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.
FSIS is soliciting feedback on the framework by Dec. 16, 2022.Provide Your Comments on Regulations.gov
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.
1The 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.
2The 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.
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:
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.
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.
1On 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.
2FSIS 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).
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.
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.
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.