It’s Not Easy To Be Green

It is not new news that romaine lettuce has been the subject of several E. coli O157:H7 recalls, with significant impact to human health and safety in the past two years alone. Below RQA review the situation and suggest what can be done to help prevent a similar issue in the future.

Early April 2018

In early April 2018, the U. S. Food and Drug Administration (FDA) began to investigate a multi-state outbreak of E. coli O157:H7 infections. When this outbreak was declared as ‘over’ by the U.S. Centers for Disease Control and Prevention (CDC) two months later, it was the largest outbreak of E. coli O157:H7 infections in the United States since 2006, with 210 reported illnesses from 36 states, resulting in 96 hospitalizations, 27 cases of hemolytic uremic syndrome (HUS) and five deaths.

Late 2018

In late 2018, a number of California farms were implicated in an E. coli outbreak that hospitalized dozens of Americans. Of the sick people interviewed, 83 percent reported eating romaine lettuce the week before the illness. Officials announced the outbreak just before Thanksgiving, causing a nationwide purging of romaine lettuce. Overall, the outbreak sickened 62, hospitalizing 25 across 16 states.

Pre-Thanksgiving 2019

A pre-Thanksgiving “repeat” occurred in 2019 linked to romaine lettuce grown in the Salinas region of California. This region, which includes Santa Cruz, Santa Clara, San Benito and Monterey counties, produces 61% of the nation’s leaf lettuce. As of December 4, 2019, the FDA announced that an outbreak of E. coli linked to romaine lettuce grown in this region had spread to 23 states with 102 illnesses and 58 hospitalizations reported by the CDC. The following week, the FDA, CDC, and the Canadian Food Inspection Agency announced an outbreak linked to chopped salad kits. At the time, the CDC reported eight confirmed cases in the U.S. across three states associated with this cluster of illnesses. The Public Health Agency of Canada also reported 24 cases in six Canadian provinces. Concurrently, the FDA had been working with health officials in Washington State regarding an outbreak of E. coli O157:H7 associated with romaine consumption at a local restaurant chain. Washington State officials reported 10 confirmed and three probable cases in this outbreak with all reports of exposure in early to mid-November. The FDA considered these as three separate outbreaks caused by three different strains of E. coli O157:H7 and had identified a common grower between each of the outbreaks.

January 2020

On January 15, 2020 the FDA announced that it was lifting the consumer advisory to avoid romaine lettuce from Salinas as the growing season for this region was over. The two multi-state romaine lettuce outbreaks were declared over, with one having sickened 167 people in 27 states and the other, linked to salad kits, having sickened 10 people in five states. This included 85 hospitalizations, including 15 patients who developed HUS. The third outbreak in Washington State that sickened 11 people was also declared over.

Answers Remain Elusive

The January 15th announcement stated that FDA’s traceback investigation included hundreds of supply chain records and found a commonality to a single grower with multiple fields and was able to narrow this to at least 10 fields in the lower Salinas Valley.

Guided by the FSMA Final Rule on Produce Safety (Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption), investigators visited several of these fields and sampled water, soil and compost. So far, sample results have come back negative for all three outbreak strains of E. coli O157:H7. That said, a strain of E. coli that is unrelated to any illnesses was found in a soil sample taken near a run-off point in a buffer zone between a field where product was harvested and where cattle are known to occasionally graze. While FDA considers this a potentially important clue, it does not explain the illnesses seen in these outbreaks. The investigation continues.

The Trouble with Traceback and Possible Solutions

While progress has been made, conducting traceback investigations into many segments of the produce industry remains challenging, requiring records review to work backward from patients to the point of purchase, and then through the supply chain to the source. Current written records may result in slowed access and consolidation of data, human error and difficulty sorting product. Produce consolidation is common through the supply chain, also impacting effectiveness during traceback.

FDA’s Office of Food Policy and Response announced in April of 2019 that the agency is developing a Strategic Blueprint to outline how FDA plans to leverage technology, and other tools, to create a more digital, traceable and safer food system. Beyond technology the approach looks to industry to develop simpler, more efficient operations and embedding a food safety culture. A number of supply chain-wide electronic traceability initiatives are emerging to improve traceability turnaround time. Systems such as Blockchain initiatives and The Produce Traceability Initiative1 support supply chain-wide electronic traceability. Some grocery chains are requesting these electronic traceability or similar systems be implemented.

Compliance is Key

In a December 12, 2019 statement, Frank Yiannas, FDA’s Deputy Commissioner for Food Policy and Response, stated: “Food safety is not a competitive issue, so everyone involved in the farm to table supply chain of fresh leafy greens (growers, distributors, retailers and foodservice companies) must work collaboratively, with a sense of urgency, and do everything possible to fully understand how and why these outbreaks continue to occur. Moreover, they must aggressively implement additional preventive measures to address any shortcomings identified to further protect consumers.”2

The key requirements of The Produce Safety Rule are agricultural water, biological soil amendments, sprouts, domesticated and wild animals, worker training and health and hygiene, and equipment, tools and buildings. Water quality monitoring including criteria, sampling and testing is specified, as well as usage requirements for raw manure and stabilized compost. While the Rule is too comprehensive to summarize here, it may be found at

Industry Must Commit

The bulk of the romaine sold in the United States comes from two growing areas: the Salinas Valley of California (harvested in late spring, summer and fall) and the Yuma, AZ, growing region that includes the Imperial and Coachella valleys of Southern California (winter and early spring). Growers remain frustrated that their own standards to prevent contamination, codified in the California Leafy Greens Marketing Agreement (LGMA), have not resolved the problem. The coalition, which represents thousands of farms that produce over 90% of leafy greens grown in the US, created its first industry standards to prevent pathogen contamination in 2007, a year after nearly 200 people became ill after eating spinach contaminated with E. coli. Nearly half were hospitalized, 31 developed kidney failure and three people died. The Agreement was updated in late 2019 to align with the Produce Safety Rule.

After last year’s outbreak, the FDA determined the E. coli strain that sickened people across the country came from surface water rather than ground water pumped from an aquifer.

As a result, the coalition of leafy green growers decided to ban the use of surface water unless it is treated with anti-bacterial chemicals 21 days before harvest. Scott Horsfall, CEO of the California Leafy Greens Marketing Agreement, said that gives the chemicals ample time to kill E. coli and other pathogens. “The FDA believes [the bacteria] dies off after four or five days,” Horsfall said. “We went to 21 days to be conservative.” The industry took additional measures as outbreaks continued, requiring farther setbacks of septic tanks from agricultural fields, and tripling the buffer between livestock and leafy greens operations from 400 to 1,200 feet.

Today the LGMA is conducting an overhaul of the food safety practices included in its program3. A special meeting hosted by the California Department of Food and Agriculture (CDFA) takes place in early February in Salinas, CA. At that meeting, growers will participate in discussions about research opportunities that will monitor environmental conditions in California that may be contributing to outbreaks.

“Growers face a far harder challenge to maintain quality standards in this environment than those operating from within the controlled bubble of a modern processing facility. We see many clients stepping up testing regimes at all stages of the production process. I have no doubt that increased testing will form a key part of the solution here as, coupled with good traceability, it will be vital to help eradicate the issue.”

Neil Evans, Crisis Management, Talbot Underwriting

What can be done to prevent future outbreaks?

Although there is no single answer, romaine lettuce and other leafy green growers, and all parts of the downstream supply chain, should be fully knowledgeable about current best science and regulatory requirements and implement these fully and expeditiously if they have not already done so. This includes traceback capability that is applied to all areas of risk, even through retail product labeling. They should also engage with resources from the local, state and federal regulators for support, and leverage the power of industry coalitions so as to prevent future outbreaks.

How can RQA help you?

As Talbot’s product recall consultants, RQA work with growers and their supply chains to ensure their policies, procedures and training reflect regulatory requirements and a strong food safety culture. Expert risk assessment and on-going training support supplement internal resources, while RQA’s review of traceability and recall plans will ensure they are current and leverage technology. Recall or crisis simulation exercises are custom tailored and ensure team members are knowledgeable and plans are efficient and effective.

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RQA & Talbot – US Romaine Lettuce Article.

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