The slivered onions have been linked to an E. coli outbreak that sickened over 100, putting 1 man in an early grave. The FDA inspection report – redacted – makes an interesting read – full report below.

OBSERVATION 1
You did not implement your sanitation preventive control, monitoring, corrective action and verification

OBSERVATION 2
You did not have sanitation control monitoring, corrective action and verification records.

OBSERVATION 3
You did not conduct operations under conditions and controls necessary to minimize the potential for contamination of food.

Taylor Farms Colorado, Inc. of Colorado Springs, Colorado FDA Inspection Report.

FSIS published a report on the why’s of the outbreak and a list of things it intends to do to prevent another “Boar’s Head”

FSIS Assessment of Factors Contributing to Outbreak Associated with Boar’s Head Establishment M12612

M12612 is a large establishment in Jarratt, VA, that received its grant of inspection in April 1984. The establishment produced a variety of RTE deli meats and hot dogs including hams, bologna, liverwurst, Canadian bacon, head cheese, franks, and kielbasa, which were distributed directly to retail outlets. The facility has a federal grant of inspection and was inspected by the Virginia Department of Agriculture and Consumer Services (VDACS), through a Talmadge-Aiken (TA) cooperative agreement, established under the Talmadge-Aiken Act of 1962 (“the TA Act;” 7 U.S.C.1633).

Findings related to M12612

FSIS reviewed inspection documents and establishment sampling data from January 2022 to September 2024 and conducted in-person observations as part of this review. Based on records and observations, FSIS identified several factors that may have contributed to the outbreak. A notable contributing factor was the facility’s inadequate sanitation practices.

Observations by VDACS inspection personnel documented in noncompliance records (NR) demonstrated multiple instances of noncompliance with Sanitation Standard Operating Procedures and Sanitation:

• Performance Standards. While sanitary conditions were required to be restored for each documented noncompliance, repeated instances of insanitary conditions can present opportunities for growth or sustained presence of Lm. Documented instances of noncompliance included:

• Product Residue: Inspectors identified the presence of meat and fat residue from the previous day’s production on equipment, including packaging equipment and in the RTE processing area during pre-operational sanitation checks. Residue can provide a substrate for Lm to survive and grow in the food processing environment and form biofilms, which can become more resistant to cleaning regimens. Biofilms are thin layers of bacteria that can form on equipment and other surfaces (similar to plaque on teeth). Once biofilms form, they must be removed by scrubbing or other mechanical action.

• Condensation: Inspectors identified multiple instances of condensation in the RTE environment (e.g., dripping condensate on exposed product and a fan blowing condensate directly on products).

• Structural and Facility Problems: Inspectors observed facility and structural-related issues (e.g., cracks, holes and broken flooring) that could hold moisture and contribute to wet conditions. Additional conditions documented included rust, beaded condensation and peeling caulk.

I will leave what FSIS intends to do going forward for another day – it’s been a long week.

Full Report Here.

Perhaps we should become Canada’s 11th Province?

The full article is worth a read.

Nontyphoidal Salmonella enterica infections are a leading cause of enteric disease in Canada, most commonly associated with foodborne exposures. Raw frozen breaded chicken products (FBCP) have been implicated in 16 Salmonella outbreaks between 2017 and 2019. This study quantified the impact of the 1 April 2019 requirement by the Canadian Food Inspection Agency (CFIA) for manufacturers to reduce Salmonella in raw FBCP. An intervention study approach utilizing the pre–post intervention data with a comparison group methodology was used to: (1) estimate the reduction in FBCP Salmonella prevalence using retail meat FoodNet Canada data; (2) estimate the reduction in the human salmonellosis incidence rate using data from the Canadian National Enteric Surveillance Program; and (3) estimate the proportion of reported cases attributed to FBCP if the human exposure to Salmonella through FBCP was completely eliminated. The FBCP Salmonella prevalence decreased from 28% observed before 1 April 2019 to 2.9% after the requirement implementation. The CFIA requirement was estimated to reduce the human salmonellosis incidence rate by 23%. An estimated 26% of cases during the pre-intervention period can be attributed to FBCP. The CFIA requirement was successful at significantly reducing Salmonella prevalence in retail FBCP, and at reducing salmonellosis burden.

The Food and Drug Administration (FDA) conducted thousands of routine surveillance food safety inspections of domestic and foreign food facilities from fiscal year 2018 through fiscal year 2023 (see fig.). According to GAO’s analysis of FDA data, FDA conducted an average of 8,353 domestic inspections per year and an average of 917 foreign inspections per year.

FDA has not met its domestic and foreign inspection targets since fiscal year 2018. The FDA Food Safety Modernization Act (FSMA) directs FDA to inspect each high-risk domestic food facility at least once every 3 years and each non-high-risk facility at least once every 5 years. GAO’s analysis of FDA data shows that FDA nearly met its mandated targets for both high-risk and non-high-risk domestic facilities in fiscal years 2018 and 2019, but faced significant challenges in meeting mandated targets beginning in fiscal year 2020—largely due to the COVID-19 pandemic. For example, according to FDA data, FDA did not inspect about 7 percent of high-risk domestic facilities due for inspection during fiscal year 2019. In contrast, the data show that in fiscal years 2020 and 2021, the percentage increased to 40 percent and 49 percent, respectively.

For foreign facility inspections, FDA conducted far fewer than the annual target of 19,200 inspections identified by FSMA, according to FDA data. For example, the highest annual number FDA completed was in fiscal year 2019 when FDA inspected 1,727 foreign facilities—about 9 percent of the annual target. FDA considers the existing target to be unrealistic and unachievable. However, FDA has not identified an appropriate annual target and communicated this information to Congress, as we recommended in January 2015.

FDA officials identified limited workforce capacity as FDA’s primary challenge to meeting inspection targets. FDA’s investigator cadre has remained understaffed for years. For example, in July 2024, FDA had a total of 432 investigators—90 percent of the full-time equivalent ceiling—for conducting both domestic and foreign inspections, according to FDA officials. Taking steps to determine the appropriate size of its foreign investigator cadre would help FDA better plan its foreign inspection efforts and, in turn, better ensure the safety of imported food for U.S. consumers.

FDA has not identified and implemented additional procedures for minimizing incidences where investigators attempt but are unable to complete an inspection. Doing so would better ensure the efficient use of FDA’s resources. FDA also does not yet have a formal performance management process focused on its food safety inspection efforts. Developing and implementing such a process would provide FDA with greater assurance the agency is achieving its goals. For example, FDA could develop goals and measures for use in assessing agency progress in recruiting and retaining investigators. Systematically collecting such performance information and using it to assess progress and inform decision-making would assist FDA in its efforts to safeguard the U.S. food supply and protect the Americans who rely on it.

Here is full REPORT

According to the CDC, the total of 113 people infected with the outbreak strain of Salmonella were reported from 23 states: Alaska 2, Arizona 1, California 4, Colorado 8, Iowa 3, Illinois 4, Massachusetts 6, Michigan 3, Montana 18, Nebraska 1, Nevada 1, New Jersey 2, New Mexico 1, New York 1, Ohio 1, Oregon 9, Pennsylvania 1, South Dakota 5, Texas 8, Utah 3, Washington 9, Wisconsin 13, Wyoming 9.

Illnesses started on dates ranging from October 12, 2024, to December 7, 2024. Of the 99 people for whom information was available, 28 were hospitalized. No deaths were reported. 

The true number of sick people in this outbreak was likely much higher than the number reported, and the outbreak may not have been limited to the states with known illnesses. This is because many people recover without medical care and are not tested for Salmonella.

According to the FDA, many companies have recalled cucumbers or foods made with them. CDC advises people not to eat and businesses not to sell or serve recalled cucumbers. FDA continues to work with additional importers that received cucumbers grown by Agrotato S.A. de C.V.

CompanyFoodPackagingLink to Recall
Baloian Farms of Arizona Co.Whole bulk cucumbersBulk, “PamPak” clear bag of 6Baloian Farms Recall | FDA
Baloian Farms of Arizona Co.Salads and wrapsMultiple brands, clear plastic wrapBaloian Farms Recall | FDA
Dairyland Produce, LLCWhole bulkBulk; Costco in Houston & Dallas TXDairyland Produce Recall| FDA
F & S Fresh FoodsMediterranean party trayRalph’s stores; some states; Tzatziki sauceF & S Fresh Foods Recall| FDA
Fresh Creative FoodsGyro meal kitSam’s Club nationally; Express meal kitFresh Creative Foods Recall| FDA
JFE Franchising, Inc.Sushi, vegetable bowls, vegetable trays, cucumber slices with Tajin, cucumber bowls, salad kits, and cucumber saladsSNOWFRUIT and SNOWFOX brand, plastic containersJFE Franchising, Inc. Recall | FDA
Reser’s Fine Foods, IncGyro meal kitSprouts Farmers Market; tzatziki sauceReser’s Fine Foods Recall| FDA
Russ Davis WholesaleCucumbers (whole, diced, peeled and sliced, or skin on sliced), salad kits, and wrapsClear plastic packaging of multiple sizesRuss Davis Wholesale Recall | FDA
SunFed Produce LLCWhole bulk cucumbersBulk, may have a stickerSunfed Produce, LLC Recall | FDA
Supreme Service Solutions LLCCucumber slices, salads, vegetable trays, vegetable bowls, snack cupsMultipleSupreme Produce Recall | FDA
WalmartCucumber slicesMarketside; only in Texas; plastic containerWalmart Marketside Recall | FDA
Yummi Sushi LLCSushiMultiple; Kroger only in TexasYummi Sushi Recall | FDA

Salmonella:  Marler Clark, The Food Safety Law Firm, is the nation’s leading law firm representing victims of Salmonella outbreaks. The Salmonella lawyers of Marler Clark have represented thousands of victims of Salmonella and other foodborne illness outbreaks and have recovered over $900 million for clients.  Marler Clark is the only law firm in the nation with a practice focused exclusively on foodborne illness litigation.  Our Salmonella lawyers have litigated Salmonella cases stemming from outbreaks traced to a variety of foods, such as cantaloupe, tomatoes, ground turkey, salami, sprouts, cereal, peanut butter, and food served in restaurants.  The law firm has brought Salmonella lawsuits against such companies as Cargill, ConAgra, Peanut Corporation of America, Sheetz, Taco Bell, Subway and Wal-Mart.  

If you or a family member became ill with a Salmonella infection, including Reactive Arthritis or Irritable bowel syndrome (IBS), after consuming food and you’re interested in pursuing a legal claim, contact the Marler Clark Salmonella attorneys for a free case evaluation.

Additional Resources:

In early December 2024 the FDA stated:

“The FDA and CDC, in collaboration with state and local partners are investigating illnesses in a multistate outbreak of E. coli O157:H7 infections linked to an iceberg and romaine lettuce blend served at catering events, restaurants, and a school. Based on epidemiological information collected by CDC, a total of 69 people infected with the same strain of E. coli O157 have been reported from 10 states. FDA’s traceback investigation has identified an iceberg and romaine lettuce blend from a common supplier as the source of this outbreak; however, impacted product identified to date appears to be past shelf life and no longer on the market. FDA is continuing to work with the supplier to determine if any additional product could be impacted. At this time, there does not appear to be any ongoing risk to public health and there is no recommendation for consumers to avoid iceberg or romaine lettuce. FDA’s investigation is ongoing, and more information will be provided as it becomes available.”

Today the FDA quietly announced that the outbreak – linked to romaine lettuce – had ended with 88 sick (nearly a 20 person increase) after traceback, inspection and testing was initiated.

The clear multistate E. coli outbreak linked to romaine lettuce raises concern about the FDA and transparency — the failure to disclose where consumers purchased the tainted product and who the FDA traced the romaine lettuce back to where they inspected and tested. 

We all know the FDA, state health authorities, the common supplier, retailers and restaurants know this information, but they keep it from the public. Why?

After 32 years doing food litigation, I am seldom surprised by the announcement of a foodborne illness outbreak. People in government or in various parts of the food industry know that an outbreak is brewing weeks before the evidence becomes too overwhelming to ignore, so on more than a few occasions, when the delay between government and industry knowledge and a public announcement becomes too slow for concerned people and I get a call, text of email.

But it is not how the information gets out that concerns me – there will always be a difficult balance in foodborne epidemiology about when to go public. If a contaminated food product is missed by proper production and testing, we will not know of the problem until people become ill. And the time between consumption, illness, investigation and recall can stretch for weeks or months depending on the numbers of people sick and the numbers of jurisdictions that encompass the outbreak.  Foodborne illness surveillance will always have challenges and continuing to make the process faster and more accurate must always be the goal.

However, what continues to both concern and perplex me is the FDA’s failure to be more transparent with the public once they know the cause of the outbreak. 

In the early 2000s the USDA/FSIS had a policy that it would publicly announce who manufactured E. coli O157:H7 contaminated meat but refused to reveal the location of where the product was sold – specific retailers or restaurants. In 2002 ConAgra recalled beef in relation to an E. coli O157:H7 outbreak that sickened dozens and killed one. Most of the illnesses happened on or around the 4th of July.  However, a couple of illnesses happened later that fall when people unthawed meat they had frozen months earlier. When asked whether they had heard of the ConAgra outbreak and recall some of those sickened said they had, but “we bought our meat at Safeway, not at ConAgra.”

It was not until 2008 that USDA/FSIS began to routinely disclose retail distribution lists, so retailers and consumers would know where tainted product was shipped and potentially sold. According to a recent article in the Washington Post:

In the early 2000s, the Food Safety and Inspection Service — the branch of the U.S. Department of Agriculture that regulates meat, poultry and egg products — decided to revisit its own interpretation of the trade secrets rule. During a lengthy comments period, industry groups concerned with protecting their distribution lists from competitors faced off against consumer advocates. In 2008, after several years of debate, FSIS’s final rule concluded that it would “not cause substantial harm to the competitive position of any business” to disclose retailer names.

Not surprisingly retailers of USDA/FSIA regulated products have survived disclosure – transparency has been a benefit to consumer confidence.

Conversely, FDA has jurisdiction over 80 percent of the food supply but  has remained silent and opaque leaving, retailers and consumers confused and at times angry at the lack of transparency. In an article in the Washington Post some years ago the confusion was plain:

“In a statement to The Washington Post, the FDA affirmed that it believes its disclosure measures are sufficient and blamed the lack of downstream recall information on federal disclosure rules. Federal regulations do limit the sort of information that can be released to the public. Under the Freedom of Information Act and Title 21 of the Code of Regulations, government agencies — and specifically, the FDA — are told to exempt trade secrets and commercial information from any of their releases.”

“Examples of [confidential consumer information] include raw material supplier lists, finished product customer lists, trace back information, etc.,” said Peter Cassell, a spokesman for the FDA. “CCI is exempt from Freedom of Information Act requests but can be shared through certain information sharing agreements (including with other Federal agencies).”

“The FDA publicizes recall notices, including pictures of affected products, and uses social media accounts to reach consumers as swiftly as possible,” he later added. “In some cases, the FDA can release certain information that is otherwise exempt from disclosure if it is necessary to effectuate a recall. In many cases, it is most efficient for the company to directly notify its distributors, so they can take appropriate action.”

“Cassell declined to make an agency lawyer available for comment or explain how the FDA had arrived at its definitions.”

Let me weigh in where the FDA would not. Let me also be blunt – there is no reason, especially when faced with an outbreak of foodborne illness, for the FDA to claim that the retail distribution list is a trade secret.  Transparency of the food chain for products overseen by USDA/FSIS has not lead to a collapse of trade secrets. The FDA might well learn from a 20-year history of its sister food safety agency. Chicken Little, the sky did not fall.

An egregious example of FDA’s failure to not name retailers was 2017 E. coli outbreak linked to I.M. Healthy — great name for a product with a pathogen — soy nut butter that sickened dozens, some children seriously so. The outbreak began in December 2016 and reached critical mass in April 2017.  A recall was publicly announced, but no retailers were named. I.M. Healthy went bankrupt and was likely uninterested or unavailable to assist in the recall. Not surprisingly, product remained available to purchase in retail settings and online several months after the outbreak and recall were announced.

Seriously, someone at the FDA needs to explain why an arguable “trade secret” trumps public health? The chain of distribution needed a good dose of transparency – both retailers and consumers were confused – not by too much information, but from too little.

Confused? Me too.

So, my advice to the mystery FDA lawyer is simple – focus on public health and what should be disclosed and what is a trade secret will become clear. Formulations, ingredients and how products are made are trade secrets.  Who supplied the tainted raw material, who made the tainted product and where the tainted product was sold are not a trade secrets – especially during an outbreak.  Simplicity, transparency and consistency allows for a visible supply chain and one that consumers can have confidence in. Hiding behind “trade secrets” creates confusion and mistrust – not something that is helpful in the sale of food.

CDC is saddened by Louisiana’s report that a person previously hospitalized with severe avian influenza A(H5N1) illness (“H5N1 bird flu”) has passed away. While tragic, a death from H5N1 bird flu in the United States is not unexpected because of the known potential for infection with these viruses to cause severe illness and death. As of January 6, 2025, there have been 66 confirmed human cases of H5N1 bird flu in the United States since 2024 and 67 since 2022. This is the first person in the United States who has died as a result of an H5 infection. Outside the United States, more than 950 cases of H5N1 bird flu have been reported to the World Health Organization; about half of those have resulted in death. 

CDC has carefully studied the available information about the person who died in Louisiana and continues to assess that the risk to the general public remains low. Most importantly, no person-to-person transmission spread has been identified. As with the case in Louisiana, most H5 bird flu infections are related to animal-to-human exposures. Additionally, there are no concerning virologic changes actively spreading in wild birds, poultry, or cows that would raise the risk to human health. (CDC reported previously on its analysis of the viruses isolated from the patient in Louisiana.) However, people with job-related or recreational exposures to infected birds or other animals are at greater risk of infection. For these and others, CDC has developed prevention resources about how to protect yourself. 

CDC is continually: 

  • Supporting critical epidemiologic investigations with state and local partners to assess the public health impact of each H5 case.
  • Working closely with state and local partners to conduct active surveillance for H5 cases.
  • Monitoring for changes that might suggest H5 viruses are becoming better adapted to mammals and therefore might spread more easily from animals-to-humans or human-to-human or cause more severe disease.
  • Monitoring for any viral changes that could make these viruses less responsive to flu antiviral medications or the available candidate vaccine viruses.

Additional information about H5 bird flu is available on the CDC website.

Perhaps, more information will be forthcoming this week.

FDA Traceback Initiated: Used to identify the source and distribution of the implicated food and remove the contaminated product from the marketplace, to distinguish between two or more implicated food products, and to determine potential routes and/or sources of contamination in order to help prevent future illnesses. For additional information, see How the FDA Uses Traceback to Respond to Foodborne Illness Outbreaks.

FDA Inspection Initiated: An official examination by FDA of the operational processes of a facility to determine its compliance with federal law, which may include, among other things, record and sample collection. Activities reported on the table are limited to those conducted by FDA; however, state and local partners work in coordination with FDA and may also conduct inspectional activities. Additional information on the different types of inspections conducted by FDA can be found on the FDA website.

FDA Sampling Initiated: Collection of samples for the presence or absence of a pathogen in a food or in the environment surrounding the food. Samples reported on the table include those collected by the FDA or state collected samples that are analyzed by the FDA. Significant sample findings are reviewed by FDA and are reported in Public Health Advisories.

Last week the FDA left this cryptic remark on its website:

For the outbreak of E. coli O157:H7 (ref #1280), the confirmed vehicle was updated from iceberg/romaine lettuce blend to romaine lettuce due to the traceback investigation. The case count has increased from 86 to 88.

Previously the FDA had announced that they were investigating illnesses in a multistate outbreak of E. coli O157:H7 infections linked to an iceberg and romaine lettuce blend served at catering events, restaurants, and a school.

Still the events and the producer remain unnamed.

The public, and specifically the people listed below, should be told who the supplier is of the romaine lettuce, where it was grown and where it was sold and served.

Last week I count 88 clinical cases (humans) with NCBI upload dates between 11-21 and 12-15.

The red one about is a young boy that suffered severe hemolytic uremic syndrome (HUS).

NOROVIRUS:

Human norovirus is a major cause of foodborne illness worldwide (WHO, 2023) and is estimated to cause approximately 685 million cases and 212,000 deaths of acute gastroenteritis per year (Kirk et al., 2015). The symptoms of norovirus infections are nausea, vomiting, non-bloody diarrhea, and abdominal pain, which are all self-limiting (WHO, 2023).

HEPATITIS A:

Hepatitis A virus causes more than 159 million infections a year globally, with 39,000 deaths according to the World Health Organization (WHO) (WHO, 2022; HME, 2019). Approximately 14 million cases and 27 000 deaths are attributed to foodborne transmission (Kirk et al., 2015). The proportion of HAV cases attributed to food is estimated at 40 percent (Havelaar et al., 2015; WHO 2015); 30 percent for Europe (Severi et al., 2023). The United States Centers for Disease Control (CDC) estimates that in the United States of America, 41 percent of HAV cases are due to international travel while 7 percent are domestic foodborne cases (Scallan et al., 2011). For HAV outbreaks in regions with low population immunity, and which are related to contaminated food, the food has been imported from intermediate or high endemic areas. Foodborne outbreaks with ongoing transmission, via person-to-person contact occurring weeks or months later, are also frequently reported (FAO and WHO, 2008).

HEPATITIS E:

Hepatitis E is an important disease in many developing countries where it is epidemic, but it is also endemic in many industrialized countries. According to the WHO, an estimated 20 million people worldwide are infected by hepatitis E virus (HEV) each year via contaminated water, food, or other vehicles, leading to 3.3 million cases of hepatitis E and 44,000 hepatitis E-related deaths (WHO, 2023). There is no global estimation of cases that are attributed to food. For Europe, where foodborne transmission of HEV appears to be a major route, 21,000 acute clinical cases with 28 fatalities were notified between 2005 and 2015 (EFSA, 2017). However, hepatitis E is not notifiable in all European countries, and it is still considered to be an under diagnosed disease in Europe (EFSA, 2017) and likely in other regions of the world as well.

https://www.marlerblog.com/files/2025/01/9789240101074-eng.pdf