There’s no indication yet that anyone is the least bit embarrassed about the failure to yet identify the precise source of an E. coli O157: H7 outbreak involving at least 32 states and four Canadian provinces.  But nine consumer and food safety groups have stepped forward to demand that FDA Commissioner Scott Gottlieb add regulations within the next six months “for comprehensive and rapid traceability of produce, including leafy greens.”

In a May 24 letter to Gottlieb, the groups said all FDA needs to do is to “implement the long-overdue directive laid out by Congress in the Food Safety Modernization Act (FSMA) requiring the agency to issue a proposed rule establishing recordkeeping requirements for high-risk foods.”

“This will improve the agency’s ability to quickly trace the source of foods linked to an outbreak of foodborne illness, so it can initiate swift recalls,” said the consumer and food safety groups in the letter.

Romaine lettuce is grown in the Yuma, AZ  region is the likely source of the 172 E. coli illnesses in the U.S. and at least another half dozen in Canada.  FDA has only been able to identify Yuma’s Harrison Farms as the grower and sole source of whole-head romaine lettuce that sickened eight inmates at an Alaskan correctional facility. It does not know where in the supply chain that contamination occurred.

“The FDA should also immediately provide advice and communication to the leafy greens industry on existing requirements and best practices to enhance traceability,” the group letter adds.

More than two weeks ago, industry representatives went public with their criticisms of the FDA investigation, which they said was shunning offers of help from growers. Jennifer McEntire, United Fresh Produce Association vice president of food safety, described the FDA’s investigation as “mystifying.” She said allied associations and their members had provided “information about processing and handling as well as product shipment data” to FDA.

Both FDA and state officials have repeatedly told Food Safety News that investigations of the current outbreak, which has recorded one death,  and others are slowed by hand-written records, a lack of uniformity in traceability labeling, and incomplete shipping and receiving records.  The consumer groups say existing recordkeeping requires only “one step forward, one step back” records that result in a “tangled web of inconsistent and inadequate” information for those tracking outbreaks.

Section 204 of the FSMA provides for enhanced record requirements for “high risk” foods.

“The repeated outbreaks linked to produce and leafy greens since passage of FSMA leave no doubt that these products belong in the “high-risk” category, according to the consumer and food safety groups. 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 the Trust for America’s Health.

The groups expressed trust in high tech.

“Current technology makes it possible for retailers to track and trace products with extraordinary speed and accuracy. Retailers using advanced technology, such as blockchain, now report they can identify the origin of certain produce shipments in as little as 2.2 seconds,” they told Gottlieb.  “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.”

Another unrelated leafy green outbreak that also went unsolved occurred shortly before the current romaine-related outbreak.

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