FDA Weighing Risk, Traceability Rules for Leafy Greens

While some recommendations are being implemented, the high-risk foods list and traceability mechanisms are not. “Without effective traceability, neither the agency nor industry can begin to address these challenges and prevent future outbreaks,” the food safety and consumer groups wrote.

High-Risk Leafy Greens

Between 2009 and 2013, fresh produce was responsible for more than 58 percent of all foodborne illnesses due to Listeria monocytogenes, 51 percent of E. coli O157, 46 percent of Salmonella, and 33 percent of Campylobacter, according to a recent report from the Interagency Food Safety Analytics Collaboration.

This year has seen several multistate produce-related food safety outbreaks. Most prominently, an E. coli outbreak linked to romaine lettuce from the Yuma, Ariz., growing region sickened 210 people in 36 states, with 96 hospitalizations and five deaths. No specific farms, packing, or distribution facilities have been implicated. In June, FDA officials told a meeting of the Leafy Greens Food Safety Task Force, an ad hoc industry/government group, that canal water contaminated with manure from a nearby large cattle feeding operation may have been the source.

The Yuma romaine lettuce outbreak was not related to an earlier multistate outbreak of E. coli O157:H7 infections linked to leafy greens in the U.S. and romaine lettuce in Canada. That outbreak was associated with a different DNA fingerprint of the bacterium. Among the 21 people affected by that outbreak, nine were hospitalized and one died. The Public Health Agency of Canada identified romaine lettuce as the source of their infections, while U.S. investigators suggested a variety of leafy greens, but could not identify a specific type.

Also during the summer, more than 500 people became infected with the Cyclospora cayetanensis parasite after consuming salads from McDonald’s restaurants in 16 states. For this outbreak investigation, FDA used a new, real-time PCR detection method. Cyclospora is generally transmitted through feces-contaminated food and water. FDA investigated distribution and supplier information for romaine and carrots but results were inconclusive.

Separately, 250 laboratory-confirmed cases of Cyclospora infection were reported among people who ate pre-packaged Del Monte vegetable trays purchased from convenience stores in the Upper Midwest. As in the other cases, FDA’s traceback investigation did not identify a single source or potential point of contamination.

FDA’s long delay in issuing the high-risk food list and traceability requirements under FSMA Section 204 “is untenable in light of the recent unsolved outbreaks,” the food safety and consumer groups wrote. As David Acheson, MD, former FDA associate commissioner for foods and president and CEO of The Acheson Group, puts it, “Our tracking systems still don’t work. They take much too long and are too imprecise.”

Industry Response

Dr. Acheson is concerned that the leafy greens industry, particularly the romaine lettuce sector, will suffer in sales much as spinach did after a massive E. coli outbreak in 2006 that sickened more than 300 people and killed three. Similarly, a Salmonella outbreak from salsa in 2008 was initially blamed on tomatoes, but eventually linked to peppers from Mexico.

“Because it took so long to trace the contamination and determine peppers as the actual culprit, the tomato industry was ravaged as consumers began avoiding tomatoes altogether based on advice from states and FDA,” Dr. Acheson says. The scare ended up costing the tomato industry hundreds of millions of dollars in lost sales.

Growing and shipping records, when they exist, are often handwritten and the types of information they contain can vary from company to company. Traceback becomes even more difficult when a single production lot of bagged salad may contain romaine and other leafy greens from multiple ranches.

“Better recordkeeping at businesses producing and distributing the nation’s food would increase the speed and effectiveness of outbreak investigations and recalls,” says Sandra Eskin, food safety project director at The Pew Charitable Trusts. “FDA can and should spur these improvements.”