May 24, 2018
FDA, still searching for source of romaine E Coli outbreak, is hampered by inadequate traceability system
WASHINGTON, D.C. – Consumer and food safety groups called on the U.S. Food and Drug Administration to propose, within six months, requirements for comprehensive and rapid traceability of produce, including leafy greens. The Center for Science in the Public Interest, Consumer Federation of America, Consumers Union, The Pew Charitable Trusts and five other organizations pressed the FDA in a letter today to take action in light of the still unsolved multistate outbreak of E. coli infections linked to romaine lettuce that has sickened more than 170 people and caused one death.
The groups urged the FDA to implement long overdue provisions of the 2011 FDA Food Safety and Modernization Act (FSMA), which require the agency to establish recordkeeping requirements for high-risk foods to improve its ability to quickly trace the source of foodborne illness and initiate swift recalls. In addition, the groups urged the FDA to enhance communications with the produce and leafy greens industry to ensure full compliance with existing requirements and encourage the adoption of voluntary measures to improve traceability.
In a letter sent to the FDA, the groups noted, “Current technology makes it possible for retailers to track and trace products with extraordinary speed and accuracy. Given these advances, it is no longer acceptable that the FDA has no means to swiftly determine where a bag of lettuce was grown or packaged.”
Current federal rules, established under the Bioterrorism Act of 2002, require only minimal, one step forward and one step back, recordkeeping by businesses involved in the food supply chain. Under this regulatory framework, efforts to trace the movement of produce back through the supply chain during outbreaks of foodborne illness have long been plagued by a tangled web of inconsistent and inadequate records.
Section 204 of the FSMA required the FDA to create enhanced recordkeeping requirements for high-risk foods. Yet, seven years after the enactment of FSMA, the FDA has failed to carry out Congress’ mandate to create a list of high-risk food and issue a proposed rule for enhanced recordkeeping. “The repeated outbreaks linked to leafy greens since passage of FSMA leave no doubt that these products belong in the ‘high risk’ category. The FDA should act swiftly to improve the traceability of these foods and protect consumers,” say the groups in the letter.
The FDA is currently still investigating the recent outbreak of E. coli O157:H7 infections linked to romaine lettuce, in which more than 170 people are known to become ill and one has died. While the current outbreak appears to be nearing an end, the FDA has been unable to identify the farm or farms that produced the contaminated lettuce. The currently stalled investigation comes on the heels of another unsolved E. coli outbreak linked to leafy greens last fall.
Michael McCauley, Consumers Union, firstname.lastname@example.org, 415-431-6747, ext. 7606