The State of Arkansas is stepping up as a leader and pushing responsible retailers to stop selling a defective and potentially deadly product. Hopefully the FDA will act as well as the DEA.

Manufacturers and retailers be forewarned; if you sell this product and it causes harm, you will be held to account.  Insurers of these manufacturers and retailers, ask yourself is this a good insurance risk?

Senator Cotton Warns of Opioid Overdoses from Unwashed Poppy Seeds

An opioid epidemic is sweeping the country. More than sixty thousand Americans are dying from opioid overdoses each year-more than the number of Americans who died in all twenty years of the Vietnam War. What a staggering fact that is. But behind each number is a tragedy for a family who loses its loved one. Today, I want to tell the story of the Hacala family from Rogers, Arkansas. It’s a story of love, persistence, courage. And, I hope, a story that will save other families from the tragedy they felt.

Betty and Steve Hacala are joining us in the gallery today. I met Betty and Steve three weeks ago at a roundtable on the opioid epidemic in Little Rock with Attorney General Leslie Rutledge, state and local law enforcement, and the families of opioid victims. The news is full of tragic deaths from heroin, fentanyl, and prescription drugs. I met families that day whose children died from those well-known drugs. But I learned from the Hacalas about another killer: unwashed poppy seeds.

Their son, Stephen Jr., died in his sleep from an overdose two years ago. Stephen was only 24 years old, a recent graduate of the University of Arkansas. He loved to play guitar, and he was very accomplished at it. He was the joy of his parents’ life; he was the joy of his sisters Christina and Lauren’s lives. His sudden death came as a shock to them. But they got another shock when an autopsy determined that Stephen died of morphine intoxication. There were no drugs in his apartment-no pill bottles, no needles, nothing. What had been found was a five-pound bag of unwashed poppy seeds; Stephen had ordered the seeds on Amazon. The Arkansas Crime Lab soon determined that the poppy seeds were the source of the morphine that killed Stephen.

Stephen’s death resulted in part because of a dangerous gap in our nation’s drug laws. It’s been well known for ages that poppies are dangerous, both addictive and toxic. That’s why it’s illegal to grow or own almost any part of the poppy-the straw, the pod, the latex. But there’s an exception, of course, for poppy seeds, which many people enjoy on bagels, muffins, cakes, and other pastries. The seed itself isn’t addictive, but unwashed seeds tend to still have bits of the plant on them, which can be washed off and used to create a powerful narcotic. To give you a sense of just how deadly poppy-seed tea can be, a lethal dose of morphine is about 200 milligrams, but researchers at Sam Houston State University, commissioned by the Hacalas, concluded that there were about 6,000 milligrams of morphine in that five-pound bag of seeds that Stephen bought. That’s over 30 times the lethal dose. Stephen had no way of knowing just how toxic these seeds were.

While there are plenty of legitimate uses for washed poppy seeds, there are no legitimate uses for unwashed seeds. Yet drug dealers and unscrupulous merchants are abusing the legal status of washed seeds to profit and to push unwashed seeds, which are widely available through online retailers. And when you read the user comments, you can easily find instructions for how to brew poppy-seed tea and a description of its narcotic effects. So there’s no question of these unwashed seeds being used for grandma’s poppy-seed cake-it’s plain they’re being used to smuggle the banned drug into our homes, and the manufacturers and distributors should know that.

And Betty and Steve made sure they did. It’s hard to imagine the grief they feel. It would’ve been easy to despair. But they did not. They wanted to save other families from their fate, to be sure Stephen’s death would have meaning. They researched the issue, commissioning that report at Sam Houston State and studying the market for unwashed poppy seeds. And they became advocates, meeting with community leaders and elected officials. As I said, I only learned about the danger of unwashed poppy seeds by meeting the Hacalas.

After that meeting, I put in a call to the leadership of Walmart and Amazon, which at the time both allowed unwashed poppy seeds to be sold on their websites. They listened to our case and quickly agreed to stop selling poppy seeds that are labeled as unwashed. This is important. The two behemoths of online commerce agreeing to take down those seeds was a victory and a testament to what normal citizens like Steve and Betty can accomplish.

But this is more than a labeling problem. In fact, some of the most potent and deadly seeds, which we know about thanks to the work of Steve and Betty, are not labeled as unwashed and are still available for purchase. Therefore, I will work in the Senate and with the Drug Enforcement Agency to ban unwashed seeds entirely, but today I do want to take a moment to thank Amazon and Walmart for taking an important first step-for our country, for our state, and for the Hacalas and families like theirs.

It’s always hard to lose a loved one, and a child is the hardest loss of all. I suspect that nothing can assuage that kind of grief. But because of the Hacalas’ courage and determination, we can hope that a few more families will be spared it. That’s an act of true love, for Stephen and for their fellow Americans.

218 sick

28 with hemolytic uremic syndrome

5 deaths

In 2018 in the United Sates, 210 people infected with the outbreak strain of E. coli O157 were reported from 36 states. 96 people were hospitalized, including 27 people who developed a type of kidney failure called hemolytic uremic syndrome (HUS). 5 deaths were reported from Arkansas, California, Minnesota (2), and New York. In Canada, 8 cases of E. coli O157 that were genetically similar to the U.S. outbreak linked to romaine lettuce coming from the Yuma growing region in the U.S. The 8 Canadian illnesses were reported in 5 provinces: British Columbia, Alberta, Saskatchewan, Ontario and Quebec. 1 of the Canadian cases was hospitalized with HUS and no deaths were reported in Canada.

Health officials in both Canada and the U.S. have worked hard to do the hard epidemiological and environmental investigations that lead to traceback and root cause analysis that lead to new ways of preventing these tragedies for the consumers and the producers.  However, the hard work is essentially done in obscurity with little or no transparency.  Through the litigation process we are cracking open the door so the public can see both where product was grown (more to come on that in the coming weeks) and were the product was sold.

Because of the lack of transparency on behalf of investigators we have to do it through litigation.  Here is where the FDA is to date:

Here is where we are to date:

Here are some helpful documents from the FDA and CDC – romaine2 – romaine5 – Ecoli O157 1804MLEXH-1 06272018-2

And, the CAFO is still in Yuma:

No amount of money can compensate for the loss of a child or another family member.  I recall the Jensen Farms Listeria outbreak in 2011 that sickened 147, killing over 33 and the impact on the families.  All the deaths were horribly memorable, but I recall two WWII vets who survived years of war only to be killed by a cantaloupe.  Being involved in a lawsuit nearly 10 times the size is sobering.

  • For the 204 dead $265 to $525 Million US – Mortality cases were assigned compensation values of US$1,244,747 and US$2,524,312 per fatality for minimum and maximum human life valuation adjusted for South Africa which was 15% to 80% of U.S. values. The total valuation of mortalities over the 16 months of the outbreak ranged from US$265 million using the low valuation for a fatality to US$525 million using the high valuation.
  • For those who survived – Hospitalization costs associated with one-month recovery from listeriosis were estimated at US$10.4 million.  Note, however, the direct costs that were not estimated consisted of: current and future value of outpatient care and medication costs to treat chronic and acute cases, future cost of human suffering and lost productivity.

Here is my summarization of a well-done article:

According to a recent article in Food Control, 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[1]. According to the authors, the objective of this research was to determine the cost implications of the 2017 listeriosis outbreaks in South Africa on morbidity and hospitalization costs, mortality, and productivity losses to affected individuals.

The cost calculator of Listeria foodborne illness produced by the USDA Economic Research Service was used to compute costs associated with listeriosis outbreaks in South Africa. The computation had low, average, and high cost listeriosis-case outbreak scenarios. The components of listeriosis losses were estimated as direct and indirect costs. The direct costs were computed from valuation of human life (value of statistical life ($/person) × deaths from outbreak), hospitalization costs (mean cost of regular or internal care unit ($/person) × number of hospital cases), work losses from Listeria affected individuals was computed as mean productivity loss ($/person × number of cases missing work).[2]

The human impacts and health outcomes associated with listeriosis outbreak were derived from the listeriosis situation report. These included sick individuals but those who did not go to the doctor (costs can’t be quantified), sick and went to the doctor, and hospitalized with final outcomes within time periods (costs measured), sick and hospitalized without a final outcome (costs could not be measured). Data for hospitalization consisted of adolescent, mothers, children, infants (newborn to <28 days). The hospitalized outcomes for infants, children, and adolescents were based on age groups with morbidity and mortality records for cost analyses.

In order to calibrate the ERS model for South African conditions, we evaluated mortality compensation values from Miller which were estimated for all countries in the world through meta-analysis of available global data to derive ranges of multipliers (global average ~120) required to convert per capita GDP to the estimated value of a human life. These multipliers estimated for South Africa were used to derive the minimum to maximum range of life valuation for the analysis. Therefore, mortality cases were assigned compensation values of US$ 1,244,747 and US$ 2,524,312 per fatality for minimum and maximum human life valuation adjusted for South Africa which was 15% to 80% of U.S. values. Compensation values for mortality were derived by adjusting current South African per capita GDP by estimated multipliers. These values were then multiplied by the average percent (64.94%) of South African life expectancy remaining for all age-classes specific to the 204 outbreak fatalities.

In this computation, the South African hospital costs per patient were assumed to be 12.1% of U.S. hospital costs. The medical cost estimates included the average costs per care of regular hospitalization due to listeriosis for intensive care units (ICU) based on South African conditions. We excluded the cost computations for chronic cases of listeriosis, as data on disability attributed to listeriosis were not readily available and chronic conditions have yet to manifest themselves. In some instances, the outcomes of hospitalization were still pending (have not yet been determined).

Productivity losses (the average number of work days) due to listeriosis outbreak was assessed, on the assumption that able-bodied working age (15 to 64 years old) individuals were gainfully employed. The productivity losses per case were computed for a duration of one month, as this was the estimated duration of hospitalization and medical recovery from listeriosis for acute or non-fatal cases and pending in which case outcomes have not yet been determined (185 cases of 15-49 years old and 34 cases of 50-64 years old) as well as 89 (15-49 years old) and 26 (50-64 years old) cases discharged from hospitalization. Lost income during hospitalization was computed using the average monthly income in South Africa.

The outbreak of listeriosis contamination of polony and associated deli meat products led to serious health consequences for consumers in South Africa. Listeriosis occurrences were recorded in all nine provinces in South Africa. Among the provinces, confirmed listeriosis ranged from 6 to 606 cases with mortality of 3 to 106 cases. Overall, there were 1,034 total confirmed listeriosis cases with 204 fatalities. Listeriosis was recorded on babies (≤ 28 days old) to adults over 65 years old. The total cases varied among age groups as 441 cases were babies and 83 cases were > 65 years old. The number of fatalities was lowest for those > 65 years old, and highest for infants. No data were available on the exact ages of listeriosis-affected individuals due to confidentiality regulations. Reports indicated that all individuals diagnosed with listeriosis had consumed polony or deli meat contaminated with L. monocytogenes.

The total valuation of mortalities over the 16 months of the outbreak ranged from US$ 265 million using the low valuation for a fatality to US$ 525 million using the high valuation. At both one year (52 weeks) and at the recall for contaminated product at 62 weeks of listeriosis, the cumulative costs of listeriosis were already approaching values similar to the total estimated cost for listeriosis for both minimum and maximum estimates. The South African Rand (ZAR) equivalent cost estimates are also presented.

There was a total of 544 adults, where hospitalized cases consisted of 338 adults and 92 mothers, while mortality totaled 114 cases. Hospitalized newborn recovery from listeriosis totaled 400 cases with 90 mortalities. For adolescents and adults greater than 15 years of age or those in unknown age groups, there were 285 cases. The hospitalized adolescents and adults over 15 years old or those with unknown ages and with pending outcome of hospitalization from foodborne listeriosis had 145 cases. There were 255 hospitalized newborns that recovered, while newborns with pending outcome comprised 145 listeriosis cases. The total mortality costs for 204 individuals was at least US$ 265 million. The hospitalization costs for babies born with listeriosis were estimated at US$ 15,840 per case with a total estimated cost of over US$ 6 million. The mortality cases of babies born with listeriosis computed based on standards amounted to US$ 1.28 million/case for a total cost of US$ 115 million. For the adults, the medical costs for maternal hospitalization cases amounted to over US$ 364,000, while for other adults and deceased adults, hospitalization costs were over US$ 1.3 million and US$ 902,000, respectively. The costs associated with the mortality of 114 adults attributed to listeriosis amounted to over US$ 145 million. The total costs associated with the projected hospitalization were US$ 10,367,280. Hospitalization costs per case varied at US$ 15,840/case for babies, US$ 7,920/case for hospitalized older individuals that died, and US$ 3,960/case for being hospitalized.[3]

The total losses in one month of lost productivity for maternal, adult cases was computed as US$ 184,276 at US$ 2,003 per case. For other adults with moderate cases (no mortality recorded) of listeriosis, loss productivity was computed at US$ 1,230 per case totaling US$ 415,740. Productivity losses were only 0.22% of listeria outbreak costs.[4]

And, if anyone ever questions why surveillance and prevention of foodborne illness makes economic sense:

__________________________________

[1] According to the authors, in Sub-Saharan Africa (South Africa inclusive), costs associated with foodborne pathogens and illnesses are not precisely known, as many cases go unreported or have incomplete diagnosis (De Noordhout et al., 2014).

[2] The direct costs that were not estimated consisted of: current and future value of outpatient care and medication costs to treat chronic and acute cases, future cost of human suffering and lost productivity.

[3] The drawbacks for this study are that there were some direct and indirect costs that could not be quantified due to medical confidentiality issues that were excluded from the analyses. These include medication costs, sampling, laboratory/diagnosis costs, administrative costs, surveillance costs, the long-term effects of listeriosis on affected individuals in South Africa and possibly other countries.

[4] According to the authors, no attempt was made to quantify disability-adjusted life years (DALY, where one DALY equals one year of healthy life lost, that was attributed to listeriosis), due to lack of specific data (exact ages, case severity, and duration) of affected individuals. Therefore, hospitalization costs were assumed to be the same for all cases.

Following the declaration of the Listeria outbreak in December 2017, a multi-sectoral outbreak response was initiated. Findings were shared by the Minister of Health, Dr. Aaron Motsoaledi at a public media briefing on 4 March 2018 (statement available at www.nicd.ac.za), and are summarized below. In addition, the National Department of Health requested a full recall of implicated processed meat products.  According to Dr. Aaron Motsoaledi:

In our constant search for the source of the outbreak and the treatment of people who are affected, a team from the NICD has interviewed 109 ill people to obtain details about foods they had eaten in the month before falling ill. Ninety-three (85%) people reported eating ready-to-eat (RTE) processed meat products, of which polony was the most common followed by viennas/sausages and then other ‘cold meats’.

On Friday 12th January, nine children under the age of 5 years presented to Chris Hani Baragwanath Hospital with febrile gastro-enteritis. The paediatrician suspected foodborne disease, including listeriosis, as a possible cause. The environmental health practitioners (EHPs) were informed and on the same day visited the crèche, and obtained samples from two unrelated polony brands (manufactured by Enterprise and Rainbow Chicken Limited (RCL) respectively) and submitted these to the laboratory for testing.

Listeria monocytogenes was isolated from stool collected from one of the ill children, and from both of the polony specimens collected from the crèche. These isolates were sent to the NICD Centre for Enteric Diseases, and underwent whole genome sequencing and genomic analysis. The ST6 sequence type was confirmed on all three isolates on Saturday 27th January. Remember that in the last press conference I informed you that from clinical isolates obtained from patients (patient blood), 9 sequence types of Listeria monocytogenes were isolated and 91% were of sequence type 6 (ST6). We had then concluded that time that this outbreak is driven by ST6.

Following the lead from the tests performed on these children from Soweto and the food they had ingested, the EHPs (Environmental Health Practitioners), together with the NICD and DAFF representatives, accompanied by 3 technical advisors from the World Health Organisation in Geneva, visited a food- production site in Polokwane and conducted an extensive food product and environmental sampling.

Listeria monocytogenes was isolated from over 30% of the environmental samples collected from this site, which happens to be the Enterprise factory in Polokwane.

To conclude the investigation, whole genome sequencing analysis was performed from this Enterprise factory and the results became available midnight or last night. The outbreak strain, ST6, was confirmed in at least 16 environmental samples collected from this Enterprise facility. 

THE CONCLUSION FROM THIS IS THAT THE SOURCE OF THE PRESENT OUTBREAK CAN BE CONFIRMED TO BE THE ENTERPRISE FOOD-PRODUCTION FACILITY IN POLOKWANE

According to the Centre for Enteric Diseases (CED) and Division of Public Health Surveillance and Response, Outbreak Response Unit (ORU), National Institute for Communicable Diseases (NICD)/ National Health Laboratory Service (NHLS) the current number of ill and deceased are as follows:

As of 26 July 2018, 1060 laboratory-confirmed listeriosis cases have been reported to NICD from all provinces since 01 January 2017.

To date, 749 cases were reported in 2017, and 311 cases in 2018. Females account for 56% (549/979) cases where gender is reported. Neonates ≤28 days of age are the most affected age group, followed by adults aged 15 – 49 years of age. Most cases have been reported from Gauteng Province (58%, 614/1060) followed by Western Cape (13%, 136/1060) and KwaZulu-Natal (8%, 83/1060) provinces. Final outcome data is available for 76% (806/1060) of cases, of which 27% (216/806) died.

218 sick

28 with hemolytic uremic syndrome

5 deaths

In 2018 in the United Sates, 210 people infected with the outbreak strain of E. coli O157 were reported from 36 states. 96 people were hospitalized, including 27 people who developed a type of kidney failure called hemolytic uremic syndrome (HUS). 5 deaths were reported from Arkansas, California, Minnesota (2), and New York. In Canada, 8 cases of E. coli O157 that were genetically similar to the U.S. outbreak linked to romaine lettuce coming from the Yuma growing region in the U.S. The 8 Canadian illnesses were reported in 5 provinces: British Columbia, Alberta, Saskatchewan, Ontario and Quebec. 1 of the Canadian cases was hospitalized with HUS and no deaths were reported in Canada.

Health officials in both Canada and the U.S. have worked hard to do the hard epidemiological and environmental investigations that lead to traceback and root cause analysis that lead to new ways of preventing these tragedies for the consumers and the producers.  However, the hard work is essentially done in obscurity with little or no transparency.  Through the litigation process we are cracking open the door so the public can see both where product was grown (more to come on that in the coming weeks) and were the product was sold.

CDC

FDA

We have a romaine E. coli case in Idaho of a young man who suffered a severe case of hemolytic uremic syndrome (HUS), was hospitalized for a month and incurred nearly $250,000 in medical expenses and lost wages.  He has a risk of future kidney complications (including a transplant), but not likely to meet the legal standard of more likely than not – greater than 50%.  He did suffer seizures because of the HUS, but it is well maintained on medications, and it is hopeful, over time, that he may well be weaned off the medications and be able to drive again.  Under Idaho law he will be able to recover wage loss and medical expenses (economic damages) and a capped amount for nonmonetary losses (pain and suffering) – Well, unless a court and a jury determines that it is “reckless misconduct” to grow, process and sell romaine lettuce.

Sometimes bad facts make good law – recall the lawsuit against the auditor in the Jensen Farms Listeria cantaloupe case?

Idaho Code § 6-1603 established in 2003 a cap of $250,000.00 for noneconomic damages, damages that are subjective, nonmonetary losses including, but not limited to, pain, suffering, inconvenience, mental anguish, disability or disfigurement incurred by the injured party; emotional distress; loss of society and companionship; loss of consortium; or destruction or impairment of the parent-child relationship. Idaho Code § 6-1603(1) also provides for an annual adjustment tied to the increase or decrease of the annual wage; for 2018, the effective cap was established at $357,210.62.

The full text of the statute reads as follows:

6-1603.  LIMITATION ON NONECONOMIC DAMAGES. (1) In no action seeking damages for personal injury, including death, shall a judgment for noneconomic damages be entered for a claimant exceeding the maximum amount of two hundred fifty thousand dollars ($250,000); provided, however, that beginning on July 1, 2004, and each July 1 thereafter, the cap on noneconomic damages established in this section shall increase or decrease in accordance with the percentage amount of increase or decrease by which the Idaho industrial commission adjusts the average annual wage as computed pursuant to section 72-409(2), Idaho Code.

(2)  The limitation contained in this section applies to the sum of: (a) noneconomic damages sustained by a claimant who incurred personal injury or who is asserting a wrongful death; (b) noneconomic damages sustained by a claimant, regardless of the number of persons responsible for the damages or the number of actions filed.

(3)  If a case is tried to a jury, the jury shall not be informed of the limitation contained in subsection (1) of this section.

(4)  The limitation of awards of noneconomic damages shall not apply to:

(a)  Causes of action arising out of willful or reckless misconduct.

(b)  Causes of action arising out of an act or acts which the trier of fact finds beyond a reasonable doubt would constitute a felony under state or federal law.

Setting aside the fairness of capping noneconomic damages at $357,210.62 for a case as serious as this one, the real issue is whether the cap applies at all under section (4)(a) above?  In 2018 was it “reckless misconduct” to grow, process, source and sell romaine lettuce from Yuma?

Certainly, as well cited above, leafy greens have been a source of E. coli-related illnesses for decades, and there have been concerns raised about lettuce grown in the Yuma region.  The CDC reports as of May 20, 2010, a total of 26 confirmed and 7 probable cases related to an E. coli O145 outbreak have been reported from 5 states since March 1, 2010 linked to shredded romaine grown in Yuma.[1] In the FDA’s “Environmental Assessment Report in December 2010,” the authors determined:

that the R.V. park is a reasonably likely potential source of the outbreak pathogen based upon the evidence of direct drainage into the lateral irrigation canal; the moist soil in this drainage area; the multiple sewage leach systems on the property; the presence of other STEC found in the lateral irrigation canal and in the growing fields of the suspect farm; and the fact that the section of the lateral canal downstream from the R.V. park supplies water to only one other farm in addition to the suspect farm.

Two pumps are located on the main Wellton canal near the lateral canal split that supplies water to fields of the suspect farm; one gasoline powered pump on a trailer and one permanent electric pump with an attached hose. The electric pump supplies canal water to an attached open-end hose. The site is not secured from vehicles and the hose pump is also unsecured. At the time of this investigation there were people living in recreational vehicles on undeveloped land within one mile of the hose pump. The fact that this area is open to vehicles and the pump and hose are unsecured make it possible for an R.V. owner to dump and rinse out their R.V. septic system into the main Wellton canal at the lateral canal split that supplies the farm. The ground near the hose pump shows erosion evidence of drainage into the Wellton canal. Soil collected from this erosion site tested positive for other Stx2-producing STEC but did not match the outbreak strain.

In a 2009 “Survey of Selected Bacteria in Irrigation Canal Water – Third Year” written by Jorge M. Fonseca, he correctly predicted the human and industry problems that were likely to plague the Yuma lettuce growers:

Despite the fact that no Arizona lettuce grower has been involved in any contaminated-lettuce outbreak, it is of paramount importance to determine the reasons why Arizona lettuce is regarded as safe. This can help lower possibilities of any emerging problem and prevent a catastrophic damage to the industry, as it has occurred in other regions when no control was taken to reduce risks of contaminated product.

A PowerPoint done by Dr. Fonseca again illustrated the varying risks of lettuce production in Yuma.  An example of a few of his points of concern:

And, then the 2018 romaine lettuce E. coli outbreak struck, sickening hundreds in the United States and Canada with dozens suffering from acute kidney failure with five reported deaths.  Once again, the Wellton Irrigation Canal was the focus of attention in the “Memorandum to File on the 2018 Environmental Assessment”:

During this EA, three samples of irrigation canal water collected by the team were found to contain E coli O157:H7 with the same rare molecular fingerprint (using whole genome sequencing (WGS)) as the strain that produced human illnesses (the outbreak strain). These samples were collected from an approximate 3.5-mile stretch of an irrigation canal in the Wellton area of Yuma County that delivers water to several of the farms identified in the traceback investigation as shipping romaine lettuce that was potentially contaminated with the outbreak strain. The outbreak strain was not identified in any of the other samples collected during this EA, although other pathogens of public health significance were detected.

 

Not surprisingly, the FDA in its full “Environmental Assessment of Factors Potentially Contributing to the Contamination of Romaine Lettuce Implicated in a Multi-State Outbreak of E. coli O157:H7,”[2] concluded that the risk of environmental contamination was in fact a well-know and long-standing risk:

Food safety problems related to raw whole and fresh-cut (e.g., bagged salad) leafy greens are a longstanding issue. As far back as 2004, FDA issued letters to the leafy greens industry to express concerns about continuing outbreaks associated with these commodities. FDA and our partners at CDC identified 28 foodborne illness outbreaks of Shiga-toxin producing E. coli (STEC) with a confirmed or suspected link to leafy greens in the United States between 2009 and 2017. This is a time frame that followed industry implementation of measures to address safety concerns after a large 2006 outbreak of E. coli O157:H7 caused by bagged spinach. STEC contamination of leafy greens has been identified by traceback to most likely occur in the farm environment.

Contamination occurring in the farm environment may be amplified during fresh-cut produce manufacturing/processing if appropriate preventive controls are not in place. Unlike other foodborne pathogens, STEC, including E. coli O157:H7, is not considered to be an environmental contaminant in fresh-cut produce manufacturing/processing plants.

Well-established reservoirs for E. coli O157:H7 are the intestinal tract of ruminant animals (e.g., cattle, goats, and deer) that are colonized with STEC and shed the organism in manure. Ruminant animals colonized with STEC typically have no symptoms. In contrast, human infection with E. coli O157:H7 usually produces symptomatic illness often marked by severe, often bloody, diarrhea; severe adverse health outcomes or even death can result. Humans shed E. coli O157:H7 in the stool while ill and sometimes for short periods after symptoms have gone away, but humans are not chronic carriers. Various fresh water sources, including municipal well, and recreational water, have been the source of E. coli O157:H7 infections in humans, as has contact with colonized animals at farms or petting zoos. However, most E. coli O157:H7 infections in humans occur from consuming contaminated food.

In its summary of its environmental findings (also summarized in a November 1, 2018 to public officials) the “FDA [in part] identified the following factors and findings as those that most likely contributed to the contamination of romaine lettuce from the Yuma growing region with E. coli O157:H7 that caused this outbreak”:

  • FDA has concluded that the water from the irrigation canal where the outbreak strain was found most likely led to contamination of the romaine lettuce consumed during this outbreak.
  • There are several ways that irrigation canal water may have come in contact with the implicated romaine lettuce including direct application to the crop and/or use of irrigation canal water to dilute crop protection chemicals applied to the lettuce crop, either through aerial or ground-based spray applications.
  • How and when the irrigation canal became contaminated with the outbreak strain is unknown. A large animal feeding operation is nearby but no obvious route for contamination from this facility to the irrigation canal was identified. Other explanations are possible although the EA team found no evidence to support them.

Idaho Code Section 6-1603(4)(a) states that the statutory limit on non-economic damages in tort actions seeking damages for personal injury or death does not apply in cases where the cause of action arises “out of willful or reckless misconduct.” Idaho Pattern Civil Jury Instruction 2.25 provides the definition of “willful and wanton,” and notes that there is no distinction between “reckless” and “willful and wanton.” Hennefer v. Blaine County Sch. Dist. 61 158 Idaho 242, 248 (2015). According to the IDJI, “[t]he words ‘willful and wanton’…mean more than ordinary negligence. The words mean intentional or reckless actions, taken under circumstances where the actor knew or should have known that the actions not only created an unreasonable risk of harm to another, but involved a high degree of probability that such harm would actually result.” IDJI 2.25

While Idaho considers reckless or willful misconduct “simply a degree of negligence…that involves both intentional conduct and knowledge of a substantial risk of harm,” its courts have further elaborated that while “use of the words ‘intentional’ and ‘knowledge’ might indicate a purely subjective standard for recklessness…there is an objective element to the recklessness standard.” Hennefer 158 Idaho at 248.  Thus, while reckless misconduct can consist of a conscious choice of a course of action with knowledge of the serious danger to others, (subjective), it can also consist of a conscious choice of a course of action with knowledge of facts that would disclose the danger to any reasonable man (objective). Id. The serious danger mentioned in the standard is one that “involves a risk substantially greater in amount than that which is necessary to make the conduct negligent.” Id. Accordingly, a jury need only find that a defendant should have known that his actions created a high probability that harm would actually result; such a finding is considered sufficient to meet the standard espoused by Idaho Code section 6-1603. Id. at 249.

Using this standard, there is substantial evidence supporting the conclusion that growing, processing, sourcing, and selling romaine lettuce from Yuma constituted reckless misconduct. It is widely known that STEC infections are life-threatening to humans and the most common cause of infection is consumption of contaminated food. Additionally, STEC outbreaks associated with leafy greens are unsettlingly common occurrences as evidenced by the 28 identified outbreaks occurring between 2009 and 2017. The FDA, CDC, and other governmental agencies have sought to combat the frequency of these occurrences by issuing various communications with state officials, publishing the results of its investigations into the outbreaks, and advising on best practices to avoid such outbreaks.

Among the FDA’s many suggestions, it recommended that the leafy green industry should assess the need for and develop commodity-specific procedures, policies, and best practices to enhance the safety of leafy greens, including, at a minimum, address (1) how agricultural water directly contacting harvestable portions of the crop can be guaranteed safe and adequate for its intended use; (2) how risks related to land uses near or adjacent to growing fields that may contaminate agricultural water or leafy green crops directly (e.g., nearby cattle operations or dairy farms, manure, or composting facilities) can be assessed and mitigated; (3) how food safety procedures, policies, and practices are developed and consistently implemented on farms as well as regularly verified to minimize the potential for contamination and/or spread of human pathogens; and (4) how a root cause analysis should be performed to determine the likely source of any contamination by a foodborne pathogen identified in the agricultural environment, agricultural water, or in the fresh-cut ready-to-eat produce.

Given the available knowledge regarding STEC, its transmission to and effect on humans, as well as the nature—and demonstrated prior history— of STEC transmission from ruminant animal operations to leafy greens and the repeated government advisory and caution of that danger, the undeterred insistence of growing, processing, sourcing, and selling romaine lettuce from a region repeatedly plagued by STEC contamination and subsequent outbreaks is a considerably reckless activity. The findings from the 2018 romaine lettuce outbreak considerably enhance the veracity of that conclusion. Despite all the aforementioned knowledge, the source of the 2018 outbreak that affected hundreds and killed five was found to be a contaminated irrigation canal that supplied water to several farms identified in the traceback investigation who were downstream from a sizeable cattle operation. Such undeterred action in spite of the substantial available knowledge on the risks developed and disseminated over the years fits squarely within Idaho’s characterization of reckless misconduct and should accordingly be treated as such.

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[1] https://www.cdc.gov/ecoli/2010/shredded-romaine-5-21-10.html

[2] https://www.fda.gov/Food/RecallsOutbreaksEmergencies/Outbreaks/ucm624546.htm

I have been talking about food safety and litigation for the last few decades.  The groups I have spoken to have been all types in the food industry – from beef to leafy greens – as well as the heroes of public and environmental health.  I had a chance today  to talk to leaders in the insurance industry about how they can save money by encouraging their insureds to put food safety first.

According to the CDC, since the last update on December 21, 2018, 63 ill people from 24 states, and the District of Columbia, have been added to this investigation.

As of February 13, 2019, 279 people infected with the outbreak strain of Salmonella Reading have been reported from 41 states and the District of Columbia. 107 people have been hospitalized. One death has been reported from California.

Epidemiologic and laboratory evidence indicates that raw turkey products from a variety of sources are contaminated with Salmonella Reading and are making people sick. In interviews, ill people report eating different types and brands of turkey products purchased from many different locations. Four ill people lived in households where raw turkey pet food was fed to pets. The outbreak strain has been identified in samples taken from raw turkey pet food, raw turkey products, and live turkeys.

Several turkey products have been recalled because they might have been contaminated with Salmonella. Please see the list of recalled items below. A single, common supplier of raw turkey products or of live turkeys has not been identified that could account for the whole outbreak.

The Public Health Agency of Canada has identified ill people in Canada infected with Salmonella Reading bacteria with the same DNA fingerprint.  As of January 31, 2019, there have been 72 confirmed cases of Salmonella Reading illness investigated in the following provinces and territories: British Columbia (20), Alberta (24), Saskatchewan (6), Manitoba (13), Ontario (6), New Brunswick (1), Northwest Territories (1), and Nunavut (1). Individuals became sick between April 2017 and early January 2019. Eighteen individuals have been hospitalized. One individual has died. Individuals who became ill are between 0 and 96 years of age. The majority of cases (55%) are female.

The outbreak strain of Salmonella Reading is present in live turkeys and in many types of raw turkey products, indicating it might be widespread in the turkey industry. CDC and USDA-FSIS have shared this information with representatives from the turkey industry and requested that they take steps to reduce Salmonella contamination.

The FDA today published its “Investigation Summary: Factors Potentially Contributing to the Contamination of Romaine Lettuce Implicated in the Fall 2018 Multi-State Outbreak of E. coli O157:H7.”

First, a hat tip to the FDA investigators for getting at the report critically fast and during the governmental shutdown.  It is prompt, science based, investigations that will identify the “root cause” of an outbreak that will then be used to stop or at least minimize future foodborne illness clusters of outbreaks. Despite the good work, however, except for the one named farm the rest of the traceback work is shrouded in mystery.  The FDA and the leafy green industry knows way more than it is telling the public, and that is wrong for too many reasons.

Some interesting, and alarming findings the outbreak and the initial investigation impressions:

  • There were 62 reported illnesses in 16 states and the District of Columbia, resulting in 25 hospitalizations and two cases of hemolytic uremic syndrome (HUS). There were no deaths. However, the FDA and the CDC just gives the public numbers, not some of the brutal realities of the long-term impacts like the 70-year-old New York woman who will remain on dialysis for the rest of her life or the 3-year-old Canadian boy who suffered severe brain damage and will require a life time of ongoing care.
  • All E. coli O157:H7 isolates in Fall of 2018 from ill consumers had a rare genetic fingerprint, as determined by whole genome sequencing, that was closely related to one previously seen in ill consumers in the U.S. and Canada in the Fall of 2016 and the Fall of 2017. This is significant as it indicates, not only has there been multiple, significant E. coli outbreaks, but they are likely linked to the same growing region and probably the same farm.
  • The romaine lettuce that made people sick was likely harvested between late September and mid-November 2018, a conclusion based on: known production practices; the anticipated shelf-life of romaine lettuce; and the fact that reported illness- onset dates occurred from October 7 through December 4, 2018.

Through its investigation the FDA has identified the following factors and findings as those that most likely contributed to the contamination of romaine lettuce from one farm (Adams Brothers Farm) in Santa Maria in Santa Barbara County, California, that was linked to some illnesses during this outbreak.

  • The outbreak strain of E. coli O157:H7 was found in the sediment of an on-farm water reservoir in Santa Maria in Santa Barbara County, California.
  • The outbreak strain was not found anywhere else in sampling done during the investigation in various California leafy greens growing areas and counties.
  • FDA has concluded that the water from the on-farm water reservoir where the outbreak strain was found most likely led to contamination of some romaine lettuce consumed during this outbreak.
  • Traceback investigation analysis indicated that other ranches owned by the same farm as well as other farms may have introduced into commerce contaminated romaine lettuce or other produce items. These other farms did not use water from the water reservoir where the outbreak strain of E. coli O157:H7 was found and FDA was unable to identify a potential source of contamination.
  • FDA has concluded that the water from the on-farm water reservoir where the outbreak strain was found was most likely not effectively treated with a sanitizer and this may have led to contaminated water directly contacting romaine lettuce after harvest or by the washing/rinsing harvest equipment food contact surfaces.
  • There are several ways in which water from the on-farm water reservoir may have come into contact with the implicated romaine lettuce, including direct harvest/postharvest application to the crop and/or use of reservoir agricultural water on harvest equipment food contact surfaces.
  • Foodborne illness outbreaks caused by this specific strain of E. coli O157:H7 occurred in 2016, 2017, and 2018, indicating that the outbreak strain may have either persisted in the environment or may been repeatedly introduced into the environment from an unknown source. Public health officials in the U.S. and Canada were unable to definitively confirm the food vehicle and ultimate source(s) of the 2016 and 2017 illnesses.

Despite finding that E. coli outbreaks spanning years likely came from the same are or farm and was most likely caused by the same factors enumerated above, the FDA only sets forth “recommendations” that growers of leafy greens assess their growing operations for compliance with applicable requirements of the FSMA Produce Safety Rule and GAPs, including (see my snide comments in bold):

  • Assure that all agricultural water (water that directly contacts the harvestable portion of the crop and/or food contact surfaces and harvest equipment) used by growers is safe and of adequate sanitary quality for its intended use. This may (not must) include the development and use of validated and verified treatment of agricultural water, when growers choose to use agricultural water treatment as a preventive measure (any agricultural water treatment must also adhere to any other Federal, State, Local, or other regulations on implementation);
  • Assess and mitigate risks related to wild animal intrusion that may contaminate agricultural water (without a requirement to do so);
  • Assess and mitigate risks related to land uses near or adjacent to agricultural water sources that may contaminate agricultural water (without a requirement to do so); and
  • Perform a root cause analysis when a foodborne pathogen is identified in the growing environment, in agricultural inputs (e.g., agricultural water or soil amendments), in raw agricultural commodities or in fresh-cut ready-to-eat produce. The goal of a root cause analysis is to determine the likely source of the contamination, if prevention measures have failed, and whether additional measures are needed to prevent a reoccurrence (without a requirement to do so).

Other FDA recommendations have a broader target audience.

  • FDA urges (at least it is not begging) other government and non-government entities, produce growers and trade associations both domestically and internationally to develop real time procedures to quickly explore the possible scope, source(s) and route(s) of contamination when human pathogens of public health significance are detected by routine pre-harvest or finished product verification testing. Local in-depth knowledge and actions are critical in helping determine likely potential routes of contamination of leafy greens in the regions in which they are grown. This information is critical to developing and implementing appropriate science and risk based preventive measures to reduce the potential for another outbreak associated with leafy greens or other fresh produce commodities. Widespread sharing of such findings among the leafy greens and produce industry would also be helpful to increase awareness of potential routes of contamination and preventive measures (without a requirement to do so).
  • FDA continues to recommend (suggest, plead, beg, whine) that leafy green growers, buyer/shippers, and retailers be able to trace product back to the specific source in real time and make information about the source, such as harvest date and standardized growing regions, readily available for consumers on either packaging, point of sale signs, or by other means. In response to this outbreak FDA requested, and the leafy greens industry agreed to provide, voluntary labeling of romaine lettuce products to provide consumers with information on where their romaine lettuce is grown and the date on which it was harvested. The purpose of this new voluntary (why voluntary?) labeling was to help consumers discern, in the event of an outbreak, whether romaine lettuce products available for purchase at retail stores or restaurants were harvested after the outbreak or not grown in an implicated growing region. The voluntary labeling also provides for improved romaine lettuce traceability and, if need be, provides FDA with the ability to focus future public health communications about the safety of romaine lettuce from a particular growing region or harvest date.
  • FDA strongly encourages (emphasis on “strongly”) the entire leafy greens supply chain to adopt traceability best practices and state-of-the-art technology to assure quick, accurate and easy access to key data elements from farm to fork when leafy greens are involved in a potential recall or outbreak. Fresh produce, including leafy greens, are a highly perishable commodity, and traceability information should facilitate the rapid tracking of implicated product throughout the entire supply chain to expedite its removal from commerce, prevent additional consumer exposures, and properly focus any recall actions. A key element that would assist tracing efforts during an outbreak is the ability to identify specific farms or ranches and dates of harvest for product that contribute to production lots if product has been commingled. While it is important to understand where the product was grown and not simply the location of the business entity that shipped or processed it, it is equally important to be able to determine which farm(s) and growing region(s) are responsible for supplying the contaminated product, and the time frame when product was supplied.
  • This information is crucial to the development of accurate public health messages to protect the public and empower retail establishments and consumers to take appropriate actions to prevent exposure. Without the ability to identify the growing region or specific suppliers of suspected shipments, public messaging by FDA and other public health partners during outbreaks or recalls will continue to be broad out of necessity, likely including farms and growing regions that are not responsible for the contamination. If supplier data are maintained when the product is co-mingled and consumers can differentiate where and when product was harvested, it is easier to narrow the number of suspected shipments and suppliers of the contaminated product once it is processed – after so many outbreaks the co-mingling and lack of transparency may well be the point – keep things confused and perhaps no one will be singled out?

My takeaway?  FDA has the skill to help industry combat these outbreaks by getting to the likely “root cause” of an outbreak.  However, the FDA is hampered by lack of public transparency with its traceback findings.  This lack of transparency leaves the public in a fog as to how to be smart consumers of a food product that has an unfortunate history that is likely to be its future as well.  Furthermore, it is past time for pleas and voluntary requirements.  The FDA and the leafy green growers know what needs to be done to minimize illnesses and loss of life.  It’s past time for please!