Basil Imported from Columbia Recalled Due to Cyclospora

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.  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.  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).

This past November, this same company also recalled basil imported from Columbia for Cyclopora.

https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/shenandoah-growers-inc-issues-limited-voluntary-recall-specific-imported-organic-basil-because
Shenandoah Growers, Inc Issues a Limited, Voluntary Recall of Specific Imported Organic Basil Because of Potential Health Risk
Summary
Company Announcement Date: February 08, 2021
FDA Publish Date: February 08, 2021
Product Type: Food & Beverages
Reason for Announcement: Potential Cyclospora contamination
Company Name: Shenandoah Growers, Inc
Brand Name: Simple Truth, That’s Tasty, Shenandoah Growers
Product Description: Basil

Fresh-Pack Basil Recalled After State Laboratory Finds Cyclospora

Shenandoah Growers, Inc (Harrisonburg, VA) is recalling of approximately 15,000 units in select packages, due to a possible health risk from Cyclospora after a retail sample was tested by Florida Department of Agriculture on 11/2/2020 from a retail store in Florida indicated the potential presence of Cyclospora.  These were packed under branded and private label fresh cut organic certified basil clamshells at its Jefferson, GA facility and Harrisonburg, VA facility with the following lot codes, all with the country of origin of Colombia. 

Shennandoah Growers are one of these upcoming greenhouse operations that rely on indoor growing for controlled environment. (https://www.shenandoahgrowers.com/innovation).  However, this product was from Colombia.  The source of the cyclospora would be the irrigation water, and once there on the delicate leaves of the basil, it will not likely be removed through the gentle washing systems used.  It is on SG to ensure that their supplier is using a good water source.

https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/shenandoah-growers-inc-issues-limited-voluntary-recall-certain-imported-organic-basil-because
Shenandoah Growers Inc Issues a Limited, Voluntary Recall of Certain Imported Organic Basil Because of Potential Health Risk
Summary
Company Announcement Date: November 24, 2020
FDA Publish Date: November 24, 2020
Product Type:  Food & Beverages
Reason for Announcement:  Possible Cyclospora contamination
Company Name:  Shenandoah Growers, Inc
Brand Name:  The Fresh Market, Good & Gather and more
Product Description:  Organic Basil

FDA and CDC Update Cyclospora Outbreak Linked to Salad Items, Source Not Yet Determined

FDA issued an update on the Cyclospora outbreak related to Fresh Express salads.  As of July 22, 2020, there are now 641 cases across 11 states, with majority of cases in Illinois and Iowa.  The last update was issued on July 9, 2020.  The actual food source of the outbreak has still not been determined.

FDA Outbreak Investigation
https://www.fda.gov/food/outbreaks-foodborne-illness/outbreak-investigation-cyclospora-bagged-salads-june-2020
Outbreak Investigation of Cyclospora: Bagged Salads (June 2020)
FDA’s traceback investigation continues. CDC reports additional cases.
07/24/2020
Case Counts
Total Illnesses: 641
Hospitalizations: 37
Deaths: 0
Illness Onset Date Range: 5/11/2020 – 7/5/2020

Cyclospora Outbreak Associated with Bagged Salads in Midwest US, 76 Cases to Date

The FDA, along with CDC and state and local partners are investigating a multistate outbreak of Cyclospora infections potentially linked to ALDI, Hy-Vee, and Jewel-Osco grocery store brand “garden salads” containing iceberg lettuce, red cabbage, and carrots.  As of June 19th, there have been 76 cases with 16 hospitalizations, with onset date ranging from May 11th through June 14th.

"FDA and CDC are recommending that consumers should not eat, and restaurants and retailers should not sell or serve all ALDI Little Salad Bar Brand Garden Salad sold in Iowa, Illinois, Minnesota, and Missouri, all Hy-Vee Brand Garden Salad sold in Iowa, Illinois, Kansas, Minnesota, Missouri, and Nebraska, and Jewel-Osco Signature Farms Brand Garden Salad sold in Illinois."

https://www.fda.gov/food/outbreaks-foodborne-illness/outbreak-investigation-cyclospora-bagged-salads-june-2020
Outbreak Investigation of Cyclospora: Bagged Salads (June 2020)
Don’t eat ALDI, Hy-Vee, or Jewel-Osco store brand bagged salads labeled as ‘garden salads’ and sold in six mid-western states.
Case Counts
Total Illnesses: 76
Hospitalizations: 16
Deaths: 0
Illness Onset Date Range: 5/11/2020 - 6/14/2020
States with Cases: IA (28), IL (23), KS (1), MN (10), MO (7), NE (7)

Basil Imported from Columbia Recalled Due to Cyclospora

United Natural Foods, Inc. (UNFI) is recalling their  Wild Harvest® Organic Basil because of the potential to be contaminated by Cyclospora cayetanensi.  The product was distributed out of their  MN distribution center.  The recall comes after routine sampling found the pathogen.  The product is out of Columbia.

Cyclospora cayetanensis is a parasite that causes intestinal illness when consumed.  There have been a number of outbreaks associated with fresh RTE greens such as basil and cilantro.  It gets on these items from the irrigation water used for growing the product.

https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/unfi-voluntarily-recalls-wild-harvestr-organic-basil-due-possible-health-risk
UNFI Voluntarily Recalls Wild Harvest® Organic Basil Due to Possible Health Risk
Summary
Company Announcement Date:  May 11, 2020
FDA Publish Date:  May 11, 2020
Product Type:  Food & Beverages  Vegetable Products
Reason for Announcement:  Contaminated by Cyclospora cayetanensis
Company Name:  United Natural Foods, Inc.
Brand Name:  Wild Harvest
Product Description:  Organic Fresh Basil

Ongoing Cyclospora Outbreak in Northeastern US....FDA Warns Fresh Basil May Be a Source.

Cyclospora, the single celled parasite has caused numerous cases of infection in the northeastern states.   Massachusetts is reporting over 100 cases since May and Virginia has had 39 cases and Maryland has had 42 according to the Washington Post (June 25).

FDA issued a warning for fresh basil in that it may be potentially related to the outbreak.  The exporting firm, Siga Logistics de RL de CV of Morelos, Mexico,  has agreed with the FDA to issue a recall of their product

Symptoms for this parasite include diarrhea, abdominal cramps, nausea and fatigue and can last from a few days to over a month.

Fresh raw produce is often the source with the parasite getting onto the produce through irrigating with contaminated water.  Like cilantro which has been the source food for Cyclospora, basil is a herb that is used fresh and must be more washed more gently in order to preserve leaf integrity.

The Packer
https://www.thepacker.com/article/northeastern-cyclospora-outbreak-source-investigated
Northeastern cyclospora outbreak source investigated 
Chris Koger
July 25, 2019 11:24 AM

Restaurant in FL Linked to Cyclospora Outbreak

A restaurant in Florida has been linked to a Cyclospora outbreak.  The source has yet to be identified, but in many cases related to this parasite, it tends to be produce which was watered or washed with water contaminated with the parasite.

Cyclospora is a single cell parasite where humans are the only definitive host.  From the CDC:

People become infected with Cyclospora by ingesting sporulated oocysts, which are the infective form of the parasite. This most commonly occurs when food or water contaminated with feces is consumed. An infected person sheds unsporulated (immature, non-infective) Cyclospora oocysts in the feces. The oocysts are thought to require at least 1–2 weeks in favorable environmental conditions to sporulate and become infective. Therefore, direct person-to-person transmission is unlikely, as is transmission via ingestion of newly contaminated food or water.

 In the United States, foodborne outbreaks of cyclosporiasis have been linked to various types of imported fresh produce, such as raspberries, basil, snow peas, mesclun lettuce, and cilantro; no commercially frozen or canned produce has been implicated to date.

So while many may blame the restaurant, that restaurant was unlikely to have had much impact on removing the parasite if already on the produce.   And this is the challenge with Cyclospora.  Last month, a panel was put together to investigate how this parasite can be controlled.  While some preventive measures were discussed, no specific source was identified.

https://www.news4jax.com/news/local/jacksonville/attorneys-2-dozen-sick-after-food-poisoning-at-popular-restaurant
Attorneys: About 2 dozen sick after food poisoning at popular restaurant
Group claims to have contracted parasite from Cooper's Hawk Winery & Restaurant
By Vic Micolucci - I-TEAM reporter, anchor
Posted: 3:10 PM, July 09, 2019
Updated: 12:41 PM, July 10, 2019

Preliminary Findings from Cyclospora Outbreak Associated with Romaine Lettuce in 2018

A Blue Ribbon Panel was put together to investigate the 2018 cyclospora outbreak associated with Romaine lettuce.   Little is know about this parasite and the goal of the panel was to focus on root-cause assessment, preventive measures/controls, collaborative approach, and testing validation.  "Although several outbreaks attributed to C. cayetanensis occurred during 2018 that were linked to fresh produce — particularly multi-commodity vegetable trays, cilantro, and others — this working group focused initial attention on the outbreak associated with a romaine lettuce mix."

Cyclospora is a human-specfic parasite that has been problematic in RTE produce such as lettuce (2018), veggie trays (2018), raspberries, and cilantro.  Cyclospora is spread by people ingesting food or water that was contaminated with feces from an infected individual.

For this case, "Outbreak investigative evidence, epidemiology, trace-back, and secondary on-farm investigative follow-up strongly indicated raw material contamination to a domestic production source in California"

While the report provides a pretty broad list in the root cause analysis, the recommendations for preventive controls focus on key elements:

"Recommendations

• Source protection for agricultural water should emphasize protection against human fecal contamination.
• Because humans appear to be the primary reservoir for C. cayetanensis, surveillance of diarrheal illness among workers involved in propagation and harvesting of fresh produce should be conducted, and workers with diarrheal illnesses be tested for C. cayetanensis and other enteric infections.
• Equipment used in propagation and harvesting of fresh produce should be maintained and cleaned to prevent C. cayetanensis transmission.
• Prevention measures need to account for the extrinsic maturation period of C. cayetanensis. This should include awareness of events and activities in the field at least 1 to 2 weeks before harvest, or at the time of harvest with regard to water, equipment, or environmental materials that were contaminated 1 to 2 weeks earlier."

The report also provides a summary of why control measures for STEC (pathogenic E. coli are different than for Cyclospora.

"Although industry-wide efforts to prevent contamination of romaine lettuce by pathogenic bacteria focus on the use of agricultural water, several key features of C. cayetanensis differ from STEC and need to be addressed in preventing Cyclospora transmission.

• Cyclospora is more resistant to routine chemical disinfection processes than STEC. Thus, water testing and treatment targeted to control STEC may not be adequate to control C. cayetanensis
• Water source protection is focused on animal reservoirs, primarily cattle, whereas C. cayetanensis is not known to have an animal reservoir hosts. Though animals may ingest C. cayetanensis oocysts and mechanically spread them through their feces, they are not known to become infected or to amplify the number of oocysts. Thus, prevention of human fecal contamination appears to be the primary need for water source protection.
• C. cayetanensis appears to require at least 1 to 2 weeks under favorable environmental conditions to become infectious. This lengthy extrinsic maturation period must be taken into account when considering the possibility and plausibility of fresh produce becoming contaminated through various means and for the oocysts (if not already infective when the produce becomes contaminated) to have sufficient time, under favorable conditions, to become infective by the time that the contaminated produce is consumed."

There were additional recommendations made on surveillance and testing.

https://www.freshexpress.com/sites/default/files/brp_interim_report_6.5.19-final.2_2.pdf
Interim Report:
Blue-Ribbon Panel on the Prevention of Foodborne Cyclospora Outbreaks
June 5, 2019

FDA Statement on Efforts to Prevent Cyclospora

FDA released a statement concerning Cyclospora in produce in light of the two large outbreaks - Fresh Express and McDonald's Salads where 511 cases where people were infected, and the Del Monte Veggie Tray with 250 cases.

In short, they were not able to find a source in either of the outbreaks, but with the new test they developed, they detected Cyclospora in domestically grown cilantro and romaine lettuce.  From the statement,  "During our investigation, two samples of domestically grown romaine lettuce were also found to be positive for Cyclospora even though they were not sourced from locations associated with the lettuce that was linked to this outbreak. None of the romaine lettuce associated with these positive test results for Cyclospora went into the marketplace and all of the produce suspected of being contaminated was destroyed, preventing additional Cyclospora illnesses from occurring. "

Though increased surveillance of domestic and imported produce along with the implementation of the Produce Safety Rule by farms, FDA hopes to get a handle on this parasite.

https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm620867.htm
Statement from FDA Commissioner Scott Gottlieb, M.D., on the FDA’s ongoing efforts to prevent foodborne outbreaks of Cyclospora
For Immediate Release
September 18, 2018

FDA and CDC Announce Veggie Tray-Linked Cyclospora Outbreak Over

The FDA and CDC announced that the Cyclospora outbreak associated with Del Monte vegetable trays is over. There were a total of 250 hospitalizations with the last illness starting on 6/14/18.  The announcement of the outbreak was in early June.

https://www.fda.gov/Food/RecallsOutbreaksEmergencies/Outbreaks/ucm610982.htm
FDA Investigation of Multistate Outbreak of Cyclospora Illnesses Linked to Del Monte Vegetable Trays Ends

The FDA, CDC, along with state and local officials investigated a multi-state outbreak of cyclosporiasis illnesses associated with Del Monte vegetable trays recalled from Kwik Trip/Kwik Star locations in the United States.

Case Counts
Total Illnesses: 250
Hospitalizations: 8
Deaths: 0
Last illness onset: 6/14/2018
States with Cases: IA, MN, WI, MI

Cyclospora Cases Continue to Increase in Number, FDA Sampling Finds Cyclospora in Imported and Domestic Cilantro

In Texas, there continues to be an increase in the number of Cyclospora infections.  No specific source has been identified.  Last week, CDC issued an update for the number of cases of Cyclospora related to Frehs Express Salads distributed through McDonalds.  That number had risen to 507 cases in 16 states.

FDA released results of its produce sampling that revealed that samples of cilantro were positive for cyclospora.  Two samples of imported cilantro as well as some domestic product.   "The results of this increased surveillance sampling so far this summer have been that two samples of cilantro offered for import from two producers in Mexico were positive for Cyclospora. In response to the finding, FDA refused entry for these shipments, and will take action to prevent contaminated cilantro from those firms from entering the U.S. "  "Domestically, a cilantro sample collected at a distributor in July tested positive for Cyclospora. Following that finding, FDA initiated an investigation and another sample was collected on the farm that also tested positive for Cyclospora."  This positive finding in domestic cilantro was not linked to ongoing cases in the US.

The parasite is a difficult organism for the produce industry to deal with - it is difficult to wash from produce and is more resistant to sanitizers.  Another issue is that when people have the illness, the Cyclospora infects the small intestine and causes watery diarrhea, with frequent, sometimes
explosive, stools. This can last from a few days to months.  During this time, they shed the oocyte, which can make its way to source water where it takes time for it to transition to its infectious state. So this is why we may see this organism becoming a bigger and bigger problem over time.

https://www.centexproud.com/news/local/cyclospora-continues-to-show-up/1404470770
Cyclospora continues to show up
By: Roland Richter 
Posted: Aug 29, 2018 11:50 AM CDT
Updated: Aug 29, 2018 09:52 PM CDT

FDA Provides Update of Cyclospora Outbreak Associated with McDonald's Salads

As of August 2, 2018, there have been a total of 395 laboratory-confirmed cases of Cyclospora infection reported in people who consumed salads from McDonald’s restaurants; the cases were reported by 15 states.   McDonald's immediately discontinued sales of the salads upon notification.

FDA found cyclospora in product packed by Fresh Express, but by the time the analysis was complete, the product had date-expired.  

Fresh Express recalled product that went to Caito Foods and thus the recall by that company.

https://www.fda.gov/Food/RecallsOutbreaksEmergencies/Outbreaks/ucm613513.htm

FDA Investigates Multistate Outbreak of Cyclospora Illnesses Linked to Fresh Express Salad Mix Served at McDonald’s