As of June 1, the Centers for Disease Control and Prevention (CDC) and the U.S. Food and Drug Administration stated that they could not determine the site-specific origins of the contamination by the E. coli (STEC) 0157 of romaine lettuce that began in late 2017. Consumer Reports had advised its readers to avoid eating romaine lettuce on January 3, about seven weeks after U.S. officials had identified the lettuce as the probable cause of a foodborne illness outbreak that has sickened nearly 200 consumers, required at least 89 hospitalizations, and has claimed five lives. According to a July 2016 CDC report, E. coli contamination of meat and horticulture products accounted for about four percent of all foodborne illness hospitalizations, an estimated 2,138 in 2015.
In a May 31 blog, FDA Commissioner Dr. Scott Gottlieb and Deputy Commissioner for Food and Veterinary Medicine Stephen Ostroff explained how FDA conducted its traceback program, noting that chain of custody records were mostly on paper and sometimes incomplete. After more than six weeks of CDC and FDA investigations into another romaine lettuce caused outbreak in April, they could only conclude, “Any contaminated product from the Yuma [AZ] growing region has already worked its way through the food supply and is no longer available for consumption.”
If these words were intended to comfort consumers, a highly-detailed diagram in the blog, redacted to prevent publication of what FDA regarded as Confidential Business Information (CBI) (i.e. the commercial contamination sites), will irritate, if not infuriate, them. Bill Marler, publisher of Food Safety News and a litigator on behalf of the victims of foodborne illness, has discovered some of the consumption and distribution points of the contaminated lettuce and promises to publish more names as he obtains them, including outlets of Red Lobster, Panera Bread, Papa Murphy’s, Texas Roadhouse and Freshway Foods, a produce distributor.
No matter how much restitution Marler or other litigators can obtain for their clients, most likely in out of court settlements with no public record, FDA’s policy of treating public health information as CBI means that FDA is very unlikely to provide the kind of evidence in court that will aid the victims or force changes in produce industry growing, processing, record-keeping and product distribution practices. As in past foodborne illness outbreaks, the horticulture industry will form a new task force to work with FDA to take voluntary measures to improve their practices and prevent foodborne illness.
Frustrated with the FDA’s slow and incomplete traceback program, seven years after President Barack Obama signed the Food Safety Modernization Act (FSMA), nine consumer and food safety groups wrote to Dr. Gottlieb on May 24 to urge the FDA to write a rule, mandated by the FSMA, to classify leafy green vegetables as a high-risk food requiring greater regulatory scrutiny:
The repeated outbreaks linked to produce and leafy greens since passage of FSMA leave no doubt that these products belong in the “high-risk” category. The FDA should act promptly to improve the traceability of these foods and protect consumers.
The classification of leafy greens as a high-risk for foodborne illness food, requiring more record-keeping to enable traceback, will not sit well with the California and Arizona Leafy Greens Marketing Agreement (LGMA) officials. Lettuce and spinach are supposed to be good for you. How and where are they being contaminated with pathogenic bacteria of animal origin? If LGMA doesn’t want leafy greens to be classified as a high risk food, but contamination outbreaks are larger than the 2006 contaminated spinach outbreak that triggered hearings that resulted in the FSMA, what will growers do to keep a low risk designation for leafy greens? For example, what will they do to ensure that liquid manure spread on their fields as fertilizer does not contain pathogens like E. coli O157?
Industry representatives, like FDA, emphasized a major impediment to tracing back to the origin of contamination. “It is very difficult to identify an issue weeks or months after the fact, primarily because of the expediency with which our product is harvested and in the marketplace,” said Arizona Leafy Greens Marketing Agreement Chair Jerry Muldoon. The industry estimates that there is a maximum of 21 days between harvest and consumption, too short of a time to do traceback to locate the contamination origin and warn consumers after the “fact” of the first-known foodborne illness.
The consumer and food safety group letter advocated the use of encrypted digital ledger technology (DLT), commonly called Blockchain, to replace the paper-based system that traces only one step forward and one step back in the chain of product custody. Citing an August 2017 article in Forbes, the letter stated that Walmart had experimented with a Blockchain digital program to trace back its products for supply chain and food safety traceback purposes. The DLT experiment took 2.2 seconds, compared to Walmart’s average of slightly less than seven days for traditional traceback. The sensors placed within a produce consignment communicate an array of agreed data blocks that can be input by authorized users at every point of the supply chain (Blockchain technology being a subset of DLT).
The Blockchain-connected sensors can locate and communicate the source of contaminated produce far more quickly than traditional traceback communication, and well within the 21 days of the harvest to wholesale processing to retail to consumption cycle. Reducing the time for identification of the source of food borne illness will not only protect more consumers, but increase the brand value and reduce the reputation risk that comes with being identified after the fact of contamination as a site of foodborne illness.
But will individual produce growers adopt Blockchain technology, if the liability exposure cost of doing so is greater than the traceability technology savings? FDA could write a record-keeping rule that would phase in adoption of Blockchain, at least for large scale produce growers. But will FDA take the next step to reducing foodborne illness by unmasking the company specific sites of contamination by ruling that CBI claims will no longer apply to public health information? Or will FDA let the industry’s desire to keep that information from the public be a foe of DLT adoption to improve food safety management of produce?
The May 24 consumer and food safety group letter to FDA Commissioner Gottlieb is a major first step to recognize that the prevalence and severity of leafy green contamination justifies categorizing leafy greens as a high-risk food requiring far better record keeping of food safety measures and produce chain of custody. The letter also challenges FDA to require industry to adopt a traceability technology that will reduce foodborne illness, and incentivize improved food safety management by reducing traceability costs and increasing the speed of access to both supply chain and contamination data.
Improving traceability will not prevent contamination at its origin (e.g. contaminated agricultural water used to irrigate leafy greens and other produce). To implement FSMA produce safety requirements, FDA has proposed an agricultural water rule, which if finalized, will apply to large scale growers in 2022 and to smaller scale growers in 2024. Until then, at least, the contamination of produce by pathogens of animal origin will be a recurrent and likely growing risk for consumers and producers.
