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CNN Lets ‘Food Babe’ Spout Pseudoscience on Lettuce Outbreak
There’s another wonderful headline. Everyone has something to say about Romaine lettuce and pathogenic E. coli. Everyone I know anyway. I do not spout pseudoscience, but I have previously written about our first Romaine recall of 2018 here, and I use credible sources for my information like CDC and FDA.

The United States is currently in a second E. coli O157:H7 outbreak linked to Romaine.
Our friends to the north in Canada are with us in this outbreak too. The CDC reported on November 26, that 43 cases in the US have been diagnosed across 12 states, with 16 hospitalizations and no deaths. The illness for at least one person has resulted in hemolytic uremic syndrome (HUS), i.e. kidney failure. The outbreak started the beginning of October, and more cases are expected to be reported.

Romaine is currently not harvested from Arizona.
The first 2018 outbreak of pathogenic E. coli was traced to Romaine grown in Arizona. It took some time to detect, but the source of the Romaine for the current outbreak is California, not Arizona. In fact, the search has narrowed to six counties in California where Romaine was grown and harvested.

Where was my Romaine grown?
In the last outbreak, family members were asking me if they really had to throw away the old Romaine in the refrigerator and the fresh Romaine they just bought at the store. Yes! All Romaine was discarded in the supply chain. Growers, processors, stores and restaurants are understandably upset at having to dispose of Romaine again. Thanks to government and industry working together, FDA is urging processors to label Romaine with used by dates, harvest location and harvest date.

Do you remember the outbreak of 2017?
Yes, we were in a similar spot a year ago with an E. coli outbreak in the United States and Canada. Data pointed to leafy greens, but the source of the outbreak was never found, and a recall was never announced by the FDA. Canada’s traceback investigation landed on Romaine as the source. In the US, there were 25 cases across 15 states with the outbreak starting the beginning of November. By the end of February, two people had HUS and one person had died. Canada saw 42 cases and one death.

Are all these E. coli the same? No, and Maybe.
No. The FDA states that the E. coli O157:H7 from the first outbreak of 2018 and from Arizona Romaine is different genetically from the E. coli O157:H7 of California, like non-identical twins. Close, but not the same.
Maybe. However, when comparing the E. coli O157:H7 of the current outbreak to the E. coli O157:H7 of the outbreak this time last year, they are identical twins:

    Genetic analysis indicates that illnesses reported in this current outbreak are caused by the same strain of E. coli O157:H7 seen in a previous outbreak that occurred in fall of 2017 that affected consumers in both Canada and the U.S.

Smart people are working on this problem in the United States and Canada. In the meantime, toss away any Romaine you have in your refrigerator. Recalls are stressful situations. The Preventive Controls for Human Food rule under FSMA requires a written recall plan.

ConnectFood can help you meet the requirement of the rule and be prepared for a potential recall. The ConnectFood website has free resources, and the folks at ConnectFood are here to help! Contact us.

About the Author
Kathy Knutson, Ph.D.
Kathy Knutson Food Safety Consulting LLC
Dr. Kathy Knutson works nationwide with food manufacturers on recall investigations, problem-solving, training, and Food and Drug Administration (FDA) compliance. After being trained in 2016 as a Lead Instructor with the FDA-recognized curriculum for Preventive Controls Qualified Individuals, she has delivered over 20 workshops to the food industry. With 35+ years in microbiology and 15 years of full-time teaching, Dr. Knutson is passionate about training and is an active communicator at all levels of an organization. She has taught and consulted with companies on laboratory methods, interpretation of lab results, quality assurance, sanitation, environmental monitoring, Standard Operating Procedures (SOPs), Good Manufacturing Practices (GMPs), Hazard Analysis and Critical Control Points (HACCP) and the FDA’s Food Safety Modernization Act (FSMA). As a life-long learner, Dr. Knutson is trained in the prevention of intentional adulteration, a topic on the horizon for the food industry. Dr. Knutson is a contributing author at CannabisIndustryJournal.com. Dr. Knutson writes a food safety blog and contributes expert services to manufacturers through ConnectFood.com, an online site for writing HACCP and food safety plans. When Dr. Knutson is not traveling, she works from home in Green Bay, Wisconsin, where she lives with her husband, two sons, and an adorable Bernedoodle. Learn more about her at https://www.linkedin.com/in/kathyknutsonphd.

It has been two weeks since the CDC updated the case count and epi curve on their website. The reasoning is good, because the outbreak of E. coli O157:H7 associated with Romaine lettuce is mostly over and data are arriving more slowly. There is no Romaine lettuce from the Yuma, Arizona growing region being harvested. All Romaine lettuce from the Yuma growing region is beyond its shelf-life and is no longer being consumed. The public health community is waiting for the reporting of any new cases and the fate of those stricken with the illness. It is sad to report that the death count raised from one to a total of five souls.

A look at the epi curve shows a normal distribution of cases, a week where the number of cases dwindled to single digits and days without new cases, great signs that the outbreak will soon be declared over by the CDC. An onset time of three weeks is possible coupled with time for medical diagnosis and reporting to CDC means there may be more cases reported. The case count currently is 197.

There are several striking features of this E. coli O157: H7 outbreak:

    • 89 people have been hospitalized. A hospitalization rate of 45% is high.
    • Similarly, the rate of patients developing hemolytic uremic syndrome (HUS), a form of kidney failure, is high at 13% for 26 people.
    E. coli O157:H7 with the same DNA fingerprint and associated with Romaine lettuce caused illness in Canada.
    • Illnesses have been reported in 35 states, including Alaska.

While the CDC continues to monitor the outbreak and many organizations, including the FDA, are investigating, one of the most striking features is that no Romaine lettuce is available for pathogen testing. Because of the typical, long onset time for the illness, any unconsumed Romaine is long discarded. Most outbreak investigations will gather samples from consumer homes, restaurants and grocery stores. In this outbreak, the implicated product availability is very limited. The outbreak investigation is very difficult as illustrated in the traceback model created by the FDA and showing some of the traceback for Romaine lettuce. With no common point of service, distribution center or processor, the source of contamination may be found in the growing region.

All this news should cause us to take a hard look at our own recall plans. If your company is audited, mock recalls are conducted at some frequency, and there are always learnings from mock recalls. If you are under compliance for the Preventive Controls for Human Food rule, a written recall plan is required as part of the food safety plan. I encourage you to take time now to review and update the recall plan. From my experience of working with companies on recall investigations, it is better to take time now to be prepared than to be figuring this out during a recall. The ConnectFood website has free resources, and the folks at ConnectFood are here to help! Contact us.

About the Author
Kathy Knutson, Ph.D.
Kathy Knutson Food Safety Consulting
Dr. Kathy Knutson works nationwide with food manufacturers on recall investigations, problem-solving, training, and Food and Drug Administration (FDA) compliance. After being trained in 2016 as a Lead Instructor with the FDA-recognized curriculum for Preventive Controls Qualified Individuals, she delivered over 20 workshops to industry. With over 35 years in microbiology and 15 years of full-time teaching, Dr. Knutson is passionate about training and is an effective communicator at all levels in an organization. She has taught and consulted with companies on laboratory methods, interpretation of lab results, quality assurance, sanitation, environmental monitoring, Standard Operating Procedures (SOPs), Good Manufacturing Practices (GMPs), Hazard Analysis and Critical Control Points (HACCP) and the FDA’s Food Safety Modernization Act (FSMA). As a life-long learner, Dr. Knutson is trained in prevention of intentional adulteration, a topic on the horizon for the food industry. Dr. Knutson is a contributing author at CannabisIndustryJournal.com. Dr. Knutson writes a food safety blog and contributes expert services to manufacturers through ConnectFood.com, an online site for writing HACCP and food safety plans. When Dr. Knutson is not traveling, she works from home in Green Bay, Wisconsin, where she lives with her husband, two sons, and an adorable Bernedoodle. Learn more about her at https://www.linkedin.com/in/kathyknutsonphd