I have the Honor to speak today at this conference.

It is our pleasure to invite you to a symposium sponsored by the University of Minnesota. There is no fee for this in-person symposium designed to bring together academia, veterinary science and research, public health, agriculture, and affiliated industry in Minnesota to discuss foodborne outbreaks of Salmonella. 

The goal of the symposium is to inform you with “behind the scenes” science and legal issues that occur during these outbreaks, to stimulate open discussion between groups from different backgrounds, and to promote future collaborative efforts between the different groups in attendance.

Our program features world-renowned experts on Salmonella biology, epidemiology, outbreak investigations, and food safety litigation. The program starts with a complimentary lunch, then takes a deep dive into the complex issues surrounding foodborne Salmonella from various perspectives. There will be opportunities for engagement and interaction with the audience and speakers, both during roundtable discussions and at the reception following our symposium.

Pseudomonas aeruginosa

This is frightening.

Pseudomonas aeruginosa is a bacteria that’s commonly found in the environment, for example in soil and water. It can be spread to people in health care settings through contaminated surfaces, hands, and equipment. It can cause serious infections in certain people. 

As of March 14, 2023, CDC, in partnership with state and local health departments, identified 68 patients in 16 states (CA, CO, CT, FL, IL, NC, NJ, NM, NY, NV, PA, SD, TX, UT, WA, WI) with VIM-GES-CRPA, a rare strain of extensively drug-resistant P. aeruginosa. Thirty-seven patients were linked to four healthcare facility clusters. Three people have died and there have been 8 reports of vision loss and 4 reports of enucleation (surgical removal of eyeball). Dates of specimen collection were from May 2022 to February 2023. Isolates have been identified from clinical cultures of sputum or bronchial wash (15), cornea (17), urine (10), other nonsterile sources (4), and blood (2), and from rectal swabs (26) collected for surveillance; some patients had specimens collected from more than one anatomic site.

Most patients reported using artificial tears. Patients reported over 10 different brands of artificial tears and some patients used multiple brands. EzriCare Artificial Tears, a preservative-free, over-the-counter product packaged in multidose bottles, was the brand most commonly reported. This was the only common artificial tears product identified across the four healthcare facility clusters. Laboratory testing by CDC identified the presence of VIM-GES-CRPA in opened EzriCare bottles from multiple lots; these bottles were collected from patients with and without eye infections and from two states. VIM-GES-CRPA recovered from opened products match the outbreak strain. Testing of unopened bottles of EzriCare Artificial Tears is ongoing to assist in evaluating for whether contamination may have occurred during manufacturing. Patients and healthcare providers should immediately stop the use of EzriCare Artificial Tears pending additional information and guidance from CDC and FDA.

Patients should stop using EzriCare or Delsam Pharma’s Artificial Tears pending additional information and guidance from CDC and FDA. If patients were advised to use EzriCare or Delsam Pharma’s Artificial Tears by their healthcare provider, they should follow up with their healthcare provider for recommendations about alternative treatment options.

Patients who have used EzriCare or Delsam Pharma’s artificial tears and who have signs or symptoms of an eye infection should seek medical care immediately. At this time, there is no recommendation for testing of patients who have used this product and who are not experiencing any signs or symptoms of infection.

Eye infection symptoms may include:

  • Yellow, green, or clear discharge from the eye
  • Eye pain or discomfort
  • Redness of the eye or eyelid
  • Feeling of something in your eye (foreign body sensation)
  • Increased sensitivity to light
  • Blurry vision

Another Hepatitis A outbreak appears to be brewing in the US linked to imported frozen strawberries. Here is a bit(e) of a compilation of past outbreaks.

Hepatitis A outbreaks associated with fresh, frozen, and minimally processed produce worldwide from 1983 to 2022—adapted and expanded from Sivapalasingam et al., 2004 and Fiore, 2004. Italics indicate instances where the food was locally sourced with respect to the cases. The implicated foods were raw unless listed otherwise.

Hepatitis A outbreaks associated with fresh, frozen, and minimally processed produce, worldwide, from 1983 to 2022

Year# CasesImplicated foodLocation of casesSource of implicated foodSuspected cause of contaminationReference
198324Raspberries (frozen)ScotlandScotlandInfected pickers or packersReid et al., 1987[1]
19875Raspberries (frozen)ScotlandTayside, ScotlandInfected pickers Ramsay and Upton, 1989[2]
1988202Iceberg lettuceKentuckyUnknown, suspected to be from MexicoBelieved to have occurred prior to distribution, since multiple restaurants involved Rosenblum et al., 1990[3]
199035 Strawberries (frozen)Montana, GeorgiaCaliforniaSuspect an infected picker at farmSivapalasingam et al., 2004;[4]Niu et al., 1992[5]
199630Salad ingredientsFinlandImported salad ingredientsUnknownPebody et al., 1998[6]
1997256Strawberries (frozen)Michigan, Maine, Wisconsin, Arizona, Louisiana, TennesseeGrown in Mexico,processed and frozen at a single California facility a year before consumption Inconclusive due to time between harvest and consumption, suspect barehanded contact with berries at harvesting, coupled with few latrines and handwashing facilities on siteHutin et al., 1999[7]
199843Green onionsOhioOne of two Mexican farms or a farm in CaliforniaBelieved to be contaminated before arrival at restaurantDentinger et al., 2001[8]
200031Green onions or tomatoesKentucky, FloridaGreen onions: California or MexicoTomatoes: UnknownUnknownWheeler et al., 2005[9]; Datta et al., 2001[10]; Fiore, 2004[11]
200281BlueberriesNew ZealandNew Zealand, one orchard Inadequate bathroom facilities in fields, workers had barehanded contact with product, polluted groundwater from nearby latrines a possibilityCalder et al., 2003[12]
2003601Green onions Pennsylvania, Tennessee, Georgia, North CarolinaMexico, two farmsContaminated during or before packing at farmCDC, 2003[13]; Wheeler et al., 2005[14]
2009562Tomatoes (semidried)AustraliaUnknown; imported and domestic product involvedProduct suspected to be imported due to concurrent outbreaks elsewhere at the time, source of contamination unknownDonnan et al., 2012[15]
200913Tomatoes (semidried)NetherlandsUnknown; imported product suspectedIdentical strain to the 2009 Australian outbreakPetrignani et al., 2010[16]
201059Tomatoes (semidried)FranceLikely Turkey, single batch of productUnable to determine when and where contamination occurred. Virus was slightly different from one in the 2009 Australian and Dutch outbreaks. Gallot et al., 2011[17]
2012 9Pomegranate seeds (frozen)CanadaEgyptSuspect product contamination before export. Some history of travel to endemic areas among workers at Canadian processing facility, but less likely as only one product was associated with illness.CDC 2013[18]; Swinkels et al., 2014[19]
2013 103 Strawberries (frozen)Other frozen berries may have been involvedDenmark, Finland, Norway, SwedenSuspected Egypt and Morocco based on virus strain and import historyUnknown, some cases matched the strain of the larger 2013 European outbreak (see below)Nordic Outbreak Investigation Team, 2013[20]
20131589Berries (frozen)Italy (90% of cases), Austria, Bulgaria, Denmark, England, Finland, France, Germany, Ireland, the Netherlands, Norway, Poland, SwedenMultiple food items containing frozen mixed berries (cakes, smoothies); Bulgarian blackberries and Polish redcurrants were the most common ingredients in the implicated lotsUnknown, no single source found. Some cases also related to travel to Italy.Severi et al., 2015[21]; EFSA 2014[22]; Chiapponi et al., 2014[23]; Rizzo et al., 2013[24]; Guzman-Herrador et al., 2014[25]; Fitzgerald et al., 2014[26]
2013165Pomegranate arils (frozen)Arizona, California, Colorado, Hawaii, New Hampshire, New Jersey, New Mexico, Nevada, Utah, WisconsinTurkeyUnknownCollier et al., 2014[27]; CDC 2013[28]
2016143Strawberries (frozen)Arkansas, California, Maryland, New York, North Carolina, Oregon, Virginia, West Virginia, WisconsinEgyptUnknownCDC 2016[29]
202219Strawberries(frozen)CaliforniaArizonaNorth DakotaMinnesotaMexicoUnknownCDC 2022[30]

[1]           Reid, T., Robinson, H. (1987). Frozen raspberries and hepatitis A. Epidemiol Infect, 98: 109–112.

[2]           Ramsay, C. N. and Upton, P. A. (1989). Hepatitis A and frozen raspberries. Lancet, 1: 43–44.

[3]           Rosenblum, L. S., Mirkin, I. R., Allen, D. T., Safford, S., Hadler, S. C. (1990). A multifocal outbreak of hepatitis A traced to commercially distributed lettuce. American Journal of Public Health, 80(9): 1075-1079.

[4]           Sivapalasingam, S., Friedman, C. R., Cohen, L., Taube, R. V. (2004). Fresh produce: a growing cause of outbreaks of foodborne illness in the United States, 1973 through 1997. J Food Prot, 67: 2342-2353. 

[5]           Niu, M. T., Polish, L. B., Robertson, B. H. (1992). Multistate outbreak of hepatitis A associated with frozen strawberries. J Infect Dis 166: 518-524.

[6]           Pebody, R. G., Leino, T., Ruutu, P., Kinnunen, L., Davidkin, I., Nohynek, H., & Leinikki, P. (1998). Foodborne outbreaks of hepatitis A in a low endemic country: an emerging problem? Epidemiology and infection, 120(1): 55-59.

[7]           Hutin, Y. J., Pool, V., Cramer, E. H., Nainan, O. V., Weth, J., Williams, I. T. et al. (1999). A multistate, foodborne outbreak of hepatitis A. New England Journal of Medicine, 340(8): 595-602.

[8]           Dentinger, C. M., Bower, W. A., Nainan, O. V., Cotter, S. M., Myers, G., Dubusky, L. M., Fowler, S., Salehi, E. D. P., and Bell, B. P. (2001). An outbreak of hepatitis A associated with green onions. J Infect Dis, 183: 1273-1276.

[9]           Wheeler, C., Vogt, T. M., Armstrong, G. L., Vaughan, G., Weltman, A., Nainan, O. V. et al. (2005). An outbreak of hepatitis A associated with green onions. New England Journal of Medicine, 353(9): 890-897.

[10]         Datta, S. D., Traeger, M. S., & Nainan, O. V. (2001). Identification of a multi-state outbreak of hepatitis A associated with green onions using a novel molecular epidemiologic technique [abstract 896]. In Program and abstracts of the 39th Annual Meeting of the Infectious Diseases Society of America. Alexandra, VA: Infectious Diseases Society of America (Vol. 192).

[11]         Fiore, A. E. (2004). Hepatitis A transmitted by food. Clinical Infectious Diseases, 38(5): 705-715.

[12]         Calder, L., Simmons, G., Thornley, G. (2003). An outbreak of hepatitis A associated with consumption of raw blueberries. Epidemiol Infect,131: 745-751

[13]         Centers for Disease Control and Prevention (CDC). (2003). Hepatitis A outbreak associated with green onions at a restaurant–Monaca, Pennsylvania, 2003. MMWR, 52(47): 1155-1157. Available at https://www.cdc.gov/mmwr/preview/mmwrhtml/mm5247a5.htm

[14]         Wheeler, C., Vogt, T. M., Armstrong, G. L., Vaughan, G., Weltman, A., Nainan, O. V. et al. (2005). An outbreak of hepatitis A associated with green onions. New England Journal of Medicine, 353(9): 890-897.

[15]         Donnan, E. J., Fielding, J. E., Gregory, J. E., et al. (2012). A multistate outbreak of hepatitis A associated with semidried tomatoes in Australia, 2009. Clin Infect Dis, 54: 775–781.

[16]         Petrignani, M., Harms, M., Verhoef, L. (2010). Update: a food-borne outbreak of hepatitis A in The Netherlands related to semi-dried tomatoes in oil, January-February 2010. Euro Surveillance, 15(20): 19572. 

[17]         Gallot, C., Grout, L., Roque-Afonso, A., Couturier, E., Carrillo-Santisteve, P., Pouey, J. et al. (2011). Hepatitis A Associated with Semidried Tomatoes, France, 2010. Emerging Infectious Diseases, 17(3): 566-567. 

[18]         Centers for Disease Control and Prevention (CDC). (2013). Multistate outbreak of hepatitis A virus infections linked to pomegranate seeds from Turkey (Final Update). Available at: https://www.cdc.gov/hepatitis/outbreaks/2013/a1b-03-31/

[19]         Swinkels, H. M., Kuo, M., Embree, G., Andonov, A., Henry, B., Buxton, J. A. (2014). Hepatitis A outbreak in British Columbia, Canada: the roles of established surveillance, consumer loyalty cards and collaboration, February to May 2012. Euro Surveillance, 19: 20792.

[20]         Nordic Outbreak Investigation Team C (2013). Joint analysis by the Nordic countries of a hepatitis A outbreak, October 2012 to June 2013: frozen strawberries suspected. Euro Surveillance, 18(27): 20520.

[21]         Severi, E., Verhoef, L., Thornton, L., Guzman-Herrador, B. R., Faber, M., Sundqvist, L. et al. (2015). Large and prolonged food-borne multistate hepatitis A outbreak in Europe associated with consumption of frozen berries, 2013 to 2014. Euro Surveillance, 20(29): 1-9.

[22]         European Food Safety Authority (EFSA). (2014). Tracing of food items in connection to a multinational hepatitis A virus outbreak in Europe. EFSA Journal, 12(9): 3821-4007. Available at http:// www.efsa.europa.eu/en/efsajournal/pub/3821.htm  

[23]         Chiapponi, C., Pavoni, E., Bertasi, B., Baioni, L., Scaltriti, E., Chiesa, E., et al. (2014). Isolation and genomic sequence of hepatitis A virus from mixed frozen berries in Italy. Food Environ Virol, 6(3): 202-206.

[24]         Rizzo, C., Alfonsi, V., Bruni, R., Busani, L., Ciccaglione, A., De Medici, D., et al. (2013). Ongoing outbreak of hepatitis A in Italy: preliminary report as of 31 May 2013. Euro Surveillance, 18(27): 20518. 

[25]         Guzman-Herrador, B., Jensvoll, L., Einoder-Moreno, M.,
Lange, H., Myking, S., Nygard, K., et al. (2014). Ongoing hepatitis A outbreak in Europe 2013 to 2014: imported berry mix cake suspected to be the source of infection in Norway. Euro Surveillance, 19(15): 20775. 

[26]         Fitzgerald, M., Thornton, L., O’Gorman, J., O Connor, L., Garvey, P., Boland, M., et al. (2014). Outbreak of hepatitis A infection associated with the consumption of frozen berries, Ireland, 2013 – linked to an international outbreak. Euro Surveillance: European communicable disease bulletin, 19(43).

[27]         Collier, M. G., Khudyakov, Y. E., Selvage, D., Adams-Cameron, M., Chiepson, E., Cronquist, A., et al. (2014). Outbreak of hepatitis A in the USA associated with frozen pomegranate arils imported from Turkey: an epidemiological case study. Lancet Infectious Diseases, 14(10): 976-981.

[28]         Centers for Disease Control and Prevention (CDC). (2013) – Multistate outbreak of hepatitis A virus infections linked to pomegranate seeds from Turkey (Final Update), supra note 85.

[29]         Centers for Disease Control and Prevention (CDC). (2016). 2016 – Multistate outbreak of hepatitis A linked to frozen strawberries (Final Update). Available at https://www.cdc.gov/hepatitis/outbreaks/2016/hav-strawberries.htm

[30]         Centers for Disease Control and Prevention (CDC). (2016). 2016 – Multistate outbreak of hepatitis A linked to frozen strawberries (Final Update). Available at https://www.cdc.gov/hepatitis/outbreaks/2022/hav-contaminated-food/index.htm

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 ever 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.”  

The requests for t-shirts has been a bit overwhelming – as have been the supportive comments.

Although I set aside 100 for the first 100 that emailed me (bmarler@marlerclark.com) their mailing address, I have had over 300 requests. I have ordered more to fill the requests.

So, keep the requests coming. If inclined, post pictures to social media.

Next week these t-shirts will be hand-delivered to key members of Congress who have oversight of the FDA. Hopefully, the HHS Secretary and the President are tuning in as well – guys want a t-shirt? They come in a nice – and quite relevant- package – it does make the t-shirt a bit wrinkled at first.

Here are the ads that are running in Hill newspapers and on Food Safety News.

The first 100 people to email me at bmarler@marlerclark.com and leave their mailing address will get a free-t-shirt.  

GET THE FACTS:  WHY WE CAN NO LONGER TRUST THE FOOD AND DRUG ADMINISTRATION TO KEEP US SAFE FROM CONTAMINATED FOOD

Each year, millions of Americans are sickened, and thousands die from foodborne illness.  And yet, the leadership of the Food and Drug Administration continues to be preoccupied with drug oversight and overlook food safety. Last Fall the credibility of the FDA again was on the butcher block.  This time it was the FDA’s failure to adequately inspect an infant formula manufacturer which led to likely ill children, a recall, a plant closure, and shelves bare of infant formula.

People, including babies, have continued to die needlessly because the FDA has been slow to prevent foodborne illness.  

And, the FDA Commissioner has ignored what all the experts – including an independent panel Califf himself commissioned – told him is needed to fix the problems.

It is not only galling, but also tragic that the Commissioner’s so-called plan to fix the dysfunctional structure and culture that allows for messes like the infant formula fiasco, ongoing foodborne illness outbreaks and the surge in obesity, diabetes and heart disease caused by food.

The changes the Commissioner has proposed stand no chance of fixing the systemic problems with the agency and simply exposes the flaw in having drug experts oversee the nation’s food supply.  

What’s the Solution?

It is time to “GET THE F OUT OF THE FDA.” The F is Food.  The D is Drugs.  We need to separate the FDA functions between Food (food safety and human nutrition) and Drugs (and medical devices).  For too long, those at the top of FDA have focused on what they know and care about – medical drugs and devices.  And FDA food issues have been overlooked and underfunded. 

It is time the White House and the Congress take responsibility for protecting the public by breaking the FDA apart and creating a new dedicated foods agency. At the same time, they need to reject the Commissioner’s ineffective plan, and immediately direct the Commissioner to unify all parts of the foods program and budget under an empowered and accountable Deputy Commissioner.   

I’m not the first to call for a new foods agency.  Last year, in an op-ed by Michael Taylor (a former FDA deputy Commissioner) put forth the idea of creating a new foods agency.  And, last year Representative de Lauro and Senator Durbin introduced legislation that would establish a separate food agency.

I believe this can work.  Food safety is a bipartisan issue.  The victims I have represented come from all political persuasions.  And it’s an issue that has consumer groups, the food industry and state regulators all on the same page.   

That’s why I’ve launched the “GET THE F OUT OF THE FDA” advertising campaign.

On the heels of the infant formula crisis, I’ve launched the “GET THE F OUT OF THE FDA” advertising campaign to urge Congress and the White House to break apart the FDA and create a new dedicated foods agency focused on both food safety and nutrition.  

The campaign includes online advertisements, social media promotion, and survivors of foodborne illness coming to Washington DC to visit Congressional leaders and hand out “GET THE F OUT OF THE FDA” t-shirts. 

“My goal in launching this campaign is to say let’s make this happen now.  I don’t want the failures of the FDA to create new victims I will need to represent.  Create a new foods agency and ‘put me out of business, please!’ I don’t want to have to represent families who will have lost their children because FDA doesn’t have the courage to act.”

ACIP Secretariat

Advisory Committee on Immunization Practices 

1600 Clifton Road, N.E., Mailstop H24-8

Atlanta, GA 30329-4027

acip@cdc.gov

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.[1] 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.

On Feb. 28, 2023, the Centers for Disease Control and Prevention (CDC) announced that the multistate outbreak of Salmonella Typhimurium infections linked to Sun Sprouts-brand alfalfa sprouts grown by SunSprout Enterprises of Fremont, NE, is over.

CDC reports a total of 63 illnesses, with 10 people requiring hospitalization. Illnesses were reported in eight states with the last illness onset on Feb. 2, 2023. States with cases include Arizona (1), Iowa (6), Kansas (6), Missouri (9), Nebraska (26), New Hampshire (1), Oklahoma (1) and South Dakota (13).

The investigation was conducted by the U.S. Food and Drug Administration (FDA), along with the Centers for Disease Control and Prevention (CDC) and state and local partners.

On Dec. 29, 2022, SunSprout Enterprises initiated a voluntary recall of two lots (# 4211 and 5211) of raw alfalfa sprouts because of potential contamination with Salmonella. On the same day, SunSprout Enterprises expanded their voluntary recall to include two additional lots (# 3212, and 4212) of raw alfalfa sprouts. The raw alfalfa sprouts for all recalled lots (#4211, 5211, 3212, and 4212) are packaged in 4-ounce clamshells and 2.5-lb packages with best sold-by dates between 12/10/2022 and 1/7/2023.

The Food and Drug Administration has begun traceback efforts related to a multi-state outbreak of infections from Listeria monocytogenes.

The source of the outbreak continues to be listed as unknown by the FDA even though it has begun product traceback.

So, top contenders? Leafy Greens? Cheese? Deli Meat? Enoki Mushrooms – again?

According to the Centers for Disease Control and Prevention, there have been 11 people infected across 10 states. Ten of the patients have been so sick that they had to be admitted to hospitals. No deaths have been reported.

The outbreak is long-running with patients having been identified from July 2018 through January this year, according to the CDC. The patients range in age from 47 to 88 years old, with a median age of 73. One-fourth of the patients are female.

Public health officials are continuing to interview patients to find out what foods they ate in the weeks before becoming sick. It can take from several days up to more than two months for symptoms of Listeria infection to develop.

The patients have been identified and linked using whole genome sequencing, which provides DNA fingerprints of the bacteria. The patients’ samples have the same genetic signatures, which shows they are all part of a single outbreak.

The sick people live across the country, suggesting nationally distributed food. The patients live in Washington, California, Colorado, South Dakota, Missouri, Arkansas, Michigan, New York, Pennsylvania, and North Carolina.

As reported at Food Safety News, on Feb. 23, Publisher Bill Marler and Food Safety News were honored by the New Jersey Association of Justice (NJAJ) with its Gold Medal for Distinguished Journalism.

But, before we get into the award, that was accepted by Jonan Pilet, who with Joe Whitworth, Coral Beach, Dan Flynn and Cookson Beecher make-up the current staff (along with Chuck Jolly selling ads). However, since its founding in 2009, we have also had a number of stellar writers – not in any particular order: Mary Rothchild, Ross Anderson, Andy Schneider, Gretchen Goetz, Helena Bottemiller, James Andrews, Suzanne Schreck and others. I thank them all for their professionalism.

Food Safety News was founded during the run-up to the passage of the Food Safety Modernization Act when major media was not fully covering the story. Some say Food Safety News has become the “go-to” place for all news food safety. Food Safety News is funded for the most part by Marler Clark with some advertising revenue. Despite being funded by Marler Clark, I think the readership sees the coverage as even-handed. I thank the staff for that.

Well, back to the story on the award.

The New Jersey Association for Justice is an exclusive statewide association dedicated to trial lawyers. They have more than 2,700 members in private practice and public service, paralegals, law clerks, law students and law school graduates.

The award was presented by NJAJ President James Lynch, who said, “The Gold Medal for Distinguished Journalism is being presented to Bill Marler in recognition of his ongoing work to inform Americans about food safety issues both as an attorney representing clients stricken with foodborne illness and as publisher of Food Safety News, which provides outstanding, award-winning coverage of topics ranging from policy and politics to foodborne illness outbreaks to sustainability, science, and research.

“Food Safety News shines a needed light on the issue of vital importance to American consumers.

“The members of the New Jersey Association thank you for bringing these issues to the attention of the general public.”

About Bill Marler from NJAJ
Bill Marler is an accomplished attorney and national expert in food safety. He has become the most prominent foodborne illness lawyer in America and a major force in food policy in the U.S. and around the world. Over the last 30 years, Marler Clark, The Food Safety Law Firm, has represented thousands of individuals in claims against food companies whose contaminated products have caused life-altering injury and even death.

Marler began litigating foodborne illness cases in 1993, when he represented Brianne Kiner, the most seriously injured survivor of the historic Jack in the Box E. coli 0157:H7 outbreak.

For the last 30 years, Marler has represented victims of every large foodborne illness outbreak in the United States and has consulted on cases in Europe, Asia and Africa. He has filed lawsuits against such companies as Cargill, Chili’s, Chi-Chi’s. Chipotle, ConAgra, Dole, Excel, Golden Corral, KFC, McDonald’s, Odwalla, Peanut Corporation of America, Sheetz, Sizzler, Supervalu, Taco Bell and Wendy’s.

In 2010, Marler was awarded the NSF Food Safety Leadership Award for Education and in 2008 earned the Outstanding Lawyer Award by the King County Bar Association. He also received the Public Justice Award from the Washington State Trial Lawyers Association in 2008.

Bill Marler could not attend the event, so Food Safety News’ Staff Writer Jonan Pilet attended the Awards dinner and accepted the award for him.

Staff Writer Jonan Pilet’s acceptance speech on behalf of Bill Marler and Food Safety News:
“I am incredibly honored and humbled to accept this award on behalf of Bill Marler and the entire team at Food Safety News. I want to thank the New Jersey Association for Justice for their recognition of our work, and for the tireless efforts of everyone at Food Safety News— Dan Flynn, Coral Beach, Joe Whitworth, Chuck Jolley and Cookson Beecher. I am honored to call them colleagues.

As a journalist with Food Safety News, I know that this award represents the culmination of countless hours of hard work, dedication, and a commitment to the highest journalistic standards. At Food Safety News we cover the critical issues of food safety — including outbreaks, recalls, victim stories, government regulations, research, and so much more. We aim to provide our readers with accurate, trustworthy information that can help them make informed decisions.

Bill Marler has been a relentless advocate for food safety for decades, and his work has been instrumental in improving the safety of the food we eat here in the U.S. and around the world. He is a mentor and a source of inspiration to all of us at Food Safety News, and we are proud to work alongside him.

Most importantly, I want to recognize the people who have shared their stories with us and the reason we do what we do — the victims of foodborne illness, and their families. Their bravery and resilience, and willingness to speak out are what drive us to continue our work. We hope that this award will shine more light on their situation and inspire continued change to make the food we eat safer for everyone.

Finally, let me say that this award is not just a recognition of our work, but a reminder of the critical importance of the work that we do. Food safety is a fundamental issue that affects us all, and we must remain vigilant in our reporting, our research, and our advocacy.

Once again, thank you for this incredible honor. Bill Marler, the Food Safety News team, and I are truly grateful.”