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The Romaine Health Advisory: Scope And Implications

This article was originally published in Law 360, and is republished with permission.

Under the Federal Food, Drug, and Cosmetic Act, the U.S. Food and Drug Administration may “cause to be disseminated information regarding food” in situations that present “imminent danger” to the health of consumers.[1] On Nov. 20, 2018, the FDA and the Centers for Disease Control and Prevention issued a broad health advisory notifying the public of the agencies’ investigation of a new multi­state outbreak of Shiga toxin-producing Escherichia. coli (E. coli) 0157:H7, linked by preliminary epidemiological evidence to romaine lettuce.[2]

As of Dec. 3, there were 43 reported cases of E. coli 0157:H7 tied to the outbreak strain, in 12 states, resulting in 16 hospitalizations (including 1 person who developed hemolytic uremic syndrome, a type of kidney failure), with no deaths reported. The illness dates range from Oct. 8 to Oct. 31, 2018.

Generally, it can take at least two to three weeks for an E. coli illness to be reported due to the incubation period (two to eight days after ingestion) plus the time elapsing between infection and reporting.[3] Thus, the CDC does not consider an outbreak to have ended until the number of new illnesses drops to a level within the expected background range, based in part on the shelf life of the suspected food source.

The advisory, released just days before Thanksgiving, recommended that consumers avoid eating romaine lettuce from any source and in any form (including whole head, hearts, chopped romaine and salad mix) and discard any romaine lettuce present in their homes. The timing of the warning was apparently related to concern about the expected increase in consumption of romaine over the holiday.

The FDA lacked sufficient traceback information to identify a common grower, processor, distributor, retail brand or food service chain in connection with the outbreak, and did not request a recall. Instead, the FDA recommended that the produce industry voluntarily withdraw romaine from the market, and not distribute newly harvested romaine unless a “clean break” from product on the market could be established.[4]

Through whole genome sequencing, the agencies determined that the particular strain of E. coli 0157:H7 associated with this outbreak was the same strain that caused an outbreak in fall 2017, which had been traced to the Central California growing region, at the end of that growing season. The FDA was unable to confirm the specific source of contamination in the fall 2017 outbreak.

This year, based on further investigation, the FDA and the CDC were able to narrow the potential source of this outbreak again to romaine from the Central California growing region — Monterey, San Benito, San Luis Obispo, Santa Barbara, Santa Cruz and Ventura counties — where most domestic romaine is grown from March to November. The investigation into the specific source, through the collection and analysis of epidemiological, traceback and environmental assessment data, is continuing. In the winter, from November to March, most domestic romaine is grown in the Yuma, Arizona, desert region and the California desert regions of the Imperial and Riverside Valleys.

On Nov. 26, the agencies issued updates narrowing the advisory’s scope to romaine originating from the Central Coast growing regions of northern and central California. As a result, romaine from the winter regions was then exempt from the scope of the advisory, as long as the harvest location and date were known.

After ongoing discussions between the FDA and industry representatives, a number of romaine growers, shippers and processors agreed to implement a voluntary labeling program (at least temporarily) to label new romaine entering the market with the harvest location and date, and therefore differentiate it from romaine subject to the advisory.

In addition to the voluntary labeling program, many companies in the produce industry agreed to establish a task force to explore the possibility of long-term labeling of romaine lettuce and other leafy greens, to help identify products and to consider standards for the traceability of products.

This outbreak was not limited to the U.S. As of Nov. 29, 2018, the Public Health Agency of Canada identified 24 confirmed illnesses linked to E. coli 0157:H7 with the same genetic fingerprint as the U.S. cases, in 4 provinces, with 8 individuals hospitalized (including 1 individual suffering from hemolytic uremic syndrome), and no deaths reported.[5]

As a result, the Canadian Food Inspection Agency announced new trade restrictions mandating that shipments of romaine lettuce from California — and shipments of salads originating from anywhere in the U.S. — must be accompanied by a proof of origin letter, on letterhead, signed by the exporter and declaring the municipality, county and state of harvest (or for salads from the U.S. that do not contain any romaine lettuce, a declaration stating: “Does not contain romaine lettuce”). Romaine lettuce originating from the counties of Monterey, San Benito, San Luis Obispo, Santa Barbara, Santa Cruz and Ventura are denied entry into Canada.[6]

The impact of the initial advisory on the romaine industry has been significant, with many in the industry criticizing the scope as too broad, given the recent shift to the winter growing region and the relatively short shelf life of romaine. But there are challenges to the FDA’s timely obtaining of sufficient information regarding supply chains, to facilitate more narrow and tailored advisories.

One issue is traceability in the produce industry, due in part to company systems which may be incompatible with those of trading partners, thus slowing the speed of tracebacks. And although better lines of communication between the FDA and industry during outbreak investigations could provide important information about current growing areas and supply chains, confidentiality concerns and potential conflicts of interest place limitations on the degree of industry involvement.

Looking ahead, technological solutions such as blockchain technology may improve product traceability and permit almost instantaneous tracebacks. A produce industry pilot project tested the amount of time it took to trace a package of sliced mangoes from Mexico to a retail destination in the U.S. A traceback using existing paper and electronic records took almost 7 days, whereas a parallel search through blockchain data took just 2.2 seconds.[7]

Another critical food safety benefit of advances in technology would be greater efficiency and accuracy in a "trace forward" from a supplier of adulterated products to its processor customers, in order to expedite the identification of adulterated foods on the market that incorporated the adulterated food, or to avoid the use of adulterated foods that had not yet been used in production.

Improvements in traceability are just one focus of the produce industry’s food safety efforts. Other top priorities are the full implementation of the Food Safety Modernization Act requirements applicable to produce, and ongoing extensive research to better understand and control the risk factors regarding pathogens in produce.


[1]  21 U.S.C. § 375(b).