In 2021, multiple outbreaks of cyclosporiasis cases associated with different restaurants or events were investigated by state public health authorities, CDC, and FDA.CDC investigated two large multistate outbreaks of cyclosporiasis, one including 40 illnesses and one with 130 illnesses, in which ill people reported eating various types of leafy greens. State officials and FDA conducted traceback investigations for these two outbreaks, but a specific type or grower of leafy greens was not identified as the source of either outbreak.

As of September 28, 2021, 1,020 laboratory-confirmed cases of cyclosporiasis in people who had no history of international travel during the 14-day period before illness onset have been reported to CDC by 37 jurisdictions, including 36 states and New York City, since May 1, 2021.The median illness onset date is June 25, 2021 (range: May 1–August 31, 2021).

At least 70 people have been hospitalized; no deaths have been reported.

The number of reported cases of domestically acquired cyclosporiasis illnesses has increased by 402 cases since the last update on July 29, 2021. Cases continue to be reported to CDC.

As of August 25, 2021, 864 laboratory-confirmed cases of cyclosporiasis in people who had no history of international travel during the 14-day period before illness onset have been reported to CDC by 35 jurisdictions, including 34 states and New York City.The median illness onset date is June 24, 2021 (range: May 1, 2021–August 7, 2021).

At least 59 people have been hospitalized; no deaths have been reported.

As of July 13, 2021, 208 laboratory-confirmed cases of cyclosporiasis in people who had no history of international travel during the 14-day period before illness onset have been reported to CDC by 23 jurisdictions, including 22 states and New York City.

The median illness onset date is June 17, 2021 (range: May 1, 2021–July 3, 2021).

At least 21 people have been hospitalized; no deaths have been reported.

Cyclospora cayetanensis is a unicellular, microscopic parasite that can cause food- or water-related gastrointestinal illness. Cyclospora cannot be transmitted directly from one person to another through infected fecal matter; the parasite must complete part of its lifecycle outside of a host. Most cases of cyclosporiasis occur in underdeveloped tropical and subtropical regions of the world where the parasite is endemic.

In the United States, Cyclospora causes about 11,000 illnesses and 11 hospitalizations, but infestations of this parasite do not typically result in death. Due to the self-limiting nature of the pathogen (which causes some people to not seek medical care), difficulty in diagnosing it specifically, and other factors, the Centers for Disease Control and Prevention (CDC) estimates that there could be very broad ranges of infection, from 140 to 38,000 annual cases. In North America, outbreaks of cyclosporiasis in humans have been reported mostly from contaminated fresh food products, such as soft fruits (raspberries, blackberries, and strawberries), leafy vegetables (lettuce and mixed salad), and herbs (basil and cilantro). Soil is another possible infection source, particularly in areas with poor environmental sanitation.

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. These can include disorders of malabsorption, reactive arthritis, cholecystitis (inflammation of the gallbladder), and, possibly, Guillain-Barré Syndrome. 

Shenandoah Growers, Inc (Harrisonburg, VA) out of an abundance of caution, has issued a limited, voluntary recall of approximately 3240 units of branded fresh cut, packaged organic basil clamshells packed at its Indianapolis, Indiana location due to a possible health risk from Cyclospora.

Cyclosporiasis is an intestinal infection caused by the Cyclospora parasite. A person may become infected after ingesting contaminated food or water. Common symptoms include severe abdominal pain, watery diarrhea, nausea and vomiting, body aches and fatigue. The infection is treated with antibiotics and most people respond quickly to treatment.

Only the following specific lot codes are affected:

PV40515 1034     PV40515 3034     PV40515 4034     PV40515 3035

The affected product has a country of origin of Colombia and was harvested entirely from Puerto Vallarta Herbs SAS (Farm) and imported by Vallarta Organics LLC dba Organic Destiny (Importer).

Affected lot codes shipped:

Lot Code: Pack Date: Brand: Size: Location UPC:
PV40515 1034 2/3/2021 Shenandoah Growers by That’s Tasty 0.75 oz Indianapolis Fruit 7-68573-00101-4
PV40515 1034 2/3/2021 Shenandoah Growers by That’s Tasty 2.0 oz Indianapolis Fruit 7-68573-02143-2
PV40515 1034 2/3/2021 Shenandoah Growers by That’s Tasty 4.0 oz Indianapolis Fruit 7-68573-00141-0
PV40515 3034 2/3/2021 That’s Tasty (Pasta Blend) 0.5 oz Vine Line Produce 7-68573-52008-9
PV40515 3034 2/3/2021 That’s Tasty 0.5 oz Vine Line Produce 7-68573-50502-4
PV40515 3034 2/3/2021 Shenandoah Growers by That’s Tasty 4 oz Vine Line Produce Bulk N/A
PV40515 3034 2/3/2021 Shenandoah Growers by That’s Tasty 1 lb. Vine Line Produce Bulk N/A
PV40515 4034 2/3/2021 Simple Truth 3.0 oz Kroger 0-11110-00876-3
PV40515 1034 2/3/2021 That’s Tasty 0.25 oz J&J Distributing 7-68573-02515-7
PV40515 1034 2/3/2021 Shenandoah Growers by That’s Tasty 0.75 oz J&J Distributing 7-68573-00101-4
PV40515 3035 2/4/2021 That’s Tasty 3.0 oz Schnucks 7-68573-53001-9

Recalled products were distributed to select retail stores between 2/3/2021 to 2/4/2021 in the following states: Illinois, Indiana, Iowa, Michigan, Minnesota, Mississippi, Missouri, Ohio, Tennessee, and Wisconsin.

This recall notification is being issued due to a single instance in which a sample of bulk product was pulled at the port of entry in Miami and tested by the FDA as part of routine surveillance and indicated the potential presence of Cyclospora.

Affected Shenandoah Growers customers have been notified of the recall and instructed to immediately remove and discard recalled products from all store shelves, distribution and other inventories to ensure they are no longer available for sale or consumption.

The Shenandoah Growers recall includes only those clamshells of certified organic basil clearly marked with the affected lot codes listed above. The lot code can be found printed on each clamshell.

No other Shenandoah Growers products are subject to recall, and the company has no knowledge of any illness reported or related to this product to date.

Consumers who may have a recalled basil product should discard it immediately and not eat it.

 

Cyclospora – Salads

As of September 23, 2020, a total of 701 people with laboratory confirmed Cyclospora infections associated with this outbreak were reported from 14 states: GA, IL, IA, KS, MA, MI, MN, MO, NE, ND, OH, PA, SD, WI. Exposures were reported in 13 states (IL, IA, KS, MA, MI, MN, MO, NE, ND, OH, PA, SD, WI).

Illnesses started on dates ranging from May 11, 2020 to July 24, 2020. Ill people ranged in age from 11 to 92 years with a median age of 57; 51% were female. 38 (5%) people were hospitalized. No deaths were reported in this outbreak.

Epidemiologic evidence and product traceback indicated that bagged salad mix containing iceberg lettuce, carrots, and red cabbage produced by Fresh Express was a likely source of this outbreak.

Fresh Express recalled Fresh Express brand and private label brand salad products produced at its Streamwood, IL facility that contained iceberg lettuce, red cabbage, and/or carrots on June 27, 2020.

In interviews, ill people answered questions about the foods they ate and other exposures in the 2 weeks before they became ill. An illness cluster is defined as two or more people who do not live in the same household who report eating at the same restaurant location, attending a common event, or shopping at the same location of a grocery store in the week before becoming ill. Investigating illness clusters provides critical clues about the source of an outbreak. If several unrelated ill people ate or shopped at the same location of a restaurant or store within several days of each other, it suggests that the contaminated food item was served or sold there. In this bagged salad-associated cluster, there were several situations in which people reported purchasing the product from the same stores.

The FDA and regulatory officials in several states collected records to determine the source of the bagged salad that ill people ate in the affected areas. Product distribution information indicated that the Streamwood, Illinois Fresh Express production facility is the likely producer of the bagged salad mixes eaten by ill people.

Southeastern Grocers announced Friday that they are voluntarily recalling SE Grocers Naturally Better Organic Fresh Cut Basil.

The recall is due to Cyclospora. Cyclospora infections, known as cyclosporiasis, can cause diarrhea, abdominal cramps, nausea and vomiting, among other symptoms.

SE Grocers says if customers still have this product, regardless of the expiration date, they should throw it out or return it to the store purchased for a full refund.

BI-LO, Fresco y Más, Harveys Supermarkets and Winn-Dixie are all SEG stores.

Customers with questions about the recalled products may contact the Southeastern Grocers Customer Call Center at (844) 745-0463, Monday through Friday from 8 a.m. to 7 p.m., and Saturday from 8 a.m. to 4 p.m.

The UPC code for SE Grocers Naturally Better Organic Fresh Cut Basil is as follow:

  • SE Grocers Naturally Better Organic Fresh Cut Basil – 0.5 oz container: 6-07880-20230-4

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.

Cyclosporiasis is an intestinal illness caused by the parasite Cyclospora cayetanensis, which is transmissible by ingestion of fecally contaminated food or water.[1] Cyclosporiasis is most common in tropical and subtropical regions of the world. In the United States, foodborne outbreaks of cyclosporiasis have been linked to various types of imported fresh produce (e.g., basil, raspberries, and snow peas). Validated molecular typing tools, which could facilitate detection and investigation of outbreaks, are not yet available for C. cayetanensis.

Outbreaks of cyclosporiasis in humans have been reported mostly from North America, from the infection sources of contaminated fresh food products, such as soft fruits (raspberries), leafy vegetables (coriander, basil, and mixed salad), and herbs. Soil is another possible infection source, particularly in areas with poor environmental sanitation.[2]

The Centers for Disease Control and Prevention (CDC) has been conducting national surveillance for cyclosporiasis since it became a nationally notifiable disease in January 1999. As of 2015, cyclosporiasis was a reportable condition in 42 states, the District of Columbia, and New York City (NYC). Health departments voluntarily notify CDC of cases of cyclosporiasis through the National Notifiable Diseases Surveillance System and submit additional case information using the CDC cyclosporiasis case report form or the Cyclosporiasis National Hypothesis Generating Questionnaire (CNHGQ).[3]

While cyclosporiasis cases are reported year-round in the United States, cyclosporiasis acquired in the United States (i.e., “domestically acquired,” or cases of cyclosporiasis that are not associated with travel to a country that is considered endemic for Cyclospora) is most common during the spring and summer months. The exact timing and duration of U.S. cyclosporiasis seasons can vary, but reports tend to increase starting in May. In 2020, multiple outbreaks of cyclosporiasis were identified and found to be linked to different produce items. As of September 23, 2020, the CDC documented 1,241 laboratory-confirmed cases of cyclosporiasis in people who had no history of international travel during the 14-day period before illness onset.[4]

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. The time between becoming infected and becoming ill is usually about one week. If not treated, the illness may last from a few days up to six weeks. Symptoms also may recur one or more times (relapse). In addition, people who have previously been infected with Cyclospora can become infected again.[5]

Where does Cyclospora come from?

The modes of transmission of C. cayetanensis are still not completely documented, although fecal–oral transmission is the major route. Direct person-to-person transmission is unlikely. Indirect transmission can occur if an infected person contaminates the environment, the oocysts sporulate under the right conditions, and then contaminated food and water are ingested. The role of soil in transmission has also been proposed. The relative importance of these various modes of transmission and sources of infection is not known.[6]

The dissemination of infective Cyclospora oocysts via water, soil, and unprocessed foods (e.g., fruits and vegetables, including ready-to-eat salads) is enabled by their small size (8–10 μm), low specific gravity, and high infectivity. Such oocysts can survive for weeks to months in water and food, depending on the environmental temperature, and are resistant to the routine sanitization or chemical disinfection procedures used in irrigation systems, recreational waters, or drinking water treatment plants.[7]

How is Cyclospora diagnosed?

Cyclosporiasis is usually diagnosed symptomatically in clinical settings, including the presence of watery diarrhea, abdominal cramping, and bloating. In untreated, immunocompetent people, the diarrhea can last from days to weeks to a month or more, and can wax and wane, with variable oocyst shedding. Oocysts can continue to be shed (intermittently or continuously) by non-symptomatic people, and symptoms can also persist in the absence of oocysts in feces. In a clinical context, conventional diagnosis usually involves microscopic examination of intestinal tissue biopsy sections, stool samples for the presence of developmental stages of Cyclospora, or advanced molecular testing for DNA. Improved specificity and sensitivity have been possible largely through the use of PCR, which enables the specific amplification of genetic loci from tiny amounts of genomic DNA of Cyclospora. Because of the intermittent nature of oocyst shedding and the low numbers of this stage in feces, it is recommended that multiple stool samples be collected at 2–3 day intervals over a period of more than a week, to increase the likelihood of identifying the disease microscopically.[8]

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

Cyclospora has been associated with a variety of chronic complications such as malabsorption, reactive arthritis, and cholecystitis (inflammation of the gallbladder). 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.[9]

Although human cyclosporiasis is usually not fatal in developed countries such as the United States, protracted diarrhea often leads to dehydration, particularly in infants who are at greatest risk of severe dehydration and death, especially if cyclosporiasis is complicated by infections with other pathogens (viral, bacterial, or parasitic—e.g., Cryptosporidium and Giardia), malnutrition, or malabsorption, particularly in underprivileged communities.[10]

According to the CDC[11], the recommended treatment is a combination of two antibiotics, trimethoprim-sulfamethoxazole, also known as Bactrim, Septra, or Cotrim. It is advisable for people who have diarrhea to also rest and drink plenty of fluids.

[1]           Casillas, S. M., Hall, R. L., & Herwaldt, B. L. (2019). Cyclosporiasis Surveillance – United States, 2011-2015. Morbidity and mortality weekly report. Surveillance summaries (Washington, D.C. : 2002)68(3), 1–16. https://doi.org/10.15585/mmwr.ss6803a1

[2]           Giangaspero, A., & Gasser, R. B. (2019). Human cyclosporiasis. The Lancet Infectious Diseases, 19(7), e226–e236. https://doi.org/10.1016/S1473-3099(18)30789-8

[3]           Casillas, Ibid, Note 1 at Page 1.

[4]           CDC. (2020, September 24). Cyclosporiasis Outbreak Investigations – United States, 2020. Centers for Disease Control and Prevention. https://www.cdc.gov/parasites/cyclosporiasis/outbreaks/2020/seasonal/index.html

[5]           Cyclosporiasis – Disease. (2018, May 11). https://www.cdc.gov/parasites/cyclosporiasis/disease.html

[6]           Almeria S, Cinar HN, Dubey JP. Cyclospora cayetanensis and Cyclosporiasis: An Update. Microorganisms. 2019; 7(9):317.

[7]           Giangaspero, Ibid, Note 2 at Page 1.

[8]           Giangaspero, Ibid, Note 2 at Page 3-4.

[9]           CDC. (2020, October 21). CDC – Cyclosporiasis – Resources for Health Professionals. Centers for Disease Control and Prevention. https://www.cdc.gov/parasites/cyclosporiasis/health_professionals/index.html

[10]         Giangaspero, Ibid, Note 2 at Page 2.

[11]         CDC. (2020, September 17). CDC – Cyclosporiasis – General Information – Cyclosporiasis FAQs. https://www.cdc.gov/parasites/cyclosporiasis/gen_info/faqs.html

CDC, public health and regulatory officials in 14 states, and the U.S. Food and Drug Administration investigated a multistate outbreak of Cyclospora infections.

In Canada, as of July 8, 2020, there are 37 confirmed cases of Cyclospora illness linked to this outbreak in three provinces: Ontario (26), Quebec (10) and Newfoundland and Labrador (1). Individuals became sick between mid-May and mid-June 2020. One individual has been hospitalized. No deaths have been reported. Individuals who became ill are between 21 and 70 years of age. The majority of cases (76%) are female.

As of September 23, 2020, a total of 701 people with laboratory-confirmed Cyclospora infections associated with this outbreak were reported from 14 states: GA, IL, IA, KS, MA, MI, MN, MO, NE, ND, OH, PA, SD, WI. Exposures were reported in 13 states (IL, IA, KS, MA, MI, MN, MO, NE, ND, OH, PA, SD, WI).

Illnesses started on dates ranging from May 11, 2020 to July 24, 2020. Ill people ranged in age from 11 to 92 years with a median age of 57; 51% were female.

38 (5%) people were hospitalized. No deaths were reported in this outbreak.

Epidemiologic evidence and product traceback indicated that bagged salad mix containing iceberg lettuce, carrots, and red cabbage produced by Fresh Express was a likely source of this outbreak.

Fresh Express brand and private label brand salad products produced at its Streamwood, IL facility that contained iceberg lettuce, red cabbage, and/or carrots on June 27, 2020.

The CDC reports that as of August 12, 2020, a total of 690 people with laboratory-confirmed Cyclospora infections associated with this outbreak have been reported from 13 states: Georgia (1), Illinois (209), Iowa (206), Kansas (5), Massachusetts (1), Minnesota (86), Missouri (57) Nebraska (55), North Dakota (6), Ohio (4), Pennsylvania (2), South Dakota (13), and Wisconsin (45). The ill person from Georgia purchased and ate a bagged salad product while traveling in Missouri.

Illnesses started on dates ranging from May 11, 2020 to July 20, 2020. Ill people range in age from 10 to 92 years with a median age of 57; 51% are female. Of 680 people with available information, 37 people (5%) have been hospitalized. No deaths have been reported.

Illnesses might not yet be reported due to the time it takes between when a person becomes ill and when the illness is reported. This takes an average of 4 to 6 weeks. If the number of cases reported by CDC is different from the number reported by state or local health officials, data reported by local jurisdictions should be considered the most up to date. Any differences may be due to the timing of reporting and website updates.

As of July 8, 2020, there are 37 confirmed cases of Cyclospora illness linked to this outbreak in three provinces: Ontario (26), Quebec (10) and Newfoundland and Labrador (1). Individuals became sick between mid-May and mid-June 2020. One individual has been hospitalized. No deaths have been reported. Individuals who became ill are between 21 and 70 years of age. The majority of cases (76%) are female.

According to the FDA, FDA’s traceback investigation identified several farms in the U.S. that may have provided product used in the Fresh Express salads that were recalled. FDA investigated multiple farms identified in the traceback. In Florida, FDA analyzed water samples from two public access points along a regional water management canal (C-23), located west of Port St. Lucie, Florida. These samples tested positive for Cyclospora cayetanensis using FDA’s validated testing method. Given the emerging nature of genetic typing methodologies for this parasite, the FDA has been unable to determine if the Cyclospora detected in the canal is a genetic match to the clinical cases, therefore, there is currently not enough evidence to conclusively determine the cause of this outbreak. Nevertheless, the current state of the investigation helps advance what we know about Cyclospora and offers important clues to inform future preventive measures.