A May 24 letter from nine consumer and food safety groups urges the U.S. Food and Drug Administration (FDA) “to designate produce, including leafy greens, as a high-risk food category and propose regulations that will enhance product tracing for produce in the event of an outbreak.”  The six-page letter was signed by the Center for Foodborne Illness Research & Prevention; Center for Science in the Public Interest; Consumer Federation of America; Consumers Union; Food & Water Watch; National Consumers League; The Pew Charitable Trusts; STOP Foodborne Illness; and Trust for America’s Health.

As discussed in this blog, FDA and the Centers for Disease Control and Prevention (CDC) are investigating a multistate outbreak of E. coli O157:H7 illnesses linked to romaine lettuce from the Yuma, Arizona growing region.  A June 1, 2018 update to FDA’s website (devoted to the ongoing investigation), indicates the Arizona Leafy Greens Marketing Agreement has confirmed that romaine lettuce is no longer being produced and distributed from the Yuma growing region and the last date of harvest was April 16, 2018 (i.e., well beyond the 21-day shelf life for Romaine).  However, as noted in the May 24, 2018 letter from consumer and food safety groups, the source of the E. coli contamination has not been precisely identified.  Regarding the lack of traceability requirements for produce, the May 24, 2018 letter states “FDA has no means to swiftly determine where a bag of lettuce was grown or packaged.”

Farms are entirely excluded from the traceability requirements of the Bioterrorism Act.  Further, while the Food Safety Modernization Act (FSMA) Produce Safety Rule established specific recordkeeping requirements, traceability coding is not a requirement.  FDA completed a study on enhancing traceability and issued a FSMA-mandated Report to Congress in 2016, but has yet to create a list of high-risk foods and issue a proposed rule for enhanced recordkeeping.

It is unlikely that FDA will establish traceability requirements for high risk foods or produce a list of high risk foods (which could potentially include leafy greens) within the 6-month timeframe that is requested by the May 24, 2018 letter.  But greater adoption throughout the supply chain of the Produce Traceability Initiative (PTI),  a voluntary industry system introduced years ago, would make it easier for agencies to track supply chains when investigating illness outbreaks.  It is estimated that only 60% of produce is shipped in cases that have PTI labels.  Other companies may use different traceability programs, using their own codes for a field, a season, a production location, or a commodity.  Consistency in traceability programs would improve the speed and accuracy of tracebacks.