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-Lmhttp://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-02178215xAD20BATTACHMENT 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.

This is a stunning piece of both journalism and photo journalism by Nomatter Ndebele and Thom Pierce of the Maverick Citizen

Thank you for taking the time to tell these peoples’ stories.

The victims of the 2017 listeriosis tragedy and the surviving families of those who died are taking on Tiger Brands in an effort to win some form of justice and force some form of accountability. A Maverick Citizen team travelled to all four corners of South Africa to tell the stories of the claimants who are fighting back.   (see more on the status of the class action and Marler Clark’s role at https://listeriaclassaction.co.za/)

Alana Julie, 37

Alana Julie with her children (L-R) Jayden, Joshua, Lance, Tamsyn and Caitlan; in their bedroom at Alana’s mother’s house in Mitchells Plain, Cape Town. In 2017 Alana’s husband, Antonio, died from listeriosis at the age of 42. (Photo: Thom Pierce)

In 2017, Alana Julie lost her husband, Antonio. He died a gruesome death. He was in excruciating pain from the moment he fell ill. Within 72 hours, Antonio lost his eyesight. By the fourth day he was put on life support, and by the fifth, all his organs had shut down. Doctors told Alana she had two hours to decide whether or not to take him off life support. Since Antonio died, Alana has moved back to her mother’s house, where she shares a single bedroom with her five children. The family struggles to make ends meet, living solely off Alana’s salary, which doesn’t go very far. Her children remember their dad as an ever-present father who used to play the guitar and sing songs to them. A few weeks ago, their house was broken into and thieves stole Antonio’s guitar, devastating his eldest son Jayden.

Carla Verlaat, 23

Carla Verlaat at home in Manenburg, Cape Town. At 22 weeks pregnant, Carla lost her baby, Shem. He was diagnosed as having listeriosis. (Photo: Thom Pierce)

Carla Verlaat lost her first baby in 2017. She went into premature labour at 22 weeks. Her son Shem only lived for 24 hours before he died. The doctors told Carla her baby had a clot in his brain and he was later diagnosed with listeriosis. Carla cries as she speaks about the pain of her milk running out of her breasts intended for a baby who had died. She has a single picture of Shem on her phone. He is lying in an incubator, with many pipes attached to his fragile body, his face a dark grey. Since Shem passed away, Carla has battled with her grief. Despite having gone to therapy, she still struggles to manage her mood swings. Sometimes she stabs her bedroom door with a knife, in an attempt to find some kind of release. She blames herself for Shem’s death and is too afraid to have another baby.

Annelize le Roux, 42

Annelize and Martin Le Roux with their dog Max and their pet lion Caesar on their farm in Winburg, Free State. Annelize suffered a miscarriage at 23 weeks, their baby boy was later diagnosed with listeriosis. (Photo: Thom Pierce)

Annelize le Roux lost her “miracle baby”. The year before giving birth to her miracle, she terminated another pregnancy when told the unborn baby had Down’s syndrome. She was told that she would never have another child. Being subsequently pregnant with her son Andreas was an unexpected but happy surprise. The family was devastated when Andreas died.

Before Andreas died, Annelize’s whole family fell ill. “It was just like strong flu symptoms,” she said. Her husband Martin did not think much of his illness. Annelize, who is a microbiologist, was determined to find out what happened. So after Andreas died, they sent his blood for tests to England. The results confirmed that Andreas had contracted listeriosis while in his mother’s womb. When Annelize found out about the outbreak, she isolated and packaged foodstuffs from her fridge. When the health inspectors came to her home, she had prepared all the samples for them. This played a crucial role in assisting the health department in confirming the source of the contaminated foodstuffs.

Amelia Govender, 28, and Kyle Victor, 26

Kyle Victor and Amelia Govender at their home in Kingsburgh, KwaZulu-Natal. At one day old, their daughter Summer Reign died from listeriosis. For the last two years Amelia has suffered severe health complications brought on by listeriosis. (Photo: Thom Pierce)

Amelia and Kyle were incredibly excited for the arrival of their baby girl, Summer Reign. They both describe the birth of their little girl as the best day of their lives. Kyle, who had initially hoped for a boy, fell in love with his daughter at first sight. “I saw her and I just thought, ‘why did I ever want a boy?’” Amelia and Kyle had been thoroughly prepared for their baby. Amelia had bought little outfits for Summer Reign, she’d even got her a Louis Vuitton designer baby blanket. She became worried when her baby’s movements started to wane. That was the first sign of trouble. A few days later, Summer died. She and Kyle were devastated. Amelia has tears in her eyes as she talks about how she prayed that her baby would wake up during her funeral, but Summer was gone. Since then, Amelia has dealt with debilitating health issues. Every morning, she wakes up to a swollen face, and often her lower body breaks out in an itchy rash that leaves welts all over her. She still has not been able to figure out the cause of her symptoms.

Meryl Khotia, 38

Meryl and Shabeer Khotia at home in Shallcross, KwaZulu-Natal. At seven months, Meryl had to have an emergency Caesarean section and gave birth to a boy, Saiheer, who died less than 24 hours later. He was diagnosed with listeriosis. (Photo: Thom Pierce)

Meryl and her husband were looking forward to having their first child together in 2017. Shabeer immediately started a separate savings account to cater for the baby’s future needs. Seven months into her pregnancy, Meryl started to feel ill. She struggled with fever on and off, until the doctors told her they would have to perform an emergency Caesarean section. Baby Saiheer was born on 28 November 2017 and, as far as Meryl was aware, the baby was healthy. When her husband arrived at the hospital to see her and the baby, he found little Saiheer dead. Saiheer had lived less than a day before he died due to a listeriosis infection contracted while in his mother’s womb.

After Meryl was discharged from the hospital, she started to notice that she was getting severe allergic reactions, especially when it was hot. Her skin would start to itch badly and welts would develop where she scratched. She also described her face swelling up, so much so that she is afraid of leaving the house. “I don’t want people to see me like that,” she said.

Johan Keisser, 65

Johan Keisser at home in Forest Hill, Gauteng. In late 2017, Johan was rushed to hospital where he spent a total of 25 days, 12 of which were in the hospital intensive care unit. He was diagnosed with listeriosis and considers himself lucky to be alive. (Photo: Thom Pierce)

Johan Keisser considers himself “one of the lucky ones”. The 65-year-old pensioner fell ill and was taken to hospital by his wife. He has no recollection of being in the hospital for 25 days, 12 of which he spent in the hospital’s intensive care unit. “I took polony with cheese, lettuce and tomatoes to work every single day, and it almost cost me my life,” he said. While Johan has made a full recovery, he notes that he has a weakness in his legs, making it difficult for him to get up when sitting. He has high praise for the doctors who attended to him. “I am so grateful that they pulled me through because, according to me, I was a dead person for 20 days,” he says.

Aletta Masie, 44

Aletta Masie at home in Xihoko, Limpopo. Annette spent two weeks in hospital being treated for listeriosis after her one-day old baby died from the infection. (Photo: Thom Pierce)

Aletta Masie held her baby girl only once before she died. The infant contracted listeriosis in her womb and died soon after birth. As the baby was premature and weighed less than a kilogram, the foetus was disposed of as medical waste. She was unable to have a funeral for her child. She was discharged the same day and told to come back at a later stage to have her womb cleaned.

Aletta spent at least two weeks in hospital being treated for listeriosis with antibiotic intravenous drips. When she finally returned home to Limpopo, accompanied by her husband Thomas, her two elder children were devastated to find that she did not come home with a baby. “Losing my baby was so painful, especially because I didn’t really know what killed my baby,” said Anetta. Since the death of her baby girl, Anetta does not eat any Enterprise products. She is terrified that she will get ill again.

Christina Ledwaba, 31

Christina Ledwaba at home in Mankweng, Limpopo. Since losing her baby, Mohau, to listeriosis, Christina has managed to give birth to a healthy baby girl.(Photo: Thom Pierce)

Christina Ledwaba’s baby was stillborn.

She knew something was amiss when she noticed that the unborn baby’s movements in her womb had dwindled. She consulted the gynaecologist in Mankweng, Limpopo, who told her not to worry, that perhaps baby was “sleeping”. Not long afterwards Christina fell ill, suffering headaches and a fever. She was again taken to hospital to check on her baby.

“I knew something was wrong the minute I saw that sonar,” she said. Doctors confirmed that the baby had no heartbeat. She then gave birth to Mohau. When the baby was delivered, the nurses merely left the umbilical cord attached. For hours she lay on the bed with her dead baby under her legs.

Since then Christina has had another baby, but when she was eight months pregnant, she experienced diarrhoea and started to panic, worried that something was wrong again, but she was able to give birth to a healthy little girl. Despite good evidence that her stillborn baby’s death was linked to listeriosis, Christina still consumes Enterprise products, but she makes sure that the food is heated first.

Stephen Thokwane, 43

Stephen Thokwane at his home in Steelpoort, Limpopo where he lives with his wife and four children. Once fit and healthy, Stephen contracted listeriosis and is now a shadow of his former self. (Photo: Thom Pierce)

Stephen Thokwane is a shadow of his former self. The once fit and healthy man fell ill in December 2017. What started off as a headache and flu-like symptoms turned into a nightmare for his family.

Dumbfounded by his sudden illness, which he self-diagnosed as a stroke, the family first sought spiritual help. The family said that the prophet told the family that they needed to pray for Stephen. Stephen deteriorated and he was admitted to hospital, where he lost his eyesight, suffering severe delirium and temporary paralysis.

The man, who used to jog 15 kilometres at a time, found himself having to learn how to walk again. And while he is back on his feet, his health is still not what it was. He is fatigued, and he has lost strength. Due to this, he is no longer able to continue his work as a boilermaker, something he did part-time besides his formal employment, in order to support his family.

Thokwane is now working towards paying off a loan he took out to build a house for his wife and four kids. “After he got so sick, he was worried that he may die without leaving us with a roof over our heads, so he took out a loan to build this house,” his wife Maggi said.

Monthla Ngobeni, 37

Monthla Ngobeni with her daughter, Thetho, at home in Polokwane, Limpopo. Montlha is the first named claimant in the listeriosis class action. Thetho was born with severe health complications due to contracting listeriosis in the womb. (Photo: Thom Pierce)

Monthla Ngobeni is the first named claimant in the court papers. Her daughter Thetho, who is almost two, has undergone four operations since she was born. After contracting listeriosis in her mother’s womb, Thetho developed a condition called Hydrocephalus, a build-up of fluid in the brain. A shunt that drains the fluid has been inserted into Thetho’s head in order to manage her condition and, ultimately, save her life. She will always have a shunt and it will have to be replaced periodically as she grows.

The shunt has been blocked twice so far, forcing the little girl to undergo surgery to remove and replace it. Doctors have told Monthla that Thetho’s development milestones will be significantly delayed. At two, Thetho cannot speak yet. There is no certainty of what the future holds for her.

Monthla has fallen into debt trying to manage both her and Thetho’s medical bills. She currently owes a hospital R26,000 for a hip replacement that she needed due to her own listeriosis infection.

Ephraim Chinula, 64

Ephraim Chinula, Riley’s grandfather, at home in Eldorado Park, Soweto. After his grandson fell ill along with nine other children from their creche, Ephraim rallied the community and the result has been the listeriosis class action. (Photo: Thom Pierce)

Ephraim Chinula is Riley Chinula’s grandfather. Riley Chinula contracted Listeriosis alongside nine other children after eating contaminated meat at their creche in Soweto. The stools from the sick children were investigated and led to the first confirmation of the listeriosis outbreak.

Riley, who was three years old at the time, was the youngest of the kids at the creche. They all had high fevers, stomach cramps, vomiting and diarrhoea. The entire group was taken to Chris Hani Baragwanath hospital, where doctors were ready to receive them.

“I got the impression that the doctors knew what they were dealing with, as they had been briefed by the local clinic, so they already suspected listeriosis.”

Laboratory tests were run on the kids and it was confirmed that the children had indeed contracted listeriosis. When the news broke, the community came together and committed themselves to seeking justice for what they viewed as negligence on the part of Tiger Brands.

Tebogo Ntjana, 31

Teddy and Tebogo Ntjana at home in Midrand, Johannesburg. They lost their second daughter to listeriosis, Tebogo and Teddy are still searching for closure. (Photo: Thom Pierce)

Tebogo became very ill in October 2017 and was taken to hospital where she later suffered a miscarriage, four months into her pregnancy. The doctors took blood samples and told her that she had contracted listeriosis. Not knowing anything about the illness, Tebogo and her husband, Teddy, searched online for it and were alarmed to discover the severity of the condition. “We googled listeria … yoh, we got scared.”

Thinking that it was a singular case, they presumed that they had done something to cause the illness.

One month later, the couple heard the then minister of health, Dr Aaron Motsoaledi, announcing the listeriosis outbreak on the radio. The news came as a relief to the couple who would often buy polony and viennas from a Tiger Brands factory shop in Germiston. They have been blaming themselves for the miscarriage since it happened. “You blame yourself as if you killed your baby,” Tebogo said.

If I had heard about the problem even one week earlier … life today would be very different.’

By CHRISTINE HAUGHNEY and POLITICO

People had been getting sick from eating I.M. Healthy Original Creamy SoyNut Butter for more than two months when Peter Ebb, a 59-year-old Boston lawyer and health enthusiast, went for a run and then ate his usual gluten-free English muffin smeared with soy nut butter.

Later that morning — March 6, 2017 — Ebb saw a message from Amazon, which had sold him the nut butter, that the manufacturer had recalled it for contamination by E. coli bacteria. Ebb threw away a protein drink he had made with the soy nut butter, but didn’t worry too much. The Food and Drug Administration warning that was linked to the email was worded very cautiously: Though serious illnesses might result, even potentially leading to death, “most healthy adults can recover completely within a week.”

Six days later, Ebb was hospitalized and developed a deadly type of kidney failure. Within days, doctors told his wife to send for their children in case they needed to bid him a last goodbye. He survived, but remains unable to work full time and has trouble climbing the stairs. Now , he’s joining with 18 other victims to file claims against the companies responsible and call attention to the inadequacy of the nation’s recall system.

“If I had heard about the problem even one week earlier and stopped then, I might have been able to avoid the disease completely, and life today would be very different,” Ebb said.

A POLITICO investigation found that the I.M. Healthy SoyNut Butter case — which officials at the FDA and the Centers for Disease Control and Prevention have hailed as an improvement over past failures — was nonetheless emblematic of persistent weaknesses in the nation’s food-safety system, some of which haven’t been corrected for two years after being flagged by the agency’s inspector general.

Two months elapsed between the first person sickened by eating I.M. Healthy SoyNut Butter on Jan . 4 and the recall orders that began on March 3 and expanded three more times until March 10. The FDA, working through a national network of labs that identifies outbreaks, pinpointed the contamination on Feb . 22. The nine-day lag time in persuading the manufacturer to begin recalling the tainted products was a significant improvement over previous lag times — which were as high as 165 days in one infamous case, according to the inspector general. But victims maintain that the FDA should have ordered a recall on its own authority, given that a few days or even hours can make a difference in a deadly outbreak.

“They have the authority to mandate a recall and, in theory, that would go more quickly than a voluntary recall,” said Sandra Eskin, who directs food safety at the Pew Charitable Trusts. The FDA has used its authority to order recalls only three times since 2011. Instead, it usually waits to give companies time to decide whether to pull a product from shelves voluntarily.

There were complications, as well, in alerting customers to the fact of the recall. The FDA did not identify which retailers sold the contaminated batches of products. (The agency has traditionally considered this information to be trade secrets, and left it to manufacturer s to alert retailers.) Thus, customers who saw only the FDA’s recall notice had no way of knowing whether the products they bought were among those that were contaminated.

“They just did not effectively execute the recall,” said Eskin. “You really have to monitor where the product is sold and reach out to the sellers online.”

Indeed, the contaminated products remained available for months afterward . Linda Harris, a food-safety microbiologist for the University of California at Davis who researched the case for the victims, said she was able to buy a three-pack of I.M. Healthy Original Creamy SoyNut Butter on Amazon in September, five months after the recall. In addition, some stores either missed or ignored the recall and kept the product on the shelves, Harris discovered.

Part of the problem, critics contend, was a lack of urgency: The cautious language of the FDA’s warning didn’t mention potential illnesses until the third paragraph, and the only instruction offered was to return the product to the place it was bought to receive “a full refund.”

“Amazon didn’t provide the information about the seriousness of the recall and the reason,” contended Sarah Sorscher, deputy director of regulatory affairs for the Center for Science in the Public Interest. “You should not have to click through to a government website while you’re eating breakfast to find out that you have a deadly product in your kitchen.”

The weaknesses in the soy nut butter case were all the more notable because they came 8½ months after the FDA’s inspector general declared that it lacked adequate procedures for handling food outbreaks.

“We found that the FDA did not have an efficient and effective food recall initiation process that helps ensure the safety of the Nation’s food supply ,” Inspector General Daniel Levinson wrote on June 8, 2016. “This issue is a significant matter and requires the FDA’s immediate attention.”

Now, more than two years after the IG’s warning, the agency is still updating its procedures. In congressional hearings and blog posts earlier this year, FDA officials have pledged to take specific steps to improve the recall system, including a proposed rule to alert the public to dangers before recalls are announced. Among the other changes promised include revealing which retailers sold the tainted products “in certain cases,” developing a database to help the agency identify contaminated products and requiring companies to issue public warnings more quickly .

Meanwhile, the Trump administration, seeking to improve safety standards, proposed in mid-June consolidating all food-safety functions in a new agency within the U.S. Department of Agriculture as part of a broader reorganization that would require congressional approval. But few observers expect any congressional action in the near term.

In a statement to POLITICO, FDA Commissioner Scott Gottlieb, who took over the agency in May 2017, just after the soy nut butter recall, stressed his commitment to improving the current system.

“When the FDA learns about potentially unsafe foods in the marketplace, we must act quickly to keep people from getting sick or being harmed,” Gottlieb wrote. “The FDA is taking several policy steps this year as part of a broader action plan to further improve our oversight of food safety, and ensure that all food recalls are initiated, overseen, and completed quickly and effectively to best protect consumers. These and other efforts will increase transparency, empower consumers and ultimately lead to fewer potential recall situations with less people getting sick from contaminated food.”

Ten-year-old Mason Stoll began showing digestive symptoms suggestive of a food-borne illness on Jan . 7, 2017. Within four days, the boy was admitted to Johns Hopkins University Hospital, where his father, Bob, works as a project manager in the Applied Physics Laboratory.

Pretty soon, Mason was clinging to life with complications so severe that he coded four times. As he fought for his life, his parents began speaking with Maryland State Department of Health officials, trying to locate the cause of the contamination and passing on information about everything Mason had eaten, including the soy nut butter.

Like many of the families whose relatives were poisoned by contaminated I.M. Healthy Original Creamy SoyNut Butter, the Stolls were familiar with the threats posed by digestive illnesses: Many of the victims were eating soy nut butter because they had food-borne allergies or diseases like Crohn’s that left them unable to eat nuts or dairy products. For his part, Mason was allergic to peanuts, dairy and eggs. The Stolls were comfortable navigating the public-health bureaucracy. Like other families who spoke to POLITICO, they moved quickly on their own initiative to brief local officials and eventually the CDC, sharing receipts and providing detailed information about the foods they consumed.

More than three weeks after Mason began feeling sick, on Jan . 30, an 8-year-old boy named Trevor Simmons entered a hospital in Santa Clara, California , suffering from E. coli poisoning.

Trevor’s mother, Erin Parisi Simmons, said she spoke within two days to the Santa Clara Health Department and discussed possible sources of the illness. When his condition worsened, Trevor was moved to the intensive-care unit of the Stanford Medical Center. Erin Parisi Simmons recalled with chagrin that she unsuspectingly brought I.M. Healthy Original Creamy SoyNut Butter to the hospital on two different occasions to try to entice Trevor to eat, because it was his favorite food. Fortunately, he was too sick even to take a bite.

Around the same time, a Seattle woman named Nicole Cash purchased soy nut butter for her 11-year-old son, Oliver, and 8-year-old daughter, Hannah: Because of Oliver’s peanut allergy, the soy nut butter was a family staple. By Feb . 21, Hannah was experiencing diarrhea so severe that Nicole had to put her in diapers; when Hannah said she had blood in her stool and began vomiting uncontrollably, Nicole rushed her to the hospital.

Within a few days , Hannah was experiencing kidney failure and had to go on dialysis, and Nicole was talking to the CDC about what products m ight have made the girl so sick.

On March 2, Nicole had her answer, via an unlikely source: A closed group of people on Facebook who were posting reports about the E. coli outbreak said it was caused by soy nut butter, a day before I.M. Healthy began its first recalls.

At the same time, Maryland state officials told Mason Stoll’s family that his E. coli poisoning was caused by I.M. Healthy Original Creamy SoyNut Butter, which contained fecal matter. And California officials delivered the same news to Erin Parisi Simmons.

On March 3, the SoyNut Butter Company began its series of voluntary recalls. Even then, the recall s applied only to products with best-by dates of Aug . 30 and 31, 2018. More batches of soy nut butter were recalled the following day, March 4, and the recall was expanded again on March 7 and 10.

The FDA launched an inspection of the facility in which the soy nut butter was made by a food services company called Dixie Dew. Inspectors were at the Dixie Dew facility from March 3 through March 15, finding that it had rodent droppings, a sink that had not had hot water running in two years and an infestation of flies.

FDA records show that it wasn’t until March 28 that the agency finally suspended operations at the Dixie Dew facility.

Even though the FDA announced that the recall was completed by May 4, batches of the tainted products remained on sale through the fall. Over Labor Day weekend, Harris, the University of California at Davis food-safety microbiologist helping lawyer Bill Marler , who represents 19 victims, bought a three-pack on Amazon for $40. Once she received it, she notified Amazon and the state of California.

“It was a complicated recall, in part because it was a small company,” said Harris. “It still was a product that should not have been on the market.”

The vendor selling the nut butter contacted Harris to tell her that the specific jars she purchased were not affected. Harris had to explain that they were, indeed, part of the lot that was recalled. Amazon pulled the nut butter from its site by the Tuesday after Labor Day.

“They did not scroll to the bottom of the website and click to the link that said expanded recall,” Harris said. “When there are these complex recalls that happen in stages, you can’t have the notice of the expanded recall at the bottom of the page.”

Then, in October, Harris found another online retailer selling the nut butter and contacted FDA. The agency ensured that it was removed quickly. But it took until Oct . 13 for the FDA to issue a statement that read “FDA Reminds Public that All I.M. Healthy Soy Nut Butter Products are Recalled.” The notice added that “retailers cannot legally offer for sale” the product.

The FDA said it responded promptly once it learned that the recalled products were being offered for sale.

“The agency worked quickly to locate any remaining products to ensure they were no longer available to consumers and we put out a public notice to remind consumers of the dangers of these recalled products,” an FDA spokesman wrote in an email.

While the recall may be over, most of the victims are still dealing with long-term health effects and the trauma the experience left on their families.

After Peter Ebb left the hospital on March 30, his family had to reconfigure their house because he has trouble taking the stairs. He remains anemic and his kidneys have not returned to normal. “It’s definitely been a life – changing event, one of the worst,” said his wife, Fran Green.

Nicole Cash’s daughter Hannah has largely recovered, but she still has annual checkups to make sure there are no lingering complications. The Cashes, who are Australian, have reconsidered why they are living so far away from family.

Erin Parisi Simmons said her son is still being seen regularly by Stanford University’s nephrology department and is struggling with post-traumatic stress disorder. Her family is trying to stitch itself back together: She said she lost her tech job because her company was taken over while she was caring for her son. Her husband is trying to restore his stature within his company since some colleagues did not understand why he was off for so long. And their older son is still struggling with feelings of abandonment because his parents spent so much time caring for Trevor.

Bob Stoll reports that Mason’s 14 months of illness have depleted the family’s savings. Mason returned to school full time in April. On June 26, he had cervical spine surgery. And they’re preparing for a kidney transplant in their son’s future.

“It has had an emotional impact,” said Bob. “We’re just trying to piece together what normal looks like again.”

In the months after the outbreak, Marler, the victims’ attorney, filed four lawsuits in federal court in Chicago, after which both the SoyNut Butter Company and Dixie Dew declared bankruptcy. Now , the 19 victims represented by Marler are applying to bankruptcy court to divide up $12 million in insurance and assets. After that, Marler said, he plans to file suit against the retailers and shippers who provided the products.

Terrence Guolee, the lawyer representing the SoyNut Butter Company, said that his client only handled marketing and that Dixie Dew handled the manufacturing.

“My client’s company shut down within a couple of weeks of being notified by the CDC as to what happened because they couldn’t survive any further,” Guolee explained.

Dixie Dew did not respond to requests for comment through its lawyer.

An Amazon spokesperson said in an email that “Customer safety is our highest priority. Third-party sellers are required to comply with all relevant laws and regulations when listing items for sale on Amazon. When sellers don’t comply with our terms, we work quickly to take action on behalf of customers.”

The spokesperson noted that after FDA sent out its March recall, Amazon immediately stopped selling the soy nut butter. Then, six months later, when a third-party seller evaded Amazon’s systems and offered the item again for sale, Amazon took the item down, took action against the seller and notified customers.

While Marler is targeting the companies involved, he also has choice words for the FDA, particularly over its failure to publicize the retailers who sold the tainted products.

“This is, in my view, a classic failure of the FDA’s recall system,” he said. “When you don’t have full transparency, there’s confusion not only from consumers — retailers fall into the same trap. They either ignored the warnings or they simply didn’t understand the recall notice.”

In most cases, the FDA does not publicize the stores, restaurants or online retailers that sold contaminated food, a policy that has raised the ire of some members of Congress. “The primary goal of the FDA is to keep food safe,” declared Rep. Rosa DeLauro (D-Conn.). “FDA’s mission is not to protect the trade secrets of corporations.”

The FDA policy is especially perplexing since the U.S. Department of Agriculture, which is responsible for the safety of meat and poultry, changed its own policy against disclosing retailers nearly a decade ago.

Former USDA Under Secretary for Food Safety Richard Raymond recalls taking on the Grocery Manufacturers Association and other big food lobbies to get the policy changed. “Most of the people at USDA said ‘You won’t get this done. You’re wasting your time,’ ” said Raymond. “The FDA does not have to replow new ground. It was plowed by me.”

Gottlieb, the FDA commissioner, suggested in a statement that his agency is moving toward providing more information about retailers.

“Following on our commitment earlier this year to improve our oversight of food safety and how we implement our recall authorities, the FDA will soon issue guidance on additional information the FDA will now make available during certain recall notifications,” Gottlieb wrote. “Note that the agency recently released detailed distribution information by state for the outbreak linked to pre-cut melon so consumers could better know how to avoid the hazardous recalled food.”

As to lessons learned from the soy nut butter case, he wrote: “Anytime there’s a serious outbreak and consumers are hurt the answer is that we could always have done better. We won’t be able to prevent every outbreak and prevent every consumer from being at risk of a food-borne illness but our aim is a system that continues to reduce these risks and we strive toward that goal. I believe we’re heading in the right direction and over time we will see the benefits of our efforts.”

The Trump administration’s proposal to combine all the government’s food-safety functions into a new agency under USDA will continue to be debated. The notion of creating a new food-safety agency won the early support of key advocates and the House Agriculture Committee Chairman Mike Conaway (R-Texas), though even he suggested that it was just the start of a longer review process.

Changes cannot come quickly enough for the victims of the I.M. Healthy contamination, who remain convinced that tighter government oversight and earlier warnings might have spared themselves or their children.

“When it was happening, we felt helpless,” said Bob Stoll. “Now I don’t feel helpless. I feel angry.”

Leafy green vegetables have become the leading cause of E. coli poisoning. And the federal government still lacks the means, and maybe the will, to take it on.

By Christine Haughney of the Boston Globe

Nathan Parker slept with his son Lucas Parker on a mattress in the living room because of his medically fragile condition. Lucas Parker suffered severe permanent injuries after eating romaine lettuce contaminated with E. coli bacteria during a visit to California in 2018. SUZANNE KREITER/GLOBE STAFF

RICHMOND, BRITISH COLUMBIA — It was the vacation of a lifetime for three generations of the Parker family. For much of 2018, Nathan Parker and his wife, Karla Terry, plotted their road trip from this Vancouver suburb down the Oregon coast to their final destination: Disneyland.

No one was more thrilled than Lucas Parker, the endlessly energetic 2-year-old who knew Mickey Mouse’s hot dog dance by heart. When the big week finally came in early October, Lucas and his two siblings delighted in exploring Disneyland’s Tomorrowland and descending into the darkness of the Pirates of the Caribbean ride.

Then Lucas began to throw up.

By the time his mother changed his diaper that early morning, it was bloody. “He was shaking. He was pale,” said Nathan Parker. “He looked just horrible.”

The Parkers immediately started the 22-hour drive home to seek medical help, but family members were so worried that they stopped at an emergency room in Olympia, Wash.

“My kid is limp in my arms,” he recalled. A doctor told him, “I suspect it’s E. coli.’’

The Parkers had no way of knowing, but Lucas was one of the first victims of a disease outbreak that would shake public confidence in a seemingly benign, even virtuous, vegetable: lettuce. Five bites of a salad the boy shared with his father nearly a week earlier were enough to infect him with the toxic bacteria.

Over the next month, 61 more people in 16 states would be diagnosed with E. coli poisoning — all traced to romaine lettuce. Many more might have been sickened if not for drastic action by Scott Gottlieb, then director of the Food and Drug Administration, who tweeted to a startled nation that they should stop eating romaine lettuce just two days before Thanksgiving 2018.

It was a crisis that faded from the news almost as soon as it was safe to restock store shelves. Still, it should have been the wake-up call that mobilized the government to defeat this threat to food safety.

But the call was muted, and the response so far underwhelming.

More than a year after the Thanksgiving outbreak, the E. coli threat is as real as it ever was, and the government still lacks the means, and maybe the will, to take it on, a six-month Globe review finds. There have been four E. coli outbreaks traced to lettuce since September alone, sickening people in more than two dozen states. Since 2017, there are nearly 500 documented victims and six deaths from leafy green vegetables contaminated by E. coli. Because the disease is difficult to document, the actual numbers are likely many times higher.

In fact, leafy green vegetables now cause more E. coli outbreaks than any other food, including beef, but the government’s efforts to secure the safety of greens remains a pale shadow of its policing of red meat. The Globe review found that the FDA still sometimes seems more concerned with preventing panic than fully informing the public about health hazards in the food supply.

Despite the growing number of outbreaks, the agency remains protective of the growers, taking little enforcement action and sometimes shielding growers suspected of causing outbreaks from bad publicity. Consider:

■ The FDA has called little attention to the surge in E. coli outbreaks from leafy green vegetables. It has been slow to investigate or publicize risks and did not disclose one outbreak to the public until the Globe contacted agency officials about reports of E. coli poisonings. FDA officials insist they planned to disclose the early fall 2019 outbreak all along.

■ The FDA has not punished any farm or distributor in connection with the seven outbreaks traced to lettuce since 2017 even though federal law prohibits the sale of contaminated foods. The agency concluded that three of the outbreaks were linked to a single California lettuce grower but declined to release the name.

■ The FDA staff monitoring lettuce production is just a small fraction of that detailed to the federal oversight of beef: There are 614 FDA field investigators responsible for leafy greens compared to 7,068 workers overseeing beef for the Department of Agriculture. Congress recently gave the FDA $8 million to better handle outbreaks, but the agency doesn’t want to talk about the state of its staffing. When the Globe tried to examine just how understaffed the agency is, officials redacted hundreds of pages of records discussing their internal problems.

■ The agency relies almost entirely on voluntary cooperation from the lettuce industry, an approach that has brought about some safety improvements. But FDA has asked relatively little of the industry and recently delayed implementing rules aimed at preventing E. coli contamination of irrigation water until 2022.

“There is no oversight,” said food safety lawyer Shawn Stevens, who previously represented beef powerhouse Cargill in cases brought by contamination victims and who sees the major differences between the regulation of meat and leafy greens. “There is no one watching (lettuce) being harvested or distributed or transported to the processing facility or being washed or being packaged.”

FDA officials defend their performance, noting that pinpointing the source of E. coli contamination is complex, especially for lettuce. Many of the outbreaks appear unrelated to each other, they said, and investigators have not always been able to conclusively identify the source.

“We did not conclude in any of these outbreaks, which are not all related, how the romaine lettuce (or leafy greens) . . . became contaminated,” said spokeswoman Lyndsay Meyer. “We often are not able to explain the full route of contamination.”

Nathan Parker built an aquatic center for his son Lucas in their home. Nathan said the best days of Lucas’s childhood are behind him. “I still have dreams of him running around here,” said Nathan, but he knows that’s extremely unlikely. SUZANNE KREITER/GLOBE STAFF

The importance of closing that investigative gap is as clear as the potential consequences of E. coli poisoning are devastating. Fifteen months after the Parkers’ trip of a lifetime, Lucas still deals with the long-term consequences: He is legally blind. He cannot speak or move. He requires a feeding tube because he cannot swallow, and his medical records show he suffers a litany of other serious conditions.

Nathan Parker now cares for his son full time. As Lucas rested on his chest in the family’s cramped apartment, the father of four wondered what he could have done differently. He thought he was eating sensibly and encouraging his family to do the same. He never saw any warnings to avoid eating lettuce.

“I had no reason to believe that I couldn’t eat salad,” said Nathan Parker. “It’s America’s best kept secret.”

Green Gold 

ACROSS 101,500 DUSTY and sun-soaked acres of Yuma, Ariz., and California’s Central Coast, farmers grow the greens that fill the salad bowls of much of the nation. Over the faint buzz of insects, row after meticulously planted row of romaine lettuce sprout and bloom like verdant bouquets. Once picked, they are sent to processors, where the leaves are soaked in sudsy baths, packaged, boxed, and shipped to restaurants and supermarkets.

The arrival of these delicate greens on menus and supermarket shelves is welcomed by consumers in these health-conscious times. US lettuce production has grown nearly 50 percent since 2000, reaching 4 billion pounds in 2018, according to federal figures.

Romaine lettuce has become a star among leafy greens, its crunchy leaves most often used in Caesar salad or as the bed for countless foods, from a scoop of chicken salad to a charcuterie platter.

But just as consumers have learned to love lettuce, so has a dangerous type of bacteria. A particular strain of E. coli called “Shiga Toxin producing E. coli” or sometimes STEC O157:H7 for short, is a common contaminant, especially of romaine lettuce. Scientists have found that the thirsty plants, which grow close to the ground, offer easy access for E. coli to latch onto them through soil or by water. Once E. coli has landed on romaine’s leaves, it settles into the plant’s pores and rides along through the long journey from field to salad bowl.

Modern farming has made E. coli and lettuce a perfect match. Lettuce thrives in water-starved areas where finding any water and keeping that water clean are ongoing challenges. When water levels are low, contamination becomes even more of a problem, because irrigation is essential and E. coli often settles into sediments at the bottom of the canals that bring water to crops.

Romaine lettuce grew near Yuma, Ariz., one of the nation’s leading producers of leafy green vegetables. At least one recent E. coli outbreak has been traced to farms in the region. CAITLIN O’HARA/FILE 2016

Under the best of circumstances, E. coli is a maddening bacteria for investigators to trace; the Shiga toxin complicates the process further because it takes its time doing its dirty work. Lucas Parker, as is typical for those infected, did not get sick until a week after he ate contaminated lettuce. By that time, any traces of the contaminated lettuce have often been disposed of, making the path of contamination that much harder to trace.

Also, only a few of those infected become seriously ill, dampening the sense of regulatory urgency. The severity of symptoms varies widely. Some victims have mild diarrhea while a few become gravely ill. Case in point: Lucas Parker’s father, grandmother, aunt, and younger brother all had brief symptoms of vomiting or diarrhea after eating the same salad. But they recovered quickly and are fine.

Perhaps not surprisingly, the vast majority of victims are never even identified. The Centers for Disease Control estimates that 265,000 Americans are sickened by E. coli from all causes each year, though only a few thousand cases are confirmed.

Facing this formidable and many-layered challenge, the FDA deploys a modest, overworked team that struggles to handle the workload, especially during a contamination crisis.

A review of 413 pages of internal FDA e-mails during the October-November 2018 outbreak shows that the FDA team worked day and night and through the Thanksgiving holiday weekend to obtain basic information about the outbreak from the leafy greens industry, which still uses paper documentation for much of its produce tracking.

The agency was also, in that moment, still dealing with a previous E. coli outbreak caused by lettuce, tying up staff. On Nov. 27, 2018, FDA executive Jim Gorny, who had returned to FDA to help prevent illnesses caused by contaminated produce, wrote to colleagues, in a heavily redacted e-mail, “I have no resources to deploy.”

FDA spokeswoman Meyer, who responded on behalf of Gorny, said that because Gorny’s job is an advisory position, “he simply meant that he personally could not send anyone to assist” because he had no direct staff. However, Gorny declined to explain his comments.

“The FDA has a number of agents and staff, but nothing in terms of the number of field inspectors needed,” said Darin Detwiler, a Northeastern University dean with an expertise in food policy. His research has found staff shortages are a chronic problem.

Two days before Thanksgiving in 2018, Scott Gottlieb, then commissioner of the Food and Drug Administration, urged consumers to dispose of all romaine lettuce amid an outbreak of E. coli. It was a stark reminder of the perils of toxic bacteria in the US supply of produce. DREW ANGERER/FILE 2017/GETTY IMAGES

The FDA is further hamstrung by what Gottlieb called the agency’s culture of caution, a fear that putting out a false alarm about an E. coli outbreak could damage public trust in the FDA — and needlessly alarm consumers. They want to be absolutely sure they have found the correct source before going public. But this cautiousness has a price.

In the E. coli outbreak that sickened Lucas in October 2018, the FDA waited three weeks after it first heard about the problem to announce anything. The outbreak finally came to national attention two days before Thanksgiving, when Gottlieb, fearful that millions of Americans were about to eat E. coli-contaminated salads with their holiday meals, tweeted that Americans should just throw away all their romaine lettuce. The health warning triggered a massive disposal of lettuce. Gottlieb felt he had no choice.

“This information was getting into the press,” said Gottlieb. “I thought it was important for the agency to have a voice in speaking to these issues.”

A beefy comparison

IN JANUARY 1993, Jack in the Box restaurants triggered one of the worst E. coli outbreaks in US history when workers mostly in the Seattle area did not follow newly created standards to cook its burgers. Detwiler, who was then living in Seattle, found himself caught in the crisis.

Detwiler’s toddler son, Riley, had never even eaten a hamburger. But he picked up E. coli in day care from another child whose parents both worked at Jack in the Box. Riley was one of four who died in the outbreak.

The tragedy upended Detwiler’s life, wrecking his marriage and turning him into an influential advocate for food safety. It also brought unprecedented pressure on the agency charged with keeping meat safe, the Department of Agriculture. New inspectors were hired, and a sophisticated tracking system called PulseNet was launched, bringing together data from 82 labs in all 50 states and accelerating identification of emerging outbreaks and their source.

It was a much-needed regulatory revolution — but it had little impact on the oversight of leafy green vegetables.

These changes “had nothing to do with produce,” said Detwiler. “I actually think that in terms of food safety, you’re better off eating ground beef than you are eating leafy greens today.”

Indeed, since the late 1990s, leafy green vegetables have overtaken beef as a source of E. coli poisonings. Data compiled by the Centers for Disease Control show that, from 2009 to 2018, almost twice as many people suffered E. coli poisoning from leafy green vegetables compared to beef.

Detwiler notes that most produce inspectors are concentrated overseas and at borders, forcing the FDA to delegate most monitoring to state agencies. Most farms are inspected every three years. By comparison, beef has a much more clear-cut system. Federal officials are assigned to individual plants to oversee daily inspections of the process.

After beef leaves the packing plant, the industry employs sophisticated tracking systems that enable investigators to more easily isolate the source of an outbreak without disrupting the nation’s entire beef supply anytime an outbreak occurs. By comparison, both FDA officials and lawyers involved with leafy green outbreaks note that farmers, distributors, restaurants, and retailers still keep paper files and have no computerized way to trace the source.

The Agriculture Department also discloses far more information about retailers that are selling contaminated beef so that customers have better information about whether their local supermarket has been affected. The FDA releases only limited information about retailers selling potentially contaminated produce, arguing that the disclosure could reveal “trade secrets” or information desired by competing stores. The FDA has not identified individual stores selling contaminated lettuce in any of the outbreaks.

But the lettuce industry never had a galvanizing event like the Jack in the Box outbreak to give urgency to the need for reforms. Detwiler predicts it’s only a matter of time. “Pathogens like E. coli, they do not discriminate,” he said.

Missed opportunities

EMERGENCY ROOM STAFF at New Jersey hospitals were the first to notice what would turn out to be the biggest E. coli outbreak linked to lettuce in a decade. In late March 2018, multiple patients with gastro-intestinal symptoms said they had eaten at a Panera restaurant, and doctors began asking other ER patients whether they, too, had visited the chain. Some had, including one woman who tested positive for E. coli.

The outbreak would officially sicken 240 people and kill five across 36 states, a toll that rivaled the Jack in the Box outbreak. But the FDA was slow to catch on that an outbreak was unfolding, first hearing about the growing number of illnesses on April 5, 2018, when a county health official in New Jersey confirmed to a reporter they were investigating two E. coli cases traced to a Panera. By then, the Centers for Disease Control had seen a rise in E. coli cases on PulseNet, but CDC officials said nothing to the FDA until April 4 because “the source of the illnesses was unclear at the time,” a CDC spokesman said.

Despite the specific warnings from New Jersey health officials, the FDA waited another six days before it said anything publicly. An FDA official explained to the Globe that they waited to make an announcement in part because “we did not have a specific location where the romaine was coming from.”

The delays didn’t stop there. The agency got a break in April when eight inmates at an Alaska prison got E. coli poisoning that was traced to some lettuce from Harrison Farms in Yuma, Ariz. That immediately narrowed the search for the cause of at least some poisonings, holding out the promise that, this time, FDA might move quickly.

But the FDA did not send field inspectors to the 140-mile stretch of Arizona farms until June 4, two months after their first call from the New Jersey Department of Health. Meyer, the FDA spokeswoman, said the agency initially did not have enough information to go on.

Karla Terry had her hands full with children, Seth, 4 months, Alex, 2, and Lucas, 3. Lucas became so gravely ill from eating contaminated romaine lettuce that doctors had prepared Terry and her husband, Nathan Parker, for his death. They had Lucas baptized and waited at his bedside. “He never really woke up from the coma,’’ Parker said. SUZANNE KREITER/GLOBE STAFF

But she said the FDA treated the episode as “a major outbreak with all hands on deck,” including nearly two dozen workers in the field and more staff at headquarters.

Eventually, FDA officials found three samples of E. coli O157:H7 in water within a mile of the Wellton irrigation canal that provides water for the lettuce fields in Yuma. The same strain of E. coli was found one mile upstream, next to a large lot where thousands of Holsteins cattle were fed.

Stephen Ostroff, then a top FDA commissioner overseeing the case, said agency investigators had to negotiate with the feedlot owners for access to the land and ended up with only six samples from the manure and water, an amount Ostroff called “inadequate to fully assess” whether E. coli was present.

A vice president of the company, Five Rivers Cattle Feeding, insisted that FDA investigators were welcome to take as many samples as they wanted and that the company cooperated fully.

Officials from Five Rivers as well as the National Cattlemen’s Beef Association went to FDA headquarters in September 2018 to press their case that the feedlot didn’t cause the E. coli outbreak. Ostroff, who attended the meeting, said industry officials thought there was considerable uncertainty about the cause.

In the end, Gottlieb concluded, mildly, that the cattle feed operation was “one potential source” that could have caused the outbreaks.

No one was ever penalized in the spring 2018 outbreak. No lettuce was ever officially recalled.

Some important changes, however, did follow that outbreak. The Leafy Greens Food Safety Task Force, composed of more than 100 industry representatives, called for longer distances between romaine lettuce fields and large-scale cattle feeding operations.

Protecting the source

AT LEAST SOME of the cases in the Thanksgiving outbreak — the one that sickened Lucas — were eventually traced back to one California farm. It is a vast fifth-generation family business located roughly 75 miles north of Santa Barbara that local press reports have said employs hundreds of workers to tend to thousands of acres.

Adam Brothers had sent its harvested lettuce seven miles away to a distributor, United Foods, in Nipomo, Calif. Then United Foods shipped an order of romaine 11 miles away to Gino’s Pizza, which is where the Parkers placed their delivery order for salad and pizza.

The FDA found that the chemical tablets Adam Brothers used to sanitize its irrigation water had not dissolved, leaving the water dirty. Though investigators could not determine where the E. coli had come from, the farm’s failure to fully treat the water allowed the bacteria to survive, contributing to an outbreak that sickened at least 62 people in the US and another 29 in Canada, including Lucas.

Nonetheless, FDA took no action against Adam Brothers, and even allowed the farmers to announce their own recall of potentially tainted red and green leaf lettuce and cauliflower. The farm’s Dec. 13, 2018, announcement of an outbreak did not mention that Adam Brothers had been the source of the deadly contamination. It did, however, mention other Adam Brothers vegetables subject to the recall, noting that “no illnesses have been reported” from eating those.

FDA spokesman Peter Cassell defended Adam Brothers’ recall statement in an e-mail, saying he did not find it misleading. Cassell’s FDA colleague, Meyer, reiterated that “Adam Brothers was cooperative and agreed to a voluntary recall” of other vegetables it grew. That meant “no additional action was needed.”

Adam Brothers officials declined to speak to the Globe, but one of the brothers, Peter Adam, seemed to take the whole episode in stride, telling a local television outlet that the recall was nothing special.

“This isn’t the first time we’ve been under the microscope,” Adam said in the February 2019 interview. “This is part of life in vegetable world in California today and maybe just in business in general in the United States.”

The produce industry took some additional steps.

In September, 100 public health and industry professionals released a report, facilitated by food producers, with specific suggestions on how to avoid outbreaks, encouraging growers to follow higher standards for issues such as the water they irrigate with. As of Jan. 1, the task force instructed all leafy green suppliers to place scannable labels on their products. Industry officials say the vast majority have complied.

Jennifer McEntire, vice president of food safety and technology for United Fresh, one of the organizations that worked on the report, stressed industry’s commitment to helping federal authorities solve the E. coli problem.

Contaminants, the report said, must be traced to their source and eliminated quickly, through the combined efforts of business and government. Otherwise, “we are preordained to repeat those results and ultimately may find ourselves in the middle of yet another outbreak.”

Nathan Parker delivered one of six morning medications through the feeding tube for his son Lucas. Parker quit his job to care for his son full time. SUZANNE KREITER/GLOBE STAFF

What does the public need to know?

ANOTHER OUTBREAK CAME very soon, posing a test of the FDA’s new commitment to protect consumers of leafy greens.

What followed was a repeat of the old patterns, with the FDA trailing a state agency — and the Globe — in taking full notice of the new threat,

The New York State Health Department confirmed to the Globe that it had identified one case tied to a multistate outbreak. Within hours of that announcement, a CDC spokesman confirmed to the Globe that the outbreak had grown to sicken 23 people across 12 states between July and September.

Still, the CDC issued no public warning, a spokesman said, because the “romaine lettuce eaten by sick people was past its shelf life and no longer available for sale.” The FDA took a similarly low-key posture, saying it made no sense to notify the public about an outbreak that was over.

“We don’t have anything specific to tell consumers,” an FDA official told the Globe. “We can’t point to a company and say their lettuce is bad.”

But the night before FDA officials believed the Globe was about to report on the outbreak, and the agency’s passive response, they changed course. FDA contacted the Safe Food Coalition, a group of consumer advocates and foodborne illness victims, to say it would soon announce that a recent outbreak had come and gone.

Frank Yiannas, a former Walmart executive and the current FDA deputy commissioner for Food Policy and Response, then personally called members of the foodborne illness community to say he had planned to announce the outbreak all along. Meyer reiterated that claim in a statement. “FDA was always planning to report, as we did, that an outbreak occurred,” the spokeswoman said. “It was simply not an urgent advisory.”

Since then, the FDA has faced three E. coli outbreaks affecting lettuce that state health departments in Maryland and Wisconsin helped them solve. Combined they sickened 193 people in 29 states. All three outbreaks were traced back to a single grower in Salinas — California’s largest growing region with nearly 60 percent of the state’s total lettuce acreage.

The FDA, citing lingering uncertainty, declined to identify the “common grower” when asked by the Globe.

“It’s still too early to determine whether this grower was in fact the source of this outbreak,” said FDA spokeswoman Meyer.

Karla Terry and Nathan Parker traveled with their children last month to have photos taken with Santa. Lucas (right) became uncomfortable and cried as they made their way through the Home Depot parking lot. They missed last year’s holiday photo because Lucas was in the hospital battling the effects of the contaminated lettuce he ate. SUZANNE KREITER/GLOBE STAFF

Lucas

SINCE LUCAS PARKER was discharged from the hospital in March 2019, he has rarely moved from his family’s couch. On a recent morning, Lucas had his right arm wrapped around his gold-colored Care Bear. His eyes flitted toward the sounds of the History Channel in the background, while Ginger, his grandma’s Chihuahua, and Bella, the Parkers’ cat, protectively encircled him. The only sounds Lucas seems to make are mournful, guttural cries when he needs help.

Lucas’s relatives search for hopeful signs: Lucas’s aunt asked him if he had a busy day and it looks as if he was nodding. Nathan Parker said Lucas lights up at the sounds of wrestling on television. His mother pressed a chocolate doughnut to his lips, and he cooed.

Before his debilitating sickness, Lucas loved to watch Star Wars movies with his father, Nathan, who still props up a phone for Lucas to watch. SUZANNE KREITER/GLOBE STAFF

The Parkers’ lawyer, Bill Marler, said he is getting as many as three calls a week about people who have contracted E. coli from eating romaine lettuce. Ninety percent of his E. coli cases now involve lettuce instead of ground beef. The damage has been so devastating that they have fetched settlements for more than $15 million.

But that number, while large, is far from adequate, given the number of victims and the cost of the medical care Lucas and others will require. Lucas, despite his dire condition, could live a long life. Will the expense and complexity of his care one day outrun his family’s capacity?

Nathan Parker wonders: What will happen to his broader family, when he can no longer care for his son?

“Everybody is gonna be affected by this in their own way,” he said. “This is like casting a stone in a pond and watching ripples. You know, those ripples just get bigger and bigger and bigger.”