As virtually everyone in North America now knows, the Centers for Disease Control and the Food and Drug Administration have issued a public advisory telling consumers not to eat romaine lettuce and the food industry not to sell or serve it, following an outbreak of E.coli 0157-H7 that has caused at least 32 cases of illness across 11 states, as well as 18 cases in Canada. As a result, shoppers have been instructed to dispose of any romaine lettuce they bought before the advisory was issued.
The current outbreak of foodborne illness -- believed to have originated in lettuce grown in California -- is the second this year linked to contaminated romaine, which occurred from March to June and resulted in 210 cases in 36 states, with five fatalities.
What does this latest advisory mean for the companies involved, however? For one thing, more than romaine lettuce is likely to take a hit.
“A recall of this magnitude, especially during the holiday week will impact not only romaine, but other leafy green vegetables such as spinach,” said Michael Droke, a partner at the international law firm Dorsey & Whitney devoted to the areas of agriculture and cooperative law, and in the food and agriculture industries. “Retailers will be pulling romaine and possibly all other lettuce/leafy greens from their shelves – a process called quarantining – until the source is found.”
Avoiding Mandatory Recalls
Droke added while the advisory appears to be voluntary, the mandatory-recall authority that FDA received this month under the Food Safety Modernization Act (FSMA) is an additional nudge for retailers to move quickly on their own.
The legislation “overhauled the nation’s food safety systems for the first time in over a generation,” he said. “Among other changes, the food safety law gave the Federal Food and Drug Administration (FDA) mandatory recall authority for foods if there is a reasonable probability that the food is adulterated or misbranded, and that the food could cause serious illnesses or death. Put another way, the FDA was given authority to force a recall even if the retailer, supplier or producer wanted to avoid it. The FDA must allow the responsible party to conduct a voluntary recall before ordering a mandatory recall. Prior to the FSMA, the FDA could only rely on manufacturers to voluntarily recall certain potentially harmful food products.”
Continued Droke: “Before the FDA can use its mandatory-recall authority, the FDA must make a determination that there is a reasonable probability that the food is adulterated or misbranded. The FDA must also make a determination that there is a reasonable probability that using, or exposure to, such food will cause serious adverse health consequences or death to humans or animals,” otherwise known as a “SAHCODHA” hazard.
The mandatory-recall authority “gives teeth to the FDA’s enforcement right,” he asserts. “This agency’s guidance helps employers understand when that authority will be used, and will encourage companies to [voluntarily] recall products to avoid a mandatory sanction.”
Therefore, according to Droke, “[f]ood and ingredient companies should prepare in advance for the need to recall their products to minimize the risk of a mandatory order.”
However, in the opinion of Mike Koeris, chief innovation officer of Boston-based food safety software provider Corvium and a member of the Food Safety Technology Council of the Washington, D.C.-based United Fresh Produce Association: “The list of recent recalls proves that the FSMA isn’t working. Even though it’s been a legal requirement since 2011, a lack of enforcement has allowed many to ignore the modernization mandate. In fact, 90 percent of the food industry is still operating on Excel, paper and email. Information is so siloed and feedback loops so slow that risks are caught way too late – once dangerous products have already reached consumers.”
Koeris goes on to assert: “These salmonella and listeria recalls are preventable. If companies make the right investments now to control processing environments and address contamination, they can avoid expensive recalls and, most importantly, prevent consumers from getting sick.”
Restoring Consumer Confidence
Aside from the legal considerations, what can stakeholders do to minimize the immediate negative effects on their sales and reputations that such recalls inevitably bring?
“The best way to limit the impact of this outbreak is to solve it quickly,” noted the Newark, Del.-based Produce Marketing Association in a member alert shortly after the news broke. “We are working aggressively with stakeholders to try to narrow the source of the outbreak so that FDA can withdraw this comprehensive advisory. If industry members receive a request from a regulator for traceback information, please respond as quickly as possible.”
“Retailers and grocers should move quickly to quarantine the affected product, and post communications in the store to explain the steps being taken to ensure consumer safety,” agreed Droke. “They should explain that the removal is a proactive step to ensure safety while the source investigation is underway. By moving quickly and communicating well, retailers can enhance customer trust in spite of the increase in food-related recall events.”
"Consumer loss of confidence is a real risk in the aftermath of an outbreak that can reverberate across an entire industry," affirmed Mary Coppola, senior director, marketing and communication for United Fresh. "One of our goals as the trade association representing that industry is to help mitigate the misinformation being published that will lead to further deterioration of trust from consumers. It’s important to reiterate that the industry’s top priority is food safety and the safety of consumers’ health. Our best recommendation for retailers and suppliers is to stick to the facts, be transparent and work with the government agencies to bring this crisis to a swift conclusion. Consumers are smart, savvy and more informed than ever. Genuine transparency and empathy are key traits for companies involved and will ensure a steady foundation to rebuild upon in the aftermath."