Publisher’s Platform: A few Senators seems bothered by deadly pathogens in infant formula
“Never let a good crisis go to waste.”
I was heartened a few days ago to see someone in politics being concerned about a bacterial contamination event that has sickened at least four with either Cronobacter sakazakii or Salmonella, hospitalizing all and leaving one infant dead. The letter from two powerful Senate Democrats calls on Abbott, and presumably the FDA and Public Health, to explain how this could have happened and why it took so long for a recall.
The subsequent Abbott recall, coming months after the first reported illness (note: inexplicably, Cronobacter sakazakii is NOT reportable in most states) has caused a worldwide recall of Abbott’s Similac, Alimentum, and EleCare infant formula; causing worried parents to scramble for alternatives and wondering if their baby had been impacted.
It is probable that more illnesses will be uncovered that occurred during the intervening months as the product continued to be sold despite after an FDA inspection in September 2021 (tip-o-pen to efoodalert), when the FDA inspector cited Abbott for a single issue, stating:
- Personnel working directly with infant formula, its raw materials, packaging, or equipment or utensil contact surfaces did not wash hands thoroughly in a handwashing facility at a suitable temperature after the hands may have become soiled or contaminated.
- You did not maintain a building used in the manufacture, processing, packing, or holding of infant formula in a clean and sanitary condition
- An instrument you used to measure, regulate, or control a processing parameter was not properly maintained.
- You did not monitor the temperature in thermal processing equipment at a frequency as is necessary to maintain temperature control.
- You did not install a filter capable of retaining particles 0.5 micrometers or smaller when compressed gas is used at a product filling machine.
In its recall notice, Abbott acknowledged having found “evidence of Cronobacter sakazakii in the plant in non-product contact areas, ”but denied having found the bacterium in the finished product. This would appear to be in direct contradiction to the FDA’s revelation that the company had recorded the destruction of the product in the past due to the presence of Cronobacter. Specifically, “a review of the firm’s internal records also indicates environmental contamination with Cronobacter sakazakii and the firm’s destruction of product due to the presence of Cronobacter.”
We will see if this is more than just a letter-writing campaign, or if the Senators hold anyone to account. It is hard to get policy makers’ attention without a crisis and once the crisis passes, it has been my sad experience that everyone seems to just move along. Perhaps it is just crisis enough.
Not to take anything away from what these two Senators might do, but hey, here are some ongoing food safety problems that are ongoing with little if any interest by those in power that could actually do something. Here are some examples of crises going on now without the media coverage that focuses Senator’s attention:
In 2019 we filed a Petition for an Interpretive Rule declaring ‘Outbreak’ Serotypes of Salmonella enterica subspecies enterica to be Adulterants Within the Meanings of 21 U.S.C. § 601(m)(1) and 21 U.S.C. § 453(g)(1). In essence, each of the 31 Outbreak Serotypes of Salmonella we seek to be deemed adulterants has a demonstrable history associated with either an illness outbreak or a product recall and is proven to be injurious to human health. Altogether, these 31 Outbreak Serotypes currently account for the greatest number of Salmonella illnesses. As Salmonella evolves, however, serotypes of public concern could be added (as was the case with the “Big Six” non-O157 strains of STEC E. coli) or subtracted from a variable list of outbreak serotypes.
Each year, CDC’s Interagency Food Safety Analytics Collaboration (IFSAC) generates a report that uses outbreak data to produce annual estimates for foods responsible for foodborne illnesses caused by four pathogens, including Salmonella. In its latest publication, IFSAC, using data from 1,532 foodborne disease outbreaks that occurred from 1998 through 2019, reported that chicken is responsible for 16.8% of all Salmonella illnesses, making it the single most important source of Salmonella illnesses of any food category. Chicken and turkey, taken together, account for over 23% of those illnesses.
The percentage of Salmonella illnesses associated with poultry has increased year over year. In 2015, IFSAC reported that chicken was the second-largest source of Salmonella illnesses, responsible for 11.8% of Salmonella illnesses. The following year, IFSAC reported that chicken was responsible for 12.7% of Salmonella illnesses. In 2017, the chicken was linked to 14% of foodborne illnesses attributed to Salmonella. The following year, in 2018, chicken became the number one source of Salmonella illnesses (dethroning seeded vegetables), responsible for 14.3% of illnesses.
Despite Salmonella causing countless illnesses and deaths, I have seen no Senate letter calling the chicken producers and the USDA/FSIS to answer the simple question: Why is it allowable to knowingly sell meat tainted with Salmonella to the public? For a deeper dive, please take a look at PBS Frontline: Trouble with Chicken, The New Yorker: A Bug in the System, and The Washington Post: He helped make burgers safer. Now he is fighting food poisoning again.
Seems like there might be some good questions to be asked – if only there was a crisis.
And let’s not forget about leafy greens. Perhaps it is time for a Senate letter or a hearing or two on why salads continue to make us ill.
In 2018, the CDC reported that a total, 240 people infected with the outbreak strains of E. coli O157:H7 were reported from 37 states. Illnesses started on dates ranging from March 13, 2018, to August 22, 2018. Ill people ranged in age from 1 to 93 years, with a median age of 26. Sixty-six percent of ill people were female. Of the more than 201 people with information available, 104 were hospitalized, including 28 people who developed the hemolytic uremic syndrome, a type of kidney failure. Five deaths were reported from Arkansas, California, Minnesota, and New York.
In addition to this outbreak being unusually large, the case-patient clinical course was unusually severe. The proportion of case patients developing HUS (12.7%) was twice as high as previous outbreaks of Shiga toxin-producing E. coli O157 (6.3%). There were five deaths in this outbreak (2.2%), which is almost four times higher than expected (0.6%). This could be explained by the strain’s Stx2a toxin subtype, which produces more virulent toxins than other types. Outbreaks with Stx2 toxin are more likely to result in increased rates of HUS.
Epidemiologic, laboratory and traceback evidence indicated that romaine lettuce from the Yuma growing region was the likely source of this outbreak.
The FDA and state and local regulatory officials traced the romaine lettuce to 23 farms and 36 fields in the Yuma growing region. The FDA, along with CDC and state partners, started an environmental assessment in the Yuma growing region and collected samples of water, soil, and manure. CDC laboratory testing identified the outbreak strain of E. coli O157:H7 in water samples taken from a canal in the Yuma growing region. WGS showed that the E. coli O157:H7 found in the canal water is closely related genetically to the E. coli O157:H7 from ill people. Laboratory testing for other environmental samples is continuing. FDA is continuing to investigate to learn more about how the E. coli bacteria could have entered the water and ways this water could have contaminated romaine lettuce in the region.
Leafy greens have been a source of E. coli-related illnesses for decades, and there have been concerns raised about lettuce grown in the Yuma region. The CDC reports as of May 20, 2010, a total of 26 confirmed and 7 probable cases related to an E. coli O145 outbreak have been reported from 5 states since March 1, 2010, linked to shredded romaine grown in Yuma. In the FDA’s “Environmental Assessment Report in December 2010,” the authors determined:
that the R.V. park is a reasonably likely potential source of the outbreak pathogen based upon the evidence of direct drainage into the lateral irrigation canal; the moist soil in this drainage area; the multiple sewage leach systems on the property; the presence of other STEC found in the lateral irrigation canal and in the growing fields of the suspect farm; and the fact that the section of the lateral canal downstream from the R.V. park supplies water to only one other farm in addition to the suspect farm.
Two pumps are located on the main Wellton canal near the lateral canal split that supplies water to fields of the suspect farm; one gasoline-powered pump on a trailer and one permanent electric pump with an attached hose. The electric pump supplies canal water to an attached open-end hose. The site is not secured from vehicles and the hose pump is also unsecured. At the time of this investigation, there were people living in recreational vehicles on undeveloped land within one mile of the hose pump. The fact that this area is open to vehicles and the pump and hose are unsecured makes it possible for an R.V. owner to dump and rinse out their R.V. septic system into the main Wellton canal at the lateral canal split that supplies the farm. The ground near the hose pump shows erosion evidence of drainage into the Wellton canal. Soil collected from this erosion site tested positive for other Stx2-producing STEC but did not match the outbreak strain.
In a 2009 “Survey of Selected Bacteria in Irrigation Canal Water – Third Year” written by Jorge M. Fonseca, he correctly predicted the human and industrial problems that were likely to plague the Yuma lettuce growers:
Despite the fact that no Arizona lettuce grower has been involved in any contaminated-lettuce outbreak, it is of paramount importance to determine the reasons why Arizona lettuce is regarded as safe. This can help lower the possibilities of any emerging problem and prevent catastrophic damage to the industry, as it has occurred in other regions when no control was taken to reduce risks of contaminated products.
And, then the 2018 romaine lettuce E. coli outbreak struck, sickening hundreds in the United States and Canada with dozens suffering from acute kidney failure with five reported deaths. Once again, the Wellton Irrigation Canal was the focus of attention in the “Memorandum to File on the 2018 Environmental Assessment”:
During this EA, three samples of irrigation canal water collected by the team were found to contain E. coli O157:H7 with the same rare molecular fingerprint (using whole-genome sequencing (WGS)) as the strain that produced human illnesses (the outbreak strain). These samples were collected from an approximately 3.5-mile stretch of an irrigation canal in the Wellton area of Yuma County that delivers water to several of the farms identified in the traceback investigation as shipping romaine lettuce that was potentially contaminated with the outbreak strain. The outbreak strain was not identified in any of the other samples collected during this EA, although other pathogens of public health significance were detected.
Not surprisingly, the FDA in its full “Environmental Assessment of Factors Potentially Contributing to the Contamination of Romaine Lettuce Implicated in a Multi-State Outbreak of E. coli O157:H7,” concluded that the risk of environmental contamination was in fact a well-known and long-standing risk:
Food safety problems related to the raw whole and fresh-cut (e.g., bagged salad) leafy greens are a longstanding issue. As far back as 2004, FDA issued letters to the leafy greens industry to express concerns about continuing outbreaks associated with these commodities. FDA and our partners at CDC identified 28 foodborne illness outbreaks of Shiga-toxin-producing E. coli (STEC) with a confirmed or suspected link to leafy greens in the United States between 2009 and 2017. This is a time frame that followed industry implementation of measures to address safety concerns after a large 2006 outbreak of E. coli O157:H7 caused by bagged spinach. STEC contamination of leafy greens has been identified by traceback to most likely occur in the farm environment.
Contamination occurring in the farm environment may be amplified during fresh-cut produce manufacturing/processing if appropriate preventive controls are not in place. Unlike other foodborne pathogens, STEC, including E. coli O157:H7, is not considered to be an environmental contaminant in fresh-cut produce manufacturing/processing plants.
Well-established reservoirs for E. coli O157:H7 are the intestinal tract of ruminant animals (e.g., cattle, goats, and deer) that are colonized with STEC and shed the organism in manure. Ruminant animals colonized with STEC typically have no symptoms. In contrast, human infection with E. coli O157:H7 usually produces symptomatic illness often marked by severe, often bloody, diarrhea; severe adverse health outcomes or even death can result. Humans shed E. coli O157:H7 in the stool while ill and sometimes for short periods after symptoms have gone away, but humans are not chronic carriers. Various freshwater sources, including municipal wells, and recreational water, have been the source of E. coli O157:H7 infections in humans, as has contact with colonized animals at farms or petting zoos. However, most E. coli O157:H7 infections in humans occur from consuming contaminated food.
In its summary of its environmental findings (also summarized in a November 1, 2018 communication to public officials), the “FDA [in part] identified the following factors and findings as those that most likely contributed to the contamination of romaine lettuce from the Yuma growing region with E. coli O157:H7 that caused this outbreak”:
- FDA has concluded that the water from the irrigation canal where the outbreak strain was found most likely led to contamination of the romaine lettuce consumed during this outbreak.
- There are several ways that irrigation canal water may have come in contact with the implicated romaine lettuce including direct application to the crop and/or use of irrigation canal water to dilute crop-protection chemicals applied to the lettuce crop, either through aerial or ground-based spray applications.
- How and when the irrigation canal became contaminated with the outbreak strain is unknown. A large animal feeding operation is nearby but no obvious route for contamination from this facility to the irrigation canal was identified. Other explanations are possible although the EA team found no evidence to support them.
Seems like there might be some good questions to be asked – if only there was a crisis.
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