- An environmental assessment released Thursday by the Food and Drug Administration confirmed that the presence of E. coli in irrigation canal water samples in Yuma, Arizona most likely led to this spring's massive contamination of romaine lettuce.
- When the Centers for Disease Control and Prevention declared the outbreak over in late June, it was the largest E. coli outbreak to occur in the U.S. since 2006. There were 210 illnesses reported from 36 states, including 96 hospitalizations, 27 cases of hemolytic uremic syndrome — a potentially life-threatening complication of E. coli infection — and five deaths.
- FDA Commissioner Scott Gottlieb said in a statement that as the romaine-growing season gets underway in the Yuma region, the agency wants to prevent future outbreaks. He pledged to work with the produce industry to help it comply with Food Safety Modernization Act water standards, explore ways to standardize record keeping, and determine whether the use of additional tools on packaging could improve traceability. He also said FDA will collect and analyze romaine samples using a new surveillance sampling assignment to identify pathogens and remove any product from the market found to be contaminated.
The FDA's environmental assessment didn't rule out other ways the romaine lettuce could have become contaminated with the outbreak strain of E. coli, but the agency said direct application of the irrigation canal water to the crop or to dilute chemicals applied to the crop were two possibilities.
The E. coli outbreak stretched on for weeks before the CDC was able to identify a contamination source, or even tell consumers where the suspect lettuce was grown. Meanwhile, illnesses continued to be reported even though romaine lettuce from the Yuma area was reportedly no longer being distributed and restaurants and retailers were sourcing it from California's Salinas Valley.
It's still unknown how the irrigation canal water became contaminated. The FDA said there is a large concentrated animal feeding operation nearby, but no obvious route was identified from the facility to the canal. Also, samples taken from the facility did not reveal the outbreak strain, the agency said.
Gottlieb identified two major problems that held up the investigation. Much of the finished lettuce product contained romaine sourced from multiple ranches, which made the typical traceback process challenging and required documentation from each point in the supply chain. Complicating such a large investigation even further, he said most of the records collected were either on paper or handwritten.
Sarah Sorscher, regulatory affairs director for the Center for Science in the Public Interest, wrote in a statement the FDA report indicates the "urgent need" to fully implement the FSMA produce safety rule. Concern about reducing the regulatory burden on farmers prompted the agency last year to delay water testing requirements meant to identify higher levels of fecal contamination and keep contaminated water from being used on produce.
"If we have learned anything from the recent outbreak, it is that regulatory protections need to be stronger, not weaker," Sorscher said. "Rather than focus on reducing the regulatory burden on industry, the FDA should focus on identifying ways [to] make our food safety protections stronger to prevent further deadly outbreaks."
There's no question leafy greens producers, processors and distributors face a slew of new and expensive requirements under the regulations. It may not be realistic to expect smaller and medium-sized operations to automate record-keeping and supply chain traceback functions without some assistance.
But illnesses and recalls are even more expensive, and once the reputation of a brand or product is tarnished from being part of a foodborne outbreak, it can be very difficult to earn back consumer trust. According to The Wall Street Journal, growers, retailers and restaurants lost millions from this E. coli outbreak. Romaine prices fell by more than 50% and farmers either plowed under lettuce fields or left them to rot. Restaurants that served romaine lettuce were sued by customers, and wholesalers scrambled for replacement greens as eateries removed it from their menus. After this outbreak, Walmart announced its plan to mandate blockchain use for leafy green suppliers.
It may take full implementation of FSMA, along with additional ways of assisting the fresh produce industry with compliance, before such outbreaks begin to subside. While the FDA, CDC, local health officials, epidemiologists and other public health investigators did follow up on this and other outbreaks, additional government regulatory approaches and enforcement actions could be needed to make sure food safety and the public health stays front and center.