We are understandably focused on the recent hepatitis A outbreak linked to organic strawberries that has sickened at least 27 in the United States and Canada. However, in the United States we have had a nationwide hepatitis problem since 2016. Since the outbreaks were first identified in 2016, 37 states have publicly reported the following as of June 3, 2022

  • Cases: 44,301
  • Hospitalizations: 27,086 (61%)
  • Deaths: 421

According to the CDC, when hearing about hepatitis A, many people think about contaminated food and water. However, in the United States, hepatitis A is more commonly spread from person to person. Since March 2017, CDC’s Division of Viral Hepatitis (DVH) has been assisting multiple state and local health departments with hepatitis A outbreaks, spread through person-to-person contact.

The hepatitis A vaccine is the best way to prevent hepatitis A virus (HAV) infection

I was reminded about the below post when I saw this headline this morning; California pays out more than $4 million to settle lawsuit stemming from E. coli outbreak:

Bill Marler, a Seattle attorney with decades of experience in food safety law who has represented dozens of families with loved ones sickened by E. coli infections, said the settlements generally seemed reasonable based on an expected judgment of between $3 million and $5 million at trial for the Cabezuela case alone.

He said judgements can be much higher in situations where a person survives, but becomes irreparably injured. One recent case, he said, involved a young person who suffered a debilitating stroke after infection who will forever struggle with severe impairments.

“He can no longer walk, talk or feed himself but will likely have a 40- to 50-year life expectancy where he’s going to need round-the-clock care,” Marler said.

The 2022 fair starts Wednesday, and it is the first time since 2019 that the event will operate at full capacity after a very limited engagement in 2021 and pandemic cancellation in 2020.

Animal-related events remain on the docket this year, including daily pig races, cow and goat milking demonstrations, a horse show and the traditional Junior Livestock Show & Auction. According to a 35-page guide posted on the fair’s website, the auction runs from June 18 through June 26. Daily pen cleaning and immediate removal of sick animals are specifically called out in the guide, though common infection control measures, such as regular hand washing, are not.

No petting zoo or pony rides are listed in the fair’s online calendar this year, though it was not clear if the list is comprehensive. Those two locations were heavily scrutinized in 2019 after E. coli infections began to appear, though testing of animals in the fair’s petting zoo and pony rides came back negative. Testing of livestock was much less comprehensive because most animals had already left the event by the time it became clear that an outbreak was underway.

Walls and pens used by livestock were swabbed and tested, with none of 32 environmental samples confirming the presence of the particular type of E. coli present in those who became ill.

Marler, the Seattle attorney specializing in food safety, said that eliminating petting zoos is common after lawyers with organizations come to understand potential risks and the court settlements they may cause.

Cattle are the main known reservoir of the type of E. coli that caused the 2019 outbreak, according to an exhaustive analysis from the University of Wisconsin-Madison. The virus generally appears in a cow’s droppings, which can easily end up mixed with dirt, mud and even dust that is part of or close to animal living quarters.

Marler said families would do well to keep this in mind when entering livestock barns where cattle and other types of animals are housed, making sure to keep all food consumption separate. Given that it only takes a microscopic amount of bacteria to cause a deadly infection, and the fact that some outbreaks have been linked to bacteria carried in dust that can blow around in a breeze, it just does not make sense to be eating while passing through these spaces.

“Eat your cotton candy, eat your ice cream cone, your hamburger, everything, outside,” Marler said. “That way, you’re not mixing potential contamination with the main path that a pathogen takes to get into your body.”

Kids of all ages, but especially the young ones, he added, should be kept from touching animals and from putting their hands in their mouths while inside livestock barns and should have their hands washed after exiting. Parents should also, he added, remember that the ground they are pushing their strollers across could have trace amounts of bacteria-carrying material present, so should put away items such as pacifiers and bottles when in these areas.

And some habits that generally cause zero consequences should be set aside in places where animals live.

“When your kid drops his binky on the ground, the first one, you might sanitize it, but if it’s your third kid, you might just wipe it on your jeans and give it back to them,” Marler said. “There are reasonable precautions that parents should take in order to protect their kids.”

This morning I read that 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 reported four confirmed pediatric cases of Shiga-toxin-producing E. coli linked to contact with the animals.

It all brought back memories of another tragedy that happened almost four years ago across the country.

In September 2015 two children, Myles Herschaft and Colton Guay, were diagnosed with E. coli O111. The incubation period (i.e., the time between exposure to a bacteria and onset of symptoms) for Shiga toxin E. coli averages 2 to 5 days, (range 1 to 10 days). Colton Guay attended the Oxford Fair on September 16 and on September 19. He experienced symptom onset on September 25, developed hemolytic uremic syndrome and died. Myles Herschaft attended the fair on September 18 and experienced symptom onset on September 25 and developed hemolytic uremic syndrome but survived after weeks in kidney dialysis

Genetic testing showed that Myles Herschaft and Colton Guay were infected with an indistinguishable strain of E. coli O111 identified as PulseNet Pattern Identification Numbers XDX01.1540/EXDA26.1144. There were no other patients infected with this genetic strain occurring temporally in the United States. Given the rarity of strain XDX01.1540/EXDA26.1144, Myles Herschaft and Colton Guay shared a common exposure to this specific strain. Public health investigators identified two potential exposures, consumption of green grapes and attending the Oxford County Fair. Investigators ruled out green grapes as a source of infection after learning the grapes were prepackaged and distributed nationally. E. coli O111 was not found when samples were collected 18 days after the fair had ended and the grounds had been cleaned. It is noteworthy, however, that a different Shiga toxin E. coli, E. coli O100 was found in an environmental sample. There was no testing of animals that were exhibited at the Oxford County Fair.

Transmission of STEC from animal areas of fairgrounds is a well-known risk factor and multiple outbreaks have occurred in the US over the past 10 years – see www.fair-safety.com. Exposure to petting zoo animals and the petting zoo environment at the Oxford County Fair was the only plausible exposure to explain how Colton Guay and Myles Herschaft acquired their genetically indistinguishable E. coli O111 infections.

Drs. John Dunn and Kirk Smith were uniquely qualified to assess the facts of this case and acted as experts for the families of Myles Herschaft and Colton Guay. Co-authors of the “Compendium of Measures to Prevent Disease Associated with Animals in Public Settings, 2013” published by the National Association of State Public Health Veterinarians and the CDC, Dr. Dunn and Dr. Smith reviewed ME CDC outbreak investigation documents. Independently they reached the same conclusion that Colton Quay and Myles Herschaft became ill with STEC O111 as a result of attending the Oxford County Fair.

Dr. Smith opined that the source of the E. coli O111 infections experienced by Myles Herschaft and Colton Quay was more likely than not the Oxford County Fair. Dr. Smith also opined that the Fair did not implement at least several critical prevention measures recommended in long-standing, widely available, national recommendations to prevent illness in visitors to public animal contact venues. He asserted that had these critical recommendations been implemented at the Fair, more likely than not the boys’ infections would have been avoided.

Dr. Dunn concured stating that with regard to the outbreak of STEC O111 and subsequent HUS affecting Colton Guay and Myles Herschaft, “…with a reasonable degree of epidemiological certainty it is more likely than not that transmission occurred at the Oxford County Fair petting zoo.”  He noted that information about measures taken to prevent disease transmission to fairgoers was limited but wrote that “applicable recommendations from the Compendium were not implemented or implementation was not clearly evident in the materials” he reviewed. He stated that in his opinion “to a reasonable degree of epidemiologic certainty, had the recommendations from the Compendium been implemented, it is more likely than not that the risk of STEC O111 infection for Colton Guay and Myles Herschaft would have been minimized and potentially prevented.”

Marler Clark represented both of the children affected by the outbreak, achieving settlements for both families.

Bill Marler has been involved in numerous E. coli outbreaks linked to petting zoos:

I have spoken on the risks posed by petting zoos since the early 2000’s:

2005 washington fair assoc from Bill Marler

The risk of transmission in exhibition settings of zoonotic diseases in general and E. coli O157:H7 in particular is not – or should not be – news. A survey as far back as 2003 of the literature, including CDC’s Morbidity and Mortality Weekly Report (MMWR), revealed at least 23 outbreaks of zoonotic disease, including illnesses from E. coli O157:H7, associated with animal exhibitions in the United Kingdom and the United States. These prior outbreaks included an E. coli O157:H7 outbreak associated with a county fair in Medina, Ohio, in August, 2000; two E. coli O157:H7 outbreaks in Pennsylvania in 2000 and 2001 associated with farm animals; 92 E. coli O157:H7 cases associated with the Wyandot County Fair in Ohio in September 2001; and the largest E. coli O157:H7 outbreak in Oregon history at the Lane County Fair in September 2002. And, over the last decade there is not a year that has gone by that many other outbreaks have left hundreds and hundreds sickened.

In addition, research has shown that E. coli O157:H7 is prevalent even among the prize livestock exhibited at agricultural fairs. A 2003 study on the prevalence of E. coli O157: H7 in livestock at 29 county and three large state agricultural fairs in the United States found that E. coli O157:H7 could be isolated from 13.8 percent of beef cattle, 5.9 percent of dairy cattle, 3.6 percent of pigs, 5.2 percent of sheep, and 2.8 percent of goats. Over 7 percent of pest-fly pools also tested positive for E. coli O157:H7.

Against this backdrop, the CDC published recommendations for reducing the risk that enteric pathogens will be transmitted at petting zoos, open farms, and animal exhibits. The most updated version of these recommendations can be found on CDC’s MMWR Web site. These recommendations arise out of several documented outbreaks in which enteric pathogens were passed to humans in such settings. Draft recommendations were published in MMWR on April 20, 2001; readers were invited to submit comments and suggestions; and the final recommendations were posted on the Internet on October 26, 2001. The recommendations encapsulated on the CDC Web site and in MMWR were created by the National Association of State Public Health Veterinarians (NASPHN). Many of the recommendations are common sense and most, if not all were likely ignored by those involved with the Milk Maker’s Fest:

Venue operators should take the following steps:

  • Become familiar with and implement the recommendations in this compendium.
  • Consult with veterinarians, state and local agencies, and cooperative extension personnel on implementation of the recommendations.
  • Become knowledgeable about the risks for disease and injury associated with animals and be able to explain risk-reduction measures to staff members and visitors.
  • Be aware that direct contact with some animals is inappropriate in public settings, and this should be evaluated separately for different audiences.
  • Develop or obtain training and educational materials and train staff members.
  • Ensure that visitors receive educational messages before they enter the exhibit, including information that animals can cause injuries or carry organ- isms that can cause serious illness.
  • Provide information in a simple and easy-to-under- stand format that is age and language appropriate.
  • Provide information in multiple formats (eg, signs, stickers, handouts, and verbal information) and languages.
  • Provide information to persons arranging school field trips or classroom exhibits so that they can educate participants and parents before the visit.

Venue staff members should take the following steps:

  • Become knowledgeable about the risks for dis- ease and injury associated with animals and be able to explain risk-reduction recommendations to visitors.
  • Ensure that visitors receive educational messages regarding risks and prevention measures.
  • Encourage compliance by the public with risk- reduction recommendations, especially compliance with hand-washing procedures as visitors exit animal areas.

Recommendations for nonanimal areas are as follows:

  • Do not permit animals, except for service animals, in nonanimal areas.
  • Store, prepare, serve, or consume food and beverages only in nonanimal areas.
  • Provide hand-washing facilities and display hand- washing signs where food or beverages are served.
  • Entrance transition areas should be designed to facilitate education.
  • Post signs or otherwise notify visitors that they are entering an animal area and that there are risks associated with animal contact.
  • Instruct visitors not to eat, drink, smoke, and place their hands in their mouth, or use bottles or pacifiers while in the animal area.
  • Establish storage or holding areas for strollers and related items (eg, wagons and diaper bags).
  • Control visitor traffic to prevent overcrowding.
  • Exit transition areas should be designed to facilitate hand washing.
  • Post signs or otherwise instruct visitors to wash their hands when leaving the animal area.
  • Provide accessible hand-washing stations for all visitors, including children and persons with disabilities. Position venue staff members near exits to encourage compliance with proper hand washing.

Recommendations for animal areas are as follows:

  • Do not allow consumption of food and beverages in these areas.
  • Do not allow toys, pacifiers, spill-proof cups, baby bottles, strollers, or similar items to enter the area.
  • Prohibit smoking and other tobacco product use.
  • Supervise children closely to discourage hand-to- mouth activities (eg, nail biting and thumb sucking), contact with manure, and contact with soiled bedding. Children should not be allowed to sit or play on the ground in animal areas. If hands become soiled, supervise hand washing immediately.
  • Ensure that regular animal feed and water are not accessible to the public.
  • Allow the public to feed animals only if contact with animals is controlled (eg, with barriers).
  • Do not provide animal feed in containers that can be eaten by humans (eg, ice cream cones) to decrease the risk of children eating food that has come into contact with animals.
  • Promptly remove manure and soiled animal bedding from these areas.
  • Assign trained staff members to encourage appropriate human-animal interactions, identify and reduce potential risks for patrons, and process reports of injuries and exposures.
  • Store animal waste and specific tools for waste removal (eg, shovels and pitchforks) in designated areas that are restricted from public access.
  • Avoid transporting manure and soiled bedding through nonanimal areas or transition areas. If this is unavoidable, take precautions to prevent spillage.
  • Where feasible, disinfect the area (eg, flooring and railings) at least once daily.
  • Provide adequate ventilation both for animals and humans.
  • Minimize the use of animal areas for public activities (eg, weddings and dances). • If areas previously used for animals must be used for public events, they should be cleaned and disinfected, particularly if food and beverages are served.

In addition, the Pennsylvania legislature enacted a law mandating standards for animal exhibition sanitation. The Pennsylvania law requires animal exhibit operators to “promote public awareness of the risk of contracting a zoonotic disease” by posting notices. The law further requires adequate hand-cleansing facilities and prohibits the exhibition of any animal not properly cared for by a veterinarian.

Thus, even before the outbreaks in North Carolina and Florida in the fall and winter of 2004-2005, the risk of disease transmission and the means of reducing that risk were well known. This common knowledge forms the basis of legal liability for both the private and governmental entities that operate animal exhibitions. While laws vary from state to state, the liability of these entities to those sickened through exposure to animals on site would be based in the premises of both liability and negligence.

Under premises liability law, the entity or entities responsible for managing an animal exhibition have a duty of care to those it invites onto the premises. This duty includes the responsibility to adequately reduce risks the entity is or should be aware of. The duty also carries a responsibility to warn fairgoers of risks present at the exhibition.

The principles of negligence also revolve around the risks to fairgoers that animal exhibitors know of or reasonably should know of. To successfully bring a negligence claim, a sickened person would need to show that the actions of an animal exhibitor fell below a reasonable standard of care in the operation of the exhibit. Failing to implement the well-established recommendations of the CDC and NASPHV constitutes falling below that standard of care.

Both bases for liability on the part of animal exhibitors-premises liability and negligence-carry with them a burden of education on the part of the exhibitor. Because the law holds people to a standard of what they reasonably should know, ignorance of the risks involved is not an effective defense. The law thus provides no impetus to stray from the course of action that is best for both customers and exhibitors in the first place-recognizing the risk and taking steps to reduce it.

Following the E. coli O157:H7 outbreak in North Carolina, the Terry Sanford Institute of Public Policy at Duke University contracted with the North Carolina Department of Health and Human Services to develop recommendations on regulating petting zoos. The researchers concluded:

In response to the largest outbreak of Escherichia coli (E. coli) in North Carolina history, we recommend that the North Carolina Department of Health and Human Services (DHHS) issue guidelines and pursue legislation that will control public contact with animals, inform the public of risks related to animal contact, provide transition areas, regulate animal care, and license petting zoos.

The North Carolina Legislature subsequently adopted “Aedin’s Law,” named after a young child who was severely injured in the outbreak. According to the preamble of the bill, the child was hospitalized for 36 days and will suffer lifelong injury from complications of HUS. Aedin’s Law requires that animal exhibitors acquire a public permit. The bill further requires the North Carolina State Board of Agriculture to adopt regulations in line with those of the Duke University study and CDC.

There are benefits to continuing the tradition of animal exhibits – it is a recreational and educational link to our country’s ongoing agricultural heritage. Slowly heeding the hard lessons learned, private, public, and legal forces are at work to reduce the risks associated with this pastime. Animal exhibitors are unwise to view these changes as a threat, or those working for change as enemies. Likewise, it is shortsighted to resist the recommendations and guidelines offered to make the animal exhibits safer. The long-term existence of animal exhibits to the public cannot be assured in an environment that permits the possibility of large-scale, life-threatening disease outbreaks like those that occurred in North Carolina and Florida. And, the best way to keep the lawyers out of it is to keep the children safe.

References

  1. See E. coli O157:H7 outbreak in Whatcom County, Washington Final Investigation Summary – http://wa-whatcomcounty.civicplus.com/CivicSend/ViewMessage/Message?id=5760
  2. See http://www.fair-safety.com/fair-outbreaks.htm
  3. Keen, T.E. Wittum, J.R. Dunn, J.L. Bono, and M.E. Fontenot. 2003. “Occurrence of STEC O157, O111, and O26 in Livestock at Agricultural Fairs in the United States,” Proc. 5th Int. Symp. on Shiga Toxin-Producing Escherichia coli Infections, Edinburgh, UK 22 (2003) – http://www.ars.usda.gov/research/publications/Publications.htm?seq_no_115=144426
  4. National Association of State Public Health Veterinarians, Inc. (NASPHV). “Compendium of Measures to Prevent Disease Associated with Animals in Public Settings – http://nasphv.org/documentsCompendiumAnimals.html
  5. CDC, “Notice to Readers: Availability of Final Recommendations on Reducing the Risk for Transmission of Enteric Pathogens at Petting Zoos, Open Farms, Animal Exhibits, and Other Venues,” 50 MMWR Weekly, 928 (October 25, 2001) – http://www.cdc.gov/mmwr/preview/mmwrhtml/mm5042a6.htm
  6. Outbreak Response and Surveillance Unit, Recommendations: Farm Animal Contact, (Atlanta, CDC September 2002) – http://www.cdc.gov/foodborneoutbreaks/publication/recomm_farm_animal.htm
  7. See 3 Pa. C.S. [section]2501 et seq
  8. Dustyn Baker, Tugba Gurcanlar, Emily Hildebrand, Matthew Perault, & Kuang-zhen Wu, “E. coli Outbreak Creates Need for Government Regulation” (Terry Sanford Institute of Public Policy May 2005) – http://www.fair-safety.com/ecoli-public-policy.pdf
  9. See N.C. S. L. 2005-191
  10. Marler speech to Washington State Fair Association 2005 – http://www.slideshare.net/marlerclark/2005-washington-fair-assoc

Outbreak at a glance:

Six hundred and fifty probable cases of acute hepatitis of unknown aetiology in children have been reported to WHO from 33 countries in five WHO Regions between 5 April and 26 May 2022. The aetiology of this severe acute hepatitis remains unknown and under investigation; the cases are more clinically severe and a higher proportion develops acute liver failure compared with previous reports of acute hepatitis of unknown aetiology in children. It remains to be established whether and where the detected cases are above-expected baseline levels. WHO assesses the risk at the global level as moderate.

Outbreak description:

Following the WHO Multicountry Disease Outbreak News on Acute hepatitis of unknown aetiologypublished on 23 April 2022, there have been continuing reports of cases of acute hepatitis of unknown cause among young children.

As of 26 May 2022, 650 probable cases fitting the WHO case definition1 have been reported to WHO from 33 countries in five WHO Regions, with 99 additional cases pending classification. The majority of reported cases (n=374; 58%) are from the WHO European Region (22 countries), with 222 (34%) cases from the United Kingdom of Great Britiain and Northern Ireland alone. Probable cases and cases pending classification have also been reported from the Region of the Americas (n=240, including 216 cases in the United States of America), Western Pacific Region (n=34), the South-East Asia Region (n=14) and Eastern Mediterranean Region (n=5) (Figure 1, Table 1).

Figure 1. Distribution of probable cases of acute severe hepatitis of unknown aetiology in children by country, as of 26 May 2022 (n=650).

Table 1. Classification of reported probable cases per country since 1 October 2021, as of 26 May 2022.

Out of the 650 probable cases, at least 38 (6%) children have required transplants, and nine (1%) deaths have been reported to WHO.

According to the latest Joint Surveillance Report by the WHO Regional Office for Europe (EURO) and the European Centre for Disease Prevention and Control (ECDC) on cases from EU/EEA countries which have been reported through the European Surveillance System (TESSy), as of 20 May 2022:

  • Three quarters (75.4%) of cases are <5 years of age.
  • Of 156 cases with information on hospital admission, 22 (14.1%) were admitted to an intensive care unit. Of the 117 cases for which this information was available, 14 (12%) have received a liver transplant.
  • Overall, 181 cases were tested for adenovirus by any specimen type, of which 110 (60.8%) tested positive. The positivity rate was the highest in whole blood specimens (69.5%).
  • Of the 188 cases PCR tested for SARS-CoV-2, 23 (12.2%) tested positive. Serology results for SARS-CoV-2 were only available for 26 cases, of which 19 (73.1%) had a positive finding.
  • Of the 63 cases with data on COVID-19 vaccination, 53 (84.1%) were unvaccinated.
  • Most of the reported cases appear to be unrelated and extensive epidemiological investigations are underway to identify common exposures, risk factors or links between cases. Two pairs of cases have been reported as epidemiologically linked in Scotland, and linked cases have also been reported in the Netherlands.

Based on the working case definition for probable cases, laboratory testing has excluded hepatitis A-E viruses in these children. SARS-CoV-2 and/or adenovirus have been detected in a number of the cases, although the data reported to WHO are incomplete. The United Kingdom has recently observed an increase in adenovirus activity, which is co-circulating with SARS-CoV-2, though the role of these viruses in the pathogenesis is not yet clear.

Further detailed epidemiological, clinical, laboratory, histopathological and toxicological investigations of the possible cause(s) of these cases are underway by several national authorities, research networks and across different working groups in WHO and with partners. Additional investigations are also planned to ascertain whether and where the detected cases are above-expected baseline levels.

Public health response:

Clinical and public health incident responses have been activated across the affected regions to coordinate case finding with investigation into the cause of illness in these children.

Further investigations by various national authorities are ongoing to include more detailed exposure histories, toxicology testing, and additional virological/microbiological tests.

Additionally, a case-control study to establish the frequency of adenovirus detection in the cases hospitalised with acute hepatitis compared to those hospitalised for other reasons is underway in the United Kingdom. Research actions are also being coordinated across the WHO regions and with partners.

WHO continues to support sharing of information with professional networks and specialist liver units.

Guidance is being developed to support Member States with diagnostics, case investigation and reporting, clinical characterization and clinical management of acute liver failure in children.

The initial survey of paediatric and liver centres conducted mainly in Europe, has been expanded to establish whether the number of current cases of severe acute hepatitis of unknown aetiology in children is above background rates in multiple countries or only certain countries.

WHO risk assessment:

WHO assesses the risk at the global level as moderate considering that:

  • The aetiology of this severe acute hepatitis remains unknown and under investigation; the cases are more clinically severe and a higher proportion develops acute liver failure compared with previous reports of acute hepatitis of unknown aetiology in children;
  • Limited epidemiological, laboratory, histopathological and clinical information is currently available to WHO;
  • The actual number of cases may be underestimated in some settings, in part due to the limited surveillance capacity in place;
  • The source and mode of transmission of the potential aetiologic agent(s) has not yet been determined, and so the likelihood of further spread cannot  be fully assessed;
  • Although there are no available reports of healthcare-associated infections, human-to-human transmission cannot be ruled out as there have been a few reports of epidemiologically linked cases.

Adenovirus has been found in 75% of the cases tested in the United Kingdom, but the data for other countries are incomplete. Of the small number of samples that have so far been typed, a majority have been confirmed for Type 41 adenovirus (in the United Kingdom, in 27 of 35 cases with an available result). Adenovirus associated virus 2 (AAV-2) has also been detected in a small number of cases in the United Kingdom using meta-genomics in liver and blood samples. However, many of the remaining cases did not have appropriate samples taken, highlighting the importance of appropriate sampling (whole blood) to further characterize the type of adenovirus detected. Additionally, Type 41 adenovirus infection has not previously been linked to such a clinical presentation in otherwise healthy children.

While adenovirus is a plausible hypothesis as part of the pathogenesis mechanism, further investigations are ongoing for the causative agent; adenovirus infection (which generally causes mild self-limiting gastrointestinal or respiratory infections in young children) does not fully explain the more severe clinical picture observed with these cases. Factors such as increased susceptibility amongst young children following a lower level of circulation of adenovirus during the COVID-19 pandemic, the potential emergence of a novel adenovirus, SARS-CoV-2 co-infection or a complication of previous SARS-CoV-2 infection, leading to superantigen-mediated immune cell activation, proposed a causal mechanism of multisystem inflammatory syndrome in children need to be further investigated. Hypotheses related to side effects from COVID-19 vaccines are currently not supported as most of the affected children did not receive these vaccines. Other infectious and non-infectious explanations as independent or contributory factors need to be excluded to fully assess and manage the risk. It is important to note that the current apparent association identified with adenovirus could be an incidental finding due to enhanced laboratory testing in association with increased levels of community transmission of adenovirus. This will be further clarified with the expansion of adenovirus testing to other cases beyond Europe and the United States, and reporting of the findings from the UKHSA case-control study currently underway.

The absence of a confirmed aetiology poses additional challenges in some countries, including implementation of WHO’s case definition and further diagnostic exclusion, due to limited testing capacity, including for Hepatitis A-E viruses and adenovirus. The presence of cases of acute hepatitis in children cannot be ruled out in countries where cases have not been detected or reported yet, but it is unlikely that symptomatic and severely ill case patients requiring hospitalization would remain undetected.

WHO advice:

Member States are strongly encouraged to identify, investigate and report potential cases fitting the case definition above. Core epidemiological and risk factor information can be collected and submitted by Member States to WHO and partner agencies through agreed reporting mechanisms (e.g. IHR, the TESSy platform in the European Region, and others). WHO is developing a clinical case reporting form to support data collection through the existing WHO Global Clinical Data Platform.

Whole blood, serum, urine, stool, respiratory and liver biopsy (if available) samples should be undertaken for all cases meeting the case definition. Especially if testing capacity is limited to conduct a full investigation of the cause, facilities should collect and store samples for future testing, typing, and/or referral testing, as capacity limitations necessitate. WHO is developing interim guidance and establishing a network of regional and global referral labs to support Member States with laboratory testing.

Any epidemiological links between/among the cases might provide clues for tracking the source of illness. Temporal and geographical information of cases, as well as their contacts should be reviewed for potential risk factors. There is an urgent need to gather additional information to assess the potential role of infections, including current adenovirus and on current and past SARS-CoV-2 infection, as well as investigate other potential explanatory/contributing factors (either other infections, toxins, medications, or other underlying diseases.

For the prevention of adenovirus and other common infections, perform regular hand washing and respiratory hygiene.

Until more is known, general infection prevention and control practices include:

  • Perform frequent hand hygiene, using soap and water or an alcohol-based hand-gel
  • Avoid crowded spaces and maintain a distance from others
  • Ensure good ventilation when indoors
  • Wear a well-fitted mask covering your mouth and nose when recommended
  • Cover coughs and sneezes
  • Use safe water for drinking
  • Follow safe food handling and cooking practices
  • Regular cleaning of surfaces you frequently touch with your hands
  • Stay home when unwell and seek medical attention
  • Health facilities should adhere to standard precautions and implement contact and droplet precautions for suspected or probable cases.

In children with acute hepatitis, the main concern is to identify cases early to ensure optimal case management and to determine the cause, since management and control measures and capacities will depend on the specific causative agent.  While most countries have the capacity for medical treatment of acute hepatitis, this is not true for liver transplantation capacity or for intensive support and care for liver failure.

As of 04/05/2022, 56 confirmed cases have been identified, of which 54 are linked to STEC O26 strains, and 2 to STEC O103 strains.

These 56 cases occurred in 55 children and 1 adult, who presented symptoms between 18/01/2022 (week 3) and 05/04/2022 (week 14) (Figure 1). The epidemic peak is in week 7 (14/02 to 20/02) and week 9 (28/02 to 06/03), with 10 cases each of these weeks.

These 56 cases occurred in 12 regions of metropolitan France: Hauts-de-France (12 cases), Ile-de-France (9 cases), New Aquitaine (8 cases), Pays de la Loire (7 cases), Brittany ( 6 cases), Grand Est (3 cases), Provence-Alpes-Côte d’Azur (3 cases), Auvergne-Rhône-Alpes (2 cases), Occitanie (2 cases), Center Val-de-Loire (2 cases) , Bourgogne Franche-Comté (1 case) and Normandy (1 case) (Figure 2).

The 55 sick children are aged from 1 to 17 years with a median age of 6 years; 25 (45%) are female; 48 (87%) presented with HUS, 7 (13%) with STEC gastroenteritis. Two children died. The adult did not present with HUS.

The authorities point out that after consuming the products concerned by the recall, it is important to quickly consult a doctor by reporting this consumption if:

  • within 10 days, people have diarrhea, abdominal pain, or vomiting;
  • within 15 days, people show signs of great fatigue, pallor, a decrease in the volume of urine, which becomes darker.
  • In the absence of symptoms within 15 days of consumption, it is also reminded that there is no need to worry.

Given this situation, the authorities are asking people who hold Buitoni brand Fraîch’Up pizzas not to eat them and to destroy them . Each household is invited to ensure that its freezer does not contain any.

It is also recommended that people holding frozen pizzas in their freezer that have been separated from their box, and whose range and brand cannot be formally identified or clearly known, not to consume them and to destroy them.

As a precaution, the company proceeded on March 18 to withdraw and recall all pizzas from the Fraîch’Up range, Buitoni brand, marketed since June 2021. The authorities are fully mobilized to ensure the effectiveness of the withdrawal/recall measures implemented, in particular through more than 10,000 checks in the various distribution channels. Beyond the checks, if consumers find that Fraîch’Up pizzas from the Buitoni brand are still on the market, they are invited to file a report on the SignalConso platform .

As of 18 May 2022, 324 cases (266 confirmed and 58 probable) have been reported in the EU/EEA (Austria, Belgium, Denmark, France, Germany, Ireland, Italy, Luxembourg, Netherlands, Norway, Spain, Sweden) and the UK, including two distinct strains of monophasic S. Typhimurium. In addition, cases have been identified in Canada, Switzerland, and the United States.

Most infections (86.3%) are among children at or younger than 10 years old, and for all cases in the EU/EEA and the UK with information available, 41.3% of them have been hospitalised. No deaths were reported.

The two Salmonella strains are multidrug-resistant, and some tested isolates also carry resistance to disinfectants that are based on quaternary ammonium compounds and hydrogen peroxide, but remain susceptible to azithromycin, ciprofloxacin, meropenem, and third generation cephalosporins. Epidemiological and microbiological investigations have identified specific chocolate products manufactured in the processing Plant in Arlon, Belgium, as likely vehicles of infection.

The two outbreak strains of monophasic S. Typhimurium were identified in ten of 81 Salmonella positive samples taken in the plant between December 2021 and January 2022, including raw material (buttermilk), semi-finished and finished products. The buttermilk was provided by an Italian supplier where Salmonella was not detected. The Italian supplier has delivered the buttermilk also to other production plants of the company and based on the available evidence, Salmonella has not been detected in other plants.

The closure of the Belgian processing plant on 8 April 2022 and the global recall and withdrawal of all their products have reduced the risk of exposure, but new cases may occur due to the long shelf life and possible storage of products at home.

The public health impact of the rigorous control measures implemented can be reflected in the significant drop of reported cases between weeks 14 and 15 in April 2022. However, among 156 cases reported in this outbreak with available dates, the median delay between disease onset and notification to the national surveillance system was three weeks with a maximum of five weeks. It is also likely that cases in countries that have not reported cases may have remained undetected if cases were not sequenced routinely.

Finally, there are eight cases, which cannot be explained by consumption of chocolate products from the same processing plant in Belgium, suggesting that there may also be other sources of infection, albeit secondary infections, which cannot be excluded.

ECDC continues to monitor the situation and encourages Member States to be alert for new cases and investigate human infections with strains that have multi-drug resistance profiles. Further sequencing of such isolates is recommended, and ECDC offers sequencing support for countries with limited or no genome-sequencing capacity.

In addition, ECDC further encourages public health authorities to cooperate closely with food safety authorities in the countries affected.

Following the detections of Salmonella in buttermilk, semi-finished and finished products, the company implemented hygiene control measures and increased sampling and testing of the products and the processing environment. Batches of products were released to the market after negative results of Salmonella testing. The chocolate products have been distributed across Europe and globally.

In the beginning of April 2022, upon availability of sequencing data, scientists linked human cases to Belgian chocolate factory through advanced molecular typing techniques.

Since 2 April 2022, national competent authorities have begun to issue public health warnings. On 8 April 2022, the food safety authority in Belgium performed official controls at the factory and withdrew the company’s authorization for production. In addition, the company initiated recalls of all batches of products produced at the Arlon factory, regardless of their lot number or expiration date.

Full Report: 1st-update-ROA_monophasic-S-Typhimurium-ST34_May2022

International outbreak of salmonellosis in young children linked to the consumption of Kinder brand products. Update in France as of June 2, 2022.
Update on 06/02/22 following the recall of several Kinder range products manufactured in a factory in Belgium due to suspected contamination by Salmonella Typhimurium .

Non-typhoidal salmonellosis is an infectious disease caused by salmonella which infects the digestive tract. They are usually characterized by gastrointestinal disturbances.

Following the investigations carried out by the Belgian health authorities, together with their English, European and in particular French counterparts, the company Ferrero proceeded on April 5, 2022 to the recall of several Kinder range products manufactured in a factory in Belgium due to suspected contamination by Salmonella Typhimurium . On April 8, 2022, the recall finally affected all Kinder products from this factory, regardless of their expiry date. On April 14, 2022, an update of the recalled products, including the 2021 Christmas Advent Calendars, was released.

Case of salmonellosis in France: update on June 2, 2022

In total, as of 02/06/2022: 118 cases of salmonellosis with a strain belonging to the epidemic have been identified by the National Reference Center (CNR) for salmonella at the Institut Pasteur in France (figure 1) . Figure 1 – Epidemic curve: number of confirmed cases of salmonellosis caused by Salmonella Typhimurium, monophasic variant (cluster 1 HC5_296366 and cluster 2 HC5_298160), by week of isolation (with in red the week corresponding to the recall of products from the production plant) ‘Arlon in Belgium) – Metropolitan France, weeks 2 to 18, 2022 (N=118)


The 118 cases are spread over 12 metropolitan regions (Ile-de-France (24 cases), Grand-Est (19 cases), Auvergne-Rhône-Alpes (17 cases), Provence-Alpes-Côte d’Azur (17 cases) , Hauts-de-France (9 cases), Bourgogne-Franche-Comté (7 cases), Occitanie (7 cases), Normandy (6 cases), New Aquitaine (6 cases), Brittany (3 cases), Corsica (2 cases) and Pays de la Loire (1 case)) with a median age of 4 years, and concern 57 girls and 61 boys. Figure 2 – Geographical distribution of confirmed cases of salmonellosis due to Salmonella Typhimurium, monophasic variant (cluster 1 HC5_296366 and cluster 2 HC5_298160), by region of residence – metropolitan France, weeks 2 to 18, 2022.

Fifty-one cases were questioned by Public Health France. All the cases, except 1, report, before the onset of their symptoms (which occurred between 20/01 and 04/04/2022), the consumption of chocolates of the brand cited here.

Twenty-two people were hospitalized for their salmonellosis, all discharged since. No deaths were reported.

The foods in question having been identified and the management measures taken, the weekly situation updates are drawn up. Public Health France continues to monitor the reporting of cases by the NR, which are expected due to the different delays inherent in monitoring ( see the infographic dedicated to food alerts ).

The successive withdrawals and recalls of the Kinder brand products concerned, produced by the Belgian factory with its closure by the Belgian authorities, should limit the occurrence in France of new cases of salmonellosis in connection with these chocolates.

The possible identification of new cases with dates of isolation at a distance from the recall withdrawal measures will be the subject of investigations if necessary.

To find out the list of products concerned by the withdrawal-recall: https://rappel.conso.gouv.fr/

People who have consumed the products mentioned above and who present symptoms (gastrointestinal disorders, fever within 72 hours of consumption), are invited to consult their doctor without delay, notifying him of this consumption.

In order to limit person-to-person transmission (especially in households with young children), it is recommended to wash your hands well with soap and water after using the toilet, after changing your child, and before to cook.

Follow these steps:

  • Check if you have Jif peanut butter in your home.
  • Locate the lot code on the back of the jar, under the Best If Used By Date (the lot code may be next to the Best If Used By Date for cups or squeeze pouches).
  • In the lot code, if the first four digits are between 1274 and 2140, and if the next three numbers after that are ‘425’, this product has been recalled and you should not consume this product. An example is below.

As of May 21 2022, a total of 14 people infected with the outbreak strain of Salmonella Senftenberg have been reported from 12 states – Arkansas (1), Georgia (2), Illinois (1), Massachusetts (1), Missouri (1), Ohio (1), North Carolina (1), New York (1), South Carolina (1), Texas (2), Virginia  (1), and Washington (1).

FDA recommends that if you have used the recalled Jif brand peanut butter that have lot code numbers 1274425 through 2140425 and the first seven digits end with 425, you should wash and sanitize surfaces and utensils that could have touched the peanut butter. If you or someone in your household ate this peanut butter and have symptoms of salmonellosis, please contact your healthcare provider.

CDC, public health and regulatory officials in several states, and the U.S. Food and Drug Administration are investigating a multistate outbreak of hepatitis A potentially linked to contaminated fresh organic strawberries reportedly sold as FreshKampo or HEB, purchased in the United States between March 5, 2022, and April 25, 2022. The Public Health Agency of Canada and the Canadian Food Inspection Agency are also investigating an outbreak of hepatitis A; imported fresh organic strawberries have been identified as the likely source of that outbreak. Traceback investigations show that outbreak-associated cases in California, Minnesota, and Canada report having purchased fresh organic strawberries prior to becoming ill.  Complaint – ArthurBrown – Complaint 6.2.22 Final WDM – To Be Filed

As of May 31, 2022, in the United Sates, a total of 17 outbreak-associated cases of hepatitis A have been reported from 3 states.

Illnesses started on dates ranging from March 28, 2022, to April 30, 2022. Ill people range in age from 9 to 73 years, with a median age of 58. Seventy-one percent of ill people are female. Of 17 people with available information, 12 (71%) have been hospitalized. No deaths have been reported.

Epidemiologic and traceback evidence indicate that fresh organic strawberries are a likely source of this outbreak. The potentially affected FreshKampo and HEB products are past shelf life and no longer available for purchase in the United States. People who purchased FreshKampo or HEB fresh organic strawberries between March 5, 2022, and April 25, 2022 and then froze those strawberries for later consumption should not eat them. These products may have been sold at the following retailers, including, but not limited to: HEB, Kroger, Safeway, Sprouts Farmers Market, Trader Joe’s, Walmart, Weis Markets, and WinCo Foods.

In Canada, as of June 2, 2022, there are 10 laboratory-confirmed cases of hepatitis A illness being investigated in two provinces: Alberta (4) and Saskatchewan (6). Individuals became ill between early and mid April 2022. Individuals who became ill are between 10 to 75 years of age. Four individuals have been hospitalized. No deaths have been reported.

The CFIA is conducting a food safety investigation into the FreshKampo brand fresh organic strawberries purchased between March 5 and 9, 2022 at Co-op stores in Alberta and Saskatchewan. Currently, there are no food recall warnings associated with this outbreak.

In interviews, ill people answered questions about the foods they ate and other exposures in the 2 to 7 weeks before they became ill. Of people who were interviewed, 10/13 (77%) reported eating fresh organic strawberries. This proportion was significantly higher than results from a survey of healthy people in which 50% reported eating fresh strawberries in the week before they were interviewed.

Currently, the potentially affected FreshKampo and HEB products are past shelf life. People who purchased FreshKampo and HEB fresh organic strawberries between March 5, 2022, and April 25, 2022, and then froze those strawberries for later consumption should not eat them. These products were sold at the following retailers, including, but not limited to:

Aldi

HEB

Kroger

Safeway

Sprouts Farmers Market

Trader Joe’s

Walmart

Weis Markets

WinCo Foods

Canadian Co-op stores

Contact your healthcare provider if you think you may have symptoms of a hepatitis A infection after eating these fresh organic strawberries, or if you believe that you have eaten these strawberries in the last two weeks. If you have eaten these organic strawberries, purchased fresh and later frozen, or have symptoms consistent with hepatitis A, see your health care provider immediately. Vaccination can prevent a hepatitis A infection if given within 14 days of exposure. Symptoms of hepatitis A include:

fever

dark urine

loss of appetite

fatigue (tiredness)

nausea and vomiting

stomach cramps or abdominal pain

jaundice (yellowing of the skin and eyes)

After you have been exposed to hepatitis A, symptoms typically appear 14 to 28 days later, but may occur up to 50 days later.

Symptoms usually last less than two months. Mild symptoms may last only one or two weeks, while severe symptoms can last up to nine months.

Anyone can become ill with hepatitis A infection. Most people who become ill from a hepatitis A infection will recover fully, but the risk of serious complications increases with older age and in those with underlying liver disease.

It is possible for some people to be infected with hepatitis A and to not get ill or show any symptoms, but to still be able to spread the virus to others.

Wash and sanitize any drawers, shelves, or containers where the products were stored using a kitchen sanitizer (follow the directions on the container) or prepare a bleach solution in a labelled spray bottle (you can use a ratio of 5 ml of household bleach to 750 ml of water) and rinse with water.

Wash your hands before and after preparing or eating food, and after using the washroom or changing diapers.

If you have been diagnosed with hepatitis A, do not prepare or serve food and drinks to others.

Good on Public Health doing good public health.

WDBJ reports that the Virginia Department of Health is offering free Hepatitis A vaccines for restaurant workers.

The Roanoke City Alleghany Health District Director Dr. Cynthia Morrow, says that the Health District will host the vaccination clinic Monday, June 6 at the Williamson Road Branch Library from 11 a.m. until 3 p.m.

Appointments are first come, first served and appointments are preferred, according to the health district. Those who are interested can make an appointment by calling 540-613-6597.

The clinic comes after three local restaurants identified health care workers who were positive for Hepatitis A within the last several months.

Last week I posted: Publisher’s Platform: Please, Roanoke restaurants, whether it is for moral or business reasons, offer hepatitis A vaccinations to your employees.  Here is an offer you can’t refuse. No one took me up on the offer, but here is what I said:

In January of this year the owners of Roanoke’s Famous Anthony’s restaurant filed for bankruptcy for two of their restaurant locations after a hepatitis A outbreak originating from one of their food service workers killed four people, hospitalized 36, sickened 52, with one requiring a liver transplant, and on facing a liver transplant soon. The food service worker who worked at three locations – Grandin Road Extension, Williamson Road and Crystal Spring Avenue – tested positive for the hepatitis a virus and contaminated customers with this human fecal virus.

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

On May 24th, Roanoke health officials issued an alert following a report about an employee at a Star City restaurant being infected with hepatitis A. The Roanoke City and Alleghany Health Districts (RCHAD) said the report came in on Monday, May 23 involving an employee at Tuco’s Taqueria Garaje in the 400 block of Salem Avenue in Roanoke.  The RCHAD has offered, at taxpayers’ expense, hepatitis A vaccines to anyone who ate at Tuco’s Taqueria Garaje between May 3 and May 15.

This news comes about a week after the RCHAD announced a hepatitis A exposure at Luigi’s Restaurant in Roanoke. Once again, at taxpayer’s expense, the RCHAD offered hepatitis A vaccines to anyone who ate at Luigi’s between the dates of April 26 – May 17.

Hardly a week goes by in the United States 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 countless illnesses, deaths, thousands of customers who have had to stand in long lines to get preventative vaccines, and some restaurants have shuttered. There certainly have been lawsuits.

Over the last decades I have advocated for vaccinating food services workers primarily due to the tragic toll that it takes on customers and their families, but clearly sickening 52, hospitalizing 36 and killing 4 of your customers is bad for business.  And, in Roanoke, on top of the Famous Anthony’s tragedy, we now have hepatitis A scares at Tuco’s Taqueria Garaje and Luigi’s Restaurants.

One would think the Roanoke restaurants would see moral and business reasons to offer food service employees hepatitis A vaccinations.  Perhaps they need some encouragement. So, here is my offer – to every Roanoke restaurant that will offer hepatitis A vaccinations to all present and future employees – I will agree to consult with that restaurant for $1.00 and conflict Marler Clark from being on the opposite side of the courtroom.

This seems like an “offer you can’t refuse.”

Whether or not you take me up on my offer, consider offering to vaccinate your employees anyway – be a food safety leader.  In addition to being the right thing to do during a nation-wide outbreak of hepatitis A, it is good for your employees, your customers, your brand – and, for taking money out of my pocket.

Thanks Dr. Cynthia Morrow.

Report not to issue until 2023?  Hey, OIG, see below,  we need answers sooner and I will give you a head start.

HHS, OIG posted this morning:

The Federal Food, Drug, and Cosmetic Act requires the Food and Drug Administration (FDA) to safeguard the Nation’s food supply, including infant formula, and ensure that all ingredients are safe. As part of its oversight activities, FDA conducts inspections at infant formula manufacturers and can require infant formula manufacturers to recall adulterated infant formula that presents a risk to human health. We will determine whether FDA followed the inspections and recall process for infant formula in accordance with Federal requirements. Specifically, we will review FDA’s actions leading up to the infant formula recall at the Abbott facility in February 2022 to determine whether FDA followed applicable policies and procedures to: (1) conduct inspections of the manufacturing facility and (2) oversee Abbott’s initiation of the infant formula recall.

Announced or Revised Agency Title Component Report Number(s) Expected Issue Date (FY)
June 2022 Food and Drug Administration Food and Drug Administration’s Actions Regarding the Abbott Infant Formula Recall Office of Audit Services W-00-22-59472 2023

According to the CDC and FDA, at least 4 kids were sickened and of those two died, from drinking Abbott infant formula.  Abbott denies the connection.  However, the resulting investigation and inspection (and whistleblower documents) uncovered enough problems in the Abbott facility to shutter it causing havoc with supplies of infant formula.  The facility is now set to reopen, but not before the U.S. Attorney sued Abbott and several employees. In the complaint, filed by the U.S. Department of Justice on behalf of the FDA, the government alleges that powdered infant formula products manufactured at Abbott Nutrition’s Sturgis facility were adulterated because they were made under insanitary conditions and in violation of current good manufacturing practice requirements.

Abbott is essentially confessing to the violations in the below consent decree. Under the proposed consent decree, Abbott Nutrition will be required to retain an independent expert to review the Sturgis facility’s operations to ensure compliance with the law. It also includes requirements for testing products, as well as ceasing production, and promptly notifying the FDA should contamination be detected. The proposed consent decree also requires the implementation of a sanitation plan, environmental monitoring plan and employee training programs.

Here are the key documents:

Here is the 2019 inspection report at the plant – APPLIED – FOI II – Abbott Nutrition FEI# 1815692 EIR 9-24-2019

Here is the 2021 inspection report at the plant – APPLIED – FOI II – BR Abbott Nutritions- FEI# 1815692 9-2021 EIR.

Here are the whistleblower documents – Redacted Confidential Disclosure re Abbott Laboratories – 10-19-2021_Redacted (1)

Here is the 2022 inspection report at the plant – Updated Final Applied_Unapplied Redactions Abbott Nutrition Sturgis FEI 1815692 FDA 483 1-31022 to 3-16-22 – ISSUED_Redacted

Here is the complaint – abbott_complaint_0

Here is the consent decree – abbott_proposed_consent_decree_0

Please read the above and ask the question: is this how infant formula should have been manufactured?

So, what gives the government the right to charge a company and certain employees with either a felony or a misdemeanor?

Congress passed the Federal Food, Drug, and Cosmetic Act in 1938 in reaction to growing public safety demands.  The primary goal of the Act was to protect the health and safety of the public by preventing deleterious, adulterated or misbranded articles from entering interstate commerce.  Under section 402(a)(4) of the Act, a food product is deemed “adulterated” if the food was “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.” A food product is also considered “adulterated” if it bears or contains any poisonous or deleterious substance, which may render it injurious to health.  The 1938 Act, and the recently signed Food Safety Modernization Act, stand today as the primary means by which the federal government enforces food safety standards.

Chapter III of the Act addresses prohibited acts, subjecting violators to both civil and criminal liability. Provisions for criminal sanctions are clear:

Felony violations include adulterating or misbranding a food, drug, or device, and putting an adulterated or misbranded food, drug, or device into interstate commerce.  Any person who commits a prohibited act violates the FDCA.  A person committing a prohibited act “with the intent to defraud or mislead” is guilty of a felony punishable by years in jail and millions in fines or both.

A misdemeanor conviction under the FDCA, unlike a felony conviction, does not require proof of fraudulent intent, or even of knowing or willful conduct.  Rather, a person may be convicted if he or she held a position of responsibility or authority in a firm such that the person could have prevented the violation.  Convictions under the misdemeanor provisions are punishable by not more than one year or fined not more than $250,000, or both.

The legal jargon aside, if you are a producer of food and knowingly or not manufacturer and sell adulterated food, you can (and should) face fines and jail time.