Canada called the imported romaine lettuce E. coli outbreak over after eight people were sickened.  It is expected that the CDC will update the US part of the outbreak in the morning.  The numbers of ill are likely to be far above 200 and the number of deaths may likely rise as well.  Those with long-term complications – (HUS) will still be extraordinary high, as will be the percent of hospitalizations.

Thus far the FDA has been “somewhat silent” on the chain of distribution and will unfortunately remain so.  Here is what they have told the public as of the end of May:

We have been busy doing both a trace forward and trace back.  With over 100 clients, most can identify the specific place that they consumed romaine (point of service) in the 3-5 days before the onset of illness.  Some have multiple purchases and consumptions, which for now, make linking the supply chain a challenge.  But I like a challenge.

I expect that the various retailers (points of service) will continue to provide information on the supply chain (distribution center, processor, grower/harvester) – either willingly or by subpoena.  And, once we have that information (trace back), we can than trace forward to eliminate situations where E. coli culture matched victims had multiple purchases in the incubation period.

Check back for more information.

Retailers above, please give me a call.

The Mexican federal consumer protection agency has issued a warning about the possible presence of salmonella in boxes of Kellogg’s Honey Smacks cereal.

The warning from the Federal Consumer Protection Agency in Mexico (Profeco)

comes almost a week after the first reports of the contaminated cereal, manufactured and packaged in the United States, began to surface.

That US Food and Drug Administration alerted consumers last week after 73 people in 31 states were reported to have become sick after eating salmonella-infected Honey Smacks. The illnesses took place between March and May. Twenty-four people were hospitalized, but there have been no fatalities.

Profeco said the 434, 652 and 866-gram boxes of the cereal are most likely to be contaminated, but authorities in Mexico and the U.S. have advised consumers to avoid the cereal altogether.

The affected products have “best before” dates between June 14, 2018 and June 14, 2019.

On its Mexico website Kellogg’s asked consumers who bought the product not to eat it, dispose of it and contact the company for an exchange with another Kellogg’s product. It said no other product was affected by the salmonella contamination.

There had been limited distribution of the Honey Smacks cereal in Mexico and several other countries, the company said.

Perhaps Mexico will pay for it!

As of June 14, 2018, 73 people infected with the outbreak strain of Salmonella Mbandaka have been reported from 31 states. A list of the states and the number of cases in each can be found on the Case Count Map page.

Illnesses started on dates from March 3, 2018, to May 28, 2018. Ill people range in age from less than one year to 87, with a median age of 58. Sixty-five percent are female. Out of 55 people with information available, 24 (44%) have been hospitalized. No deaths have been reported.

Epidemiologic evidence indicates that Kellogg’s Honey Smacks cereal is a likely source of this multistate outbreak.

In interviews, ill people answered questions about the foods they ate and other exposures in the week before they became ill. Thirty (77%) of 39 people interviewed reported eating cold cereal. In interviews, 14 people specifically reported eating Kellogg’s Honey Smacks cereal. Ill people in this outbreak reported this cereal more often than any other cereals or food items.

On June 14, 2018, the Kellogg Company recalled 15.3 oz. and 23 oz. packages of Kellogg’s Honey Smacks cereal.

Recalled Kellogg’s Honey Smacks cereal have a “best if used by” date from June 14, 2018 through June 14, 2019. The “best if used by” date is on the box top.

The recalled 15.3 oz. Kellogg’s Honey Smacks cereal has a UPC code of 38000 39103. The recalled 23.0 oz. Kellogg’s Honey Smacks cereal has a UPC code of 38000 14810. The UPC code is on the bottom of the box.

I have no idea if this is a change of policy – but it should be.  I have been complaining a bit over at www.foodsafetynews.com about the FDA not being as transparent as it should when it comes to recalls.  So, when it does it right, you have to give credit where credit is due.

Thanks to the FDA for making the retail recall notification on the Caito manufactured cut melon recall available.  It helps make consumers aware of the at risk items and helps retailers get the product off shelves. Here is the complete list to date:

https://www.fda.gov/downloads/Food/RecallsOutbreaksEmergencies/Outbreaks/UCM610720.pdf

And here is the latest from the FDA on the outbreak and recall:

  • FDA advises consumers not to eat recalled fresh cut watermelon, honeydew melon, cantaloupe, and fresh-cut fruit medley products containing any of these melons produced at the Caito Foods facility in Indianapolis, Indiana. Products produced at this facility have been distributed in Georgia, Illinois, Indiana, Iowa, Kentucky, Michigan, Missouri, North Carolina, Ohio, Pennsylvania, West Virginia, and Wisconsin. The products were packaged in clear, plastic clamshell containers and distributed to Costco, Jay C, Kroger, Payless, Owen’s, Sprouts, Trader Joe’s, Walgreens, Walmart, and Whole Foods/Amazon. Caito Foods, LLC has voluntarily recalled fruit salad mixes that contain pre-cut melons to prevent further distribution of potentially contaminated products.
  • The CDC reports that 60 people in five Midwestern states have become ill. Among 47 people with information available, thirty-one cases (66%) have been hospitalized.
  • The 60 illnesses occurred within the period of April 30, 2018 to May 28, 2018.
  • The FDA is working with CDC, along with state partners in Illinois, Indiana, Michigan, Missouri, Iowa, and Ohio to trace back the pre-cut melons to identify the source to determine the full distribution of pre-cut melons, and to learn more about the potential route of contamination.
  • As this is an ongoing investigation, the FDA will update this page as more information becomes available, such as product information, epidemiological results, and recalls.
  • Additional distribution information has been added that identifies retail locations that received potentially contaminated product. The FDA is advising consumers to discard any recalled products purchased at the listed locations. The FDA is sharing this information with consumers as soon as possible and additional distribution information may be added as it becomes available. It is possible that some stores may be mentioned more than once because they received more than one shipment or more than one product. Consumers may wish to ask a firm directly if the recalled product was available for sale.
  • Consumers who have symptoms of Salmonella infection should contact their health care provider to report their symptoms and receive care. Most people infected with Salmonella develop diarrhea, fever, and abdominal cramps. Most infections usually lasts 4 to 7 days and most people recover without treatment, however some people develop diarrhea so severe that they need to be hospitalized.

After 25 years doing food litigation, I am seldom surprised by the announcement of a foodborne illness outbreak.  It was no different last Friday when the Indiana Department of Health announced a multi-state Salmonella outbreak linked to cut fruit – mainly melons sold at large retailers in several states.  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 we know the cause of the outbreak.  In the early 2000’s the USDA/FSIS had a policy that would publicly announce who manufactured E. coli O157:H7 meat but refused to announce the location of where the product was sold – retailers or restaurants.  In 2002 the ConAgra beef E. coli O157:H7 outbreak and recall sickened dozens and killed one.  Most of the illnesses happened on or around the 4thof July.  However, a couple of illnesses happened later that Fall. When asked if those sickened had heard of the ConAgra outbreak and recall they 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 the retail distribution lists, so retailers and consumers would know where tainted product was shipped and potentially served.  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, 80% of the food supply – that regulated by the FDA – has remained silent and opaque leaving retailers and consumers confused and at times angry at the lack of transparency.  According to the same Washington Post article:

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 ten-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.

Now back to last Friday when Indiana announced a multi-state Salmonella outbreak linked to cut fruit – mainly melons sold at large retailers in several states.  Here, the Indiana State Department of Health – not FDA, nor the manufacturer – announced the outbreak.  There was no recall yet, but Indiana did name several retailers, but not the manufacturer. The first news articles targeted retailers, not the manufacturer.  Several hours later the CDC and FDA announced a 60 – person Salmonella outbreak and named the manufacturer, but not the retail chain.  Then the manufacturer posted a press release naming the retailer chain.

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 a product are made are trade secrets.  Who supplied the tainted raw material, who made the tainted product and where the tainted product was sold is not a trade secret – especially during and 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.

The Centers for Disease Control and Prevention (CDC) is reporting 60 cases from five states – Illinois, Indiana, Michigan, Missouri, and Ohio. The CDC investigation indicates pre-cut melons, including fruit salads, are a likely source of this multistate outbreak.  SpartanNash appears to be the supplier and processor, but may be named under Renaissance or Caito Foods.

“The Illinois Department of Public Health is urging people not to eat pre-cut melon purchased from any Walmart store in Illinois, or any of the other affected states, at this time,” said IDPH Director Nirav D. Shah, M.D., J.D. “If you have recently purchased pre-cut melon from Walmart, throw it out. If you have recently eaten pre-cut melon from a Walmart store and experience diarrhea, fever, and cramps, contact your health care provider.”

Illinois cases range in age from 23 to 87 years and have been reported in all regions of the state. Therefore, it is recommended that people not eat pre-cut melon from Walmart stores anywhere in Illinois. As the investigation continues, additional grocery stores may be added.

Most people affected by Salmonella develop diarrhea, fever, and abdominal cramps 12 to 72 hours after eating food contaminated by the bacteria. The illness usually lasts 4 to 7 days, and most people recover without treatment. However, diarrhea for some people may be so severe that they need to be hospitalized. The CDC has indicated there have been more hospitalizations with this outbreak than what is typically seen. The elderly, infants, and those with compromised immune systems are more likely to have a severe illness.

The U.S. Food and Drug Administration is working to identify the source of Salmonella and there may be recalls as more information is learned. Walmart stores in Illinois have removed pre-cut melons linked to this outbreak from their shelves.

Time to dust off www.fair-safety.com and www.realrawmilkfacts.com

The Knox County Health Department (KCHD) is investigating a cluster of Escherichia coli (E. coli) O157 cases in children likely associated with consumption of raw milk and contact with farm animals.

Most of the children are known to have consumed raw milk from a local cow-share dairy. Due to possible contamination with E. coli O157 and out of an abundance of caution, KCHD advises the public not to consume raw milk or any other unpasteurized products from French Broad Farm in Mascot, Tenn. at this time. Officials also recommend consumers dispose of all raw milk and unpasteurized products they may have from this farm.

Any further exposure to the farm animals in question has been mitigated as the facility is not currently operating. Therefore, no further directive on that potential source is necessary.

“Bacteria, like E. coli, cannot be seen with the naked eye,” said KCHD Director Dr. Martha Buchanan. “For some perspective, roughly 1,800 can fit on the head of a pen, and it only takes about 10 to make you sick.”

Raw milk and other unpasteurized products can contain harmful bacteria, including E. coli O157. While it is possible to get sick from many other foods, raw milk is one of the riskiest. E. coli can also be found in the feces of cattle, goats, sheep and other ruminant animals. Historically, the major source for human illness is cattle, which can carry E. coli 0157 and show no signs of illness. These bacteria, however, can cause severe diarrhea and even life-threatening complications for humans, especially children, older adults, pregnant women and those with compromised immune systems. Information on preventing E. coli can be found on the CDC’s website.

Symptoms of E. coli infection vary for each person, but often include severe stomach cramps, diarrhea (often bloody), and vomiting. Some may have a low fever (less than 101 ̊F). Some infections are mild, but others can be severe.

As of May 30, 2018, there are 197 cases in 35 states: Alaska (8), Arkansas (1), Arizona (9), California (45), Colorado (3), Connecticut (2), Florida (1), Georgia (5), Idaho (11), Illinois (2), Iowa (1), Kentucky (1), Louisiana (1), Massachusetts (4), Michigan (5), Minnesota (12), Mississippi (1), Missouri (1), Montana (9), Nebraska (1), New Jersey (8), New York (10), North Carolina (1), North Dakota (3), Ohio (7), Oklahoma (1), Oregon (1), Pennsylvania (24), South Dakota (1), Tennessee (3), Texas (3), Utah (1), Virginia (1), Washington (7), and Wisconsin (3).

Illnesses started on dates ranging from March 13, 2018 to May 12, 2018. Ill people range in age from 1 to 88 years, with a median age of 29. Sixty-eight percent of ill people are female. Of 187 people with information available, 89 (48%) have been hospitalized, including 26 people who developed hemolytic uremic syndrome, a type of kidney failure. Five deaths have been reported from Arkansas (1), California (1), Minnesota (2), and New York (1).

As of 1 PM (ET) October 6, 2006, Friday, 199 persons infected with the outbreak strain of E. coli O157:H7 have been reported to CDC from 26 states.

Among the ill persons, 102 (51%) were hospitalized and 31 (16%) developed a type of kidney failure called hemolytic-uremic syndrome (HUS). One hundred forty-one (71%) were female and 22 (11%) were children under 5 years old. The proportion of persons who developed HUS was 29% in children (<18 years old), 8% in persons 18 to 59 years old, and 14% in persons 60 years old or older. Among ill persons who provided the date when their illnesses began, 80% became ill between August 19 and September 5. The peak time when illnesses began was August 30 to September 1- 31% of persons with the outbreak strain became ill on one of those 3 days.

Three deaths in confirmed cases have been associated with the outbreak. One was in an elderly woman from Wisconsin. Yesterday, Idaho confirmed that stool samples from a 2-year-old child with HUS who died on September 20 contained E. coli O157 with a “DNA fingerprint” pattern that matches the outbreak strain. Today, Nebraska reported the death of an elderly woman with an illness compatible with E. coli O157 infection who consumed raw spinach; E. coli O157 with the outbreak strain “DNA fingerprint” was detected in the remaining spinach. Maryland is investigating a suspect case in an elderly woman who died on September 13 and had recently consumed fresh spinach. E. coli O157 was cultured from her stool, but “DNA fingerprinting” has not been possible.

1034 sick with 204 dead as of two weeks ago – this week 1038 sick with 208 dead.

NICD Listeria Situation Report Update:  1038 cases have been reported from 01 January 2017 to 22 May 2018. The number of new cases reported each week has decreased since the implicated products were recalled on 04 March 2018 (Figure 1). Neonates ≤28 days of age are the most affected age group, followed by adults aged 15 – 49 years of age (Figure 2). Most cases have been reported from Gauteng Province (58 %, 607/1038), followed by Western Cape (13%, 130/1038) and KwaZulu-Natal (7%, 76/1038) provinces (Table 1).