Food Safety Groups Urge FDA to Designate Leafy Greens as High-Risk

Over 58 percent of Listeria, 51 percent of E. coli O157, 46 percent of Salmonella, and 33 percent of Campylobacter foodborne cases are associated with produce, according to a recent Interagency Food Safety Analytics Collaboration report, but such crops are not considered a high-risk food. Without that FDA designation and the associated recordkeeping requirements, contaminated produce cannot be swiftly recalled.

After a series of E. coli outbreaks linked to lettuce this year sickened over 200 people and killed five, nine food safety groups wrote to the FDA’s Commissioner Scott Gottlieb in May urging the FDA to classify leafy greens as a high-risk food and to establish recordkeeping requirements to improve traceability in the event of a foodborne illness outbreak. “We were concerned that the agency has repeatedly faced difficulty tracking down the source of contamination in outbreaks linked to leafy greens,” says Sarah Sorscher, deputy director of r­­egulatory affairs, the Center for Science in the Public Interest, one of the groups behind the letter.

The groups’ frustration has been building for years before the recent outbreaks. In 2011, Congress passed the Food Safety Modernization Act (FSMA), in which a provision required the agency to establish recordkeeping requirements for high-risk foods, but it has yet to carry out the mandate.

According to FDA spokesperson Corinne Newhart, “the agency has spent the years since the passage of FSMA developing and implementing rules that transform our food safety system from being reactive to preventive.” She says the FDA has also completed two pilot projects on improving product tracing in March 2013 and submitted a report to Congress about the recommendations from the pilot projects in January 2017.

Part of the delay is due to the methodology for designating high-risk foods, according to Patricia Buck, co-founder and executive director of the Center for Foodborne Illness Research & Prevention. “Unfortunately, the U.S. has not been collecting food attribution data for a long period of time, meaning that there is simply not enough data to scientifically develop an accurate list,” she says. Buck says new testing procedures like whole genome sequencing and PulseNET, the CDC’s national food and foodborne illness database, have helped, but such designation could take years. Until that time, Buck urges the FDA to develop interim lists of high-risk foods with the understanding that they will evolve over time.

With no federal recordkeeping regulations in place for leafy greens, the groups hope those in the produce industry will take their own steps in addressing outbreaks. Sorscher points out, “If the FDA comes knocking at their door saying there is a problem with one of their products, can they tell them exactly where it came from, all the way back to the field where it was grown?”

Sorscher advises produce professionals to move to electronic recordkeeping, ideally with blockchain technology that offers decentralized information that is coordinated and standard between all parts of the supply chain.