“I am confident in the safety of the food I eat.” Five years ago, only one-third of U.S. consumers strongly agreed with this statement. While they held the government primarily responsible for food safety, followed by food companies and farmers, when it came to trusting them, farmers were third, federal regulators were eighth, and food companies were eleventh. And we in food safety wonder why consumers don’t always adhere to good food safety practices or follow label instructions. How can food safety experts from government, industry and academia communicate with consumers in a meaningful way? How can we convey that just because something can happen, the likelihood that it will happen varies? And how can we convince consumers to take steps to reduce their risk of foodborne illness?

The 2023 virtual Food Safety Forum, organized by the American Frozen Food Institute (AFFI), will address these questions and more. Taking place Sept.13 and free to attend, the Food Safety Forum is taking a deep dive into the state of risk communications. Science is complicated. Consumers want simple, unambiguous answers, and misinformation is abundant. Effective communication is hard and communicating public health risk — the likelihood that one will get sick, not to be confused with hazards — is an ongoing challenge. 

Like it or not, food safety professionals are risk communicators. Family and friends often ask for my opinion when they see alarming headlines about the safety of our food supply. On a broad scale, scientists are seldom viewed as great communicators and most of us are not trained that way. But facts and data don’t speak for themselves. Most consumers prefer a “tell me what to do” approach rather than delve into the complexities of contamination rates and dose responses. AFFI’s Food Safety Forum is bringing together the right group of experts from diverse backgrounds to address these topics with the goal of communicating in a way that improves public health. 

Perhaps the most notable component of the Food Safety Forum is the breadth of stakeholders from industry, government, academia and consumer groups, that all see the need for better communication of food safety risks. Many of these groups, historically viewed as adversaries, have common goals: we all want safe food and for consumers to view and act on food safety risks appropriately. The collaboration and diversity of partners for this year’s Food Safety Forum are unprecedented.

The event will kick off with the well-known Don Schaffner of Rutgers University discussing the “Current Reality of Risk Communication.” As co-host of the “Risky or Not” podcast, Don is perfectly positioned to talk about risk as distinct from hazards in a food safety context and how to explain these concepts to consumers.

No discussion of food safety communication would be complete without addressing the elephant in the room: lawyers. Whether it’s communicating about a serious outbreak, a recall that warrants immediate action or safe food handling practices, regulators are often criticized for being too slow, too fast and rash, too simplistic or too complicated. Elizabeth Fawell, an attorney with the Hogan Lovells law firm, will moderate a discussion with experts who know first-hand the challenges public health officials face when trying to clear food safety communications internally. Joining to share learnings from their experiences are Brian Ronholm with Consumer Reports, former deputy undersecretary for food safety with the U.S. Department of Agriculture’s Food Safety and Inspection Service (USDA FSIS), Roberta Wagner with the International Dairy Foods Association who formerly worked with the U.S. Food and Drug Administration and FSIS, and Frank Yiannas, former deputy commissioner at the FDA. 

Consumers are the ultimate target of food safety communications. When it comes to educating and empowering people to make informed decisions about food safety risks, the rubber meets the road for the scientific community. Who is better to address the consumer view than Mitzi Baum of STOP Foodborne Illness, who represents families of consumers impacted by foodborne illness? Joining Baum are Kristine Butler with FDA’s communications and public engagement team, Ben Chapman with North Carolina State University (and the other half of the “Risky or Not” podcast), and communications representatives from food retail and national food brands. Together, these communicators will speak to their mechanisms to earn trust and gain attention.

Finally, the Food Safety Forum will look to the future. How can risk communicators learn from previous missteps? How can we break through the noise? How can we narrow the gap between mitigating food safety hazards and communicating public health risks? Representatives from the Association of Food and Drug Officials, Consumer Reports, the Centers for Disease Control and Prevention and the food industry will discuss the lessons learned and what it means for the future of communicating food safety to consumers.

Moving the needle on consumer behavior is a lofty undertaking and discussion is needed on how to identify effective communication mechanisms and overcome barriers to meaningful communications. The collaborators convened by AFFI come from different perspectives but are united by their commitment to not only improve food safety, but to also improve consumer understanding of complex food safety topics so they can best protect their health. This topic is not going away. Attend this free event on Sept. 13 to learn more about current challenges and approaches for the future. Register now at www.affi.org/food-safety-forum.

About the author: Jennifer McEntire, Ph.D., is the Founder of Food Safety Strategy LLC. With 20 years of food and beverage association experience, she combines her technical background and regulatory insights to help the food industry assess and manage food safety risks in order to protect public health. McEntire earned a B.S. in food science from the University of Delaware and Ph.D. from Rutgers University as a USDA National Needs Fellow in food safety.

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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.

By Mitzi D. Baum, M.Sc., CEO for Stop Foodborne Illness

Stop Foodborne Illness (STOP) was born in 1994, the same year in which September was dedicated as National Food Safety Education month (NFSEM). As we quickly roll into September, I believe it’s important to reflect on the importance of both STOP and NFSEM and their contributions to public health.

STOP was formed (originally as Safe Tables Our Priority) to raise awareness and change the status quo in food safety inspection policies that were not in sync with current science. Consumers were not protected from emerging pathogens and were paying the ultimate price with their lives; four of them were children.

Through tears and pain, the parents of the children that were permanently injured or succumbed to the foodborne illnesses fought for changes in food policy that would impact everyone who eats. The first of these policy changes, in 1994, was the declaration of E. coli O157:H7 as an adulterant in ground beef. By these courageous individuals telling their horrific lived experiences brought on by food poisoning, politicians and regulatory officials made bold moves. 

NFSEM is meant to educate consumers – not the food safety industry. Let’s be honest, we regularly preach to ourselves about the fundamentality of our work. NFSEM is designed to move beyond the small world of food safety professionals to engage the community at large. This is an opportunity for all food safety professionals – that work to reduce the risk of foodborne illness – to bring attention to the amazing unrecognized work performed every day in food manufacturing, retail, and food service establishments.

There is a reason that U.S. consumers assume the foods they purchase and consume are safe – it’s because of YOU. And as a community of individuals, food producers and growers, companies, regulatory agencies, and consumer advocacy groups that are focused on food safety and risk reduction, this is our collective opportunity to engage beyond those of us that are ‘in the know’.

It’s essential that the food safety community engage in the educational component of our work to the outside world. Stop Foodborne Illness sees the need for the industry to coalesce around this issue in a way that is simple, accessible, and educational while raising awareness of food safety. STOP3000 is a 30-day challenge for everyone to walk 3,000 steps each day in September to commemorate the estimated 3,000 lives lost annually in the U.S. due to food poisoning. Consider this, since 1994 over 87,000 individuals have died because of something they ate.

We, at STOP, urge you to take the challenge, sign up, raise awareness, share food safety tidbits, and support our work by participating in our third annual STOP3000. STOP operates solely on donations – we can’t do our work without the support of the food safety community. We are grateful to our sponsors this year: Chick-fil-A, Conagra Brands, Saldesia – Goddess of Food Safety, Image Base, Kelleher Consultants, LLC, and ASI Food Safety.

STOP is “The Voice for Safe Food”. This September, help us expand our voice to improve food safety and reduce the incidence of foodborne disease.

Check us out at: https://stopfoodborneillness.org/stop3000-2023/

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In today’s society, concerns about food safety often revolve around allergens and pathogens. However, safe food goes beyond these considerations for a growing number of people in the United Kingdom.

Preventing foodborne illness and managing allergens remains vital but it is equally important to widen the definition of food safety to include the provision of essential nutritional information.

The availability of comprehensive nutritional data in all food outlets is crucial for individuals managing conditions such as diabetes. Diabetics rely on precise carbohydrate information to calculate their insulin dosage accurately.

Type 1 diabetes is a serious, autoimmune condition where the blood glucose (sugar) level is too high because your body can’t make a hormone called insulin. It has nothing to do with a poor diet or an unhealthy lifestyle, but these circumstances accelerate the chances of getting type 2.

Estimates from Diabetes UK show that 5 million people in the UK have diabetes, although not all of these are diagnosed, and it is type 1 for around 400,000 people. Nearly 1.9 million Americans have type 1 diabetes, according to the American Diabetes Association.

Living with diabetes is difficult, it is relentless, 24/7/365 and involves constant weighing of food and carbohydrate/insulin dosage calculations. Diabetes doesn’t just affect you physically, it can affect you emotionally too. There are many factors to consider, and it can be stressful knowing what’s best, but you shouldn’t need to put your life on hold. All kinds of food are fine for people with type 1 diabetes to eat.

A diabetic, or the parent of a diabetic child, inspects food labels for the nutritional content of that food (especially carbohydrates), if it is not there, we don’t buy because, without it, you cannot calculate the insulin dosage required to counteract those carbohydrates. This data is found on all packaged food products but not on any loose or pre-packed products, nor can you find it on most menus in restaurants, cafes, street vendors, or ice-cream vans.

Carb counting is really important to keep blood sugar levels steady and avoid spikes. This means matching insulin to the amount of carbs you eat and drink. It takes time and effort, but once you get the hang of it, carb counting can lead to better blood sugar control. It also gives you more choice over when – and how much – you eat. You can enjoy special occasions and treats by making changes to insulin doses.

Need for full nutritional data

When considering food safety, we must broaden our perspective to include the specific needs of individuals with various health conditions.

Food and hospitality venues should provide full nutritional data because for individuals with diabetes, knowing the carbohydrate content of foods is crucial. Access to accurate information enables them to make appropriate food choices and calculate insulin.

By providing detailed carbohydrate information, food outlets can assist diabetics in calculating insulin doses accurately, promoting better blood sugar control and reducing the risk of complications.

If comprehensive nutritional data is available, food establishments can attract health-conscious consumers, promote a positive brand reputation, and differentiate themselves in a competitive market. Additionally, accommodating specific dietary needs can increase customer satisfaction and loyalty.

Diabetes UK has published a guide with a list of outlets that have included the carbohydrate, sugar, fat and salt content in each serving on menus.

Mandating the provision of nutritional data in food venues is a critical step towards promoting transparency and accountability within the industry. It encourages manufacturers and food establishments to prioritize consumers’ health by formulating and offering healthier options.

Educational initiatives can raise awareness about the importance of issues beyond pathogens and allergens, emphasizing the significance of nutritional data. Collaboration among government agencies, food industry stakeholders, healthcare professionals, and consumer advocacy groups is also vital in developing comprehensive strategies to enhance food safety for vulnerable populations.

About the author: Ron Cook is a retired senior technical manager in the food industry who campaigns for easier access to nutritional data to help diabetics manage their condition. His efforts have been featured in The Sun and Public Sector Catering magazine. He has an 11-year-old daughter with type 1 diabetes.

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Editor’s note: This column was originally published by MEDPAGETODAY and is reposted here with permission.

In August 2006, Ruby Trautz of Omaha, Nebraska was the first person of several to die in a foodborne outbreak after eating uncooked baby spinach laced with E. coli 0157:H7, a pathogen that makes a deadly toxin not unlike the infamous poison ricin. Not that Trautz’s doctors knew it at the time. The truth is, when the lively 81-year old first passed bloody stool, then became uremic and seized, her doctors assumed (despite her negative test) that Trautz had a terrible case of colitis due to C. difficile.

Soon after Trautz expired, however, her son-in-law Ken Costello also suffered diarrhea and agonizing abdominal pain. His doctor diagnosed diverticulitis.

Finally, in mid-September, the multi-state outbreak linked to bagged, pre-washed Dole-brand spinach packed by California’s Natural Selection Foods made national headlines. When Costello and his wife learned this news, they quickly returned to the home they had previously shared with Trautz. Sure enough, still in the fridge was an open package of spinach eaten by the entire family that was later sent to a lab where a slurry was cultured. That specimen grew the outbreak strain.

The final toll of illness for 225 infected people residing in 27 states? Although there were only five confirmed deaths, more than half were hospitalized, and 39 suffered life-threatening hemolytic-uremic syndrome.

This leafy-green fiasco was just another milestone in the story of a hazardous microbe that still thrives in many U.S. livestock. Thirteen years earlier, after surfacing in undercooked Jack in the Box hamburgers, the same toxic bug launched the career of a leading plaintiffs’ attorney featured in a new Netflix documentary called “Poisoned: The Dirty Truth About Our Food.”

Not only has “Poisoned” won kudos for its frank depiction of a “broken system that often places profit over public health” the film has much to teach doctors about growing threats along American farm-to-fork chains plus modern loopholes and legislative inertia surrounding the safety of American food.

The Story of Bill Marler

In the world of foodborne illness and food safety, Seattle attorney Bill Marler, JD, is a hero to many people. For more about his one-of-a-kind passion and style, take a look at a 2015 story in The New Yorker that covers his present-day campaign against Salmonella. But back in 1993, when Jack in the Box fare started to sicken and kill, Marler had not yet found his calling.

Then came an SOS about 9-year-old Brianne Kiner, a desperately ill child who had already spent 40 days in a coma and 5 months in a hospital connected to wires and tubes. “She was just so vulnerable, and she just ate a fricking hamburger,” was Marler’s characteristic comment in “Poisoned.”

After meeting Brianne and forcing back tears, the 35-year-old lawyer then went to work, ultimately winning the largest personal injury pay-out ($15.6 million) awarded in his state to date. It wouldn’t restore her health, but at least it would cover care for the rest of Brianne’s life.

For Marler, lawsuit upon lawsuit then followed, some stemming from further outbreaks of E. coli 0157, others involving different foodborne perps such as Salmonella, Campylobacter, hepatitis A, and Listeria. But perhaps Marler’s proudest (non-monetary) 1990s win came when Michael Taylor, JD, then a senior lawyer at the U.S. Department of Agriculture (USDA), announced that raw ground beef contaminated with E. coli 0157 would henceforth be deemed “adulterated.”

The industry reforms that followed now mean that eating a fast-food hamburger in the U.S. poses only a fraction of the risk of fresh produce, as shown by the outbreak that killed Trautz.

“Poisoned” advances this theme by educating viewers about the proximity of massive cattle feedlots and agricultural lands in Yuma, Arizona, and California’s Central Valley, a modern recipe for disaster that periodically allows animal feces to enter irrigation canals and contaminate downstream crops like romaine lettuce. Or the blatant disregard for crowding of animals and on-site sanitation in other factory farms that fuels Salmonella-laced filth that can ultimately taint poultry and eggs.

Egregious violations have even prompted criminal prosecution. The most dramatic example? The 28-year prison sentence meted out to Stewart Parnell, former CEO of the Peanut Corporation of America, after Parnell repeatedly instructed certain employees to cover up positive Salmonella tests in 2008 to 2009. The final outcome of this wanton falsification was a multistate outbreak of Salmonella typhimurium that killed at least nine people and sickened many hundreds more who consumed a slew of peanut-containing items sold in 46 states.

A Medical Call to Action

What is more relatable than food? After all, everyone eats, and everyone occasionally suffers a foodborne illness. However, some U.S. doctors tend to discount foodborne illnesses because — despite our food supply’s many imperfections — Americans suffer fewer such incidents and related deaths than residents of most other countries. Oft-cited statistics from a seminal CDC study published in 2011 concluded that, at that time, one in six Americans — roughly 48 million people — suffered a foodborne illness each year, 128,000 were hospitalized, and 3,000 died.

These data stand in stark contrast to a WHO study published in 2015. In their first-ever analysis of the global burden of foodborne disease, the authors assessed 31 individual “hazards” and reached a final estimate of 420,000 foodborne illness deaths per year — 40% in children under 5. Not surprisingly, the study listed some risks most U.S. doctors and medical students rarely if ever consider. For example, hepatotoxic aflatoxins contaminating moldy grain, or cysticercosis — larval infection with pork tapeworm — which underlies many cases of epilepsy in low- and middle-income countries.

At the same time, a universal risk both here and abroad, is non-typhoid Salmonella, which consistently ranks as the top cause of foodborne death worldwide.

My concern is that foodborne diseases and food safety are rarely covered in medical school curricula and that even seasoned MDs often lack knowledge about changing trends, contributory factors, and the messy web of government agencies and regulations (don’t get me started about the weird jurisdictions and different mindsets of the USDA and the FDA). The list goes on.

Weaving case studies involving real people, outbreaks, and regulatory policies into continuing medical education would be one way to start (for example, do most readers even know their state’s stance on the legal sale of unpasteurized milk?). Having medical students watch “Poisoned” is another.

At the end of the day, why shouldn’t doctors and other healthcare professionals join the ranks of lobbyists, advocates, and educators around ongoing farm-to-fork reform? After all, the microbes aren’t going away anytime soon, they’re only traveling farther (and becoming more antibiotic-resistant) as our food supply grows ever more global.

About the author: Claire Panosian Dunavan, MD, is a professor of medicine and infectious diseases at the David Geffen School of Medicine at UCLA and a past-president of the American Society of Tropical Medicine and Hygiene. You can read more of her writing in the “Of Parasites and Plaguesopens” column.

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In an era where multitasking is a necessity, the audio edition of “TOXIC: From Factory to Food Bowl, Pet Food Is a Risky Business” by acclaimed food safety expert Phyllis Entis arrives as an invaluable resource for busy pet owners. This gripping audiobook, now available on Audible, Amazon, and Apple platforms, delves into the hidden corners of the pet food industry, exposing shocking practices that have led to numerous safety scandals.

Drawing upon her extensive experience and research, Phyllis Entis takes listeners on a journey through the pet food industry’s dark history. Entis, also the author of the Amazon international bestseller “TAINTED: From Farm Gate to Dinner Plate, Fifty Years of Food Safety Failures,” focuses her expertise on the pet food sector this time. She unveils some of the most notorious pet food safety scandals of recent times, including pentobarbital in canned dog food, aflatoxin in kibble, and Salmonella in commercial raw pet foods.

“Pathogens and pentobarbital. Flies and filth. Obfuscation and outright lies,” writes Entis in the opening lines of the book. “For almost as long as commercial pet foods have existed, consumers have been forced to tease out the facts from the flummery when choosing what to feed their four-legged companions.” These words set the tone for the book, highlighting the long-standing challenge faced by pet owners in deciphering the truth behind their pets’ nutrition.

“TOXIC” is not just an exposé of the pet food industry; it’s a guide for pet owners seeking to make informed choices for their furry companions. With a passion for food safety that stems from her early career as a food safety microbiologist, Entis provides valuable insights and practical tips to help pet owners navigate the complex landscape of pet food choices.

Entis, who shares her home with an Australian Cobberdog named Rutlands Shalom, understands the importance of ensuring pet nutrition. This personal connection fuels her determination to inform pet owners about the hidden dangers lurking behind seemingly harmless packaging and advertisements.

Former global pathogen product manager George Nagle praised “TOXIC” as a worthy companion to Entis’s previous work. He commended the book for its meticulous insights, accountability, and its ability to empower readers with knowledge.

A section titled “Pentobarbital’s Pervasive Presence” exemplifies the book’s impactful narrative. The book recounts the tragic story of Mark Johnson, whose dogs fell ill and died after consuming tainted dog food, illustrating the urgent need for transparency and awareness in the pet food industry.

“TOXIC” is available in digital format from major ebook retailers and can also be purchased in paperback on Amazon, making it accessible to a wide range of readers and listeners.

Entis’s dedication to food safety and her compelling storytelling ability have once again converged in “TOXIC,” shedding light on the hidden truths of the pet food industry. As more pet owners seek the truth behind their pets’ nutrition, Entis’s audiobook promises to be an indispensable resource for those striving to keep their beloved animals safe and healthy.

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On July 29 the International Food Industry Think Tank discussed “Energizing Food Safety and Quality Assurance Transformation Process.” That discussion inspired the launching of the Safety, Security, and Quality Assurance (2S-QA) Movement on Aug. 2. The premise for this movement comes from this understanding:

“If we do not energize the Food Industry Transformation Process through the direct actions of every stakeholder, our good intentions, aspirations, and proposals will only hover aimlessly in the space of academic and theoretical discourse without realizing desirable results.”

By coincidence or through providence, the Netflix documentary “Poisoned: The Dirty Truth About Your Food” (Soechtig, 2023) was also released on Aug. 2. It calls for action to prevent future food-related tragedies. The food industry needs a radical paradigm shift along the lines of the proposed SSQA transformation recommendations:

 A transition from restrictive and confusing rules to having useful tools; from an obsession with superficial third-party certifications to fortifying food operations against food safety and quality failures; from rights and responsibility contracts to participatory alliance agreements; from collaboration with separate interests to working together with synchronized interests; from micro-managed to auto-managed systems; the transformation of operation personnel into active safety, security and quality assurance practitioners; the transition of managers from fire fighters to visionaries; from certification scheme owners to technical information providers; from certification bodies to facilitation service providers, from auditors to facilitators. Regulators are expected to maintain their role of enforcing the laws and regulations as the only necessary and legally enforced rules.

If you have seen the documentary “Poisoned,” how did it make you feel? To stop eating would be an impossible position to take in response to the documentary. To eat, with one’s fingers crossed shows a blind trust. 

Uncertainty about what one person could do to prevent food poisoning outbreaks tend to force people to take the fingers-crossed approach. Hopefully, that uncertainty will give way to increased assurance as we develop and deploy relevant actions. Where we have complete control over our food, for example, in our gardens and kitchens, we could act to prevent hazardous food contamination. 

Realistically, we do not have complete control over every item of food that we need. We depend on other people and food companies. As such, we need the collaboration and cooperation of everyone throughout the food supply network. We need to deploy the SSQA participatory alliance (SSQA-PA) strategy. Predictably, the 2S-QA movement will accelerate the development and deployment of SSQA-PA strategies.

Under ordinary circumstances, the required level of collaboration and cooperation may seem impossible. However, the direct and consistent mobilization of all stakeholders through the 2S-QA Movement should help. Food safety, security, and quality assurance efforts need to be maintained by individuals, businesses, corporations, academic institutions, industry associations, nonprofit organizations, advocacy groups, community associations, governments (law enforcement and regulatory agencies).

 Problems often arise where the parties that must collaborate have different motives. Identifying and agreeing on what really matters unifies the motives and focus of collaborators. It may take time for the diverse groups to agree on what really matters and be committed to a unified focus. At the same time, reaching a consensus could happen quickly through the deliberate mobilization. If we become rightly motivated and mobilized, things could rapidly improve to the benefit everyone and the planet.

 The 2S-QA movement and the “Poisoned” documentary have the capacity to fuel the needed mobilization. The industry must stop practices that caused past tragedies and the chronic health problems that victims are still experiencing.

 The 2S-QA movement provides a platform for us to decisively act. We can and must act, right where we are, in our kitchens, workplaces, through broader industry engagements, through national and global programs. This movement should be supported by anyone who wishes to engage in direct and progressive action. Food business managers are encouraged to follow the SSQA Implementations Manual (Amiri, 2022) as their pathfinder guide.

The 2S-QA movement, as a universal mandate, exists to galvanize and energize industry stakeholders with the anticipated outcome of an equitable, trustworthy, and healthy food system for the benefit of all consumers and the planet. You have the choice of how you wish to participate.

We must together drive observable good results both in the short and long terms. Hopefully, the results will prove the usefulness of our collective engagement. Visit the web site for additional information: https://afisservices.wixsite.com/2s-qa-movement

References
Amiri, F. (2022, December). Global Consumer Protection SSQA Development and Implementation: A Manual for the Food Industry. Retrieved June 16, 2023, from Afisservices.com: http://www.afisservices.com/gcse-fhp/SSQAFullManual.html

Soechtig, S. (Producer). (2023). Poisoned: The Dirty Truth About Your Food [Motion Picture]. Retrieved August 2, 2023, from https://www.netflix.com/ca/title/81460481?src=tudum&trackId=259776131&trkId=259776131

About the author: Felix Amiri is the Technical Director at Amiri Food Industry Support Services (AFISS). He leads an International Food Industry Think Tank with meetings held monthly. Felix teaches part time at Conestoga College, Institute of Food Processing Technology, Cambridge, Ontario, Canada, and regularly engages in industry discussion panels. He leads the Safety Security, and Quality Assurance (SSQA) Development Academy. He recently launched the SSQA-Based 2S-QA Movement (details available upon request). 

His published works and books include:

The Safety, Security and Quality Assurance (SSQA) Implementation Manual. Felix has written several articles dealing with different matters pertaining to the food industry. 

His published books, available on Amazon, include:

Food Protection Diaries

FSQA–Efficacy versus Compliance

FSQA-Commitment Plans for National & International Regulations

FSQA-A Survey of Food Laws and Regulations

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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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As I was settling in on my first day at Marler Clark, Bill nonchalantly gave me my first assignment: “Hey, I need you to write up a petition urging the U.S. Department of Agriculture to designate Salmonella as an adulterant in all meat and poultry products sold in the U.S.” Instantly I felt a surge of nerves. As the nerves subsided, imposter syndrome began to rear its head. Although I had two years of college-level food science courses under my belt, my experience relevant to the law firm’s work was limited to a single food safety and sanitation class. But determined to give the assignment my best effort, and with Bill’s assurance that I would have access to experts in the field, I set out on a three-month petition-drafting journey.

— OPINION —

Long story short, that is how, one summer afternoon, as a slightly hesitant but determined intern, I found myself in the charming and eclectic town of Port Townsend, Washington. There, I sat in a dimly lit bar, joined by a scientist and two seasoned lawyers, all of us engrossed in the thorough review of my 61-page draft. That is how Marler Clark’s Salmonella petition (as we now fondly refer to it) came to fruition. 

More than three years later, on April 25, 2023, the USDA released a proposed determination to declare Salmonella an adulterant in breaded stuffed raw chicken products — a first step in the right direction. This proposal was supported by various factors, one being the investigation of 14 Salmonella outbreaks and about 200 illnesses linked to these products since 1998.

But while the USDA’s proposal is encouraging, it remains a small step in the face of a much larger issue. According to the CDC, Salmonella bacteria cause a staggering 1.35 million illnesses, resulting in 26,500 hospitalizations and 420 deaths in the United States every year. This data highlights the urgency of implementing more substantial and effective measures to address this serious problem.

The days of interning at Marler Clark are behind me, as I now proudly serve as an attorney. Yet four years have passed since the drafting and submission of Marler Clark’s Salmonella petition, and regrettably, not much has changed. Nevertheless, Marler Clark’s relentless pursuit for a safer food supply will persist, as we continue to advocate for the designation of Salmonella as an adulterant in meat and poultry products.

The experts guiding me were none other than Carl Custer, an esteemed scientist, and former USDA inspector, alongside Denis Stearns and Bill Marler, two of Marler Clark’s founding partners with a combined 60 years of experience in foodborne illness litigation and advocacy. I was in good hands.

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By Sarah Sorscher, Director of Regulatory Affairs, CSPI 

Today, Netflix will release a powerful documentary, “Poisoned: The Dirty Truth About Your Food,” which shines a harsh light on the American food system, often touted as the “safest food in the world.”  

The truth is, our food is nowhere near as safe as it should be. Regulators and the food industry have not done enough to mitigate deadly pathogens like STEC E. coli and Salmonella, and consumers remain ill-prepared to manage food poisoning risks in our kitchens. We continue to be sickened and die at unacceptably high rates due to contaminated foods as a result.  

But the documentary also highlights the moments when outrage has translated into effective change, such as when USDA moved to ban pathogenic E. coli from ground beef in the 1990s, resulting in dramatic declines in illnesses from beef. 

Here is another truth: We have the opportunity now for policy action. The USDA has proposed a framework to ban dangerous forms of Salmonella contamination in raw poultry, following the same model used in ground beef. Congresswoman Rosa DeLauro has sponsored a bill, the Expanded Food Safety Investigation Act, that would allow federal investigators to investigate foodborne outbreaks that emerge from large animal farms.  

Policymakers should support these key changes, and consumers should take action now to tell their representatives in Congress to prioritize food safety reforms, and tell USDA to move forward with its plans to ban Salmonella from raw poultry. 

We deserve safe food, and together we have the power to make it a reality, by creating a system where consumers can truly have confidence in our food.

(To sign up for a free subscription to Food Safety News,click here)

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.

Based on the bestselling book “Poisoned: The True Story of the Deadly E. Coli Outbreak That Changed the Way Americans Eat,” the film delivers a shocking exposé that will resonate with consumers, the food industry, regulators, politicians and all those concerned about food safety.

“Poisoned” serves as a call to action for officials with the power to mitigate the dangers posed by foodborne illnesses, which claim thousands of lives annually in the U.S. It also lays bare an alarming indictment of the food industry and regulatory system, showcasing how decades of apathy and misconduct have left American consumers vulnerable to such deadly outbreaks.

The documentary is directed by Stephanie Soechtig, known for her works such as “Under the Gun”, “Fed Up”, and Netflix’s “Knock Down the House.” Jeff Benedict, author of “Poisoned: The True Story of the Deadly E. Coli Outbreak That Changed the Way Americans Eat”, is executive producer 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.

The documentary heavily features Food Safety News‘ Publisher and food safety lawyer Bill Marler, as well as people personally impacted by foodborne illness, such as Darin Detwiler, who lost his 16-month-old son Riley to E.coli during the 1993 Jack in the Box outbreak.

The Food Safety News team watched the documentary and gave some early reviews:

(Warning: spoilers ahead)

— — —

Dan Flynn, Editor in Chief

When author Jeff Benedict first wrote “Poisoned,” he followed in the  tradition of Upton Sinclair’s “The Jungle.”  The socialist Sinclair wanted to draw support for Chicago’s slaughterhouse workers, but as he said, “I aimed at the public’s heart and by accident hit its stomach.”

The film version of Poisoned is laser-focused on telling the food safety story of the past 25 years or so. Using both archival film and some focused contemporary reporting, “Poisoned” catches up the viewer with how food safety has evolved since the infamous hamburger outbreak of 25 years ago and what’s happened since.

The documentary makes mincemeat of the belief that food safety in the United  States is the safest in the world. In “Poisoned,” we see one gap after another in U.S. food safety. The film shows how Salmonella in chicken remains unsolved in the U.S. while ‘pathogen-free’ chicken is found for sale in Europe.

The film also documents how concentrated animal operations spread dangerous E. Coli O157:H7 on the nearby Romaine fields.

The viewer will leave “Poisoned” knowing enough to take defensive food safety measures and not rely on ‘the system.’  That means “Poisoned” is likely one of the most important documentaries you will ever see.

— — —

Coral Beach, Managing Editor

If you believe that the United States has the safest food supply in the world, you need to watch “Poisoned.” This movie takes the viewer on a journey with victims’ families, government regulators and industry leaders telling the story of food poisoning in America. 

If there is one takeaway from “Poisoned,” it is that the American government can have success stories, but that it still has work to do. After the deadly outbreak of E. Coli infections traced to Jack in the Box hamburgers in 1993 the top food safety official at the USDA declared it illegal to sell hamburger contaminated with E. Coli O157. 

This documentary shows how the current USDA leadership needs to take the same action regarding Salmonella in poultry. And, the Food and Drug Administration needs to be able to enforce common sense regulations for foods such as romaine lettuce grown in close proximity to animal feedlots.

Viewers will be moved to tears and outraged at the status of food safety in our country, and will hopefully be motivated to contact their representatives and senators and tell them — not ask, but tell them — to act now for safer food.

— — —

Joe Whitworth, Staff Writer

Food safety is something most people take for granted and the topic only gets attention when it goes wrong. There are many passionate people working every day to ensure safe food but the figures on foodborne disease remain high and don’t seem to be improving.  

Watching “Poisoned” reminds us all that the statistics showing 48 million sick each year in the United States are people like you and me and while illness might be mild for many, 3,000 die annually. Often it is the most vulnerable – either young children or older adults – that suffer the most. 

The food system is extremely complex with lots of moving parts in supply chains that are global but while food safety is everyone’s responsibility, there needs to be accountability to drive the seriousness of the message home for industry.  

Whether it is a one-off mistake, complacency or blatantly ignoring regulations, those in the food sector must learn when something they produce, handle, distribute or sell causes an outbreak, and regulators need to assess the gaps in legislation to avoid repeated incidents.  

“Poisoned” does not try to cover every issue from all angles, which would overload the viewer. It will give people the initial vibe that something is not right with the system and the hunger to find out more for themselves. 

— — —

Jonan Pilet, Staff Writer

“Poisoned” exposes the dark side of the food industry, revealing crime, corruption, negligence and waste. This wake-up call should leave viewers rightfully angered by a system that jeopardizes their health. While the film feels hopeless at times, it highlights progress and urges consumers to pressure Congress to make needed changes. The documentary excels in explaining the American food system and the current issues being faced, backed by a captivating score, sharp editing and top-notch production. It vividly showcases the severity of the U.S. food safety crisis and humanizes victims through their poignant interviews.

As someone who follows and reports on the impact of foodborne illness, I hope “Poisoned” sparks crucial attention and action. The alarm has been sounded on the country’s largest streaming platform. How will American consumers respond?

— — —

Cookson Beecher, Contributing Writer

I remember it so well. It was almost dark, raining hard, cold and dismal. Early winter in 1993. As I waited to cross the street, I saw a newspaper headline about yet another child stricken with something called E. coli. The picture of the child was heartbreaking. Many children were in the hospital and one had already died.

It was scary news . . . as though an invisible killer was amongst us. But what was it? And what, if anything, could be done about it?

Fortunately, state health inspectors managed to trace the problem to the “Monster Burgers,” sold at a special discounted price at some of the Jack in the Box fast-food restaurants.  Ironically, the slogan in the promotions was “So good it’s scary!”

“Poisoned” is a movie described as a ‘legal thriller.’  Although this played out in the courtroom, it goes past the legal chambers and into our own lives. Because it did so much to clean up the way the nation’s ground beef is produced, we’ve all come out as the winners.

— — —

Watch the trailer and once you’ve seen the film on Aug. 2, we’d love to hear from you. Submit your thoughts on the film in the comments section below this story.

(To sign up for a free subscription to Food Safety News, click here.)

In June 2023, the U.S. Department of Agriculture Food Safety and Inspection Service (USDA-FSIS) issued new Directives and a Notice regarding the regulation of cell cultured food products derived from cell lines of USDA-amenable species. These newly-released USDA-FSIS documents —  Directive 7800.1, Directive 5730.1, and Notice 31-23 — address the inspection, sampling, and responsibilities of establishments producing cell-cultured meat and poultry products also commonly referred to as cultivated meat. 

With the publication of these Directives and Notice, we now have much more clarity on how USDA-FSIS plans to execute its regulatory obligations in this space, fresh off the heels of the agency’s June 2023 issuance of federal grants of inspection to two U.S. cell-cultured chicken manufacturers and approval of their cell-cultured chicken labeling.  USDA’s actions also both follow FDA’s relatively recent issuances of “no-questions” letters to both companies finding that the companies’ products “are as safe as comparable foods produced by other methods.” According to FDA Commissioner Robert Califf and the FDA’s director of the Center for Food Safety and Applied Nutrition, federal agencies are “committed to supporting innovation in the food supply” and working collaboratively with USDA-FSIS in a joint regulatory framework.

Meat from cells? 

In 2013, Dutch scientist Mark Post showcased the first cell-cultured meat burger on live television. Since then, the industry has ballooned to more than 150 companies and counting on 6 continents, propelled by $2.6B in investments, by some estimates. 

Harnessing cell culture technology to produce food or cellular agriculture refers to the production of agricultural products from cell cultures, like meat, poultry, and seafood ex vivo, grown outside the animal. Each company’s manufacturing process for animal cell-based food products varies, in part, depending on the type of cell line used (e.g., livestock, poultry, fish or seafood) and the nature of the final product (e.g. nuggets or steak). That said, at a high level, the key manufacturing stages include (1) target tissue or cell procurement, selection, isolation, preparation and storage, (2) cell proliferation, as well as possible cell differentiation, during biomass production (in a specially designed bioreactor) (3) cell harvesting, and (4) processing and formulation of food products. Each stage can potentially include various sub-steps dependent upon on the source and desired final food type. Manufacturers aim to produce a finished product that replicates the characteristics of muscle harvested from food-producing animals.  

How Are Cell-Cultured Foods Regulated?

USDA-FSIS and FDA jointly regulate cell-cultured food products derived from cell lines of livestock and poultry under a 2019 Formal Agreement. FDA oversees the pre-harvest production phase of the animal cell culture technology process for all cell-cultured foods. For cell-cultured meat and poultry derived from cell lines of USDA-amenable species, jurisdiction then shifts to USDA-FSIS at the point of harvest. Consistent with the Formal Agreement, any company producing USDA-regulated cell-cultured foods must obtain a federal grant of inspection from USDA-FSIS. That agency oversees the harvesting, processing, packaging, and labeling of such foods. In particular, USDA-FSIS subjects labels under its purview to preapproval and is developing new labeling requirements for cell-cultured meat products consistent with its 2021 Advanced Notice of Proposed Rulemaking (ANPR).

For all other cell-cultured foods falling outside USDA-FSIS oversight– such as most seafood and meat from non-USDA-amenable species (such as elk, deer, antelope, and certain other species). FDA maintains oversight for the duration of the entire production process. 

What’s in the New USDA Directives and Notice?

The new USDA-FSIS Directives clarify the regulatory oversight of cell-cultured meat and poultry products pursuant to the 2019 Formal Agreement. Companies producing such products should review the directives in depth, and highlights are presented below.

• Regulated Like Conventional Meat and Poultry Products: The Agency emphasizes that cell-cultured meat is subject to the same regulatory requirements and oversight authority as conventional meat and poultry. 
• No Generic Approval: Labels applied to USDA-FSIS regulated cell-cultured meat or poultry must be submitted to the agency for review and approval before they are used in commerce (e.g., “sketch approval” in USDA-FSIS parlance).
• Dual Jurisdiction Establishments: Facilities that harvest cell-cultured meat and poultry products are Dual Jurisdiction Establishments — meaning that they are regulated by both FDA and USDA-FSIS. As noted above, FDA oversees the pre-harvest production phase, and USDA-FSIS, which inspects harvest and any postharvest production that may occur in the same establishment. 
• Restrictions on Imports and Exports: Cell-cultured meat and poultry products may not be exported into the United States unless the agency has determined that the foreign country has “a regulatory food safety inspection system that is equivalent to that of the United States for the production of cell-cultured meat or poultry food products.” When USDA-FSIS deems a country to be equivalent for such products, it will add the country as eligible to export “cell-cultured” meat or poultry food products to the United States by species in the agency’s import library. Cell-cultured meat and poultry food products are subject to the same USDA-FSIS import and export regulations and policies as meat and poultry food products derived from slaughter.
• Substances Must Be Considered Safe and Suitable: Ingredients, including processing aids, used pre-harvest that remain in the harvested cells and any ingredients used post-harvest must be considered safe and suitable for use by USDA-FSIS and used in accordance with applicable standards, namely 9 C.F.R. § 424.21(c) or Directive 7120.1 (Safe and Suitable Ingredients Used in the Production of Meat, Poultry, and Egg Products). Ingredients that do not appear in 9 C.F.R. § 424.21(c) or Directive 7120.1 require a technical review, as described in Directive 5020.2 (The Technical Review Process).
• Ingredients already authorized for use in conventional meat and poultry.  Ingredients listed as approved for meat and poultry by USDA-FSIS regulation or Directive 7120.1 may be used in cell-cultured meat and poultry food products if the ingredient’s intended use aligns with the application (i.e., as an antimicrobial dip or as an ingredient component), product type (i.e., for use on whole-muscle or comminuted  product), and any other enumerated criteria. USDA-FSIS also explained that manufacturers must compare Directive 7120.1 to other applicable requirements, such as those for standard of identity to determine whether an ingredient (e.g. an antimicrobial or binder) can be used in a particular product. As noted above, if an ingredient is not listed at 9 CFR 424.21(c) or Directive 7120.1, then the ingredient requires a technical review under Directive 5020.2.

• Inspections:USDA-FSIS inspectors will examine a facility’s operations at a minimum of once per shift.

In addition, USDA-FSIS Notice 31-23 discusses food safety and process controls. Among other things, raw products samples will be tested for Aerobic Count (AC), Salmonella, chemical residues, speciation, and pathology. Food contact surfaces and environments at facilities producing raw products will be tested for AC and Salmonella. Ready-to-eat product samples will be tested for AC, Listeria monocytogenes (Lm), chemical residues, speciation, and pathology. Food contact surfaces and environments at facilities producing raw products at establishments producing Ready-to-Eat products will be tested for AC and Lm. Samples will be at least 60 grams and collected from every other batch until at least 10 samples are collected.

What’s Next?

Cell-cultured meat and poultry products have officially arrived in the U.S. marketplace and are poised to enter the market more broadly in the coming years. Already, USDA-FSIS approved labeling and issued grants of federal inspection services to two U.S. cell-cultured poultry manufacturers in June 2023. These companies also both recently received FDA “no-questions” letters finding that the companies’ products “are as safe as comparable foods produced by other methods.” As these products move to market, companies should take care to comply with a complex dual jurisdiction environment and obtain regulatory approvals necessary from both FDA and USDA-FSIS.

About the authors:

• Brian P. Sylvester is a partner in Perkins Coie’s Washington office. A former USDA regulatory counsel, he advises emerging and established companies in the food, beverage, and agricultural biotechnology sectors, with an emphasis on innovative foods.  He is a leading authority on food tech regulation and serves as a trusted advisor to global brands, startups, life science companies, investors, and trade associations.

• Tommy Tobin, is an associate in Perkins Coie’s Seattle office. He is a Lecturer at UCLA Law, where he teaches a seminar on Food Litigation. Tommy edited the ABA’s Food Law: A Practical Guide, a resource book for practitioners to assist them in meeting the unique needs of food and beverage clients across various domains of legal practice.

Food safety is a significant concern for both consumers and the food service industry. Ensuring that the food we consume is safe to eat is of utmost importance, and the application of Artificial Intelligence (AI) in the food industry has been widely recognized as a promising solution to address this issue.

Building consumer trust is an essential effort. The CDC estimates that 48 million people get sick,128,000 are hospitalized, and 3,000 die from foodborne diseases in the US each year.

As consumers continue to read frightening headlines about food recalls, foodborne illness incidents, and other food safety breaches, they’re demanding transparency more than ever before. The food industry should, therefore, continue to explore the potential applications of AI in food safety to ensure that consumers can have greater confidence that the food they consume is safe.

As AI grows more affordable and accessible for organizations of all sizes and budgets, it will become an increasingly essential tool to boost transparency, verification, validation, traceability, communication, and safety throughout the entire supply chain.

Predictive modeling and quality control
AI can help enhance food safety in several ways. Predictive modeling is one of the most prominent applications of AI in the food service industry. AI algorithms can predict potential foodborne illness outbreaks by using data gathered from various sources, such as environmental factors, ingredient quality, processing operations, and historical records of contamination. The information obtained can be used to proactively take action to prevent such outbreaks from happening.

Another way in which AI can increase food safety is through food quality control. AI algorithms can analyze images of food and packages in real-time to detect abnormalities, such as missing labels or torn packaging. This helps identify contaminated products before they reach store shelves (or consumers).

Food safety can also be enhanced through AI-powered automated food processing systems. By using sensors and cameras, these systems can detect and correct issues like temperatures, liquid levels, gas flow, humidity, and even food hygiene that could lead to food contamination during manufacturing and processing.

Additionally, AI can be used to trace the origins of food products. Using technology and AI algorithms, food producers can track food products from farm to table, providing consumers greater transparency and accountability in the food supply chain.

Ways that AI will improve food safety
Creating AI with verification and validation checkpoints is essential to improving traceability within the supply chain.

AI will improve food safety throughout the supply chain by:

• Improving communication. Good communication is a critical aspect of verification, validation, and traceability. Strong, accurate, real-time communication is essential throughout the food chain to maximize safety, transparency, and trust. 
• Boosting transparency and validation. Everyone in the supply chain must understand the importance of validation and transparency and the role they play. This will help build consumer trust and confidence in the food produced.
• Making the process faster and easier. AI will minimize the number of steps it takes to get validated and the number of people suppliers must talk to during the process. As a result, more suppliers will participate.
• Reducing redundancies. AI will decrease the number of databases that companies have to work with, reducing the redundancies that come with duplicating information in each database. Since these redundancies waste time, labor, and money, AI will help the processes be more efficient, cost-effective, and streamlined, reducing administrative burden dramatically.
• Simplifying the process. The newest AI technologies make these systems simple, straightforward, and multi-faceted rather than complicated with minimal functionality. It’s time to work smarter, not harder!

Reliability and cost factors
However, as with any technology, the use of AI in food safety has its challenges. One major concern is the reliability of AI models. AI models are only as good as the data that is entered, and if the data is flawed or biased, the AI model will produce unsatisfactory results. 

Additionally, there are concerns about the cost of implementing AI in the food industry and the potential for job loss due to automation. Though the use of AI in food safety should not replace human labor entirely. For example, food safety inspections and quality testing will continue to require human involvement to ensure the food meets safety standards and regulations. AI is also expected to create job opportunities in various fields, such as software engineering, data science, and quality control.

However, it’s important to note that the affordability and accessibility of AI may depend on various factors, such as the type of technology, infrastructure availability, and cost of implementation. Tech investments can also have a tremendous ROI, as AI can increase efficiency and reduce costs, and there are even currently affordable options for small businesses.

Despite these challenges, the potential benefits of using AI to enhance food safety are significant. By providing real-time monitoring, detection, and prediction, AI can help to prevent foodborne illness outbreaks, reduce food waste, improve sustainability, and enhance accountability in the food supply chain. 

About the author: Francine L. Shaw, food safety specialist, podcaster, and co-founder of My Food Source, is a successful entrepreneur, author, and speaker who spent 20+ years working in the foodservice industry. Her career has included performing services (operating partner, corporate/private trainer, health inspector, 3rd party inspector, adjunct professor) in various sectors of the foodservice industry. She has written hundreds of articles for national trade magazines and appeared on Dr. Oz, the BBC World Series Radio, and iHeart Radio as a food safety expert. 

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.

We are talking about Jose Emilio Esteban, our new USDA Undersecretary for Food Safety.

This week’s International Association for Food Protection annual meeting and conference was the first opportunity for him to engage with the larger food safety community and for them to see Esteban up close and personal.

When he was confirmed by the U.S. Senate shortly before 2023 began, Esteban was already experienced in the leadership of the International Association for Food Protection (IAFP).  He only had to withdraw  because the President named him to the highest food safety office in the federal government.

To become sworn in as Undersecretary of food safety is no small accomplishment. It took Esteban 10 months to be approved for the Presidential appointment, and then he had to wait another 10 months for his Senate confirmation. He says it is helpful to have patience in his skillset.

His long wait was likely easier than some of his predecessors experienced. He was not from out of town but already in the leadership of USDA’s Food Safety and Inspection Service (FSIS). And Esteban has been a resident of  the Washington D.C. area for five years.

Before his confirmation as Undersecretary for Food Safety, Esteban worked since 2001 in several roles at the FSIS. Most recently, he was chief scientist at the FSIS from 2018 to 2022. 

And before joining the USDA, Esteban was at the Centers for Disease Control and Prevention. 

During his first months as Undersecretary, Esteban made decisions about cell-cultured products, “Product of USA” labeling, and food safety labeling in general.

In his speaking engagements and private remarks at IAFP in Toronto, Esteban explained that three options are being considered when it comes to Salmonella in poultry.

Incoming flocks might be tested for Salmonella before entering a slaughter establishment, better process control monitoring and FSIS verification could be required, or an enforceable final product standard might be adopted.

Esteban trained as a veterinarian in Mexico. He holds an MBA, a master’s degree in Preventive Veterinary Medicine, and a Ph.D. in Epidemiology from the University of California-Davis.

Esteban said that public comments run until July 27 on whether not-ready-to-eat breaded stuffed chicken products that contain Salmonella at levels of one colony-forming unit per gram or higher are adulterated.  Esteban said the comment period might be extended because there has been a request for more time.

A veterinarian himself, Esteban also must deal with the shortage of licensed DVMs that makes it difficult for USDA to recruit and hire additional veterinarians. He said exit interviews indicate that USDA is not losing DVMs over money but because they dislike the job requirements.

There has not been  any “get to know you” time since Esteban assumed command of food safety at USDA. Deputy Undersecretary Sandra Eskin, FSIS Administrator Paul Kiecker, and all the others at the top of FSIS are all well known to Esteban, and they know him.

Under Esteban, there’s the possibility lining up that some food safety improvements could be in the makings.  Esteban knows the power he now has and how short his time will likely be.

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Soft fruits like strawberries, raspberries, blackberries, and berry blends play an important part of an overall healthy diet. While millions of servings are consumed safely every day, they continue to be occasionally linked to hepatitis A (HAV) and norovirus outbreaks around the globe.

Investigation of a recent United States’ HAV outbreak, epidemiologically linked to frozen organic strawberries, has revealed complexities in assessing and determining the safety of frozen berry supply chains. These events have led to a recent call for HAV testing of finished products as a mandatory component by a retail food safety management program. We the authors describe the limitations of testing for HAV contamination in soft fruits, advise of the unintended consequences that could hinder more meaningful progress, and offer some alternative food safety management suggestions.

Limitations of the Enteric Virus test method
An important difference between testing for bacteria (e.g., Salmonella or L. monocytogenes) vs. viral pathogens in foods is that the viruses do not reproduce outside their host. This means culture enrichment is impossible, so testing protocols must rely on concentrating the virus from the food sample, followed by nucleic acid (RNA) extraction, and then detection of the virus genome using RT-qPCR. While this three-step method is currently the best approach available, it has inherent flaws. RT-qPCR detection limits tend to be higher than what we see for bacteria because of poor virus extraction efficiency and the presence of residual matrix-associated inhibitors. RT-qPCR is designed to detect only a small fragment of the viral genome. Since nucleic acids can be environmentally stable, detectable long after viruses are no longer infectious, a positive PCR result does not necessarily correspond to the presence of an intact and infectious viral particle. In short, a PCR positive cannot be automatically construed as an indication that the product contains infectious virus and constitutes a public health risk.

Limitations of sample size and sampling plans
HAV enters the berry supply chain through infected individuals, often via poor water and waste management systems. Unfortunately, the ultimate source of contamination is rarely identified through traceback, and the nature of any contamination event can vary widely from highly focal to much more diffuse. In many instances, HAV would be expected to be distributed in a non-uniform manner throughout a given lot of food. The table below was extracted from a simplified modeling exercise intended to investigate the likelihood of detecting HAV under different contamination scenarios¹. 

The analysis shows that the probability of detection is higher under what one might call a “gross” contamination event in which the entire production lot is contaminated. Note that this result is very dependent on the assumed concentration. If this assumed concentration is at or below the limit of detection for the test, even this contamination may not be detected.

Also, note that the likelihood of detection is always quite low when the contaminant enters the food through more focal events like poor personal hygiene of a hand harvester. Both concentration and prevalence of virus contamination drive the likelihood of detection. Detection probability can be improved by using bigger samples or testing more samples. Since sample size is fixed (e.g., 25 g for the ISO 15216-2 method), and virus testing costs usually exceed $150/sample, there is little opportunity for improving the utility of testing. In summary, sampling considerations, such as lack of statistical power, provide an additional hurdle to the value of screening finished products for HAV contamination. 

Table 1. Synopsis (best and worst case scenarios) of modeling exercise to investigate the likelihood of detecting HAV under different contamination scenarios with different numbers of samples (1 to 5) per lot tested using ISO 15216-2.

* This analysis relied on a number of assumptions: Virus may be present in some or all of a lot, and in different concentrations as detailed below; one virus particle is equivalent to one genome copy; when less than 1 virus particle is present in the ISO analytical unit of 1.25 g, the virus is present a fraction of the time (e.g., 0.1 virus particles per 1.25 g means the virus is present 10 percent of the time); This analysis also assumes that virus concentrations below the LOD₅₀ lower bound will always detected if present. This means that the high probability of detection from the raw sewage scenario may significantly over-estimate effectiveness.

** This high probability of detection is very sensitive to whether the virus concentration is above or below the assay limit of detection (LoD). If below the LoD, this probability is considerably lower.

Relationship between positive test result and public health risk
Taken alone, the RT-qPCR detection assay is highly sensitive, with a theoretical detection limit of one single target template molecule. However, this method has no reliable means by which to determine if that target template (1) comes from an infectious virus that can make someone sick; or (2) is just stray viral nucleic acid material or is associated with a non-infectious particle. In the first instance, there is a clear risk to public health; in the latter, essentially no risk. Until methods are available to determine whether a positive result is indicative of the presence of infectious virus (methods that are likely a decade or more away), interpretation of a positive PCR test is ambiguous. Interestingly, the Food and Agriculture Organization of the World Health Organization (FAO-WHO) has initiated a project to quantify the public health risk associated with potential enteric virus contamination in foods. Until an exercise like this is completed, the public health implications of testing and finding nucleic acid of HAV in frozen berries via random testing (especially when its concentration is very low), and without corresponding epidemiologically-linked illnesses is unclear. 

Where to go from here – addressing research gaps and a focus on prevention
The discussion above illustrates the myriad issues associated with detection of any non-cultivable foodborne pathogen in complex sample matrices. While testing is an important tool in the food safety toolbox, at the current time, there remain many research gaps that need to be answered to determine how to best use testing as a validation or verification tool. For example, could testing be used in a more focused and strategic manner as part of a risk assessment to determine potential sources of contamination such as irrigation water or wellness of a crew through testing portable toilet waste? Because HAV is so resistant to inactivation and disinfection, preventing contamination should be the top priority. Vaccination of food workers in direct contact with product along the supply chain is one means of minimizing the potential for contamination. While vaccination is expensive, so is testing, and a cost benefit analysis of farm crew vaccination should also be considered. A laser focus on personal hygiene practices of food handlers, Good Agricultural Practices, and proper water and waste management will all reduce the chance of an HAV contamination event and remain the current primary defenses for virus control in the berry supply chain. 

In summary, while tens of millions of fresh and frozen berries are consumed safely every day, unfortunately, berries are still occasionally implicated in HAV outbreaks and there is more the industry and regulators can do. Therefore, it is our view that an over-focus or reliance on end-product testing, using current vetted methods and low powered sampling plans, while well intentioned, could actually provide a false sense of security and hinder more meaningful and needed progress to further strengthen the safety of these important and nutritious products.

 Authors: Dr. Lee-Ann Jaykus, William Neal Reynolds Distinguished Professor, NC State University; Dr. Donald Schaffner, Graduate Program Director, Distinguished Professor and Extension Specialist, Rutgers University; Frank Yiannas, Former Deputy Commissioner, Food Policy and Response, U.S. Food and Drug Administration; Dr. Sanjay Gummalla, Senior Vice President of Scientific Affairs, American Frozen Food Institute

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Dear Editor,

As an advocate for comprehensive organizational change in FDA’s Food Program, I give Commissioner Califf and his team the credit they are due for the changes he announced this week. I still think that food inspectors should report to the Food Program leader, but the Commissioner’s plan moves strongly in the direction of a unified structure that can operate with much greater efficiency and unity of purpose than the current structure.   

As I read the proposal, it effectively dismantles the old version of the Office of Regulatory Affairs by taking out the state partnership office, the field food labs, and most of ORA’s headquarters staff working on food and moving them into a reshuffled version of the Center for Food Safety and Applied Nutrition under a single accountable leader. These are big changes, for which the commissioner deserves credit. Overall, it looks to me like a new organization with a chance for a fresh start, albeit with huge implementation challenges.  

My largest outstanding question is whether the new Deputy Commissioner will ultimately have the formal and practical authority within FDA to fully implement the reorganization plan, in both headquarters and the field, and to lead the necessary shift to a food safety culture of transparent engagement and collaboration, laser focused on risk-based prevention of foodborne illness.  The new structure makes this culture change possible but not inevitable.  FDA deserves the food community’s continued input and support to make it happen. 

Mike Taylor
Former FDA deputy commissioner for foods and current Board Member Emeritus at Stop Foodborne Illness

Editor’s note: This is part of a series of papers written by students in the Food Safety Litigation class taught by Professors Bill Marler and Denis Stearns in the LL.M. Program in Agricultural and Food Law at the University of Arkansas School of Law.

You hear them say, “Oh my God, I love it so much,” with happiness in their voice, a smile on their face, eagerness in their demeanor, and love in their eyes. You’ll be curious find out the object of their affection. If you look closely, you might be dismayed to see that it’s simply a tomato fruit. In fact, the U.S. Supreme Court ruled more than 125 years ago that a tomato is a vegetable rather than a fruit for the purposes of tariffs, imports, and customs, but I digress.

The southern region of the United States is known for its warm welcomes, politeness that isn’t pretentious, and genuine helpfulness. Strangers are made to feel welcome in a Southern house by the practice known as southern hospitality.

Corporate America has discovered a way to use Southern hospitality as a weapon that makes customers feel welcome in corporate spaces. Shops feel like home for customers. When they enter any place of business, American customers have come to expect to be welcomed like guests in a Southern house.

“For all its ups and downs, Walmart is no doubt a genuine American institution.”
“In our culture, we have excessively high expectations,” Robin Kowalski, a psychology professor at Business School told Vox in an interview.

“The way we evaluate things is a function of expectations…If we’re used to a level of customer service, which Americans are, and then things change, like prices go up or things slow down, the violation of that expectation is what causes disappointment, anger, all of these sorts of things,” Deborah Small, a marketing professor of psychology at Wharton was quoted in the same Vox interviewer.

Meeting expectation of consumers is the vehicle on which businesses and to a large extend the American society run. “Consumer society, in fact, is not just about the satisfaction of needs, but in many ways, it is about the forms through which we view the world and our position within it … The arrival of consumer society during the last one hundred years has transformed not only our material existence but also our ontology, our very being itself.”

Walmart became the largest retailer in the world by perfecting meeting the needs of the American consumer.

Walmart’s genuine Americanness, however, was the cause of its failure in Germany. One of the American practices was requiring sale clerks to smile at customers. In Germany, customers interpreted the smiling to be flirting. “People found these things strange; Germans just don’t behave that way,” said Hans-Martin Poschmann, the secretary of the Walmart employees’ union told the New York Times in 2006, when Walmart pulled out of Germany after almost a decade of failing to make profit in the market. People do not expect their business to have a personal touch to it in Germany and as the New York Times pointed out, in other countries.

The Arkansas native-founded Walmart is not the only company that perfected the art of adding a personal touch to doing business. Georgia-based Delta Airlines, for example, touted its personal touch as a show of their Southern hospitality.

“Delta garnered the reputation for being a service-oriented southern airline with all the graciousness the Southern Hospitality is an expression that has historically been used to refer to the graciousness and civility that is associated with people from the southern part of the United States.

“It is no exaggeration to say that we are among the nicest people you are likely to meet,” Writer Florence King is quoted to have said.

“The most common qualities of southern hospitality include politeness, charm, kindness, helpfulness, and charity. These qualities are seen as aligning with the idea of what it means to be a good host.”

Southern Hospitality is often on full display at the Fayetteville Downtown Square every Saturday since 1974 when a city ordinance designated that space to be used as the Fayetteville Farmer’s Market. The setting at the market is relaxed, pleasant, inviting, and welcoming. To make customers feel like friends, farmers extend a kind greeting to their booth, inquire about their personal life, and enthusiastically volunteer information about their personal lives.

The market’s small-town neighborhood atmosphere can occasionally conceal the reality that it is a business district governed by laws established by the Fayetteville City Council and different departments of the state of Arkansas.

The primary laws that govern the market are summarized in the Farmers’ Market Vendor Guide. The latest guided of the document was drafted by the Arkansas Department of Health and Arkansas Department of Agriculture in September 2021.

The Guide quotes Arkansas State Act 1040 of 2021, allowing the sale of Non Time/Temperature Control for Safety (Non-TCS) Foods directly to consumers.

Non-TCS Foods was defined as “food that does not require time or temperature control for safety to limit pathogenic microorganism growth or toxin production and as defined in the rules of the Department of Health.”

“Uncut fresh fruits and vegetables” were explicitly named to fall under the non-TCS foods. The Guide named Ready-to-eat foods as food, which are covered under the non-TCS foods.

“Any ready–to-eat food that is prepared on site or any food that is provided to the consumer in a non- prepackaged form can only be sold or served from an ADH permitted and inspected facility. Any establishment preparing, selling, or serving any of these food items must fully comply with the Arkansas Department of Health’s Rules and Regulations.”

A tomato is a non-TCS food, however, a cut tomato may be considered a ready-to-eat food. And there lies the issue.

“The intention of the regulations that do exist is to mitigate the risk of foodborne illness. Any time a food is “processed” the risk for pathogens to contaminate the food is increased. As such the rules allow a vendor to offer an uncut cherry tomato as a sample, or a small muffin, but if the vendor has to cut the product in order to offer a sample (like slice a tomato or slice bread) it must be either pre-prepared in a commercial ADH inspected kitchen, or the vendor must have appropriate prep means at the market, that have been inspected and approved by an ADH Health inspector (similar to the requirements for businesses like Food Trucks or our sellers who prepare drinks like coffee at market)”, Julia Den Herder, one of the managers of the Fayetteville Farmers’ Market and a vendor herself, explains the distinction in an email.

A tomato fruit (or vegetable) is a non-TCS food but when it is cut and offered to the consumer, it is considered a ready-to-eat food which will require the permission of the Arkansas Department of Health to be sold on the market.

The American consumer, who is accustomed to getting what they want, purchases tomatoes for their appearance, texture, flavor, and aroma. The consumer can evaluate the tomato’s appearance and texture fairly with an uncut tomato (just by touching it). It provides no indication of its taste. Before making a final decision, the customer wants to taste the fruit. Although the tomato cannot be taste- tested if the customer purchases it from a Walmart, the Fayetteville Market’s relaxed attitude leads the customer to believe that this is exempted from the grocery store’s guidelines that Walmart is governed by.

The seller informs the customer that “the market does not permit us to offer samples to consumers” in order to please the customer while upholding the graciousness associated with Southern Hospitality. The supplier gives the customer a better deal. “I will offer you a sample in secret,” he says. “Come inside my booth so I may cut it for you in private.” The customer accepts the sample based on the seller’s claim after believing both claims provided by the vendor. The vendor has thus misrepresented the rules on sampling to the customer, in their bid to be polite.

“The market does not have policies that make it illegal to offer samples to buyers; however, sampling food products is regulated by ADH and RMPE rules about offering samples are in compliance with those regulations. Some of these rules are consistent with grocery store requirements for food sampling (like needing a three compartment sink for appropriate sanitation) and some are specific to Farmers Markets due to the nature of markets being distinct from other retail environments”, Julia Den Herder clarified.

The vendor has thus opened himself up to legal issues by the “innocent of politeness” that the “market does not allow us to offer samples.” Under Arkansas law, fraudulent inducement to contract (making a sale being a contract) is considered both a criminal offense and a ground for voiding a contract. The Arkansas Supreme Court explained the effect of fraudulent inducement in Wal-Mart Stores v. Coughlin.

Each situation in a food safety lawsuit has a slightly different liability. Some of it directly affects the market, and some of it affects the vendor. For instance, the Arkansas Department of Health will decide who is responsible in cases of food poisoning after looking into the source of the infection; if the vendor is discovered to be the pathogen’s original source, they will be held accountable. The market will find it simpler to hold the vendor entirely responsible if there has been misrepresentation.

Even though southern hospitality is generally excellent, it is not an acceptable alternative to a direct, firm response to a request, whether the response is a yes or a no.

About the author: Anthony Owura-Akuaku is a Former Paralegal, 1st Law Legal Practitioners/Consultants and Former Communications Assistant to the President, Musicians Union of Ghana LL.B., Central University Secondary School Certificate, Business, St. Peter’s Boys’ Senior Secondary School.

The Physical Security Team issues and manages LincPass badges that grant FSIS employees access to agency facilities and laptops. The team also completes security assessments of agency buildings, including doors, windows and security systems, and ensures they meet or exceed FSIS requirements. The Safety Team helps ensure employee health and safety by managing personal protective equipment (PPE) — face masks, face shields, cut-resistant gloves, hard hats and lab coats — for FSIS field employees. This team also provides their technical expertise to the Office of Field Operations (OFO) and follows up if an employee is injured or reports hazards on the job. Per Yoon, “Worker safety is paramount. FSIS employees must be able to focus on their mission without having to worry about their safety.”

Yoon joined the agency in January 2022, and quickly implemented biweekly one-on-one meetings with all members of his team. He believes it is his job to ensure his staff has everything they need to be successful in their roles, and these meetings are critical to his providing support wherever it is needed. “I am a big believer in servant leadership, where I work for my staff to ensure their needs are met. I ask, ‘How can I help you? What do you need to perform your job?’ It’s good for morale and provides them opportunities to grow,” said Yoon.

In early 2022, Yoon and his team worked with the Office of Employee Experience and Development (OEED) to create videos for OFO on properly wearing PPE. OEED provided the script (reviewed and approved by SPSB) and actors, and the Safety Team supervised during filming. The result is a collection of videos available to all OFO employees. “This project makes me feel really good because I know I am directly affecting people’s lives. We want people to be safe and go home to their families at the end of each shift,” said Yoon.

FSIS Core Values
Yoon is a firm believer in all four FSIS Core Values — Accountable, Collaborative, Empowered and Solutions-Oriented. “As a leader, one must be accountable for achieving goals,” said Yoon. Additionally, he always takes accountability for his team’s actions, as well as his own.

Yoon is collaborative by reaching out to others in the organization and building relationships. Through training, he feels empowered to do his job. Yoon also believes it’s his job as a manager to ensure members of his team apply themselves, and he works with them to identify together what training they need. Said Yoon, “Professional development for me and my staff is important, and FSIS provides many opportunities for training.”

Finally, he enjoys working with other program areas to develop solutions to address agency issues. Currently, the Safety Team is working with the Office of Planning, Analysis and Risk Management to develop an in-house safety database that can provide data analysis for safety key performance indicators (KPI). For example, if an employee experiences an issue with the peracetic acid used as an antimicrobial on the production line, he will complete a form. The information from the form will be deposited in a database. The data is then filtered and provided to Yoon’s team to help identify trends and provide corrective actions based on those trends. The safety team will start by watching for trends with hazards and then move on to tracking injuries.

Education and Background
Yoon earned a Bachelor of Science degree in occupational safety and health from Columbia Southern University in 2012 and a Master of Business Administration from Northcentral University in 2015. He went on to receive a graduate certificate in business intelligence from Villanova University in 2016 and a certificate in executive leadership and management from the University of Notre Dame in 2017.

Wishing to serve his country and earn money for college, Yoon served in the U.S. Marine Corps Reserves as a supply administration and operations specialist from 2000 to 2002. After the events of 9/11, Yoon wanted to go into intelligence; after all, he already spoke a foreign language (Korean). He served active duty with the U.S. Navy from 2002 to 2012, where he learned to read, write and speak Pashto over the course of a year.

Later, as a Pashto linguist, Yoon was deployed to Afghanistan four times. In 2010, when he could no longer deploy, he worked full time in the safety office, something he had done as a collateral duty during his first eight years with the Navy. As a safety officer, he gained experience presenting concepts to high level leadership, including the base commanding officer. This experience has served him well in later safety positions with the American Red Cross and FSIS.

After his time with the U.S. Navy, Yoon spent the next ten years with the American Red Cross, nine of which he served as a safety officer to the division director. In his last year with the nonprofit, Yoon was accepted into their executive development program and promoted to corporate finance director, where he learned about KPIs and analysis, and briefed the chief operating officer monthly.

In late 2021, Yoon decided to pursue a career in public service that would complement both his military service and safety background. A career transition specialist at Wounded Warrior Project helped Yoon improve his resume and identified the SPSB position with FSIS. He applied for the job because it seemed like the right opportunity, given his education and experience.

Of her new branch chief, Yoon’s supervisor, Yolanda Chambers, Director, Administrative Services Division, said, “Jerome has been with OM Administrative Services Division a little over a year. During his time with us, he has demonstrated excellent leadership and technical expertise in taking on new challenges and meeting the demands of the agency by leading his team in tackling employee safety issues and strategically streamlining processes for physical security. He has successfully guided and motivated the Safety and Physical Security Branch in completing several mission critical projects for the agency.”

Outside of Office Hours
Yoon and his wife Jenny are the proud parents of Ethan, 6, and Alyssa, 3. Food safety is important to his family, as his son has six food allergies that were identified when Ethan was a baby. When he’s not in the office helping FSIS achieve its mission, Yoon enjoys playing golf, cheering on the Baltimore Ravens and Orioles, and playing with his children.

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Editor’s note: This is part of a series of papers written by students in the Food Safety Litigation class taught by Professors Bill Marler and Denis Stearns in the LL.M. Program in Agricultural and Food Law at the University of Arkansas School of Law.

By Brittany Rowe

On March 29, 2023, the Center for Food Safety filed a lawsuit against Wood Farms in the U. S. District Court for the Northern District of New York for violating the Clean Water Act for polluting the St. Lawrence River. The lawsuit alleges that Wood Farms, a mega-dairy located in Clayton, New York that confines over 2,200 cows, has repeatedly discharged pollutants including solid manure and liquid manure, process wastewater, and related operational waste products, into waters of the United States in violation of its clean water permit for a period of five years and sixty days. Plaintiff seeks declaratory relief, injunctive relief, and civil penalties. 

Plaintiff Center for Food Safety is a nonprofit public interest and environmental advocacy organization with over 830,000 members nationwide whose mission is to “empower people, support farmers, and protect the earth from the harmful impacts of industrial agriculture.” The Center for Food Safety brought this civil action against Wood Farms pursuant to the citizen suit provision of the Clean Water Act . The Clean Water Act requires facilities that intend to discharge pollutants into navigable waters obtain a National Pollutant Discharge Elimination System (NPDES) permit. One such facility that requires an NPDES permit is a concentrated animal feeding operation, or CAFO. A large CAFO is defined as an animal feeding operation where “animals (other than aquatic animals) have been, are or will be stabled or confined and fed or maintained for a total of 45 days or more in any 12-month period, and . . . crops, vegetation, forage growth, or post-harvest residues are not sustained in the normal growing season over any portion of the lot or facility” and confines a specific number of animals set out under 40 CFR § 122.23(b)(4). Wood Dairy Farm falls under the definition of a large CAFO because it has over 700 mature dairy cows. Once a facility is regulated by a NPDES permit, the facility must comply with all terms and conditions of the permit. If a facility fails to comply with the permit, the Clean Water Act permits citizens to file suit for violation of the Act. 

Wood Farms generates solid and liquid manure which it stores in lagoons, which the complaint alleges leak into the soil and discharge into the St. Lawrence River and associated tributaries, including Wheeler Creek, Lake Ontario, Kents Creek, Mud Bay, and adjacent tributaries, ditches, and wetlands (Wood Farms Discharge Waters) and load onto trucks for land application. The complaint alleges that Wood Farms has discharged pollutants in violation of the Clean Water Act in several ways. First, Wood Farms has discharged wastewater into surface waters of the State, which are excluded from coverage under its NPDES permit. Second, Wood Farms has discharged manure to surface waters of the State, which violates its NPDES permit. Third, Wood Farms has discharged “manure or process wastewater in saturated conditions including applications made on saturated soil (either fluid-saturated or frozen-saturated soil conditions) or applications made at a rate that creates or causes the soil to become saturated a the time of that application,” which violates its NPDES permit. Fourth, Wood Farms has discharged manure or process wastewater to land application areas during winter months in a way that does not conform with the 2015 Cornell Guide or NRCS NY590 Standard, a nonconformity that violate its NPDES permit. The pollutants contained in the discharged liquid and solid animal wastes include fecal coliform and E. coli, other pathogens, nitrogen, phosphorus, and suspended solids. These pollutants harm water quality and pose a public health risk for people who use the Wood Farms Discharge Waters and degrade the surrounding environment. 

The complaint includes photographs taken in January 2023 at Wheeler Creek near where it joins the St. Lawrence River that show significant foam formation from phosphorus and other pollutants Plaintiffs allege came from Wood Farms’ manure or process water discharges. Similar photographs were taken in February 2019 and March 2014. Wood Farms was cited back in 2014 for violations related to an unpermitted overflow pipe and again in 2008 for process wastewater from Wood Farms to Wheeler Creek. Thus, the complaint claims 1) Wood Farms discharged pollutants in violation of its NPDES permit, and 2) Wood Farms failed to comply with the reporting requirements of its NPDES permit, both of which violate the Clean Water Act.   

Mega-dairies, large-scale commercial dairy operations that are a type of CAFO, generate large quantities of manure that carry nutrients and pathogens, leading to water pollution and public health risks. CAFOs are a leading source of water pollution and a point source that requires a permit under the Clean Water Act. Historically, however, only a small percentage of CAFOs are regulated and the Clean Water Act permits fail to adequately protect waterways from the pollution generated by CAFOs. 

This case is part of a larger effort by nonprofit public interest organizations to hold CAFOs accountable for the pollution they create and close loopholes that allow CAFOs to skirt accountability. In January, the EPA responded to a 2021 Food and Water Watch lawsuit that urged the EPA to scrutinize water pollution stemming from CAFOs. The EPA announced that it would undertake several new studies to collect and analyze data on factory farm water pollution to determine what steps it needs to take to strengthen the Clean Water Act. Specifically, the EPA intends to “undertake a detailed study of the Concentrated Animal Feeding Operations (CAFOs) Category (40 CFR part 412), which will focus on collecting further information to enable the Agency to make an informed, reasoned decision on whether to undertaking rulemaking to revise the ELG for CAFOs.” This is the first time in fifteen years that the EPA will revisit the regulation of water pollution from factory farms. 

Soon after the Wood Farms case was filed, the EPA came to an agreement with the Center for Food Safety, Food & Water Watch, and nine other organizations related to the Agency’s unreasonable delay in responding to a 2017 petition to overhaul water pollution regulation for CAFOs. The petition recommendations included: 1) revising the agricultural stormwater exemption; 2) establishing a presumption that CAFOs cause pollution and require them to obtain permits; 3) improving discharge monitoring; 4) prohibiting practices that harm water quality; and 5) strengthening effluent limitation guidelines. After the EPA failed to respond to the petition, Food & Water Watch filed a lawsuit in the Ninth Circuit Court of Appeals in October 2022. In April 2023, the EPA agreed to answer the petition by August 15, 2023, which could lead to tighter water pollution standards for CAFOs in the United States.

About the author: Brittany Rowe is former Judicial Pool Clerk, Lane County Circuit Court, Oregon; J.D., Lewis and Clark Law School, Animal Law Certificate; Co-Editor in Chief, Animal Law Review; Author, 2020 Foreign and International Legislative Review, 27 ANIMAL L. REV. 175 (2021); B.S., Sociology and Anthropology, West Virginia University.

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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Editor’s note: This is the first in a series of papers written by students in the Food Safety Litigation class taught by Professors Bill Marler and Denis Stearns in the LL.M. Program in Agricultural and Food Law at the University of Arkansas School of Law.

By John Mulcahy

“We have met the enemy and he is us.” -Walt Kelly

It has been over thirty years since the West Coast fast food chain, Jack in the Box, found itself embroiled in litigation over an E. coli outbreak that stemmed from undercooked hamburger patties sold in several of its locations.  Sickening, maiming, and killing children in several Western States, the insidious nature of the outbreak proved to be a watershed moment in food safety.  From lawyers and doctors to government officials and c-suite executives, interested parties vowed to improve food safety.  Jack in the Box, then the sixth largest fast-food chain in the United States, exerted pressure on its suppliers, Congress held hearings, and lawyers brought actions, all in an effort to ensure that the devastation that resulted from the outbreak would not be replicated.    

Since the resolution of the last remnants of the litigation that stemmed from the Jack in the Box outbreak, advances in science and technology have proliferated at an unfathomable rate, all while the public commitment to ensuring a safe food supply has remained steadfast.  Because of this, it would be reasonable to assume that widespread outbreaks of foodborne illness no longer pose a health risk.  Yet, in the intervening three decades, the incidents of food borne illness in America have climbed year over year, with little exception.  And, with each new outbreak, comes a rash of litigation. 

The role that litigation plays in advancing society’s collective goal of ensuring a safe food supply is viewed differently by the various stakeholders.  Certainly, the victims of a foodborne illness outbreak maintain a favorable view of the lawyers who hold producers and purveyors to account through the justice system.  The governmental officials on whose watch the outbreaks occurred and the companies that failed to protect consumers, however, do not hold the lawyers or their tactics in the same regard.  In their eyes, the lawyers are profiteering off of tragedy, advancing their own pecuniary goals under the guise of altruistic service.  The retort from the legal community is simple and direct: if you don’t want further litigation and the criticism that comes with it, deliver a safe product to consumers.  This message, though, is delivered with a wry smile from the litigators filing the lawsuits on behalf of the sick and injured because they know, as we all do, that no degree of care can eliminate the proliferation of foodborne illnesses.  

While goods can be manufactured to the strictest specifications and subjected to multiple, often computerized, quality control regimes, it is impossible to remove the human element from the food chain.  And, whenever safety depends on the vigilance of everyday people, it is not possible to maintain a perfect track record.  This is illustrated by certain aspects of two foodborne illness outbreaks that occurred decades apart, the Jack in the Box E. coli outbreak of 1993 and the Chipotle norovirus outbreaks of 2015.  In both outbreaks, the human factor was dispositive, but not necessarily in the way one would expect.    

On its face, the many failures that caused the Jack in the Box E. coli outbreak seem apparent.  Jack in the Box purchased meat that contained E. coli and then failed to cook the meat to the temperature required by the State of Washington.  If the meat had been cooked to the required temperature, the E. coli would have been killed and the outbreak would not have occurred.  From the management of the meat processing plants, to the State of Washington health officials, to the Jack in the Box corporate officers, the number of people who, if they had done their jobs properly, could have stopped the outbreak are many.  Their failings, though, are outsized and would lead one to believe their ineptitude could be remediated to ensure that an outbreak of that nature would never happen again.  But, remember, perfection is not possible and there was another less apparent aspect of Jack in the Box’s operations that, in essence, caused the outbreak.  

While many of the Jack in the Box restaurants received the tainted meat, only the patrons of some of the restaurants were sickened.  Like most fast-food restaurant chains, the meat was cooked for the same amount of time, at the same temperature and in the same manner at each Jack in the Box restaurant.  It was anomalous that the exact same conditions could result in such wildly different results.  While it is true that the meat was cooked exactly the same way in each restaurant, the age of the grills the meat was cooked on varied from restaurant to restaurant.  The newer grills held their temperature, and the older grills did not.  It was fortuitous that Jack in the Box failed to adopt the State of Washington’s requirement that all meat be cooked to 155 degrees.  The E. coli was killed at Jack in the Box’s standardized cooking temperature of 140 degrees, which was achieved at each restaurant that utilized the newer grills.  Stripping the Jack in the Box outbreak down to its simplest form reveals that had Jack in the Box properly calibrated its grills, the outbreak would not have occurred.  The ineptitude of the meat processors, the health inspectors and the executives at Jack in the Box would have been rendered moot had someone confirmed the grills actually reached their set temperature.  Food safety requires an unbroken chain of perfection.  If any link is broken, ensuring an outbreak does not occur is impossible.

 The Department of Justice’s press release from 2020 was, in part, succinct, “Chipotle failed to ensure that its employees both understood and complied with its food safety protocols, resulting in hundreds of customers across the country getting sick.” One of the sicknesses referred to in the press release was norovirus, a highly contagious pathogen that can cause diarrhea and vomiting.  Unlike Jack in the Box where a bacterium in the food being served caused the outbreak, the food that was being served by Chipotle was safe, it was workers serving the food that were not.  In separate instances in California and Massachusetts, hundreds of Chipotle customers were sickened when a single employee in each of the restaurants came to work ill.  In 2015, the year of the norovirus outbreaks, Chipotle had nearly 60,000 employees, representing 60,000 links in the food safety chain.  It took the actions of two such employees to break the chain and affect the lives of hundreds of people.  

When the food safety record of a multi-national company that employs thousands of workers comes down to the actions of a single employee, the scale of the monumental challenge of ensuring food safety comes into focus.  Today, Chipotle employs nearly 100,000 people and it is self-evident that it would be impossible to ensure that each individual follows all of the company’s food safety protocols.  In fact, the only action that has resulted in a reduction in the incidents of food borne illness in the last several decades, was the wholesale closure of restaurants during coronavirus pandemic.  According to FoodNet, incidents of food borne illness decreased in both 2020 and 2021.  While there is some debate as to whether other factors contributed to these reductions, such as a lack of access to in-person medical care or testing, given the sheer number of outbreaks that originate from restaurants, it is reasonable to assume that at least some of the amelioration of foodborne illness during this time was due to the remedial measures put in place to combat the pandemic.  The multi-year reductions illustrate that the only completely safe restaurant is a closed restaurant.   

According to the U.S. Bureau of Labor Statistics, in 2022, the last reporting year, millions of Americans worked in the food service industry.  Which means, on any given day, there is an infinite number of opportunities for human transgression.  Whether it is a Jack in the Box employee who fails to calibrate a grill or a Chipotle employee who comes to work symptomatic, it is not possible to hedge every apparent or obscure risk.  And, when one error has the potential to result in widespread sickness, it is no surprise that it has proven to be impossible over time to curtail the incidents of food borne illness.  As long as Americans are eating, the outbreaks will continue and, like it or not, so too will the litigation. 

About the author: John Mulcahy of Connecticut, is Vice President, Shareholder, & Director, Updike, Kelly & Spellacy, P.C. He is J.D., Quinnipiac University School of Law Merit Scholar. Quinnipiac Law Review M.S., summa cum laude, Political Science, Southern Connecticut State University B.S., Political Science, Southern Connecticut State University.

Dear colleagues,

As her service comes to an end on May 31, it is appropriate to thank Dr. Susan Mayne for more than eight years of professional dedication as Director of FDA’s Center for Food Safety and Applied Nutrition. Upon her arrival in 2015, Dr. Mayne made it a priority to learn quickly the ongoing issues within CFSAN offices while also providing leadership in an expanded applied nutrition component at the center. She brought a bright and upbeat personality and interacted frequently with CFSAN leaders and other employees on issues impacting food safety, applied nutrition, foodborne outbreaks, recalls, new regulations and a multitude of other items.

During her tenure as CFSAN Director, it was necessary for Dr. Mayne to move quickly through a constantly changing environment of complex issues. She did so with the expert professionalism demanded of a center director. Her skillful leadership and work ethic were key attributes in the successful completion of many CFSAN achievements, such as issuing multiple FSMA rules and guidance documents, along with addressing PFAS chemicals, toxic elements in foods targeting infants and children, asbestos in talc-containing cosmetics, sesame as a major food allergen, and providing consumers with new information on the Nutrition Facts label to support healthy food choices, among many, many others.

CFSAN provided staff with a professional work environment where we worked as a team to address common goals such as promulgation of impactful regulations, clarification of agency expectations through guidance documents, development of strong stakeholder relationships, and informing stakeholders of agency positions through public presentations. Prior to our independent retirements of recent years, both of us had a large variety of interactions with Dr. Mayne and her immediate staff. Those interactions clearly displayed Dr. Mayne’s vision and leadership skills needed to ensure that CFSAN would survive and thrive despite budget and administrative challenges. From a variety of food-related issues to dealing with Covid, or dealing with a 35-day government shutdown, Dr. Mayne provided a steady hand in overcoming obstacles and meeting the next challenge around the corner. For her dedicated leadership over the years, we are grateful to her and wish her well in her future endeavors.

In summary, Dr. Mayne provided strong, deliberate leadership for CFSAN during both smooth and turbulent times. She maintained an even-handed approach to ensure that center priorities and employees received appropriate attention by FDA. The accomplishments of CFSAN under Dr Mayne’s leadership will have a major impact on food safety and nutrition for years to come, and she deserves recognition and thanks for all she helped CFSAN accomplish.

Kind regards,

Jenny Scott
Senior Advisor (retired) CFSAN Office of Food Safety

Mickey Parish, Ph.D.
CFSAN Senior Science Advisor (retired)

2

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.

When do dark kitchens need the sanitizing light of local consumer safety oversight?

Never, according to Montana Gov. Greg Gianforte, Republican, and Sen. Greg Hertz, R-Polson. This is the clear message sent to the public when Gianforte signed Hertz’s myopicaly negligent homemade food bill into law May 2 (Senate Bill 202). It’s a throwback not to 1923, but 1823 when consumer safety regulations were almost nonexistent at any government level throughout the United States.

The outcome for consumers will likely be additional preventable illnesses and possibly death. I already investigated and documented one outbreak with my colleagues. We attributed the cause to the previous version of this law. There will be more, but it’s likely we might never know of them, unless they are reported.

The 2023 version of this law prohibits operators of local farmers markets from establishing their own rules to protect consumers. Prior to May 2, wise operators of farmers markets allowed safer homemade canned foods and disallowed others that might be sources for botulism. This is the disease caused by the most potent neurotoxin known to humans. Food botulinum toxin is too often found in improperly canned homemade foods that are low in acidity and high in moisture content, such as most vegetables and fruits. 

The dark kitchen law welcomes any and all such homemade foods, no questions asked. It is absent any and all local authority, reasonability or science, based solely on a nonsensical and unreasonable antigovernment agenda. It concentrates authority to the state legislature. 

But Gianforte and Hertz are not the ultimate source of the dark kitchen law, legally titled the “Montana Local Food Choice Act.” The dark kitchen law has 2011 origins, under a “local” marketing gimmick, wrapped in a “food freedom” flag ruse, perpetuated by the libertarian political advocacy group, “Americans for Prosperity” (AFP). The conservative group AFP was founded in 2004 and funded by billionaire brothers Charles and David Koch. The antigovernment movement is an extremist response to the federal “Food Safety and Modernization Act,” signed into national law by President Barack Obama on Jan. 4, 2011. After its enactment, many Rocky Mountain states have been throwing a tantrum, in an effort to drag consumers back into the dark.   

And Gianforte used to cheer local input. At least, that’s what he said in a May 24, 2017, video published by Guardian News and Media when Gianforte was a congressional candidate. 

He said: “Well, I, think that, um, one of the problems with the way these monuments were established was it did not include local input. There are certainly monuments we should have, and others have been designated without local input. And I just don’t think Montanans want bureaucrats in Washington telling us how to live our lives. (The Guardian video May 24, 2017 at 8:00 – 8:33).”

But like the dark kitchen law, Gianforte is also wrong about designation of national monuments. The Upper Missouri River Breaks National Monument in Montana was created by proclamation on Jan. 17, 2001, by President Bill Clinton for land already owned and managed by the federal government, but only after a year of massive public input from locals and non-locals on the issue. 

The only significant link between these two separate subjects of local dark kitchens and national monuments is Republican extremist responses to presidential actions, implemented by Democrats Clinton and Obama. 

If only Gianforte, and his political and administrative minions, recognized the fact that the dark kitchen law is arguably in violation of Montana’s Constitution. It fails to separate the subjects of federal jurisdictional authority from state and local jurisdictional authority, regarding both food ingredients and products. 

Gianforte and Hertz seem to believe that people are like mushrooms: better to keep them fed waste and in the dark. 

About the Author: Jeff Havens is former commercial food lead for the Montana Food and Consumer Safety Section with the Department of Public Health and Human Services where he worked for more than a decade. He has a pending complaint against the state with the Montana Human Rights Bureau.

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By Wendelyn Jones, PhD

According the United Nations Industrial Development Organization Corporate Social Responsibility is a management concept whereby companies integrate social and environmental concerns into their business  operations and stakeholder interactions. 

At IAFNS, we believe that food safety efforts — which can often be thankless tasks – should count in CSR tallies at companies. CSR is generally understood as the way through which a company achieves a balance of economic, environmental and social imperatives — the “Triple Bottom-Line Approach.” CSR can take many forms, from community volunteering to support of local charities to company programs and projects with a national scope. But food safety is a global good that companies should be proud of. 

In the food and beverage space, for example, IAFNS members track the safety of sodium and caffeine as part of ongoing initiatives. Producing food means companies take responsibility for food safety and other “public goods” from their supply chain to the consumer.

But let’s split “responsibility” into its constituent parts. The term “responsibility” implies obligation, and while there is a strong element of that in CSR, thinking of it in terms of “response-ability” is closer to what IAFNS endeavors to deliver in the food safety space. 

For example, foods like pistachios, chocolate and cereal are generally considered ready-to-eat, low-moisture food (LMFs) products. Some foodborne viral outbreaks associated with LMFs have been reported in recent years. IAFNS invested in understanding pathogens in low-moisture foods, giving firms and other organizations in the food sector the response-ability to change their food processing and storage protocols to address any residual pathogen risks. As foodborne pathogens can persist for some time, IAFNS-supported researchers found that a method called Advanced Oxidative Process treatment worked optimally as an inactivator.

Another example involves IAFNS-supported studies of protein in the diet. A recent analysis found that increasing protein intake while dieting leads to improved intake of green vegetables and healthier diets. Increasing dietary protein during caloric restriction improved diet quality and helped to maintain Lean Body Mass in the study. This particular paper has been cited in multiple media stories including the San Francisco Gate and Yahoo! News and gives both company formulators and interested consumers the response-ability to update their practices.

Finally, sodium consumption has been covered by Food Safety News previously. An IAFNS-supported study extracted analytical methods, broad and specific reduction categories, significant outcomes, and other strategies for decreasing sodium. Methods included salt removal, salt replacement, flavor modification, functional modification, or physical modification. Although salt removal and salt replacement were the main strategies, future public health improvement efforts may benefit from combining methods focused on the food supply. In addition, it’s important to look at sensory characteristics, technology and consumer perceptions. IAFNS response-ability in this area includes a searchable database of papers on options for salt reduction techniques for adoption in the food sector. Watch this space for our database of sodium reduction papers and other tools as they become available.

In this way, scientific research on food safety contributes to and shapes CSR. Research efforts empower companies, cooks and consumers to make key choices as a result of new knowledge which IAFNS helps generate. This response-ability provides new, well-informed options for those in the food and beverage ecosystem to optimize their food safety choices, reduce risks and interact constructively with their stakeholders.

About the author: Wendelyn Jones is Executive Director of the Institute for the Advancement of Food and Nutrition Sciences (IAFNS). She has a passion for bringing together science and society, drawing from her global experiences working across chemical, agricultural, food, and health sectors. She applies her PhD in life sciences to extend IAFNS’ contribution to, and impact within, diverse scientific and health communities.

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