Tag Archives: salmonella

Salmonella

USDA Declares Salmonella an Adulterant in Breaded Stuffed Raw Chicken Products

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Salmonella

On August 1, the U.S. Department of Agriculture’s (USDA) Food Safety and Inspection Service (FSIS) announced that it will be declaring Salmonella an adulterant in breaded and stuffed raw chicken products.

The FSIS noted that since 1998, breaded and stuffed raw chicken products have been associated with up to 14 outbreaks and approximately 200 illnesses. Products in this category are found in the freezer section and include some chicken cordon bleu or chicken Kiev products. The challenge is that these products appear cooked to consumers, but they are heat-treated only to set the batter or breading. The products contain raw poultry, and continual efforts to improve the product labeling have not been effective at reducing consumer illnesses, said the FSIS.

By declaring Salmonella an adulterant in these products, 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. FSIS is 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.

“Today’s announcement is an important moment in U.S. food safety because we are declaring Salmonella an adulterant in a raw poultry product,” said Sandra Eskin, USDA Deputy Under Secretary for Food Safety. “This is just the beginning of our efforts to improve public health.”

The notice is expected to publish in the Federal Register in the fall. FSIS will be seeking public comments that address what the standard should be as well as to inform its final implementation plan, including a verification testing program. Once published, the notice will be posted in FSIS’ Federal Register & 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.

In October 2021, USDA announced it was reevaluating its strategy for controlling Salmonella in poultry, including whether Salmonella should be considered an adulterant in specific raw poultry products. Since launching this effort, USDA has been focusing on gathering information by meeting with stakeholders to hear their ideas, asking for recommendations from food safety experts and soliciting ideas for pilot projects from industry to test drive different control strategies in poultry establishments. USDA plans to present a proposed framework for a new comprehensive strategy to reduce Salmonella illnesses attributable to poultry in October and convene a public meeting to discuss it in November.

Miguel Villa

USDA FSIS Integrates Salmonella Quantification Testing into Regional Labs

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Miguel Villa

In June, the USDA Food Safety and Inspection Services (FSIS) announced that it was rethinking its approach to Salmonella in poultry based on a review of data from 2015 to 2020 that showed a higher than anticipated reduction in Salmonella-contaminated chicken parts but no corresponding decrease in Salmonella-related illnesses attributable to poultry products.

Part of the new approach, shared in July, is the integration of Salmonella quantification testing in FSIS regional laboratories. The agency is now using GENE-UP QUANT Salmonella assay from bioMérieux, a non-enrichment quantification diagnostic tool for Salmonella.

We spoke with Miguel Villa, vice president of industrial applications for the Americas at bioMérieux to learn more about the new assay and how quantification methods may better serve public health initiatives.

Food Safety Tech (FST): How did your work with USDA FSIS come about?

Villa: bioMerieux is a French company with many, many years in the field of in vitro diagnostics. The background of the company is in human health care and life sciences. The legacy of this group is in vaccines going back to the time of Louis Pasteur. In fact, the founder of the group was a disciple of Louis Pasteur.

For the past 30 years, we have also been designing and manufacturing diagnostic tools and tests for the pharmaceutical and food industries. And for the past three years we—and other companies—have been in dialogue with the USDA FSIS and the FDA about the use of quantification for food safety and food testing for the benefit of public health.

There was discussion about the fact that, after years and years of better controls, increased testing and an increasing regulatory framework around food safety the level of foodborne illness that we continue to see is not where the regulators or the public want it to be. Based on that, we have had discussions about what are the next steps and how can we take this further to reduce diseases that are coming from food sources. There is a lot of focus on animal protein products, and one of the main contaminants has been Salmonella.

FST: What are some of the concerns or limitations of the current or traditional standards of testing?

Villa: The regulations now are focused on the presence or absence of Salmonella, and the regulators have accepted recently that we need to do more. One of the things that has been discussed quite a bit is quantification—not only do we want to know whether Salmonella is present, we want to know how much is present. This is what the GENE-UP QUANT Salmonella assay measures.

How this works is, whenever the FSIS gets a particular sample that is positive, they will use the assay to check how much Salmonella there is to get a better understanding of what they’re dealing with in terms of risk to public health.

FST: This is a non-enrichment detection method, why is that important?

Villa: True quantification can only come from the original sample. If you do something to that sample to stimulate growth, the organism typically does not grow in a linear fashion or you might be promoting limits of growth in that medium. So, the picture you get after enrichment is not exactly what is in the original sample, which is what you’re trying to understand.

FST: Is the assay quantifying only the density of Salmonella in the sample or is it also looking at serotypes?

Villa: Only the quantity. We are not looking at serotypes at this stage, but we are involved in the development of serotyping tools based on what we see coming down the road.

FST: Is the technology behind the GENE UP QUANT assay a new technology or new to the food safety industry?

Villa: GENE UP is a PCR (polymerase chain reaction) test, and PCR has been around for more than 20 years, so the tool itself is not new. What is new—or what is recent—are the methods that we are using to develop tests. They are more accurate and precise. And they are able to use mathematical modeling to correlate the things that you see in the sample, quantify them and also assess them accurately from a sample that is not enriched.

In the future, we will use the same techniques to develop rapid, accessible tools to identify specific serotypes.

FST: The USDA FSIS has brought this testing into its regional laboratories, are food manufacturers and processors also using these in their facilities? Should they be thinking about that?

Villa: Now that it is public knowledge that the FSIS is using this testing and performing Salmonella quantification, they are educating the market about why they’re doing this. As a result, we are beginning to receive inquiries from clients of ours about the test. It is not a mandate at this stage, but for their own risk management processes, many companies will likely start incorporating it.

FST:  What is the benefit of quantification? Why is it important to regulators and food safety professionals to know not only if Salmonella is present, but how much?

Villa: The industry has been very interested in moving away from presence/absence testing only for a while, because many people think that not all Salmonella is pathogenic. In addition, we need to find better ways to gauge risk but at the same time not be as costly or as shotgun in our approach.

Quantification was recognized several years ago as a potential way for us to start correlating clinical outcomes—or the lack of them—with certain levels of Salmonella. We think there will come a time where people will start to agree that one of the data points you need as part of your risk assessment to make decisions at an industrial level is how much Salmonella is in the original sample. If it’s below a certain level, it may not be considered as risky.

In the future, by combining quantification and serotyping, we believe that we will be able to give manufacturers very accurate readings with all the information needed to make good decisions and good calls about their products.

 

Pork

USDA FSIS Eyes New Salmonella Standards for Raw Pork Products

By Food Safety Tech Staff
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Pork

The USDA Food Safety and Inspection Service (FSIS) is considering new Salmonella performance standards focused on raw pork products, due to concerns about recent Salmonella outbreaks linked to these products. The concerns were raised in a study, “Temporal Changes in the Proportion of Salmonella Outbreaks Associated with Twelve Broad Commodity Classes in the United States,” published by the FSIS in Epidemiology & Infection.

The study examined changes in the proportion of foodborne Salmonella outbreaks attributed to 12 commodity groups between 1998 and 2017. Amongst the 12 commodity groups, only pork demonstrated a significant increasing trend—between 1998 and 2017, the estimated proportion of Salmonella outbreaks attributable to pork increased from 4% to 18%—while the proportion of outbreaks for other commodity groups remained essentially unchanged or constant during the 20-year study period.

“Amongst meat and poultry commodities, the consistent and significant increase in the proportion of pork-associated outbreaks is of concern,” noted authors Michael S. Williams and Eric D. Ebel. “Pork ranks as the third most frequently consumed meat commodity in the United States, yet only the chicken and the fruits–nuts commodities are responsible for a larger average proportion of outbreaks in the later years of the dataset. This suggests that the risk of illness per serving from pork may have increased and is high relative to the other meat and poultry commodities.”

The USDA FSIS will be using the results of this study, in addition to public comments on the proposed performance standards for Salmonella on pork products, to inform the development of new policies targeted to reduce Salmonella illnesses attributable to pork.

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NARMS Publishes 2019 Report on Antimicrobial Resistance Trends in Pathogens

By Food Safety Tech Staff
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The National Antimicrobial Resistance Monitoring System (NARMS) has published its 2019 Integrated Report Summary, which reviews antimicrobial resistance trends in Salmonella, Campylobacter, generic E. coli, and Enterococcus. The report also discusses genomic information for Salmonella, Campylobacter and E. coli in retail meat and food producing animals.

NARMS is a partnership between FDA, CDC, USDA’s FSIS, the Animal and Plant Health Inspection Service, the Agricultural Research Service, and other state and local public health departments and federal agencies. The national surveillance in the report helps all public health partners identify new types and patterns of resistance and changes over time.

“FSIS and the CDC use NARMS information on a case-by-case basis to investigate foodborne illnesses and outbreaks. FDA routinely uses NARMS data in its regulatory review and approval of new animal antimicrobial drugs, and to develop and update policies on the judicious use of antimicrobial in animals. NARMS findings help public health partners continually assess the nature and magnitude of bacterial antibiotic resistance at different points along the farm-to-fork continuum.” – USDA

The report includes a new way to calculate multidrug resistance (MDR), which means a resistance to three or more antimicrobial drug classes. The method is supposed to provide more consistency to the NARMS year-to-year MDR trend analysis and comparisons.

The Integrated Report Summary is available on FDA’s website.

Kinder

Ferrero Recalls Certain Kinder Chocolates due to Potential Salmonella Contamination

By Food Safety Tech Staff
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Kinder

Parsippany, NJ-based Ferrero U.S.A., Inc. has issued a voluntary recall of its Kinder Happy Moments Chocolate Assortment and Kinder Mix Chocolate Treats basket over concerns that the products may be contaminated with Salmonella Typhimurium.

“Ferrero deeply regrets this situation. We take food safety extremely seriously and every step we have taken has been guided by our commitment to consumer care. We will continue to work cooperatively with the Food and Drug Administration to address this matter.” – Ferrero, U.S.A.

Several Kinder products have been recalled outside the United States, including in the United Kingdom, Belgium, Germany, France and Luxembourg, as a result of Salmonella contamination. Thus far there have been reportedly 105 confirmed cases of illnesses and 29 suspected cases—mainly in children under 10 years old.

Alert

FDA Tells Consumers to Throw out Certain Powdered Infant Formulas due to Contamination

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Alert

–UPDATE–March 14, 2022 — In an agency update, the FDA stated that it has removed the Salmonella Newport illness that was previously noted in the investigation. “In the early stages of this investigation, FDA included all consumer complaints of illness with exposure to products from the Sturgis, MI, facility. After further investigation, the FDA has determined that there is not enough information to definitively link this illness to powdered infant formula. CDC confirmed that this single Salmonella illness is not linked to an outbreak. The FDA and CDC are continuing to monitor for Salmonella cases and consumer complaints that may be related to this incident,” the FDA stated.

–END UPDATE–

Earlier this week Abbott issued a recall of infant powdered formulas (including Similac, Alimentum and EleCare) that were manufactured at the company’s Sturgis, Michigan plant. The company received consumer complaints in infants who had consumed powdered infant formula manufactured in this facility—specifically, three reports of Cronobacter sakazakii and one report of Salmonella Newport. All cases resulted in hospitalization, and one death was reported.

FDA began onsite inspection at the facility and thus far has found several positive Cronobacter results from environmental samples and reported adverse inspectional observations. “A review of the firm’s internal records also indicate environmental contamination with Cronobacter sakazakii and the firm’s destruction of product due to the presence of Cronobacter,” FDA stated in a CFSAN update.

The recalled Similac, Alimentum and EleCare products can be identified by their 7-to-9 digit code and expiration date:

  • First two digits of the code are 22 through 37 and
  • Code on the container contains K8, SH, or Z2, and
  • Expiration date of 4-1-2022 (APR 2022) or later.

In a company announcement published on FDA’s website, Abbott stated, during testing in our Sturgis, Mich., facility, we found evidence of Cronobacter sakazakii in the plant in non-product contact areas. We found no evidence of Salmonella Newport. This investigation is ongoing.” It added that “no distributed product has tested positive for the presence of either of these bacteria” but that the company will continue to conduct testing.

Parents and caregivers can find out whether the product they have is included in the recall by visiting the Similac recall website.

Food Safety Tech Hazards Series:  Salmonella

From leafy greens to poultry, Salmonella continues to cause outbreaks and trigger recalls in food products. Experts will review the incidence of Salmonella and relevant recalls, and how companies can approach reducing the pathogen’s presence, along with a review of the incidence of Salmonella in food products and strategies that focus on prevention as the goal.

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FSIS Reflects on 2021, Points to Progress in Transparency, More Collaboration

By Food Safety Tech Staff
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Just as FDA recently called out its 2021 achievements, USDA’s FSIS is highlighting its efforts from last year. In a news release issued last week, the agency pointed to several areas of progress, including:

  • Stronger moves to reduce Salmonella illnesses from poultry products. The initiative seeks more innovative methods for pathogen control.
  • Supporting small and very small plants via trying to take the cost burden off these establishments. The agency lowered overtime and holiday inspection fees for small establishments by 30% and by 75% for very small establishments.
  • Proposed rulemaking related to the labeling of meat and poultry products that are comprised of or contain cultured cells from animals.
  • Review of “Product of USA” labeling.
  • Collaboration with public health partners that include the FDA and CDC. The agencies signed a Memorandum of Understanding to enable more efficient use of resources.

A full review of the FSIS 2021 highlights are available on the agency’s website.

FDA

FDA Releases Report on Salmonella Outbreak in Packaged Leafy Greens

By Food Safety Tech Staff
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FDA

FDA has released a report on the multiagency investigation of a Salmonella Typhimurium outbreak associated with packaged salad greens grown in a controlled environment agriculture (CEA) operation. The outbreak, which occurred between June and August 2021, resulted in 31 reported illnesses and four hospitalizations. It is also believed to be the first of its kind associated with leafy greens grown in a CEA facility.

No “conclusive” root cause was found, but the FDA did pinpoint the outbreak strain of Salmonella to a stormwater retention basin located next to the CEA farm. The investigation did not, however, find that this was the definitive source of contamination of the leafy greens. The agency also identified certain conditions, factors and practices that could lead to contamination, including the pond water used, growth media storage methods, water management practices and overall sanitation practices.

In the report, the FDA listed eight requirements and recommendations that apply to hydroponic facilities using CEA, including implementing effective sanitation procedures and sampling plans, conducting pre- and post-harvest sampling and testing of food, water and the physical environment, implementing procedures that are effective in rapidly cooling and cold-holding harvested leafy greens after harvest, and ensuring all growing pond water is safe and of sanitary quality.

The eight-page Investigation Report: Factors Potentially Contributing to the Contamination of Packaged Leafy Greens Implicated in the Outbreak of Salmonella Typhimurium During the Summer of 2021 is available on FDA’s website.

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IFSAC to Continue Focus on Finding Sources of Foodborne Illnesses

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The Interagency Food Safety Analytics Collaboration (IFSAC) has published its 2022–2023 Interim Strategic Plan, placing continued emphasis on foodborne illness source attribution for Salmonella, E. coli O157:H7, Listeria monocytogenes and Campylobacter. Over the next year, IFSAC will address several short-term goals surrounding improvement of methods to evaluate and identify foodborne illness source attribution through the use of outbreak and non-outbreak-associated disease data, and continued collaboration with external partners in an effort to boost data access and capabilities. The group will be targeting several efforts in the coming year, including:

  • Analysis of trends related to foodborne disease outbreak-associated illnesses over the past two decades, with a subsequent peer-reviewed journal article that reveals results.
  • Development and improvement of machine-learning methods used to predict food sources of illnesses that have an unknown source. WGS will be used to compare Salmonella isolates of known and unknown sources.
  • Collaboration with FoodNet when assessing key food sources for sporadic Salmonella Enteritidis and Campylobacter illnesses. The group will develop case-control studies using specific FoodNet data.

Formed in 2011, IFSAC is a partnership between FDA, FSIS and the CDC that seeks to strengthen federal interagency efforts and maximize use of food safety data collection, analysis and use. During 2022–2023, IFSAC will publish its yearly reports on foodborne illness source attribution for the previously mentioned priority pathogens.