USDA’s Food Safety and Inspection Service (FSIS) has announced its final determination to declare Salmonella an adulterant in raw breaded stuffed chicken products when they exceed a specific threshold of 1 colony forming unit (CFU) per gram or higher for Salmonella contamination.

This determination is part of the agency’s efforts to reduce Salmonella illnesses associated with the raw poultry supply in the U.S. FSIS intends to address Salmonella contamination in other raw poultry products later this year.

“This final determination marks the first time that Salmonella is being declared an adulterant in a class of raw poultry products,” said Tom Vilsack, agriculture secretary, in an April 26 statement. “This policy change is important because it will allow us to stop the sale of these products when we find levels of Salmonella contamination that could make people sick.”

FSIS will carry out verification procedures, including sampling and testing of the raw incoming chicken component of these products prior to stuffing and breading, to ensure producing establishments control Salmonella in these products. If the chicken component in these products does not meet this standard, the product lot represented by the sampled component would not be permitted to be used to produce the final raw breaded stuffed chicken products. The determination, including FSIS’ sampling and verification testing, will be effective 12 months after its publication in the Federal Register.

In determining that Salmonella is an adulterant in raw breaded stuffed chicken products, FSIS considered the best available science and data using similar criteria as in its 1994, 1999, and 2011 E. coli policymaking. When FSIS declared seven Shiga toxin-producing E. coli (STEC) strains to be adulterants in select raw beef products, it relied on several factors, including the available information on serotypes linked to human illnesses, infectious dose, severity of illnesses and typical consumer preparation practices associated with a product. The breaded stuffed chicken products determination relied on the same factors.

FSIS and its public health partners have investigated 14 Salmonella outbreaks and approximately 200 illnesses associated with these products since 1998. The most recent outbreak was in 2021 and resulted in illnesses across 11 states. These products account for less than 0.15% of the total domestic chicken supply, but outbreaks linked to these products represented approximately 5% of all chicken-associated outbreaks in the U.S. from 1998 to 2020.

Raw breaded stuffed chicken products are pre-browned and may appear cooked, but the chicken is raw. The products are typically cooked by consumers from a frozen state, which increases the risk of the product not reaching the internal temperature needed to destroy Salmonella. Despite to improve labeling, these products continue to be associated with Salmonella illness outbreaks.

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Tomato juice can kill Salmonella Typhi and other, according to research published in the journal Microbiology Spectrum. Salmonella Typhi is a human-specific pathogen that causes typhoid fever.

“Our main goal in this study was to find out if tomato and tomato juice can kill enteric pathogens, including Salmonella Typhi and, if so, what qualities they have that make them work,” said Jeongmin Song, PhD, associate professor in the department of microbiology and immunology at Cornell University in Ithaca, NY, and principal study investigator, in a press release.

First, the researchers checked to see whether tomato juice really does kill Salmonella Typhi. Once they determined that it did, the team looked at the tomato’s genome to find the antimicrobial peptides that were involved. Antimicrobial peptides are very small proteins that impair the bacterial membrane that keeps them as intact organisms. The researchers found two antimicrobial peptides in the tomato that proved effective against the pathogen.

The investigators conducted more tests on Salmonella Typhi variants that appear in places where the disease is common. They also conducted a digital study to learn more about how the antibacterial peptides kill this and other enteric pathogens.

The researchers concluded that tomato juice is effective in eliminating Salmonella Typhi, its hypervirulent variants, and other bacteria that can harm human digestive and urinary tract health. Specifically, two antimicrobial peptides in the product can eliminate these pathogens by impairing the bacterial membrane, a protective layer that surrounds the pathogen.

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USDA’s Food Safety and Inspection Service (FSIS) has issued a public health alert out of an abundance of caution due to concerns about Salmonella illnesses that may be associated with ready-to-eat (RTE) charcuterie meat products in Busseto brand Charcuterie Sampler and Fratelli Beretta brand Antipasto Gran Beretta.

FSIS has been working with the Centers for Disease Control and Prevention (CDC) and state public health partners to investigate a multistate outbreak of 47 Salmonella-related illnesses in 22 states with onset dates ranging from November 20, 2023, through January 1, 2024. FSIS will continue the investigation and issue new information as it becomes available.

The Fratelli Beretta brand Antipasto Gran Beretta was sold at Costco in a 24-oz. twin-pack (two 12-oz. trays). The Busseto brand Charcuterie Sampler was sold at Sam’s Club in an 18-oz. twin-pack (two 9-oz. trays). Any lot code associated with either product is potentially contaminated. The products are no longer available for purchase at Costco and Sam’s Club. Label images can be found in the CDC’s food safety alert.

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FDA has released an updated infant formula compliance program for FDA investigators, laboratory analysts, and compliance officers. The program is designed to outline the agency’s approach for inspections, sample collection, sample analysis, and compliance as part of its effort to strengthen the safety, resiliency, and oversight of the formula industry.

In September 2022, FDA released its internal evaluation of the ifant formula response, which recommended that the agency review and update its compliance program to ensure it reflected the latest science on Cronobacter.

The agency says the updated program builds on lessons learned over the last several years to expand on its approaches for inspections, sampling, laboratory analysis, and imported formula products. For example, updates include instructions for annual environmental sampling of Cronobacter and Salmonella at powdered infant formula facilities. The compliance program provides instruction for FDA notification should a sample test positive for Cronobacter or Salmonella.

The compliance program also includes instructions for how product or environmental positives identified during records reviews should be immediately escalated to the appropriate subject matter expert within the Human Foods Program.

Additional background on the risks associated with Salmonella and Cronobacter in formula products, and the conditions that could lead to environmental contamination within the manufacturing facilities, is included in the updated compliance program. In addition, it further elaborates on new related requirements included in the Food and Drug Omnibus Reform Act of 2022.

All updates related to the oversight of infant formula can be found on FDA’s infant formula webpage.

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On April 25, USDA’s Food Safety and Inspection Service (FSIS) released a proposed determination to declare Salmonella an adulterant in breaded stuffed raw chicken products when they exceed a very low level of Salmonella contamination. This announcement is a significant first step that builds on FSIS’s proposed regulatory framework to reduce Salmonella infections linked to poultry products, which was released in October 2022.

“USDA is taking science-based, decisive action to drive down Salmonella illnesses linked to poultry products,” said Agriculture Secretary Tom Vilsack in a statement. “Today’s proposal represents the first step in a broader effort to control Salmonella contamination in all poultry products, as well as a continued commitment to protecting American consumers from foodborne illness.”

Under this proposal, FSIS would consider any breaded stuffed raw chicken products that include a chicken component that tested positive for Salmonella at 1 colony forming unit (CFU) per gram prior to stuffing and breading to be adulterated. FSIS is also proposing to carry out verification procedures, including sampling and testing of the chicken component of breaded stuffed raw chicken products prior to stuffing and breading, to ensure producing establishments control Salmonella in these products. If the chicken component in these products does not meet this standard, the product lot represented by the sampled component would not be permitted to be used to produce the final breaded stuffed raw chicken products. The chicken component represented by the sampled lot would need to be diverted to a use other than breaded stuffed raw chicken products.

In proposing to declare Salmonella an adulterant in breaded stuffed raw chicken products, FSIS based its decision on several factors, including that since 1998, FSIS and its public health partners have investigated 14 Salmonella outbreaks and approximately 200 illnesses associated with these products. The most recent outbreak was in 2021 and resulted in illnesses across 11 states.

Breaded stuffed raw chicken products are pre-browned and may appear cooked, but the chicken is raw. These products are stuffed with ingredients, such as a raw vegetable, butter, cheese, or meat such as ham. The labeling of these products has undergone significant changes over time to better inform consumers that they are raw and to provide instructions on how to prepare them safely. Despite these efforts to improve labeling, these products continue to be associated with Salmonella illness outbreaks.

A public meeting was held on November 3, 2022, to allow stakeholders the opportunity to provide information that would help focus the development of regulations to implement the policy. To date, more than 1,000 comments have been submitted to this docket.

Concurrently, FSIS is gathering scientific evidence relevant to the approaches presented in the proposed 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.
• FSIS is transitioning from using presence-based tests to tests that quantify the amount of all Salmonella

FSIS is seeking public comments on the proposed determination and the proposed verification sampling program. Comments may be submitted online via the federal eRulemaking portal.

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A study conducted at the University of Connecticut in Storrs and recently published in Food Microbiology found that protective bacterial cultures offer a promising mechanism for combating antibiotic-resistant Salmonella in food.

Dennis D’Amico, PhD, associate professor of dairy foods in the University of Connecticut’s College of Agriculture, Health and Natural Resources, led the study as part of his ongoing work involving the use of protective bacterial cultures to prevent illness from foodborne pathogens. He has previously studied the use of bacterial cultures to control the growth of pathogens in food products and to impede their ability to cause sickness.

Dr. D’Amico says that some microbial strains, including many strains of Salmonella, have developed resistance to many of the antibiotics used in human medicine, so the goal of this study was to find an effective way to target those pathogens without using antibiotics. The study authors considered the ability of a protective culture called Hafnia alvei B16 to prevent infection by two Salmonella serovars.

Previously, Dr. D’Amico’s lab had identified Hafnia alvei B16 as effective in inhibiting the growth of both E. coli and Salmonella in milk, and it also successfully stopped the growth of Staphylococcus aureus, preventing it from producing toxin levels sufficient to cause disease in humans.

“Protective cultures like the commercial products we have tested in the lab work against other bacteria in various ways, typically through competitive exclusion and the production of antimicrobial metabolites such as organic acids and bacteriocins,” Dr. D’Amico tells Food Quality & Safety. “They are typically added to products to inactivate or suppress the growth of unwanted microbes. We have shown this [result] with several cultures against several pathogens in food.”

Once ingested, certain pathogens must continue to grow in the gut until the population is large enough to cause disease. Other microbes such as Staph aureus produce a toxin that can cause severe disease if they are allowed to grow unchecked.

The report explains that these cultures can also reduce the virulence of certain pathogens when present together in a food, much like other cultures labeled as probiotics. These cultures can improve food safety by controlling pathogen growth and survival in a food product, thereby attenuating their virulence in food, and/or providing protection against colonization in the host.

“In this case, we see these effects even against antibiotic resistant strains,” Dr. D’Amico says. “The most important takeaway is that these cultures, which are typically used only to control the outgrowth of pathogens in food, have additional functions to provide a multi-pronged approach to improving food safety and public health.”

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The year 2022 has been a significant one for all things Salmonella related. With the recent USDA announcement classifying Salmonella as an adulterant in breaded and stuffed raw chicken products when exceeding 1 colony-forming unit (CFU) per gram, as well as the selection of a new Salmonella testing method of choice for USDA-Food Safety Inspection Service laboratories, there seems to be an increased interest from the poultry industry in how biomapping data can enhance statistics-based process control from flock to fork. The process of quantifying pathogens and microbial indicators, i.e., biomapping, has been described as an effective tool for process control, as it can highlight the effective interventions, provide a real-time status of the health of the process, and, ultimately, allow for risk-based decision making.

Despite many interventions over the past 20 years, the number of Salmonella incidences has not decreased significantly. This has been attributed to various factors but, when we look at available testing approaches, there are a few things to keep in mind, no matter what your method of choice is:

• Testing alone will never reduce the prevalence or quantity of Salmonella. The old saying that you cannot test your way to food safety remains true. A single test is unable to provide a full view of the information needed to identify points of concern within the production process. Furthermore, the testing data must be analyzed within the context of process metadata.
• Your method of choice must accompany a statistically valid sampling plan. This is the only way to ensure that your statistical process control programs are working properly.
• Don’t run microbiology tests if you don’t have a plan for the data. Otherwise, you’re wasting time and money. Data produced from tests help you understand gaps in your process and enable decision making about what tools are needed to address concerns.

Biomapping helps processors monitor the efficacy of antimicrobial interventions by sampling at critical control points (CCPs) where contamination levels can be assessed. When implemented accurately, biomapping can help to:

1. Improve processors’ understanding of the antimicrobial interventions efficacy;
2. Provide a holistic view of the process while providing deeper insights through monitoring CCPs; and
3. Ultimately, improve the microbiological quality of processors’ products through better process controls.

Biomapping of CCPs allows for continuous improvements including improved risk assessments of the overall production process. If you don’t have a biomapping element in your testing process, you can incorporate one into existing protocols by identifying CCPs where contamination challenges are evident by existing microbial indicator data.

Quantification

Biomapping via quantification of non-pathogenic microbes has long been a way to perform sanitation verification or biomapping. More recently, though, the tools for quantification have evolved from the use of indicator organisms to a more specific Salmonella quantification, and the quantification technology has evolved to more precise quantitative (q) PCR. As it stands today, this combination of indicator and Salmonella quantification remains the most potent way to understand the microbial makeup and load of the process. Also, with the availability of the qPCR technology, this trend of specific pathogen quantification is likely going to intensify via better use of data, and a potential expansion to include other pathogens of interest.

As is the case in our technology-driven world, however, all methods are not created equal, and technology advancements happen faster than we can keep up with them. Existing microbial quantification options have their drawbacks: Direct counting (optical microscopy) has a limited application, most probable number (MPN) is cumbersome and expensive, and direct plating does not offer a high certainty that a contaminant is Salmonella and therefore requires confirmation. The emergence of qPCR technologies, with or without enrichment, can correlate inversely with target DNA fragments, allowing for a validation on a per matrix basis (i.e., carcass versus parts versus ground) and decision making in a time bound manner. While biomapping remains a viable means of process improvement, the end will, and should, remain with how we leverage the data for improving our processes.

As someone with a passion for translating science into action, it is my deep belief that data enable us to make superior decisions and to raise the bar for food safety across industries. The democratization of technology should allow for easy and pertinent data collection. The focus now passes to how we use these data. It will be interesting to see where the collective industry goes from here and what the future holds for food safety and, ultimately, global food security.

Dr. Dutta is senior director, scientific affairs, for bioMérieux. Reach him at vikrant.dutta@biomerieux.com.

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Despite decades of progress in reducing Salmonella prevalence in poultry products, USDA’s Food Safety and Inspection Service (FSIS) has failed to see those reductions translate into fewer illnesses among consumers.

Led by the U.S. Department of Health and Human Services (HHS), the Healthy People initiative has identified science-based objectives with targets to monitor progress in reductions of Salmonella infections from all sources for every decade since 1980. The 2010 and 2020 Healthy People goals were not met, although there were reductions in prevalence. For example, during the five-year period from 2017 through 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 prevalent in the U.S. each year.

The most recent report from the Interagency Food Safety Analytics Collaboration estimates that more than 23% of foodborne Salmonella illnesses are attributable to poultry consumption with almost 17% from chicken and more than 6% from turkey. The Healthy People 2030 target is set to reduce Salmonella infections to a national case rate of no more than 11.5 per 100,000 consumers per year. To reach the 2030 target, illnesses attributable to poultry must be reduced by 25%, or more than twice the reductions seen in in either of the previous two decades (roughly 6% and 11%, respectively).

To accomplish this ambitious goal, FSIS is implementing a new strategic framework that will be supported by an expansive risk assessment and more effective, measurable controls. Additional supporting data gathered includes identifying the types of microbiological criteria that would better result in preventing infections, identifying various serotypes involved in contaminations and infections, using quantitative testing methods instead of presence/absence methods, and expanding a sampling program to provide better risk assessment and control measures.

Proposed Framework Components

FSIS has also released a Proposed Regulatory Framework made up of three components that is now open for public comment. The three components of the new regulatory framework provide a comprehensive farm-to-fork approach based on the knowledge that Salmonella enters the food chain in or on the live bird, allowing contamination to expand downstream to consumers from there.

Component 1: Require incoming flocks to be tested for Salmonella before entering an establishment

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.

The goal of this component is to incentivize the use of pre-harvest interventions that reduce the level of incoming Salmonella contamination or mitigate the risk of a particular serotype entering the establishment.

Component 2: Enhance process control monitoring and FSIS verification

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.

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.

Component 3: Implement an enforceable final product standard

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.

FSIS has already released the requirement that Salmonella be considered an adulterant in not-ready-to-eat (NRTE) breaded and stuffed raw chicken products. At the same time, FSIS is exploring whether a single product standard for Salmonella in all raw poultry products is 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.

FSIS will hold a public meeting on November 3 from 10am to 4pm Eastern that will allow for discussion and feedback on the proposed regulatory strategy. Register for the meeting on the FSIS website.

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One of the outcomes of the COVID-19 pandemic has been an increased awareness of and sensitivity to food safety issues by the general public. As government regulators, food testing laboratories, and food producers have become better at conducting outbreak tracing, companies are realizing the necessity of having a robust pathogen testing program in place to avoid the risk of an outbreak.

As a result of the increased awareness, food testing labs faced some challenges early in the pandemic while trying to meet demand for pathogen testing and detection. At the same time, some new trends and ideas have come about, demonstrating how the understanding of food pathogens and food safety is always advancing.

The Current State of Food Safety Pathogen Testing

Generally speaking, the U.S. public is well aware, either through personal experiences or conversation, of the ongoing labor shortages caused in part by the pandemic. The food manufacturing industry has also felt the effects of these shortages—from lab technician turnover and struggling to find new technicians to replace those who are leaving, and issues with working in person in a laboratory setting where social distancing requirements are enforced. Meanwhile, as restaurants, schools, and other food service venues closed, food production in retail spiked, sending demand for retail food testing to new heights.

On top of this elevated retail demand, consumers have become more invested in the safety of the food they are purchasing, and more demanding of food safety testing information. As a result, food manufacturing labs have had to keep up with increased customer demands, such as those calling for robust validations, including different sample sizes than typically used, requesting quicker turnaround times, and requiring novel matrices.

To keep pace with these increased demands among ongoing labor shortages, labs have relied more heavily on implementing the most efficient testing solutions. Automation in the lab can provide a solution that allows for time savings, while also taking out the subjectivity of the test method and results interpretation.

Where Pathogen Testing Is Heading

One rising solution to labor shortages is the use of automation in food testing laboratories. As labs struggled to source employees during the pandemic, there was a major shift toward using contract labs to help keep up with testing demands; however, contract labs have faced the same worker shortage struggles and are leaning heavily on automation technologies as a result. In fact, some contract labs are now leading a shift to testing automation because these technologies help food testing labs increase efficiency by reducing technician time when testing for pathogens. Additionally, the learning curve when hiring new technicians to replace lost workers is significantly shorter with automated testing, as the technician does not need to manually count.

Customer demand influences the future of pathogen testing and detection. Historically, pathogen testing has been a qualitative result—looking to see whether there is a presence or an absence of the target pathogen. However, a new concept of pathogen testing has emerged due, in part, to increased knowledge and sensitivity around food safety. Customers are increasingly demanding quantitative testing. With quantitative testing, labs are now looking for the number of a target pathogen that is present in food. This method is of major interest to the poultry industry, which is currently the leading industry seeking advancement for quantitative testing. Quantitative results are especially important for Salmonella testing in the poultry industry, as the pathogen is widely present, and knowing the qualitative result of Salmonella testing is not as valuable as knowing how much of it is present.

Another concept at the forefront of pathogen testing is the idea of serotyping. Serotypes are groups within a single species of microorganism that have distinctive surface features that may make them more of a food safety risk. For example, certain Salmonella serotypes have a higher propensity to cause foodborne illness, so if food manufacturers can concentrate on limiting the levels of these Salmonella serotypes, they will produce a safer food for their consumers. As the industry continues researching pathogens, scientists can further understand the different strains of each pathogen, allowing pathogen testing and detection methods to continue advancing.

Our knowledge of pathogen testing is ever-changing as we continue to research prevalent and emerging food pathogens and continue to make advancements in testing technologies and detection methods. As we try to recover from the lasting effects of the pandemic, automation technology and new testing methods will help shape the industry moving forward.

Thevenet is a U.S. and Canada technical sales manager and pathogen manager for 3M Food Safety.

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PITTSBURGH—During this year’s International Association for Food Protection Annual Meeting in Pittsburgh, Sandra Eskin, USDA deputy undersecretary for food safety, announced that the agency’s Food Safety and Inspection Service (FSIS) will declaring all strains of Salmonella an adulterant in breaded and stuffed raw chicken products.

The announcement came during a session at the meeting on August 1. Since 1998, breaded and stuffed raw chicken products have been associated with up to 14 outbreaks and approximately 200 illnesses, according to USDA. Products in this category are found in the freezer section and include some chicken cordon bleu or chicken Kiev products. These products appear cooked, but they are heat-treated only to set the batter or breading and the product contains raw poultry. Continual efforts to improve the product labeling have not been effective at reducing consumer illnesses.

Breaded and stuffed raw chicken products will be considered adulterated when they exceed a very low level of Salmonella contamination and would be subject to regulatory action, according to USDA. FSIS will be proposing to set the limit at 1 colony forming unit (CFU) of Salmonella per gram for these products, a level that the agency believes will significantly reduce the risk of illness from consuming these products. The agency will also seek comment on whether a different standard for adulteration, such as zero tolerance or one based on specific serotypes, would be more appropriate.

The notice is expected to publish in the federal register in the fall and FSIS will be seeking public comments that address what the standard should be. Once published, the notice will be posted in the FSIS Federal Register and Rulemaking page for review and comment. When the proposal is finalized, FSIS will announce its final implementation plans and the date it will begin routine testing for Salmonella in these products.

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