From the FDA:
Although you stated that corrective actions were implemented following the 2019 and 2012 outbreaks, you have not provided FDA with any information demonstrating long-term, sustainable corrections have been implemented throughout your organization to prevent this violation from recurring in the future. For example, providing FDA with documentation of policies and practices demonstrating that you have made a corporate commitment to ensure produce covered by the Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption (Produce Safety Rule), Title 21 Code of Federal Regulations, Part 112 (21 CFR Part 112), specifically sprouts, and sourced by any Jimmy John’s restaurant will be procured from a farm or firm operating in compliance with the Produce Safety Rule, the Act, and, as applicable, the Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Foods (PC Rule), 21 CFR Part 117.
Jimmy John’s outbreaks in the past dozen years
- Multistate E. coli O103 Outbreak, Jimmy John’s Restaurants Sprouts 2020
Sprouts Unlimited has initiated a recall of clover sprouts because of possible E. coli O103 contamination. The clover sprouts were distributed to Hy Vee Food stores, Fareway Food Stores and used by Jimmy John’s restaurants in Iowa.
“Sprouts Unlimited Inc. became aware of the potential contamination after receiving information from the Iowa Department of Inspections and Appeals, Des Moines, IA, that a cluster of E. coli O103 illnesses epidemiologically linked to clover sprouts from Sprouts Unlimited Inc.,” according to the company’s recall notice. “An investigation and further tests are being conducted to determine the source.”
- Multistate Salmonella Outbreak, Jimmy John’s Restaurants Sprouts 2018
As of January 18, 2018, eight people infected with the outbreak strain of Salmonella Montevideo had been reported from Illinois, Wisconsin and Minnesota. Illnesses started on dates ranging from December 20, 2017, to January 3, 2018. Ill people ranged in age from 26 to 50, with a median age of 34. All 8 were female. No hospitalizations and no deaths were reported. Evidence indicated that raw sprouts served at Jimmy John’s restaurants were a likely source of outbreak.
Federal, state, and local health and regulatory officials conducted traceback investigations from the six Jimmy John’s locations where ill people ate raw sprouts.
- Multistate E. coli O121 Outbreak, Jimmy John’s Restaurants Alfalfa Sprouts 2014
19 Sickened – Public health officials in California, Idaho, Michigan, Montana, Utah and Washington collaborated with their federal partners at the Centers for Disease Control and Prevention (CDC) and the Food and Drug Administration (FDA) to investigate an outbreak of E. coli O121 that occurred in May 2014. A total of 19 people with the outbreak strain, identified by the CDC’s PulseNet PFGE Pattern Identification Numbers EXKX01.0011/EXKA26.0001, were reported. Among people for whom information was available, dates of illness onset ranged from May 1, 2014, to May 20, 2014. Ill people ranged from 11 years to 52 years old. Seven of 16 victims for whom information was available were hospitalized. None of the confirmed patients developed hemolytic uremic syndrome and no deaths were reported.
Epidemiologic and traceback investigations conducted by public health officials implicated raw clover sprouts produced by Evergreen Fresh Sprouts LLC of Hayden, Idaho as the likely source of this outbreak. Thirteen (81%) of 16 ill people reported eating raw clover sprouts in the week before becoming ill. Ill people in Washington and Idaho reported eating sprouts in sandwiches at several local food establishments including several Jimmy John’s locations, the Pita Pit, and Daanen’s Deli.
As part of the investigation the FDA performed a traceback analysis and determined that Evergreen Fresh Sprouts supplied sprouts to seven restaurants with outbreak associated cases. This analysis used documents collected directly from the distributors and the grower, Evergreen Fresh Sprouts, as well as documents collected by the states from the points of service.
The FDA conducted several inspections at the Evergreen Fresh Sprouts facility in May and June. During the inspections FDA investigators observed a number of unsanitary conditions, including condensate and irrigation water dripping from rusty valves, a rusty and corroded watering system in the mung bean room, tennis rackets were being used to scoop mung bean sprouts that had scratches, chips and frayed plastic; a pitchfork used to transfer mung bean sprouts had corroded metal, and a squeegee used to agitate mung bean sprouts inside a soak vat that had visible corroded metal and non-treated wood.
On June 26, 2014, the FDA and CDC held a meeting with the owner of Evergreen Fresh Sprouts to advise the firm of FDA’s concerns that the seed lot used to row clover sprouts linked to this outbreak might be contaminated and to encourage Evergreen Fresh Sprouts to discontinue using that seed lot. The owner of Evergreen Fresh Sprouts agreed to stop using the suspect lot of seeds.
- Multistate E. coli O157 Outbreak, Jimmy John’s Restaurants Cucumbers 2013
On Friday, October 18, 2013, public health investigators at the Colorado Department of Public Health (CDPHE) detected an increase in Denver area patients reported as having E. coli O157. Preliminary interviews revealed that patients had eaten at Jimmy John’s restaurants and shopped at an area grocery store chain. CDPHE epidemiologist, Nicole Comstock, noted in an October 22 email sent to county health departments that “at this time we are not ruling any exposures out yet.” Ms. Comstock encouraged county investigators to interview newly reported patients diagnosed with E. coli O157 promptly using a standardized questionnaire. By October 23, CDPHE epidemiologists described the association between illness and sandwiches prepared at area Jimmy John’s restaurants “too strong to ignore.”
CDPHE and their local and federal public health partners conducted case finding, two case control studies (“Study I” and “Study II”), an environmental investigation, produce traceback, and laboratory testing. Case finding occurred via routine public health surveillance methods. Case control “Study I” was conducted to assess restaurant exposures reported by case-patients. Case control “Study II” was conducted subsequently to assess foods consumed at Jimmy John’s. For “Study II” online and phone order records were used to recruit controls (non-ill Jimmy John’s customers) who purchased food from the same Jimmy John’s locations on the dates as case-patients.
Eight patient’s laboratory confirmed with E. coli O157:H7 were identified as outbreak associated cases. All eight patients were infected with an indistinguishable genetic strain (EXHX01.0074/EXHA26.0569) of E. coli O157 as determined by PFGE and MLVA. This strain was not seen elsewhere in the United States in October 2014. One patient was classified as a “probable” case since she was not culture positive for E. coli O157 due to collection of her stool specimen post-antibiotic treatment. Three blood specimens collected from her would later test positive for IgG and IgM antibodies to E. coli O157:H7, confirming a recent acute infection with E. coli O157. All nine outbreak-associated-cases ate food from one of three Jimmy John’s locations in the metro-Denver area. This finding was highly statistically significant based on analysis of data collected in Case control Study I. Case control Study II data showed that all nine outbreak-associated-cases consumed cucumbers on Jimmy John’s sandwiches, also a highly statistically significant finding. No other food items were statistically associated with illness. Meal dates for case patients were October 5th, 6th, 7th and 9th. Median age of patients was 23 years; 78% were female.
Three (3) Jimmy John’s locations were identified by patients. One was located in Lakewood, Colorado at 180 South Union and was inspected by the Jefferson County Health Department (JCHD). Two (2) fell within the jurisdiction of the Tri-County Health Department (TCHD): 2610 West Belleview Avenue, Littleton, Colorado and 1140 South Colorado Boulevard, Glendale, Colorado. Local health environmental health staff conducted on-site investigations at each restaurant. They examined produce-handling practices and obtained invoices for traceback. Colo-Pac Produce Inc. (“Colo-Pac”) delivered whole cucumbers and other produce to all three stores approximately two times a week. Cucumbers and other produce (lettuce, tomatoes and onions) were washed, chopped, and prepared fresh daily for use at each restaurant. Although no restaurant had leftover food from the implicated meal dates, TCPH and JCHD staff collected food samples for laboratory testing at the CDPHE Public Health Laboratory. All food tests were negative for the presence of E. coli O157 at the state laboratory.
Based on customer purchase order number/bills of lading provided by Colo-Pac, investigators determined that a single lot (Lot 19158) of cucumbers was delivered to all three implicated Jimmy John’s locations during the time frame of interest (September 9, 2013 to October 9, 2013). Further traceback showed that the cucumbers were grown in Torreon, Coahulia, Mexico by grower/packer Ganadera Vigo. They were imported into the United States by GR Produce of McAllen, Texas, which then sold full cases to Colo-Pac. Colo-Pac sold full cases to two of the implicated Jimmy John’s; one store received split cases boxed at Colo-Pac. CDPHE staff conducted an onset inspection at Colo-Pac and obtained 55 swab samples from the warehouse and delivery trucks. All specimens were negative for E. coli O157.
- Multistate E. coli O26 Outbreak, Jimmy John’s Restaurants Alfalfa Sprouts 2012
29 Sickened – A total of 29 individuals infected with the outbreak strain of E. coli O26 were reported from 11 states, including: Alabama (1), Arkansas (1), Iowa (5), Kansas (2), Michigan (10), Missouri (3), Ohio (3), Pennsylvania (1), Washington (1), Wisconsin (1), and West Virginia (1).
Of the 27-ill people with available information, 23 (85%) reported consuming sprouts at Jimmy John’s restaurants in the seven days preceding illness. Among 29 ill people, illness onset dates ranged from December 25, 2011, to March 3, 2012. Ill people ranged in age from 9 years to 57 years old, with a median age of 26 years; 89% of the patients were female. Among the 29 ill persons, seven (24%) were hospitalized. None developed HUS, and no deaths were reported.
Preliminary traceback information identified a common lot of clover seeds used to grow clover sprouts served at Jimmy John’s restaurant locations where ill persons ate. FDA and states conducted a traceback that identified two separate sprouting facilities; both used the same lot of seed to grow clover sprouts served at these Jimmy John’s restaurant locations. On February 10, 2012, the seed supplier initiated a notification process for sprouting facilities that received the implicated lot of clover seed to stop using it.
Results of the epidemiologic and traceback investigations indicated eating raw clover sprouts at Jimmy John’s restaurants was the likely cause of this outbreak.
- Sprouters Northwest, Jimmy John’s Restaurants Clover Salmonella Sprouts Outbreak 2010
7 Sickened – Sprouters Northwest of Kent, WA, issued a product recall after the company’s clover sprouts had been implicated in an outbreak of Salmonella Newport in Oregon and Washington. At least some of the cases had consumed clover sprouts while at a Jimmy John’s restaurant. Concurrent with this outbreak, a separate outbreak of Salmonella, serotype I 4,5,12,i- ; involving alfalfa sprouts served at Jimmy John’s restaurants was under investigation. The recall of Northwest Sprouters products included: clover; clover and onion; spicy sprouts; and deli sprouts. The Sprouters Northwest products had been sold to grocery stores and wholesale operations in Washington, Oregon, Idaho, Alaska, British Columbia, Saskatchewan, and Alberta. The FDA inspection found serious sanitary violations.
- Multistate Salmonella Outbreak, Tiny Greens Organic Farm, Jimmy John’s Restaurants Alfalfa Sprouts 2010
140 Sickened – On December 17, the Illinois Department of Health announced that an investigation was underway into an outbreak of Salmonella, serotype I4,,12:i:-. Many of the Illinois patients had eaten alfalfa sprouts at various Jimmy John’s restaurants in the Illinois counties of Adams, Champaign, Cook, DuPage, Kankakee, Macon, McHenry, McLean, Peoria, and Will counties. The sprouts were suspected to be the cause of the illnesses. On Dec. 21 that year Jimmy John Liautaud, the owner of the franchised restaurant chain, requested that all franchisees remove all sprouts from the menu as a “precautionary” measure. On Dec. 23, the Centers for Disease Control revealed that outbreak cases had been detected in other states and that the outbreak was linked with eating alfalfa sprouts from a nationwide sandwich chain. On Dec. 26, preliminary results of the investigation indicated a link to eating Tiny Greens’ Alfalfa Sprouts at Jimmy John’s restaurant outlets. The FDA subsequently advised consumers and restaurants to avoid Tiny Greens Brand Alfalfa Sprouts and Spicy Sprouts produced by Tiny Greens Organic Farm of Urbana, Illinois. The Spicy Sprouts contained alfalfa, radish and clover sprouts. On January 14, 2011, it was revealed that the FDA had isolated Salmonella serotype I4,,12:i:- from a water runoff sample collected from Tiny Greens Organic Farm; the Salmonella isolated was indistinguishable from the outbreak strain. The several FDA inspections of the sprout growing facility revealed factors that likely led to contamination of the sprouts.
- CW Sprouts, Inc., SunSprout Sprouts, “restaurant chain (Chain A),” a.k.a. Jimmy John’s Salmonella Outbreak 2009
256 Sickened – In February, Nebraska Department of Health and Human Services officials identified six isolates of Salmonella Saintpaul. Although this is a common strain of Salmonella, during 2008, only three cases had been detected in Nebraska and only four subtypes of this outbreak strain had been identified in 2008 in the entire USA. As additional reports were made, a case control study was conducted; alfalfa sprout consumption was found to be significantly related to illness. The initial tracebacks of the sprouts indicated that although the sprouts had been distributed by various companies, the sprouts from the first cases originated from the same sprouting facility in Omaha, NE. Forty-two of the illnesses beginning on March 15 were attributed to sprout growing facilities in other states; these facilities had obtained seed from the same seed producer, Caudill Seed Company of Kentucky. The implicated seeds had been sold in many states. On April 26, the FDA and CDC recommended that consumers not eat raw alfalfa sprouts, including sprout blends containing alfalfa sprouts. In May, FDA alerted sprout growers and retailers that a seed supplier, Caudill Seed Company of Kentucky, was withdrawing all alfalfa seeds with a specific three-digit prefix. Many of the illnesses occurred at “restaurant chain (Chain A),” according to the CDC, which generally does not identify specific business.
- Jimmy John’s Restaurant Alfalfa Sprouts and Iceberg Lettuce E. coli Outbreak 2008
28 Sickened – Several University of Colorado students from one sorority became ill with symptoms of bloody diarrhea and cramping. Additional illnesses were reported. E. coli O157:NM(H-) was determined to be the cause. Consumption of alfalfa sprouts at the Jimmy John’s Restaurants in Boulder County and Adams County were risk factors for illness. In addition, the environmental investigation identified Boulder Jimmy John’s food handlers who were infected with E. coli and who had worked while ill. The health department investigation found a number of critical food handling violations, including inadequate hand-washing. The fourteen isolates from confirmed cases were a genetic match to one another.