Outbreak investigation of Listeria monocytogenes: Hard-boiled eggs (December 2019)

Why did Listeria appear in hard-boiled eggs? Insufficient cooking? Cross-contamination? Dirty pails? This report doesn’t say.

The U.S. Food and Drug Administration, the U.S. Centers for Disease Control, CDC, and state and local partners investigated an outbreak of Listeria monocytogenes infections linked to hard-boiled eggs produced by Almark Foods’ Gainesville, Georgia facility. Almark Foods announced an initial voluntary recall of hard-boiled and peeled eggs in pails on December 20, 2019, and then on December 23, 2019 expanded the recall to include all hard-boiled eggs produced at the Gainesville, Georgia facility. All recalled products are now past their “best by” dates.

CDC has announced this outbreak is over. FDA’s investigational activities, including an inspection, are complete. At this time, the firm is no longer producing products at this facility.

Recommendation

Recalled products are now past their “best by” dates and should be thrown away.

FDA recommends that food processors, restaurants and retailers who received recalled products use extra vigilance in cleaning and sanitizing any surfaces that may have come in contact with these products, to reduce the risk of cross-contamination.

Case Counts

Total Illnesses: 8
Illnesses in 2019: 5
Hospitalizations: 5
Deaths: 1
Last illness isolation date: December 7, 2019
States with Cases: FL (1), ME (2), PA (1), SC (2), TX (2)
States with Cases in 2019: FL (1), ME (2), SC (2), TX (1)
Product Distribution*: Nationwide
*Distribution has been confirmed for states list, but at this time we believe the product was distributed nationwide. Updates will be provided as more information becomes available.

What Products are Recalled?

Recalled products include bulk product sold in pails, as well as products sold at retail. Companies who received recalled product from Almark Foods have initiated recalls of products containing these eggs. A list of all these recalls is available on the FDA website.

 

Lettuce is overrated: FDA’s leafy greens STEC action

I’ll say it again, as a comic in all seriousness: Lettuce is overrated.

My favorite salad is a Greek one with all those veggies and no lettuce.

The U.S. Food and Drug Administration announced last week that between 2009 and 2018, FDA and the Centers for Disease Control and Prevention (CDC) identified 40 foodborne outbreaks of Shiga toxin-producing E. coli (STEC) infections in the U.S. with a confirmed or suspected link to leafy greens.

Holy shit.

This is why The Tragically Hip were so great, and why they never appealed much beyond Canada.

I feel the same about academia.

And why Osterholm called me 15 years ago as a consultant for Fresh Express, and asked me how dare I the lettuce and skull picture, and I said because I can and it was fairly apt given there have been 40 outbreaks.

Holy shit (this is me echoing my John Oliver voice).

Coronavirus is just confirming: Go public, go often, go hard.

It’s the only way people will pay attention.

And as this story in the N.Y. Times points out, there have been spectacular public health failures by people who tell others, just shut the fuck up.

According to the FDA, it has an unwavering commitment to advancing the safety of fresh leafy greens. Leafy greens are among the most widely consumed vegetables and an important part of an overall healthy diet. While millions of servings are consumed safely every day, this produce commodity has been implicated too often in outbreaks of foodborne illness, and we believe that FDA, along with leafy greens sector stakeholders, can do more.

Between 2009 and 2018, FDA and Centers for Disease Control and Prevention (CDC) identified 40 foodborne outbreaks of Shiga toxin-producing E. coli (STEC) infections in the U.S. with a confirmed or suspected link to leafy greens. While most strains of E. coli are harmless, STEC can cause bloody diarrhea, anemia, blood-clotting problems, and kidney failure – conditions that are potentially life-threatening. The most common STEC, E. coli O157:H7, is the type most often associated with outbreaks.

Most leafy greens are grown outdoors, where they are exposed to soil, animals, and water, all of which can be a source of pathogen contamination. In addition, leafy greens are mostly consumed raw, without cooking or other processing steps to eliminate microbial hazards. The Produce Safety Rule under the FDA Food Safety Modernization Act (FSMA) sets science-based standards to help ensure that water, soil amendments (e.g., fertilizer or compost), food contact surfaces and other materials that touch produce during growing, harvesting, packing, and holding do not contribute to produce contamination. The Produce Safety Rule also addresses animal intrusion into fields and worker hygiene.

Due to the recurring nature of outbreaks associated with leafy greens, FDA has developed this commodity-specific action plan. What follows is an overview of the actions FDA plans to take in 2020 to advance work in three areas: (1) prevention, (2) response, and (3) addressing knowledge gaps.

It’s not a war: FDA arming itself with science to help prevent Cyclospora infections

Steven Musser Ph.D., Deputy Director for Scientific Operations, FDA’s Center for Food Safety and Applied Nutrition (CFSAN) and Alexandre da Silva, Ph.D., Lead Parasitologist at CFSAN’s Office of Applied Research and Safety Assessment, write that Cyclospora cayetanensis is so small that it can only be seen with a microscope. However, there is nothing small about the U.S. Food and Drug Administration’s work to help protect consumers from the foodborne illness that this parasite can cause.

Of course it’s small. So are the trillion of microorganisms inside each of us.

Cyclospora has been on the public radar since at least 1996.

Cyclosporiasis is an intestinal illness caused by consumption of foods, mainly fresh produce, that are contaminated with Cyclospora. The FDA has been working to help prevent contaminated product from reaching consumers, gathering the scientific knowledge that will help to better detect the parasite in food and the environment, and gathering data to better understand how food is contaminated by the parasite and help prevent contamination in the future. We’re also sharing what we know with stakeholders in the public and private sectors.

Because several past outbreaks have been associated with fresh herbs, the FDA has been conducting surveillance sampling of fresh cilantro, parsley and basil. A quarterly update on this food surveillance study was released today. As this effort continues, our goal is to collect enough samples to provide a precise estimate of the prevalence of contamination of Cyclospora in our food supply, enabling us to better understand our vulnerability to Cyclospora contamination.     

The FDA is also acting on what we already know about where Cyclospora is found and how contamination can be prevented.   

In 2019, 10% of the Cyclospora infections reported between May and August were linked to a multi-state outbreak associated with fresh imported basil that started in mid-June and was declared over in October. FDA increased its screening at the border of basil exported by the company tied to the outbreak before the company voluntarily recalled its product and ceased shipping while corrective measures were implemented.

The FDA is also tracking contamination in domestically-grown produce. The first confirmed evidence of Cyclospora in domestically grown produce was detected in 2018 in cilantro, a finding not associated with an outbreak of illnesses. As with bacterial pathogens, if the parasite is found on produce, the FDA follows up with inspections and sampling, working with the business to take the actions needed to protect public health.

The FDA has been reaching out to farmers to increase awareness of Cyclospora and actions that can be taken on the farm to reduce the likelihood of contamination. For example, ways to control sources of contamination include proper use, maintenance and cleaning of toilet and handwashing facilities. We created education and outreach materials for farmers, including the Cyclosporiasis and Fresh Produce Fact Sheet

In late 2014, the FDA’s Center for Food Safety and Applied Nutrition established a Foodborne Parasitology Research Program, and in collaboration with the CDC, has been sequencing the genomes of several different strains of C. cayetanensis, enabling the development of genetic typing methods. In 2016, we created a genome database named “CycloTrakr” to be used as a public repository of genomic data at the National Center for Biotechnology Information (NCBI). This is an important first step towards the goal of linking, in real-time, the genetic fingerprints of Cyclospora in contaminated food and sick people to pinpoint the source of the outbreaks.

The agency has also pioneered ways to detect the parasite, developing and validating new methods to test for Cyclospora in produce and water. The first of these new methods was used for the first time in 2018 to confirm the presence of the parasite in a salad mix product tied to an outbreak that sickened hundreds of people. 

In July 2019, the FDA made its second major advance in Cyclospora detection, completing studies that resulted in a novel, validated method to test agricultural water for the presence of the parasite. Water used on farms is a potential source of the contaminants that cause foodborne illnesses. Analysts from FDA laboratories are being trained in the use of this method for regulatory testing. 

From the duh files: Corinthian Foods recalls fish nuggets mislabeled as chicken nuggets

Corinthian Trading, Inc./DBA Corinthian Foods is recalling 5 lb. retail bags of Uncooked Sweet Potato Crusted Alaska Pollack Nuggets 1 oz. with date code CF35319 due to mislabeling. The bag contains Chicken Nuggets instead of Fish Nuggets. The product is packaged in clear 5 lb. bags with a white label with black writing.

Product was distributed in the state of Michigan, and may reach consumers through retail stores.

All allergens are properly declared, and no illness have been reported.

The problem was discovered when cases were opened to put out for retail sale, and the label on the retail package did not match the label and description of the master case. Subsequent investigation indicates the problem was caused during the packaging process. The incorrect labels were applied to the product causing the product to be mislabeled.

Nestle invests $200 million more in Aimmune after peanut allergy drug approval

Saumya Joseph of Reuters reports Aimmune Therapeutics Inc said on Wednesday the health science arm of Nestle SA will invest an additional $200 million, days after the drugmaker won U.S. approval for its peanut allergy therapy, touted as a potential blockbuster.

The funding brings Nestle’s total investment to $473 million, increasing the Swiss company’s stake to 19.9% of Aimmune’s outstanding stock and voting power.

Aimmune shares rose 5.7% in early morning trading, after falling 11% on Tuesday. Its therapy, Palforzia, was approved on Friday after markets close.

Nestle’s investment is an incremental positive for Aimmune’s shares, which have seen some weakness due to investor worries over financing, Piper Sandler analyst Christopher Raymond wrote in a note.

“With this additional investment, we think the prospect of an outright take out by Nestle (or anyone else for that matter) has to be factored in more than before,” Raymond said.

Nestle has been trying to become a “nutrition, health and wellness” company, with its Nestle Health Science unit playing a pivotal role, as packaged food sales slow amid changing tastes.

The unit invested $145 million in Aimmune in 2016, followed by $30 million as part of the drugmaker’s public offering in February 2018, and another $98 million in November 2018.

Aimmune would use the latest Nestle investment to fund the launch of Palforzia, which is the first approved therapy for reducing and potentially eliminating allergic reactions to peanuts in children.

FDA warns Purell to stop making ‘unproven’ claims that sanitizer can eliminate Ebola

WTKR reports that the U.S. Food and Drug Administration has issued a warning to the maker of Purell hand sanitizer to stop making unproven claims that the product can help eliminate diseases like Ebola, MRSA and the flu.

According to CNN, the FDA’s director of compliance sent a “warning letter” to Gojo, Purell’s parent company, to stop making unproven claims for marketing purposes that could position the hand sanitizer as a pharmaceutical drug.

The letter from the FDA reportedly notes that Purell says on its website and on social media that the sanitizer “kills more than 99.99% of the most common germs that may cause illness in a healthcare setting, including MRSA & VRE.” Purell and Gojo also note that “Purell Advanced Gel, Foam, and Ultra-Nourishing Foam Hand Sanitizer products demonstrated effectiveness against a drug resistant clinical strain of Candida auris in lab testing.

Finally, the FDA chastized Purell for claiming on the Q&A section on its website that the product can be “effective against viruses such as the Ebola virus, norovirus and influenza.” The FDA says it is not aware of any hand sanitizers that have been tested against Ebola.

As romaine problems continue, US FDA takes closer look

Chris Koger of The Packer writes the U.S. Food and Drug Administration will be collecting romaine samples in California and Arizona for a year to test for salmonella and E. coli following several foodborne outbreaks linked to the lettuce.

The new program begins this month, according to the FDA, citing two E. coli outbreaks in 2018 linked to romaine, and another one in October that was suspected to be from the leafy green. In its notice on the surveillance program, the FDA also cited a 2012 Salmonella Newport outbreak from romaine.

“Consistent with the FDA’s mission to protect consumers, if one of the target pathogens is detected as a result of this assignment, the agency will perform whole genome sequencing of the microorganism’s DNA to determine its virulence and whether it is genetically related to isolates causing human illness,” according to the notice.

 All samples will be tested before processing to allow the FDA to quickly find the point of origin, which has been problematic in recent outbreaks as public and federal health agencies traced lettuce through the supply chain. In part, traceability hurdles have led to the FDA’s New Era of Smarter Food Safety program, which tasks the industry with enhancing traceability methods and technology.

Trimmed and washed lettuce will be tested, but not fresh-cut lettuce, and no lettuce at the farm-level will be involved in the surveillance program.

Samples will be targeted at facilities and farms identified in the outbreaks starting in 2017, including wholesalers, foodservice distribution centers, and commercial cooling and cold storage facilities, according to the FDA notice.

23 sick from Romaine lettuce: Was FDA’s outbreak announcement delay inexcusable or sensible

I love Mondays in Australia because it’s Sunday in the U.S., football and hockey are on TV for background, the kid is at school when not in France, and I write (Sorenne painting in France).

Fourteen years ago, me and Chapman went on a road trip to Prince George (where Ben thought he would be eaten by bears) to Seattle, then to Manhattan, Kansas, where in the first week I met a girl, got a job, and then spinach happened.

Leafy greens are still covered in shit.

I am drowning in nostalgia, but things haven’t changed, and, as John Prine wrote, all the news just repeats itself.

Same with relationships.

Former U.S. Food and Drug Administration food safety chief, David Acheson, writes that on October 31, 2019, FDA announced a romaine lettuce E. coli O157:H7 outbreak for which the active investigation had ended and the outbreak appeared to be over. As such FDA stated there was no “current or ongoing risk to the public” and no avoidance of the produce was recommended.

Since that announcement, however, I have seen a number of articles condemning FDA and CDC. Why? Because the traceback investigation of the outbreak began in mid-September when CDC notified FDA of an illness cluster that had sickened 23 people across 12 states. So why the delay in announcing it to the public?

Despite the critical (and rather self-serving; always self-serving) stance on the “inexcusable” delay taken by a prominent foodborne illness attorney and his Food Safety “News” publication – which blasted a headline FDA “hid” the outbreak – my stance, having been an FDA official myself involved in outbreak investigations, is that the delay was practical and sensible.

Why? As FDA states right in its announcement:

When romaine lettuce was identified as the likely source, the available data indicated that the outbreak was not ongoing and romaine lettuce eaten by sick people was past its shelf life and no longer available for sale.

Even once romaine was identified as the likely cause, no common source or point of contamination was identified that could be used to further protect the public.

During the traceback investigation, the outbreak strain was not detected in any of the samples collected from farms, and there were no new cases.

Thus, neither FDA nor CDC identified any actionable information for consumers.

So, if it is not in consumers’ best interest to publicize an issue that no longer exists, why should they be driven away from a healthy food alternative? Why should unfounded unease be generated that will damage the industry, providing no benefit for consumers but ultimately impacting their pockets? There is just no upside to making an allegation without information. We’ve seen the impact on consumers and the industry when an announcement of a suspected food turns out to be incorrect; specifically “don’t eat the tomatoes” when it turned out to be jalapeno and serrano peppers. Having learned from such incidents, FDA’s approach is: If we don’t have a message that will help protect the public, then there is no message to be imparted.

So, rather than condemn FDA and CDC, I would commend them for getting the balance correct. And, perhaps, instead of any condemning, we should be working together to get the answers faster, to get outbreak data through better, faster, more efficient and coordinated traceability. Our entire system is too slow – a topic we have discussed many times in these newsletters.

I disagree.

The public and the scientific community need to be informed to prevent additional people from barfing.

I also rarely eat lettuce of any sort because it is overrated and the hygiene controls are not adequate.

Greek salad without lettuce is my fave.

Going public: Early disclosure of food risks for the benefit of public health

Mar.17

NEHA, Volume 79.7, Pages 8-14

Benjamin Chapman, Maria Sol Erdozaim, Douglas Powell

http://www.neha.org/node/58904

Often during an outbreak of foodborne illness, there are health officials who have data indicating that there is a risk prior to notifying the public. During the lag period between the first public health signal and some release of public information, there are decision makers who are weighing evidence with the impacts of going public. Multiple agencies and analysts have lamented that there is not a common playbook or decision tree for how public health agencies determine what information to release and when. Regularly, health authorities suggest that how and when public information is released is evaluated on a case-by-case basis without sharing the steps and criteria used to make decisions. Information provision on its own is not enough. Risk communication, to be effective and grounded in behavior theory, should provide control measure options for risk management decisions. There is no indication in the literature that consumers benefit from paternalistic protection decisions to guard against information overload. A review of the risk communication literature related to outbreaks, as well as case studies of actual incidents, are explored and a blueprint for health authorities to follow is provided.

Food fraud: People are still drinking bleach and barfing

The U.S. Food and Drug Administration says that unscrupulous sellers have sold “miracle” bleach elixirs for decades, claiming that they can cure everything from cancer to HIV/AIDS, hepatitis, flu, hair loss, and more. Some have promoted it to parents as a way to cure autism in children.

The health claims are false, not to mention abhorrent. When users prepare the solution as instructed, it turns into the potent bleaching agent chlorine dioxide, which is an industrial cleaner. It’s toxic to drink and can cause severe diarrhea, vomiting, life-threatening low blood pressure, acute liver failure, and damage to the digestive tract and kidneys.

Stocknews Brief reports that poison control centers across the country have seen 16,500 cases involving chlorine dioxide since 2014. At least 50 of those cases were deemed life-threatening. Eight people died.

FDA says that the products have been hard to scrub out because of claims on social media, where the drinks are promoted along with false health information.

Salmonella, E. coli O157, Listeria, Campy: 1.9 million foodborne illnesses in US per year

In an ongoing effort to understand sources of foodborne illness in the United States, the Interagency Food Safety Analytics Collaboration (IFSAC) collects and analyzes outbreak data to produce an annual report with estimates of foods responsible for foodborne illnesses caused by pathogens. The report estimates the degree to which four pathogens – Salmonella, E. coli O157, Listeria monocytogenes, and Campylobacter – and specific foods and food categories are responsible for foodborne illnesses.

The Centers for Disease Control and Prevention (CDC) estimates that, together, these four pathogens cause 1.9 million foodborne illnesses in the United States each year. The newest report (PDF), entitled “Foodborne illness source attribution estimates for 2017 for Salmonella, Escherichia coli O157, Listeria monocytogenes, and Campylobacter using multi-year outbreak surveillance data, United States,” can be found on the IFSAC website.

The updated estimates, combined with other data, may help shape agency priorities and inform the creation of targeted interventions that can help to reduce foodborne illnesses caused by these pathogens. As more data become available and methods evolve, attribution estimates may improve. These estimates are intended to inform and engage stakeholders and to improve federal agencies’ abilities to assess whether prevention measures are working.

Foodborne illness source attribution estimates for 2017 for salmonella, Escherichia coli O157, listeria monocytogenes, and campylobacter using multi-year outbreak surveillance data, United States, Sept.2019

CDC, FDA, USDA-FSIS

https://www.cdc.gov/foodsafety/ifsac/pdf/P19-2017-report-TriAgency-508.pdf?deliveryName=DM10264