FDA: Romaine surveillance, testing program on the way

The FDA investigation into an E. coli outbreak from Yuma, Ariz., romaine turned up no specific source, but concluded it’s likely contaminated irrigation water from a canal that passes near a cattle operation.

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(File photo)

The Food and Drug Administration’s investigation into a deadly E. coli outbreak traced to Yuma, Ariz., romaine turned up no specific source of the pathogen, but concluded it’s likely contaminated irrigation water from a canal that passes near a cattle operation.

In releasing a number of documents on the investigation Nov. 1, the FDA notified the leafy greens industry it will soon start a romaine lettuce surveillance program, analyzing samples from all growing areas. If pathogens are detected, the FDA will follow the supply chain to its source to determine if it was produce under “insanitary conditions that render them adulterated.”

“FDA will also explore regulatory options and consider appropriate enforcement actions against firms and farms that grow, pack or process fresh lettuce and leafy greens under insanitary conditions,” according to a letter co-written by Stephen Ostroff, deputy commissioner for foods and veterinary medicine, and Melinda Plaisier, associate commissioner for regulatory affairs.

The letter was addressed to the heads of the California and Arizona Leafy Greens Marketing Agreement and the departments of agriculture for those states, which produce most of the leafy greens in the U.S. The letter, posted on the FDA’s website, was also copied to the United Fresh Produce Association, Produce Marketing Association, Western Growers, the Florida Fruit and Vegetable Association and Yuma ag groups.

In recounting steps taken by federal and state agencies to trace the source of the lethal outbreak, FDA Commissioner Scott Gottlieb said efforts were hampered because the “majority of the records collected in this investigation were either paper or handwritten.”

That will change, according to Gottlieb’s Nov. 1 statement. Producers and distributors need to:

  • Adopt traceability best practices and technology to ensure easy access to farm-to-fork data;
  • Explore modern approaches to standardized record-keeping; and
  • Use additional tools or labels on packaging to improve traceability.

The FDA is exploring ways to “best tap into new technologies” to slash traceback times. Although Gottlieb did not mention blockchain technology, the agency recently announced the hiring of Frank Yiannas, Walmart vice president of food safety, who is instrumental in the retailer’s blockchain trials. Yiannas joins the FDA early next year when Ostroff retires.

For more information on the FDA’s investigation and outbreak response, see:

Gottlieb’s statement;

The FDA’s environmental assessment of factors potentially contributing to the lettuce contamination;

Memo of the investigation — a 33-page document that follows the details of the investigation;

The Ostroff/Plaisier letter; and

Outbreak timeline.

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