Restaurants, PLEASE vaccinate your employees.

According to New York press reports, the Oneida County Health Department as well as Rome Memorial Hospital are partnering to provide Hepatitis A. vaccinations to those who think they were exposed.

This comes after the health department announced that an employee at Cianfroccos in Rome tested positive for Hepatitis A. Management at the restaurant has urged that the health department has checked the property and their customers have nothing to be worried about.

But health officials aren’t taking any chances, so far this weekend, over 130 people have participated in the vaccinations.

Hospital officials want to stress that there has been no outbreak of the virus. But encourage anyone who thinks they may have been exposed during a certain period of time, to take advantage of the vaccination.

The window of exposure that we have identified seems to be between February 12th and 23rd.

Vaccines will be available at the E. Chestnut Commons from 8 am to 4 pm on Sunday, March 1st.

In Missouri, health officials in Joplin confirm a case of Hepatitis A at Chili’s on Range Line. The department was first notified of the Hepatitis A case on Tuesday by a local hospital. That notification was made per state regulations not only for tracking purposes, but because it was at a restaurant.

Health officials say a work restriction was placed on Chili’s employees who may have had contact with the person involved. “To lift the restriction the employee has to provide proof of prior Hepatitis A vaccination, they have to get a hepatitis a vaccination now and not be ill currently.”

Chili’s parent company, Brinker International sent a statement saying quote:

“After learning one of our team members was affected, we immediately excluded this individual from work and partnered with the Joplin Department of Health to prevent the potential spread by proactively offering vaccinations to all of our team members.”

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,[5],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,[5],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.

The FDA is cautioning pet owners not to feed their pet’s certain Aunt Jeni’s Home Made frozen raw pet food “as it poses a serious threat to consumer and animal health” because of Salmonella Infantis contamination.

The Salmonella was discovered in January when the FDA collected one retail sample of Aunt Jeni’s Home Made Turkey Dinner Dog Food.  The Salmonella was also found to be resistant to multiple antibiotic drugs.

Salmonella in pet food is a threat to human and animal health because pets can get sick from this pathogen and can also be carriers of the bacteria and pass it on to their owners without appearing to be ill. People can also get sick from handling the contaminated pet food, or touching surfaces that have had contact with the contaminated food.

The Product:

  • Aunt Jeni’s Home Made All-Natural Raw Turkey Dinner Dog Food, 5 lb. (2.3 kg), lot 175331 NOV2020.

Consumers who purchased the product are urged to not feed it to their pet, throw it away, and sanitize surfaces that may have come in contact with the product. If consumers have the product and cannot determine the lot code,  the FDA recommends that the product be thrown away.

Retailers, distributors and other operators who have sold the product should wash and sanitize display cases and refrigerators where the product was stored.

The FDA also suggests that, “Consumers who have had this product in their homes should clean refrigerators/freezers where the product was stored and clean and disinfect all bowls, utensils, food prep surfaces, pet bedding, toys, floors, and any other surfaces that the food or pet may have had contact with.

“Because animals can shed the bacteria in the feces when they have bowel movements, it’s particularly important to clean up the animal’s feces in yards or parks where people or other animals may become exposed, in addition to cleaning items in the home. Consumers should thoroughly wash their hands after handling the affected product or cleaning up potentially contaminated items and surfaces.”

Consumers who think their pet has salmonellosis after consuming the pet food product should contact their veterinarian.

In today’s New England Journal of Medicine – https://www.nejm.org/doi/full/10.1056/NEJMoa1907462?query=TOC

Thanks to the good work of:

  • Juno Thomas, M.D.,
  • Nevashan Govender, M.Sc., M.P.H.,
  • Kerrigan M. McCarthy, M.D.,
  • Linda K. Erasmus, M.D.,
  • Timothy J. Doyle, Ph.D.,
  • Mushal Allam, Ph.D.,
  • Arshad Ismail, Ph.D.,
  • Ntsieni Ramalwa, M.P.H.,
  • Phuti Sekwadi, M.P.H.,
  • Genevie Ntshoe, M.P.H.,
  • Andronica Shonhiwa, M.P.H.,
  • Vivien Essel, M.D.,
  • Nomsa Tau, M.S.,
  • Shannon Smouse, M.S.,
  • Hlengiwe M. Ngomane, M.T.,
  • Bolele Disenyeng, M.T.,
  • Nicola A. Page, Ph.D.,
  • Nelesh P. Govender, M.D.,
  • Adriano G. Duse, M.D.,
  • Rob Stewart, M.T.,
  • Teena Thomas, M.D.,
  • Deon Mahoney, M.S.,
  • Mathieu Tourdjman, M.D.,
  • Olivier Disson, Ph.D.,
  • Pierre Thouvenot, B.S.,
  • Mylène M. Maury, Ph.D.,
  • Alexandre Leclercq, M.S.,
  • Marc Lecuit, M.D., Ph.D.,
  • Anthony M. Smith, Ph.D.,
  • Lucille H. Blumberg, M.D.

BACKGROUND

An outbreak of listeriosis was identified in South Africa in 2017. The source was unknown [Note, the source was polony produced by Tiger Brands – how the Listeria monocytogenes entered the plant was not determined].

METHODS

We conducted epidemiologic, trace-back, and environmental investigations and used whole-genome sequencing to type Listeria monocytogenes isolates. A case was defined as laboratory-confirmed L. monocytogenes infection during the period from June 11, 2017, to April 7, 2018.

RESULTS

A total of 937 cases were identified, of which 465 (50%) were associated with pregnancy; 406 of the pregnancy-associated cases (87%) occurred in neonates. Of the 937 cases, 229 (24%) occurred in patients 15 to 49 years of age (excluding those who were pregnant). Among the patients in whom human immunodeficiency virus (HIV) status was known, 38% of those with pregnancy-associated cases (77 of 204) and 46% of the remaining patients (97 of 211) were infected with HIV. Among 728 patients with a known outcome, 193 (27%) died. Clinical isolates from 609 patients were sequenced, and 567 (93%) were identified as sequence type 6 (ST6). In a case–control analysis, patients with ST6 infections were more likely to have eaten polony (a ready-to-eat processed meat) than those with non-ST6 infections (odds ratio, 8.55; 95% confidence interval, 1.66 to 43.35). Polony and environmental samples also yielded ST6 isolates, which, together with the isolates from the patients, belonged to the same core-genome multilocus sequence typing cluster with no more than 4 allelic differences; these findings showed that polony produced at a single facility was the outbreak source. A recall of ready-to-eat processed meat products from this facility was associated with a rapid decline in the incidence of L. monocytogenes ST6 infections.

CONCLUSIONS

This investigation showed that in a middle-income country with a high prevalence of HIV infection, L. monocytogenes caused disproportionate illness among pregnant girls and women and HIV-infected persons. Whole-genome sequencing facilitated the detection of the outbreak and guided the trace-back investigations that led to the identification of the source.

Listeriosis, a severe foodborne disease that has substantial mortality (20 to 30%), primarily affects persons with impaired cell-mediated immunity associated with pregnancy, extremes of age, underlying malignant conditions, human immunodeficiency virus (HIV) infection, chronic disease, or immunosuppressive therapy.1-5 Outbreaks are increasingly recognized,6,7 predominantly in upper-income countries where infection is more readily diagnosed,8where existing surveillance programs facilitate early recognition,9 and where strain typing by whole-genome sequencing, which allows for identification of outbreak-linked cases and definitive attribution of the source, is accessible.10-14

An increase in the number of cases of listeriosis at two public hospitals in Gauteng Province, South Africa, during July and August 2017 prompted an investigation. Case numbers rapidly increased nationwide, and whole-genome multilocus sequence typing15 of Listeria monocytogenes isolates from patients identified a single sequence type (sequence type 6 [ST6]) in 93% of the cases. We used whole-genome sequencing and intensive epidemiologic and trace-back investigations to pursue the source of the outbreak. This report describes the key findings from the investigation.

Methods

CASE DEFINITION

Figure 1. Incidence of Laboratory-Confirmed Cases of Listeriosis in South Africa during the Outbreak Period, According to District.

We defined an outbreak-associated case as laboratory-confirmed infection with L. monocytogenes, as determined by means of bacterial culture or polymerase-chain-reaction (PCR) assay of any clinical sample, during the outbreak period (June 11, 2017 [epidemiologic week 24 of that year], to April 7, 2018 [epidemiologic week 14]). This period was defined as the interval during which the case numbers at the national level exceeded and remained above a weekly threshold of five cases per week. The threshold of five cases per week was determined with the use of baseline laboratory data from January 1, 2013, to December 31, 2016. All L. monocytogenes infections were initially included in the case definition, because it was not possible to definitively exclude non-ST6 cases from the outbreak event; however, for the case–control analysis, the case definition was later refined to include ST6 cases only. Pregnancy-associated cases included illness with an onset during pregnancy or within the first 2 weeks of the postpartum period and illness in the neonate. The mothers of infected neonates were not counted among those who had cases if they did not have symptomatic laboratory-confirmed listeriosis; infection in a maternal–neonatal pair was defined as laboratory-confirmed infection in both the mother and neonate and was counted as a single case. Neonatal cases were classified as early onset (diagnosed between birth and day 6) or late onset (diagnosed between days 7 and 28). A map showing the incidence of infections according to district was generated (Figure 1).

EPIDEMIOLOGIC CASE INVESTIGATION

Clinical and demographic details and underlying medical conditions were ascertained through patient interviews or abstracted from medical records or laboratory reports with the use of a standardized case-investigation form. This investigation was reviewed in accordance with local and Centers for Disease Control and Prevention procedures for protection of human research participants and was considered nonresearch disease-control activity in a public health emergency. From November 1, 2017, all patients with newly reported cases were contacted to assess food exposures during the 4 weeks preceding the onset of illness with the use of a semistructured questionnaire. In cases in which the patient was a child, had died, or was too ill to respond, the next of kin were interviewed as proxies. In neonatal cases, history of food consumption by the mother during pregnancy was obtained.

Among the subgroup of patients with a detailed food history and available whole-genome sequencing results, a case–control analysis was performed to estimate the odds ratios for the association between specific food exposures and outbreak-associated illness. In this analysis, a case patient was defined as a person with L. monocytogenes ST6 infection and a control patient as a person with non-ST6 listeriosis during the outbreak period.

ENVIRONMENTAL AND TRACE-BACK INVESTIGATIONS

Health authorities initiated the collection of food samples from the homes of patients in mid-November 2017. When L. monocytogenes was isolated from a food sample, a trace-back investigation was conducted.

CHARACTERIZATION OF THE OUTBREAK STRAIN

L. monocytogenes isolates were sent to a national reference laboratory, where genomic bacterial DNA was isolated and whole-genome sequencing analysis performed as described previously.17Genome assemblies were analyzed with the use of the multilocus sequence typing analysis pipeline at the Center for Genomic Epidemiology (www.genomicepidemiology.org. opens in new tab). Data from multilocus sequence typing were used to determine clonal complexes and sequence types.15 Raw sequencing data were analyzed with the use of the Bacterial Isolate Genome Sequence Database for L. monocytogenes (BIGSdb-Lm, http://bigsdb.pasteur.fr/listeria/listeria.html. opens in new tab) to determine sublineages and core-genome multilocus sequence types.18 The data exported from the BIGSdb-Lm were analyzed with BioNumerics Software, version 7.6.2 (bioMérieux) in order to perform a core-genome multilocus sequence typing–based phylogenetic analysis with the use of a single-linkage clustering algorithm.

The virulence of the ST6 strain was assessed in 7-to-10-week-old E16P KI C57BL/6 female mice, as previously described19; approval was obtained from the Institut Pasteur ethics committee. We assessed the virulence of the ST6/CT4148 YA00061615 CLIP2018/00699 human isolate (L1-SL6-ST6-CT4148, in which L denotes phylogenetic lineage, SL sublineage, ST sequence type, and CT core-genome multilocus sequence type) as the South African strain, and compared it with that of the EGDe ST9 reference strain (L2-SL9-ST35-CT637; National Center for Biotechnology Information (NCBI) GenBank accession number, NC_003210)20 and the CLIP2009/01092 ST6 isolate (L1-SL6-ST6-CT451; NCBI accession number, PRJEB10792).21 Overnight culture of L. monocytogenes was diluted in brain–heart infusion medium to reach mid-log growth phase. The mice were inoculated intragastrically through a feeding needle with 2×108 colony-forming units. The infected animals were killed 4 days after inoculation, and the organs were dissected and homogenized. Serial dilutions of ground-tissue suspensions in phosphate-buffered saline were inoculated on brain–heart infusion agar plates. After 24 hours of incubation at 37°C, the colony-forming units were counted.

Results

OUTBREAK CASES

Figure 2. Number of Laboratory-Confirmed Cases of Listeriosis, According to Epidemiologic Week and Major Events (January 1, 2017, to August 21, 2018).

A total of 937 cases were reported during the outbreak period, with case numbers peaking at 41 per week in mid-November 2017 (epidemiologic week 46) (Figure 2). ST6 was identified in 567 of 609 sequenced clinical isolates (93%). Although ST6 cases predominated during the outbreak period, smaller peaks of non-ST6 cases were noted. The number of cases decreased dramatically after recall of the implicated products on March 4, 2018. By mid-April 2018 (6 weeks after recall), fewer than 5 cases were reported weekly. Although cases were reported in all provinces, 543 of the 937 cases (58%) occurred in Gauteng Province, where the incidence reached 5 cases per 100,000 population in several districts (Figure 1).

CLINICAL INFORMATION

Table 1. Characteristics of Patients with Laboratory-Confirmed Listeriosis during the Outbreak Period (June 11, 2017, to April 7, 2018).

A total of 465 of the 937 cases (50%) were associated with pregnancy: 406 cases (43%) occurred in neonates and 59 (6%) in pregnant girls and women. Nine maternal–neonatal pairs were identified. Early-onset disease occurred in 95% of the neonatal cases. Of the 937 cases, 229 (24%) occurred in patients 15 to 49 years of age (excluding those who were pregnant) (Table 1). With the exclusion of the 59 girls and women known to be pregnant, female patients were overrepresented in the age group of 15 to 49 years (140 of 229 [61%]). A total of 83 cases (9%) occurred in persons 65 years of age or older. Overall, all but 2 patients were hospitalized, and no health care–associated infections were documented.

HIV status was known in 415 of the 937 cases (44%). In 204 pregnancy-associated cases with known HIV status, 77 patients (38%) had positive HIV status, which included HIV exposure in 60 of 158 neonates (38%) and HIV infection in 17 of 46 pregnant girls and women (37%). Among the remaining 211 patients, 97 (46%) were infected with HIV. Among the 114 patients (excluding neonates) who were infected with HIV, 82 (72%) had available data on the CD4 T-lymphocyte count; the median count was 194 cells per cubic millimeter (interquartile range, 91 to 387). Maternal CD4 T-lymphocyte counts were known for 12 HIV-exposed neonates (20%); the median count was 479 cells per cubic millimeter (interquartile range, 322 to 575). After adjusting for age and sex, we found that the odds of ST6 infection were 48% lower among HIV-infected patients than among those without HIV infection, although odds lower than 78% or higher than 25% are also compatible with our data (odds ratio for ST6 infection, 0.52; 95% confidence interval [CI], 0.22 to 1.25). HIV-infected patients older than 1 month of age were 2.6 times as likely to have meningitis (confirmed by means of PCR assay of cerebrospinal fluid or cerebrospinal fluid culture) as HIV-negative patients (odds ratio, 2.55; 95% CI, 1.38 to 4.72). Predisposing medical conditions other than HIV infection were more common among patients 50 years of age or older.

The outcome was known for 728 patients (78%), among whom 193 deaths were reported (case-fatality ratio, 27%). HIV infection was associated with a 53% increased odds of death among patients older than 1 month, after adjustment for age and sex (odds ratio, 1.53; 95% CI, 0.75 to 3.15). Of the 4 maternal deaths reported, the underlying risk factors were known in 1 patient (diabetes mellitus and HIV infection). Fetal loss occurred in 27 of the 59 pregnant girls and women (46%).

CASE–CONTROL ANALYSIS

Table 2. Case–Control Analysis of the Association between Specific Food Exposures and Listeria monocytogenes ST6 Infection.

A total of 109 patients were interviewed. Consumption of polony (a ready-to-eat processed meat containing chicken, pork, beef, or any combination of these, similar to bologna) was reported by 93 patients (85%), and the brands produced by Facility A were the most commonly reported. Sequence data were available for 76 of the 109 patients: 65 had ST6 infections (case patients) and 11 had non-ST6 infections (control patients). The food items most strongly associated with ST6 infection included polony (odds ratio, 8.55; 95% CI, 1.66 to 43.35) and frozen chicken (odds ratio, 4.90; 95% CI, 1.04 to 25.55) (Table 2). Of the 57 case patients who reported eating polony, 50 (88%) reported eating brands manufactured at Facility A, although several patients reported eating several brands or did not specify a particular brand.

TRACE-BACK AND ENVIRONMENTAL INVESTIGATIONS

On January 13, 2018, febrile gastroenteritis developed in 10 children from a nursery in Gauteng Province. Several stool samples were collected, and one yielded L. monocytogenes ST6. Sandwiches prepared and eaten at the nursery were the only common food exposure, and polony was the common ingredient. Polony was recovered from the nursery refrigerator, and L. monocytogenes ST6 was identified in the polony produced at Facility A.

On February 2, 2018, an environmental investigation was conducted at Facility A, located in Limpopo Province. Production of the polony entailed grinding and mixing raw ingredients, stuffing the emulsion into clipped nylon casings, cooking the polony loaves in hot water, and cooling the loaves in a brine chiller. Several areas were in poor repair, and many opportunities for cross-contamination of food products were identified, including condensation, unrestricted movement of workers, and prolonged reuse of brine for chilling.

L. monocytogenes was isolated from 47 of the 317 environmental samples (15%) collected at Facility A. A total of 34 of the 47 typed isolates (72%) were identified as ST6. These isolates originated from samples collected at several facility sections (precooking and postcooking), including from food-contact surfaces, non–food-contact surfaces, and chilling brine. L. monocytogenes ST6 was detected in 2 of 13 samples of unopened polony loaves collected at the facility and subsequently from polony loaves sold in retail stores.

CHARACTERIZATION OF THE OUTBREAK STRAIN

Whole-genome sequencing was performed in 710 human L. monocytogenes isolates (8 isolates collected in 2015; 37 in 2016; 455 in 2017; and 210 in 2018) and in 1061 food and environmental L. monocytogenesisolates collected between September 1, 2017, and March 31, 2018. On the basis of multilocus sequence typing, 567 of 609 isolates (93%) from the outbreak cases were identified as ST6, and the remainder represented 14 other sequence types. A total of 34 environmental isolates from Facility A and 19 isolates from food produced at Facility A were identified as ST6.

Figure 3. Population Structure of the South AfricanListeria monocytogenes ST6 Outbreak–Associated Isolates and of L. monocytogenes ST6 Isolates Collected Worldwide.

Whole-genome sequencing data for 386 ST6 isolates were analyzed with the use of core-genome multilocus sequence typing. Four human ST6 isolates that were recovered in 2017 and 2018 differed by at least 14 alleles, but the remaining 382 differed by no more than 4 alleles (out of 1748 loci included in the scheme) (Figure 3A).18This maximum 4-allelic difference is within the 7-allelic difference threshold that defines potentially epidemiologically linked isolates, as described by Moura et al.18 These 382 isolates, including 336 human isolates and 19 food and 27 environmental isolates from Facility A, were assigned to the same core-genome multilocus sequence type (CT4148; complete genotype, L1-SL6-ST6-CT4148). The oldest South African CT4148 isolates date from September 2015 and are related to a cluster of three cases of listeriosis in Western Cape Province28; this finding suggests a potential epidemiologic link to the 2017–2018 outbreak (Figure 3A).

Whole-genome sequencing data were compared with information from curated databases through international networks and with isolates representative of previous major ST6 outbreaks to detect possible matches, and none were found (Figure 3B, and Fig. S1 in the Supplementary Appendix, available with the full text of this article at NEJM.org); genome sequences for 10 L. monocytogenes ST6 isolates associated with this South African outbreak have been deposited at the NCBI GenBank repository under the accession numbers QEXB00000000 to QEXK00000000 (BioProject number, PRJNA451422; and BioSample numbers, SAMN08970424 to SAMN08970415). Outbreak ST6 isolates had a hypervirulent phenotype, as described previously for L. monocytogenes ST6,21 but were not more virulent than a strain representative of ST6 (Fig. S2).

CONTROL MEASURES

On March 4, 2018, the Minister of Health announced the outbreak source. Facility A products were traced and recalled from distributors and retailers, and the public was advised to return products for reimbursement. Facility A was closed immediately. The World Health Organization assisted in recalling the products that had been exported to 15 African countries (Angola, Botswana, Democratic Republic of Congo, Ghana, Lesotho, Madagascar, Malawi, Mauritius, Mozambique, Namibia, Nigeria, eSwatini, Uganda, Zambia, and Zimbabwe). A single case of listeriosis was reported in Namibia during March 2018, but the patient’s isolate was confirmed as non-ST6; no other countries reported cases during the period from January 1, 2017, to September 3, 2018, when the outbreak was declared over.

Discussion

Contaminated polony that was produced at a single facility was the cause of a large national outbreak of listeriosis predominantly associated with an L. monocytogenes ST6 strain in South Africa. Evidence supporting the cause includes a strong association between eating polony and ST6 infection, the detection of ST6 isolates in polony recovered from the refrigerator in the nursery, the detection of ST6 isolates in unopened polony loaves collected at the production facility, the detection of ST6 isolates in environmental samples collected from the production facility, a decline in ST6 cases after a recall of the products and closure of the facility, and the fact that outbreak-associated ST6 isolates from patients as well as food and environmental isolates from the facility belonged to a single core-genome multilocus sequence type.

Ready-to-eat processed meats are a well-known vehicle for listeriosis outbreaks.29,30 Polony is a low-cost, readily available food popular across all socioeconomic groups in South Africa and is used in kota, a fast food favored in urban areas. Polony has a shelf life of 5 months and is produced in large quantities by several manufacturers for local consumption and export.

Unique features of this outbreak include its recognition in a middle-income country with a high prevalence of HIV infection and a high fertility rate. HIV infection is a well-recognized risk factor for listeriosis.2,31-34 In 2017, the prevalence of HIV infection in South Africa was 12.6%, and an estimated 7.9 million people were living with HIV infection. The prevalence of HIV infection in the age group of 15 to 49 years was 26.3% among female persons and 14.8% among male persons.16 Of the nearly 1.2 million girls and women who gave birth in 2017, approximately 265,000 (22%) were infected with HIV.35In this outbreak, HIV infection was the most common predisposing condition among patients younger than 65 years of age. We also found that a large percentage of pregnant girls and women were infected with HIV (37% [17 of 46]), and a similar percentage of neonates were exposed to HIV (38% [60 of 158]). The percentage of female patients was highest in the age group of 15 to 49 years, which suggests that possible unrecognized HIV infection or pregnancy were predisposing conditions. Culture-confirmed or PCR assay–confirmed L. monocytogenes infections were reported in more cerebrospinal fluid samples from HIV-positive patients than from HIV-negative patients. It is possible that HIV infection is associated with an increased mortality, but given the missing data and study design, the analyses were not powered to detect a difference between the HIV-infected group and the HIV-uninfected group.

The size and velocity of the outbreak were noteworthy and most likely resulted from the wide distribution of large volumes of contaminated products in a large population vulnerable to invasive listeriosis. Likely explanations for the predominance of cases in Gauteng Province include consumer behavior, food preferences, and higher socioeconomic status in this densely populated province, but increased reporting or differential health-seeking and physician-testing behavior may have been contributing factors. We found no evidence that this ST6 outbreak–associated strain was more virulent than a strain representative of ST6.21

No outbreak-associated cases were detected in the 15 low-to-middle-income countries that imported polony from Facility A. However, cases were probably missed because of nonspecific clinical presentation, physician-testing behavior, limited diagnostic capacity at the laboratory, and lack of surveillance for listeriosis. The burden of listeriosis is most likely higher than is currently recognized in low-income and middle-income countries,8 particularly those with large populations of people living with HIV.

Before this outbreak, listeriosis was not required to be reported and not under surveillance in South Africa. A national surveillance system has since been implemented, and all isolates from patients are analyzed by means of whole-genome sequencing. This outbreak catalyzed a revision of local food-safety regulations; certification through the Hazard Analysis and Critical Control Point system is now a legal requirement for ready-to-eat meat producers, and microbiologic criteria for L. monocytogenes in ready-to-eat foods are under review.

This outbreak investigation had several limitations. Not all clinical isolates were available for whole-genome sequence typing. Microbiologic investigations are not routinely conducted in pregnant women with mild, nonspecific febrile illness or in those who have had miscarriages or stillbirths; therefore, the number of patients with pregnancy-related listeriosis was most likely underestimated. With respect to the period under study, limited case-investigation forms were available, and data were of varying completeness. Insufficient clinical data prohibited a description of clinical syndromes. Sources of the data on HIV status included laboratory reports and reports from the patients themselves, which probably resulted in underreported positive status. On the basis of the findings from core-genome multilocus sequence typing, it is likely that the ST6 cluster in 2015 was associated with the 2017–2018 outbreak; however, incomplete histories of food consumption and trace-back data precluded a conclusive epidemiologic link.

The findings showcase the power of complementary epidemiologic data and whole-genome sequence typing for detecting and investigating foodborne disease outbreaks and show that whole-genome sequencing technology can be ably implemented and used in developing countries. As the global shift to whole-genome sequence typing for foodborne-pathogen surveillance accelerates,36-38 developing countries should build the capacity to leverage this technology in a rapidly evolving landscape of food-safety concerns. Targeted health communication for the prevention of listeriosis among pregnant girls and women and HIV-infected persons in developing countries may help mitigate the risk of disease in these vulnerable groups.

Fresh Herbs Results as of 10/1/2019

The FDA plans to collect 1,600 fresh herbs samples (761 domestic, and 839 of international origin) under this assignment. As of September 30, 2019, the agency had collected and tested 746 domestic samples (98 percent) and 468  import samples (56 percent) of the totals. The following figures summarize the interim sampling results. As the testing is still underway, no conclusions can be drawn at this time.

Herb Sampling Results 10012019

Processed Avocado and Guacamole Results as of 10/15/2019

The FDA initially planned to collect 1,600 processed avocado and guacamole samples (800 domestic, and 800 of international origin) under this assignment. In July 2018, the FDA adjusted its collection target to 1,200 samples (936 domestic, and 264 of international origin) after initial sampling confirmed that a relatively small number of firms produce and/or distribute processed avocado. The agency’s intent was to avoid biasing the data by oversampling product from the same firms and to minimize the burden on industry. Further, the FDA learned that an increasing number of processors have begun to use high pressure processing, which is a kill step. In March 2019, the FDA further reduced its collection target to 1,056 samples (824 domestic, and 232 of international origin) given the 35-day lapse in appropriations that began on December 22, 2018, and the associated impact on the workload of the agency’s field staff.

The FDA has stopped its collection of processed avocado and guacamole samples, coinciding with the close of FY2019. The final collection total is 887 samples (777 domestic, and 110 import). The final collection total, as compared to the original target, will increase the margin of error of the prevalence estimate from 0.5 percent to approximately 0.65 percent.  The FDA has recently begun its analyses of the data; final figures and a breakdown of the findings will be included in the forthcoming summary report.

Processed Avocado and Guacamole Sampling Results as of 10152019

In 2013, five years after the nationwide Salmonella outbreak in 2009 that killed 9 people and sickened more than 700, the U.S. Department of Justice on Thursday announced a 76-count indictment has been filed charging four former officials of the Peanut Corporation of America (PCA) and a related company for selling Salmonella-contaminated peanut butter products.

Former PCA owner and president Stewart Parnell, of Lynchburg, VA, and three other former company leaders, have been charged with mail and wire fraud, the introduction of adulterated and misbranded food into interstate commerce with the intent to defraud or mislead, and conspiracy, according to the Department of Justice.  Stewart Parnell and two others were also charged with obstruction of justice.

In a White House press release, DOJ said charges against former PCA operations manager Daniel Kilgore, of Blakely, GA, was unsealed and that he pleaded guilty to charges of mail and wire fraud, the introduction of adulterated and misbranded food into interstate commerce with the intent to defraud or mislead, and conspiracy.

The investigation into the activity at PCA began in 2009, after the U.S. Food and Drug Administration and the U.S. Centers for Disease Control and Prevention traced a national outbreak of Salmonella to a PCA plant in Blakely.  As alleged in the indictment, the Blakely plant was a peanut roasting facility where PCA roasted raw peanuts and produced granulated peanuts, peanut butter, and peanut paste; PCA sold these peanut products to its customers around the country.

In company emails obtained through investigation, Parnell allegedly ordered the shipment and sale of products known to be contaminated with Salmonella. When other lots of peanuts tested positive for Salmonella, he ordered them to be retested.

“These indictments will have a far reaching impact on the food industry,” said attorney Bill Marler, who represented hundreds of individuals in claims against PCA. “Corporate executives and directors of food safety will need to think hard about the safety of their product when it enters the stream of commerce.  Felony counts like this one are rare, but misdemeanor charges that can include fines and jail time can and should happen.”

The PCA indictment can be viewed here. Kilgore’s filed information can be viewed here.

Last night Food Safety News reported that Mary Wilkerson, quality control officer for the defunct Peanut Corporation of America, is free after serving a 5-year federal prison sentence for obstruction of justice. Wilkerson, 46 of Edison, GA., was released from a re-entry center, or half-way house, in Atlanta earlier this week. Her full release date was moved up by one month to Feb 2 by the U.S. Probation Office in Albany, GA. The mother of two has been separated from her husband and family for the past five years.

Wilkerson was indicted and tried with the company CEO and his brother, Stewart and Michael Parnell. Stewart Parnell was the chief executive of PCA, while Michael Parnell was its peanut broker.

Wilkerson’s offense was a “process crime” over misleading federal agents during the investigation. The government acknowledged she was not part of the conspiracy that led to the Salmonella poisonings that sickened thousands and killed nine. She was not responsible for making restitution to any of the victims.

Samuel Lightsey, who managed the PCA plant in Blakely, GA, at the time of the deadly outbreak, was the government’s star witness at trial and served less than three years.

Another former PCA plant manager, Daniel Kilgore, also made a deal with the government for his testimony for a six-year sentence. He’s next up for release, now set for Jan 30, 2021. He is at a minimum-security federal prison in Oakdale, LA.

Doing the most time for the PCA-related convictions, however, are the Parnell brothers. The Albany, GA, federal jury found Stewart guilty on 67 federal felony counts and Michael guilty on 30. The second generation of his family to run PCA, which spanned three southern states, Stewart was sentenced to 28 years in prison, and his brother to 20.

I edited this email I recently got from a client to protect their identity.

Dear Bill,

What to say? Thank you so much for your tireless work on __________’s behalf. We are so grateful for your willingness to take on her case, and for the help you offered before she was even your client. We know it could have worked out very differently if it weren’t for your generosity, knowledge and finesse. We consider ourselves very lucky….

All the folks at Marler Clark have been amazing. It’s quite a team you have there. Please extend our thanks to everyone. I know we kept Marybeth, Josh and Chris busy for some time. We are grateful for their patience with us, and their careful and thorough work. We know others were drawn in, Bruce, Drew, Jenny, maybe everyone? Thank you to all!

I won’t forget my first phone call with you, Bill, and how you said that after all your years of working on these cases you still couldn’t imagine the hell we went through (and also that you were an ass for making me relive it). I knew that you were a different kind of lawyer. Thank you for your patience when I kept thinking of another horrible story to share. It was cathartic for me, but not your job to listen to it all….

I still can’t believe your responsiveness to email, calls and texts. I thought I might wear you out, but you hung in there. It made it all so much easier knowing that you would be there for us if anything came up. Thank you….

Speaking of that, I am more than willing to be available if there is ever anything, I can do to help you, or your clients…. Believe it or not, I’ve become pretty good at listening to and supporting folks coping with hardship.

Feel free to share my contact info with other parents if you think I could be helpful. I will also speak highly of you, of course. And, I’m happy to be another pair of eyes on any mediation letter:0) Pretty sure if it’s not my kid’s it won’t take me 10 iterations to get it right.

I am so happy __________ will be spending the summer at your firm. What an opportunity for her! Thank you for that too! I hope she is able to contribute to your work.

I will forever be grateful for all you’ve done for our family, and the immeasurable difference you’ve made on food safety. My interest in your good work will not fade.

I will always think the world of you.

With much love and gratitude,

Your friend,

__________

In March 2017, the Centers for Disease Control and Prevention (CDC) and several state health departments attributed a multi-state outbreak of Shiga toxin-producing Escherichia coli O157:H7 to I.M. Healthy brand SoyNut Butter manufactured by Dixie Dew, sold through the World Finer and KeHe distribution network and sold at retail at Target and other retailers.[1]

Outbreak investigators collected open containers of SoyNut Butter from the homes of sick people, and unopened containers from retail locations. Containers of SoyNut Butter from lots #243162 and 244161 tested positive for E. coli. Whole genome sequencing revealed that the same strain of E. coli was found in clinical isolates from sick people and containers of I.M. Healthy SoyNut Butter. Epidemiologic investigation determined that 32 people ill with this strain of E. coli had been infected by eating or attending a facility that served I.M. Healthy SoyNut Butter. This included residents of Arizona (4), California (5), Florida (2), Illinois (1), Massachusetts (1), Maryland (1), Missouri (1), New Jersey (1), Oregon (11), Virginia (2), Washington (2), and Wisconsin (1).[2]

During the outbreak, investigators identified 2 ill people who either developed HUS or had a culture independent diagnostic test (CIDT) showing infection with STEC bacteria. In interviews, both patients reported eating I.M Healthy SoyNut Butter in the week before the illness. However, the CDC did not include these people as case patients because no bacterial isolates were available for molecular subtyping, so there were unable to confirm if they were infected with one of the outbreak strains.

On March 7, 2017, The SoyNut Butter Company recalled all varieties of I.M. Healthy SoyNut Butters and all varieties of I.M. Healthy Granola products. On March 10, 2017, The SoyNut Butter Company expanded its recall to include Dixie Diner’s Club brand Carb Not Beanit Butter. On March 24, 2017, Pro Sports Club recalled 20/20 Lifestyle Yogurt Peanut Crunch Bars because they contain a recalled ingredient. However, I.M. Healthy SoyNut Butter continued to be sold at least through early September 2017.

An outbreak strain of STEC O157 was isolated from 11 I.M Healthy SoyNut Butter samples. Multiple STEC isolates were identified from some samples. Nine samples were from opened, leftover products from case patient homes in California, Oregon, and Washington, and 2 samples were from unopened containers from retail stores in California; all had best-by dates of August 30, 2018 (10 products) or August 31, 2018 (1 product).

On March 3, 2017, the FDA issued a warning about the presence of E. coli O157:H7 in I.M. Healthy Creamy SoyNut Butter with a Best Buy Date of 08/30/2018.  Outbreak investigators identified Lot No. 243162 as one of the lots that was contaminated with E. coli O157:H7.

What the FDA found

The FDA inspected the facility between March 3 and 15, 2017.  On March 3, 2017, Dixie Dew refused to allow FDA investigators access to the facility’s environmental sampling and production records; the FDA subsequently issued a Demand for Records under section 414 of the Federal Food, Drug, and Cosmetic Act. After receiving the Demand for Records, Dixie Dew provided FDA investigators with the necessary records. At the close of the inspection, the FDA provided Dixie Dew with a list of the investigators’ inspectional observations (Form FDA 483), noting objectionable conditions seen during the inspection. Dixie Dew responded to the report in writing with a list of actions it had taken to correct the conditions; however, FDA found the corrective actions were not adequate to fully address the risks that were identified and issued the Suspension Order to prevent further illnesses from occurring.

The FDA announced on March 28, 2017, the FDA used authorities granted under the 2011 FDA Food Safety Modernization Act to suspend the food facility registration of Dixie Dew Products, Inc. (Dixie Dew) of Erlanger, Kentucky, because products manufactured in this facility may be contaminated. The FDA’s decision to suspend the registration of Dixie Dew Products was prompted by the E. coli O157:H7 outbreak and the findings of FDA’s March 2017 inspection of Dixie Dew, which identified insanitary conditions that could lead to contamination with E. coli O157:H7 in finished products. The FDA determined that no food could leave the Dixie Dew facility for sale or distribution while the food facility registration was suspended.

Specific problems noted in the suspension order and Form 483 included (blanks reflect redacted information):

  • investigators observed grossly insanitary conditions that cause your firm’s soy nut butter products to be adulterated;
  • food contact surfaces, floors, walls, and ceilings in the soy nut butter processing and packaging rooms were heavily coated with soy nut butter build-up from previous production runs;
  • firm does not routinely wash and sanitize smaller pipes, pipe fittings, gaskets, seals, “or the rubber _____ plug” when broken down following a production run;
  • firm does not conduct a kill step for SoyNut Butter product remaining in your firm’s mixing kettle leftover from a production run;
  • plant Manager stated, up to _____ may remain in the kettle overnight or weekend prior to resuming production. You and your Plant Manager stated the kettle is shut off when product remains in the kettle overnight and/or over the weekend;
  • plant manager and maintenance supervisor reported your _____ machine, used for fine mixing of the SoyNut Butter and ________, routinely shuts off during processing. Your Plant Manager stated this occurs one to two times per day and, this problem has persisted for approximately 15 years despite repeated maintenance intended to correct the problem;
  • firm monitors the SoyNut ______ with a ______ thermometer, but plant manager stated he has never verified the accuracy of this instrument;
  • you and your plant manager report, your temperature probe and chart recorder, initially engineered to verify and record _____ of product in the large mixing kettle, is not functioning properly and has not been used for well over a year.

FDA inspectors also noted problems with Dixie Dew’s food safety testing program, noting the company’s “failure to perform microbial testing where necessary to identify possible food contamination.” Inspectors found the testing materials on hand at Dixie Dew had expired in July 2016 and October 2015.

Problems in the Dixie Dew quality control lab were described in detail by FDA inspectors.

“An apparent fly infestation in your firm’s Quality Control and Product Development Laboratory was observed on 3/13/2017. Small apparent flies and fly larvae, too numerous to count, were inside an unplugged chest freezer,” according to the 483 report.

“A sealed blue plastic bag was inside the freezer and according to your plant manager, contained an egg product that became rotten when power was disconnected. The small apparent flies were observed along the laboratory counters and flying throughout the laboratory.”

Linda J. Harris, Ph.D., a well-known and respected expert from the University of California at Davis, critiqued the failure of Dixie Dew to have an adequate plan to control for the risk of bacterial contamination.  Specifically, after visiting the facility, Dr. Harris commented:

The Dixie Dew documents and especially the FDA 483 report based on inspections conducted March 3 to 15, 2017 as well as the onsite tour of the facility May 9, 2019 clearly show that Dixie Dew had not implemented either basic Good Manufacturing Practices or best practices for low moisture foods. Outbreaks of foodborne illness from nut butters in the U.S. in 2006/2007, 2008/2009, 2013, and 2014 are well known among food industry professionals and food safety community. These outbreaks are frequently used as instructional tools that provide multiple examples of what not to do when producing food. The outbreaks have been influential in changing the way that the microbial safety of low moisture foods are viewed and have led to well documented and freely shared industry best practices. In 2016, IM Healthy and those buying from them should have been aware of the risks of foodborne pathogens (both Salmonella and E. coli O157:H7) in their products. Any reasonable audit or inspection would have identified substantial systemic food safety issues in the production of Soynut butter at Dixie Dew.

The issues were there to be seen.

PAST OUTBREAKS LINKED TO NUT BUTTERS

It is not as if, in 2017, contaminated nut butters were not a foreseeable issue for manufacturers, suppliers and retailers.

In November 2006, public health officials detected a substantial increase in reports of Salmonella Tennessee isolates. In February 2007, a multistate, case-control study linked the consumption of either Peter Pan or Great Value Peanut Butter brands to infection[3]. As a result of that outbreak, 715 people were sickened and 129 required hospitalization. Subsequently the same strain of Salmonella Tennessee was isolated from unopened jars of peanut butter and from environmental samples collected from the processing plant. The product was recalled, and new illness reports declined. Unsanitary conditions at the Sylvester, Georgia, processing plant were known about since 2004. On April 5, 2007, ConAgra announced that inadvertent moisture from a leaking roof and sprinkler system could have promoted bacteria growth in the plant. Great Value brand was sold at Walmart stores.[4]

Beginning in November 2008, CDC PulseNet staff noted a small and highly dispersed, multistate cluster of Salmonella Typhimurium isolates. The outbreak consisted of two pulsed field gel electrophoresis (PFGE) defined clusters of illness. The first cluster displayed a unique primary enzyme (XbaI) restriction pattern and an uncommon secondary enzyme (BlnI) pattern. The second cluster had two closely related XbaI patterns that were very similar to the first cluster and a BlnI pattern that was indistinguishable from the first cluster. Illnesses continued to be revealed through April 2009, when the last CDC report on the outbreak was published. A total of 714 were sickened, with 171 hospitalized, and at least nine deaths. Peanut butter and peanut butter containing products produced by the Peanut Corporation of America plant in Blakely, Georgia, were implicated. King Nut brand peanut butter was sold to institutional settings. Peanut paste was sold to many food companies for use as an ingredient. Implicated peanut products were sold widely throughout the USA, 23 countries, and non-U.S. territories.[5]

On September 22, 2012, the CDC announced a multistate outbreak of Salmonella serotype Bredeney linked to Trader Joe’s Valencia Creamy Salted Peanut Butter. Collaborative efforts by local, state, and federal public health and regulatory officials traced the product to Sunland, Inc., a Portales, New Mexico company. Sunland issued a recall of multiple nut butters and products made with nut butters. When the outbreak was declared over, a total of 42 people infected with the outbreak strain of Salmonella serotype Bredeney had been reported by 20 states. Among persons for whom information was available, illness onset dates ranged from June 14, 2012 to September 21, 2012. Ill persons ranged in age from less than 1 year to 79 years, with a median age of 7 years. Sixty-one percent of ill persons were children less than 10 years old. Among 36 persons with available information, 10(28%) patients had been hospitalized. The FDA confirmed that environmental samples collected at the Sunland facility had a DNA fingerprint that was indistinguishable to the DNA fingerprint found in outbreak associated patients.[6]

On August 21, 2014, the CDC announced a multistate outbreak of Salmonella Braenderup involving 6 people residing in Connecticut (1), Iowa (1), New Mexico (1), Tennessee (1), and Texas (2). Almond and peanut butter manufactured by nSpired Natural Foods, Inc. was named as the likely source of this outbreak. The outbreak was declared over on October 16, 2014. Illness onset dates range from January 22, 2014 to May 16, 2014. Among 5 ill persons with available information, one person reported being hospitalized. During inspections at the nSpired Natural Food facility in Ashland, Oregon, between January 2014 and August 2014, the FDA isolated Salmonella Braenderup from environmental samples. A search of the PulseNet database linked ill patients to the environmental isolates taken from the nSpired production plant. On August 19, 2014 nSpired Natural Foods issued a voluntary recall of certain lots of almond and peanut butters because of potential contamination with Salmonella. The recalled brands include Arrowhead Mills, MaraNatha, and specific private label almond and peanut butters.[7]

On December 2, 2015, JEM Raw Chocolate LLC (JEM Raw) of Bend, Oregon announced a recall of its full line of all nut butter spreads due to possible contamination with Salmonella. Health authorities at the FDA, Oregon Health Authority, Oregon Department of Agriculture and the CDC had linked illnesses in 13 persons who consumed nut spreads. Dates of onset ranged from July 18, 2015 to November 22, 2015. Cases were reported from California, Colorado, Georgia, Hawaii, Idaho, Illinois, Maine, North Carolina, New Jersey and Oregon.[8]

___________________

[1]           https://www.cdc.gov/ecoli/2017/o157h7-03-17/index.html

[2]           32 cases from 12 states. Twenty-six (81%) cases occurred in children,18 years old; 8 children developed hemolytic uremic syndrome. Twenty-five (78%) case patients ate the same brand of soy nut butter or attended facilities that served it. We identified 3 illness subclusters, including a childcare center where person-to-person transmission may have occurred. Testing isolated an outbreak strain from 11 soy nut butter samples. Investigations identified violations of good manufacturing practices at the soy nut butter manufacturing facility with opportunities for product contamination, although the specific route of contamination was undetermined. See, A Multistate Outbreak of E Coli O157: H7 Infections Linked to Soy Nut Butter – PEDIATRICS Volume 144, number 4, October 2019:e20183978.

[3]           A 1996 Salmonella Mbandaka outbreak linked to peanut butter sickened at least 15 in Australia – Aust NZJ Public Health 1998; 22: 536-9.

[4]           https://www.cdc.gov/mmwr/preview/mmwrhtml/mm5621a1.htm

[5]           https://www.cdc.gov/mmwr/preview/mmwrhtml/mm58e0129a1.htm

[6]           https://www.cdc.gov/salmonella/bredeney-09-12/

[7]           https://www.cdc.gov/salmonella/braenderup-08-14/

[8]           https://www.cdc.gov/salmonella/paratyphi-b-12-15/

See also – ATTACHMENT NO. 2 – J.-Pediatrics-Article-02178215xAD20B, ATTACHMENT NO. 5 – Suspension-of-Food-Facility-Registration-Order-to-Dixie-Dew-Products–Inc., ATTACHMENT NO. 6 – Dixie-Dew-Products-Inc.-Erlanger–KY.-483-Dated-03-15-17

There are few in the business of combating diarrhea that I respect more that Frank Yiannis and Rob Tauxe.

I am sure that it is not reciprocated, because I am one of those “damn ambulance chasers.”  But, guys, it is past time to stop hiding foodborne illness outbreaks – regardless of the thin legal justification.

Failing to be transparent gives a false sense of security to both the leafy green industry and the public. And, when the outbreak is outed, there is no doubt that many consider that you are being toadies to the industry – that is not good and it is not accurate.  You and the agencies you lead are far, far too valuable to squander your good names.

If the two of you want to debate the pros and cons of transparency, please name the time and place.

This week from the good people at Food Safety News:

January 24, 2020:  Federal officials today confirmed another E. coli outbreak that they had previously not revealed to the public. Specific details were not available from the CDC or the FDA, but at least four states have been reported with confirmed patients.

The most likely source of the E. coli O157:H7, reported by 9 of 11 sick people who ate at fast food locations, was lettuce on Subway sandwiches, according to a source close to the investigation. Neither the FDA nor the CDC would confirm that Subway products are involved.

“This is an ongoing investigation into an outbreak that was identified in December,” Food Safety News learned from Peter Cassell, a press officer for the Food and Drug Administration.

“Upon detection, the outbreak had already ended. In an abundance of caution and to try to inform future prevention, we are working to see if we can identify the source. Per CDC and FDA policy, since there were no specific, clear and actionable steps for consumers to take to protect themselves from contaminated food associated with this outbreak, there was and is no current public health advisory.

“Should our investigation conclusively identify a source and/or contributing factors that could inform future prevention, we are committed to publicly communicating these insights.”

The CDC also provided Food Safety News with confirmation of the previously undisclosed outbreak. An official comment from the agency did not include any specific details except that patients were confirmed in four states.

“In early December 2019, CDC, along with the U.S. Food and Drug Administration and four states, began investigating a multistate outbreak of E. Coli O157 infections,” according to a press officer from the Centers for Disease Control and Prevention.

“No new illnesses have been reported since CDC initially identified this cluster, and the outbreak is over. CDC is continuing to work with FDA to identify the source of the outbreak.”

The four states are Nevada, Maine, Vermont and New Hampshire, according to a source close to the investigation.

January 28, 2020: Officials in two states have confirmed they are working with federal officials on an investigation into E. coli illnesses linked to lettuce served by a national restaurant chain.

Spokespeople with the Nevada and Vermont state health departments say the agencies are working with the federal agencies on the investigation. Both the CDC and the FDA confirmed for Food Safety News on Friday that they have an open investigation into the outbreak, which had not previously been made public. A source close to the investigation says the implicated restaurant chain is Subway.

Health department officials in the other two outbreak states, Maine and New Hampshire, did not respond to requests for information about the outbreak and investigation. Vermont had five confirmed patients, Maine had four and New Hampshire and Nevada each had one.

A spokeswoman for the Vermont health department said the state’s five confirmed outbreak patients were all children. She could not provide any information regarding how many were hospitalized because of the department’s patient privacy policy. However, she said none of the children developed hemolytic uremic syndrome (HUS), which is a type of kidney failure that is often fatal.

The Vermont spokeswoman echoed what federal officials said Friday in regard to why the public had not been informed about the outbreak when it was discovered. She said there wasn’t any actionable information for the public and that public risk has now passed.

However, as with the FDA’s statement, the Vermont spokeswoman said officials became aware of outbreak illnesses in November but then said that by the time the outbreak was discovered in December the illnesses had stopped.

The FDA and CDC are being notably silent on the outbreak and ongoing investigation.

The outbreak marks the second time in the recent months when the FDA and CDC did not go public with information about an outbreak.

On Halloween, Food Safety News learned of an E. coli O157:H7 outbreak that the two federal agencies had not revealed to the public. It ended in September and involved romaine lettuce. [A total of 23 people infected with the outbreak strain of E. coli O157:H7 were reported from 12 states: Arizona (3), California (8), Florida (1), Georgia (1), Illinois (2), Maryland (1), North Carolina (1), Nevada (1), New York (1), Oregon (1), Pennsylvania (2) and South Carolina (1). Eleven people were hospitalized and no deaths were reported. Illnesses started on dates ranging from July 12, 2019 to Sept. 8, 2019. No illnesses were reported after CDC began investigating the outbreak on Sept. 17, 2019.]

Spokespeople from FDA and CDC said at the time that because they believed all of the implicated romaine had passed expiration dates by the time the outbreak was discovered, agency officials did not think the public needed to know.

I wrote this several years ago when I was complaining about the same lack of transparency in another case:

It is therefore with mixed emotions, and the knowledge that I likely make my relationship with public health – both federal and state – even more tenuous, that I question his quotes in today’s MSNBC dust-up over the disclosure or non-disclosure of “Mexican-style fast food restaurant chain, Restaurant Chain A” that is a source of a Salmonella outbreak that sickened 68 people in 10 states.  Here is what he had to say to MSNBC:

Dr. Robert Tauxe, a top CDC official, defended the agency’s practice of withholding company identities, which he said aims to protect not only public health, but also the bottom line of businesses that could be hurt by bad publicity. The CDC, the Food and Drug Administration and state health departments often identify companies responsible for outbreaks, but sometimes do not.

“The longstanding policy is we publicly identify a company only when people can use that information to take specific action to protect their health,” said Tauxe, the CDC’s deputy director of the Division of Foodborne, Waterborne and Environmental Diseases.

“On the other hand, if there’s not an important public health reason to use the name publicly, CDC doesn’t use the name publicly.”

Because companies supply vital information about outbreaks voluntarily, CDC seeks to preserve cordial relationships.

“We don’t want to compromise that cooperation we’ll need,” Tauxe said. …

Tauxe acknowledged there’s no written policy or checklist that governs that decision, only decades of precedent.

“It’s a case-by-case thing and all the way back, as far as people can remember, there’s discussions of ‘hotel X’ or ‘cruise ship Y,” he said.

I too was quoted in the article above and was repeatedly asked if I thought that the CDC was bending to company pressure to keep the restaurant name quiet.  I said emphatically no!  But that did not make it into the article.  So, not to put words in Dr. Tauxe’s mouth (and granted he may have had more to say), but as best as I can tell, these are his arguments for disclosure and non-disclosure and my thoughts in italics:

A.  Although there is no written policy, it is the way we have done things for years;

Why do I hear my mom saying, “just because so and so does that does not mean you should too.” Like all government policies (and neckwear) – change is good.

B.  Since the outbreak has concluded, there is not an immediate public health threat;

Frankly, that is true in most foodborne illness outbreaks.  In nearly every single outbreak investigated by the CDC the outbreak is figured out far after the peak of the illnesses happened.  However, disclosure gives the public information on which companies have a strong or weak food safety record.

C.  Disclosing the name of the company jeopardizes cooperation from the company in this and future outbreaks; and

If a company will only cooperate if they are placed in a witness protection program and with promises of non-disclosure, it does not say much for our government’s and the company’s commitment to safe food.

D.  Bad publicity may cause economic hardship on the restaurant.

True, but not poisoning your customers is a better business practice.

I would also add a couple more reasons that I have received via email (mostly anonymously):

1.  The source was an unknown supplier, so naming the restaurant might place unfair blame on the restaurant;

This one does make some sense.  However, is this the unnamed restaurants first problem with a faulty supplier, or is this a pattern?  And, even if it is the first time, perhaps some of the unnamed product is still in the market?

2.  Since the outbreak involves a perishable item, by the time the CDC announces the outbreak, the tainted product has long been consumed;

This one I have heard a “bunch” of times – especially in leafy green outbreaks.  However, why should the public be left in the dark about the type of product that sickens as well as the likely grower and shipper so they can make future decision who to buy from?

3.  Going public with the name of the restaurant compromises the epidemiologic investigation by suggesting the source of the outbreak before the investigation is complete;

I completely agree with this one.  This is a tough call, and one that must create the most angst for public health officials – they decide the balance between having enough data to go forward to protect the public health or wait for more data.  The point is do not go forward until the investigation is complete.

4.  Public health is concerned of making an investigation mistake like, it’s the tomatoes, err, I mean peppers; and

See my answer to 3 above.  This is why under the law; public health officials are immune for liability for the decisions that they make in good faith to protect the public.

5.  Public health – especially surveillance – is under budgetary pressures and there is simply not the resources to complete investigations; and

There is no question that this is true.  I have seen it in dropped investigations over the last few years.  Labs are not doing genetic fingerprinting to help reveal links between ill people.  And, many tracebacks are stopped by the lack of peoplepower to do the research necessary to find the “root cause” of an outbreak.

For me it is easy – the public has a right to know and to use the information as it sees fit, and people – especially government employees – have no right to decide what we should and should not know.

Perhaps when Congress gets back to governing, we can do a hearing or two on the above.  Its been a decade since Energy and Commerce grappled with food safety issues.  It is past time to do it again.