Pritzker Hageman, P.A. is a national food safety law firm that represents people sickened by contaminated food. For more information, or if you or a loved one has been sickened in a foodborne outbreak, contact us online or at 1-888-377-8900.
Pritzker Hageman, P.A. is a national food safety law firm that represents people sickened by contaminated food. For more information, or if you or a loved one has been sickened in a foodborne outbreak, contact us online or at 1-888-377-8900.
2020: It Looks Like Fecal-Contaminated Romaine Is Likely Making People Sick Again
DANGEROUSLY CONTAMINATED ROMAINE LETTUCE IS A PROBLEM THE FDA KEEPS PROMISING, YET FAILING, TO SOLVE
Foodborne illness outbreaks caused by leafy green vegetables including romaine lettuce adulterated with E. coli O157:H7 are tragically frequent and extremely dangerous. Recent examples include three national outbreaks in 2019 caused by adulterated lettuce grown in the Salinas Valley (California), another romaine lettuce outbreak in 2018 and a 2017 outbreak linked to leafy greens.
These outbreaks, which affected hundreds of people throughout the United States, caused death and severe injuries including permanent kidney and brain damage.
THE CDC ANNOUNCED ON OCTOBER 28TH THAT THEY ARE INVESTIGATING TWO MYSTERY OUTBREAKS
The two outbreaks (Outbreak A / Outbreak B) have sickened 44 people, hospitalized 18, and led to the death of 1 person so far across 14 states combined. While the CDC has not implicated any particular product yet, and is not issuing any warnings not to consume specific foods, the timing of the illnesses and the known case counts would indicate the possibility that one or both outbreaks is related to leafy greens, with romaine a key suspect.
In a press release following the CDC announcements, Frank Yiannas, FDA Deputy Commissioner for Food Policy and Response indicated that that the Outbreak A strain of E. coli O157:H7 closely matched the strain implicated in the 2018 Yuma, AZ growing region outbreak; and the Outbreak B strain closely matched the 2019 Salinas, CA growing region outbreak. These new outbreaks seem to indicate that, despite promised reforms, the fecal contamination problem in both regions still remains unaddressed.
FECAL CONTAMINATED ROMAINE AND OTHER LEAFY GREENS KEEP MAKING PEOPLE SICK. VERY SICK.
Shiga-toxin producing E. coli (STEC) strains, like E. coli O157:H7, are not like other more common strains of E. coli. They can make people extremely sick. They can destroy people’s kidneys, something it does to children with even more frequency than adults. They can infect people’s organs, including their brains, leaving victims with permanent brain injuries. They can cause severe damage that will last a lifetime. And worst of all, they can even kill.
Leafy greens are the second most common source of STEC outbreaks in the U.S. Between 2009 and 2018, there were 40 STEC outbreaks linked to leafy greens and over half of those were linked to romaine lettuce specifically.
The reason leafy greens are so frequently implicated in STEC outbreaks is simple: they are most often consumed raw (in salads), and like most raw products, no amount of rinsing and washing can effectively remove all of the fecal contaminants including E. coli O157:H7.
So how does STEC get on romaine lettuce to begin with? Most often, it’s due to the close proximity of animal grazing and feed lots to the farms and ranches where the lettuce is grown. It’s also common for run-off and wind-blown dust (containing feces) from the cattle operations to enter water sources used for crop irrigation and processing. This is reflected in the FDA’s analysis of factors contributing to the 2019 outbreak:
FDA has identified the following factors and findings as those that may have contributed to the contamination of romaine lettuce from the Salinas Valley growing region of California with the E. coli O157:H7 strains that caused these outbreaks:
- For the Salinas Valley growing region farms, animal grazing or feeding operations of all sizes appear to be the most likely sources of outbreak strains of coli O157:H7, as cattle are a persistent reservoir of E. coli O157:H7 and other STECs. This is especially true when cattle are adjacent to and are at higher elevations than produce fields.
- Although the route of transmission from cattle to the produce is unknown, plausible ways in which implicated romaine lettuce may have become contaminated include:
- Run-off from these nearby lands;
- Direct transmission from animal operations to romaine lettuce growing fields by wind, animals or farming activities such as vehicles, harvest crews, or harvest equipment;
- Application of agricultural water contaminated with fecal material from animal operations regardless of size.
THE FDA KEEPS SAYING THEY HAVE “SOLUTIONS,” BUT THEY CONTINUE TO PROPOSE THINGS THAT DON’T SOLVE THE PROBLEM
The FDA has embarked upon several initiatives, including a new “Leafy Greens STEC 2020 Action Plan,” and the “2011 Food Safety Modernization Act: Produce Safety Rule.” Every time they announce a new initiative the FDA claims it will make leafy greens safer and help prevent future outbreaks. But the fact is announcing “initiatives” does not mean taking effective action. In reality, very little has actually been done and the changes that have been made so far have been either toothless or ineffective.
We know the problems can be addressed if fields are irrigated with only clean contamination-free water, and manure-laden dust is kept off crops during growing, harvesting and transportation. We know that adequate testing, regulation and enforcement is the only way to understand if actions are working and catch problems when they aren’t. We know that if contaminated lettuce does get harvested and sold that we can quickly stop any further problems by having a system to trace it back to the farm that produced it…this even keeps all the farmers who grew safe lettuce from having to pay the price of a recall for the few farms that didn’t. We know that properly labeling lettuce sold to consumers with the actual origin and distribution of every component in the package would allow for immediate identification of the grower, processors and distributors. Outbreaks could be ended quickly and those who violate food-safety laws could be held responsible.
Yet even though the FDA knows what needs to be done, actual action either keeps getting delayed, is not taken at all or is made “voluntary.” Unfortunately, “proposed” procedures and “recommended” actions do not protect consumers. Mandatory safety and tracking rules, effective testing and actual enforcement do.
Consumers still do not have the ability to know where their lettuce comes from or whether producers have a record of prior contamination. Produce growers still do not have to comply with irrigation water requirements. Irrigation water is still not adequately tested or monitored. And people are still getting sick. Leadership at the FDA keeps putting the industry it’s supposedly regulating first. It’s time they start putting the American consumer they are supposedly protecting first.
BACKGROUND INFORMATION
Overview: Fall 2019 Romaine Lettuce E. coli (STEC) Outbreaks
In the fall of 2019, the FDA and CDC investigated three E. coli O157:H7 outbreaks (referred to as “Outbreak A,” “Outbreak B” and “Outbreak C”) linked to contaminated romaine lettuce. While each outbreak was caused by different strains of E. coli O157:H7, traceback investigations identified a common grower with multiple ranches and fields that supplied romaine lettuce during the timeframe associated with each outbreak. Several months after the outbreak was declared over, the FDA released findings that contributing factors include cattle near lettuce growing fields and contaminated irrigation water. The strain of E. coli O157:H7 that caused Outbreak A was found in a fecal-soil composite sample from a cattle grate located less than two miles from a produce farm that was linked to the outbreaks.
The FDA never releases the name of any farm implicated in the outbreaks.
- Outbreak A: Romaine lettuce harvested in the Salinas Valley growing region of California
- Outbreak B: Leafy greens consumed at Evergreens Restaurant in Seattle, WA
- Outbreak C: Fresh Express® Sunflower Crisp Chopped Salad Kits
| Totals | Outbreak A | Outbreak B | Outbreak C |
| Reported Cases | 167 | 16 | 10 |
| States with Illnesses | 27 | 1 | 5 |
| Hospitalizations | 85 | 3 | 4 |
| Diagnosed with Hemolytic Uremic Syndrome (HUS) | 15 | 0 | 1 |
Timeline of the 2019 Outbreaks
8/24/20 At least 22 new people have been sickened with E. coli O157:H7 infections with a genotype that closely matches that of the 2019 romaine lettuce E. coli outbreaks.
5/21/20 FDA releases findings on contributing factors to the 2019 romaine lettuce E. coli outbreaks.
3/5/20 FDA announces “2020 Leafy Greens STEC Action Plan.”
1/15/20 CDC declares outbreaks over.
12/10/19 Wisconsin Department of Health Services identifies the strain of E. coli O157:H7 that caused Outbreak A in an unopened bag of Fresh Express® Leafy Green Romaine collected from an ill person’s home.
12/9/19 CDC and FDA announce Outbreak C with illness onset dates of November 5-16, 2019.
11/26/20 King County Health Department announces Outbreak B with illness onset dates of November 8-17, 2019.
11/21/19 USDA’s FSIS announces an E. coli recall by Missa Bay for salad products that contain meat or poultry. The same lot of lettuce associated with this recall was used to produce the Ready Pac Foods Bistro® Chicken Caesar Salad that the Maryland Department of Health found to test positive for the outbreak strain.
11/20/19 CDC and FDA announce Outbreak A with illness onset dates of September 18 to December 21, 2019.
11/18/19 The Maryland Department of Health identifies the same E. coli O157:H7 strain that caused Outbreak A in an unopened package of Ready Pac Foods Bistro® Chicken Caesar Salad that was purchased from a Sam’s Club and collected from a sick person’s home.
2018 Leafy Green E. coli (STEC) Outbreak
E. coli O157:H7 Outbreak Linked to Romaine Lettuce from the growing region in Yuma, AZ
The FDA determined that the source of this outbreak was romaine lettuce grown in Yuma, AZ but were not able to specifically narrow down the source because multiple processors, growers, shippers and farms supplied the lettuce associated with this outbreak to restaurants and retailers. Traceback investigations discovered the outbreak strain in irrigation canals, but the FDA was not able to determine how it got there. Samples from a nearby concentrated animal feeding operation (CAFO) did not test positive for the outbreak strain, although the FDA listed it as a possible contamination source. Among the challenges that the FDA listed in the traceback investigation include the fact that the product contained romaine lettuce from various farms and the majority of records were on paper and even hand-written. This prompted the agency to make promises that they have yet to follow through on, including the use of new technology to conduct faster traceback investigations and plans to test romaine lettuce samples.
| Reported Cases | 210 |
| States with Illnesses | 36 |
| Hospitalizations | 96 |
| Diagnosed with Hemolytic Uremic Syndrome (HUS) | 27 |
| Deaths | 5 |
Timeline:
6/28/18 CDC declares Yuma outbreak over.
4/19/18 Alaska Correctional Facility outbreak linked to whole romaine lettuce heads from Yuma, AZ.
4/10/18 CDC and FDA announce Yuma outbreak with illness onset dates of March 13 – June 7, 2018 but are unable to identify a source.
2017 Leafy Green E. coli (STEC) Outbreaks
E. coli O157:H7 Outbreak Linked to Leafy Greens
While the FDA had long claimed legislation such as the Food Safety Modernization Act (FSMA) made lettuce safer and investigations of outbreaks easier, a large outbreak in 2017 was never able to be publicly tied to a specific product by the FDA and CDC, even though the Public Health Agency of Canada had already tied what appeared to be the same outbreak specifically to romaine; and even though epidemiological evidence also pointed strongly to romaine – by the end of the investigation, 93% of ill people reported eating leafy greens generally and 55% reported specifically eating romaine lettuce. The FDA and CDC did not end up identifying a grower or even definitively identifying a specific region, although the Salinas Valley of California was by far the most likely region given the timing of the outbreak.
| Reported Cases | 25 |
| States with Illnesses | 15 |
| Hospitalizations | 9 |
| Diagnosed with Hemolytic Uremic Syndrome (HUS) | 2 |
| Deaths | 1 |
Timeline:
1/25/18 CDC declares the outbreak over. The final report links the outbreak to leafy greens generically, not romaine specifically.
12/28/17 On the same day as the CDC and FDA announcements, the Public Health Agency of Canada announces that the U.S. outbreak strains are genetically related to the Canadian romaine outbreak.
12/28/17 CDC and FDA announce mystery E. coli O157:H7 outbreak with illness onset dates of November 5, 2017 to December 12, 2017.
12/11/17 The Public Health Agency of Canada announces they have linked an E. coli O157:H7 outbreak in Canada to romaine lettuce.
Irrigation Water Requirements
In 2011, Congress enacted rules that would have required all produce growers to test and monitor irrigation water for dangerous pathogens such as E. coli by 2018. Under these rules, growers would have been required to test their irrigation water for pathogens at least once per growing season. Farms closer to potential pathogen sources may have been required to test more frequently. If contamination was discovered, the rules would have required switching to an uncontaminated water source or water treatment in order to alleviate the problem.
Just two months after the romaine lettuce E. coli outbreaks in 2019 were declared over, the FDA announced that produce growers do not need to comply with irrigation water regulations until at least 2022. The smallest farms do not need to comply until 2026. In addition to postponing the requirements, the FDA is also considering major changes that would allow some produce growers to test less frequently or find alternatives to water testing to prioritize the safety of their crops.
E. coli outbreaks from contaminated irrigation water are not a new problem. In 2018, the FDA’s traceback investigation linked the Yuma outbreak to irrigation canals. About a decade earlier in 2006, an outbreak linked to spinach sickened at least 200 people in 26 states, killing a two-year-old boy and two elderly women. After this outbreak, some leafy green growers in California and Arizona signed agreements to voluntarily test their irrigation water. However, some industry groups argue that water testing is too expensive and should not apply to all produce. Stronger water requirements are necessary in order to keep people safe. By prioritizing the needs of the industry that it is supposed to be regulating, the government is failing to protect consumers. People are still getting sick and outbreaks will continue.
WERE YOU DIAGNOSED WITH AN E. COLI INFECTION AFTER EATING CONTAMINATED LETTUCE?
Attorney Fred Pritzker helps people sickened by E. coli contaminated food get compensation and justice.
The national food safety lawyers at Pritzker Hageman, P.A. have won multi-million dollar settlements for people who became sick from E. coli, including $4.5 million for a teenager who suffered kidney failure.
If you or someone you love got sick, contact Fred for a free consultation.
Call: 888-377-8900 | Text: 612-261-0856
Food Poisoning Attorney Fred Pritzker
Proven Results
The lawyers at Pritzker Hageman have won hundreds of millions of dollars for their clients, including over 70 separate verdicts and settlements greater than $1,000,000. A number of them are among the largest recoveries ever obtained for similar cases.
$6.5 Million
Our attorneys won this landmark verdict in a case against Foster Poultry Farms. Our client was a 5-year-old child who suffered brain damage from a food borne infection.
$4.5 Million
On behalf of a man who developed meningitis from a food borne infection and almost died.
