, and the establishment must demonstrate that its subsequent process will be effective in 

reducing Salmonella so that the product will meet the final product standard.

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Component 1: Requiring incoming flocks be tested for 

Salmonella before entering an establishment

Component 2

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Salmonella

Indicator 

organisms

Testing For:
Salmonella enters an establishment in and on the birds. The goal of this component is to incentivize use of preharvest 

interventions that reduce the level of incoming Salmonella contamination or mitigate the risk of a particular serotype entering 

the establishment. 

FSIS is currently evaluating whether Salmonella is a hazard reasonably likely to occur at receiving and if establishments must, 

therefore, address Salmonella at receiving as part of their Hazard Analysis and Critical Control Point (HACCP) plans. HACCP, 

which is FSIS’ prevention-based approach to food safety, requires that an establishment’s hazard analysis include food safety 

hazards that can occur before, during, and after entry into the establishment. Salmonella is a significant microbial hazard 

in raw poultry and for this reason, 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 the incoming 

Salmonella levels. 

This component of the framework under consideration would also require that each flock received at the establishment is 

accompanied with documentation demonstrating that the birds were tested for Salmonella before slaughter and documenting 

the Salmonella levels or serotypes. FSIS would use periodic Salmonella testing at rehang to verify this 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 and additional interventions necessary to reduce 

the Salmonella load and meet the final product standard, such as processing a more contaminated flock at the end of the 

day (“logistical slaughter”). This assessment could be based on the documented ability of an establishment’s processes to 

consistently decrease the Salmonella load.

Under this approach, FSIS does not intend to require industry to adopt any specific pre-harvest interventions but would allow 

flexibility for industry to adopt the practices that are most effective at controlling Salmonella in each particular operation. 

Establishments would be encouraged to work with their suppliers and contractors to ensure they are implementing best 

practices in reducing the Salmonella hazard in breeding facilities, hatcheries, grow out, and throughout transport.

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Component 1: Requiring incoming flocks be tested for 

Salmonella before entering an establishment (continued)

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To ensure that poultry slaughter establishments are effectively controlling Salmonella throughout their operations, 

FSIS may propose to modify its current regulations to prescribe enhanced establishment monitoring procedures, 

including revised locations for multipoint sampling and use of a statistical approach to process control.

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Component 2: Enhanced Establishment Process Control 

Monitoring and FSIS Verification

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Salmonella

Indicator 

organisms

Testing For:

*Under this proposed framework, testing for Salmonella would also occur during the same steps in production as testing for

indicator organisms.

*
The second component of this proposed framework builds on HACCP, FSIS’ prevention-based approach to food safety. To 

ensure pathogen control throughout slaughter and processing operations, 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. As part of the proposal, establishments may be required to test for indicator organisms (e.g., aerobic plate count [APC], 

Enterobacteriaceae). FSIS would consider production volume when determining the frequency that establishments must 

collect samples. 

FSIS is considering the following modifications to the regulations related to preventing contamination throughout 

establishment operations:

Changes in location for multipoint sampling: FSIS may propose requiring that the pre-chill location at which 

establishments must conduct sampling for indicator organisms should be at rehang. The requirement to sample at 

post-chill would remain unchanged. Specifying that establishments will sample at rehang would standardize the paired 

microbial data generated by establishments and enable FSIS to improve instructions to FSIS in-plant personnel on how 

to verify establishments’ process control.

Use of statistical process control: FSIS is also considering requiring that establishments use a standardized 

statistical approach to process control. Requiring establishments to use the same statistical process-control method 

will standardize the microbial data definition of process control at a particular establishment and ensure 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.

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Component 2: Enhanced Establishment Process Control 

Monitoring and FSIS Verification (continued)

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FSIS is assessing whether certain levels or types of Salmonella on raw poultry product present an elevated risk 

of causing human illness such that they should be considered adulterants. As a result, the Agency is considering 

implementing a final product standard or standards to ensure that product contaminated with Salmonella that is 

likely to make people sick is not sold to consumers. 

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Component 3: Enforceable Final Product Standard

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Salmonella

Indicator 

organisms

Testing For:
To protect public health, FSIS regulations should prevent product with high levels of contamination and/or specific serotypes 

from entering commerce. This goal would be accomplished by declaring Salmonella an adulterant. In doing so, FSIS would 

rely on criteria that were applied to STECs. These criteria are: consideration of serotypes associated with human illness; low 

infectious dose; severity of human illnesses; and typical consumer cooking practices.

Consistent with its approach to determining the status of certain STECs as adulterants in specific raw beef products, FSIS is 

considering whether there are specific Salmonella and raw poultry product pairs that have characteristics that distinguish 

them from other raw poultry products contaminated with Salmonella, such that Salmonella at certain levels and/or types of 

Salmonella should be considered as an adulterant when present in that specific raw poultry product. For example, FSIS will 

soon be releasing a proposal that Salmonella meets the critiera to be considered an adulterant in not-ready-to-eat (NRTE) 

breaded and stuffed raw chicken products, an action that will allow the Agency to better protect public health1

.

At the same time, FSIS is exploring if a single product standard for Salmonella in all raw poultry products may be appropriate. 

From a consumer’s perspective, exposure to a quantity and/or serotype of Salmonella likely to make them sick is a key risk 

factor for illness that may be consistent across product types. 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, the Agency is considering initially developing an enforceable final product standard based on 

quantification rather than a “zero- tolerance” standard for Salmonella.

This final product standard would promote Salmonella reduction by establishments and incentivize upstream practices 

that reduce Salmonella, including on-farm and transportation practices. As noted above, the interventions at slaughter and 

processing must demonstrate that they are capable of achieving the final product standard.

1

FSIS will soon release a proposed notice of determination declaring that NRTE breaded and stuffed raw chicken products that contain Salmonella at levels of 1 colony forming unit (CFU) per gram 

or higher are adulterated.

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Component 3: Enforceable Final Product Standard (continued)

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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 sunsetting the current

Salmonella performances standards, including the moving window-approach to sampling and categorization of establishments.

Component 3: Enforceable Final Product Standard (continued)

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Testing for Salmonella

FSIS’ goal is to use the most widely accessible, cost-effective, and rapid laboratory technology to determine as precisely as 

possible if a product is contaminated with Salmonella at a level and/or with a serotype more likely to cause human illness. FSIS 

is transitioning from using presence-based tests to tests that quantify1

 the amount of all Salmonella cells, because more highly 

contaminated product is more likely to cause human illness. Presently, quantification is the most practical testing technology 

that meets the above criteria, and that FSIS can rely on to help inform regulatory decision-making. 

FSIS is considering targeting the serotypes of Salmonella found in poultry that are most likely to cause human illness. There are 

over 2,500 Salmonella serotypes, but current scientific evidence suggests that less than one hundred Salmonella serotypes are 

associated with human illness. After analyzing recent data on human illness from the Centers of Disease Control and Prevention 

and FSIS sampling results from chicken and turkey products, the Agency has decided to focus at this time on three serotypes: 

Enteritidis, Typhimurium, and Infantis2, which together cause 33% of all Salmonella illnesses. However, there are currently no 

available and affordable rapid tests to identify specific serotypes.

While FSIS aims to test for Salmonella serotypes to more accurately identify the products that are most likely to cause human 

illness, the 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. The technology to detect specific pathogenicity factors is not yet available; 

however, as the science and testing technology evolve to reliably identify serotypes and pathogenicity factors, FSIS expects to 

revise its testing requirements and, as appropriate, update the final product standard(s), to incorporate these developments. 

1

On August 8, 2022, FSIS laboratories began using quantification for Salmonella in raw poultry rinses. FSIS also plans to extend pathogen quantification technology to other samples.

2

FSIS has developed an annual Key Performance Indicator (KPI) related to the three Salmonella serotypes (Enteritidis, Typhimurium, and Infantis) to help evaluate its success in meeting the performance 

objective. The KPI is the reduction in the proportion of poultry samples that are positive for the three Salmonella serotypes, including the rate of reduction, as compared to the baseline (the recent four 

years of FSIS sampling data).

Cross-cutting Issues

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Cross-cutting Issues (continued)

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In addition to FSIS in-plant personnel, establishments would also test for Salmonella at rehang under this proposed 

framework. FSIS would require that samples are tested for Salmonella by a laboratory that is using methods equivalent to FSIS 

laboratory methods and that is accredited to ISO/IEC standard 17025:2017 or by the FSIS Accredited Laboratory Program.

Small and Very Small Establishments 

FSIS understands that low volume producing establishments have resource constraints that differ from those of larger volume, 

vertically integrated poultry establishments. To help alleviate the resource burden on small and very small establishments, 

FSIS is considering how to account for production volume and other additional options, as appropriate, to factor establishment 

size into our proposal. For example, if an establishment has a low production volume, then FSIS could instead collect and test 

the samples at rehang and post-chill to verify process control. FSIS will also consider 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.

Data Sharing

In addition to the current requirement of establishments making sampling data available to FSIS in-plant personnel for review, 

FSIS is considering developing 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 this data with FSIS electronically. This data 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.

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We know that there is no single solution to a complex problem like Salmonella contamination in poultry, so we need a 

comprehensive strategy with components that work together to reduce human illness. The Agency is confident that a new 

regulatory strategy based on this framework would help to reduce Salmonella illnesses associated with poultry and move us 

closer to the Healthy People 2030 goal.

FSIS will continue to seek stakeholder input on this proposed framework. The Agency will aim to be methodical and transparent 

in our approach as we move towards implementing a final strategy. We will publish a proposed notice of determination to 

declare Salmonella an adulterant in NRTE breaded and stuffed chicken products in 2022, and we intend to publish additional 

proposed rules and policies implementing this strategy in 2023, with the goal of finalizing any rules by mid-2024.

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Looking Forward

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Page 2

National Advisory Committee on Microbiological Criteria for Foods (NACMCF): https://www.fsis.usda.gov/policy/advisorycommittees/national-advisory-committee-microbiological-criteria-foods-nacmcf/2021

Constituent Update - July 1, 2022: https://www.fsis.usda.gov/news-events/news-press-releases/constituent-update-july-1-2022

Revised Young Chicken Carcass Exploratory Sampling Program: https://www.fsis.usda.gov/policy/fsis-notice/44-22

Constituent Update - August 5, 2022: https://www.fsis.usda.gov/news-events/news-press-releases/constituent-updateaugust-5-2022-0

Page 3

Healthy People: https://health.gov/healthypeople

Foodborne illness source attribution estimates for 2019 for Salmonella, Escherichia coli O157, Listeria monocytogenes, and 

Campylobacter using multi-year outbreak surveillance data, United States: https://www.cdc.gov/foodsafety/ifsac/pdf/P19-

2019-report-TriAgency-508.pdf

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[Footnote] USDA Announces Action to Declare Salmonella an Adulterant in Breaded Stuffed Raw Chicken Products: https://

www.usda.gov/media/press-releases/2022/08/01/usda-announces-action-declare-salmonella-adulterant-breaded-stuffed

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[Footnote] USDA Announces Action to Declare Salmonella an Adulterant in Breaded Stuffed Raw Chicken Products: https://

www.usda.gov/media/press-releases/2022/08/01/usda-announces-action-declare-salmonella-adulterant-breaded-stuffed

[Footnote] FY 2022-2026 Food Safety Key Performance Indicator: https://www.fsis.usda.gov/inspection/inspection-programs/

inspection-poultry-products/reducing-salmonella-poultry/salmonella-0#:~:text=A%20key%20performance%20

indicator%20(KPI,)%202022%2D2026%20Strategic%20Plan.

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Reference Links

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