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As of August 16, 2018 (3pm EDT), a total of 476 laboratory-confirmed cases of Cyclospora infection were reported in people who consumed salads from McDonald’s restaurants; the cases were reported by 15 states. Note, the Connecticut, Tennessee, and Virginia case-patients purchased salads while traveling in Illinois; the Florida case-patient purchased a salad while traveling in Kentucky.  Illnesses started on or after May 20, 2018. The median illness onset date is June 29, 2018 (range: May 20 to July 20). Ill people range in age from 14 to 91 years old, with a median age of 53. Sixty-six percent (66%) are female. At least 21 people have been hospitalized; no deaths have been reported.

Epidemiologic evidence indicates that salads purchased from McDonald’s restaurants are one likely source of these infections. The investigation is ongoing, and FDA is working to determine the sources of the ingredients that were in common to the salads served at McDonald’s.

On July 26, 2018, FDA completed analysis of an unused package of romaine lettuce and carrot mix distributed to McDonald’s by the Fresh Express processor in Streamwood, IL. The analysis confirmed the presence of Cyclospora in that mix. On July 27, 2018, FDA informed Fresh Express of these results.

Fresh Express reported to FDA that the carrots in the mix went to McDonald’s restaurant locations only, and that the romaine lettuce was the only ingredient in the mix that was distributed to other locations. Romaine lettuce from the same lot that was positive for Cyclospora was distributed in pre-made salads and wraps distributed by Caito Foods LLC of Indianapolis, IN. Fresh Express also reported that no romaine lettuce from the lot that was positive for Cyclospora was packaged for direct retail sale to consumers.

On July 30, 2018, The U.S. Department of Agriculture’s Food Safety and Inspection Service (FSIS) issued a public health alert about pre-made salads and wraps containing romaine lettuce that were distributed by Caito Foods LLC of Indianapolis, IN. The pre-made salads and wraps were shipped to distribution centers nationwide. The pre-made salads and wraps were produced July 15 to July 18, 2018 and have a “Best By,” “Enjoy by,” “Best if Sold By,” or “Sell By” date ranging from July 18 through July 23, 2018. See the product labels here. The pre-made salads and wraps have establishment number “EST. 39985” or “P-39985” inside or next to the USDA mark of inspection. See the full list of products, product labels, UPC code numbers, and other identifying information here.

The CDC, public health and regulatory officials in several states, and the U.S. Food and Drug Administration are investigating a multistate outbreak of Cyclospora infections. As of August 9, 2018 (11am EDT), a total of 436 laboratory-confirmed cases of Cyclospora infection were reported in people who consumed salads from McDonald’s restaurants; the cases were reported by 15 states. Note, the Connecticut, Tennessee, and Virginia case-patients purchased salads while traveling in Illinois; the Florida case-patient purchased a salad while traveling in Kentucky.

Illnesses started on or after May 20, 2018. The median illness onset date is June 29, 2018 (range: May 20 to July 20). Ill people range in age from 14 to 91 years old, with a median age of 53. Sixty-six percent (66%) are female. At least 20 people have been hospitalized; no deaths have been reported.

On July 26, 2018, FDA completed analysis of an unused package of romaine lettuce and carrot mix distributed to McDonald’s by the Fresh Express processor in Streamwood, IL. The analysis confirmed the presence of Cyclospora in that mix. On July 27, 2018, FDA informed Fresh Express of these results.

Fresh Express reported to FDA that the carrots in the mix went to McDonald’s restaurant locations only, and that the romaine lettuce was the only ingredient in the mix that was distributed to other locations. Romaine lettuce from the same lot that was positive for Cyclospora was distributed in pre-made salads and wraps distributed by Caito Foods LLC of Indianapolis, IN. Fresh Express also reported that no romaine lettuce from the lot that was positive for Cyclospora was packaged for direct retail sale to consumers.

On July 30, 2018, The U.S. Department of Agriculture’s Food Safety and Inspection Service (FSIS) issued a public health alert about pre-made salads and wraps containing romaine lettuce that were distributed by Caito Foods LLC of Indianapolis, IN. The pre-made salads and wraps were shipped to distribution centers nationwide. The pre-made salads and wraps were produced July 15 to July 18, 2018 and have a “Best By,” “Enjoy by,” “Best if Sold By,” or “Sell By” date ranging from July 18 through July 23, 2018. See the product labels here. The pre-made salads and wraps have establishment number “EST. 39985” or “P-39985” inside or next to the USDA mark of inspection. See the full list of products, product labels, UPC code numbers, and other identifying information here.

What is Cyclospora?

Cyclospora is a parasite composed of one cell, too small to be seen without a microscope. The organism was previously thought to be a blue-green alga or a large form of cryptosporidium. Cyclospora cayetanensis is the only species of this organism found in humans. The first known human cases of illness caused by cyclospora infection (that is, cyclosporiasis) were first discovered in 1977. An increase in the number of cases being reported began in the mid-1980s, in part due to the availability of better diagnostic techniques. Over 15,000 cases are estimated to occur in the United States each year. The first recorded Cyclospora outbreak in North America occurred in 1990 and was linked to contaminated water. Since then, several cyclosporiasis outbreaks have been reported in the U.S. and Canada, many associated with eating fresh fruits or vegetables. In some developing countries, cyclosporiasis is common among the population and travelers to those areas have become infected as well.

Where does Cyclospora come from?

Cyclospora is spread when people ingest water or food contaminated with infected stool. For example, exposure to contaminated water among farm workers may have been the original source of the parasite in raspberry-associated outbreaks in North America.

Cyclospora needs time (one to several weeks) after being passed in a bowel movement to become infectious. Therefore, it is unlikely that Cyclospora is passed directly from one person to another. It is not known whether or not animals can be infected and pass infection to people.

What are the typical symptoms of Cyclospora infection?

Cyclospora infects the small intestine (bowel) and usually causes watery diarrhea, bloating, increased gas, stomach cramps, and loss of appetite, nausea, low-grade fever, and fatigue. In some cases, vomiting, explosive diarrhea, muscle aches, and substantial weight loss can occur. Some people who are infected with Cyclospora do not have any symptoms. Symptoms generally appear about a week after infection. If not treated, the illness may last from a few days up to six weeks. Symptoms may also recur one or more times. In addition, people who have previously been infected with Cyclospora can become infected again.

What are the serious and long-term risks of Cyclospora infection?

Cyclospora has been associated with a variety of chronic complications such as Guillain-Barre syndrome, reactive arthritis or Reiter’s syndrome, biliary disease, and acalculous cholecystitis. Since Cyclospora infections tend to respond to the appropriate treatment, complications are more likely to occur in individuals who are not treated or not treated promptly. Extraintestinal infection also appears to occur more commonly in individuals with a compromised immune system.

How is Cyclospora infection detected?

Your health care provider may ask you to submit stool specimen for analysis. Because testing for Cyclospora infection can be difficult, you may be asked to submit several stool specimens over several days. Identification of this parasite in stool requires special laboratory tests that are not routinely done. Therefore, your health care provider should specifically request testing for Cyclospora if it is suspected. Your health care provider might have your stool checked for other organisms that can cause similar symptoms.

How is Cyclospora infection treated?

The recommended treatment for infection with cyclospora is a combination of two antibiotics, trimethoprim-sulfamethoxazole, also known as Bactrim, Septra, or Cotrim. People who have diarrhea should rest and drink plenty of fluids. No alternative drugs have been identified yet for people with Cyclospora infection who are unable to take sulfa drugs. Some experimental studies, however, have suggested that ciprofloxacin or nitazoxanide may be effective, although to a lesser degree than trimethoprim-sulfamethoxazole. See your health care provider to discuss alternative treatment options.

How can Cyclospora infection be prevented?

Avoiding water or food that may be contaminated is advisable when traveling. Drinking bottled or boiled water and avoiding fresh ready-to-eat produce should help to reduce the risk of infection in regions with high rates of infection. Improving sanitary conditions in developing regions with poor environmental and economic conditions is likely to help to reduce exposure.

Washing fresh fruits and vegetables at home may help to remove some of the organisms, but Cyclospora may remain on produce even after washing.

Marler Clark, The Food Safety Law Firm, is the nation’s leading law firm representing victims of Cyclospora outbreaks. The Cyclospora Attorneys and Lawyers have represented victims of Cyclospora and other foodborne illness outbreaks and have recovered over $650 million for clients.  Marler Clark is the only law firm in the nation with a practice focused exclusively on foodborne illness litigation.

If you or a family member became ill with a Cyclospora infection after consuming food and you are interested in pursuing a legal claim, contact the Marler Clark Hepatitis A attorneys for a free case evaluation.

Surprised?  I did not think so.  Cattle feces from a CAFO gets into the water supply that is used to irrigate romaine lettuce – what possibly could go wrong?

Of note, the FDA still has not been transparent (except that “romaine [lettuce] from the Yuma growing region as the likely source of contamination”) as to where the romaine was consumed (except for the “Alaskan correctional facility back to a single farm – [Harrison]”).  Nor, has the FDA been transparent what farms grew the romaine, where and who processed it and who shipped it.  The FDA in fact knows most, if not all, of this, but refuses to release the information citing, “trade secrets.”

As the CDC reported in its final assessment of the outbreak on June 28, 2018, there are 210 cases in 36 states: Alabama (3) Alaska (8), Arkansas (1), Arizona (9), California (49), Colorado (3), Connecticut (2), Florida (3), Georgia (5), Idaho (12), Illinois (2), Iowa (1), Kentucky (1), Louisiana (1), Massachusetts (4), Michigan (5), Minnesota (12), Mississippi (1), Missouri (1), Montana (9), Nebraska (1), New Jersey (8), New York (11), North Carolina (1), North Dakota (3), Ohio (7), Oklahoma (1), Oregon (1), Pennsylvania (24), South Dakota (1), Tennessee (3), Texas (4), Utah (1), Virginia (1), Washington (8), and Wisconsin (3). 5 deaths were reported from Arkansas, California, Minnesota (2), and New York.  8 illnesses were reported in Canada linked to the same outbreak.

On August 6, 2018, the FDA posted an update on the status of its ongoing environmental assessment on the likely, what used to be called the “root cause.” The FDA’s update was as follows:

On July 31 and August 1, 2018, the FDA participated in a meeting of the Leafy Greens Food Safety Task Force that was formed in response to the serious outbreak of E. coli O157:H7 associated with romaine lettuce that occurred earlier this year. During the meeting FDA shared preliminary hypotheses from the Environmental Assessment in Yuma to facilitate conversations with state and local officials, industry and local growers on the hypotheses and associated actions necessary to prevent such an outbreak from occurring again.

As FDA has previously stated, samples of canal water have tested positive for the outbreak strain of E. coli. FDA continues to consider that contaminated water coming into contact with produce, either through direct irrigation or other means, is a viable explanation for the pattern of contamination. But other hypotheses were discussed as well. FDA notes that the canal is close to a Concentrated Animal Feeding Operation (CAFO), a facility with a large number of cattle on the premises. The CAFO can hold in excess of 100,000 head of cattle at any one time and the FDA traceback information showed a clustering of romaine lettuce farms nearby.

Our experts continue to work on examining potential links between the CAFO, adjacent water, and geologic and other factors that may explain the contamination and its relationship to the outbreak. Additional sampling activities will be conducted to further explore and narrow down hypotheses in the near future. Our findings will be detailed in a finalized environmental assessment report.

We urge other government and non-government entities, produce growers in the region, and those engaged in managing the canal systems to work with FDA and marshal and deploy resources to achieve our collective food safety goal. Broad engagement from the surrounding community is critical to developing and implementing remediation measures to reduce the potential for another outbreak. We believe local in-depth knowledge and actions are critical in helping resolve this issue in order to protect public health.

The Environmental Assessment report will be made publicly available when complete.

And, then there is this – for those “geographically challenged,” Yuma is near the dark purple in the lower left corner:

To date, we have filed 10 lawsuits and are making great progress tracing back from restaurants and grocery stores that sold the E. coli-tainted romaine in the spring.  And, once the “points of sale” flip the supply chain of the romaine, we are making great progress finding out who brokered the sale and who processed the romaine.  We are making slower process identifying specific farms, but that information is coming. Once we have the names of more farms, we will move back up other chains of distribution identifying additional shippers, brokers, processors and eventually more restaurants and grocery stores.

Having discovery and subpoena power is a great tool for truth.

Fresh Express Statement about Recall of a Limited Number of Cases of Expired Products Not Marked or Labeled for Retail Sale:

At Fresh Express, our top priority is providing consumers with the highest quality and safest fresh lettuce and leafy greens products available.

In its investigation, the US Food and Drug Administration (FDA) took several random samples of products and one sample, yielded a positive result for Cyclospora. Although the sample taken was an already-expired institutional foodservice product, it none-the-less necessitated a precautionary recall by Fresh Express on July 27th of a limited number of cases.

The products recalled were packaged in clear plastic, multi-pound packs that did not display the Fresh Express logo and were not marked or labeled for retail sale to consumers.

The Fresh Express food safety team, along with our outside food safety experts, have collaborated closely with FDA, the US Centers for Disease Control and Prevention and state public health agencies in their outbreak investigations, and we continue to do so. As of now, there is no clear understanding about the contamination pathway or the definitive source of infection.

Fresh Express follows rigid food safety requirements and preventive controls throughout our supply chain that are carefully designed to mitigate against potential health risks. Working together with public health officials, we are hopeful a definitive source of the outbreak clusters will be identified soon.

NICD updated this Listeria Outbreak at the end of July.  Of note, the numbers of ill have continued to drop following the recall of Tiger Brands Enterprise Foods polony in March. However, it appears that some of the “recalled” product is still being consumed.  NICD’s partial report is below.

1,060 laboratory-confirmed cases have been reported from 01 January 2017 to 17 July 2018. The number of new cases reported each week has decreased since the implicated products were recalled on 04 March 2018 with no new cases of listeriosis reported during the week prior to release of this sitrep (Figure 1). Neonates ≤28 days of age are the most affected age group (42%, 443/1 060), followed by adults aged 15 – 49 years of age (32%, 334/1 060) – Figure 2. Most cases have been reported from Gauteng Province (58%, 614/1 060), followed by Western Cape (13%, 136/1 060) and KwaZulu-Natal (8%, 83/1 060) provinces (Table 1). Final outcome (i.e. death or discharge) is known for 76% (806/1 060) of total cases to date; 27% (216/806) with known outcome died.

Following a recall of the implicated products, the number of cases has steadily decreased. However, it is anticipated that cases could still be reported for the following reasons:

  • The incubation period of listeriosis can be up to 70 days.
  • The implicated products have a long shelf life and it is possible that despite the recall some products have not been removed from retail or consumer’s homes.
  • Cross-contamination at retail and in the home can occur.

Post recall (05 March 2018 to date), all new cases of laboratory-confirmed listeriosis are contacted by IMT members, and a comprehensive food history is obtained. Exposure to food products implicated in the listeria outbreak is determined.

Of 87 post-recall cases, 65 have been interviewed to date.

Of those interviewed, 38/65 (58%) of ill people or their proxy reported consuming polony prior to their illness onset; brands manufactured by Tiger Brands Enterprise Foods were most commonly reported to have been consumed where brand of polony was known.

Prior to 2017, an average of 60 to 80 laboratory-confirmed listeriosis cases per year (approximately 1 per week), were reported in South Africa. In July 2017, an increase in laboratory-confirmed cases of listeriosis was reported to National Institute for Communicable Diseases (NICD) which triggered further investigation. On 05 December 2017, the listeriosis outbreak was declared by the Minister of Health, Dr. Aaron Motsoaledi. The source of the outbreak was identified as ready-to-eat processed meat products manufactured at Tiger Brand’s Enterprise Foods’ Polokwane production facility. A recall of affected products was initiated on 04 March 2018.

The U.S. Department of Agriculture’s Food Safety and Inspection Service (FSIS) is issuing a public health alert out of an abundance of caution due to concerns about contamination with Cyclospora. The beef, pork and poultry salad and wrap products were distributed by Caito Foods LLC, an Indianapolis, Ind. establishment.

The beef, pork and poultry salad and wrap items were produced between July 15 to 18, 2018, with the either “Best By,” “Enjoy by,” Best if Sold By” or “Sell By” dates ranging from July 18 through July 23, 2018. [View Label (PDF only)]

The complete list of products, product labels, the UPC code numbers and other identifying information can be found here.

The products bear establishment number “EST. 39985 or P-39985” inside or next to the USDA mark of inspection. These items were shipped to distribution centers nationwide.

The problem was discovered when Caito Foods LLC received notification from their lettuce supplier, Fresh Express, that the chopped romaine that is used to manufacture some of their salads and wraps was being recalled.

FSIS is concerned that some product may be in consumers’ refrigerators and that consumers may be at risk due to the length of the Cyclospora incubation period. Consumers who have purchased these products are urged not to consume them. These products should be thrown away or returned to the place of purchase. Caito Foods LLC and FSIS are working together to remove the products from commerce.

Anyone concerned about an illness should contact a health care provider. Cyclospora infection is an illness cause by the intestinal parasite, Cyclospora cayetanensis. The incubation period for Cyclospora ranges from two to 14 days, which would include the dates of July 25 through August 6, 2018. Illnesses might not have been reported yet due to the time it takes between when a person becomes ill and when the illness is reported. For Cyclospora infections this could take up to six weeks.

As of July 24, 2018, 77 people infected with the outbreak strain of Salmonella Adelaide were reported from nine states. A list of the states and the number of cases in each can be found on the Case Count Map page.

Illnesses started on dates ranging from April 30, 2018, to July 2, 2018. Ill people ranged in age from less than 1 year to 97, with a median age of 67. Among ill people, 67% were female. Out of 70 people with information available, 36 (51%) were hospitalized. No deaths were reported.

Epidemiologic and traceback evidence indicated that pre-cut melon supplied by the Caito Foods, LLC of Indianapolis, Indiana was the likely source of this multistate outbreak.

Information collected from stores where ill people shopped indicated that Caito Foods, LLC supplied pre-cut melon to these stores. On June 8, 2018, Caito Foods, LLC recalled fresh-cut watermelon, honeydew melon, cantaloupe, and fresh-cut fruit medley products containing one of these melons that were produced at the Caito Foods facility in Indianapolis, Indiana.

As of June 27, 2018, the CDC reported 210 people infected with the outbreak strain of E. coli O157:H7 were reported from 36 states.  Canada reported 8 sickened.

Illnesses started on dates ranging from March 13, 2018 to June 6, 2018. Ill people ranged in age from 1 to 88 years, with a median age of 28.

Sixty-seven percent of ill people were female.

Of 201 people with information available, 96 (48%) were hospitalized, including 27 people who developed hemolytic uremic syndrome, a type of kidney failure.

Five deaths were reported from Arkansas, California, Minnesota (2), and New York.

Here is what the FDA has told us all as of May 31, 2018:

Epidemiologic, laboratory, and traceback evidence indicated that romaine lettuce from the Yuma growing region was the likely source of this outbreak.

The FDA and state and local regulatory officials traced the romaine lettuce to many farms in the Yuma growing region. The FDA, along with CDC and state partners, started an environmental assessment in the Yuma growing region and collected samples of water, soil, and manure. CDC laboratory testing identified the outbreak strain of E. coli O157:H7 in water samples taken from a canal in the Yuma growing region.

Here is what we have figured out through litigation to date.  More information will be added in the coming weeks:

We are now investigating the following outbreak that seemed to fall a bit below the radar.

Authors: Amelia Keaton, R. Hassan, S. Luna, I. Lee, R. Magalhaes, M. Bidlack, L. Smith, R. Maves, D. Freer, K. Flinn, G. Monk, P. Graf, K. Trinh, J. Crandall, D. Noveroske, G. Fortenberry, L. Ramos, R. Recio, C. Peak, E. McDonald, T. Waltz, K. Patel, D. Wagner, J. Espiritu, L. Christensen, L. Gieraltowski

Background: Shiga toxin-producing Escherichia coli (STEC) infections are a substantial cause of foodborne illness and a cause of hemolytic-uremic syndrome (HUS). In November 2017, CDC assisted the US Navy in a response to an outbreak of STEC illnesses in recruits at a Marine Corps Recruit Depot in San Diego (MCRD). We investigated to determine the source of this outbreak and identify prevention and mitigation measures.

Methods: In October 2017, medical providers identified a high number of gastrointestinal (GI) illnesses at MCRD. Recruits with diarrhea submitted stool specimens for culture and/or culture-independent diagnostic testing (CIDT) for GI pathogens. We performed pulsed-field gel electrophoresis (PFGE) on culture isolates. Case-patients were then defined as follows: confirmed (PFGE-confirmed STEC infection matching outbreak strains), probable (diagnosis of HUS and/or CIDT evidence of STEC), and suspected (bloody diarrhea). We conducted environmental evaluations of facilities, training areas, and barracks. A case-control study was performed using PFGE-confirmed case-patients and platoon-matched controls. We performed product traceback for foods identified as exposure risks by interview or case-control study.

Results: We identified 62 confirmed, 62 probable, and 120 suspected case-patients. Thirty case-patients required hospitalization and 15 had HUS. Case-patient ages ranged from 17-28 years (median: 18 years). Poor hygiene practices among recruits and inconsistent cooking temperatures within dining facilities were noted. Forty-three case-patients and 135 controls were interviewed about food, hygiene, and environmental exposures. Consumption of undercooked beef was found to be significantly associated with illness, (mOR 2.40, CI 1.04-5.72, p=0.04). We identified a single ground beef supplier for MCRD, but MCRD records did not document which specific lots of ground beef were used.

Conclusions: Case-control analysis and environmental observations suggested undercooked ground beef as a potential source for this outbreak. We recommended the Navy and Marine Corps retain lot information, address food handling concerns, and improve hygiene among recruits.

REF:  https://www.cdc.gov/eis/downloads/eis-conference-2018-508.pdf, page 117

Here is what the FDA has told the public thus far about the source of the 2018 Yuma Romaine Lettuce Outbreak that has sickened over 200 in the US and Canada and killed 5 in the US:

Eventually, at least for the 105 people who have hired us, we will fill in all the blanks.  I must admit as someone interested in food safety and transparency, having a lawyer in Seattle fill in the blanks that the FDA should is not how it should be.  The time has come for the FDA to reassess what are considered “trade secrets” or “confidential.”  FSIS did it a decade ago and the sky did not fall.