People always ask me why do leafy green E. coli outbreaks keep happening. I think the bottom line is that retailers, restaurants, growers, processors and the government simply do not give a cow’s pie about the sickened and/or dead consumers – they are simply the cost of doing business or staying in office. 

I am working on a recent major E. coli outbreak – I represent several children who developed HUS and will have a lifetime of complications – that was likely linked to iceberg/romaine hybrid grown in Santa Maria in California. The red spot is the particular lettuce grow field, and thanks to Google Earth, we can pan in and see what is less than a stone’s throw away – you guessed it – cow pies.

Growing lettuce in a location like this should be against both common sense and the law. Perhaps it fits the standard for punitive damages – a conscious disregard for a known risk.

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Some main points:

Estimate the loss of 204 that died was at least $240,000,000 US

Hospitalization costs were at least $10,400,000 US

Loss to businesses was at least $15,000,000 US

This does not even account for future medical expenses and/or lost productivity to those that survived and who have life-altering complications. 

And, what about the emotional cost of the survivors?

Here is the abstract:

Periodic outbreaks of foodborne pathogens have resulted in food safety concerns, due to health implications and cost consequences. Occurrence of Listeria monocytogenes in foods and listeriosis have been reported in developed countries; however, documentation of listeriosis in South Africa is limited. In 2017–2018, Listeria was reported on polony (processed deli meat) and listeriosis was observed in South Africa (L. monocytogenes sequence type 6 (ST-6) was identified as the causal agent for listeriosis). Due to its potential effects, we conducted cost estimates to assess the implications of listeriosis outbreak with respect to illnesses, hospitalizations and deaths, and productivity losses. Cost estimates were computed on publicly available data by using USDA-ERS cost computation model for Listeria. Listeriosis had significant impacts, as mortality of 204 individuals with confirmed listeriosis cases was reported, with infants having the highest percent of fatalities (42%). The cost valuation of fatality cases was over US$ 260 million. Hospitalization costs associated with one-month recovery from listeriosis were estimated at US$ 10.4 million. Productivity losses attributed to listeriosis for humans and export value losses for food processors were in excess of US$ 15 million. Increase of food safety measures in South Africa could reduce foodborne disease outbreaks. Pre-emptive pathogen detection, sanitary procedures and bacterial inactivation can enhance control of L. monocytogenes in food processing environments.

Here is what happened and why:

We are now beyond five years from the date that the NICD announced the association between Tiger Brands’ polony products and the outbreak, and the work done by all parties has only generated more evidence that the NICD’s and Tiger Brands’ conclusions are accurate. There is no evidence to the contrary.

In 2017 and 2018, the world’s largest and deadliest outbreak of listeriosis occurred in multiple provinces of South Africa (Figure 1). The outbreak was caused by contaminated polony, a ready-to-eat, processed meat product. Ready-to-eat, processed meats are a well-known vehicle for listeriosis outbreaks (Thomas et al., 2020). The Minister of Health declared that there was an outbreak of listeriosis on December 5, 2017, and, on March 4, 2018, further identified Tiger Brands’ polony products as the cause of the outbreak. The Minister of Health instructed Tiger Brands to recall all polony products the same day. See generally, Minister of Health September 3, 2018, Media Statement. The Ministry of Health based its conclusions on the investigative findings of the Joint Public Health Emergency Co-ordinating Committee, which was established for the specific purpose of identifying the cause of the outbreak and developing measures to prevent further illnesses and other outbreaks associated with processed meat products generally. Id. The relevant epidemiologic findings are set forth in the paragraphs that follow.

Figure 1. Incidence of Laboratory-Confirmed Listeriosis Cases during the Outbreak Period, According to South African Districts (Thomas et al., 2020).

Cases were reported from across the country, with most cases reported from Gauteng Province (58%). Women accounted for 55% of total cases. The ages of cases ranged from birth to 93 years. Neonates (aged £ 28 days) were the most affected age group, accounting for 43% of cases. This was followed by adults of 15 to 49 years of age, accounting for 32% of cases. The disease outcome was known for 806/1,060 (76%) of cases; 27% (216/806) had the known outcome “died” (Smith et al., 2019).

Listeriosis is a serious foodborne infection with a case-fatality rate (“death rate”) of 20-30% (Thomas et al., 2020). People primarily affected by listeriosis have impaired cell-mediated immunity. This includes those who are pregnant, elderly, or immunocompromised from conditions such as HIV, chronic disease, or immunosuppressive therapy (Thomas et al., 2020). The specific outbreak strain associated with the outbreak was Lm ST6. There are two ways that listeriosis can manifest: febrile gastroenteritis and invasive listeriosis (Coulombier). Invasive listeriosis is characterized by bacteraemia, meningitis, pneumonia, endocarditis, and sepsis (Smith et al., 2019).

A total of 1,060 cases were reported during the period of January 11, 2017, to July 17, 2018 (Figure 2)[1]. The outbreak period was defined as a duration of time during which case numbers exceeded and remained above a weekly threshold of five cases per epidemiological week (Thomas et al., 2020). At the peak of the outbreak (mid-November 2017), 41 listeriosis cases were reported in a single week. Prior to this outbreak, listeriosis was not a reportable disease in South Africa; therefore, information is not available on the prevalence, epidemiology, and description of clusters/outbreaks on listeriosis. Due to the lack of surveillance data, the baseline number of listeriosis cases was estimated from counts of listeriosis cases in 2016.

It is known that in 2015 and 2016, clusters of listeriosis occurred in South Africa. The 2015 listeriosis cluster involved 7 cases total, and the predominant strain was Lm ST6. However, researchers did not have sufficient epidemiologic evidence to connect the 2015 cluster to any specific food product (Shuping et al., 2015). For the 2016 cluster, retrospective analysis of Lm cases from the years 2012-2016 was used to calculate the expected case numbers for years 2013, 2014, 2015, and 2016 in the Gauteng province (Mathebula et al., 2016)[2]. Because there were only 3 cases in the 2016 cluster, researchers needed to estimate the baseline number of cases.

When determining if a cluster of diseases is classified as an outbreak or epidemic, it is essential to know what the baseline number of illnesses is in the population of interest. An epidemic refers to an increase in the number of cases of a disease, above what is normally expected in that population in that area, and an outbreak is defined the same but is often used for a more limited geographic area (Centers for Disease Control and Prevention [CDC], 2012).

Figure 2. Distribution of Laboratory-Confirmed Cases of Listeriosis, According to Outbreak Week and Major Events (January 1, 2017 to August 21, 2018) (Thomas et al., 2020).

Case definitions are used in outbreak investigations to help identify cases who are associated with the outbreak. A case definition includes criteria such as the subject population, implicated location, time, clinical features, and/or laboratory test results if available (CDC, 2012). The initial case definition for the primary listeriosis outbreak included all cases of listeriosis that occurred in South Africa from 2017 to 2018. The initial case definition was appropriate due to the lack of whole-genome sequencing (WGS) data at the beginning of the investigation. Multilocus sequencing typing (MLST) was used later to analyse the WGS results from all viable isolates obtained from case-patients. Researchers discovered that 93% of the clinical isolates collected from cases during the outbreak period were Lm ST6 (Thomas et al., 2020; Gerner-Smidt). The case definition later included sequence typing information to increase the likelihood of identifying a common source (Besser). This finding also showed that the outbreak strain of Listeriosis was definitively the Lm ST6 strain.

Further, we note that investigators thoroughly analysed the theoretical possibility that Lm ST6 was coming from more than just Tiger Brands’ polony products. In short, after conducting environmental investigations at all 157 ready-to-eat meat production facilities in South Africa, there was no Lm ST6 in any other products or facilities except Tiger Brands.

Together with the NCID’s clear statements that Tiger Brands polony products were the source of the outbreak, based on epidemiologic and environmental evidence, the constellation of all evidence conclusively establishes that Tiger Brands’ polony products were in fact the sole source. There is no additional analysis that will materially change these facts.

Based on its investigation findings, the Minister of Health issued a recall of Tiger Brand’s ready-to-eat meat products produced at the Enterprise facility. The Minister of Health also recalled all ready-to-eat meat products produced at Rainbow Foods, but epidemiologic and environmental findings during the investigation showed that this was a precautionary measure only—i.e., the Listeria identified at the Rainbow Foods’ production facility on environmental testing was not Lm ST6, and therefore had no causal association with illness in the outbreak. See Minister of Health March 4, 2017 Statement. Shortly after Tiger Brands’ recall, the outbreak essentially stopped (Figure 3).

Figure 3. Epidemic curve of laboratory-confirmed listeriosis cases by date of clinical specimen collection (n=1 038) and sequence type (ST) (n=564), South Africa, 01 January 2017 to 5 June 2018 (n=1049)

The environmental and epidemiologic investigative findings establish the likely causal nexus between Tiger Brands’ polony products and most all Listeriosis cases that occurred in South Africa before, during, and after the outbreak period. (Coulombier).  As stated above, 93% of clinical isolates that underwent sequencing were shown to be Lm ST6, the strain that was both epidemiologically associated with illness and repeatedly found in the production environment at the Enterprise facility, and nowhere else. But not all isolates could be sequenced, due to the lack of laboratory resources and personnel available (Besser). Based on the high percentage of Lm ST6 clinical isolates, it is highly likely that a similar percentage of non-sequenced isolates would have been Lm ST6 if sequencing could have been done (Coulombier). As further support that there was no difference between the distribution of sequence types among the non-sequenced samples and the distribution of sequence types observed in the sequenced samples, the process of selecting case isolates to be sequenced was not biased. Therefore, it is a statistically valid and provable fact that, in the absence of evidence to the contrary—i.e., sequencing that showed that a clinical isolate was not Lm ST6–a listeriosis patient diagnosed during the outbreak period had a > 90% probability of being related to the outbreak even without confirmed laboratory results (Gerner-Smidt).

After detecting the outbreak, the Centre for Enteric Diseases, a part of the National Institute for Communicable Diseases, conducted a nested case-control study that provided evidence that cases with Lm ST6 infections were more likely to have eaten polony than those with non- Lm ST6 infections (Thomas et. al, 2020). In outbreak investigations, case-control analysis is performed to estimate the odds ratio for the association between specific food items and the outbreak-associated illness. For this nested case-control study, case patients were those with Lm ST6 infections, and control patients were people infected by another strain of LM (i.e., not Lm ST6) during the outbreak period. Results from this study show that the odds ratio was 8.55 with a 95% confidence interval of 1.66 – 43.35. An odds ratio is a measure of association between the odds of becoming ill from consuming a specific food item versus the odds of becoming ill without having consumed the specific food item (Coulombier). An odds ratio of 8.55 signifies that the odds of having eaten polony in Lm ST6 cases is 8.55 times greater than the odds of having eaten polony in non-Lm ST6 cases. Based on the calculated confidence interval, this result is statistically significant because the confidence interval does not include the null value of 1. Therefore, 95% of the time, the true odds ratio fell within this interval.

Prior to the study, food history interviews were conducted to generate a hypothesis as to which food item could have been the source of the outbreak (Coulombier). The food histories were conducted with the use of a standardized questionnaire that inquired as to food consumed by a case-patient over the four weeks prior to onset of symptoms. Open-ended questions were posed to Listeriosis cases to understand each case’s food habits, such as where they purchase food, name of restaurants patronized, and use (and name) of informal food vendors. Closed-ended questions were posed to determine each case’s exposure to specific food items associated with outbreaks in the past and locally consumed foods thought to pose a high risk for listeriosis such as processed meats (e.g., biltong), cold meats (e.g., ham, polony), soft cheeses, raw milk, and raw vegetables. Brand preferences were also captured in the form.  The combination of open and closed-ended questions was and continues to be standard practice for the conduct of epidemiologic investigations internationally and provided investigators with high value data for consideration alongside other epidemiologic and environmental information.

The food history interviews were completed by November 1, 2017. The epidemiologic methods utilized throughout this investigation, including the case-control, were robust and mirrored those used in high-level investigations throughout the world. The investigators’ multi-disciplinary investigative methods were fully appropriate for the outbreak circumstances (Besser).

On January 13, 2018, febrile gastroenteritis developed in 10 children from a nursery in Gauteng Province. Several stool samples were collected from the children, and one yielded Lm ST6. Sandwiches prepared and eaten at the nursery were the only common food exposure, and polony was the common ingredient. Polony was recovered from the nursery refrigerator, and Lm ST6 was identified in the polony produced at Tiger Brands Enterprise Facility in Polokwane (Thomas et al., 2020).

On February 2, 2018, an environmental investigation took place at the Tiger Brands Enterprise Facility in Polokwane following the discovery at the nursery (Gerner-Smidt). Of 317 environmental samples taken from the Polokwane facility, 47 tested positive for Listeria monocytogenes, and of the 47 that tested positive, 34 were subtyped as the outbreak Lm ST6 strain. Additionally, two of 13 samples of unopened polony loaves collected at the facility tested positive for Listeria monocytogenes, and both were subtyped as the outbreak Lm ST6 strain.

These facts stand in stark contrast to the investigations at all other South African ready-to-eat meat producers, during which investigations no Lm ST6 was recovered in any food or environmental sample.

The fact that the public health investigation involved environmental inspections and sampling at the production facilities of other ready-to-eat meat producers is remarkable. Indeed, the public health investigation of this outbreak was unprecedented in scope, even internationally, as it is, in our experience, unprecedented to engage in such robust investigation of producers whose products are not epidemiologically associated with an outbreak. Thus, the only epidemiologic evidence establishes that Tiger Brands, and Tiger Brands alone, produced product contaminated by Lm ST6 during the outbreak period. By incorporating findings from the epidemiologic, environmental, microbiologic, and traceback data, investigators provided conclusive evidence that the source of the outbreak was polony produced fromTiger Brands Enterprise Foods Polokwane production facility, and that there were no other possible causes.

Further, and as set forth previously, the Minister of Health identified Tiger Brands’ polony products as the source of the outbreak on March 4, 2018, and instructed Tiger Brands to recall all its ready-to-eat meat products. At the point in time that Tiger Brands’ polony products were taken off of store shelves and were no longer widely available for purchase and consumption in South Africa, the outbreak ended and listeriosis cases in South Africa shortly returned to their pre-outbreak baseline. As Figure 3 demonstrates, by mid-April 2018 (6 weeks after recall), fewer than 5 cases were reported weekly. Regarding those individuals who became ill between the date of Tiger Brands’ recall and mid-April 2018, listeriosis cases continued to become ill by consumption of Tiger Brands’ polony products that were purchased before the date of the recall, which was to be expected given the lengthy incubation period for listeriosis generally (from 3 days to over one month), or from Tiger Brands’ polony products that were simply not removed from store shelves in time.

Following the findings by the NICD, Tiger Brands conducted its own internal investigation into the outbreak. During this internal investigation, based on information set forth in the discovery conducted to-date and Tiger Brands’ various public statements, Tiger Brands confirmed the presence of the Lm ST6 outbreak strain in both its products and various locations in the production environment at the Enterprise facility. Tiger Brands issued several public statements to this effect.

In a SENS statement dated 19 March 2018, Tiger Brands issued the following public statement:

“On 15 March 2018, Tiger Brands received confirmation from independent laboratory tests corroborating the DoH’s findings of the presence of LST6 in the environment at its Polokwane Enterprise Foods manufacturing Facility. In addition, there was a positive detection of LST6 on the outer casing of two samples.”

On 26 March 2018, Tiger Brands issued a public statement on its website reiterating the independent laboratory results announced in the SENS statement of 19 March 2018 as aforementioned which confirmed the presence Lm ST6 in the Tiger Brands Polokwane Facility. In the 26 March press statement, Tiger Brands CEO, Mr Lawrence Mac Dougall commented on this discovery and, inter alia, stated as follows:

“We are investing all our time and energy into not only understanding the cause of the LST6 detection, but also how it could have come into our facility.”

In a statement to shareholders dated 23 May 2018, Mr Mac Dougall stated that:

“The detection of the presence of Listeria ST6 in our factory in Polokwane was disappointing to us given our compliance with best practices and prevailing standards.”

In a SENS statement dated 25 April 2018, Tiger Brands reported that it had received independent laboratory test results following its own internal investigation which confirmed the presence of the Lm ST6 in samples of ready-to-eat meat products manufactured at the Polokwane Facility:

“The purpose of this announcement is to update shareholders on the results of the independent laboratory re-testing which was carried out in respect of the presence of LST6 in the above samples which were manufactured at the Enterprise Polokwane processing facility. On 24 April 2018, Tiger Brands received confirmation of the presence of LST6 in these samples.”

From both the NICD’s and Tiger Brands’ investigations into the outbreak, there is no evidence that the outbreak had any source other than Tiger Brands’ polony products. There is no epidemiologic support for that proposition, and there is no environmental support for that proposition because NICD found no other positive Lm ST6 samples at any other facility that produces ready-to-eat meat. In fact, Tiger Brands has, in unequivocal terms, admitted to this responsibility. For example, in the request Further Trial Particular, Tiger Brands affirmed its responsibility for Lm ST6 cases:

“Tiger Brands statement of 24 April 2018 was correct. Tiger Brands learnt that laboratory tests had found ST6 in ready-to-eat meat products from its Enterprise Foods manufacturing facility in Polokwane. It accepts that the laboratory findings were correct.”

“Tiger Brands does not know to what products the contamination extended or over what period it occurred. It accepts, however, that ST6 contaminated products from its Polokwane facility probably infected some of the people who suffered from listeriosis during the outbreak.”

“The defendants accept the test results that L. monocytogenes was detected in the polony water coolers at the Polokwane facility.”

Further, and following the Supreme Court of Appeal’s ruling in the third-party subpoena’s litigation, Tiger Brands issued the following statement to the press:

“On Friday, 4 February 2022, the Supreme Court of Appeal overturned the earlier order of the Gauteng Division of the High Court, Johannesburg which required various third parties to hand over epidemiological information relating to the listeriosis outbreak.”

“The 2018 listeriosis outbreak affected many South Africans. We are saddened by the impact it has had on the lives of the victims and those who have lost loved ones from the outbreak. Tiger Brands reiterates its commitment to ensure that a resolution of the matter is reached in the shortest possible time, in the interest of all parties, particularly the victims of listeriosis.”

That Tiger Brands is liable for the manufacture and sale of contaminated polony products that injured people is beyond doubt; the scientific findings from the multi-disciplinary investigation allow only this conclusion, and the functional life of the outbreak ended when Tiger Brands was ordered to withdraw its products from the market. The epidemiologic implications of NICD’s sequencing effort are conclusive, which is the preliminary point made by SAAFOsT, in which organization Tiger Brands is a custodian member, in its December 2017 statement that:

“This is undoubtedly one of the worst listeriosis cases in global history. A large percentage (74%) of all the clinical isolates belong to the same sequence type i.e. ST6—this means that these isolates originate from a single source, most likely a food product on the market.”

What SAAFOsT did not have the benefit of then knowing, however, was that sampling at Tiger Brands’ Polokwane facility would validate in every respect the epidemiologic implications from NICD’s sequencing efforts on human isolates.

We are now beyond four years from the date that the NICD announced the association between Tiger Brands’ polony products and the outbreak, and the work done by all parties has only generated more evidence that the NICD’s and Tiger Brands’ conclusions are accurate. There is no evidence to the contrary.

_____________________

[1]  Note: 23 October 2016 to 3 September 2018 is the “Outbreak Period” in the Certification Order.

[2] The oldest South African CT4148 isolates date from September 2015 and are related to a cluster of three cases of listeriosis in Western Cape Province28; this finding suggests a potential epidemiologic link to the 2017–2018 outbreak. Thomas, et al., 2020

References

Besser, J. (2020). Expert Opinion Regarding a Listeria Outbreak in South Africa Involving Tiger Brands Limited.

Coulombier, D. (2020). Expert Opinion Regarding a Listeria Outbreak in South Africa Involving Tiger Brands Limited.

Gerner-Smidt, P. (2020). Expert Opinion on Subtyping Aspects of the Listeria Outbreak in South Africa Involving Tiger Brands Limited.

Smith, A. M., et al. (2019). Outbreak of Listeria monocytogenes in South Africa, 2017-2018: Laboratory Activities and Experiences Associated with Whole-Genome Sequencing Analysis of Isolates. Foodborne Pathog. Dis. 16(7): 524-530. doi:10.1089/fpd.2018.2586

Thomas, J., et al. (2020). Outbreak of Listeriosis in South Africa Associated with Processed Meat. N. Engl. J. Med. 382: 632-643. doi:10.1056/NEJMoa1907462

Tiger Brands SENS statement dated 19 March 2018, “Financial Impact of Product Recall and Suspension of Operations at the Polokwane, Germiston, Pretoria and Clayville Processing facilities of Value-Added Meat Products (“VAMP”); Institution of Class Action; and Results of Independent Tests carried out in respect of the presence of Listeria monocytogenes ST6 type (“LST6”)”

Tiger Brands Public Statement dated 26 March 2018, “Tiger Brands Listeria Update”

Tiger Brands SENS Statement dated 23 May 2018, “Unaudited group results and dividend declaration for the six months ended 31 March 2018.

Tiger Brands SENS Statement dated 25 April 2018, ‘Results of Independent Tests carried out in respect of the presence of Lister monocytogenes ST6 type (“LST6”)’

Tiger Brands response to Plaintiff’s Further Particulars

Rose, “Tiger Brands Tall Tale”. Financial Mail, 10 February 2022.

Shuping, L., et al. (2015). Investigating a cluster of Listeria monocytogenes cases in the Western Cape province of South Africa, September 2015.

NICD. (2016). Investigation of Listeria monocytogenes cases at Charlotte Maxeke Johannesburg Academic Hospital in Johannesburg, December 2016.

NICD, Listeriosis Outbreak Situation Report. Dated 11 June 2018.

SAAFOST, “Listeriosis Outbreak in South Africa – Latest! By Dr Lucia Anelich, SAAFoST President”. Dated 20 December 2017.

Over two months ago, while watching the premiere of the documentary, “Poisoned,” at the Tribeca Film Festival in NYC, I got thinking again about how little in the past 30 years I feel I have moved the needle on food safety – pathogens and certainly, human nutrition.  Now that “Poisoned” is up on the Netflix platform, it has become the most watched documentary in the world – at least for the last few days.

The real issue to me is how do we engage the food industry, policy makers, academics and most importantly consumers, to focus on driving the numbers down on the pathogens that kill us quickly and the products that kill us over time.

I will focus on pathogens as I have for the past 30 plus years. I will leave it to some very smart people who are rightly concerned about the millions of us who become sick and die due to inadequate nutrition – especially the millions of illnesses and deaths due to heart disease, diabetes and obesity caused by ultra-processed foods, salt, sugar, and fat.

There is so much to do, and the list is long. So, what would I do with a Food Safety Magic Wand on day one?

Vaccinate. The first thing I would do is mandate that all food service workers be vaccinated against hepatitis A.  Perhaps to some, not the most pressing food safety issue, but it is forefront of my mind.  In the past few months, I finished up litigation around a hepatitis A outbreak involving one ill food service work who infected nearly 50 people, hospitalizing most, killing four and causing two liver transplants.  With regret, I forced a family-owned restaurant chain to file for bankruptcy.  All of this could have been prevented by a safe vaccine that has been around for decades.  It is time for the restaurant industry and the CDC to step up.

Determinate. Do science-based testing of food products at retail and publish the findings on a regular basis.  It is time to shine some light on the safety of the products that we purchase at retail and make the whole chain of distribution – including retailers — transparent and accountable. It is time to bring back a more robust version of the Microbiological Data Program (MDP).  For a time, the MDP tested fresh fruits and vegetable for human pathogens and when found the tests prompted outbreak investigations and recalls.  The industry embarrassed, had the program killed.

Investigate. Invest in public health surveillance over human pathogens, like, Listeria, E. coli and Salmonella, etc.  A dirty truth is that most culture-confirmed illnesses are never attributable to a food source, so people never know what sickened or killed them. Not because the source was not food, but because we fail to invest adequate resources in the epidemiologists that investigate illnesses and track those illnesses to the cause. Tracking illnesses to the cause gets tainted product off the market and helps us all understand what products and producers to avoid.  We need to continue to invest in the science of whole genome sequencing, so we know with certainty which pathogens are causing which illnesses. Foodborne illness epidemiology helps us understand the root cause of an outbreak and helps prevent the next one from happening at all.

Relegate. Allow public health officials access, especially during an outbreak investigation, to all areas around farms that grow fruits and vegetables.  It is long past time to allow investigators access to neighboring cattle, dairy, chicken, or hog operations that spill billions of deadly pathogens into the environment, via air or water.  We need to think of our growing regions as an integrated system and that all sectors responsible need to play a role.  Access allows investigators to understand the likely cause of an outbreak, and again, what can be done to prevent the next one.

Advocate. Make all pathogens that can sicken or kill us adulterants. In 1994 Mike Taylor making E. coli O157:H7 an adulterant has saved countless lives and has saved the beef industry from my lawsuits. We can do the same for all food producers, especially chicken, turkey, and pork. Remember, in the 1990’s nearly all the lawsuits I filed were E. coli cases linked to ground beef.  Today that is zero.  Think about it.

Educate. Give everyone a thermometer and provide better education to middle and high school teachers and students around food safety and human nutrition policy, not in a dry, technical way, but by sharing engaging history, microbiology, patient stories, and case studies. We need to teach how and why our food can be unsafe and what consumers can do about it.

Consolidate. Finally, make a single federal agency out of USDA/FSIS, FDA, and the food safety parts of CDC, NOAA, and EPA, to oversee food safety and human nutrition. Making food safety and human nutrition its own agency would help increase governmental accountability,  close regulatory loopholes, facilitate the collection and sharing of information and facilitate critical change.  I might have a suggestion for someone to run it.

With the CDC estimating 48,000,000 are sickened each year, 125,000 are hospitalized, and 3,000 die from food, preventing pathogenic foodborne illness is no simple matter. And, if you consider the millions that are impacted by the lack of adequate and safe nutrition, we have a lot to do.  However, it can be done, and the ideas above are a small start.

“Doing anything is better than doing nothing,” my Marine drill sergeant father used to say.  He used to require my brother and I to make our beds every morning and bounce quarters on them.  For the longest time I thought this was punishment.  But it was not punishment, it was accomplishment, that you could build on for the rest of the day.  Doing “little” things, like the six things above, are accomplishments. Doing them starts a process that will continue to make all our lives just a little bit safer.

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

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

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

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

Key Media Links (Selected):

• Detwiler, D. (2020). Food Safety: Past, Present, and Predictions.  (1st Ed.). Elsevier Academic Press, Cambridge, MA. ISBN: 9780128182192 https://www.elsevier.com/books/food-safety/detwiler/978-0-12-818219-2
• Detwiler, D. (2020). Building the Future of Food Safety Technology: Blockchain and Beyond. (1st Ed.). Elsevier Academic Press, Cambridge, MA. ISBN: 9780128189566 https://www.elsevier.com/books/building-the-future-of-food-safety-technology/detwiler/978-0-12-818956-6
• Guest Speaker: “Food Safety: Past, Present, and Predictions – How the PNW shaped America’s current ‘Food Safety Culture’.”  (2021, November 4). Toxicology and Societies Speaker Series, Western Washington University, Bellingham, WA Available online at: https://alumni.wwu.edu/event/food-safety-past-present-and-predictions
• Speaker: “The Future of Food at the Intersection of Corporate Social Responsibility, Technology, and Consumer Awareness.” Council on Food, Agricultural and Resource Economics (C-FARE) 2021 Jon Brandt Public Policy Forum, Washington, D.C.  Available online at: https://www.cfare.live/replay/day-2-darin-detwiler
• Podcast: “In the Loop with Dr. Darin Detwiler.”  (2022, June 10). [Podcast]. In the Loop Podcast with CMX.  ComplianceMetrix.  Available online at: https://youtu.be/i2bPUWits28
• Podcast: “Darin Detwiler: Tragedy Carves a Food Safety Hero.” (2022, February 28). Let’s Talk About Food.  [Podcast].  Heritage Radio Network.  Hosted by Louisa Kasdon.  Available online at: https://heritageradionetwork.org/episode/darin-detwiler-tragedy-carves-food-safety-hero
• Television: American Greed: “From Peanuts to Sick Millions” [TV Series Documentary]. Kurtis Productions, CNBC.  Episode AG 141. (Original Air Date July 3, 2017). Available online at: https://vimeo.com/259271860
• Documentary: “Chasing Outbreaks: How Safe is Our Food?” [News Documentary]. The New York Times, Retro Report. Available online at: http://www.nytimes.com/video/us/100000003676533/chasing-outbreaks-how-safe-is-our-food.html
• Speaker: TEDx NortheasternU 2020.  “Inspiring Change: Harnessing the Hidden Hercules.” Available online at:
  https://www.ted.com/talks/darin_detwiler_inspiring_change_harnessing_the_inner_hercules

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

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

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

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

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

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

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

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

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

Single Food Safety Agency – Press Release in 2019

Our Food Safety System is Not Working – Press Release 2011

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

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Ground Beef tainted with Salmonella can knowingly be sold as approved by the USDA/FSIS. 

It has caused a Salmonella Outbreak that has sickened 16 in Massachusetts, Connecticut, New Jersey, and New York.

As of July 24, 2023, 16 people infected with the outbreak strain of Salmonella Saintpaul have been reported from 4 states – Massachusetts, Connecticut, New Jersey, and New York. Illnesses started on dates ranging from April 27, 2023, through June 16, 2023.

State and local public health officials are interviewing people about the foods they ate in the week before they got sick. Of the 14 people interviewed, 9 (64%) reported eating ground beef. All 9 purchased the ground beef from ShopRite locations in Connecticut, New Jersey, and New York. Seven of these people specifically reported purchasing 80% lean ground beef products. Two people reported purchasing ground beef products from ShopRite but could not recall the type of ground beef.

Public health investigators are using the PulseNet system to identify illnesses that may be part of this outbreak. CDC PulseNet manages a national database of DNA fingerprints of bacteria that cause foodborne illnesses. DNA fingerprinting is performed on bacteria using a method called whole genome sequencing (WGS). WGS showed that bacteria from sick people’s samples are closely related genetically. This suggests that people in this outbreak may have gotten sick from the same food.

A routine FSIS ground beef surveillance sample collected in March 2023 was closely related to bacteria from sick people’s samples.

Hamburger – by law and with the USDA stamp of approval – can knowingly be sold tainted with a pathogen that sickens over 1,400,000 yearly.  This is because USDA/FSIS does not consider Salmonella an adulterant.

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

Ignoring Salmonella in meat makes little, if any, sense.

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

The Wisconsin Supreme Court in Kriefall v Excel called it as it saw it – at least with respect to E. coli – but the analysis is spot on for Salmonella as well:

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

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

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

Here is the law:

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

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

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

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

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

Here is the law specifically related to poultry:

Title 21 – FOOD AND DRUGS CHAPTER 10 – POULTRY AND POULTRY PRODUCTS INSPECTION

(g) The term “adulterated” shall apply to any poultry product under one or more of the following circumstances:

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

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

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

Hmmm. It is hard to read the above and not think that the words equate to all E. coli as well as Salmonella — frankly, all pathogens in food.

I know, I am just a lawyer, but don’t ya think that when food with animal feces (and a dash of E. coli O157:H7) in it is considered an adulterant, that other animal feces (with dashes of other pathogens, like Salmonella) in them, should be considered adulterated too?  But, hey, that is just me.

Another odd governmental fact is that the FDA does not seem to make a distinction between pathogens it considers adulterants or not.

FDA’s enabling legislation – Sec. 402. [21 USC §342] of the Food, Drug & Cosmetic Act also defines “Adulterated Food” as food that is:

(a) Poisonous, insanitary, or deleterious ingredients.

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

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

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

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

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

I would pay to watch it.

And so now onto some history to ruin your appetite.

In 1971 the American Public Health Association (APHA) sued the USDA on the grounds that its mark of inspection (“USDA inspected for wholesomeness”) was misleading because, even though the USDA had put its stamp of approval on meat—literally—it did not, for example, test the meat for bacteria. Moreover, APHA argued that raw meat was commonly contaminated with Salmonella, which posed a risk to the public health. According to APHA, the USDA should instead require that meat carry both a warning label and cooking instructions. The USDA opposed the APHA, helped ably (and predictably) by the meat industry. As quoted by Marion Nestle in her great book, Safe Food, the USDA’s position was that, given how many foods are contaminated with Salmonella, “it would be unjustified to single out the meat industry and ask that the [USDA] require it to identify its raw products as being hazardous to health.” Nestle at 66. (Note to Reader: No, I am really not making this up.)

In 1974, the DC Circuit Court of Appeals upheld the position of the USDA and the meat industry, doing so in a way that was as nonsensical as it was sexist. The court stated that: “The presence of salmonellae on meat does not constitute adulteration within this definition [of ‘adulterated,’ provided in 21 U.S.C. § 601 (m)]….As it said in its letter of August 18, 1971 ‘the American consumer knows that raw meat and poultry are not sterile and, if handled improperly, perhaps could cause illness.” In other words, American housewives and cooks normally are not ignorant or stupid and their methods of preparing and cooking of food do not ordinarily result in salmonellosis.’” APHA v. Butz, 511 F.2d 331, 334 (1974).

This remained the position of the USDA and the meat industry until 1994 when, in an act of both common-sense and bravado, Michael Taylor, then FSIS Administrator, announced that E. coli O157:H7 would be deemed an adulterant in raw ground beef. The Agency did not, however, change its tune with regard to any other pathogens, especially Salmonella. Indeed, in 1999, when FSIS announced it inane distinction between E. coli O157:H7 in “intact” meat versus “non-intact” meat, the Agency continued to focus on how a given meat was “customarily cooked” as a chief determinant of whether it must be treated as an adulterant. Thus, for example, because it decided that “intact steaks and roasts are customarily cooked in a manner that ensures that these products are not contaminated with E. coli O157:H7,” there was no need to treat this deadly pathogen as an adulterant on intact cuts of meat. Of course, this FSIS policy is also one that appears to have been silently jettisoned by the Agency of late.

The Agency’s position on Salmonella and meat came back to haunt it in a big way when FSIS tried to shut down Supreme Beef Processors, Inc. for repeatedly failing Salmonella performance standards that, according to the Agency, was proof that the ground beef being made there was being processed under “insanitary conditions.” Supreme Beef sued the USDA and not only won an injunction, but it succeeded in having the Salmonella regulations struck down as being “beyond the authority granted the Secretary [of the USDA] by the Federal Meat Inspection Act.” Supreme Beef v. USDA, 275 F.3d 432, 434 (5th Cir. 2001). Explaining its holding, the Court wrote:

The difficulty in this case arises, in part, because Salmonella, present in a substantial proportion of meat and poultry products, is not an adulterant per se, 21 meaning its presence does not require the USDA to refuse to stamp such meat “inspected and passed.” 22 This is because normal cooking practices for meat and poultry destroy the Salmonella organism, 23 and therefore the presence of Salmonella in meat products does not render them “injurious to health” 24 for purposes of § 601(m)(1). Salmonella-infected beef is thus routinely labeled “inspected and passed” by USDA inspectors and is legal to sell to the consumer.

Supreme Beef, 275 F.2d at 438-39. And, of course, not surprisingly, the court in this case was quick to cite the decision in APHA v. Butz, and to note that even now the “USDA agrees that Salmonella is not an adulterant per se.” Id. at 439 n. 21.

In my view the Supreme Beef decision is poorly reasoned and ill-informed. (For example, could not someone at the Court figure out that it is impossible for meat to be “infected” with Salmonella, and the proper term here is “contaminated”?) But the real lesson of Supreme Beef is that the USDA was, and continues to be, an Agency that is unable to decide whose side it is on. Sometimes it puts on its public safety hat, and sometimes—actually, most often—it puts on its pro-meat industry hat. And, unfortunately, these roles are too often contradictory. That is why USDA policy when it comes to meat safety is also too often contradictory.

Perhaps it is just time for the FSIS to take the the position that all pathogens that can kill you in meat are adulterants.  You have the authority – you just need to use it.

Salmonella can be found in a variety of foods, including beef, chicken, and pork. For this reason, it 

is important to follow proper hygiene for hands and utensils and to cook foods to the proper temperature. Always follow these four food safety steps to help prevent getting sick from Salmonella:

• Clean: Wash your hands, utensils, and surfaces often.
• Separate: Keep food that won’t be cooked separate from raw meat and poultry.
• Cook: Use a food thermometer to make sure you have cooked your food to a temperature high enough to kill germs. For ground beef, it should have a minimum internal temperature of 160°F.
• Chill: Refrigerate perishable food (food that goes bad) within 2 hours, or within 1 hour if food is exposed to temperatures above 90°F, like a hot car or a picnic. Thaw food in the refrigerator, not on the counter.

Symptoms of illness caused by Salmonella most commonly include diarrhea (that can be bloody), fever, and stomach cramps. Some people may also have nausea, vomiting, or a headache. If these symptoms are experienced six to 72 hours after eating potentially contaminated beef, people should contact a health care provider and let them know they have recently eaten beef. The symptoms can last for four to seven days.

Certain categories of people are more at risk for serious outcomes from Salmonella – these include children under the age of 5, adults over 65, those who have weakened immune systems, and those with certain types of heart or joint conditions.

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

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

Also, a good time to order the book – https://www.amazon.com/Poisoned-Deadly-Outbreak-Changed-Americans/dp/B0BPKKCSM3

The documentary first premiered at the Tribeca Film Festival with multiple screenings taking place between June 9th and June 17th first premiering at the SVA Theatre on June 9th.  It also was shown in the author, Jeff Benedict’s, hometown, as well as Bill Marler’s, the main character of the film.

Here’s what you can expect from the documentary based on the book Poisoned by Jeff Benedict (which has an updated cover to reflect the Netflix adaptation).Netflix was first announced to be attached to develop the documentary on the 2011 book back in November 2022. 

On the rerelease of the book and the new film, Benedict said: “Turning this story into a film has been a writer’s dream. Grateful to Bill and Julie Marler for trusting me with their odyssey (I didn’t expect to find a love story when I set out to write about a food borne illness outbreak),” adding, “Lucky to have worked with Ross Dinerstein and his great filmmaking team at Campfire Studios.”

The documentary comes from director Stephanie Soechtig, who has taken on the food industry with multiple documentaries, including Tapped and GMO OMG, and other subjects with titles like Under the Gun and Fed Up. For Netflix, Soechtig was behind Knock Down the House, the documentary of Bronx-born U.S. representative Alexandria Ocasio-Cortez which dropped in May 2019. Jeff Benedict serves as executive producer on the project alongside Rebecca Evans and Ross Girard with Ross M. Dinerstein and Kristin Lazure as producers. Rod Hassler serves as cinematographer on the project, and Justin Melland is the composer.

Well, it seems that the House of Representatives is paying attention to the FDA. Here is what House Appropriations Committee just released directing a restructuring – skip to page 79.

“Human Foods Program Restructuring.—The Committee directs FDA to unify the foods program under an expert, empowered Deputy Commissioner for Foods with full line authority over CFSAN, the food and feed-related activities of the Center for Veterinary Medicine (CVM), and all the food-related components of the Office of Regulatory Affairs, including inspection and compliance, food-related laboratories, import oversight, State partnerships, training, and information technology.”

Here is the full document – http://tinyurl.com/3z8cdcv9

After last years infant formula fiasco, the FDA Commissioner ask the Reagan-Udall Foundation for recommendations as how best to elevate Food Safety and Human Nutrition at the FDA. The Foundation in part suggested the following structural changes:

Structure

FDA should increase the visibility and prominence of the Human Foods Program. 

Given the economic impact that foodborne illness and diet-related chronic disease have on Americans and the federal budget, it is imperative that the Human Foods Program become more prominent. When compared to the medical products programs within FDA, the Human Foods Program continuously struggles for visibility and prominence. A component of this elevation of the Human Foods Program is strong advocacy to advance the Human Foods Program at all levels of the government, especially at the Department of Health and Human Services (HHS) and the White House, including the Office of Management and Budget. 

The Human Foods Program should have clear lines of authority. 

Within the Human Foods Program, the importance of nutrition should be elevated. 

The foods portfolio of ORA should be integrated directly with the other elements of FDA’s Human Foods Program.

The food-relevant work of CVM should be integrated with the overall FDA Human Foods Program. 

A new Foods Advisory Committee, at the Commissioner-level, should be established to strengthen external input to Human Foods Program activities.

Structure changes should be implemented with cultural transformation efforts.

Honestly, this is what I focused on. I am convinced if you get the structure right and the right leaders in place, the culture will develop, and the resources will be available. The Panel had five structural option. My preference is the first one:

The House Appropriations Committee (the folks with the cash) seem to like this one:

Here is the full Reagan-Udall Foundation report:

https://www.marlerblog.com/files/2022/12/Human-Foods-Program-Independent-Expert-Panel-Final-Report-120622.pdf

So, what will the FDA, HHS Secretary and the President do? Grab the popcorn.

The tickets are free and can be “purchased” at this Eventbright Link – or can be reserved by emailing [email protected]. There is seating for only 200.

Please join us for the premiere of the new movie Poisoned, based on the book by Jeff Benedict, which chronicles the events surrounding the worst food-poisoning epidemic in US history: the deadly Jack in the Box E. coli infections in 1993. Tickets are complimentary but we are collecting donations for Helpline House, please donate here 

There will be books available to be purchased and signed courtesy of Eagle Harbor Books. There really will be a red carpet and photos available by Hallie Kathryn along with free Poisoned t-shirts.

The showing will be from 5:30 – 6:45 followed by Q+ A moderated by Herb Weisbaum with Bill and Jeff from 6:45-to 7:15. A community gathering and celebration at Treehouse will follow. 

On December 24, 1992, six-year-old Lauren Rudolph was hospitalized with excruciating stomach pain. Less than a week later she was dead. Doctors were baffled: How could a healthy child become so sick so quickly? After a frenzied investigation, public-health officials announced that the cause was E. coli O157:H7, and the source was hamburger meat served at a Jack in the Box restaurant. During this unprecedented crisis, four children died and over seven hundred others became gravely ill. Poisoned delivers a jarringly candid narrative of the fast-moving disaster, drawing on access to confidential documents and exclusive interviews with the real-life characters at the center of the drama—the families whose children were infected, the Jack in the Box executives forced to answer for the tragedy, the physicians and scientists who identified E. coli as the culprit, and the legal teams on both sides of the historic lawsuits that ensued. Poisoned reveals the evolution and history of America’s food supply system, as well as the untold stories of the victims of notorious outbreaks, and spotlights high-profile criminal prosecutions for those responsible. Poisoned will go directly to the source, following the distribution trail from start to finish, examining where the process breaks down, as well as the bureaucratic red tape and collusion among lobbyists and lawmakers that work against addressing this life-or-death problem.

See you there. Any questions, shoot me an email at [email protected].

Even if you cannot attend, consider a donation – Helpline House, please donate here 

And, proof of life at Tribeca:

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

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

So, here is my offer – to any restaurant chain that will offer hepatitis A vaccinations to all present and future employees and I will agree to consult with that restaurant for $1.00 and conflict Marler Clark, Inc., PS 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. 

Or, at least email me ([email protected]) your mailing address for a t-shirt. I sent dozens to the NRA and the CDC.

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

ACIP Secretariat
Advisory Committee on Immunization Practices 
1600 Clifton Road, N.E., Mailstop H24-8
Atlanta, GA 30329-4027
[email protected]

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

Dear ACIP Secretariat:

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

Too bad the Taco Bell worker was not already vaccinated.

The Snohomish County Health Department has identified a case of hepatitis A that occurred in a food worker who worked at two Taco Bell locations: 2727 Broadway in Everett and 303 91st Ave NE in Lake Stevens.

Anyone who ate food from the Everett location on May 22 or 23 or from the Lake Stevens location on May 23 should take the following actions:

• Check if you are vaccinated against or immune to hepatitis A. People who are vaccinated or immune do not need to take any further action as they would be considered protected against this exposure. People can check their vaccination records by contacting their healthcare provider, using the Washington Immunization Information System at https://wa.myir.net or, if available, referring to their copy of their immunization record. People who have previously been infected with hepatitis A also may be immune. If they are not sure, they should check with their healthcare provider. 

Hepatitis A vaccine should be administered as soon as possible, within 2 weeks of exposure, to all unvaccinated people aged12 months or olderepatitia a who have recently been exposed to hepatitis A virus (HAV).

It is surprising the the Hepatitis A vaccines are not being offered to all exposed patrons by the Snohomish Department of Health.

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

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

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

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

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

Norovirus is a nasty bug.

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

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

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

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

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

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

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

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

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

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

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

Make Cronobacter sakazakii reportable and save lives.

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The Centers for Disease Control and Prevention (CDC) estimates that Salmonella bacteria cause approximately 1.35 million human infections and 26,500 hospitalizations in the United States every year. Of those infections, over 23% are attributed to poultry consumption. Foodborne illness can have a devastating impact, both personally and financially, on people’s lives, the cost of which reverberates through the economy. Data from USDA’s Economic Research Service (ERS) show the total cost for foodborne Salmonella infections in the United States is a staggering $4.1 billion annually and the cost for the loss of productivity to the economy is $88 million. These are real costs to real people that can and should be prevented.

“USDA is taking science-based, decisive action to drive down Salmonella illnesses linked to poultry products,” said Agriculture Secretary Tom Vilsack. “Today’s proposal represents the first step in a broader effort to control Salmonella contamination in all poultry products, as well as a continued commitment to protecting American consumers from foodborne illness.” 

Under this proposal, FSIS would consider any breaded stuffed raw chicken products that include a chicken component that tested positive for Salmonella at 1 colony forming unit (CFU) per gram prior to stuffing and breading to be adulterated. FSIS is also proposing to carry out verification procedures, including sampling and testing of the chicken component of breaded stuffed raw chicken products prior to stuffing and breading, to ensure producing establishments control Salmonella in these products. If the chicken component in these products does not meet this standard, the product lot represented by the sampled component would not be permitted to be used to produce the final breaded stuffed raw chicken products. The chicken component represented by the sampled lot would need to be diverted to a use other than breaded stuffed raw chicken products.

Breaded stuffed raw chicken products are pre-browned and may appear cooked, but the chicken is raw. These products are stuffed with ingredients, such as a raw vegetable, butter, cheese or meat such as ham. The products are typically cooked by consumers from a frozen state, which increases the risk of the product not reaching the internal temperature needed to destroy Salmonella. In addition, it may be difficult for a consumer to determine an accurate internal temperature of these products because they contain multiple ingredients that may cook at different rates.

In proposing to declare Salmonella an adulterant in breaded stuffed raw chicken products, FSIS based its decision on several factors, including that since 1998, FSIS and its public health partners have investigated 14 Salmonella outbreaks and approximately 200 illnesses associated with these products. The most recent outbreak was in 2021 and resulted in illnesses across 11 states. 

The labeling of these products has undergone significant changes over time to better inform consumers that they are raw and to provide instructions on how to prepare them safely. Despite these efforts to improve labeling, these products continue to be associated with Salmonella illness outbreaks. Additionally, data from outbreaks and FSIS’ consumer research show that some people may not realize these products contain raw chicken because the outside may appear browned and cooked, which leads them to believe that the product is safe to eat as is or not cook the product to a safe internal temperature.

FSIS is seeking public comments on the proposed determination and the proposed verification sampling program. 

Comments on the proposed determination and verification procedures must be received within 60 days after publication in the Federal Register.  

Comments may be submitted online via the federal Rulemaking portal, available at https://www.regulations.gov; by mail sent to Docket Clerk, U.S. Department of Agriculture, Food Safety and Inspection Service, 1400 Independence Avenue SW, Mailstop 3758, Washington, DC 20250-3700, or by hand or courier delivery to 1400 Independence Avenue SW, Jamie L. Whitten Building, Room 350-E, Washington, DC 20250-3700. All items submitted by mail or electronic mail must include the agency name and docket number FSIS-2022-0013.

Here has been my take on Salmonella as an adulterant.

USDA/FSIS has the authority to deem Salmonella and other pathogens adulterants – they just need to use it.

Everyday Americans will bring a food product (poultry) into their homes that is likely teeming with Salmonella that the manufacturer – by law and with the USDA stamp of approval – knowingly can sell knowing that it may well be tainted with a pathogen that sickens over 1,000,000 yearly.  This is because USDA/FSIS does not consider Salmonella an adulterant.

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

Ignoring Salmonella in meat makes little, if any, sense.

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

The Wisconsin Supreme Court in Kriefall v Excel called it as it saw it – at least with respect to E. coli – but the analysis is spot on for Salmonella as well:

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

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

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

Here is the law:

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

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

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

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

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

Here is the law specifically related to poultry:

Title 21 – FOOD AND DRUGS CHAPTER 10 – POULTRY AND POULTRY PRODUCTS INSPECTION

(g) The term “adulterated” shall apply to any poultry product under one or more of the following circumstances:

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

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

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

Hmmm. It is hard to read the above and not think that the words equate to all E. coli as well as Salmonella — frankly, all pathogens in food.

I know, I am just a lawyer, but don’t ya think that when food with animal feces (and a dash of E. coli O157:H7) in it is considered an adulterant, that other animal feces (with dashes of other pathogens, like Salmonella) in them, should be considered adulterated too?  But, hey, that is just me.

Another odd governmental fact is that the FDA does not seem to make a distinction between pathogens it considers adulterants or not.

FDA’s enabling legislation – Sec. 402. [21 USC §342] of the Food, Drug & Cosmetic Act also defines “Adulterated Food” as food that is:

(a) Poisonous, insanitary, or deleterious ingredients.

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

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

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

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

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

I would pay to watch it.

And so now onto some history to ruin your appetite.

In 1971 the American Public Health Association (APHA) sued the USDA on the grounds that its mark of inspection (“USDA inspected for wholesomeness”) was misleading because, even though the USDA had put its stamp of approval on meat—literally—it did not, for example, test the meat for bacteria. Moreover, APHA argued that raw meat was commonly contaminated with Salmonella, which posed a risk to the public health. According to APHA, the USDA should instead require that meat carry both a warning label and cooking instructions. The USDA opposed the APHA, helped ably (and predictably) by the meat industry. As quoted by Marion Nestle in her great book, Safe Food, the USDA’s position was that, given how many foods are contaminated with Salmonella, “it would be unjustified to single out the meat industry and ask that the [USDA] require it to identify its raw products as being hazardous to health.” Nestle at 66. (Note to Reader: No, I am really not making this up.)

In 1974, the DC Circuit Court of Appeals upheld the position of the USDA and the meat industry, doing so in a way that was as nonsensical as it was sexist. The court stated that: “The presence of salmonellae on meat does not constitute adulteration within this definition [of ‘adulterated,’ provided in 21 U.S.C. § 601 (m)]….As it said in its letter of August 18, 1971 ‘the American consumer knows that raw meat and poultry are not sterile and, if handled improperly, perhaps could cause illness.” In other words, American housewives and cooks normally are not ignorant or stupid and their methods of preparing and cooking of food do not ordinarily result in salmonellosis.’” APHA v. Butz, 511 F.2d 331, 334 (1974).

This remained the position of the USDA and the meat industry until 1994 when, in an act of both common-sense and bravado, Michael Taylor, then FSIS Administrator, announced that E. coli O157:H7 would be deemed an adulterant in raw ground beef. The Agency did not, however, change its tune with regard to any other pathogens, especially Salmonella. Indeed, in 1999, when FSIS announced it inane distinction between E. coli O157:H7 in “intact” meat versus “non-intact” meat, the Agency continued to focus on how a given meat was “customarily cooked” as a chief determinant of whether it must be treated as an adulterant. Thus, for example, because it decided that “intact steaks and roasts are customarily cooked in a manner that ensures that these products are not contaminated with E. coli O157:H7,” there was no need to treat this deadly pathogen as an adulterant on intact cuts of meat. Of course, this FSIS policy is also one that appears to have been silently jettisoned by the Agency of late.

The Agency’s position on Salmonella and meat came back to haunt it in a big way when FSIS tried to shut down Supreme Beef Processors, Inc. for repeatedly failing Salmonella performance standards that, according to the Agency, was proof that the ground beef being made there was being processed under “insanitary conditions.” Supreme Beef sued the USDA and not only won an injunction, but it succeeded in having the Salmonella regulations struck down as being “beyond the authority granted the Secretary [of the USDA] by the Federal Meat Inspection Act.” Supreme Beef v. USDA, 275 F.3d 432, 434 (5th Cir. 2001). Explaining its holding, the Court wrote:

The difficulty in this case arises, in part, because Salmonella, present in a substantial proportion of meat and poultry products, is not an adulterant per se, 21 meaning its presence does not require the USDA to refuse to stamp such meat “inspected and passed.” 22 This is because normal cooking practices for meat and poultry destroy the Salmonella organism, 23 and therefore the presence of Salmonella in meat products does not render them “injurious to health” 24 for purposes of § 601(m)(1). Salmonella-infected beef is thus routinely labeled “inspected and passed” by USDA inspectors and is legal to sell to the consumer.

Supreme Beef, 275 F.2d at 438-39. And, of course, not surprisingly, the court in this case was quick to cite the decision in APHA v. Butz, and to note that even now the “USDA agrees that Salmonella is not an adulterant per se.” Id. at 439 n. 21.

In my view the Supreme Beef decision is poorly reasoned and ill-informed. (For example, could not someone at the Court figure out that it is impossible for meat to be “infected” with Salmonella, and the proper term here is “contaminated”?) But the real lesson of Supreme Beef is that the USDA was, and continues to be, an Agency that is unable to decide whose side it is on. Sometimes it puts on its public safety hat, and sometimes—actually, most often—it puts on its pro-meat industry hat. And, unfortunately, these roles are too often contradictory. That is why USDA policy when it comes to meat safety is also too often contradictory.

Perhaps it is just time for the FSIS to take the the position that all pathogens that can kill you in meat are adulterants.  You have the authority – you just need to use it.

Here are a few pages that made it into the first paperback version, but not the current one:

Here is the latest update that also did not make it:

October 11, 2022

Just over 20 years after Bill penned an Op-ed for the Denver Post in which he challenged the USDA/FSIS and the Beef Industry to “Put me out of Business,” E. coli cases linked to ground beef have nearly, but not completely, disappeared. As Bill tells it, “I could count on a significant E. coli outbreak and recall occurring like clockwork nearly every Spring or Summer. When 2003 came, there were no outbreaks, and other than the tragic uptick in 2007 that impacted Stephanie Smith, E. coli cases linked to ground beef are no longer a part of the work we do anymore.  The industry to its credit did its job and met my challenge.”

Since the 2018 E. coli outbreak linked to Romaine lettuce from Yuma, E. coli, Salmonella, Listeria, and hepatitis A outbreaks linked to fresh fruits and vegetables now take up the bulk of Bill’s attention.  Romaine lettuce E. coli outbreaks have now replaced ground beef as the staple of the Marler Clark practice.

In 2019 Bill launched a petition to ban Salmonella from chicken like E. coli were banned from ground beef.  Thus far the USDA/FSIS has resisted, but it has banned Salmonella from certain chicken products.  As Bill says, “A win is a win, even if a small one.”

The COVID-19 Pandemic may have slowed Bill’s world-wide travel schedule, but it barely impacted reported foodborne outbreaks and the litigation that surrounds them.  Salmonella-tainted onions in 2020 and 2021 sickened thousands in the United States and Canada.  Salmonella-laced ground turkey sickened dozens, organic yogurt nearly caused the death of three children with E. coli-mediated HUS in 2021.  Hepatitis A outbreaks linked to ill workers in multiple restaurants (Bill has for decades urged the restaurant industry to offer hepatitis A vaccines to employees) in New Jersey and Virginia sickened nearly 100, causing five deaths and three liver transplants.  In 2022, a Salmonella outbreak hit peanut butter, again, and Listeria in ice cream raised its deadly head.

2022 has also put social media and “influencers” from Instagram and TikTok on the same footing as CDC epidemiologists.  Public health officials seemed completely oblivious to hundreds of people suffering with acute liver failure after consuming an organic, vegan home-delivered food produced by a company backed by the power of Serena Williams and Gwyneth Paltrow.  Bill now represents 361 of the customers in a Federal Court lawsuit that stretches from New York City to the mountains of Peru.

The pandemic years have turned Bill into nearly a “virtual” lawyer.  Instead of crisscrossing the world to appear in Court or to give a speech on “why it is a bad idea to poison your customers,” Bill will log in to his custom-built studio from his Bainbridge Island satellite office.  The pandemic has also ushered in other changes at Marler Clark, with three of the four founding partners retiring.  Bruce Clark, Denis Stearns and Andy Weisbecker have opted for a bit slower pace out of Bill’s wake.

Bill when asked when he might retire as well, quickly responds, “I still have much to do. I still love helping people and trying to do my part to make sure there are fewer Bri’s in the future than in the past or the present.” 

Well, perhaps the next version.

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You will also start seeing the below ads on a variety of social media platforms in the coming months.

FDA leadership – well, what’s left – time to pay attention.

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.”

As of March 30, 2023, 12 people infected with the outbreak strain of Salmonella have been reported from 11 states – California, Oregon, Nebraska, Minnesota, Iowa, Missouri, Illinois, Tennessee, Ohio, Virginia and New York. Illnesses started on dates ranging from Dec. 6, 2022, to Feb. 13, 2023. Sick people range in age from 12 to 81 years, with a median age of 64, and 92 percent are female. Of 10 people with race or ethnicity information available, eight are White, two are Asian, and no one reported Hispanic ethnicity. Of 12 people with information available, three have been hospitalized. No deaths have been reported. Investigators are working to identify specific brands of flour that are linked to illness. In the meantime, CDC always advises you not to eat raw cookie dough or cake batter.

2021 Multistage Outbreak of E. Coli O121 linked to Flour
As of July 27, 2021, 16 people infected with the outbreak strain of E. coli O121 were reported from 12 states. Illnesses started on dates ranging from Feb. 26, 2021, to June 21, 2021. Sick people range in age from 2 to 73 years, with a median age of 13, and 100 percent are female. Of 16 people with information available, seven have been hospitalized. One person has developed a type of kidney failure called hemolytic uremic syndrome (HUS). No deaths have been reported. FDA is conducting a traceback investigation using purchase records from locations where sick people bought cake mix to try to determine a common cake mix brand or production facility. CDC advises people not to eat raw cake batter, whether made from a mix or homemade. Eating raw cake batter can make you sick. Raw cake batter can contain harmful bacteria. Bacteria are killed only when raw batter is baked or cooked.

2018-2019 Multistate Outbreak of E coli O26 Linked to Flour
In May 2019 the CDC announced an investigation of E. coli O26 infections linked to flour produced by ADM Milling Company and sold at ALDI grocery stores. As of July 11, 2019, there were 21 outbreak associated cases reported by 9 states. Illnesses started on dates ranging from Dec. 11, 2018, to May 21, 2019. Three people were hospitalized. No one died. In interviews, four ill people reported eating, licking, or tasting raw, homemade dough or batter. Investigators with the Rhode Island Department of Health collected records and flour samples at a bakery where an ill person reported eating raw dough. The bakery used Baker’s Corner All Purpose Flour from ALDI. The outbreak strain was isolated from an unopened bag of Baker’s Corner All Purpose Flour collected at the bakery. On May 23, 2019, ADM Milling Co. and ALDI recalled 5-pound bags of Baker’s Corner All Purpose Flour. Recalled flour was sold at retail locations in Connecticut, Delaware, Massachusetts, New Hampshire, New Jersey, New York, Ohio, Pennsylvania, Rhode Island, Vermont and West Virginia. On June 13, 2019 King Arthur Flour Inc. a customer of ADM announced a recall of 14,218 cases of 5-pound bags of King Arthur Unbleached All-Purpose Flour. On June 14, 2019 another customer of ADM Milling Company, Hometown Food Company, announced a recall of 5-pound bags of Pillsbury Best Bread Flour. On June 14, 2019 Hometown Food Company, a customer of ADM Milling Co., announced a recall of Pillsbury Best Bread Flour. On June 21, 2019, Brand Castle, LLC of Bedford Heights, Ohio recalled several brands of cookie and brownie mix because the flour used in them was potentially contaminated.

2015-2016 Outbreak of E. coli O121 linked to General Mills’ Flour
In June 2016 the CDC announced that public health officials were investigating a multistate outbreak of E. coli O121 linked to flour produced at the General Mills’ Kansas City, MO, facility. In interviews with ill persons, sixteen (76 percent) reported that they or someone in their household used flour in the week before they became ill. Twelve (55 percent)of 22 people reported using Gold Medal brand flour. On Sept. 29, 2016, the outbreak was declared to be over. There were 63 ill people reported by 24 states. Seventeen people were hospitalized. One person developed hemolytic uremic syndrome. No one had died. Illness onset dates ranged from Dec. 21, 2015, to Sept. 5, 2016. The FDA identified STEC O121 in open samples of General Mills flour collected from the homes of ill persons in Colorado, Arizona and Oklahoma. On May 31, 2016 General Mills recalled several sizes and varieties of Gold Medal Flour, Gold Medal Wondra Flour, and Signature Kitchens Flour. On July 1 General Mills expanded the recall. the recall was expanded again on July 25, 2016.

2015-2016 Multistate Outbreak of E. coli O157 Linked to Dough Mix at Pizza Ranch
In 2016 public health officials investigated an outbreak of E. coli O157 linked to consumption of products made with contaminated dough mix. A total of 13 cases were reported by nine states. Eight people were hospitalized. There were no deaths. Illness onset dates ranged from Dec. 6, 2015, to Feb. 9, 2016. Nine of 12 people interviewed reported eating at one of nine locations of an unidentified restaurant during the week preceding illness onset. Eight ate a specific dessert pizza made through a proprietary dough mix provided by un unnamed manufacturer. The ninth patient consumed bread sticks made from the same dough mix. Eighty-eight samples of dry dough mix from five restaurant locations where patients reported eating were collected by public health officials in five states. The Minnesota Department of Agriculture identified non-0157 STEC in 17 collected samples, including one Shiga toxin-1-producing non-O157 STEC isolate and six Shiga toxin 2 (stx2)-producing non-O157 STEC isolates. FDA collected 6 samples of dry dough mix from the unnamed manufacturer. All six samples tested negative for STEC O157, but one yielded an stx2 producing STEC O8:H28. All identified strains lacked known adherence factors and were therefore considered to present low health risk.

2009 Multistate Outbreak of E. coli O157:H7 Linked to Nestle Raw Refrigerated Prepackaged Cookie Dough
Eighty ill people infected with a single strain of E. coli O157:H7 were identified in at least 31 states. At least 70 of these illnesses were confirmed by an advanced DNA test as being the same strain of E.coli O157: H7. An epidemiological study indicated a strong association between eating raw, prepackaged, cookie dough and infection; Nestle Toll House brand cookie dough was mentioned by most ill persons who had reported eating cookie dough. On June 29, 2009, the Food and Drug Administration announced that they had found E.coli O157:H7 in a package of cookie dough that had been collected from a Nestle plant on June 25. The strain identified from the package was different from the outbreak strain. E.coli O157:H7 infection had not been previously associated with eating raw cookie dough. The strain of E.coli O157:H7 associated with this outbreak had been associated with earlier outbreaks going back to February 2005. Although the investigation found no conclusive evidence that contaminated flour was the outbreak source, contaminated flour remained the prime suspect in this outbreak. A single, large purchase of contaminated flour could have been used to manufacture multiple lots and varieties of dough over time as was consistent with the variety of UBD codes on product packages from ill consumers.

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

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

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

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

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

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

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

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

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

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

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

A few weeks ago I posted, “Putting the F – Food – back into the FDA.”  I was wrong. 

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).

Last fall the credibility of the FDA was again 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. Faced with angry parents and politicians, the leadership at the FDA opened an old playbook to avoid accountability – ask a panel to give recommendations.

Enter the Reagan-Udall Foundation.

The Reagan-Udall panel was made up of esteemed supporters of the FDA and its function.  Those asked to testify before the panel (including myself) all had a deep desire to create a functioning FDA that would do its function at the highest levels. Click here for the full report.

My vision of a more empowered food side of the FDA would have created two Senate-appointed commissioners – one with a portfolio of all aspects of food as mentioned above and one with a portfolio of drugs and medical devices.  

The first option of the Reagan-Udall panel is to “Create Separate Food and Drug Administrations within HHS.”

Pulling from the panel’s recommendations, the FDA’s path to a better food supply seems clear, albeit a lot to “chew on.”

Here is a chart from the report:

I believe the Human Foods Program should have clear lines of authority and accountability.

Within the Human Foods Program, the importance of nutrition should be elevated – although I might add, not at the expense of food safety.

The foods portfolio of the Office of Regulatory Affairs (ORA) – the inspection arm – should be integrated directly with the other elements of FDA’s Human Foods Program.

The food-relevant work of the Center for Veterinary Medicine (CVM) should be integrated with the overall FDA Human Foods Program. 

A new Foods Advisory Committee, at the Commissioner level, should be established to strengthen external input to Human Foods Program activities.

Structure changes should be implemented with cultural transformation efforts.

Given the economic impact that foodborne illness and diet-related chronic disease have on Americans and the federal budget, it is imperative that the Human Foods Program become more prominent. When compared to the medical products programs within FDA, the Human Foods Program continuously struggles for visibility and prominence. A component of this elevation of the Human Foods Program is strong advocacy to advance the Human Foods Program at all levels of the government, especially at the Department of Health and Human Services (HHS) and the White House, including the Office of Management and Budget.

It is time the White House and Congress take responsibility for protecting the public by breaking the FDA apart and creating a new dedicated foods agency.

Go to www.marlerblog.com to check out my new “GET THE F OUT OF THE FDA” ad campaign.

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ACIP Secretariat
Advisory Committee on Immunization Practices 
1600 Clifton Road, N.E., Mailstop H24-8
Atlanta, GA 30329-4027
[email protected]

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

Dear ACIP Secretariat:

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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I was given some time to talk with Dr. Califf about the recent call by the Regan-Udall task force he empowered to give recommendations as to how the food side of the FDA should be restructured.  Here are his thoughts on how he is responding to those recommendations.

Bill Marler

I was one of the people that testified in front of the Reagan Udall group. I think I may have been the only person who was a speaker who stayed all two days and watched the whole thing. So, I had a kind of ringside seat to see a lot of good people testifying in a great committee you set up. I know what your proposal is for the new, revised position, and I guess at a 35,000-foot level — it seems — like we’re going back to the way it was with Doctor Hamburg and Mike Taylor in the Obama administration. I’d like your thoughts as to whether this new proposal is similar in kind or different from what was under the previous administration — in the Obama administration?

Dr. Robert M. Califf

Yeah, I think if all you did was look at the boxes, I completely agree with you. It’s a similar construct, but what’s very different is the focus on the operational infrastructure and how it functions, and the clarity of decision rights in a matrix organization. So, I think it is fundamentally different, but not at the box level, more at the functional level. And the systems that we’re putting into place, I would call it a modernized construct of how a complex organization should be run. I think if you look at most major corporations or universities, you’ll see a similar set of constructs because it is complex and so thinking of it all as a linear hierarchy is, in my view, not the best way to get all the things done that need to get done in a complex organization.

Bill Marler

I know you know everything in DC has a lot to do with timing. What’s your thoughts on the timing of the rollout of this? Is it something that we’re going to see in 2023? 2024? Is it going to get wrapped up into the presidential race? And then the other question is, have you thought about what the role, and the kind of person you’re going to be looking for in this deputy Commissioner?

Dr. Robert M. Califf

I think of the rollout in three phases, one of which is already well underway. A lot of things have been done with the Solomon report and the testimony of Reagan Udall, and, as I keep saying, the background of the FSMA documents and the New Era (of Smarter Food Safety) document. We got all the writing that we need to know a lot of things that need to be done. And so many of those at that sort of fundamental enterprise level are being done, like a better complaint system. All sorts of things related to the personnel. Then there’s an intermediate phase which is, we got to find a person and hire them to be the leader. We’ve got this operational group of young leaders from all the elements of the program meeting. And I think it’s always amazing when you take people that are highly dedicated to a mission who’ve not had the chance to say, “OK, if you had a hypothetical country and you were starting afresh, how would you do it?” All kind of interesting things come out. And then there’s the long term, sort of cultural things that people talk about — you don’t change those overnight. And there will be elements that will require significant investments — like information technology that will take time. Some of these are things that in private industry or in university you would do very quickly, but they can’t be done quickly in government, because we, as I’ve said, have a lot of bosses. And we also have an obligation to the employees and the unions that represent them to make sure that we reach agreement on the best way forward before we implement anything.

Bill Marler

The proposal that you have does, or does not, require congressional approval or buy off? Or is it something that can be done within FDA?

Dr. Robert M. Califf

We can do everything within this proposal with congressional notification, but this is not my first time around this block and notifying Congress with all the opinions that exist is tantamount to getting approval. Because there will be opinions expressed heavily and we want Congress’s support. This is a big change in the way the FDA functions and we want everyone to get on board and have input where it’s going to be helpful. You mentioned the leader. I’m from South Carolina, so I have these aphorisms, but “barking cat” is not a bad phrase to use because I’ve noticed in the food world that there’s not agreement across the whole food world about what should get priority. And the nutrition world and the food safety world live are connected — but they live in different universes. And we’ve got this looming issue of chemicals and the environment, which affect food, which gets into a whole different area of science. We need a leader who can bring these elements together.

Bill Marler

Obviously in in my world, I’m a hammer and E. coli and listeria are nails. So that’s kind of how I view the world. But it was fascinating sitting there listening to the folks who are very interested in nutrition testify to the Udall group. They were gentle to say, ‘gosh, you guys spend way too much time paying attention to pathogens. They sicken people right away, and you’re not paying attention to the big issues of obesity, heart disease, diabetes as much as you should.’ Do you see that as part of what you see the role of this new person? To be better at integrating nutrition and food safety and chemicals into one thing?

Dr. Robert M. Califf

Yes, and it needs to go beyond. The fine art of being an FDA politician — you learn how to say that whatever is brought up is your top priority. You need to get beyond the lip service here. I just want to hammer home this nutrition thing because it’s not either or. There are amazing things we can do with food safety as you well know but we’ve got a decline in life expectancy in this country, to the point that we’re living five years shorter than the average of other high-income countries. Driven by COVID with misinformation about vaccination, but equally as much now by the resurgence of common chronic disease, which has a nutritional origin, and if you look at the future — look at our teenagers and young adults, 600,000 teenagers with Type 2 diabetes within this decade, all driven by nutritional issues. No question about it. We’ve got to fix this. And it’s not just FDA’s issue, of course, but we have a role to play, and we need to make sure it’s elevated and done well.

Bill Marler

I think that’s the balancing act that hopefully this new person will adeptly do. I got a copy of a recent letter sent to Secretary Becerra from a large group of consumers and industry groups. I don’t know if you’ve seen that, but it did take to task your suggested change. Specifically, commenting on how this new change wouldn’t bring in ORA and veterinarian medicine aspects of the FDA under the Food Commissioner. I don’t know if you’ve seen the letter, but I think you probably heard from them in one form or another. I just wondered if you had any thoughts or comments about the concerns raised by those groups?

Dr. Robert M. Califf

I’ve talked with these groups multiple times, as you well know, and I’ve seen the letter. What I’ve said to them is, keep the drumbeat going about what you see as a problem. I’m happy to have you make suggestions, but I’m much more attuned to solving the problems, than I am to being told who should report to who. It’s OK to suggest it, but if you’d really like to get involved in that, we got jobs. So, feel free to apply and you can be involved in those details. So those are going to be worked out by the operations group that we have in play. I’m very attuned to the issues that they’re raising. I think they’re raising the right issues, but my solutions may take a different form. And if they’re not solving the problem, then we’ll have to change what we do. For example, the Center for Veterinary Medicine — I think you’re familiar with the arguments on both sides — I would say that’s emblematic of modern complex organizations where people need to be able to wear two hats at the same time. If you’re in CVM, the majority of your work is going to be animal drugs and devices. And a significant part of the work is going to be directly related to the human foods program. And so, to only wear one hat isn’t going to work. The CVM is like FDA in its entirety for animals, including all the components. So, I think it would be a mistake to have that. If you look at what happened in the old configuration, it never really worked with CVM to be only contained within a food organization. The good news is CVM is highly respected by the constituents it has, and they’ve been pretty vocal — don’t mess with our CVM. ORA is 100 years of history. Remember that I’ve been an inspectee. I’ve been on the other side of the fence. And I think the thing that’s really important is that we maintain the independence and integrity of the inspectorate, but also that the priorities are unified for whatever the program is — and that is again a matrix organization issue that we’re going to need to solve by looking at the details of exactly what are the functions and where should those functions reside within FDA and in the different organizations. Where there’s overlap or redundancy, we want to reduce it as much as we can. And where there’s interaction across areas, we need decision rights about who makes the call, which is one of the things people have pointed out over and over. When you have a situation where it’s not clear who can make the final call, and the lack of clarity leads to indecision, which is, given the pace at which things are changing out there in the world, that’s not the way to do it.

Bill Marler

When I was speaking in front of the group, I looked at how the organization of FSIS is in compared to the Under Secretary of Agriculture. Obviously, I’ve been dealing with those folks for 30 years. But I always kind of know who it is, who I need to deal with — the Under Secretary of Agriculture in charge of food. I think one of the frustrating things that I get in hearing from the variety of groups or people who’ve been at FDA in the past, or consumer groups or industry groups, is — and maybe I’m hearing something from you that maybe you and I agree — is that I think it’s sometimes not knowing who are the decision makers for those things as it relates to understanding how inspections are done, and how that fits with the whole idea of preventive controls under FSMA. I guess that’s the part of the thing that a lot of these groups, and frankly myself wonder, if not having some sort of clearer structure is going to continue this same wondering who’s in charge. Do you have any thoughts about that?

Dr. Robert M. Califf

If we succeed in our plan, there won’t be any question who’s in charge. But I would also say, you know my background was in medicine, and there was a time when the surgeon was in charge of the operating room and no one else could say anything. That was not good. And there’s plenty of research to show that team based clinical care, where the nurse can speak up, the cardiologist can come in the room and say, ‘wait a minute that’s not the right part of the heart you’re operating on,’ –  I’m a cardiologist – and the surgeon is accountable and in charge but operates under rules where people have a voice. You wouldn’t expect a surgeon to be an expert in where all the instruments were being kept in the operating room. I think by the same token, you wouldn’t expect a person who’s an expert in food safety overall and in the concepts of preventive controls to understand what’s involved in the logistics of walking into a plant or a farm and knowing all the things you have to do as an inspector. So there needs to be a voice for the inspectors, but the priorities should be the human foods program and it should be a team. The team needs to have someone who is accountable for different kinds of decisions depending on what the decisions are. If it’s what’s the most efficient way to route the flights for a multitude of inspectors — I used to run a clinical trial monitoring operation as a component to what we did in academic clinical trials — God forbid that I would have to figure out which airline to use for our monitors. That’s something that an inspections group should be able to do really first rate and save money for the organization and have a good set of flight patterns. So, it’s all about teamwork, but teams don’t work if no one knows who’s in charge. I’m also a basketball person and I grew up with Coach K. Can you imagine if you had the huddles during the timeouts and no one was ultimately going to call the shots about what the next play was going to be? And everyone had a discussion and argued about it and left with different impressions of what the next play was going to be? That wouldn’t work very well. I think this idea of the linear hierarchies are better than well-functioning teams — It’s been proven wrong in almost every aspect of society.

Bill Marler

I was a bit surprised by the Reagan Udall Foundation. Their one recommendation regarding structure, right out-of-the-box, was splitting the FDA into having two Commissioners. One Commissioner of Food that had all the aspects of food, including nutrition and the food aspects of ORA and CFSAN. And one under that Commissioner, then reporting to the HHS Secretary. And then a person with drugs and medical devices. Your portfolio in and of itself is overwhelming. But what about a structure that breaks food out of the FDA and had drugs on one side, food on the other. Do you think that’s a workable solution? Over the last 30 years, you’ve heard, Rep. Rosa Delora and Sen. Dick Durbin, and various consumer groups and industry groups tout that. How are you going to respond to that and how is what you’re doing now going to maybe assuage some of their feelings?

Dr. Robert M. Califf

The first point to make is that that’s not my call. My job is to take what I’ve got and make the best of it. Second thing I’ll say is my job is not to assuage their feelings, but it’s nicer if you do. Life is better if they feel better about it. I think it’s important to keep in mind a couple of things. One is the competition for resources and the functioning of an infrastructure, in the US government it helps to be a certain size. I think a lot of people have made the point that deconstructing this would have a significant cost. And in a time where so much change is going on in with what we’re regulating, it’s sort of like changing the tires while the thing is going down the street. So many people have raised it. I’m not saying it’s an irrational idea. One example that I think is really important to consider about the reason the FDA is a good home for a lot of this. In addition to having an inspectorate, which if as we modernize, and I think there are real economies of scale and efficiencies. Let’s look at genetic modification of organisms. The tools to do that are changing at an exponential rate. Such that you don’t have to be that sophisticated to deploy them, but you got to be really sophisticated to have some idea of what they’re doing to an organism. Whether it’s a child with a genetic disease or a plant or an animal, the basic tools are actually the same and there’s a real advantage to the expertise that we got here at FDA as we try to figure out how to regulate these technologies. I think these are going to be essential in a time of climate change on the food side, to enable us to feed the US and the world. We look at infant formula, with the specialty formulas there’s a case where having pediatricians and nutritionists who are tied in with the medical community turns out to be really, really important. I could go on and on. But it’s not my decision to make. I’m going to do the best with what I can do.

Bill Marler

The broader change of splitting and reorganizing would obviously be a congressional or presidential sort of push as opposed to the reorganization that you can accomplish with the structure of the FDA as presently designed.

Dr. Robert M. Califf

Yeah, that’s how I see it.

Bill Marler

Anything that I failed to ask you that you wanted me to ask you and that I can help you with?

Dr. Robert M. Califf

You could have asked about the vision for 10 years from now.

Bill Marler

Oh, yeah. You’re going to stick around that long?

Dr. Robert M. Califf

No, but this not about me, right? Remember, I had no reason to come back to the FDA. I was having a really, really good life and so was my family when I got the call. There was a need. If they had found somebody else to do it, I would have been perfectly happy with that.

Bill Marler

Okay, I’ll ask you the question. So where do you see this all in 10 years?

Dr. Robert M. Califf

Yeah, let’s think about climate change, supply chains, digitization, information infrastructure and architecture, including all of our new favorite thing: Chat GPT and its competitors. So, you can imagine a world where there’s a digital supply chain system, and you have the investigators doing their inspections but armed with very sophisticated algorithms about where the risks are. An education system which is just in time and immediately accessible to the whole spectrum of the 600,000 entities that we regulate in the foods system — God knows how many there will be over 10 years from now. Where regardless of your level of sophistication or knowledge or education, you can tune in and get what you need to know to prevent the problem from occurring. But if you’re not behaving, there’ll be a much better way to tell that you’re likely not behaving, based on the system that is in place. And for food outbreaks, genetic sequencing is going to be in a whole different arena. We should be able to very quickly tell and probably also include some social media component. You’re aware of that with social media, you can tell what restaurant caused the outbreak — that’s been published. And for nutrition and chemicals, we’re in this whole new era for things that were only theoretical before, like: What is the right level of something in a food, whether it’s a nutrient or a toxicant? You’d say, well, zero for toxicants. But you know, we live on a place called Earth, so 0 is not possible for a lot of things. But to figure that out, you need both exquisite measurement of the thing you’re measuring and its effect on biology and also its effect on human populations, which requires big data. We now have no limitation of big data or computer storage. So, it’s possible to envision that we could be feeding the US, a big part of feeding the world, much more nutritious food at a much lower cost to the environment, maybe even a positive environmental effect. That may be far out, but maybe. And where you could be much more assured about the safety of what you’re eating. And employees would be very happy because they wouldn’t be spending their time hand entering data, they’d be taking a picture of whatever they were doing, and AI would take care of storing all of its metadata. That’s what we’re aiming for.

Bill Marler

For a guy who’s been cut off by a judge now and again. I’m pretty good at my timing, so I’ll let you go do your do the rest of your work.

Dr. Robert M. Califf

All right, take care.

Bill Marler

All right. Thank you very much.

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I am a trial lawyer who has for the last 30 years built a practice on food pathogens. Since the Jack in the Box E. coli outbreak in 1993, I have represented thousands of families who were devastated for doing what we all do every day – eat food.  In those 30 years a variety of members of the food industry have paid my clients over $900,000,000.

This may prompt some to consider me a blood-sucking ambulance chaser who exploits other people’s personal tragedies for personal gain. If that is the case, here is my plea:

Put me out of business, please!

For this trial lawyer, E. coli, Salmonella, Listeria, and other pathogens have made a far too successful practice – and a heart-breaking one. I am tired of visiting with horribly sick kids who did not have to be sick in the first place. I am outraged with a government and food industry that allow these poisons to reach consumers. 

So, stop making kids sick and I will happily retire.

The FDA is at a crossroads.  Over 10 years after the passage of the Food Safety Modernization Act (FSMA), the goals of the most significant food safety legislation in decades have remained unfulfilled.  As well-stated recently by Senator Durbin (D-Il) and Congressmember DeLauro (C-CT):

FDA is responsible for the oversight of nearly 80 percent of food in the United States.  Too often, however, FDA has failed to protect Americans from dangerous food pathogens and outbreaks.  Every year, more than 48 million Americans are sickened, 128,000 are hospitalized, and 3,000 lose their lives because of some bacteria or virus in their food.  In 2011, FMSA was signed into law to transform the United States’ approach to foodborne illnesses.  FSMA requested FDA to be more proactive, not reactive, to foodborne illnesses to prevent outbreaks in the first place.  FSMA empowered FDA with new authorities, resources, and funding to accomplish this goal.  But, as outlined in the Reagan-Udall report, FDA has not made this shift, despite FSMA’s passage more than a decade ago.  FSMA required FDA to promulgate several rules so that it would prevent rather than respond to foodborne outbreaks.  However, more than a handful of times, FDA missed congressionally mandated deadlines to implement them.  FSMA also required FDA to “increase the frequency of inspection of all [food] facilities,” to ensure companies’ compliance with safety and quality standards.  But FDA inspections have plummeted since FSMA was signed into law.

The FDA was, and for good reason, embarrassed by the likely illnesses of infants who became sick after consuming formula produced in a manufacturing plant that seemed to care little about the safety of its product.  The FDA failed to properly inspect the plant which then led to formula shortages that still threaten infants today.  For good reason FDA Commissioner Califf asked the Reagan-Udall Foundation expert panel to suggest fixes to the FDA.  

Mr. President, Mr. HHS Secretary and FDA Commissioner please listen to those experts.  Those experts were clear that the current structure at FDA needs change to make food safer.  In its final report the Reagan-Udall Foundation panel in part recommended: 

Given the economic impact that foodborne illness and diet-related chronic disease have on Americans and the federal budget, it is imperative that the Human Foods Program [which includes both food safety and nutrition] become more prominent. When compared to the medical products programs within FDA, the Human Foods Program continuously struggles for visibility and prominence. A component of this elevation of the Human Foods Program is strong advocacy to advance the Human Foods Program at all levels of the government, especially at the Department of Health and Human Services (HHS) and the White House, including the Office of Management and Budget. 

• The Human Foods Program should have clear lines of authority. 
• Within the Human Foods Program, the importance of nutrition should be elevated. 
• The foods portfolio of ORA [inspections] should be integrated directly with the other elements of FDA’s Human Foods Program.
• The food-relevant work of CVM [animal food] should be integrated with the overall FDA Human Foods Program. 
• A new Foods Advisory Committee, at the Commissioner-level, should be established to strengthen external input to Human Foods Program activities.

My vision, perhaps a bit more aggressive, is of a more empowered food-side of the FDA that would create two Senate appointed Commissioners – one with a portfolio of all aspects of food (food safety and nutrition) as mentioned above, and one with a portfolio of drugs and medical devices.

The time for half measures is past.  It is time to be bold.  It is time to move the FDA from reactive to proactive.  It is time to do what needs to be done to bend the curve in the numbers of those negatively impacted by the food they consume.

Progress in the safety of our food supply can be made and history can be a guide.

When the Jack in the Box E. coli outbreak happened in 1993 several hundred were sickened, many severely, with at least four dead, from eating a hamburger.  It was the first crisis of the Clinton Administration and the USDA/FSIS. The meat and restaurant industries were facing the ire of an angry public. Many thought the problem insoluble. Yet, the industry, government and consumers came together to find a way to lower E. coli in hamburger and to drive the numbers of ill down.  

It worked. For years E. coli in hamburger was my firm’s “bread and butter.”  In time the numbers of people sickened by E. coli in hamburger continued to fall to a point that, with government help, the meat industry met my challenge to: Put me out of business, please!

It is now time for the FDA to be reformed enough that the successes of the USDA/FSIS in the 1990’s can be replicated today. The time is long past for the FDA to: Put me out of business, please!

Mr. President, Mr. HHS Secretary and FDA Commissioner please listen.  

Dr.  Califf, I have deep admiration for your past and ongoing public service. The hard work of trying to protect the food and drug supply in the United States is a difficult and at times thankless task. The fact that you have taken this responsibility on more than once speaks volumes to your character.

Your decision post the infant formula scare and shortage in asking the Regan-Udall Foundation to take a critical look at the culture and structure of the FDA took a bit of confidence and a lot of courage. I had the honor to testify before your chosen panel and stayed to listen to the full two days of testimony from thought leaders – consumer, industry, academia and government – on how the “F” in FDA could best accomplish its mission.

Pulling from the panel’s recommendations, the Food and Drug Administration’s path to a safer food supply seems clear albeit a lot to chew on:

Most FDA employees understand the immense responsibility of the Agency’s Human Foods Program, appreciate the importance of their work, and share a common value of striving to protect public health. However, the current culture, structure, and governance model detract from the Program’s effectiveness. 

There are several factors contributing to this culture, including the lack of a clear vision and mission; a disparate structure and a consensus governance model; competing priorities; and the lack of a strong, supportive leader and, when the situation requires, an ultimate decision-maker, who is responsible for the Human Foods Program. The lack of a clear overarching leader of the Human Foods Program has contributed to a culture of indecisiveness and inaction and created disincentives for collaboration. 

The lack of a single clearly identified person to lead the Human Foods Program has adversely impacted the organizational culture and led to overlapping roles and competing priorities that result in what is perceived as constant turmoil. As senior leaders are considered for the Human Foods Program, an ideal leadership skill set should include: 

• Expertise and knowledge in food safety and/or nutrition 
• Ability to make decisions in a complex regulatory environment 
• Ability to lead in a complex work environment 
• Strong demonstrated management capability 
• Superb communication skills 
• Ability to identify and nurture talent 
• Commitment to collaboration, not isolation 
• Capable of breaking down silos 
• Proven abilities to lead, support, and incentivize teamwork 
• Ability to support initiatives that increase staff professionalism and performance 
• Commitment to joint staff development and other activities by the collective parts of the Human Foods Program 

To move the Human Foods Program toward a more enabling and effective culture, the Panel recommends FDA leadership consider the following:

• Identify, communicate, embrace, and promote a clear and compelling vision, mission, and value statement for the Human Foods Program.
• Establish an organizational structure with a clear leader and ensure that there is a clear articulation of roles and responsibilities within the Human Foods Program and a culture that is well-equipped to survive (inevitable) leadership transitions.
• Develop and nurture a culture where regulatory decision-making is rooted in scientific evidence and FDA’s legal framework. 
• Commit to transparency, timeliness, and predictability in decision-making, with a preference toward action. 
• Commit to an on-going process of culture change from the highest levels of FDA leadership. 
• Develop and implement a change management strategy that not only manages change, but also effectively improves and monitors the environment for cultural change. 
• Build expectations and incentives into the system to embrace a positive, collaborative culture that expects, values, and rewards teamwork. 
• Create a culture of feedback and authenticity where continuous, honest, and constructive feedback is given and received.
• Nurture current staff and recruit, hire, and promote top quality staff, including strong managers. 

FDA should increase the visibility and prominence of the Human Foods Program. 

Given the economic impact that foodborne illness and diet-related chronic disease have on Americans and the federal budget, it is imperative that the Human Foods Program become more prominent. When compared to the medical products programs within FDA, the Human Foods Program continuously struggles for visibility and prominence. A component of this elevation of the Human Foods Program is strong advocacy to advance the Human Foods Program at all levels of the government, especially at the Department of Health and Human Services (HHS) and the White House, including the Office of Management and Budget. 

• The Human Foods Program should have clear lines of authority. 
• Within the Human Foods Program, the importance of nutrition should be elevated. 
• The foods portfolio of ORA should be integrated directly with the other elements of FDA’s Human Foods Program.
• The food-relevant work of CVM should be integrated with the overall FDA Human Foods Program. 
• A new Foods Advisory Committee, at the Commissioner-level, should be established to strengthen external input to Human Foods Program activities.

My vision of a more empowered food-side of the FDA would have created two Senate appointed commissioners – one with a portfolio of all aspects of food as mentioned above and one with a portfolio of drugs and medical devices.  However, I learned long ago to listen to those who swim in the deeper end of the intelligence pool.  I think you agree with that. As you were recently quoted in an interview with the Washington Post:

In 2016, there was a deputy commissioner who was empowered. First, I was very comfortable with it. Secondly, it didn’t fix all the problems. There are still issues within that that need to be dealt with. We are coalescing on a plan. I had a deputy commissioner [when I was FDA Commissioner in 2016]. Scott Gottlieb [the next FDA Commissioner] changed that. If a commissioner comes in with grandiose ideas and gets halfway through a change, that’s not good for people. I think we are going to put in structures that are going to survive.

It seems that you, the Regan-Udall Foundation and the departing Frank Yiannas agree on the need for a revised structure within the FDA and the need for a person empowered to deliver and be accountable for creating “the safest food supply in the world”. As Mr. Yiannas recently said:

One, based on my experience these past four years, I (as well as a diverse group of Bipartisan Congressional Leaders and Consumer, State Regulatory, & Industry Stakeholder Groups) firmly believe the agency would operate more effectively and be better able to protect the American public from foodborne illness, with the creation of a more integrated operating structure and a fully empowered and experienced Deputy Commissioner for Foods, with direct oversight of those centers and offices responsible for human and animal foods. In this manner, she or he can more easily make the necessary changes that are needed to transform FDA’s Food Program for the 21st Century. Secondly, I also urge you to consider transferring the small, yet exceptional staff comprising the Office of Food Policy and Response (OFPR) to a new office of the Deputy Commissioner for Foods.

Dr. Califf, thank you for your leadership. The 48,000,000 who are sickened yearly by food they consume, the 125,000 who are hospitalized and the 3,000 that die are counting on you.

Dr. Califf, one final thought; lock the door and do not let Frank Yiannas leave the building.  

Although I do not always agree with Mr. Yiannas on policy, the Reagan-Udall Foundation’s definition of “ideal leadership” reads like a Frank Yiannas resume. The FDA needs someone with broad private sector experience who understands that the power of the FDA to effectuate positive food safety changes – including human nutrition – will come from both consumer and industry stakeholders – not exclusively within the present FDA structure.

When you make the FDA structural change, you need to have someone (Frank Yiannas) at your side. Do not let this moment pass.  We all depend on you.

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— OPINION —

Here are some cases where prosecutors brought criminal charges:

In 1998 in what the first criminal conviction in a large-scale food-poisoning outbreak was, Odwalla Inc. pleaded guilty to violating Federal food safety laws and agreed to pay a $1.5 million fine for selling tainted apple juice that killed a 16-month-old girl and sickened 70 other people in several states in 1996. Odwalla, based in Half Moon Bay, California pleaded guilty to 16 counts of unknowingly delivering ”adulterated food products for introduction into interstate commerce” in the October 1996 outbreak, in which a batch of its juice infected with the toxic bacteria E. coli O157:H7 sickened people in Colorado, California, Washington and Canada. Fourteen children developed a life-threatening disease (hemolytic uremic syndrome -HUS) that ravages kidneys. At the time, the $1.5 million penalty was the largest criminal penalty in a food poisoning case.  Odwalla also was on court-supervised probation for five years, meaning that it had to submit a detailed plan to the food and drug agency demonstrating its food safety precautions and that any subsequent violations could have resulted in more serious charges.

 In 2012 Eric Jensen, age 37, and Ryan Jensen, age 33, brothers who owned and operated Jensen Farms, a fourth-generation cantaloupe operation, located in Colorado, presented themselves to U.S. marshals in Denver and were taken into custody on federal charges brought by the U.S. Attorney’s Office with the Food and Drug Administration – Office of Criminal Investigation. According to the six-count indictment, Eric and Ryan Jensen unknowingly introduced adulterated (Listeria-tainted) cantaloupe into interstate commerce. The indictment further stated that the cantaloupe was prepared, packed and held under conditions, which rendered it injurious to health.  The outbreak sickened over 147, killing over 33 in 28 states in the fall of 2011.  The Jensen’s faced up to six years in jail and $1,500,000 in fines each. They eventually pleaded guilty and were sentenced to five years’ probation.

In 2013 Austin “Jack” DeCoster and his son, Peter DeCoster, both faced charges stemming from a Salmonella outbreak caused by their Iowa egg farms in 2010.  The Salmonella outbreak ran from May 1 to November 30, 2010 and prompted the recall of more than a half-billion eggs. And, while there were 1,939 confirmed infections, statistical models used to account for Salmonella illnesses in the U.S. suggested that the eggs might have sickened more than 62,000 people. The family business, known as Quality Egg LLC, pleaded guilty in 2015 to a federal felony count of bribing a USDA egg inspector and to two misdemeanors of unknowingly introducing adulterated food into interstate commerce. As part of the plea agreement, Quality Egg paid a $6.8-million fine and the DeCosters $100,000 each, for a total of $7 million.  Both DeCosters were sentenced to three months in jail.

 In 2014 former Peanut Corporation of America owner Stewart Parnell, his brother and one-time peanut broker, Michael Parnell, and Mary Wilkerson, former quality control manager at the company’s Blakely, Georgia, plant, faced a federal jury in Albany, Georgia. The 12-member jury found Stewart Parnell guilty on 67 federal felony counts, Michael Parnell was found guilty on 30 counts, and Wilkerson was found guilty of one of the two counts of obstruction of justice charged against her. Two other PCA employees earlier pleaded guilty. The felony charges of introducing adulterated food into interstate commerce, “with the intent to defraud or mislead,” stemmed from a 2008 to 2009 Salmonella outbreak that sickened 714 and left nine dead. Stewart Parnell, Michael Parnell, and Mary Wilkerson were all found guilty on multiple charges.  Stewart and Michael are spending decades in prison.

In 2015 ConAgra Foods agreed to plead guilty and pay $11.2 million in connection with the shipment of Salmonella contaminated peanut butter linked to a 2006 through 2007 nationwide outbreak of that sickened over 700. ConAgra signed a plea agreement admitting that it unknowingly introduced Peter Pan and private label peanut butter contaminated with Salmonella into interstate commerce during the 2006 through 2007 outbreak.

In 2020 Chipotle was ordered to pay $25 million to resolve criminal charges related to the company’s involvement in foodborne illness outbreaks that sickened more than 1,100 people between 2015 and 2018. Chipotle was implicated in at least five foodborne illness outbreaks between 2015 and 2018 connected to restaurants in the Los Angeles area, Boston, Virginia, and Ohio.  These incidents primarily stemmed from store-level employees’ failure to follow company food safety protocols at company-owned restaurants, including a Chipotle policy requiring the exclusion of employees who were sick or recently had been sick. For example, in August 2015, 234 consumers and employees of a Chipotle restaurant in Simi Valley, California reported becoming ill.  Although company policies required the restaurant to report certain employee illnesses to Chipotle safety officials and to implement enhanced food safety procedures, the restaurant did not pass along information regarding an ill employee until multiple consumers already had reported being sick. In December 2015, a norovirus incident at a Chipotle restaurant in Boston sickened 141 people.  According to the DPA, that outbreak likely was the result of an ill apprentice manager who was ordered to continue working in violation of company policy after vomiting in the restaurant.  Two days later, the same employee helped package a catering order for a Boston College basketball team, whose members were among the consumers sickened by the outbreak. In July 2018, approximately 647 people who dined at a Chipotle restaurant in Powell, Ohio reported illness related to Clostridium perfringens, a pathogen that grows rapidly when food is not held at appropriate temperatures.  The local health department found critical violations of local food regulations, including those specific to time and temperature controls for lettuce and beans.

In 2020 Blue Bell pleaded guilty in May 2020 to two misdemeanor counts of distributing adulterated ice cream products.  The sentence, imposed by U.S. District Judge Robert Pitman in Austin, Texas, was consistent with the terms of a plea agreement previously filed in the case.  The $17.25 million fine and forfeiture amount is the largest-ever criminal penalty following a conviction in a food safety case. In March 2015, tests conducted by the Food and Drug Administration (FDA) and Centers for Disease Control and Prevention (CDC) linked the strain of Listeria in one of the Blue Bell ice cream products to a strain that sickened five patients at a Kansas hospital with listeriosis, the severe illness caused by ingestion of Listeria-contaminated food.  The FDA, CDC, and Blue Bell all issued public recall notifications on March 13, 2015.  Subsequent tests confirmed Listeria contamination in a product made at another Blue Bell facility in Broken Arrow, Oklahoma, which led to a second recall announcement on March 23, 2015. According to the plea agreement with the company, FDA inspections in March and April 2015 revealed sanitation issues at the Brenham and Broken Arrow facilities, including problems with the hot water supply needed to properly clean equipment and deteriorating factory conditions that could lead to insanitary water dripping into product mix during the manufacturing process.  Blue Bell temporarily closed all of its plants in late April 2015 to clean and update the facilities. Since re-opening its facilities in late 2015, Blue Bell has taken significant steps to enhance sanitation processes and enact a program to test products for Listeria prior to shipment. Paul Kruse, President and CEO of Blue Bell Ice Cream, is faced a felony trial in 2022. 

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.

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According to the CDC, as of December 29, 2022, a total of 15 people infected with the outbreak strain of Salmonella have been reported from three states Nebraska (8), Oklahoma (1) and South Dakota (6). Illnesses started on dates ranging from December 2, 2022, to December 13, 2022 linked to SunSprout alfalfa sprouts. That number is likely and undercount and that number will likely increase.

I have lost track of the numbers of “Sproutbreaks” over the years linked to E. coli, Salmonella or Listeria. My fiends at Barblog have been tracking “Sproutbreaks” for years: “We document at least 55 sprout-associated outbreaks occurring worldwide affecting a total of 15,233 people since 1988. A comprehensive table of sprout-related outbreaks can be found here.“

Is it past time for a warning label for sprouts?

Perhaps the labeling could mirror the requirements now found on unpasteurized juices?

WARNING: This product may contain harmful bacteria that can cause serious illness in children, the elderly, and persons with weakened immune systems.

Or, perhaps a bit further?

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

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

Here is the CDC warning :

Sprouts Not Healthy Food for Everyone

Children, the elderly, and persons whose immune systems are not functioning well should not eat raw sprouts, because current treatments of seeds and sprouts cannot get rid of all bacteria present. Persons who are at high risk for complications from foodborne illness should probably not eat raw sprouts, according to an article in the current issue of Emerging Infectious Diseases, CDC’s peer-reviewed journal, which tracks new and reemerging infectious diseases worldwide. Although sprouts are often considered a “health food,” the warm, humid conditions needed for growing sprouts from seeds are also ideal for bacteria to flourish. Salmonella, E. coli, and other bacteria can grow to high levels without affecting the appearance of the sprouts. Researchers have treated both seeds and sprouts with heat or washed them in solutions of chlorine, alcohol, and other chemicals. Some of these disinfectants reduced the levels of bacteria, but a potential hazard remained, especially for persons with weak immune systems. High temperatures that would kill the bacteria on the seeds would also keep them from sprouting. Until an effective way is found to prevent illness from sprouts, they should be eaten with caution, if at all.

I think it is time for a warning label — past time. Here is my idea:

This is something I posted during the COVID-19 pandemic.

Thank you www.barfblog.com

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

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

Here is the CDC warning :

Sprouts Not Healthy Food for Everyone

Children, the elderly, and persons whose immune systems are not functioning well should not eat raw sprouts, because current treatments of seeds and sprouts cannot get rid of all bacteria present. Persons who are at high risk for complications from foodborne illness should probably not eat raw sprouts, according to an article in the current issue of Emerging Infectious Diseases, CDC’s peer-reviewed journal, which tracks new and reemerging infectious diseases worldwide. Although sprouts are often considered a “health food,” the warm, humid conditions needed for growing sprouts from seeds are also ideal for bacteria to flourish. Salmonella, E. coli, and other bacteria can grow to high levels without affecting the appearance of the sprouts. Researchers have treated both seeds and sprouts with heat or washed them in solutions of chlorine, alcohol, and other chemicals. Some of these disinfectants reduced the levels of bacteria, but a potential hazard remained, especially for persons with weak immune systems. High temperatures that would kill the bacteria on the seeds would also keep them from sprouting. Until an effective way is found to prevent illness from sprouts, they should be eaten with caution, if at all.

I think it is time for a warning label — past time.

Famous Anthony’s “About Us” Page in its website tells the story of a family run, Roanoke institution that has been taken to its knees in bankruptcy because one employee was not vaccinated against hepatitis A. Sadder still are the 50 customers sickened, some so severely that they required liver transplants, and in four instances they died, including two members of one family.

The “About Page” says:

We are often asked what makes us famous.  We’ve always been known for our food and service, but to us, it’s our customer (you!) that makes us famous.  Since 1986 we’ve been an integral part of the community and our story has been woven by our customers, spanning many generations of families.  It’s their stories that makes ours.   

We are still family owned and operated and you can often find Mr. Anthony out and about in the restaurants.  So come by and give us a visit.  As our customers say, visit once and you’re family.”

My guess is that Mr. Anthony wishes that he had taken the About Page to heart and protected his family by offering vaccinations to all employees or seeking free vaccines from the local health department.  But, he did not and now it is too late for many customers and for his 40 year old business.

An outbreak of hepatitis A occurred in the early fall of 2021 in Roanoke City, 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 City Health Department, along with the Virginia Department of Health, investigated this outbreak. Three different Famous Anthony’s locations were ultimately found associated with this outbreak: 6499 Williamson Road, Roanoke; 4913 Grandin Road, Roanoke; and 2221 Crystal Springs Avenue, Roanoke. A public posting was made by the Virginia Department of Health on September 24, 2021, about this outbreak and the potential exposure risk. 

As of November 2021, a total of 52 primary cases (41 confirmed and 11 probable) were identified in this outbreak. Two secondary cases were also identified. Cases ranged from 30 to 82 years of age (median 63). In all, 57 percent of cases were male. Thirty-three cases included hospitalizations, and at least 4 cases involved deaths. Exposures to the Famous Anthony’s food establishments occurred between August 10 and 27, 2021. Illness onsets occurred between August 25 and October 15, 2021.

A cook, who also had risk factors associated with hepatitis A, was found to be 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 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. 

Exposure to hepatitis A virus (“HAV”) can cause an acute infection of the liver that is typically mild and resolves on its own.^[1] The symptoms and duration of illness vary a great deal, with many persons showing no symptoms at all.^[2] Fever and jaundice are two of the symptoms most associated with HAV infection.^[3]

Hepatitis A is the only common vaccine-preventable foodborne disease in the United States.^[4] This virus is one of five human hepatitis viruses that primarily infect the human liver and cause human illness.^[5] Unlike hepatitis B and C, hepatitis A does not develop into chronic hepatitis or cirrhosis, which are both potentially fatal conditions.^[6]Nonetheless, infection with the hepatitis A virus (HAV) can lead to acute liver failure and death.^[7]

Hepatitis A is a communicable (or contagious) disease that often spreads from person to person.^[8] Person-to-person transmission occurs via the “fecal-oral route,” while all other exposure is generally attributable to contaminated food or water.^[9] Food-related outbreaks are usually associated with contamination of food during preparation by a HAV-infected food handler.^[10] The food handler is generally not ill because the peak time of infectivity—that is, when the most virus is present in the stool of an infected individual—occurs two weeks before illness begins.^[11]

According to Lin & Fang^[12], the recent upsurgence of hepatitis A transmitted from person-to-person has raised alarm among public health officials. Although hepatitis A is primarily foodborne, hepatitis A virus (HAV) can also be transmitted through close contact. The authors point to increasing rates of person-to-person transmission of hepatitis A across the world since 2015, which international health organizations now recognize as a reemerging health threat. 

In the United States, the increase in hepatitis A outbreaks from 2016 to the present are thought to be at least partially related to people using drugs and being homeless; however, both medical and nonmedical factors account for the observed increase of hospitalization and deaths. Of particular concern is the rising risk of morbidity during this wave of outbreaks. Recent studies cited by Lin & Fang show that more than half (52%) of patients were hospitalized, of whom 10% required intensive care, 4% developed fulminant hepatitis, and 1% died. This is in sharp contrast to past studies, where serious hepatic complications associated with acute hepatitis A were rarely reported. Nonetheless, these findings highlight the importance of HAV vaccinations for at-risk populations. 

As recommended in the United States by the Advisory Committee on Immunization Practices (ACIP), from a public health perspective, HAV vaccination is the most effective prevention strategy to control a person-to-person transmitted hepatitis A outbreak. HAV vaccines are highly immunogenic, and >95% of immunocompetent individuals achieve seroconversion within 4 weeks after the first dose. Despite the benefits of vaccination, several barriers and missed opportunities to vaccination were identified from the experiences during the hepatitis A outbreaks. Hofmeister et. al^[13]cite recent research describing that information on HAV vaccination status was missing in nearly two-thirds of study participants, and nearly 90% of those with available information had not previously received HAV vaccines. Citing another study reporting a hepatitis A outbreak in San Diego County, no hepatitis A case patients had ever received a full series of HAV vaccinations.

HAV is relatively stable and can survive for several hours on fingertips and hands, and up to two months on dry surfaces.^[14] The virus can be inactivated by heating to 185°F (85°C) or higher for one minute or disinfecting surfaces with a 1:100 dilution  of household bleach in tap water.^[15] HAV can still be spread from cooked food if it is contaminated after cooking.^[16]

Hepatitis A may cause no symptoms at all when it is contracted, especially in children.^[17] Asymptomatic individuals will only know they were infected (and have become immune, given that you can only get hepatitis A once) by getting a blood test later in life.^[18] Approximately 10 to 12 days after exposure, HAV is present in blood and is excreted via the biliary system into the feces.^[19] Although the virus is present in the blood, its concentration is much higher in feces.^[20] HAV excretion begins to decline at the onset of clinical illness, and decreases significantly by 7 to 10 days after onset of symptoms.^[21] Most infected persons no longer excrete virus in the feces by the third week of illness. Children may excrete HAV longer than adults.^[22]

Seventy percent of HAV infections in children younger than six years of age are asymptomatic; in older children and adults, infection tends to be symptomatic with more than 70% of those infected developing jaundice.^[23] Symptoms typically begin about 28 days after contracting HAV but can begin as early as 15 days or as late as 50 days after exposure.^[24] The symptoms include muscle aches, headache, anorexia (loss of appetite), abdominal discomfort, fever, and malaise.^[25]

After a few days of typical symptoms, jaundice (also termed “icterus”) sets in.^[26] Jaundice is a yellowing of the skin, eyes, and mucous membranes that occurs because bile flows poorly through the liver and backs up into the blood.^[27] The urine will also turn dark with bile and the stool light or clay-colored from lack of bile.^[28] When jaundice sets in, initial symptoms such as fever and headache begin to subside.^[29]

In general, symptoms usually last less than two months, although 10% to 15% of symptomatic persons have prolonged or relapsing disease for up to 6 months.^[30] It is not unusual, however, for blood tests to remain abnormal for six months or more.^[31] The jaundice so commonly associated with HAV can also linger for a prolonged period in some infected persons, sometimes as long as eight months or more.^[32] Additionally, pruritus, or severe “itchiness” of the skin, can persist for several months after the onset of symptoms. These conditions are frequently accompanied by diarrhea, anorexia, and fatigue.^[33]

Relapse is possible with hepatitis A, typically within three months of the initial onset of symptoms.^[34] Although relapse is more common in children, it does occur with some regularity in adults.^[35] The vast majority of persons who are infected with hepatitis A fully recover, and do not develop chronic hepatitis.^[36] Persons do not carry HAV long-term as with hepatitis B and C.^[37]

Fulminant hepatitis A, or acute liver failure, is a rare but devastating complication of HAV infection.^[38] As many as 50% of individuals with acute liver failure may die or require emergency liver transplantation.^[39] Elderly patients and patients with chronic liver disease are at higher risk for fulminant hepatitis A.^[40] In parallel with a declining incidence of acute HAV infection in the general population, however, the incidence of fulminant HAV appears to be decreasing.^[41]

HAV infects the liver’s parenchymal cells (internal liver cells).^[42] Once a cell has been penetrated by the viral particles, the hepatitis A releases its own toxins that cause, in essence, a hostile takeover of the host’s cellular system.^[43] The cell then produces new viral components that are released into the bile capillaries or tubes that run between the liver’s parenchymal cells.^[44] This process results in the death of liver cells, called hepatic necrosis.^[45]

The fulminant form of hepatitis occurs when this necrotic process kills so many liver cells—upwards of three-quarters of the liver’s total cell count—that the liver can no longer perform its job.^[46] Aside from the loss of liver function, fulminant hepatic failure can lead to encephalopathy and cerebral edema.^[47] Encephalopathy is a brain disorder that causes central nervous system depression and abnormal neuromuscular function.^[48] Cerebral edema is a swelling of the brain that can result in dangerous intracranial pressure.^[49] Intracranial hypertensions leading to a brain stem death and sepsis with multiple organ failure are the leading causes of death in individuals with fulminant hepatic failure.^[50]

^[1]           Feinstone, Stephen and Gust, Ian, “Hepatitis A Virus,” in Mandell, Douglas, & Bennett’s PRINCIPLES AND PRACTICE OF INFECTIOUS DISEASES, Fifth Edition, Chap. 161, pp. 1920-40 (2000); Mayo Clinic Staff, “Hepatitis A,” (last updated Sept 1, 2011). Articles available online at http://www.mayoclinic.com/health/hepatitis-a/DS00397.

^[2]           Feinstone, Stephen and Gust, Ian, “Hepatitis A Virus,” supra note 1.

^[3]           Mayo Clinic Staff, “Hepatitis A,” supra note 1.

^[4]           Id.; See also Fiore, Anthony, Division of Viral Hepatitis, CDC, “Hepatitis A Transmitted by Food,” Clinical Infectious Diseases, Vol. 38, 705-715 (March 1, 2004). Full text online at http://www.cdc.gov/hepatitis/PDFs/fiore_ha_transmitted_by_food.pdf.

^[5]           Feinstone, Stephen and Gust, Ian, “Hepatitis A Virus,” supra note 1.

^[6]           Id.

^[7]           Fiore, Anthony, Division of Viral Hepatitis, CDC, “Hepatitis A Transmitted by Food,” supra note 7; Mayo Clinic Staff, “Hepatitis A,” supra note 1. 

^[8]           Feinstone, Stephen and Gust, Ian, “Hepatitis A Virus,” supra note 1.

^[9]           Id.; See also Jaykus Lee Ann, “Epidemiology and Detection as Options for Control of Viral and Parasitic Foodborne Disease,” Emerging Infectious Diseases, Vol. 3, No. 4, pp. 529-39 (October-December 1997). Full text of the article is available online at http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2640072/pdf/9366607.pdf

^[10]         Fiore, Anthony, supra note 7; CDC, “Hepatitis A,” supra note 5; See also CDC, “Surveillance for Acute Viral Hepatitis – United States, 2007, Morbidity and Mortality Weekly Report, Surveillance Summaries, Vol. 58, No. SS03 (May 22, 2009) at http://www.cdc.gov/mmwr/preview/mmwrhtml/ss5803a1.htm.

^[11]         Fiore, Anthony, Division of Viral Hepatitis, CDC, “Hepatitis A Transmitted by Food,” supra note 7. 

^[12]         Lin, K. Y., & Fang, C. T. (2021). Public health responses to person-to-person hepatitis A outbreaks. The Journal of Infectious Diseases, 223(3), 359-361.

^[13]          Hofmeister, M. G., Xing, J., Foster, M. A., Augustine, R. J., Burkholder, C., Collins, J., … & Spradling, P. R. (2021). Hepatitis A person-to-person outbreaks: Epidemiology, morbidity burden, and factors associated with hospitalization—Multiple States, 2016–2019. The Journal of Infectious Diseases, 223(3), 426-434.

^[14]         Feinstone, Stephen and Gust, Ian, “Hepatitis A Virus,” supra note 1; Mayo Clinic Staff, “Hepatitis A,” supra note 1.

^[15]         CDC, “Updated recommendations from Advisory Committee on Immunization Practices (ACIP) for use of hepatitis A vaccine in close contacts of newly arriving international adoptees,” Morbidity and Mortality Weekly Report, Vol. 58, No. 36,  (Sept. 18, 2006), http://www.cdc.gov/mmwr/preview/mmwrhtml/mm5836a4.htm; Fiore, Anthony, et al., Advisory Committee on Immunization Practices (ACIP), Prevention of Hepatitis-A Through Active or Passive Immunization: Recommendations, Morbidity & Mortality Weekly Review, Vol. 55, Report 407, (May 29, 2006) at http://www.cdc.gov/mmwr/preview/mmwrhtml/rr5507a1.htm; Todd, Ewan C.D., et al., “Outbreaks Where Food Workers Have Been Implicated in the Spread of Foodborne Disease. Part 6. Transmission and Survival of Pathogens in the Food Processing and Preparation-environment,” Journal of Food Protection, Vol. 72, 202-19 (2009). Full text of the article is available online at http://courses.washington.edu/eh451/articles/Todd_2009_food%20processing.pdf.

^[16]         Fiore, Anthony, Division of Viral Hepatitis, CDC, “Hepatitis A Transmitted by Food,” supra note 7.

^[17]         Fiore, Anthony, Division of Viral Hepatitis, CDC, “Hepatitis A Transmitted by Food,” supra note 7

^[18]         Mayo Clinic Staff, “Hepatitis A,” supra note 1. 

^[19]         CDC, “Hepatitis A,” supra note 5; Feinstone, Stephen and Gust, Ian, “Hepatitis A Virus,” supra note 1

^[20]         Feinstone, Stephen and Gust, Ian, “Hepatitis A Virus,” supra note 1

^[21]         Id.

^[22]         Id.; See also Sagliocca, Luciano, et al., “Efficacy of Hepatitis A Vaccine in Prevention of Secondary Hepatitis A Infection: A Randomized Trial,” Lancet, Vol. 353, 1136-39 (1999). Abstract at http://www.thelancet.com/journals/lancet/article/PIIS0140-6736(98)08139-2/abstract.

^[23]         CDC, “Hepatitis A,” supra note 5.

^[24]         Id.: See also Feinstone, Stephen and Gust, Ian, “Hepatitis A Virus,” supra note 1; Fiore, Anthony, Division of Viral Hepatitis, CDC, “Hepatitis A Transmitted by Food,” supra note 7.

^[25]         CDC, “Hepatitis A,” supra note 5; Feinstone, Stephen and Gust, Ian, “Hepatitis A Virus,” supra note 1; Mayo Clinic Staff, “Hepatitis A,” supra note 1.

^[26]         Feinstone, Stephen and Gust, Ian, “Hepatitis A Virus,” supra note 1; Mayo Clinic Staff, “Hepatitis A,” supra note 1.

^[27]         Mayo Clinic Staff, “Hepatitis A,” supra note 1.

^[28]         CDC, “Hepatitis A,” supra note 5; Feinstone, Stephen and Gust, Ian, “Hepatitis A Virus,” supra note 1; Mayo Clinic Staff, “Hepatitis A,” supra note 1. 

^[29]         Mayo Clinic Staff, “Hepatitis A,” supra note 1.

^[30]         Fiore, Anthony, et al., Advisory Committee on Immunization Practices (ACIP), Prevention of Hepatitis-A Through Active or Passive Immunization: Recommendations,” supra note 20; Gilkson Miryam, et al., “Relapsing Hepatitis A. Review of 14 cases and literature survey,” Medicine, Vol. 71, No. 1, 14-23 (Jan. 1992). Abstract of article online at http://www.ncbi.nlm.nih.gov/pubmed/1312659.

^[31]         Feinstone, Stephen and Gust, Ian, “Hepatitis A Virus,” supra note 1.

^[32]         Feinstone, Stephen and Gust, Ian, “Hepatitis A Virus,” supra note 1; Mayo Clinic Staff, “Hepatitis A,” supra note 1.

^[33]         CDC, “Hepatitis A,” supra note 5; Mayo Clinic Staff, “Hepatitis A,” supra note 1.

^[34]         Gilkson Miryam, et al., “Relapsing Hepatitis A. Review of 14 cases and literature survey,” supra note 37.

^[35]         Feinstone, Stephen and Gust, Ian, “Hepatitis A Virus,” supra note 1; Gilkson Miryam, et al., “Relapsing Hepatitis A. Review of 14 cases and literature survey,” supra note 37.

^[36]         Mayo Clinic Staff, “Hepatitis A,” supra note 1.

^[37]         CDC Summary, “Disease Burden from Viral Hepatitis A, B and C in the United States, 2004-2009, at http://www.cdc.gov/hepatitis/pdfs/disease_burden.pdf; CDC, “Hepatitis A,” supra note 5.

^[38]         Detry, Oliver, et al., “Brain Edema and Intracranial Hypertension in Fulminant Hepatic Failure: Pathophysiology and Management,” World Journal of Gastroenterology, Vol. 12, No. 46 pp. 7405-7412 (Dec. 14, 2006). Full article is available online at http://www.wjgnet.com/1007-9327/12/7405.pdf.

^[39]         Taylor, Ryan, et al., “Fulminant Hepatitis A Virus Infection in the United States: Incidence, Prognosis, and Outcomes,” Hepatology, Vol. 44, 1589-1597. Full text http://deepblue.lib.umich.edu/bitstream/2027.42/55879/1/21349_ftp.pdf.

^[40]         Id.: See also Feinstone, Stephen and Gust, Ian, “Hepatitis A Virus,” supra note 1.

^[41]         Taylor, Ryan, et. al., “Fulminant Hepatitis A Virus Infection in the United States: Incidence, Prognosis, and Outcomes,” supra note 46. 

^[42]         Detry, Oliver, et al., “Brain Edema and Intracranial Hypertension in Fulminant Hepatic Failure: Pathophysiology and Management,” supra note 45; Feinstone, Stephen and Gust, Ian, “Hepatitis A Virus,” supra note 1.

^[43]         Feinstone, Stephen and Gust, Ian, “Hepatitis A Virus,” supra note 1; Schiff, E.R., “Atypical Manifestations of hepatitis-A,” supra note 23. 

^[44]         Detry, Oliver, et al., “Brain Edema and Intracranial Hypertension in Fulminant Hepatic Failure: Pathophysiology and Management,” supra note 45.

^[45]         Id.; See also Taylor, Ryan, et. al., “Fulminant Hepatitis A Virus Infection in the United States: Incidence, Prognosis, and Outcomes,” supra note 46. 

^[46]         Detry, Oliver, et al., “Brain Edema and Intracranial Hypertension in Fulminant Hepatic Failure: Pathophysiology and Management,” supra note 45; Taylor, Ryan, et. al., “Fulminant Hepatitis A Virus Infection in the United States: Incidence, Prognosis, and Outcomes,” supra note 46.

^[47]         Detry, Oliver, et al., “Brain Edema and Intracranial Hypertension in Fulminant Hepatic Failure: Pathophysiology and Management,” supra note 45.

^[48]         Detry, Oliver, et al., “Brain Edema and Intracranial Hypertension in Fulminant Hepatic Failure: Pathophysiology and Management,” supranote 45; Feinstone, Stephen and Gust, Ian, “Hepatitis A Virus,” supra note 1.

^[49]         Detry, Oliver, et al., “Brain Edema and Intracranial Hypertension in Fulminant Hepatic Failure: Pathophysiology and Management,” supra note 45.

^[50]         Detry, Oliver, et al., “Brain Edema and Intracranial Hypertension in Fulminant Hepatic Failure: Pathophysiology and Management,” supra note 45; Taylor, Ryan, et. al., “Fulminant Hepatitis A Virus Infection in the United States: Incidence, Prognosis, and Outcomes,” supra note 46.

A produce nightmare at retail – the only thing those consumers will remember is your father’s restaurant

Your father had a great idea for a restaurant when he was still alive.  After 20 years of working seven days a week, your father built an impressive chain of ten restaurants.  The restaurants were the place where first dates bloomed, where engagements happened, where anniversaries and birthdays were celebrated, and where, in the overflowing banquet rooms, passings were celebrated.  Business deals were made over long lunches, and a few affairs began and ended in the leather-seated bar.  Your father’s restaurants reflected him, but more importantly, they reflected a high standard of quality within the community.  All the reviews were glowing.  The restaurants set a standard that competitors could only envy.

Your father cared about the safety of the food he served his customers.  For the most part, it was because he saw his customers as friends and family.  However, he also understood how a sickened customer (or customers) could, with one meal, ruin the brand he had worked tirelessly to create.  He paid attention to the cleanliness of all his restaurants and the training of his employees.  Your father was at times an annoying stickler as to the quality of all the food that entered his restaurant.  He took pride in never having a negative health department inspection.

A Caesar salad has been one of your father’s restaurants’ signature dishes.  Your father took pride in the table-side preparation.  All the ingredients were hand-selected from nearby farmers and suppliers that your father had known since the first restaurant opened.  The heads of romaine were stripped of the outside leaves and thoroughly washed just before the lunch rush with the same process repeated shortly before dinner.  Your father always worried about the raw eggs in the dressing even though he knew the rancher that supplied the eggs.  However, he was a quick adapter when pasteurized eggs became available.

Growing up, at times you were annoyed when your father talked about the risks of hepatitis A due to inadequate employee handwashing, or Salmonella from undercooked eggs, the dreaded E. coli in undercooked beef, or a growing problem of leafy greens and E. coli.  A Jack in the Box was never considered a toy. By the time you began working in the restaurants in high school you were well-steeped in food safety, the cold chain, and third-party audits.

When your father died in the middle of your second year in college as an English major, you did not hesitate to come home to try and step into his very large shoes.  Your mother had died a few years earlier and your siblings had no interest in the business, save for what it did to fund their education and lifestyles.

Your father’s memorial service was enormous; all expertly catered by the general managers of each of the ten restaurants. A senator gave the eulogy. Stories were told about the meaning of the restaurants to the communities they served.  The foodbanks and homeless shelters came forward with how many times your father provided gourmet food to those less fortunate.

As you said your goodbyes and thank yous, the managers hung back.  Sitting in the very first restaurant’s bar, the enormity of your task was becoming more and more apparent.  You now realized that you not only were responsible for your father’s legacy and the tens of thousands of customers, but the ten managers and the hundreds of employees and their families.  Feeling a bit unprepared, you listened to the managers offering both their condolences and their support. You thanked them and after they left, you sat there for some time wishing your father would walk through the door.

You learned a long time ago that the restaurant business is 24/7/365 – almost.  From overseeing the expanded purchasing staff to hiring and firing decisions, things came at you like a firehose.  At best of times, you only had time to make a snap decision on a supplier change or to rely on the managers to manage.  At two in the morning, you were often awakened by the decisions that needed to be made the next day and the days after.

Perhaps it was exhaustion, or perhaps it was the desire to try something new and a bit simpler, but when a new salesperson somehow got a meeting with you one day, she pitched triple-washed, chopped bagged romaine that would equal the quality of your father’s signature salad.  Intrigued, you ordered a box and asked a trusted manager to test the product.  The results were glowing.  No more time stripping leaves and washing and cutting, it was open the bag and put it in the bowl.  The price was a bit higher, but it seemed that you would make it up in labor and convenience.  The decision made, your forgot to ask about where the product was grown.  You let the disappointed romaine suppliers know that their product was no longer needed.

And then the unthinkable happened.  The Friday after a holiday Monday, the local health department called that there were a handful of patients, mostly older, but some children who were hospitalized with E. coli, two in kidney failure, that seemed to have a connection to meals served at three of your restaurants in the prior week.  Testing was still being done, and other states were also reporting E. coli cases.  Thus far, no product had been identified.

Your heart sank.  Over the next days, various local, state, and federal health agencies found that nearly 100 people were sickened in several states, but that nearly 35 people were linked to your restaurants, including now two dead children, at least six more with acute kidney failure, and a dozen of others hospitalized. Thus far, still no product had been identified.

You immediately closed all restaurants, threw out all perishable foods, and began a thorough cleaning.  The health authorities then announced that the likely source of all the infections was the triple-washed, chopped bagged romaine that you recently purchased.  The traceback to the growing location showed that the lettuce was grown within a stone’s throw of a cattle feedlot which was the likely source of the E. coli.

Even after you shut the restaurants for a week (still paying all employees) and the health authorities said salad was safe to eat, the fact that your father’s restaurants were linked to severe illnesses and deaths kept customers away.  Sales were down between 70 to 80%.  Every day, the news talked about the struggles of the victims and how it was clear that the romaine was grown in an unsafe place.  As the days and weeks wore on, sales did not improve.  The decision was made to close three restaurants, but the news picked that up, and sales in the other seven stores dropped further.  Within three months, still paying both employees and suppliers, it became apparent that more restaurants would need to close.  Then, the lawsuits started.

Sitting in the bar in the last remaining restaurant, you thought back on the decision to order the triple-washed, chopped bagged romaine, and as you sat there, you wondered what your father would say if he walked through the door.

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I have been thinking it has been some time since I dug into a Naughty or Nice list. Here is one we at Food Safety News put together (with input from readers) in 2009. Reading these brings back a lot of memories, both good and bad. Shoot me an email at [email protected] with your thoughts on who should be on this year’s list.

After much thought and consideration, here was the Food Safety News Naughty list for 2009:

NAUGHTY:  Stewart Parnell, President of Peanut Corporation of America, for asking for nearly $1 million from his bankrupt business for his own criminal defense fund after shipping peanuts his own tests showed were contaminated with Salmonella that sickened over 700 and killed at least nine. (See “PCA Executives To Divide $875,000,” Dec 11, 2009)

NAUGHTY:  President Obama for NOT appointing a new permanent U.S. Department of Agriculture Under Secretary for Food Safety. ALSO NAUGHTY: USDA Secretary Tom Vilsack for making excuses about it.  (See “FSIS Remains Leaderless,” Oct. 16, 2009) 

NAUGHTY:  Some raw milk, small and sustainable agriculture advocates who confused the entire food safety debate by making and circulating false claims about the bills.  It really is about food safety and is not a gigantic conspiracy by Monsanto to wipe out organic and backyard farms!   

NAUGHTY:  FDA’s Office of Criminal Investigations and the U.S. District Attorney in Georgia for moving so slowly with the criminal investigations of the Peanut Corporation of America and its executives, including Stewart Parnell. (See “One Year Later, Still no Charges for PCA,” Nov 07, 2009)

NAUGHTY:  President Obama and Vice-President Biden for ordering undercooked hamburgers for the Press Corps at a DC restaurant with less than stellar inspection reports.

NAUGHTY:  Washington State University for removing Michael Pollan’s “Omnivore’s Dilemma” from the Common Reading Program.

NAUGHTY:  The FDA for caving to political pressure and backing down on oyster regulations.  (See “Under Pressure, FDA Puts Oyster Policy On Hold,” Nov 14, 2009) 

NAUGHTY:  The Senate for being too slow on health care reform to pass meaningful–and decades overdue–food safety legislation before the Holidays.

NAUGHTY:  Weston A. Price Foundation for more denial of outbreaks and giving consumers false information about raw milk safety.

NAUGHTY:  FDA for its failure to control ridiculous health claims like Kellogg’s claiming that Cocoa Krispies are a “Smart Choice” because it “helps support your child’s immunity.”  (See “Do Krispies Boost Kids’ Immune Systems?” Nov 01, 2009) 

NAUGHTY:  J. Patrick Boyle of the American Meat Institute for trying to dynamite the Senate food safety bill even though it doesn’t have anything to do with the meat industry.  

NAUGHTY:  State public health department officials attending the Interstate Shellfish Sanitation Conference in October who put industry profits ahead of public health. 

NAUGHTY:  Rep. Charlie Melancon for declaring the death of 15 people a year is not too high a price to pay for a U.S. Senate seat in an oyster growing State. (See “Under Pressure, FDA Puts Oyster Policy On Hold,” Nov 14, 2009) 

NAUGHTY:  Secretary Vilsack and White House for trying, in the name of free trade, to roll over Rep. Rosa DeLauro’s efforts to assure that the US does not permit poultry processors from shipping raw poultry meat from the US to China for processing and shipping back to the US for sale until USDA has determined that China’s inspection program is equivalent to ours. (See “Deal Reached on Poultry Imports,” Sep 27, 2009)  

NAUGHTY:  FDA Commissioner Margaret Hamburg for urging Congress to give the Agency authority to reduce the intensity of inspections if they don’t get all the money they ask for.

NAUGHTY:  The FDA staff that keeps appealing to consumer advocates, “don’t set us up to fail,” when consumer advocates push for more inspection.  They never say, “help us get the law and resources we need to protect people.” 

After much thought and consideration, here was the Food Safety News Nice list for 2009:

NICE: Sen. Dick Durbin for being the driving force behind food safety legislation in the Senate and the HELP Committee for passing S. 510 out of committee with bipartisan support. (See “Senate Schedules Markup of S. 510,” Nov 11, 2009)

NICE: Rep. Rosa DeLauro and Sen. Kirsten Gillibrand for being consumer champions and persistent advocates of food safety reform. (See “DeLauro Urges Inquiry Into Beef Testing,” Nov 13, 2009, “DeLauro Calls for Beef Plant Closure,” Dec 10, 2009 and “Gillibrand to Introduce ‘E.coli Eradication’ Bill,” Oct 14, 2009) 

NICE:  Food & Drug Administration Commissioner Margaret Hamburg for improving public access to information, including “Warning Letters” and 483 Reports.  (See “FDA Expands What’s In ‘Warning Letters,’” Sep 17, 2009) 

NICE: Secretary Vilsack and Deputy Secretary Kathleen Merrigan for USDA’s new outreach programs, like “Know your farmer, know your food.”  (See “USDA Promotes Local Food,” Sep 25, 2009)

NICE: New York Times writer Michael Moss for his Pulitzer-worthy article on the dark origins of ground beef and the terrible impact of E. coli O157:H7. 

NICE: The quick work of the U.S. House Energy and Commerce Committee, whose members worked quickly and got their hands on incriminating email traffic between the PCA executives, who took the Fifth Amendment when called to testify.  

NICE:  President Obama for setting up the Food Safety Working Group.

NICE: The public, for an outpouring of support for WSU’s Common Reading Program (hat tip, Food Democracy Now). 

NICE: Makers of Food, Inc, who introduced the country to the underside of food production, and made a very watchable – if frightening – film about it.

NICE: Michelle Obama, for planting a kitchen garden at the White House, and getting kids involved in (very) local food and for getting a local DC farmer’s market through the red tape.

NICE:  FDA for getting a guilty plea by Mark McAfee of OPDC to criminal charges of misbranding raw milk and selling across state lines as “pet food.”  (See “FDA Attempts to Corral Raw Milk Producer,” Dec 17, 2009) 

NICE:  Marion Nestle for, among other things, her persistent and common sense critique of how junk food and soda is marketed to children.  (See “Q&A: Nestle on Food Safety Politics,” Sep 21, 2009) 

NICE: Mike Taylor and Don Kraemer at FDA for boldly putting public health ahead of Gulf Coast oyster industry profits.  (See “FDA Acts to Reduce Raw Oyster Poisoning,” Oct 20, 2009) 

NICE:  Consumer and public health groups that have joined with produce growers and food processors and retailers to support FDA reform legislation, making its passage possible.  (See “Victims: ‘We Want Bill Before Holidays’,” Oct 08, 2009)

NICE: Dedicated writers whose excellent articles gave insight and context to food safety issues:  Lyndsey Layton of the Washington Post for her piece on Linda Rivera’s struggle with E. coli O157:H7 from cookie dough, Peter Eisler, Elizabeth Weise, and others of USA Today for their reporting on school lunches, and Nick Grube of the Daily Triplicate for his three-part series on Mari Tardiff’s struggle to recover from the Campylobacter infection and ensuing Guillain-Barre Syndrome she got from drinking raw milk.

NICE:  Food Bloggers – Simple, Good and Tasty, Cold Truth, Ag and Food Law, Civil Eats, Grist, Weaversway, Chuck Jolley, Food Politics, Ethicurean, La Vida Locavore, Obamafoodorama, Food Shield, efoodalert, Fanatic Cook, Fresh Talk, Center for a Liveable Future, Food Law, Buy Safe Eat Well and Barf Blog.

NICE: Bill Marler and Marler Clark, LLP for their generous support of all three Food Safety News offices in Seattle, Denver, and Washington, DC to make FSN’s coverage of important food safety issues possible, even as traditional media shrink.

These lists were a compilation of submissions from the Food Safety News publisher, staff, readers, and food safety experts.

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