Tag Archives: salmonella

By Food Safety Tech Staff

On July 29, the U.S. Department of Agriculture’s (USDA) Food Safety and Inspection Service (FSIS) issued a comprehensive proposed rule and determination to more effectively reduce Salmonella contamination and illnesses associated with raw poultry products. According to the USDA’s website, this is the culmination of FSIS’ three-year effort to reevaluate their strategy for controlling Salmonella rates in poultry and protect American consumers from foodborne illness linked to consumption of poultry products.

The proposal would establish final product standards to prevent raw chicken carcasses, chicken parts, ground chicken, and ground turkey products that contain any type of Salmonella at or above 10 colony forming units (CFU) per gram/ml and any detectable level of at least one of the Salmonella serotypes of public health significance from entering commerce. The proposed Salmonella serotypes of public health significance identified for raw chicken carcasses, chicken parts, and comminuted chicken are Enteritidis, Typhimurium, and I,4,[5],12:I:- ; and for raw comminuted turkey are Hadar, Typhimurium, and Muenchen. The proposal would also require poultry establishments to develop a microbial monitoring program to prevent pathogen contamination throughout the slaughter system.

“The proposed Salmonella framework is grounded in data and rigorous scientific evaluation, and it reflects feedback from extensive stakeholder engagement,” said USDA Under Secretary for Food Safety Dr. Emilio Esteban. “We encourage all interested stakeholders to submit comments and relevant data on the proposal as we work to finalize data-driven, science-based regulatory policies to address Salmonella in poultry.”

April 30, 2024

USDA Declares Salmonella an Adulterant in Raw Breaded Stuffed Chicken Products

By Food Safety Tech Staff

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On April 26, USDA Food Safety and Inspection Service (FSIS) officially declared Salmonella an adulterant in raw breaded stuffed chicken products when they exceed a 1 colony forming unit (CFU) per gram or higher for Salmonella contamination.

The USDA FSIS announced its intent to declare Salmonella an adulterant in raw breaded stuffed chicken back in August 2022. This final determination is part of FSIS’ broader efforts to reduce Salmonella illnesses associated with the raw poultry supply in the United States. The agency noted that it intends to address Salmonella contamination in other raw poultry products later this year.

“Under President Biden’s leadership, USDA is taking significant steps toward keeping American consumers safe from foodborne illness,” said Agriculture Secretary Tom Vilsack. “This final determination marks the first time that Salmonella is being declared an adulterant in a class of raw poultry products. 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.”

Under this final determination, FSIS will consider any raw breaded stuffed chicken products that include a chicken component that tested positive for Salmonella at 1 CFU per gram or higher to be adulterated. It 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 Escherichia 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. during 1998-2020.

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 FSIS’ and industry’s efforts to improve labeling, these products continue to be associated with Salmonella illness outbreaks, said the USDA.

To view the final determination, visit the FSIS Federal Register Rules webpage.

February 27, 2024

USDA FSIS Releases 2023 Foodborne Illness Outbreak Report

By Food Safety Tech Staff

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The USDA Food Safety and Inspection Services (FSIS) has released a summary of outbreaks investigated during FY 2023.

In 2023, FSIS investigated six outbreaks in coordination with local, state, and federal public health partners. These outbreaks involved more than 100 illnesses and 30 hospitalizations. The Centers for Disease Control and Prevention (CDC) notified FSIS of five (83%) of these outbreaks. FSIS became aware of the sixth outbreak by notification from a state public health agency. Five (83%) outbreaks involved illnesses in more than one state.

Of the six outbreaks investigated by FSIS in FY 2023, three were caused by Salmonella (serotypes Newport, Saintpaul, and Typhimurium) and two by STEC (serogroup O157:H7). The sixth investigation involved a report of botulism that included commercially canned potted meat (containing chicken and pork) as a potential source. FSIS’ investigation of the establishment where the canned potted meat was produced, and laboratory testing of similar cans, did not determine that the canned potted meat was the source of the illness. The illness was later determined to not be associated with a food source.

Beef products, including beef ground and packaged at retail stores, were the food product of interest for the five Salmonella and STEC outbreaks investigated in FY 2023. The 2023 outbreak investigations did not lead to any recalls of FSIS-regulated products or public health alerts (PHAs).

January 9, 2024

FDA Releases 2022 Annual Report on Investigations of Foodborne Outbreaks

By Food Safety Tech Staff

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On January 8, the FDA Coordinated Outbreak Response & Evaluation (CORE) Network released its first annual report summarizing the investigations of foodborne outbreaks and adverse events in FDA-regulated human foods for the 2022 calendar year.

In 2022, CORE evaluated 65 incidents, responded to 28 and issued advisories for 11. These numbers show a slight increase from 2021 when 59 incidents were evaluated with 19 responses and 10 advisories. The investigations in 2022 included E. coli, Cronobacter, hepatitis A virus, Listeria monocytogenes, and Salmonella which were linked to a variety of products, including produce, dairy and fish.

CORE investigations also resulted in numerous public health actions, including recalls, public health advisories, Warning Letters, FDA prevention strategies, a country-wide Import Alert and a Consent Decree. Outbreak advisories were issued for:

E. coli O157:H7 linked to packaged salads
Cronobacter linked to infant formula
Salmonella Senftenberg linked to peanut butter
Hepatitis A Virus linked to strawberries
Unknown contaminant linked to French Lentil and Leek Crumbles
Listeria monocytogenes linked to ice cream
Listeria monocytogenes linked to Brie and Camembert soft cheese products
E. coli O121 linked to frozen falafel
Salmonella Litchfield linked to seafood
Listeria monocytogenes linked to enoki mushrooms
Salmonella Typhimurium linked to sprouts

The 2022 annual report highlights noteworthy outbreaks from 2022, including Listeria monocytogenes linked to enoki mushrooms, Salmonella linked to cantaloupe and Salmonella linked to peanut butter.

Read the full report here.

October 9, 2023

FDA Releases Updated Compliance Program for Infant Formula

By Food Safety Tech Staff

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The FDA has updated its infant formula compliance program for FDA investigators, laboratory analysts and compliance officers. The updates build on lessons learned over the last several years to elaborate on FDA’s approaches for inspections, sampling, laboratory analysis and imported infant formula products. For example, updates include instructions for annual environmental sampling of Cronobacter and Salmonella at powdered infant formula facilities and instruction for FDA notification should a sample test positive for Cronobacter or Salmonella, or if a sample is found to have nutrients that are above or below required levels per the agency’s infant formula regulation.

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 infant formula products, and the conditions that could lead to environmental contamination within the manufacturing facilities, are also included in the updated compliance program.

Inspectors are directed to perform environmental sampling once a year at each domestic powder infant formula manufacturing facility during annual or compliance follow-up inspection for both Cronobacter and Salmonella analysis if there are no significant adverse supply-chain implications.

The Division of Field Programs and Guidance (DFPG) and ORA Critical Foods Coordination Team will prioritize the annual inspection schedule based on:

the facilities’ previous inspection results
number of consumer complaints since the last inspection
number of violative samples collected by FDA in the last twelve months
the previous environmental sampling results performed by FDA

Per the instructions, environmental sampling should focus on zone two sites near potential product exposure points in the process (i.e., transfer points, fluid bed, sifters, rotary valves, man doors into drying system, filling lines, blending equipment, raw material handling equipment, etc.) including any areas indicating water accumulation. Additional sampling should also be done from zone three sites which may suggest a route of contamination (i.e., doorways, traffic routes, etc.) to dry production areas, finished product or food contact surfaces. Zone one sites should not be swabbed as these zones can be hard to reach and may introduce contamination during swabbing of a closed system. Unless conditions observed indicate a possible route of contamination, FDA does not recommend swabbing zone four areas at a high frequency.

Inspectors are advised to collect between 100-300 environmental swabs for Cronobacter spp. and 100-300 environmental swabs for Salmonella spp. at each firm, depending upon the size of the facility.

September 12, 2023

Food Genomics

Salmonella Outbreak Investigation Reinforces Importance of Drain Sanitation

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Drains can harbor pathogens and biofilms in facilities and have been cited as the cause of a Salmonella Motevideo outbreak in Quebec, Canada. For “Investigation of a Salmonella Montevideo Outbreak Related to the Environmental Contamination of a Restaurant Kitchen Drainage System, Québec, Canada, 2020–2021,” (Journal of Food Protection, October 2023), researchers André Paradis, Marie-France Beaudet, Marianne Boisvert Moreau and Caroline Huot, documented the investigation into the outbreak that affected at least 67 people between January 1, 2020 and August 13, 2021. An epidemiological investigation that included whole genome sequencing found that 66% of cases were directly linked to a restaurant in the area.

After an initial evaluation of hygiene, food safety, cases of illness among workers and food sampling failed to establish the source of the outbreak, environmental samples showed that the restaurant’s kitchen drains were contaminated with the same strain of Salmonella Montevideo as the cases in the outbreak. Several cleaning and disinfection methods were used repeatedly. When environmental sampling at the restaurant sites was repeatedly and consecutively negative, cases in the community stopped.

Over the course of the epidemiologic investigation, public health responders learned that the restaurant had experienced an accidental fire in its kitchen before the Salmonella Montevideo outbreak began. According to the Québec City fire department’s incident report, the fire started in—and was limited to—the oven used for cooking chicken.

The authors posited that the fire in the kitchen, which required emergency response from firefighters who used a powder extinguisher first, then a water jet to contain and extinguish the flames, may have played a role in the contamination of the restaurant’s sinks and drains.

The authors concluded that, “The most plausible explanation for the origin of this outbreak remains the contamination of the drains in Restaurant A. The presence of contaminated biofilm in the restaurant’s kitchen drainage system may have had a role to play in the extended duration of this outbreak.”

June 20, 2023

FDA Releases Outcomes of Refrigerated Dips and Spreads Sampling Program

By Food Safety Tech Staff

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The FDA has released the results of a March 2021-January 2022 routine sampling program of ready-to-eat (RTE) refrigerated dips and spreads to test for Listeria monocytogenes and Salmonella spp.

The goal of the testing program—launched as part of the FDA’s risk-based approach to food safety, as outlined in the FDA Food Safety Modernization Act (FSMA)—is to identify common factors or patterns related to the contamination of RTE dips and spreads. The data collected helps the FDA develop guidance and update program priorities, including sampling assignments and the prioritization of surveillance inspections.

Out of the 747 samples, four were detected to have a human pathogen.

Pathogen Findings: Salmonella

The agency detected Salmonella Havana in one hummus sample collected from a retail establishment in Kingsburg, California. The FDA performed Whole Genome Sequencing (WGS) analysis on the organism and determined that it did not match any known human illnesses and was not linked to any other product or environmental samples.

Pathogen Findings: Listeria monocytogenes

The FDA detected Listeria monocytogenes in three dips and spreads samples—two cheese samples, one cheese and pepper sample—collected from a retail establishment in Colorado Springs, Colorado. All three of the samples were produced by the same manufacturer. WGS analysis on the organisms determined they did not match any known human illnesses and were not linked to any other product or environmental samples.

The agency also detected two subspecies (i.e., Listeria welshimeri, Listeria innocua) of non-pathogenic Listeria spp. in three samples—two collected from retail establishments and one from the manufacturer/processor. Since these samples were non-pathogenic, they were not analyzed by WGS.

The agency noted that the findings suggest that Salmonella spp. and L. monocytogenes were not widespread in the multi-commodity RTE dips and spreads collected nationwide, though it cautioned against making inferences more broadly about the contamination or potential for contamination of RTE dips and spreads based solely on this testing assignment’s findings. “The presence of contamination in the samples suggests the risk of contamination still exists. For example, from FY2017 through FY2022, there were a total of 22 recalls of dips and spreads due to potential Salmonella or L. monocytogenes contamination; of these hummus and cheese dips and spreads make up 64% of the recalls (10 hummus recalls, 4 cheese dips and spread recalls),” the agency stated.

June 13, 2023

USDA FSIS Releases New Salmonella Control Guideline for Swine Slaughter and Pork Processing

By Food Safety Tech Staff

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The USDA Food Safety and Inspection Services (FSIS) has updated its voluntary guideline for federally regulated swine slaughter and pork processing establishments to control Salmonella in market hogs from pre-harvest through slaughter. The agency announced that it updated the document in response to comments on the previous guideline and to incorporate current, peer-reviewed scientific references related to pre-harvest controls, swine slaughter, processing of pork cuts, and comminuted pork products.

The guideline covers:

Pre-harvest controls, including farm rearing, multi-hurdle interventions, transport, and lairage
Slaughter controls
Best practice recommendations for pork fabrication controls, including processing, packaging, and distribution controls for pork cuts and comminuted pork products.

Download the new guideline here.

May 29, 2023

bioMérieux Expands xPRO and Predictive Diagnostics Innovation Programs

By Food Safety Tech Staff

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In vitro diagnostics provider bioMérieux recently announced its plans to open a new, 32,000 sq. ft. state-of-the-art molecular innovation center at the Navy Yard in Philadelphia. The new site will house the company’s xPRO Program, as well as the company’s Predictive Diagnostics Innovation Center.

The xPRO Program was created to speed development of advanced molecular diagnostics for food quality and safety departments in the food and beverage, nutraceutical and cannabis indsutries.

We spoke with Ben Pascal, head of xPRO at bioMérieux, about the program as well as the challenges and recent advances in the development of molecular assays and predictive diagnostics.

What is the xPro program?

Pascal: xPRO is an entrepreneurial engine for bioMérieux. We have had tremendous success with the molecular assays we’ve built over the years here, and we want to continue to invest in that innovation both in terms of the way we develop these assays, the speed with which we bring them to market, and we want to expand the partnerships that we’ve built with industry. All of these efforts are bolstered through the xPRO program and team.

What are some of the challenges in developing the molecular assays?

Pascal: In the clinical micro sector, you’ve got blood, saliva, and urine, and they are pretty uniform between everyone. When you come to the industrial micro sector, where you’re working with lettuce one day, ground beef the next and then nutraceuticals or spices, it is far more challenging to build a diagnostic that can work across all those matrices.

The challenge is how to create something that is compatible in multiple sectors, is faster and will deliver value over and over in a routine quality testing lab. Experience is crucial. Our team in Philadelphia has built and commercialized more than 30 molecular diagnostics, so we had the opportunity to put together a toolkit, if you will, to help us get through challenging matrices and speed things along with regards to recovery of target organisms.

When you talk about predictive diagnostics, is this related to gaining a better understanding of which pathogens are most likely to cause illness and at what levels?

Pascal: You do have these pathogens, but there’s a whole other concern related to spoilage. Day to day in the food and beverage sector, it’s spoilage that’s affecting quality and your brand reputation and causing recalls.

When it comes to pathogens that can cause foodborne illnesses, one cell is typically the law of the land. But when we say predictive diagnostics, we are isolating unique genes that are 100% predictive of spoilage. We know there are certain organisms that cause spoilage, but not all organisms that spoil are created equal. So what we try to tease out through our genomic and predictive diagnostic center is which unique genes allow one bug within the same species to cause spoilage, while another does not.

Traditionally, a quality director on the floor will say, I have this organism. It might spoil it might not. We’re taking the risk out of the equation. If you have a potential spoilage organism and you know that it has the specific genes that create spoilage, you can make more informed decisions on what you’re going to do with your product in terms of releasing it or remediating it.

For example, in brewing there is a yeast called saccharomyces cerevisiae that is often used. And there is a variant of saccharomyces cerevisiae that has some genes that allow it to use up residual starches in the product to produce gas, which causes the cans to swell and burst.

The problem is, you can’t tell from a culture plate whether your saccharomyces cerevisiae has this variant diastaticus or not—and not all diastaticus will go on to chew up those residual starches as an energy source and produce gas. We’ve identified a unique set of genes, and every time those genes are there, that diastaticus will go on to produce gas and create quality issues. That’s what we refer to as predictive diagnostics.

When you talk about rapid diagnostic testing, can these tests be performed in the food or beverage facility?

Pascal: Yes, they take our equipment and utilize it at their site, whether that be a third party laboratory, the production site of a brewery, a food processing facility or a nutraceutical manufacturer. We manufacture the equipment and the reagents that we’ve developed, and we put that into a test kit that customers can purchase after we’ve installed the equipment at their production site.

Are there any specific food areas that you’re focusing on now?

Pascal: Some of our key focuses relate to beverages, both alcoholic and non-alcoholic. We do quite a lot in nutraceuticals. We do quite a bit of work in cannabis, and in food safety, we’re focused on changing the game with regards to environmental monitoring. With environmental monitoring you’re looking for specific pathogens with the theory being, if you can control your environment, you can control what gets into your food products.

You’re typically looking for one of two pathogens: salmonella or listeria. We said, why not do them both together? And we created a universal medium. By providing specific data points for both pathogens within a single test, it can detect and enrich both salmonella and listeria from the environmental swab.

In all the work we do, our partnerships with industry are very important. The way that we build our pipeline is directly through partnerships with industry, which informs us on their key challenges as well as better ways to make tools. So, when we come out with a new tool, our goal is to not only meet the needs of our partner but meet or exceed the needs of their peers in the industry as well.

April 11, 2023

Highlights from Food Safety Tech’s Hazards Conference

By Food Safety Tech Staff

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The Food Safety Tech’s Hazards Conference + CFI Think Tank “Industry & Academia Advancing Food Safety Practices, Technology and Research” took place April 3-5 in Columbus, Ohio. The event offered two days of practical education on the detection, mitigation, control and regulation of key food hazards, followed by discussion geared toward identifying gaps for research and innovation.

Sandra Eskin, Deputy Under Secretary for Food Safety, USDA FSIS, opened the program to discuss the agency’s proposed Salmonella in poultry framework. She highlighted the need for a more comprehensive approach that includes incentives to bring down the Salmonella load in birds entering the slaughterhouse, enhanced monitoring of safety measures within the facility, and enforceable product standards for raw poultry products.

Day one continued with a focus on Salmonella and Listeria. Barb Masters, VP of Regulatory Policy at Tyson Foods presented “Salmonella: What We’ve Learned and Remaining Gaps in Detection and Mitigation.” Masters highlighted key gaps in Salmonella detection, mitigation and research including:

Correlating what comes from the farm to what is entering a plant
Potential benefits of quantification testing
A better understanding of products that have the highest levels of Salmonella
Identification of virulence factors of different serotypes
The need for rapid testing methods that can be used at the plant level

Sanja Ilic, Ph.D., presented findings on the risks and most effective mitigation methods for listeria in hydroponic systems, followed by a session from Stacy Vernon, Ph.D., on recent listeria outbreaks in RTE meats and ice cream.

Attorneys Bill Marler, founder of Marler Clark, and Shawn Stevens of the Food Industry Counsel opened day two with an overview of the legal and financial risks of food safety hazards. The program continued with a focus on detection and mitigation of pathogens and biofilms.

Session Highlights

Application of Ozone for Decontamination of Fresh Produce with Al Baroudi, Ph.D., VP of Quality Assurance and Food Safety, The Cheesecake Factory, and Ahmed Yousef, Ph.D., Professor and Researcher with the Department of Food Science & Technology, OSU

Estimating Mycotoxin Exposure in Guatemala and Nigeria with Ariel Garsow, Ph.D., Food Safety Technical Specialist at the Global Alliance for Improved Nutrition (GAIN)

Mitigating the Risks of Salmonella and Listeria in Your Facility & Products with Sanjay Gummalla of the American Frozen Food Institute, and Rashmi Rani, Senior Manager of Food Safety and Quality Assurance, Schwan’s Foods

How to Use Whole Genome Sequencing in Operations To Improve Food Safety and Root Cause Analysis with Fabien Robert, Head of Zone AMS, Nestlé

Biofilm Prevention and Control Practices with Charles Giambrone, Food Safety Manager, Rochester Midland

On April 5, attendees joined the Ohio State University Center for Foodborne Illness Research and Prevention (CFI), founded and directed by Barbara Kowalcyk, for its annual “Think Tank.” The program featured student research presentations and an “Einstein Lunch” that brought members of industry together with graduate students and OSU researchers to identify gaps in research in the areas of pathogen detection and mitigation, handwashing and mycotoxins.

“We’re hoping this is the first of future collaborations with CFI and Food Safety Tech, where we have industry and academia presenting together,” said Rick Biros, founder of Food Safety Tech, the Food Safety Consortium and the Food Safety Tech Hazards Conference series. “This is something I feel both academia and industry benefit from, and I look forward to working with Barbara and CFI in the future.”

“I learned a lot myself, and it was great to see this program come together,” said Kowalcyk. “I want to thank the presenters, attendees and all the people who worked behind the scenes to make this event happen.”