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Publisher’s Platform: Is it illegal to sell recalled food? Hell yes it is

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– OPINION –

A week ago one of my food safety followers on Twitter sent me this photo that was apparently circulating offering for sale on eBay a product that was recalled over a decade ago.  They asked if it was legal for someone to sell a recalled food product.

First, after a quick search on eBay I did not see the product still for sale, but it did pique my interest in the question.

Setting aside that it is stupid to try and sell (at an outrageous mark-up) a recalled product that was known to be contaminated with Salmonellathe answer is that it is illegal as viewed from the FDA and  is  against eBay’s own policies.

For a bit of history, this Salmonella outbreak sickened a total of 715 cases that were identified in 48 states. Patients had a median age of 53 years (range, 2 months to 95 years); 519 of 708 (73%) were female. Among 707 Salmonella isolates where specimen site was available, 421 (60%) were from stool specimens, 264 (37%) were from urine specimens, and 22 (3%) were from other or multiple specimen sources. The median age of patients with urine isolates was 62 years (range, 2 to 94 years), compared with 48 years (range, 2 months to 95 years) for patients with stool isolates. Ninety-four percent (247/263) of patients with urine isolates were female, compared with 62% (257/416) of patients with stool isolates .

Although the outbreak slowed after the  product was recalled in February, cases continued to be confirmed after this time period. The cases were ultimately linked to the consumption of Peter Pan and Great Value brand peanut butter manufactured in ConAgra’s Georgia peanut butter plant. Any Peter Pan or Great Value brand peanut butter beginning with product code 2111 was recalled in response to the outbreak investigation.

So, here is the illegal part.

The Federal Food Drug and Cosmetic Act under 21 US §331 – Prohibited acts:

21 US §321 defines “person” to include “individual, partnership, corporation, and association.”

21 US §331 prohibits (a) the introduction or delivery for introduction into interstate commerce of any food….that is adulterated.

21 US §333 then states: (1) any person who violates a provision of section 331 of this title shall be imprisoned for not more than one year or fined not more than $1,000 or both.

Clearly, any person selling a recalled product – for whatever purpose – is doing an illegal act under the Federal Food Drug and Cosmetic Act .

Also, eBay’s Product Safety Policy make clear that it is against its own policy to sell the product.  The rule is that selling products that pose a health or safety hazard aren’t allowed.  To ensure the safety and well-being of our members, eBay does not allow listings for items that are banned, recalled, or dangerous to a buyer. The following types of items are not allowed:

  • Products recalled by a manufacturer or government agency
  • Products where the sale of the product is prohibited by law or regulation
  • Products that pose a health or safety hazard as specified by any government agency

Well, that all seems pretty clear.

Someone also reminded me that we had a similar problem in 2017, both with online and retail sales of a recalled product.

The CDC reported that thirty-two people infected with the outbreak strains of STEC O157:H7 were reported from 12 states.

Illnesses started on dates ranging from January 4, 2017 to April 18, 2017. Ill people ranged in age from 1 to 70 years, with a median age of 9. Twenty-six (81%) of the 32 ill people were younger than 18 years. Among ill people, 59% were male. Twelve ill people were hospitalized, and 9 people developed hemolytic uremic syndrome, a type of kidney failure.

The recall happened on March 3, 2017, but recalled product continued to surface for months until the FDA posted this notice:


Publisher’s Platform: I have some questions about the infant formula outbreak — Why was there a two-year gap in FDA inspections at plant?

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First some basic facts:

One ill with Salmonella, Three ill with Cronobacter sakazakii with one death in Minnesota, Ohio and Texas

Findings to date include several positive Cronobacter results from environmental samples taken by FDA at Abbott in Sturgis, Michigan facility.

A review of the Abbott ’s internal records also indicate environmental contamination with Cronobacter sakazakii.

Abbott destroyed product due to the presence of Cronobacter sakazakii.

United State illnesses occurred between 9/6/2021 – 12/18/2021 – First recall 2/17/22

Recalled products were distributed to the following countries in addition to the United States: Australia, Bahrain, Barbados, Bermuda, Canada, Chile, China, Colombia, Costa Rica, Dominican Republic, Ecuador, Egypt, Guam, Guatemala, Hong Kong, India, Indonesia, Israel, Jordan, Kuwait, Lebanon, Malaysia, Mexico, New Zealand, Oman, Peru, Puerto Rico, Qatar, Saudi Arabia, Singapore, South Africa, Sudan, Taiwan, Thailand, United Arab Emirates, United Kingdom, and Vietnam ANI South.

According to the CDC, Cronobacter infections are rare, but they can be deadly in newborns. Infections in infants usually occur in the first days or weeks of life. About two to four cases are reported to CDC every year, but this figure may not reflect the true number of illnesses because most hospitals and laboratories are not required to report Cronobacter infections to health departments.  Although, not specifically listed as reportable in all states, in some states it is reportable under bacterial meningitis (e.g., CA). It is reportable in Minnesota.

Given that illnesses began in early September 2021, did that lack of a reportable requirement in all states cause this outbreak to linger longer?

And, thanks to efoodalert for digging into past and current inspections of the Sturgis, MI, Abbott manufacturing facility.

Abbott’s infant formula production facility in Sturgis, MI, has undergone twenty-seven FDA inspections since October 2008, according to the FDA’s inspection database.

Twenty-four of the twenty-seven inspections resulted in the company’s operations receiving a clean bill of health.

In October 2010, the FDA inspector cited the company for three issues, specifically:

  • Effective measures are not being taken to exclude pests from the processing areas
  • There is no assurance that raw materials which are susceptible to contamination with extraneous materials comply with current FDA standards and defect action levels
  • Failure to manufacture foods under conditions and controls necessary to minimize contamination.

These issues were apparently corrected, as subsequent inspections that same year and for several years did not result in any adverse reports.

The situation changed in September 2019, when the FDA inspector cited Abbott for a single issue, stating:

  • You did not test a representative sample of a production aggregate of a powdered infant formula at the final product stage and before distribution to ensure that the production aggregate meets the required microbiological quality standards.

Once again, the company corrected its procedures to the FDA’s satisfaction.

There were no inspections carried out for two full years. Then, in September 2021, the FDA returned. This time, the inspection uncovered several issues:

  • Personnel working directly with infant formula, its raw materials, packaging, or equipment or utensil contact surfaces did not wash hands thoroughly in a handwashing facility at a suitable temperature after the hands may have become soiled or contaminated.
  • You did not maintain a building used in the manufacture, processing, packing or holding of infant formula in a clean and sanitary condition
  • An instrument you used to measure, regulate, or control a processing parameter was not properly maintained.
  • You did not monitor the temperature in a thermal processing equipment at a frequency as is necessary to maintain temperature control.
  • You did not install a filter capable of retaining particles 0.5 micrometer or smaller when compressed gas is used at a product filling machine.bmarler

In its recall notice, Abbott acknowledged having found “evidence of Cronobacter sakazakii in the plant in non-product contact areas, ”but denied having found the bacterium in finished product.

This would appear to be in direct contradiction to the FDA’s revelation that the company had recorded the destruction of product in the past due to the presence ofCronobacter.  Specifically, “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.”

I have some questions.

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Publisher’s Platform: Your child should not get E. coli and kidney failure or die from eating a pizza

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OPINION

Santé publique France reports that as of 13/04/2022, 53 confirmed cases have been identified, of which 51 are linked to O26 strains, and 2 to O103 strains. For 26 other cases of HUS and STEC infections notified to Public Health France, investigations are ongoing.

These 53 cases occurred in 52 children and 1 adult, who presented symptoms between 01/18/2022 (week 3) and 03/16/2022 (week 11); for 1 adult, the date of onset of symptoms is under investigation.

These 53 cases occurred in 12 regions of metropolitan France: Hauts-de-France (11 cases), New Aquitaine (8 cases), Pays de la Loire (7 cases), Brittany (6 cases), Ile-de-France (9 cases), Auvergne-Rhône-Alpes (2 cases), Bourgogne Franche-Comté (2 cases), Grand Est (2 cases), Occitanie (2 cases), Provence-Alpes-Côte d’Azur (2 cases) and Center Val-de-Loire (1 case).

The 52 sick children are aged from 1 to 17 years with a median age of 7 years; 23 (44%) are female; 46 (88%) presented with HUS, 6 (20%) with STEC gastroenteritis. Two children died. The 2 adults are over 90 years old.

Here are several of the stories – badly translated – but, still horrible to read.

Aurélie, 34, and her husband John, 40, led “a normal family life”. Everything was turned upside down when their two sons fell seriously ill, poisoned by the E. coli bacteria via Buitoni pizzas, a brand of the food giant Nestlé. The two boys of Aurélie Micouleau and John Delpech have developed what scientists call hemolytic and uremic syndromes (HUS), which particularly affect young children. The two boys have now returned home. But the damage to the kidneys is irreversible, assures John, who put his commercial activity on hold: “No doctor is able to tell us if their condition will deteriorate in a month or in twenty years”.

https://www.capital.fr/conso/pizza-buitoni-une-cinquantaine-de-parents-portent-plainte-pour-ne-pas-que-leurs-enfants-finissent-a-lhopital-pour-un-bout-de-pizza-1434631

“She was at death’s door. She is now locked up in her body.” The parents of Léna, 12, infected in February with E. coli bacteria after eating a pizza from the Fraîch’Up range of the Buitoni brand, testify to their ordeal. A “real nightmare” that has been going on for two months now. Then the exams show “big lesions”, “in the frontal lobe and on the back of the brain”. Léna is in a vegetative state, she no longer speaks, cannot see, and is fed by nasogastric tube. ” Today, they can’t tell us if she will make it ,” the parents worry. “Our life is broken”, they conclude at the microphone of our colleagues, moved.

https://www.midilibre.fr/2022/04/13/ecoli-dans-les-pizzas-buitoni-notre-fille-est-dans-un-etat-vegetatif-le-calvaire-des-parents-de-lena-12-ans-10233311.php

Aurore and her family were infected with E. coli bacteria after eating a Buitoni pizza. Eight days later, her 19-year-old son is still suffering from worrying symptoms. Health authorities have confirmed a direct link between serious health concerns detected in some forty children and the consumption of Fraîch’Up pizzas from Buitoni. She, her husband, and her son consumed it on March 21 and all were contaminated by the bacteria after eating a Buitoni brand Fraich’Up pizza. The couple have only been sick for 48 hours but their 19-year-old son, Tristan, is still bedridden . Nausea, diarrhea, vomiting, dizziness.

https://www.rtl.fr/actu/economie-consommation/bacterie-e-coli-une-famille-contaminee-apres-avoir-mange-une-pizza-buitoni-raconte-son-calvaire-7900140065

This Monday, April 18, 2022, the mother of a little girl who ate a Buitoni pizza testified to the hell that her family is going through in TPMP. It has now been several days since pizzas contaminated with E.coli from the Buitoni brand have been recalled. Indeed, several of them have caused poisoning in children, including the death of two of them. Amélie, Julia’s nine-year-old mother, was able to go to Cyril Hanouna’s set to talk about all this. First, the young woman opened about her family’s descent into hell: ” She even ate two pizzas, one with cheese and one with Bolognese on February 16. It was going very well and on Tuesday 22 February, she started to be sick. She contracted a kind of gastro six days later. She had diarrhea, she had a lot of wind pain, she was nauseous but she was not vomiting. I went to the general practitioner Thursday, he told me that she probably had a big gastro (…) she gave me a treatment for a gastro”. But things got worse, she continues: ” The next morning she had a waxy complexion, it’s not like gastro, I felt that she was not well, she was on the ground. I was at the pediatric ward in St Etienne, they took care of me straight away, they did check-ups. She was immediately admitted to intensive care (…) Her condition was getting worse. When I asked if my daughter was going to die , I was told that they could not answer me”. The following Sunday, the little girl was transported by helicopter from Saint Etienne to Lyon. “On Monday she went to the block, we stayed six days in intensive care (…) we were released on March 15, she is under surveillance at home, she could not go back to school” lamented Amélie who is afraid to feed her daughter now. Moreover, this contamination could have serious consequences. Apart from the fact that the checkups are not good, Julia must see the doctor every week and do urine and blood tests. She could have sequelae like blood pressure or a kidney transplant that could show up in a few years… A heartbreaking story.

https://www.public.fr/News/Affaire-Buitoni-On-n-a-pas-su-me-repondre-la-maman-d-une-fillette-de-9-ans-fait-un-aveu-choc-dans-TPMP-1706350

At the end of January, it’s pizza night with Chloé’s family. Her 12-year-old son Robin eats a pizza from the Fraîch’up range by Buitoni, the family’s favorite brand. Two days later, he begins to have a stomachache, becomes pale, sleeps a lot. Doctors suspect gastroenteritis. But at the end of the week, his condition worsens: he no longer eats, can no longer stand, his eyes turn yellow. Chloe then takes him to the emergency room. “When we arrived at the hospital in Lille, the pediatrician bluntly told us that his vital prognosis was engaged, tells Chloé to RMC. If within 48 hours, it affects the liver, the brain, and the heart, it’s Your life passes before you, and you wonder if your life is going to end. You imagine that he is dead and that you are going to his funeral. And you wonder if you are going to live on without him. His two kidneys had stopped, they didn’t work anymore. Within a day, it was too late. He will be sentenced to life on a salt-free diet, and he may have kidney problems later. It became an anguish permanent every night I get up to see if he’s okay.” Robin’s parents are no longer alone with their questions. They joined a Facebook group where the parents of child victims are identified. This group is that of the association “SHU T – Typical Hemolytic and Uremic Syndrome “Let’s get out of silence””. One of the mothers says that her two sons are hospitalized, one of whom is still in intensive care. Among these angry parents, Malo, the father of a 4-year-old girl, Sacha. She too found herself between life and death after eating a Buitoni pizza. She stayed in the hospital for three weeks and on dialysis for 15 days.

https://rmc.bfmtv.com/actualites/societe/sante/pizzas-buitoni-des-familles-d-enfants-tombes-gravement-malades-envisagent-une-action-en-justice_AV-202203280246.html

In Saint-Varent in the Deux-Sèvres, three children aged two and a half, nine and ten years old were very seriously ill because of the Escherichia coli bacterium. Their mother confirms that she had bought a pizza from the Buitoni brand in January. Between January 25 and February 22, the life of this family from Saint-Varent, in Deux-Sèvres turned into a nightmare. It all starts with their ten-year-old daughter showing symptoms of gastroenteritis. The doctor, after an examination of the child, concluded that he had gastroenteritis. But two days later, the child screams in pain, vomits and becomes dehydrated. Taken to the emergency room, the child will be hospitalized after her mother insisted with the doctors by explaining that her daughter does not have the habit of screaming in pain. But her condition deteriorated, her renal functions, and she was rushed to the Nantes University Hospital, in the nephrology department. She is placed on dialysis four to five hours a day, then every other day. She receives blood transfusions and opioids to ease the pain. In addition to her kidneys, her liver is affected she has pancreatitis. And then little by little his condition improves. On February 5, the youngest of the siblings is sick. She is two and a half years old. Gastroenteritis is also diagnosed. but there again, the little girl’s condition deteriorates, she vomits, staggers, dozes. Urgently transported to Nantes hospital, she convulsed, and her heart was giving out. She spent six days in intensive care with a vital prognosis. Within an hour, she could have died. My daughter almost died. The little one is very seriously affected, her kidneys hardly work anymore, her liver is affected, her heart and even her brain. She develops encephalopathy. Then her condition improved, she left intensive care for the nephrology department. On February 15, it is the nine-year-old boy who is in turn ill. Same symptoms as his sisters, he is hospitalized in Nantes in serious condition, but will recover a few days later.

https://france3-regions.francetvinfo.fr/nouvelle-aquitaine/deux-sevres/niort/e-coli-dans-les-pizzas-buitoni-a-une-heure-pres-ma-fille-aurait-pu-mourir-2515780.html

Mickaël and Leslie are the parents of Bérénice, 7 years old. The little girl is in a coma after eating a frozen pizza: 75 children are currently affected by E.coli contamination.  Families and other families await the conclusions of this investigation, like Mickaël and Leslie, the parents of Bérénice, 7 years old. A Buitoni pizza on Wednesday noon was Bérénice’s ritual with her mother and her big sister. One Wednesday evening, at the end of February, she experiences intestinal symptoms, such as gastroenteritis: stomach aches, diarrhea. His father, Mickaël, then takes him to the doctor the next morning. He tells the rest on franceinfo: ” The doctor sent us to the emergency room. And behind, it was the descent into hell. The kidneys no longer worked; it attacked the heart. There were two cardiac arrests, including one with one-hour cardiac massage. Bérénice is sedated, placed in a coma for twelve days now.” According to the doctors of the CHRU of Tours, Bérénice suffers from a severe form of the hemolytic and uremic syndrome, caused by this bacterium. His father now tells us about the back and forth between the hospital, the house, and the school of the big one, as well as all the steps with Public Health France to find where this bacterium comes from. ” We were contacted by Public Health France the day after our admission to the hospital. They asked us questions about our diet, where did we go to do our shopping… They are still on the ‘investigation, on the analyzes, even if they are still moving towards Buitoni pizzas. It would be a trend, but we are not sure of anything yet. “

https://www.mariefrance.fr/actualite/e-coli-pizzas-buitoni-temoignage-dechirant-parents-dune-petite-fille-placee-coma-606237.html#item=1

Little Marceau, 4 and a half years old, came close to death. The child, poisoned by E.coli bacteria after eating a contaminated pizza, was finally able to be treated by doctors at Lille hospital. Extremely shocked, her mother testifies to La Dépêche of the days of anguish that the family has spent.  Marceau returned to school just ten days ago with strict recommendations: not to eat salty foods. And, if he hurts himself, do not take anti-inflammatories. “He will never be able to get stung in the arm again either, breathes his mother, still tested by the seven weeks she has just spent. We must keep his veins intact for a transfusion in case he has another kidney problem. “When I arrived at Lille hospital, he greeted me, telling me that the next 72 hours were going to be decisive. That the bacteria were attacking the kidneys but that it could potentially also attack the heart and the brain. J was devastated.”

https://www.ladepeche.fr/2022/04/05/pizza-buitoni-contaminee-par-lecoli-cest-quand-notre-fils-a-delire-quon-a-commence-a-sinquieter-10216446.php

The mother of Nolan, 12, and that of Yatis, 4, who have just left the hospital. Nolan, 12, is one of these little victims. He left the hospital a few days ago after two long weeks of anguish. “He vomited almost nine days, seven times a day. We went to the doctor who thought it was gastroenteritis. But he went to intensive care for three days. He was infused, probed, transfused We are tired. Tired of following its evolution. The doctors who tell us: ‘we don’t know how long he’s going to be like this, tired’”, says his mother, Vanessa Schneider, in the video of the 8 p.m. news at the top of this article.  Like Nolan and Yatis, 73 other children aged 1 to 18 were infected with E. coli bacteria. On Wednesday March 30, the health authorities established a link between some of these contaminations and frozen pizzas from the Fraîch’Up range of the Buitoni brand.

https://www.leparisien.fr/societe/sante/e-coli-dans-les-pizzas-buitoni-insuffisance-renale-12-jours-de-rea-cette-mere-a-failli-perdre-son-fils-de-quatre-ans-31-03-2022-NJRODK5F6BGFTGMSSZZ5IZ77UI.php

Manoé, he spent twelve days in pediatric intensive care in Nantes (Loire-Atlantique), in February. Hospitalized in Brest for three weeks, Sasha, who will soon be 5 years old, is better today, but her kidneys were no longer working after consuming Buitoni pizza in mid-February. “We go to the hospital with her child because we think she has severe gastroenteritis, and then after the analyzes we tell you that she is going to intensive care”, testifies with a heavy heart, Malo Coz, a Brestois, dad of little Sasha, almost five years old, who spent three weeks at the Morvan hospital of the Brest CHRU, from March 1.The first symptoms, as early as February 26, were stomach aches and diarrhea. It was therefore impossible to make the connection with the frozen Buitoni Fraîch’Up pizza. “The doctors told us that his kidneys were no longer working. In the operating room, he had to put a dialysis catheter. At that age, you don’t have to go through that! “, accuses Malo, whose little girl was a victim of hemolytic uremic syndrome (HUS) due to contamination by the bacterium Escherichia coli. The little Brestoise was able to leave the hospital after 15 days of dialysis and now she is better. “We came home on a very strict diet. Restrictions are easing, but there is still salt and chocolate. As she loves school, she wanted to go back as soon as possible. She begged the doctor, but she only stayed in the morning last week: she is still very tired.

https://www.letelegramme.fr/bretagne/la-petite-sasha-a-passe-15-jours-sous-dialyse-a-brest-a-cause-d-une-pizza-buitoni-son-papa-temoigne-14-04-2022-12987545.php-mourir-616ea93e-b9a5-11ec-857e-054a15b86122

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Publisher’s Platform: Colonel Colon and his League of Fecal Fighters coming soon to help make your food safer

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Over a decade ago, the mom of two clients who both developed acute kidney failure after consuming E. coli O157:H7-tainted spinach sent me an unexpected present. The outbreak sickened over 205 people, killing five, sending hundreds to the hospital, many with life-altering complications. The gift was a bobble-head that bore a similarity to a younger version on me. On the base it said: “Colonel Colon and his League of Fecal Fighters.” It sits on my desk today. 

I have always thought of doing something with the gift, and with the talent of my incredible niece, Janae Dueck, and borrowing from the work of the good food people at the FDA and FSIS, and idea is brewing of a way to help educate us all to be Fecal Fighters.

Over the next year we will be working on comic book, a cartoon video about the adventures of these superheroes, and a food safety jingle (thanks to my friend Vincent).

So, let me introduce you to the League.

Colonel Colon (above) is the leader of four fecal fighters: Clean, Separate, Cook and Chill.  Each is a superhero, but Clean, Separate, Cook and Chill have unique superpowers.

Here are the details.

Clean: 

  • Wash your hands and surfaces often.
  • Germs that cause food poisoning can survive in many places and spread around your kitchen.
  • Wash hands for 20 seconds with soap and water before, during, and after preparing food and before eating.
  • Wash your utensils, cutting boards, and countertops with hot, soapy water.
  • Rinse fresh fruits and vegetables under running water.

Separate:

  • Raw meat, poultry, seafood, and eggs can spread germs to ready-to-eat foods—unless you keep them separate.
  • Use separate cutting boards and plates for raw meat, poultry, and seafood.
  • When grocery shopping, keep raw meat, poultry, seafood, and their juices away from other foods.
  • Keep raw meat, poultry, seafood, and eggs separate from all other foods in the refrigerator.

Cook:

  • Food is safely cooked when the internal temperature gets high enough to kill germs that can make you sick. The only way to tell if food is safely cooked is to use a food thermometer. You can’t tell if food is safely cooked by checking its color and texture.
  • Use a food thermometer to ensure foods are cooked to a safe internal temperature. Check this chart for a detailed list of temperatures and foods, including shellfish and precooked ham.
  • Whole cuts of beef, veal, lamb, and pork, including fresh ham (raw): 145°F (then allow the meat to rest for 3 minutes before carving or eating)
  • Fish with fins: 145°F or cook until flesh is opaque
  • Ground meats, such as beef and pork: 160°F
  • All poultry, including ground chicken and turkey: 165°F
  • Leftovers and casseroles: 165°F

Chill:

  • Bacteria can multiply rapidly if left at room temperature or in the “Danger Zone” between 40°F and 140°F. Never leave perishable food out for more than 2 hours (or 1 hour if exposed to temperatures above 90°F).
  • Keep your refrigerator at 40°F or below and know when to throw food out.
  • Refrigerate perishable food within 2 hours. If the food is exposed to temperatures above 90°F (like a hot car or picnic), refrigerate it within 1 hour.
  • Thaw frozen food safely in the refrigerator, in cold water, or in the microwave. Never thaw foods on the counter because bacteria multiply quickly in the parts of the food that reach room temperature.

Publisher’s Platform: Be Best or Be Better

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— OPINION —

I must admit, I seldom borrow anything from the former President or the First Lady, but this seemed to fit all too well.

Late in 2022 the public learned that infants may have been sickened, and possibly died, due to the consumption of Cronobacter tainted infant formula.  The possible outbreak and the FDA investigation that followed, caused formula to be pulled from shelves and parents to be worried about how their children were going to be fed.  So, what has been the FDA’s response? Tepid at best.

On March 8, 2023, the FDA wrote a letter to the infant formula manufacturers asking the formula industry to Be Best or Be Better.  Here is part of the 2023 letter’s “Call to Action”:

This letter is directed to manufacturers, packers, distributors, exporters, importers, and retailers involved in the manufacturing and distribution of powdered infant formula. In late 2021 and early 2022, a series of Cronobacter spp. illnesses among infants in the U.S. was associated with feeding a certain brand of powdered infant formula. The U.S. Food and Drug Administration (FDA or “the Agency”) inspection of the associated manufacturing facility revealed the presence of Cronobacter spp. within the production environment, as well as other insanitary conditions, leading to a nationwide recall. This recall and the temporary shutdown of the plant was a major contributing factor to the infant formula shortage experienced across the U.S. in 2022. In response, the FDA developed a strategy to prevent future Cronobacter spp. illnesses associated with powdered infant formula and is issuing this letter to share current information to assist industry in improving the microbiological safety of powdered infant formula. 

Get this straight, the FDA, despite being humiliated by its own findings, a whistleblower report and the political fallout of babies dying, and shelves empty of formula, asks the industry to “voluntarily” – Be Best or Be Better.  

What should the FDA do given the critical nature of infant formula and the fact that there are so few manufacturers? 1) put an inspector in every plant 24/7; 2) mandate testing of products and the facility and upload any positive tests to the CDC to compare with illnesses; and 3) work to get Cronobacter a reportable bacterial infection in all states so we know what the scope of the problem is.

Why does the FDA asking an industry to Be Best or Be Better sound a bit too familiar? Let’s go back to the fall of 2005 when the FDA asked the Leafy Green Industry to “Be Best or Be Better.”

In view of continuing outbreaks associated with fresh and fresh-cut lettuce and other leafy greens, particularly from California, we are issuing this second letter to reiterate our concerns and to strongly encourage firms in your industry to review their current operations in light of the agency’s guidance for minimizing microbial food safety hazards in fresh fruits and vegetables, as well as other available information regarding the reduction or elimination of pathogens on fresh produce. We encourage firms to consider modifying their operations accordingly to ensure that they are taking the appropriate measures to provide a safe product to the consumer. We recommend that firms from the farm level through the distribution level undertake these steps. 

Months later an E. coli O157:H7 swept through the spinach industry, causing all spinach in the U.S, to be recalled (Mexico banned imports), with over 200 sickened across the U.S., many with acute kidney failure with five dead. Since that disaster, the FDA continues to ignore the “Cow in the Room” – leafy greens grown near cattle operations.

What should the FDA do to help the leafy green industry help itself? 1) gain access to nearby cattle operations and do testing for E. coli and upload any positive tests to the CDC to compare with illnesses; 2) work with both the leafy green industry and the cattle industry to set workable land and water use controls; and 3) scientifically test products and upload any positive tests to the CDC to compare with illnesses.

Will my ideas stop all illnesses – no.  Will it bend the curve of illnesses and help businesses help themselves – yes.  It is past time for the FDA to ask industries to “Be Best or Be Better.”  

Publisher’s Platform: For babies’ sake, make Cronobacter sakazakii reportable

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— OPINION —

The Abbott infant formula recall could have been prevented. The FDA had reports of safety failures months before the contaminated formula sickened babies and caused two deaths.

I sent these T-shirts to the Council of State and Territorial Epidemiologists, which is tasked to make recommendations as to what pathogens are reportable.  I also sent this message: “I hope that these T-shirts will be a reminder of the awesome responsibility that this council has to protect the public.”

The head of the FDA said in testimony to congress months ago:

“The CDC receives reports on foodborne disease outbreaks from state, local, and territorial health departments. On average, CDC receives two to four Cronobacter case reports annually; however, because Cronobacter infection is not reportable in most states, the total number of cases that occur in the United States each year is not known.”

Here is a bit of history about why having bacterial infections reportable can make a difference.

In 1992, from mid-November to mid-January, 9 cases of E. coli O157:H7-associated bloody diarrhea and the hemolytic-uremic syndrome had been reported in San Diego County, California and 1 child died. A total of 34 persons had bloody diarrhea, the hemolytic-uremic syndrome, or E. coli O157:H7 organisms isolated from stool during the period November 15, 1992, through January 31, 1993. E. coli O157:H7 was ultimately identified from 6 persons were indistinguishable from those of the Washington outbreak strain linked to Jack in the Box restaurants in Washington, Idaho, Nevada and California.  All the pre-formed frozen hamburgers were produced by Von’s in California and shipped to those restaurants in those states after the illness in California had already happened. According to public health officials:

Improved surveillance by mandating laboratory – and physician – based reporting of cases of E coli O157:H7 infection and the hemolytic uremic syndrome might have alerted health officials to this outbreak sooner, which could have resulted in earlier investigation and the institution of measures to prevent more cases.

Clearly, had E. coli O157:H7 been reportable, public health officials in California would have caught the illnesses and most likely prevented the hamburgers from being shipped to other states.  Hundreds of people – specifically children – would not have been sickened and three would likely not have died.

Make Cronobacter sakazakii reportable and save lives.

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Publisher’s Platform: Health officials should report what restaurant is linked to outbreak

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— OPINION —

I must admit, in 30 years of doing food safety, I seldom recall a health department withholding from the public the source of an outbreak – even Norovirus.

I am reminded by a story some 10 years ago – After Food Safety News broke the story that Taco Bell was the mysterious “Restaurant Chain A” linked to a Salmonella outbreak that sickened 68 people in 10 states, ABC Evening News praised Food Safety News for shining light on this story and the issue of the government’s lack of transparency when businesses make people sick.  Other media, such as the LA Times, Reuters, Daily Mail, The Consumerist, CBS News,Huffington Post, Fox News, and MSNBC, also hailed Food Safety News for shinning the light on the mystery taco restaurant.  Most recently, Barry Estabrook wrote a piece for The Atlantic detailing Food Safety New’s muckraking skills, but praised me and not the people who did all the work.

The San Luis Obispo Tribune reports that an outbreak of norovirus stemming from a North County restaurant has sickened close to 100 people, according to the San Luis Obispo County Public Health Department. SLO County Public Health Epidemiologist Jessie Burmester said 97 people have been reported sick as part of a confirmed norovirus outbreak earlier this month. Burmester said the Public Health Department traced the “unusual, very large community outbreak” back to a North County restaurant, though she did not disclose the name of the business.

“When we perform our investigations, we’re really looking for a common source or exposure point,” she said. “Individuals have provided the name of the restaurant consistently for all the individuals that have reported on behalf of the 97 people so far.” Burmester said the Public Health Department reached its threshold for an outbreak — two reported cases in separate households — on May 15. That day, the agency received more than two reports about the same exposure source, she said. Follow-up investigation showed some people experiencing symptoms of norovirus tied to that facility as early as May 11, Burmester added.

Once it was identified, the Public Health Department began working to help eliminate further spread by pushing “mass cleaning and disinfection” of the restaurant, as well as attempting to track where the cases originated. The restaurant in question has been cleaned three times since the outbreak was first reported, she said. “This has been particularly challenging outbreak,” Burmester said, “but it is not abnormal to see norovirus spread like this, because it doesn’t take much of the virus to spread at all.”

Norovirus is a nasty bug.

Noroviruses are estimated to cause 23 million cases of acute gastroenteritis (commonly called the “stomach flu”) in the U.S. each year, and are the leading cause of gastroenteritis. In addition, norovirus outbreaks may be the most common foodborne illness outbreaks. Noroviruses can cause extended outbreaks because of their high infectivity, persistence in the environment, resistance to common disinfectants, and difficulty in controlling their transmission through routine sanitary measures.

The norovirus is transmitted primarily through the fecal-oral route and fewer than 100 norovirus particles are said to be needed to cause infection. Transmission occurs either person-to-person or through contamination of food or water. Transmission can occur by:

· Touching surfaces or objects contaminated with norovirus and then placing that hand in your mouth
· Having direct contact with another person who is infected with norovirus and showing symptoms
· Sharing foods or eating utensils with someone who is ill
· Exposure to aerosolized vomit
· Consuming food contaminated by an infected food handler.

Publisher’s Platform: Two weeks until ‘Poisoned’ hits Netflix

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The much anticipated streaming of the documentary “Poisoned” hits Netflix on August 2. The film, based in part on a best selling book by the same name, has been in production since just before the COVID-19 Pandemic. I think the film will shock consumers, the food industry, regulators and politicians, and all who care about the safety of our food supply. Although there are some dark moments, I hope that the takeaway is that things can change and there is hope if we work together.

Well, pull up a comfortable chair and some popcorn on August 2.

In Poisoned, award-winning investigative journalist and #1 New York Times bestselling author Jeff Benedict delivers a jarringly candid narrative of the fast-moving disaster, drawing on access to confidential documents and exclusive interviews with the real-life characters at the center of the drama—the families whose children were infected, the Jack in the Box executives forced to answer for the tragedy, the physicians and scientists who identified E. coli as the culprit, and the legal teams on both sides of the historic lawsuits that ensued. Fast Food Nation meets A Civil Action in this riveting account of how we learned the hard way to truly watch what we eat.


Publisher’s Platform: Rosa DeLauro is just one of the heroes of ‘Poisoned’

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— OPINION —

When you are sitting comfortable at home feeding your kids or going out to dinner, remember that there are a lot of people that have your back. I will be profiling them over the coming days as Poisoned begins streaming on Netflix. One of my favorite parts of the movie is Rosa’s call for consumers to get off the sidelines and to put pressure on their government to fix this mess.

Rosa DeLauro is the Congresswoman from Connecticut’s Third Congressional District, which stretches from the Long Island Sound and New Haven, to the Naugatuck Valley and Waterbury. Rosa serves as Ranking Member of the House Appropriations Committee and sits on the Democratic Steering and Policy Committee, and she is the Ranking Member of the Labor, Health and Human Services, and Education Appropriations Subcommittee, where she oversees our nation’s investments in education, health, and employment. 

At the core of Rosa’s work is her fight for America’s working families. Rosa believes that we must raise the nation’s minimum wage, give all employees access to paid sick days, allow employees to take paid family and medical leave, and ensure equal pay for equal work. Every day, Rosa fights for legislation that would give all working families an opportunity to succeed.

Rosa believes that our first priority must be to strengthen the economy and create good middle class jobs. She supports tax cuts for working and middle class families, fought to expand the Child Tax Credit to provide tax relief to millions of families, and introduced the Young Child Tax Credit to give families with young children an economic lift.

Rosa has also fought to stop trade agreements that lower wages and ships jobs overseas, while also protecting the rights of employees and unions. She believes that we need to grow our economy by making smart innovative investments in our infrastructure, which is why she introduced legislation to create a National Infrastructure bank.

Rosa is a leader in fighting to improve and expand federal support for child nutrition and for modernizing our food safety system. She believes that the U.S. should have one agency assigned the responsibility for food safety, rather than the 15 different agencies that lay claim to different parts of our food system. Rosa fights against special interests, like tobacco and e-cigarettes, which seek to skirt our public health and safety rules.

Here are just a few of her accomplishments in food safety:

DeLauro Introduces Bill to Strengthen Food Safety Oversight of Corporate, Confined Animal Feeding Operations – Press Release 2023

DeLauro Statement on One Year Anniversary of Abbott Infant Formula Recall – Press Release 2023       

Single Food Safety Agency – Press Release in 2019

Our Food Safety System is Not Working – Press Release 2011

Congressional Food Safety Advocates Urge Farm Bill Conferees Not To Impede Food Safety – Press Release 2013

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Publisher’s Platform: A few heroes of ‘Poisoned’– Darin Detwiler

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— OPINION —

When you are sitting comfortable at home feeding your kids or going out to dinner, remember that there are a lot of people that have your back. I will be profiling them over the coming days as ‘Poisoned’ begins streaming on Netflix. Darin Detwiler has always been one of my heroes – even before he became a Netflix star.

Dr. Detwiler is a well-respected food safety academic, advisor, advocate, and author.  For nearly 30 years, he has played a unique role in controlling foodborne illness.  After losing his son, Riley, to E.coli in 1993, the Secretary of Agriculture invited Detwiler’s collaboration on consumer education.  He was twice appointed to the USDA’s National Advisory Board on Meat and Poultry Inspection, represented consumers as the Senior Policy Coordinator for STOP Foodborne Illness, served on Conference for Food Protection councils, and supported the FDA’s implementation of FSMA. 

Today, Detwiler is a Professor of food policy and corporate social responsibility at Northeastern University, where his students have gone on to leadership positions in industry and in state and federal agencies.  Detwiler’s research and insights have appeared on television and in print, including his column and articles in Quality Assurance and Food Safety Magazine and his books Food Safety: Past, Present, and Predictions and Building the Future of Food Safety Technology: Blockchain and Beyond.  In addition to his current role as the Chair of the National Environmental Health Association’s Food Safety Program, his leadership capacities include numerous advisory and editorial boards as well as having long consulted on food safety issues with industry in the U.S. and abroad. 

A U.S. Navy Nuclear Submarine Veteran, and a former high school teacher, Detwiler earned his doctorate in Law and Policy, focusing on states’ ability to implement federal food policies.  He is the recipient of the International Association for Food Protection’s 2022 Ewen C.D. Todd Control of Foodborne Illness Award as well as their 2018 Distinguished Service Award for dedicated and exceptional contributions to the reduction of risks of foodborne illness.

Key Media Links (Selected):

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Publisher's Platform: It is Time for a Sarbanes-Oxley Act for Food Safety

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Food safety programs are the crazy uncles of corporate food production – everyone has one, but no one really wants to talk about it.

Corporate management on average is far more interested in sales and profits and would just as soon ignore those people who talk incessantly about a “culture of food safety,” or “food safety from farm to fork.” Management is most interested in getting food from the farm to your grocery cart in exchange for as much cash as possible and for as little corporate cost as necessary. Food safety is overhead, as are the audits that slow the chain of distribution from revealing bad food safety behavior. True, safe food becomes important when a foodborne illness outbreak happens and the corporate brand is put at risk.  However, on a day-to-day basis, food safety is, at best — and most often — simply ignored. That is why food – most produced here in the U.S. – sickens 48 million, hospitalizes 125,000 and kills 3,000 of us yearly. What if the corporate management of a food manufacturer or retailer was required to personally certify to the public that he or she had established “internal controls” over food safety, and in fact the food produced and sold was safe? What if an auditor was required to “issue an opinion” as to the accuracy of those controls over food safety, and that in fact the audit was truthful? Stunning ideas? Not really! There is a somewhat recent and apt model for increasing corporate and auditing responsibility that would work quite well to focus attention on good food safety behavior. Fact — good food safety behavior in the long-run protects consumers, which protects the corporate brand. Not poisoning your customers is actually good for business. The Sarbanes-Oxley Act, known as the “Corporate and Auditing Accountability and Responsibility Act,” has set increased standards for all corporate management and auditing firms.  The bill was enacted in 2002 in reaction to corporate and auditing scandals in the 1990’s, which cost investors billions of dollars when share prices of public companies collapsed. As a result of Sarbanes-Oxley, top corporate management must now personally certify the accuracy of financial information. Management must certify that they are “responsible for establishing and maintaining internal controls” and “have designed such internal controls to ensure that material information relating to the company” is made known. Sarbanes-Oxley has also increased the responsibility of outside auditors who review the accuracy of corporate financial data. External auditors are now required to issue an opinion on whether management maintained effective internal control over financial reporting and that the financial statements are in fact accurate. How can the Sarbanes-Oxley Act relate to safer food? Can you imagine if the president of a food company was actually required to sign off yearly on the company’s food safety “internal controls?” If that were the case, perhaps food safety would have a direct line of communications to corporate leadership instead of lagging behind marketing and short-term profits. It would be truly revolutionary to have a food company focused on producing and selling safe food as its core mission. That would be a “culture of food safety.” And, what about audits? What if an auditor had to sign his or her name that the audit was in fact truthful and was not simply a mechanism to move product speedily, not necessarily safely, along the chain of distribution? An honest audit would be “food safety from farm to fork.” Does it not seem at least equally important that the food manufacturers or retailers ask our children to put in their bodies have some of the safeguards that investors have in the same corporation?

Publisher’s Platform: Will Whole Genome Sequencing Solve More Outbreaks?

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“No illnesses have been reported to date.” How many times have we read a food recall notice posted on either the FDA or FSIS websites and written by the companies recalling the product who use that self-serving statement?  I would say most of the time. In the past few months the CDC has reported three outbreaks – one Salmonella outbreak and two Listeria outbreaks that have used whole-genome sequencing to connect ill people to tainted product. Perhaps “No illnesses have been reported to date” is a statement of the past trumped by science. So, what is the science? State and CDC public health investigators have used the PulseNet system to identify cases of illness that were part of an outbreak for nearly two decades.  PulseNet, the national subtyping network of public health and food regulatory agency laboratories coordinated by CDC, receives from state laboratories DNA “fingerprints” of bacteria obtained through diagnostic testing using Pulsed-field Gel Electrophoresis (PFGE). Multiple Locus Variable-number Tandem Repeat Analysis (MLVA) is another technique used by scientists to generate a DNA fingerprint for a bacterial isolate. Scientists usually perform MLVA after PFGE to find out more specific details about the type of bacteria that may be causing an outbreak. Whole Genome Sequencing, is a newer, more highly discriminatory subtyping method, that has been used to define the following outbreaks:

  • Oasis Brands Inc., Cheese Recalls and Investigation of Human Listeriosis Cases – One person became ill in September 2013 and two persons became ill in June and August 2014. These three ill persons were reported from three states: New York (1), Tennessee (1), and Texas (1).  All ill persons were hospitalized. One death was reported in Tennessee. One illness was related to a pregnancy and was diagnosed in a newborn.

“No illnesses have been reported to date,” may well be a statement of the past.

Publisher’s Platform: Time to Discard That Wire Brush?

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Internal injuries from ingestion of wire grill-cleaning bristles are well documented.  In a single hospital system, 12 patients with injuries due to ingestion of wire bristles were reported between July 2009 and June 2012. The severity of injury ranged from puncture of the soft tissues of the neck, causing severe pain on swallowing, to perforation of the gastrointestinal tract requiring emergency surgery.[1] On May 29, 2012, U.S. Senator Charles E. Schumer, joined by Chuck Bell, programs director at Consumers Union, called on the Consumer Product Safety Commission (CPSC) and the U.S. Food and Drug Administration (FDA) to determine whether metal bristle grill brushes are safe for consumer use.[2] Two men from New Jersey and Washington state had also been recently hospitalized and underwent emergency surgery after accidentally swallowing a metal bristle that had broken off their grill brushes and become attached to their food. Schumer called on the CPSC and the FDA to launch a review of whether the bristles are safe and to issue warnings to consumers about the dangers of ingesting metal grill bristles. The Centers for Disease Control and Prevention (CDC) recommends actions to prevent these injuries by increasing awareness among consumers, manufacturers, retailers and medical professionals to promote prevention, timely diagnosis and appropriate treatment.  In an editorial published in the Morbidity and Mortality Weekly Report (MMWR), the agency suggests that awareness on the part of manufacturers and retailers of the risk of ingesting wire bristles might encourage alteration of current products or development of safer ones.  The CDC recommends those in the food services industry “examine whether their patrons are at risk for this injury” and advises the “use of alternative grill-cleaning methods or products.”[3] Recently, on the evening of Friday, September 19, 2014, Diane Norman bought pizzas at Domino’s Pizza located at 2800 Milton Way in Milton, Washington.  She took the pizzas home for her family to consume.  Michael Norman chose two slices of Canadian bacon and pineapple pizza and took a bite of one slice.  He swallowed and immediately felt something sharp in his throat.  He started to choke and dashed to the sink to drink water to help clear his throat.  At this point he felt a sharp tearing at his throat and drank a glass of cranberry juice.  His throat felt scratched and to relieve his pain he ate a slice of bread.  Although this action eliminated the feeling that food was lodged in his throat, Michael felt a dull pain in his stomach.  Since he no longer felt hungry, he did not eat any more pizza.  Diane Norman froze the remaining leftover pizza.  Sometime later she examined the frozen pizza slices and found a wire in a piece of the pizza she had saved. Over the next few days Michael continued to feel a dull pain in his abdomen.  His doctor ordered x-rays, which showed two metallic objects inside his abdomen.  A CT scan revealed that one of the metal objects had punctured his small intestine.  After a failed attempt to remove the metal objects via endoscopy, Michael was rushed into surgery on September 27.  It was then that surgeons removed two wires from Michael Norman’s intestines. On September 30 Michael Norman filed a complaint with the Tacoma Pierce County Health Department.  In response to his complaint, TPCHD environmental health specialist, Christina Sherman, conducted an on-site investigation at the Domino’s in Milton.  Ms. Sherman reviewed the pizza making process with Domino’s employee, James Tyler.  She noted that a wire brush was used to clean a wire rack inside the oven at the end of each day.  Ms. Sherman also observed wear on some of the brush bristles.  This wear was evident in photos of the brush taken by Ms. Sherman. On October 8 Michael Johnson at TPCHD conducted a second on-site visit to Domino’s.  Mr. Johnson wrote in the inspection report:

Observed a wire brush with food debris between the wires.  Wires on the brush were bent and pointing in different directions and did not maintain its original design.  Employee stated they had another brush that was used to clean the oven but was discarded last week.  Person in charge stated the outside of the oven is cleaned every night and the inside of the oven is cleaned once a month using the brush.

Ms. Johnson advised that”equipment and utensils must be designed and construction to be durable and to retain their characteristic qualities under normal use conditions.” The wire brush was discarded. Perhaps that is what all of us should do?  Michael has the scars to prove it.


[1] Grand DJ, Egglin TK, Mayo-Smith WW. et al. Injuries from ingesting wire bristles dislodged from grill-cleaning brushes – Providence, Rhode Island, 2009-2012. J. Safety Res. 2012 Dec. 43(5-6):413-5.)
[3] Centers for Disease Control and Prevention, Injuries from ingestion of wire bristles from grill-cleaning brushes – Providence, Rhode Island, March 2011-June 2012.  MMWR Morb Mortal Wkly Rep 2012 Jul 6;61(26):490-492.)

Publisher’s Platform: A Reasonable Proposal for Safer Meat

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http://www.dreamstime.com/royalty-free-stock-image-fast-food-hamburger-image12143746New York Senator Kirsten Gillibrand has once again proposed a law that would give the U.S. Department of Agriculture’s Food Safety and Inspection Service (FSIS) the ability that it does not believe it already has to recall meat tainted with the pathogenic Salmonella bacteria. The law, in essence, would prompt FSIS to label Salmonella for what it really is — an adulterant that should not be on the meat on our tables. In our convoluted food safety system, FSIS generally oversees beef, chicken, pork and lamb production, and the Food and Drug Administration (FDA) regulates all other manufactured food products. FDA already bans Salmonella from all food; FSIS, not at all. Salmonella is a fecal bacteria that the Centers for Disease Control and Prevention (CDC) estimates sickens 1.4 million annually in the United States, hospitalizing 15,000 and killing 400. The economic loss is just as staggering. The USDA’s own Economic Research Service reports Salmonella illnesses and deaths cost $3.6 billion yearly in medical costs, wage loss and premature death. The junior senator from New York properly recognizes the long-standing dysfunction at FSIS. Despite an 18-month Salmonella outbreak during 2013 and 2014, which sickened more than 600 people — 40 percent who were hospitalized — and linked to one chicken supplier, this supposed public health agency felt powerless to close the plants or recall the chicken because, notwithstanding the illnesses linked to the chicken, FSIS presently does not consider Salmonella an adulterant, regardless of what commonsense might otherwise tell you. As long as FSIS maintains that Salmonella is not an adulterant, it will continue to claim it lacks authority to protect public safety by recalling the tainted meat and shuttering the offending plants. This is why the senator’s proposal has merit. FSIS’ decades-long position is as perplexing as it is wrong-headed — especially in light of a history of its own success with another fecal bacterial pathogen, E. coli O157:H7. In 1993, as a new president was being inaugurated, a deadly E. coli outbreak was being linked to hamburgers. Four kids were dead, dozens suffered kidney failure, and hundreds were hospitalized. Hamburger sales dropped. The beef industry was on its knees, and the public wanted answers. Haltingly at first, the Clinton administration found its backbone when FSIS Administrator Michael Taylor (now FDA’s Deputy Commissioner for Foods) stood before the American Meat Institute and proclaimed a so-called “Zero Tolerance Rule.” The deadly E. coli bacteria would no longer be tolerated in hamburgers; it would now be considered an adulterant. At first, the beef industry balked — even litigated against the new rule — arguing that consumers should just cook the bacteria out of the meat. However, over time, industry and government found that with E. coli banned, the numbers of outbreaks and recalls linked to hamburgers fell from commonplace to infrequent. And, as a lawyer whose firm benefited from the commonplace, I was pleasantly stunned to see the flow of new clients — mainly children — slow to a trickle. It is hard to underestimate what the success that setting the E. coli bar low (with ongoing plant inspections by FSIS inspectors) has meant for consumers and the industry. All the fears of hamburger being regulated out of existence, or that the cost of production would be so high that hamburger would no longer be an American staple, never came to be. And it had the added success of fewer people sickened by E. coli-tainted hamburger, resulting in fewer lawsuits. The senator’s proposal gives us a great opportunity to learn from the hamburger/E. coli experience. We can do more to move the needle down on the 48 million sickened, 125,000 hospitalized, and 3,000 deaths per year by food, which costs our economy more than $15 billion annually. I once penned an op-ed urging action during the middle of an E. coli outbreak linked to hamburger centered in Colorado that sickened 50, killed one, and caused a half-dozen children to suffer acute kidney failure. Banking on the reality that trial lawyers are only slightly more popular than members of Congress, I suggested that something be done to “put me out of business.” As it relates to hamburger, the plea has worked. And, a few months ago, I had my first hamburger in 22 years. The senator’s proposal gives FSIS the tools it feels it needs to keep the public a bit safer. Safer food should be non-partisan. Republicans and Democrats eat and drink, and they have parents, kids, grandkids, and constituents who are some of the most vulnerable to foodborne illness. We can do something to make our food just a bit safer. The senator’s proposal is a step in the right direction.

Publisher’s Platform: 75 sproutbreaks later, fresh raw sprouts still not safe

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axx-sprout2-13-16_9Thanks to my friends at Barfblog for keeping track of the Sproutbreaks over the last couple of decades. These outbreaks have been some of the largest and most deadly in the world. Now we are seeing two being reported in the United States in the last few weeks.

  • A total of nine people infected with the outbreak strain of E. coli O157 have been reported from two states: Minnesota has seven sick and Wisconsin two. Illnesses started on dates ranging from Jan. 17 to Feb. 8. Ill people range in age from 17 years to 84, with a median age of 28. Sixty-six percent of ill people are female. Two ill people have been hospitalized. Collaborative investigative efforts of state, local, and federal public health and regulatory officials indicate that alfalfa sprouts produced by Jack & The Green Sprouts of River Falls, Wisconsin are a likely source of this outbreak.
  • A total of 13 people infected with the outbreak strain of Salmonella Muenchen have been reported from four states: Kansas has five, Missouri three, Oklahoma three and Pennsylvania two. Illnesses started on dates ranging from Dec.1, 2015, to Jan. 21 this year. Ill people range in age from 18 years to 73, with a median age of 51. Ninety-two percent of ill people are female. Among 13 ill people with available information, five reported being hospitalized. , No deaths have been reported. Collaborative investigative efforts of state, local, and federal public health and regulatory officials indicate that alfalfa sprouts produced by Sweetwater Farms of Inman, KS, are a likely source of this outbreak.

As far back as September 1998, the FDA issued a warning against sprouts urging:

Children, pregnant women and the elderly should not eat alfalfa sprouts until growers find a way to reduce the risk of a potentially deadly bacteria that infects some sprouts, the Food and Drug Administration said this week. The FDA, which is investigating sprout industry practices, said children, the elderly and people with weakened immune systems should avoid eating sprouts. The agency’s statement, issued Monday, repeated similar but little-noticed advice the U.S. Centers for Disease Control gave to doctors and researchers a year ago.

Here is the CDC warning :

Sprouts Not Healthy Food for Everyone

Children, the elderly, and persons whose immune systems are not functioning well should not eat raw sprouts, because current treatments of seeds and sprouts cannot get rid of all bacteria present.

Persons who are at high risk for complications from foodborne illness should probably not eat raw sprouts, according to an article in the current issue of Emerging Infectious Diseases, CDC’s peer-reviewed journal, which tracks new and reemerging infectious diseases worldwide.

Although sprouts are often considered a “health food,” the warm, humid conditions needed for growing sprouts from seeds are also ideal for bacteria to flourish. Salmonella, E. coli, and other bacteria can grow to high levels without affecting the appearance of the sprouts.

Researchers have treated both seeds and sprouts with heat or washed them in solutions of chlorine, alcohol, and other chemicals. Some of these disinfectants reduced the levels of bacteria, but a potential hazard remained, especially for persons with weak immune systems. High temperatures that would kill the bacteria on the seeds would also keep them from sprouting. Until an effective way is found to prevent illness from sprouts, they should be eaten with caution, if at all.

Need I say more? (To sign up for a free subscription to Food Safety News, click here.)


Publisher’s Platform: Officials still stumped by Hep A outbreak

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What can the 74 Hawaii victims do to help health officials? Be your own junior epidemiologist. Sitting in my hotel room on the shores of Waikiki in the remnants of tropical storm Darby, has given me time – perhaps too much – to think about this outbreak – especially after meeting with a few of the families. Sherlock type manThe Hawaii Department of Health (HDOH) is investigating a cluster of 74 hepatitis A infections on Oahu. Onset of illness has ranged between June 12 and July 14. Sick individuals were likely exposed to the fecal human virus through food, drink or personal exposure two to six weeks prior to the onset of symptoms – so the likely exposure period is May 1 through July 1. HDOH staff are conducting interviews with the cases in an effort to identify the source of infection. HDOH reports that identifying the source of infection continues to be a challenge because of the long incubation period of the disease and the difficulty patients have in accurately recalling the foods consumed and locations visited during the period when infection could have taken place. All of the cases are residents of Oahu with the exception of two individuals who now live on the islands of Hawaii and Maui, but were on Oahu during their exposure periods. On the 74 sickened, one was an employee of a Taco Bell on Oahu and one was an employee of a Baskin-Robbins on Oahu. They both worked prior to the onset of illness and during the peak exposure period. This has caused additional community concern that the outbreak may spread to Taco Bell and Baskin-Robbins patrons. So, what can the 74 outbreak victims do to help health officials find the common link?  Here are some suggestions that I am sure HDOH officials are already using:

  • Be cooperative – hepatitis A illnesses can last two to six months and victims are certainly not feeling their best, but their cooperation is vital.
  • Think about what you ate or drank. That may well not be too productive – trying to recall what you ate or drank several weeks ago is difficult – I can hardly recall what I ate or drank a few days ago – however, try.
  • Focus on where you have been eating and drinking in the two to six weeks prior to becoming ill – at home or out. Check your calendar, phone records and social media like Facebook and Twitter.
  • Review your credit and debit card purchases as well as any accounts you have at grocery stores or restaurants.
  • Ask friends, co-workers or family what they might recall that you did during that same time.
  • Keep in contact with HDOH. Its resources are stretched and it needs your support and assistance.

With the help of the 74 – hopefully, not more – HDOH will solve this mystery and stop the spread of this potentially deadly virus. Disease Outbreak Control Division 1250 Punchbowl Street, Room 443 Honolulu, HI 96813 Tel: (808) 587-6845 Fax: (808) 586-8347 Disease Investigation Branch Tel: (808) 586-8362 Toll free: 1-800-360-2575 Fax: (808) 586-4595   (To sign up for a free subscription to Food Safety News, click here.)

Publisher’s Platform: Please, put me out of business

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Bill Marler testified before Congress in support of the Food Safety Modernization Act, asking the government and the food industry to put him out of business.
Bill Marler testified before Congress in support of the Food Safety Modernization Act, asking the government and the food industry to put him out of business.

From about 2011 though the summer of 2015 business was slower for The Food Safety Law Firm, which meant on average less people were sickened by the food they ate. For some time I thought the food industry was actually “Putting me out of Business.”

However, the Centers for Disease Control and Prevention released its FoodNet report this week with the stats on nine pathogens in 10 states for 2016 — comparing 2013-2015[1] — and the new numbers are not great. They confirm why we seem busier lately.

In 2016, FoodNet identified 24,029 infections, 5,512 hospitalizations, and 98 deaths in the United States caused by the nine pathogens.

The pathogens covered in the report are Campylobacter, Cryptosporidium, Cyclospora, Listeria, Salmonella, Shiga toxin-producing Escherichia coli (STEC), Shigella, Vibrio, and Yersinia.

Compared with 2013-2015, the 2016 incidence of Campylobacter infection was significantly lower at 11 percent less when including only culture-confirmed infections. Incidence of STEC infection was significantly higher for confirmed infections, posting a 21 percent increase.Similarly, the incidence of Yersinia infection was significantly higher, with confirmed infections increasing 29 percent.

Incidence of confirmed Cryptosporidium infection was also significantly higher in 2016 compared with 2013–2015 with the CDC reporting a 45 percent increase.

Among 7,554 confirmed Salmonella cases in 2016, serotype information was available for 6,583, representing 87 percent of the cases. The most common serotypes were Enteritidis with 1,320 cases or 17 percent; Newport with 797 cases or 11 percent, and Typhimurium with 704 cases or 9 percent. The incidence in 2016 compared with 2013-2015 was significantly lower for Typhimurium (18% decrease; CI = 7%–21%) and unchanged for Enteritidis and Newport.Among 208, or 95 percent, of speciated Vibrio isolates, half, or 103,  were V. parahaemolyticus. There were 35, or 17 percent, that were V. alginolyticus, and 26, or 13 percent that were V. vulnificus.

Among 1,394 confirmed and serogrouped STEC cases, 36 percent, or 503 cases, were STEC O157. Another 64 percent, or 891 STEC cases, were non-O157. Among 70 percent, or 586 cases of non-O157 isolates, the most common serogroups were O26 with 190 cases, O103  with 178 cases, and O111 with 106 cases. Compared with 2013-2015, the incidence of STEC non-O157 infections in 2016 was significantly higher (26% increase; CI = 9%–46%) and the incidence of STEC O157 was unchanged.

open for business signWe are still seeing a significant downturn in E. coli cases linked to red meat, but are seeing cases in products like flour and soy nut butter, that leave all a bit perplexed.  We are also seeing less cases linked to leafy greens generally. Our growth areas seem to be imported food products and restaurant-related outbreaks.

The entire food chain, both foreign and domestic, as well as government, academia and consumers, clearly have more to do to drive me into retirement.

[1] FoodNet conducts active, population-based surveillance for laboratory-diagnosed infections caused by Campylobacter, Cryptosporidium, Cyclospora, Listeria, Salmonella, Shiga toxin-producing Escherichia coli (STEC), Shigella, Vibrio, and Yersinia for 10 sites covering approximately 15% of the U.S. population.

Editor’s note: Bill Marler is publisher of Food Safety News and a founding member of the Seattle law firm MarlerClark LLP, PS.

Publisher’s Platform: Supreme Court weighs in without a word

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I can hear a bit of silence in the board rooms of America.

Monday the U.S. Supreme Court declined to hear the appeals of Austin “Jack” DeCoster and his son, Peter DeCoster, without comment.

egg men illustration DeCosterIn April 2015 U.S. District Judge Mark Bennett sentenced the DeCosters to prison, saying they knew or should have known about the risks posed by the presence of Salmonella in and around millions of egg-laying hens. However, he allowed the DeCosters to stay free while they appealed the sentences, which they argued were unconstitutional and unreasonably harsh. The 8th U.S. Circuit Court of Appeals upheld the sentences in July 2016 and stayed any action until the U.S. Supreme Court appeal was resolved.

Now the DeCosters will now both face three-month jail sentences stemming from a Salmonella outbreak caused by their Iowa egg farms in 2010.

The Salmonella outbreak ran from May 1 to Nov. 30, 2010, and prompted the recall of more than half a billion shell eggs, the largest recall of its kind in history. And, while there were 1,939 confirmed infections, statistical models used to account for Salmonella illnesses in the U.S. suggest that the eggs may have sickened more than 62,000 people.

The family business, known as Quality Egg LLC, had already pleaded guilty to one federal felony count of bribing a U.S. Department of Agriculture egg inspector and to two federal misdemeanors associated with the outbreak. It agreed that the LLC would pay a $6.8-million fine and the DeCosters would be fined $100,000 each, for a total of $7 million.

I am not sure if the Supreme Court read Bill Neuman’s New York Times article from September 2010, “An Iowa Egg Farmer and a History of Salmonella.” However, he should. Here are some of the highlights/lowlights:

DeCoster’s frequent run-ins with regulators over labor, environmental and immigration violations have been well cataloged. But the close connections between DeCoster’s egg empire and the spread of Salmonella in the United States have received far less scrutiny.”

Farms tied to DeCoster were a primary source of Salmonella enteritidis in the U.S. in the 1980s, when some of the first major outbreaks of human illness from the bacteria in eggs occurred, according to health officials and public records. At one point, New York and Maryland regulators believed DeCoster eggs were such a threat that they banned sales of the eggs in their states. ‘When we were in the thick of it, the name that came up again and again was DeCoster Egg Farms,’ said Paul A. Blake, who was head of the Enteric Diseases Division at the Centers for Disease Control and Prevention in the 1980s, when investigators began to tackle the emerging problem of Salmonella and eggs.”

“Records released by Congressional investigators last week suggest that tougher oversight of Mr. DeCoster’s Iowa operations might have prevented the outbreak, which federal officials say is the largest of its type in the nation’s history, with more than 1,600 reported illnesses and probably tens of thousands more that have gone unreported.”

“According to the records, Mr. DeCoster’s farms in Iowa conducted tests from 2008 to 2010 that repeatedly showed strong indicators of possible toxic salmonella contamination in his barns. Such environmental contamination does not always spread to the eggs, and it is unclear what actions Mr. DeCoster took in response. However, when the Food and Drug Administrationinspected the farms after the recalls, officials found unsanitary conditions and the presence of Salmonella enteritidis in barns and feed.”

“The first enteritidis outbreak recognized by public health officials came in July 1982, when about three dozen people fell ill and one person died at the Edgewood Manor nursing home in Portsmouth, N.H. Investigators concluded that runny scrambled eggs served at a Saturday breakfast were to blame. They traced the eggs to what the Centers for Disease Control reports referred to as a large producer in Maine; interviews with investigators confirmed that it was Mr. DeCoster’s former operation. Eggs from the same farms were also suspected in a simultaneous outbreak that sickened some 400 people in Massachusetts.”

“In 1987, a deadly outbreak at Coler Memorial Hospital on Roosevelt Island occurred. Investigators determined that mayonnaise made from raw eggs had caused the outbreak. They traced the eggs to Mr. DeCoster’s Maryland farms. On a July night in 1987, scores of elderly and chronically ill patients at Bird S. Coler Memorial Hospital in New York City began to fall violently sick with food poisoningfrom eggs tainted with salmonella. ‘It was like a war zone,’ said Dr. Philippe Tassy, the doctor on call as the sickness started to rage through the hospital. By the time the outbreak ended more than two weeks later, nine people had died and about 500 people had become sick. It remains the deadliest outbreak in this country attributed to eggs infected with the bacteria known as Salmonella enteritidis.”

“After two more outbreaks were linked to DeCoster eggs the following year, New York banned Mr. DeCoster from selling eggs in the state. He was forced to agree to a rigorous program of salmonella testing on his farms in Maine and Maryland. Michael Opitz, a poultry expert retired from the University of Maine, said that the testing found that a Maine breeder flock owned by Mr. DeCoster was infected, meaning that hens there could be passing the bacteria to their chicks, which might grow up to lay tainted eggs. Widespread contamination was also found in laying barns.”

JackPeterDeCoster_406x250
Austin “Jack” DeCoster, left, and his son Peter DeCoster will each have to serve a three-month sentence for their roles in the 2010 Salmonella outbreak traced to their eggs.

“In 1991, tests revealed more salmonella contamination at one of Mr. DeCoster’s farms in Maryland. The state quarantined the eggs, allowing them to be sold only to a plant where they could be pasteurized to kill bacteria. Mr. DeCoster challenged the order and a federal judge ruled that Maryland could not block him from shipping eggs to other states. He was still barred from selling the eggs in Maryland, and in 1992, a state judge found that he had violated the quarantine by selling eggs to a local store; Mr. DeCoster was given a suspended sentence of probation and a token fine.”

“Soon after interstate shipments resumed in 1992, eggs from the Maryland farm caused a salmonella outbreak in Connecticut, according to a 1992 memo from the Maryland attorney general’s office. Federal regulators insisted that Mr. DeCoster decontaminate his barns. Dr. Roger Olson, the former state veterinarian of Maryland, said that Mr. DeCoster complained about the cost of testing and the quarantine and insisted there was little risk associated with his eggs.”

And, then there was 2010. I think Jack and Peter need some time away to think about this.

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Publisher’s Platform: Six deadliest U.S. foodborne outbreaks

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Although the United States is know world-wide as having one of the safest food supplies, there have been instances where some of the foods most commonly consumed in our country have resulted in tragedy.

Jack-in-the- Box E. coli Outbreak – 1992 – 1993

708 ill, 171 hospitalized and 4 dead

An outbreak of E. coli O157:H7 was linked to the consumption of hamburgers from the Jack-in-the-Box Restaurant chain. Cases were reported from the states of Washington (602 cases/144 hospitalizations/3 deaths), Idaho (14 cases/4 hospitalizations/no deaths), California (34 cases/14 hospitalizations/1 death), and Nevada (58 cases/9 hospitalizations/no deaths). A case control study implicated the chain’s hamburgers resulting in a multistate recall of the remaining hamburgers. Only 20 percent of the product remained at the time of the recall; this amounted to 272,672 hamburger patties. Subsequent testing of the hamburger patties showed the presence of E. coli O157:H7. The strain of E. coli O157:H7 found in ill people matched the strain isolated from uncooked hamburger patties. The outbreak illustrated the potential for large, foodborne illness outbreaks associated with restaurant chains receiving shipments of contaminated food. At the time, many clinical laboratories in the United States were not routinely culturing patients’ stool for E. coli O157:H7 by using the correct culture medium. Additionally, many local and state health departments were not actively tracking and investigating E. coli O157:H7 cases.


Chi Chi’s Green Onion Hepatitis A Outbreak – 2003

565 ill, 130 hospitalized and 3 dead

Pennsylvania State health officials first learned of a hepatitis A outbreak when unusually high numbers of hepatitis A cases were reported in late October 2003. All but one of the initial cases had eaten at the Chi Chi’s restaurant at the Beaver Valley Mall, in Monaca, PA. Ultimately, at least 565 cases were confirmed. The victims included at least 13 employees of the Chi Chi’s restaurant, and residents of six other states. Three people died as a consequence of their hepatitis A illnesses. More than 9,000 people who had eaten at the restaurant, or who had been exposed to ill people, were given a post-exposure injection as a prevention against developing hepatitis A. Preliminary analysis of a case-control study indicated fresh, green onions were the probable source of this outbreak. The investigation and tracebacks by the state health department, the CDC, and the FDA, confirmed that the green onions had been grown in Mexico.


Dole Baby Spinach E. coli Outbreak – 2006

238 ill, 103 hospitalized and 5 dead

On Sept. 13, 2006, public health officials in Wisconsin, Oregon and New Mexico noted E. coli O157:H7 infections with matching pulsed-field gel electrophoresis (PFGE) patterns. These illnesses were associated with eating fresh, bagged spinach produced by Dole Brand Natural Selection Foods. By Sept. 26 that year, infections involving the same strain of E. coli O157:H7 had been reported from 26 states with one case in Canada. A voluntary recall was issued by the company on Sept. 15. E. coli O157: H7 was isolated from 13 packages of spinach supplied by patients in 10 states. Eleven of the packages had lot codes consistent with a single manufacturing facility on a particular day. The PFGE pattern of all tested packages matched the PFGE pattern of the outbreak strain. The spinach had been grown in three California counties – Monterey, San Benito and Santa Clara. E. coli O157:H7 was found in environmental samples collected near each of the four fields that provided spinach for the product, as designated by the lot code. However, E. coli O157:H7 isolates associated with only one of the four fields, located on the Paicines Ranch in San Benito County, had a PFGE pattern indistinguishable from the outbreak strain. The PFGE pattern was identified in river water, cattle feces and wild pig feces on the Paicines Ranch, the closest of which was less than one mile from the spinach field.


Peanut Corporation of America Salmonella Outbreak – 2008 – 2009

714 ill, 171 hospitalized and 9 dead

Beginning in November 2008, CDC’s PulseNet staff noted a small and highly dispersed, multistate cluster of Salmonella Typhimurium isolates. The outbreak consisted of two pulsed-field gel electrophoresis (PFGE) defined clusters of illness. Illnesses continued to be revealed through April 2009, when the last CDC report on the outbreak was published. Peanut butter and products containing peanut butted produced at the Peanut Corporation of America plant in Blakely, GA, were implicated. King Nut brand peanut butter was sold to institutional settings. Peanut paste was sold to many food companies for use as an ingredient. Implicated peanut products were sold widely throughout the USA, 23 countries and non-U.S. territories. Criminal sanctions were brought against the owners of PCA.


Jensen Farms Cantaloupe Listeria Outbreak – 2011

147 ill, 143 hospitalized and 33 dead

A multistate outbreak of Listeria monocytogenes involving five distinct strains was associated with consumption of cantaloupe grown at Jensen Farms’ production fields near Granada, CO. A total of 147 ill people were reported to the CDC. Thirty-three people died, and one pregnant woman miscarried. Seven of the illnesses were related to pregnancy – three newborns and four pregnant women. Among 145 ill people with available information, 143 – 99 percent – were hospitalized. Source tracing of the cantaloupes indicated that they came from Jensen Farms, and were marketed as being from the Rocky Ford region. The cantaloupes were shipped from July 29 through Sept. 10, 2011, to at least 24 states, and possibly distributed elsewhere. Laboratory testing by the Colorado Department of Public Health and Environment identified Listeria monocytogenes bacteria on cantaloupes collected from grocery stores and from ill persons’ homes. Laboratory testing by FDA identified Listeria monocytogenes matching outbreak strains in samples from equipment and cantaloupe at the Jensen Farms’ packing facility in Granada, Colorado.  Criminal sanctions were brought against the two owners of Jensen Farms.


Andrew and Williamson Cucumber Salmonella Outbreak – 2015

907 ill, 204 hospitalized and 6 dead

On September 4, 2015 the CDC announced an outbreak of Salmonella Poona linked to consumption of cucumbers grown in Mexico and imported by Andrew & Williamson Fresh Produce. On March 18, 2016 the outbreak was declared to be over. A total of 907 people infected with the outbreak strains of Salmonella Poona were reported from 40 states. Among people for whom information was available, illnesses started on dates ranging from July 3, 2015 to February 29, 2016. Two hundred four ill people were hospitalized and six deaths were reported. Salmonella infection was not considered to be a contributing factor in two of the 6 deaths. Epidemiologic, laboratory, and traceback investigations identified imported cucumbers from Mexico and distributed by Andrew & Williamson Fresh Produce as the likely source of the infections in this outbreak.

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Publisher’s Platform: Tragically, “Forever Young”

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My friend, Darin Detwiler, let me post this for him tonight for tomorrow:

Today marks the 25th anniversary of the day the last of four young children died during the landmark 1993 Jack in the Box E. coli outbreak.

Riley Edward Detwiler

I learned about the reality of this foodborne pathogen on Riley’s deathbed. When he was only a few months old, I justified being out to sea on a Navy submarine by telling myself that I was making the world a safer place for him, and I thought that I would spend the rest of my life making up lost time with him when he was older.

Riley would now be older than I was during that outbreak.  I never got to see him grow older than he appears in the few photos and videos from so long ago. Over the years since his death, however, I have seen news of recalls and outbreaks and deaths on a far too regular basis. I have also seen much improvement in food safety.

We have gained new federal food safety regulations and policies at the USDA and, most recently at the FDA. We have witnessed advancements in science and data collection and even a whole new “culture of food safety.” We have training, certifications, university programs, conferences, magazines, books, and even movies that serve to inform and motivate new generations of food safety experts.

Many of the changes in food safety policies came about through the hard work of victims, families, advocacy groups and industry leaders. Statistics and charts alone achieve little without victim’s voices. Facts rarely motivate policymakers as much as seeing the faces and stories. I am very proud of their efforts. I am also proud to have stood with them and before them, trying to prevent other parents from looking at their family table with one chair forever empty due to preventable illnesses and deaths from foodborne pathogens.

One thing that hits me hard lately is how the faces and stories of victims from mass shootings are seemingly not enough to bring about change in terms of gun control. While no new policies will bring back the dead, they would bring hope and an increased safety for others. I am saddened by the thought that so many parents will live with the belief that their child’s death did not result in some element of change.

Perhaps the reasons matter not as to why parents worry about making the world a safer place for their children. Too many homes in this country include a chair forever empty at a family table due to reasons that could and should have been prevented.

Darin Detwiler Ph.D. is the assistant dean, the Lead Faculty of the MS in Regulatory Affairs of Food and Food Industry, and Professor of Food Policy at Northeastern University in Boston. In addition to serving as the executive vice president for public health at the International Food Authenticity Assurance Organization, he is the founder and president of Detwiler Consulting Group LLC. Detwiler and serves on numerous committees and advisory panels related to food science, nutrition, fraud, and policy. He is a sought-after speaker on key issues in food policy at corporate and regulatory training events, as well as national and international events. Detwiler holds a doctorate of Law and Policy.

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Publisher’s Platform: Besides hepatitis A, what do McDonald’s, Applebee’s and Texas Roadhouse have in common?

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Answer: They are all in Kentucky where a hepatitis A outbreak has been ongoing for months. With 272 people infected with Hepatitis A in Kentucky, restaurants must offer hepatitis A vaccines to employees – its common sense. – Full Report

To view a larger version of this map, please click on it.

A McDonald’s Corp. employee in Kentucky could have potentially spread hepatitis A to customers, according to local health officials, igniting a new health scare for the fast food giant.

Officials at the Madison County health department are warning people that they may have been infected by the food handler, who was working at a restaurant in the town of Berea, south of Lexington, on March 23.

An employee at the Applebee’s on Dixie Highway has been diagnosed with hepatitis A, the Louisville Department of Health said in a series of Tweets on Friday night.

The implicated Applebee’s is located at 4717 Dixie Highway.

Anyone who ate at that Applebee’s between March 23 and April 12 should get a hepatitis A vaccine, the health department said.

The Ashland-Boyd County Health Department is investigating a case involving a food preparation worker at a Texas Roadhouse who has been diagnosed with hepatitis A.

The window of possible exposure for customers and staff at the Texas Roadhouse restaurant is March 20 through April 12. The restaurant is located in the 500 block of Winchester Road.

If you have been exposed, there is a two-week window to receive the hepatitis A post-exposure vaccine. After those two weeks have passed, the vaccine may not be effective in preventing the virus.

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Publisher’s Platform: 2018 has been a Big, Bad Year for U.S. Foodborne Illnesses

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First off, yes, 2018 seems to be – and we are just 1/2 way into it – a very Big, Bad year for foodborne illnesses.

Second, I am not sure why.

It could be better surveillance by state, local and national health authorities utilizing cutting edge tools such as PFGE and WGS.  It could be a lack of support for inspectors.  It is certainly possible that it is more imports with a greater supply chain with a great chance for contamination or temperature abuse. It also could be more mass produced fresh, ready to eat foods without a “kill step.”

It also could be none of those things, but it seems to me to be more than just random events. Here are some of the highlights of 2018:

E. coli

Romaine Lettuce – 218 sick in US and Canada with 96 hospitalizations and 5 deaths.

 

Cyclospora

McDonald’s Salads – 163 sick with 3 hospitalizations.

Del Monte Vegetable Trays – 237 sick with 7 hospitalizations.

 

Salmonella

Jimmy John’s Sprouts – 10 sick.

Kratom – 199 sick with 50 hospitalizations.

Fareway/Triple T Chicken Salad – 265 sick with 94 hospitalizations and 1 death.

Go Smile Coconut – 14 sick with 3 hospitalizations.

Rose Acre Shell Eggs – 45 sick with 11 hospitalizations.

Caito Cut Melons – 70 sick with 34 hospitalizations.

Kellogg’s Honey Smacks – 100 sick with 34 hospitalizations.

Hy-Vee Pasta Salad – 21 sick with 5 hospitalizations.

Raw Turkey – 90 sick with 40 hospitalizations.

Vibrio parahaemolyticus

Venezuelan Crab Meat – 12 sick with 4 hospitalizations.

And, we are only 1/2 way through the year.

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Publisher’s Platform: Why are these fish still on store shelves? I was wrong.

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Although the brand was recalled, the Best Buy Date was not part of the recall.  My apologies to my friends at Safeway.

On July 23rd Pepperidge Farms recalled Goldfish crackers because they might be tainted with Salmonella – including packages with the UPC number 1410004921.

Guess what was being sold – and purchased – on July 26 at 3 p.m. at a Safeway grocery store in Saint Helena, CA?

FDA, seriously, it is time to make the supply chain transparent – especially during a recall and/or outbreak.

The code for the recalled Goldfish crackers can be seen on this package, which was purchased at a store in California after the recall was initiated.

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Publisher’s Platform: Anything that causes food poisoning should be considered an adulterant

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Opinion

An additional 87 ill people from 16 states were included in this investigation since the last update on Nov. 15. States with newly reported illnesses include: Michigan, Mississippi, and West Virginia.

As of Dec. 12, there are 333 people infected with the outbreak strain of Salmonella Newport. They have been reported from 28 states. Their illnesses started on dates ranging from Aug. 5 through Nov. 9. One-third of the patients have been hospitalized. No deaths have been reported.

Epidemiologic, laboratory, and traceback evidence indicates that ground beef produced by JBS Tolleson Inc. is a likely source of this outbreak.

On Oct. 4 this year, JBS Tolleson Inc. recalled approximately 6.9 million pounds of beef products that may be contaminated with Salmonella Newport. On Dec. 4 JBS Tolleson Inc. recalled an additional 5.2 million pounds of beef products.

Personally, as I said to the Los Angeles Times some time ago, “I think that anything that can poison or kill a person should be listed as an adulterant [in food].”

Ignoring Salmonella in meat makes little, if any, sense. Even after the Court’s twisted opinion in Supreme Beef v. USDA, where it found Salmonella “not an adulterant per se, meaning its presence does not require the USDA to refuse to stamp such meat ‘inspected and passed’, ” our government’s failure to confront the reality of Salmonella, especially antibiotic-resistant Salmonella, is inexcusable.

The Wisconsin Supreme Court in Kriefall v Excel called it as it saw it:

The E. coli strain that killed Brianna and made the others sick is a “deleterious substance which may render [meat] injurious to health.” There is no dispute about this. Thus, under the first part of 21 U.S.C. § 601(m)(1), meat that either “bears or contains” E. coli O157:H7 (the “deleterious substance”) is “adulterated.” That E. coli O157:H7 contamination can be rendered non-“injurious to health” by cooking thoroughly, as discussed below, does not negate this; Congress used the phrase “may render,” not “in every circumstance renders.” Moreover, if the E. coli bacteria is not considered to be “an added substance,” because it comes from some of the animals themselves and is not either applied or supplied during the slaughtering process (although we do not decide this), it cannot be said that the E. coli strain “does not ordinarily render [the meat on or in which it appears] injurious to health.” Accordingly, meat contaminated by E. coli O157:H7 is also “adulterated” under the second part of § 601(m)(1).

Now, why would Salmonella be different? According to the CDC, it is estimated that 1.4 million cases of salmonellosis occur each year in the United States. Of those cases, 95 percent are related to foodborne causes. Approximately 220 of each 1,000 cases result in hospitalization, and 8 of every 1,000 cases result in death. About 500 to 1,000 deaths – 31 percent of all food-related deaths – are caused by Salmonella infections each year.

So, where do we stand with the existing USDA/FSIS law on adulteration?  Here is the law:

21 U.S.C. § 601(m)(4) – SUBCHAPTER I – INSPECTION REQUIREMENTS; ADULTERATION AND MISBRANDING – CHAPTER 12 – MEAT INSPECTION – TITLE 21—FOOD AND DRUGS

(m) The term “adulterated” shall apply to any carcass, part thereof, meat or meat food product under one or more of the following circumstances:

(1) if it bears or contains any poisonous or deleterious substance which may render it injurious to health; but in case the substance is not an added substance, such article shall not be considered adulterated under this clause if the quantity of such substance in or on such article does not ordinarily render it injurious to health; …

(3) if it consists in whole or in part of any filthyputrid, or decomposed substance or is for any other reason unsound, unhealthfulunwholesome, or otherwise unfit for human food;

(4) if it has been prepared, packed, or held under insanitary conditions whereby it may have become contaminated with filth, or whereby it may have been rendered injurious to health; …

Hmmm. It is hard to read the above and not think that the words in bold equate to all E. coli and Salmonella — frankly, all pathogens in food. I know, I am just a lawyer, but don’t ya think that when food with animal feces (and a dash of E. coli O157:H7) in it is considered an adulterant, that other animal feces (with dashes of other pathogens, like Salmonella) in them, should be considered adulterated too?  But, hey, that is just me. Another odd governmental fact is that the FDA does not seem to make a distinction between pathogens it considers adulterants or not. FDA’s enabling legislation – Sec. 402. [21 USC §342] of the Food, Drug & Cosmetic Act also defines “Adulterated Food” as food that is: 

(a) Poisonous, insanitary, or deleterious ingredients.

(1) If it bears or contains any poisonous or deleterious substance which may render it injurious to health; but in case the substance is not an added substance such food shall not be considered adulterated under this clause if the quantity of such substance in such food does not ordinarily render it injurious to health;

(2) If it bears or contains any added poisonous or added deleterious substance … that is unsafe within the meaning of section 406;

(3) if it consists in whole or in part of any filthy, putrid, or decomposed substance, or if it is otherwise unfit for food;

(4) if it has been prepared, packed, or held under insanitary conditions whereby it may have become contaminated with filth, or whereby it may have been rendered injurious to health …

It would be interesting, and perhaps entertaining, to have House and Senate hearings focusing on what should and should not be considered adulterants in our food. I can see panels of scientists from various fields, FDA, USDA and FSIS officials, beef and produce industry representatives, and consumers discussing this. I would pay to watch it.

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Publisher’s Platform: Seriously, time to ban petting zoos?

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Opinion

This past weekend I woke up to the sad news of yet other injuries and a death linked to animal contact at a fair.

San Diego County health officials announced late Friday night that a 2-year-old child has died and three other children between 2 and 13 years old have become ill after having contact with animals at the San Diego County Fair.

The County of San Diego Health and Human Services Agency (HHSA) reported four confirmed pediatric cases of Shiga-toxin-producing E. coli linked to contact with the animals. Officials from the HHSA’s Epidemiology Program and County Department of Environmental Health are investigating the cluster of four infections, officials said.

The four children who fell ill visited the fair between June 8 and June 15 and began showing symptoms between June 10 and June 16.

Photo illustration

“Three of the four cases were not hospitalized,” county authorities said in a statement released at 10:10 p.m. Friday. “However, one of the four cases, a 2-year-old boy, was hospitalized and unfortunately died on June 24, from a complication of this disease.”

Officials at the San Diego County Fair closed public access to all animal areas, including the petting zoo, according to the statement issued by the county. The source of the E. coli bacteria remains under investigation, but all the children reportedly visited the animal areas or petting zoo or had other animal contact at the fair.

It reminded me of an op-ed I penned several years ago about banning petting zoos.

I can hear the wailing and gnashing of teeth over such an un-American suggestion.

The Centers for Disease Control and Prevention (CDC) reports the creation of yet another multiagency task force in North Carolina “to evaluate the preventive measures that were in place during the 2011 state fair and to identify additional interventions that could be applied to prevent disease transmission in livestock exhibitions where physical contact with the public might occur.” Hmm, didn’t that happen after the 2004 North Carolina State Fair E. coli outbreak, which resulted in 187 illnesses, including 15 complicated by hemolytic uremic syndrome (HUS)?

This latest task force is looking into what happened at the 2011 North Carolina State Fair, held October 13-23 in Raleigh. According to the CDC, 25 cases of E. coli O157:H7infection were identified with case-patients’ illness onsets during October 16-25; median age was 26 years (range: 1-77 years). Eight case-patients (32 percent) were hospitalized; four (16 percent) experienced HUS. Once again, the only exposure associated with illness was having visited one of the permanent structures in which sheep, goats, and pigs were housed for livestock competitions.

After decades of outbreaks, the CDC and a collection of state veterinarians have issued these stern warnings and suggestions about animal exhibits and petting zoos:

Photo illustration

– Wash hands after contact with animals to reduce the risk of zoonotic disease transmission.

– Do not allow food, drink, or pacifiers in animal areas.

– Include transition areas between animal areas and non-animal areas.

– Educate visitors about disease risk and prevention procedures.

– Properly care for and manage animals.

But, if history is any guide, guidelines are not working very well. Here is a sample of zoonotic outbreaks during the past decade:

2011 English Animal Farm Outbreak – Cruckley Animal Farm in Foston-on-the-Wolds, England is closing its gates permanently following an outbreak of E. coli O157:H7.  The family-run farm was linked to at least six cases of the life-threatening infection as of August 2011.  The owners, John and Sue Johnston, expressed sorrow at the illness and stated that “the health and safety of our visitors has always been our top priority,” thus with the news the farm was the likely source of illnesses, they decided to close.

2011 Snohomish County Petting Zoo – At least 6 people who visited the Forest Park Petting Zoo in Everett, Washington, in June 2011 became ill with E. coli O157:H7 infections. The Snohomish County Health Department investigated the E. coli outbreak and determined that there was a “clear association between disease and being in the open animal interaction area of the forest Park Animal Farm.”

2009 Utah Rodeos Outbreak – Utah state and local health officials and the CDC noted a cluster of E. coli O157:H7 cases in the summer of 2009.  The illnesses were associated with attendance to rodeos, but not all the same one.  The vast majority of the 14 cases (93 percent) had food histories containing ground beef, unsurprising for rodeo visitors. 
However, a traceback on the meat products provided at the rodeos found no contamination.

2009 Godstone Park Farm and Plan Barn E. coli Outbreak in Surrey, England – A final report of the Outbreak Control Committee of the Surrey and Sussex Health Protection Unit describes an outbreak of E. coli O157 (VTEC O157 PT21/28) occurring in August and September 2009. This was the largest documented outbreak of VTEC O157 associated with farms in the UK. Individuals became infected either through direct or indirect contact with farm livestock.

2009 “Feed the Animals” Exhibit E. coli Outbreak at the Western Stock Show – In January 2009, the Communicable Disease and Consumer Protection Divisions of the Colorado Department of Public Health noticed an increase is in the number of laboratory confirmed cases of E. coli O157.  Thirty cases were identified–including nine hospitalizations and 2 cases of HUS.  All the children had visited the National Western Stock Show in Denver, Colorado.

2007 Petting Zoo E. coli O157:H7 Outbreak in Pinellas County, FL – In May and June 2007, seven Florida children were infected with E. coli O157:H7. Six of the children had visited a Day Camp petting zoo, and the seventh was a sibling. Two of the children were hospitalized, all seven recovered.  The petting zoo was closed on the recommendation of the health department.

2005 Big Fresno Fair Petting Zoo E. coli Outbreak – At least six children were infected with E. coli O157:H7 – one gravely – visiting the petting zoo at the 2005 Big Fresno Fair. One child was 2 years old at the time of her visit to the petting zoo. She developed HUS and was hospitalized for months. Her kidneys were severely damaged and a series of strokes left her with impaired movement and vision.

2005 Campylobacteriosis Outbreak Associated with a Camping Trip to a Farm – In June 2005, King County Public Health was notified that a several children on a school trip had been ill with diarrhea, abdominal pain and fever following the trip. Campylobacter was isolated from the stool of one ill individual, and later in the week, two more cases of campylobacteriosis were reported in persons who had been on the same camping trip, held at a private farm.

2005 Florida State Fair, Central Florida Fair, and Florida Strawberry Festival E. coli Outbreak – The AgVenture Farms E. coli O157:H7 outbreak was first recognized after two separate HUS case reports were reported to the Florida Department of Health in mid-March.  The two cases (a 5-year-old girl and a 7-year-old boy) both reported hav
ing visited a fair with a petting zoo (AgVenture) a few days prior to becoming ill. The two children did not have any other common risk factors. A total of 22 confirmed, 45 suspect and 6 secondary cases were reported.

2003 Fort Bend County Fair E. coli Outbreak – Rosenberg, TX – In 2003, 25 people (fair visitors and animal exhibitors) became ill with HUS and one case of a related disease, thrombotic thrombocytopenic purpura. All seven laboratory-confirmed cases had an indistinguishable PFGE pattern, which matched 10 isolates obtained from environmental samples taken from animal housing areas.

2002 E. coli Outbreak at a Petting Zoo in Zutphen, The Netherlands  – A young child developed a Shiga toxin 2 producing strain of Escherichia coli (STEC) O157 infection after visiting a petting zoo in Zutphen, The Netherlands. The STEC strains were isolated from the fecal samples from goats and sheep on the farm and were indistinguishable from the human patient isolate.

2002 Lane County, Oregon, Fair E. coli Outbreak – The Oregon Department of Human Services (Oregon, 2002) initially documented a patient with bloody diarrhea, who attended the Lane County Fair held during August 2002. Epidemiologists identified 82 ill persons, 22 who were hospitalized, and 12 with HUS. This is the largest E. coli O157:H7 outbreak recorded in Oregon.

2002 Wyandot County, OH, Fair E. coli Outbreak – The Ohio Wyandot County Health Department received a report of an E. coli O157 outbreak in September 2001 (CDC memorandum, February, 2002). A total of 92 cases were identified, including 27 laboratory-confirmed E. coli O157 infections. Two cases were diagnosed with hemolytic uremic syndrome. Eighty-eight cases reported attending Wyandot County Fair before becoming ill.

2001 Lorain County, OH, Fair E. coli Outbreak – The Department of Health and Human Services, Public Health Services (CDC memorandum, February, 2002) reported that 23 cases of E. coli O157:H7 infection were associated with the attendance at the Lorain County Fairgrounds in September 2001. Additional cases were identified as likely due to secondary transmission from attendees at the fairgrounds. An investigation associated illness with environmental contamination at the Cow Palace.

2001 Ozaukee County, WI, Fair E. coli Outbreak – The Ozaukee County Public Health Department and Wisconsin Department of Health and Family Services (2001) investigated an outbreak of E. coli O157:H7 associated with animals at the Ozaukee County Fair in August 2001. A total of 59 E. coli O157:H7 cases were identified in this outbreak, with 25 laboratory confirmed cases (25 “primary cases” and 34 probable cases).

2001 E. coli Outbreak at a Petting Zoo in Worcester, PA – An article published by WebMD Medical News on April 23, 2001 (Bloomquist, 2001), reported an outbreak of E. coli O157:H7 among visitors to the Merrymead Farm petting zoo in Worcester, Pennsylvania. In all, 16 children who had visited the zoo contracted E. coli, and it was suspected that another 45 people became ill from the bacteria. The report indicated that one week after visiting the zoo, one of the children came down with violent stomach cramps and was hospitalized.

2000 Cryptosporidiosis Outbreak at a Farm in Wellington, New Zealand – An outbreak of Cryptosporidiosis was linked to a two-day farm educational event in the Wellington region of New Zealand. Twenty-three cases were laboratory-confirmed. The route of infection was most likely from an infected animal.

2000 E. coli Outbreak at a Dairy Farm– Crump et al (2002) discussed an outbreak of E. coli O157:H7 among visitors to a dairy farm in Pennsylvania in September 2000. A case control study among the visitors was conducted to identify the risk factors of infection, along with a household survey to determine the rates of diarrheal illness. The total number of confirmed or suspected E. coli O157:H7 cases was 51. The median age among the patients was four. Eight of the cases developed hemolytic uremic syndrome (HUS).

2000 Snohomish County, WA, Petting Zoo E. coli Outbreak – The Snohomish Health District, Communicable Disease Department (June, 2000) reported five cases of bacterial diarrhea caused by E. coli O157:H7 in children in Snohomish County in May 2000. Three of the children visited a petting zoo several days before they became sick. The fourth child did not visit the petting zoo, but lived on another farm where cattle were raised.

2000 Medina County, OH, Fair E. coli Outbreak – A cluster of E. coli O157:H7 isolates was observed in Medina County, Ohio, in August of 2000. In the case-control investigation, 43 culture confirmed E. coli O157:H7 cases were identified. The environmental investigation suggested that contamination of a section of the water distribution system supplying various vendors was the likely exposure.

So, what do you think should be done?

For more information on outbreaks and prevention measures, visit Fair-Safety.Com

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Publisher’s Platform: Captain Obvious — Nearby cow shit can cause E. coli outbreaks in leafy greens

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Opinion

This is not meant as a criticism of my friends at the FDA or the good people at LGMA – California and Arizona – or at Western Growers, United Fresh or PMA.  But seriously, since leafy green E. coli O157:H7outbreaks spiked in the early 2000’s, is anyone surprised by the following conclusion by the FDA (only that it was not said out loud sooner).

Also, the has long reported that tracebacks on all three outbreaks have identified a common grower in Salinas.  However, that grower has remained unnamed – so much for transparency.

FDA considers adjacent or nearby land use for cattle grazing as the most likely contributing factor associated with these three outbreaks. While the agency could not confirm a definitive source or route(s) of contamination of the romaine fields, the Agency considers the indirect transmission of fecal material from adjacent and nearby lands from water run-off, wind, animals or vehicles to the romaine fields, or to the agricultural water sources used to grow the romaine, as possible routes of contamination.

According to a report by the FDA released Thursday, in November and December 2019 there were three E. coli O157: H7 foodborne illness outbreaks.  One outbreak sickened 167 and was in part linked to Ready Pac Bistro® Chicken Caesar Salad and Fresh Express Leafy Green Romaine.  The romaine lettuce came from the Salinas growing region.  The second outbreak sickened 11 and was linked in part to the Evergreen’s restaurant chain and was again linked to romaine lettuce from the Salinas growing region.  The third outbreak sickened 10 and was linked to Fresh Express Sunflower Crisp Chopped Salad Kits from romaine lettuce grown in the Salinas growing region.

During the course of these investigations, the FDA determined that:

  • Each of these three outbreaks was caused by distinctly different strains of E. coli O157:H7 as determined by whole-genome sequencing (WGS) analysis;
  • Outbreak 1 strain of E. coli O157: H7 was found in two different brands of fresh-cut salads containing romaine lettuce in 2019;
  • Traceback investigations of multiple illness sub-clusters and supply chain information identified a common grower with multiple ranches/fields, which supplied romaine lettuce during the timeframe of interest to multiple business entities associated with Outbreaks 1, 2 and 3;
  • The Outbreak 1 strain of E. coli O157:H7 was detected in a fecal-soil composite sample taken from a cattle grate on public land less than two miles upslope from a produce farm with multiple fields tied to the outbreaks by the traceback investigations.
  • Other STEC strains, while not linked to outbreaks 1,2, or 3, were found in closer proximity to where romaine lettuce crops were grown, including two samples from a border area of a farm immediately next to cattle grazing land in the hills above leafy greens fields and two samples from on-farm water drainage basins.

See picture above right – cows on hillside, leafy greens below.  People say what about shit and hillsides?

The FDA has made the following recommendation (not mandates):

In light of the findings of these investigations, FDA recommends that growers of leafy greens:

  • Emphasize/Redouble efforts around Prevention
  • Assess growing operations to ensure implementation of appropriate science and risk-based preventive measures, including applicable provisions of the FSMA Produce Safety Rule and GAPs.
  • Adjacent Land Use – Assess and mitigate risks associated with adjacent and nearby land uses, including grazing lands and animal operations regardless of size. Prevent contamination from uphill adjacent cattle grazing lands, such as by produce farms increasing buffer zones if fields are adjacent to cattle grazing lands (based on assessment); and adding physical barriers such as berms, diversion ditches, and vegetative strips
  • Agricultural Water – Ensure that all agricultural water is safe and of adequate sanitary quality for its intended use. Assess and mitigate risks related to land uses near or adjacent to agricultural water sources that may contaminate agricultural water. Ensure that any agricultural water treatment is validated, verified, and in accordance with all applicable Federal, State, Local, and other regulations
  • Improve Traceability
  • Increase digitization, interoperability, and standardization of traceability records, which would expedite traceback and prevent further illnesses.
  • Broader, more consistent implementation of voluntary source labeling on packaging or point of sale signs, or by other means to help consumers and retailers more readily identify product during an outbreak or recall.
  • Improve Root Cause Analysis
  • Perform a root cause analysis when a foodborne pathogen is identified in the growing environment, in agricultural inputs (e.g., agricultural water or soil amendments), in raw agricultural commodities or in fresh-cut ready-to-eat produce.

Here is the complete report: Investigation Report:  Factors Potentially Contribution to the Contamination of Romaine Lettuce Implicated in the Three Outbreaks of E. coli O157: H7 During the Fall of 2019

Thank you captain.

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Publisher’s Platform: Good riddance to bad rubbish

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CNN reported this week that Coca-Cola is shutting down the juice and smoothie brand Odwalla at the end of July. Coca-Cola purchased the brand in 2001.

Coca-Cola made the call “given a rapidly shifting marketplace and despite every effort to support continued production,” John Hackett, president of Coca-Cola’s Minute Maid business unit, which includes the company’s juice brands, said in a statement e-mailed to CNN Business.

Coca-Cola had been assessing Odwalla’s business for the past several years, according to a company spokesperson, who added that the decision to discontinue the brand is not directly related to the coronavirus pandemic. Health-conscious consumers are less interested in smoothies than they used to be, she explained.

“This decision was not made lightly,” he added.

Forgive me if I do not “lightly” shed a tear for anyone but the child that died in 1996, and several others who were stricken with acute kidney failure, after consuming Odwalla’s unpasteurized apple juice.  I represented many of those sickened and left with life-long complications.

In October of 1996, the Seattle-King County Department of Public Health linked 13 cases of E. coli O157:H7 to unpasteurized apple juice sold by Odwalla. The FDA subsequently announced a recall of all Odwalla juices containing raw apple juice.

The E. coli outbreak eventually included 65 confirmed victims in the western United States and British Columbia. More than a dozen victims developed hemolytic uremic syndrome (HUS) from their infections (acute kidney failure). One Colorado toddler died.

During the course of the litigation, we uncovered that Odwalla had attempted to sell its juice in 1996 to the U.S. Army – no, not as a biological weapon – but to be sold in base grocery stores to our men and women service members and their families. The Army rejected the product – because it was not fit for military consumers.  This letter tells that story:

Despite being told by the Army that it would not buy Odwalla’s product, Odwalla continued to ignore the warnings and to not test its product, because it did not want to document that it was in fact unsafe.

Odwalla kept selling the product to pregnant women and children until it poisoned too many people to be ignored.

The Court ordered the disclosure of Odwalla’s emails:

Odwalla paid out 10’s of millions of dollars in settlements to the victims of its pathogenetic juice.

In 1998, Odwalla was indicted and held criminally liable for the 1996 E. coli outbreak. The company pled guilty to 16 federal criminal charges and agreed to pay a $1.5 million fine.

Good riddance to bad rubbish.

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Publisher’s Platform: Vaccinate restaurant employees against hepatitis A or suffer the consequences

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Opinion

The RCAHD is currently investigating nine cases of hepatitis A associated with this exposure.

An employee who worked at three Famous Anthony’s restaurant locations in Roanoke has been diagnosed with hepatitis A. As a result, the Roanoke City and Alleghany Health Districts (RCAHD) announced today that anyone who visited any of these three Famous Anthony’s locations — 4913 Grandin Road, 6499 Williamson Road or 2221 Crystal Spring Ave. — from Aug. 10 through 26 only, may have been exposed.

To protect your health and prevent further spread of illness, if you meet these criteria and are not vaccinated against hepatitis A, please monitor yourself for these symptoms:

• jaundice: yellowing of the skin or the eyes,
• fever,
• fatigue,
• loss of appetite,
• nausea,
• vomiting,
• abdominal pain,
• dark urine, or
• light-colored stools.

If you develop any of these symptoms, please seek medical care and let your healthcare provider know of your possible exposure. It is also very important for people with symptoms to stay home from work, especially if they work in food service, health care or child care.

It is irresponsible for restaurants to not offer hepatitis A vaccines to employees. Or, ignore the issue, sicken your customers, and be assured, you will be sued.

A fact from the CDC: “Since the hepatitis A outbreaks were first identified in 2016, more than 39,000 cases, 24,000 hospitalizations, and 374 deaths as a result of hepatitis A virus (HAV) infection have been reported.”

True, some of the above have been the homeless or drug addicts, but how many of those work at restaurants?  Where exposed at restaurants? Note: 30 percent to 40 percent of the people impacted are NOT the homeless or drug addicts.

Hardly a day passes without a warning from a health department somewhere that an infected food handler is the source of yet another potential hepatitis A outbreak.

Absent vaccinations of food handlers, combined with an effective and rigorous hand-washing policy, there will continue to be more hepatitis A outbreaks. It is time for health departments across the country to require vaccinations of food-service workers, especially those who serve the very young and the elderly.

Hepatitis A is a communicable disease that spreads from person-to-person. It is spread almost exclusively through fecal-oral contact, generally from person-to-person, or via contaminated food or water. Hepatitis A is the only foodborne illness that is vaccine preventable. According to the U.S. Centers for Disease Control and Prevention (CDC), since the inception of the vaccine, rates of infection have declined 92 percent.

CDC estimates that 83,000 cases of hepatitis A occur in the United States every year and that many of these cases are related to foodborne transmission. In 1999, more than 10,000 people were hospitalized due to hepatitis A infections, and 83 people died. In 2003, 650 people became sickened, four died, and nearly 10,000 people got IG (immunoglobulin) shots after eating at a Pennsylvania restaurant. Not only do customers get sick, but also businesses lose customers, or some simply go out of business.

Although CDC has not yet called for mandatory vaccination of food-service workers, it has repeatedly pointed out that the consumption of worker-contaminated food is a major cause of foodborne illness in the U.S.

Hepatitis A continues to be one of the most frequently reported, vaccine-preventable diseases in the U.S., despite FDA approval of hepatitis A vaccine in 1995. Widespread vaccination of appropriate susceptible populations would substantially lower disease incidence and potentially eliminate indigenous transmission of hepatitis A infections. Vaccinations cost about $50. The major economic reason that these preventive shots have not been used is because of the high turnover rate of food-service employees. Eating out becomes a whole lot less of a gamble if all food-service workers faced the same requirement.

According to the CDC, the costs associated with hepatitis A are substantial. Between 11 percent and 22 percent of persons who have hepatitis A are hospitalized. Adults who become ill lose an average of 27 days of work. Health departments incur substantial costs in providing post-exposure prophylaxis to an average of 11 contacts per case. Average costs (direct and indirect) of hepatitis A range from $1,817 to $2,459 per case for adults and from $433 to $1,492 per case for children younger than 18. In 1989, the estimated annual direct and indirect costs of hepatitis A in the U.S. were more than $200 million, equivalent to more than $300 million in 1997 dollars.  A new CDC report shows that, in 2010, slightly more than 10 percent of people between the ages of 19 and 49 got a hepatitis A shot.

Vaccinating an employee make sense.  It is moral to protect customers from an illness that can cause serious illness and death. Vaccines also protect the business from the multi-million-dollar fallout that can come if people become ill or if thousands are forced to stand in line to be vaccinated to prevent a more serious problem.

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Publisher’s Platform: It is past time to vaccinate food service workers against Hep A

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The CDC has been reporting on an ongoing person to person outbreak of Hepatitis A for years. Since the outbreaks were first identified in 2016, 37 states have publicly reported the following as of October 6, 2023:

            •           Cases: 44,915

            •           Hospitalizations: 27,445 (61%)

            •           Deaths: 423

Now, the CDC has just reported : Preventable Deaths During Widespread Community Hepatitis A Outbreaks — United States, 2016–2022

Hardly a week goes by that there is not yet another announcement of a hepatitis A positive employee putting co-workers, customers and the restaurant brand at risk. There have been illnesses, deaths, thousands of customers have had to stand in long lines to get preventative vaccines, some restaurants have shuttered and there certainly have been lawsuits.

All preventable by a hepatitis A vaccination – the only foodborne illness that is vaccine preventable.

It really is past time for public health to recommend the same. Here is what I have asked the CDC for:

ACIP Secretariat
Advisory Committee on Immunization Practices 
1600 Clifton Road, N.E., Mailstop H24-8
Atlanta, GA 30329-4027
acip@cdc.gov

Re:  Letter to the CDC’s Committee on Immunization Practices – It is time to deal with Hepatitis A and Food Service Workers

Dear ACIP Secretariat:

The Advisory Committee on Immunization Practices (ACIP) provides advice and guidance to the Director of the CDC regarding use of vaccines and related agents for control of vaccine-preventable diseases in the civilian population of the United States. Recommendations made by the ACIP are reviewed by the CDC Director and, if adopted, are published as official CDC/HHS recommendations in the Morbidity and Mortality Weekly Report (MMWR).

Presently, approximately 5% of all hepatitis A outbreaks are linked to infected food-handlers.

Here is what the CDC continues to say about vaccinating food-handlers:

Why does CDC not recommend all food handlers be vaccinated if an infected food handler can spread disease during outbreaks?

CDC does not recommend vaccinating all food handlers because doing so would not prevent or stop the ongoing outbreaks primarily affecting individuals who report using or injecting drugs and people experiencing homelessness. Food handlers are not at increased risk for hepatitis A because of their occupation. During ongoing outbreaks, transmission from food handlers to restaurant patrons has been extremely rare because standard sanitation practices of food handlers help prevent the spread of the virus. Individuals who live in a household with an infected person or who participate in risk behaviors previously described are at greater risk for hepatitis A infection.

The CDC misses the point; granted, food service workers are not more at risk of getting hepatitis A because of their occupation, but they are a risk for spreading it to customers. Food service positions are typically low paying, and certainly have the likelihood of being filled by people who are immigrants from countries where hepatitis A might be endemic or by people who have been recently experienced homelessness.

Over the past several years, there has been an ongoing outbreak of hepatitis A in the United States. As of February 2, 2023, there have been a total of 44,779 cases with a 61% hospitalization rate (approximately 27,342 hospitalizations). The death toll stands at 421. Since the outbreak started in 2016, 37 states have reported cases to the CDC.

The CDC recommends to the public that the best way to prevent hepatitis A is through vaccination, but the CDC has not explicitly stated that food service workers should be administered the vaccination. While food service workers are not traditionally designated as having an increased risk of hepatitis A transmission, they are not free from risk. 

24% of hepatitis A cases are asymptomatic, which means a food-handler carrying the virus can unknowingly transmit the disease to consumers. Historically, when an outbreak occurs, local health departments start administering the vaccine for free or at a reduced cost. The funding from these vaccinations is through taxpayer dollars. 

A mandatory vaccination policy for all food service workers was shown to be effective at reducing infections and economic burden in St. Louis County, Missouri.

From 1996 to 2003, Clark Country, Nevada had 1,523 confirmed cases of hepatitis A, which was higher than the national average. Due to these alarming rates, Clark County implemented a mandatory vaccination policy for food service workers. As a result, in 2000, the hepatitis A rates significantly dropped and reached historic lows in 2010. The county removed the mandatory vaccine rule in 2012 and are now part of the ongoing hepatitis A outbreak. 

According to the CDC, the vaccinations cost anywhere from $30 to $120 to administer, compared to thousands of dollars in hospital bills, and offer a 95% efficacy rate after the first dose and a 99% efficacy after the second dose. Furthermore, the vaccine retains its efficacy for 15-20 years.  

During an outbreak, if a food service worker is found to be hepatitis A positive, a local health department will initiate post-exposure treatment plans that must be administered within a two-week period to be effective. The economic burden also affects the health department in terms of personnel and other limited resources. Sometimes, the interventions implemented by the local health department may be ineffective. 

Though there are many examples of point-source outbreaks of hepatitis A that have occurred within the past few years around the country, a particularly egregious outbreak occurred in the early fall of 2021 in Roanoke, Virginia. The health department was notified about the outbreak on September 21, 2021, after the first case was reported by a local hospital. The Roanoke Health Department, along with the Virginia Department of Health, investigated this outbreak.

Three different locations of a local restaurant, Famous Anthony’s, were ultimately determined to be associated with this outbreak. The Virginia Department of Health published a community announcement on September 24, 2021, about the outbreak and the potential exposure risk. 

For purposes of the investigation, a case was defined as a “[p]erson with (a) discrete onset of symptoms and (b) jaundice or elevated serum aminotransferase levels and (c) [who] tested positive for hepatitis A (IgM anti-HAV-positive), and frequented any of three Famous Anthony’s locations, or was a close contact to the index case patient, during the dates of August 10 through August 27, 2021.”

As of November 2021, a total of 49 primary cases (40 confirmed and 9 probable) were identified in this outbreak. Two secondary cases were also identified. Cases ranged from 30 to 82 years of age (median age of 63). In all, 57 percent of cases were male. Thirty-one cases included hospitalizations, and at least 4 case patients died. Illness onsets occurred between August 25 and October 15, 2021.

Ultimately, the outbreak investigation revealed that a cook, who also had risk factors associated with hepatitis A, had been infected with hepatitis A while working at multiple Famous Anthony’s restaurant locations. This index case’s mother and adult son also tested positive for hepatitis A. Following an inspection, the outbreak inspector noted, “due to the etiology of hepatitis A transmission, it is assumed the infectious food handler did not perform proper hand washing or follow glove use policy.” It was determined that person-to-person spread was the most likely mode of transmission in this outbreak. Environmental contamination was also considered a possible mode of transmission. 

Overwhelmed by the number of victims who pursued legal action for their injuries, Famous Anthony’s filed for bankruptcy and several of its locations have been closed.

The tragedy of this preventable hepatitis A outbreak cannot be overstated. Four people died. In one family, two of its members lost their lives. Most of the victims were hospitalized. Many risked acute liver failures. At least one person required both a liver and kidney transplants. Medical bills for the victims totaled over $6,000,000 in acute costs with millions of dollars in future expenses. And this all because one employee did not receive a $30-$120 hepatitis A vaccine.

Affordable prevention of future tragedies like the Famous Anthony’s outbreak is possible and necessary. The time has come to at least recommend vaccinations to food service workers to reduce the spread of hepatitis A.

Sincerely, 
Bill Marler
On behalf of 31 hepatitis A victims and families

1 Privately, via mail, I am providing medical summaries for 31 of the victims so there can be a clear assessment of the impacts of hepatitis A on consumers of food at the hands of one unvaccinated food service worker.


Publisher’s Platform: Hepatitis A outbreaks have sickened tens of thousands and killed 424; all preventable by a vaccine

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— OPINION —

Since the outbreaks were first identified in 2016, 37 states have publicly reported the following as of January 12, 2024:

  • Cases: 44,947
  • Hospitalizations: 27,469 (61%)
  • Deaths: 424

Hardly a week goes by that there is not yet another announcement of a hepatitis A positive employee putting co-workers, customers and the restaurant brand at risk. There have been illnesses, deaths, thousands of customers have had to stand in long lines to get preventative vaccines, some restaurants have shuttered and there certainly have been lawsuits.

All preventable by a hepatitis A vaccination – the only foodborne illness that is vaccine preventable.

It really is past time for public health to recommend the same. Here is what I have asked the CDC for:

ACIP Secretariat
Advisory Committee on Immunization Practices 
1600 Clifton Road, N.E., Mailstop H24-8
Atlanta, GA 30329-4027
acip@cdc.gov

Re:  Letter to the CDC’s Committee on Immunization Practices – It is time to deal with Hepatitis A and Food Service Workers

Dear ACIP Secretariat:

The Advisory Committee on Immunization Practices (ACIP) provides advice and guidance to the Director of the CDC regarding use of vaccines and related agents for control of vaccine-preventable diseases in the civilian population of the United States. Recommendations made by the ACIP are reviewed by the CDC Director and, if adopted, are published as official CDC/HHS recommendations in the Morbidity and Mortality Weekly Report (MMWR).

Presently, approximately 5% of all hepatitis A outbreaks are linked to infected food-handlers.

Here is what the CDC continues to say about vaccinating food-handlers:

Why does CDC not recommend all food handlers be vaccinated if an infected food handler can spread disease during outbreaks?

CDC does not recommend vaccinating all food handlers because doing so would not prevent or stop the ongoing outbreaks primarily affecting individuals who report using or injecting drugs and people experiencing homelessness. Food handlers are not at increased risk for hepatitis A because of their occupation. During ongoing outbreaks, transmission from food handlers to restaurant patrons has been extremely rare because standard sanitation practices of food handlers help prevent the spread of the virus. Individuals who live in a household with an infected person or who participate in risk behaviors previously described are at greater risk for hepatitis A infection.

The CDC misses the point; granted, food service workers are not more at risk of getting hepatitis A because of their occupation, but they are a risk for spreading it to customers. Food service positions are typically low paying, and certainly have the likelihood of being filled by people who are immigrants from countries where hepatitis A might be endemic or by people who have been recently experienced homelessness.

Over the past several years, there has been an ongoing outbreak of hepatitis A in the United States. As of February 2, 2023, there have been a total of 44,779 cases with a 61% hospitalization rate (approximately 27,342 hospitalizations). The death toll stands at 421. Since the outbreak started in 2016, 37 states have reported cases to the CDC.

The CDC recommends to the public that the best way to prevent hepatitis A is through vaccination, but the CDC has not explicitly stated that food service workers should be administered the vaccination. While food service workers are not traditionally designated as having an increased risk of hepatitis A transmission, they are not free from risk. 

24% of hepatitis A cases are asymptomatic, which means a food-handler carrying the virus can unknowingly transmit the disease to consumers. Historically, when an outbreak occurs, local health departments start administering the vaccine for free or at a reduced cost. The funding from these vaccinations is through taxpayer dollars. 

A mandatory vaccination policy for all food service workers was shown to be effective at reducing infections and economic burden in St. Louis County, Missouri.

From 1996 to 2003, Clark Country, Nevada had 1,523 confirmed cases of hepatitis A, which was higher than the national average. Due to these alarming rates, Clark County implemented a mandatory vaccination policy for food service workers. As a result, in 2000, the hepatitis A rates significantly dropped and reached historic lows in 2010. The county removed the mandatory vaccine rule in 2012 and are now part of the ongoing hepatitis A outbreak. 

According to the CDC, the vaccinations cost anywhere from $30 to $120 to administer, compared to thousands of dollars in hospital bills, and offer a 95% efficacy rate after the first dose and a 99% efficacy after the second dose. Furthermore, the vaccine retains its efficacy for 15-20 years.  

During an outbreak, if a food service worker is found to be hepatitis A positive, a local health department will initiate post-exposure treatment plans that must be administered within a two-week period to be effective. The economic burden also affects the health department in terms of personnel and other limited resources. Sometimes, the interventions implemented by the local health department may be ineffective. 

Though there are many examples of point-source outbreaks of hepatitis A that have occurred within the past few years around the country, a particularly egregious outbreak occurred in the early fall of 2021 in Roanoke, Virginia. The health department was notified about the outbreak on September 21, 2021, after the first case was reported by a local hospital. The Roanoke Health Department, along with the Virginia Department of Health, investigated this outbreak.

Three different locations of a local restaurant, Famous Anthony’s, were ultimately determined to be associated with this outbreak. The Virginia Department of Health published a community announcement on September 24, 2021, about the outbreak and the potential exposure risk. 

For purposes of the investigation, a case was defined as a “[p]erson with (a) discrete onset of symptoms and (b) jaundice or elevated serum aminotransferase levels and (c) [who] tested positive for hepatitis A (IgM anti-HAV-positive), and frequented any of three Famous Anthony’s locations, or was a close contact to the index case patient, during the dates of August 10 through August 27, 2021.”

As of November 2021, a total of 49 primary cases (40 confirmed and 9 probable) were identified in this outbreak. Two secondary cases were also identified. Cases ranged from 30 to 82 years of age (median age of 63). In all, 57 percent of cases were male. Thirty-one cases included hospitalizations, and at least 4 case patients died. Illness onsets occurred between August 25 and October 15, 2021.

Ultimately, the outbreak investigation revealed that a cook, who also had risk factors associated with hepatitis A, had been infected with hepatitis A while working at multiple Famous Anthony’s restaurant locations. This index case’s mother and adult son also tested positive for hepatitis A. Following an inspection, the outbreak inspector noted, “due to the etiology of hepatitis A transmission, it is assumed the infectious food handler did not perform proper hand washing or follow glove use policy.” It was determined that person-to-person spread was the most likely mode of transmission in this outbreak. Environmental contamination was also considered a possible mode of transmission. 

Overwhelmed by the number of victims who pursued legal action for their injuries, Famous Anthony’s filed for bankruptcy and several of its locations have been closed.

The tragedy of this preventable hepatitis A outbreak cannot be overstated. Four people died. In one family, two of its members lost their lives. Most of the victims were hospitalized. Many risked acute liver failures. At least one person required both a liver and kidney transplants. Medical bills for the victims totaled over $6,000,000 in acute costs with millions of dollars in future expenses. And this all because one employee did not receive a $30-$120 hepatitis A vaccine.

Affordable prevention of future tragedies like the Famous Anthony’s outbreak is possible and necessary. The time has come to at least recommend vaccinations to food service workers to reduce the spread of hepatitis A.

Sincerely, 
Bill Marler
On behalf of 31 hepatitis A victims and families

1 Privately, via mail, I am providing medical summaries for 31 of the victims so there can be a clear assessment of the impacts of hepatitis A on consumers of food at the hands of one unvaccinated food service worker.





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