The facility had multiple issues as was detailed in the FDA 483 report. although the ultimate ingredient source was not identified.
Items of note from the report:
- The was the first time a peanut butter alternative such as soy nut butter has been implicated as the source of an outbreak of STEC infections in the United States
- More than one-quarter of the case patients developed HUS, and all but 1 were children <18 years old.
- CDC identified a subcluster in an Oregon child care center where secondary transmission might have contributed to the spread of the outbreak -this serves as a reminder to child care providers of the importance of appropriate hand-washing and hygiene practices to prevent the spread of infections in these settings and that children with STEC O157 infection should be excluded from attending child care centers until 2 stool cultures (obtained at least 48 hours after antimicrobial therapy, if given, has been discontinued) have negative results for STEC.
- This outbreak serves as a reminder of the important role manufacturers play in preventing foodborne outbreaks and the role brand owners have in overseeing their product safety. Soy nut butter is a ready-to-eat food with a long shelf life, and multiple foodborne outbreaks have been identified over the past few years linked to other ready-to-eat, long-shelf-life foods, such as a powdered meal replacement product, sprouted nut butters, and chia powder.
- Product contamination may have occurred through use of a contaminated ingredient or cross-contamination from contact with contaminated equipment or surfaces during manufacturing. However, because ingredient sample results were negative and multiple objectionable conditions were identified during the facility’s inspection, it was not possible to determine which specific route led to product contamination.
https://pediatrics.aappublications.org/content/early/2019/09/12/peds.2018-3978
A Multistate Outbreak of E Coli O157:H7 Infections Linked to Soy Nut Butter
Abstract
BACKGROUND: In 2017, we conducted a multistate investigation to determine the source of an outbreak of Shiga toxin-producing Escherichia coli (STEC) O157:H7 infections, which occurred primarily in children.
METHODS: We defined a case as infection with an outbreak strain of STEC O157:H7 with illness onset between January 1, 2017, and April 30, 2017. Case patients were interviewed to identify common exposures. Traceback and facility investigations were conducted; food samples were tested for STEC.
RESULTS: We identified 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 child care 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.
CONCLUSIONS: This investigation identified soy nut butter as the source of a multistate outbreak of STEC infections affecting mainly children. The ensuing recall of all soy nut butter products the facility manufactured, totaling >1.2 million lb, likely prevented additional illnesses. Prompt diagnosis of STEC infections and appropriate specimen collection aids in outbreak detection. Child care providers should follow appropriate hygiene practices to prevent secondary spread of enteric illness in child care settings. Firms should manufacture ready-to-eat foods in a manner that minimizes the risk of contamination.
BACKGROUND: In 2017, we conducted a multistate investigation to determine the source of an outbreak of Shiga toxin-producing Escherichia coli (STEC) O157:H7 infections, which occurred primarily in children.
METHODS: We defined a case as infection with an outbreak strain of STEC O157:H7 with illness onset between January 1, 2017, and April 30, 2017. Case patients were interviewed to identify common exposures. Traceback and facility investigations were conducted; food samples were tested for STEC.
RESULTS: We identified 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 child care 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.
CONCLUSIONS: This investigation identified soy nut butter as the source of a multistate outbreak of STEC infections affecting mainly children. The ensuing recall of all soy nut butter products the facility manufactured, totaling >1.2 million lb, likely prevented additional illnesses. Prompt diagnosis of STEC infections and appropriate specimen collection aids in outbreak detection. Child care providers should follow appropriate hygiene practices to prevent secondary spread of enteric illness in child care settings. Firms should manufacture ready-to-eat foods in a manner that minimizes the risk of contamination.
Discussion (section of the paper)
Epidemiological, traceback, and laboratory evidence identified soy nut butter as the source of a multistate outbreak of STEC O157 infections affecting mainly children. This is the first time a peanut butter alternative such as soy nut butter has been implicated as the source of an outbreak of STEC infections in the United States. Quick investigative work by local, state, and federal agencies led to initial product recalls and consumer advisories within 2 weeks of initiating the investigation, likely preventing additional illnesses.
This outbreak emphasizes the critical role health care providers play in detecting and investigating enteric illness outbreaks. Quick identification and subtyping of bacteria such as STEC is essential to detecting outbreaks. Prompt diagnosis by clinicians not only aids treatment but is important for timely reporting of illnesses to public health officials. The use of CIDTs, such as multiplex polymerase chain reaction assays, immunoassays, or nucleic acid amplified tests, in clinical settings is increasing because CIDTs allow clinicians to rapidly diagnose and treat the cause of a patient’s diarrheal illness. However, because PulseNet requires a bacterial isolate for molecular subtyping, increasing use of CIDTs without culturing specimens with positive results to isolate and characterize bacterial strains may hinder PulseNet’s ability to detect foodborne outbreaks, particularly geographically dispersed outbreaks.In this outbreak, we likely only recognized that the 2 additional ill people with STEC infection diagnosed by CIDT alone or HUS without an isolate were likely associated with the multistate outbreak because soy nut butter was an unusual food. To facilitate rapid and reliable outbreak detection, several public health experts recommend that patient specimens with positive results for STEC by CIDT be cultured and isolates be sent to a public health laboratory for further characterization.35,38,39
This outbreak also highlights the risk STEC infections pose to the pediatric population. More than one-quarter of the case patients developed HUS, and all but 1 were children <18 years old. The minimum infective dose for STEC can be low, which increases secondary transmission risk in settings of close person-to-person contact.40,41 We identified a subcluster in an Oregon child care center where secondary transmission might have contributed to the spread of the outbreak given the wide range of onset dates and the fact that soy nut butter was not served there. Although we did not determine how all case patients became infected with STEC, the use of compost buckets that were accessible to toddlers and the large number of diapered children are risk factors for infection. We hypothesize that case patients might have become infected from eating leftover soy nut butter at the lunch table, cross-contamination due to exposure to the compost bucket, person-to-person transmission, or a combination of these. This outbreak serves as a reminder to child care providers of the importance of appropriate hand-washing and hygiene practices to prevent the spread of infections in these settings.42 Additionally, children with STEC O157 infection should be excluded from attending child care centers until 2 stool cultures (obtained at least 48 hours after antimicrobial therapy, if given, has been discontinued) have negative results for STEC.7
This investigation is subject to several limitations. First, we were unable to determine if case patients in the Arizona and Oregon child care center subclusters had eaten soy nut butter through interviews because of their young ages. However, because they were infected with the novel outbreak strain and had several opportunities for primary or secondary exposure at the child care center, we believe it is exceeding unlikely that they would all have an unknown exposure outside the child care center. Additionally, although we identified Brand A soy nut butter as the cause of the outbreak, we were unable to determine how it became contaminated with STEC. Product contamination may have occurred through use of a contaminated ingredient or cross-contamination from contact with contaminated equipment or surfaces during manufacturing. However, because ingredient sample results were negative and multiple objectionable conditions were identified during the facility’s inspection, it was not possible to determine which specific route led to product contamination. Given the complexities of outbreak investigations and the time delay from when the contaminated product was manufactured to facility inspection, it is generally uncommon to definitively identify routes of product contamination. Regardless, successfully identifying the contaminated product led to multiple product recalls and the suspension of the firm’s ability to sell or distribute food, ultimately stopping the outbreak.
Finally, this outbreak serves as a reminder of the important role manufacturers play in preventing foodborne outbreaks and the role brand owners have in overseeing their product safety. Soy nut butter is a ready-to-eat food with a long shelf life, and multiple foodborne outbreaks have been identified over the past few years linked to other ready-to-eat, long-shelf-life foods, such as a powdered meal replacement product, sprouted nut butters, and chia powder.43–45 Ready-to-eat foods are those that consumers would not typically further treat or process in a way that would minimize bacterial risk before eating (eg, cooking to temperature).46 In all these instances, consumers presume foods are safe to eat and do not require further processing or cooking, so they rely on manufacturers to produce foods in a way that eliminates bacterial contamination. Ready-to-eat foods, particularly those often fed to children, should be manufactured to minimize the risk of bacterial contamination. In addition, it is always important that consumers practice good hygiene to prevent the spread of infectious diseases, particularly in settings with vulnerable populations, such as child care centers.
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