When Scott Gottlieb asked retailers, restaurants and other commercial outlets to voluntarily pull from the market and destroy any romaine lettuce just two days before Thanksgiving, it marked an usual and poignant request from the head of the U.S. Food and Drug Administration.
"The quick and aggressive steps we’re taking today are aimed at making sure we get ahead of this emerging outbreak, to reduce risk to consumers, and to help people protect themselves and their families from this foodborne illness outbreak," Gottlieb said in a statement on Nov. 20. "This isn’t the first romaine outbreak we have seen in the recent past, and we will continue to take steps to identify the root causes of these events and take action to prevent future outbreaks."
The leafy green industry has struggled during the past year, with three outbreaks tied to E. coli.
Romaine from Arizona this spring sickened 210 people from 36 states, hospitalized 96 and was tied to five deaths. Contaminated water located near a cattle lot was most likely the source. Another hit the U.S. and Canada in 2017, and while investigators in the United States never identified which vegetable was responsible, Canadian officials said romaine was most often tied to illnesses.
The cause of the current romaine outbreak in California, responsible for sickening 52 people across 15 states, hasn't been identified.
"It's very effective, but talk about taking a sledgehammer to crack a walnut. It's a big deal and that's why I think there is a bit more to this in terms of the political regulatory requirement, in that (these three outbreaks are) not acceptable."
FDA's former food safety czar
David Acheson, the FDA's former food safety czar who now runs his own firm to help clients reduce the risk of an outbreak, said the agency's withdraw request — the first in produce since spinach in 2006 — was as much about protecting public health as it was "sending a strong message to the produce industry that they need to look at ways to make this better than it already is."
"It's very effective, but talk about taking a sledgehammer to crack a walnut," Acheson told Food Dive. "It's a big deal and that's why I think there is a bit more to this in terms of the political regulatory requirement, in that (these three outbreaks are) not acceptable."
In recent weeks, the FDA has participated in discussions with major producers and distributors of romaine lettuce, as well as trade groups representing the produce industry in an attempt to reduce the impact of future outbreaks.
Gottlieb said last month that major growers agreed to voluntarily label romaine with the growing region and the date of harvest to help with market recalls and traceability. The new labeling could be expanded to other leafy greens and produce going forward, he added.
United Fresh, whose members represent the entire produce industry supply chain, said in a statement the deal was negotiated by "a number of romaine grower-shipper-processors" who agreed to take part. Fresh Express, Taylor Farms, Dole Fresh Vegetables and Earthbound Farm are among the companies who said they would adopt the new labels.
Deverl Maserang, president and CEO of Earthbound Farm, said in an email to Food Dive that while none of the company's products were connected to the outbreak, the government's "broad advisory to avoid romaine is very disruptive."
He was hopeful that the growing region and harvested data could assist investigators in narrowing the scope of any potential future advisories, and that the government would be more specific on what kind of product could be excluded, such as conventional versus organic or exempting baby romaine — which is grown and harvested differently than hearts and heads of romaine tied to the recent outbreak, and on different farms.
Romaine consumption getting sliced and diced
Consumption of fresh lettuce, as part of a broader consumer push to eat healthier and better-for-you foods, has been gradually trending upward. It averaged around 11.5 pounds to 12 pounds per person annually since about 2006, before spiking to 12.7 pounds and 12.5 pounds in 2016 and 2017, respectively, according to Statista.
But the outbreaks have pummeled romaine lettuce sales, according to data from Nielsen. Sales of the vegetable, typically the most widely consumed salad green, slumped 13% during the year ending Nov. 24 to $631 million, the analytics firm estimated. With less romaine lettuce available, USDA said prices of other lettuce varieties have surged, including Boston and iceberg lettuce — which saw a nearly 170% jump.
The removal of romaine lettuce was particularly damaging to the grocery industry because of the timing just before Thanksgiving, the large quantity of the product pulled and the expense to stores — including labor costs, lost sales and time spent dealing with the crisis, according to Hilary Thesmar, senior vice president of food safety for the Food Marketing Institute.
"Every single retailer we've talked to, the losses are in the millions," Thesmar told Food Dive. "The economic impact is huge."
"Every single retailer we've talked to, the losses are in the millions. The economic impact is huge."
Senior vice president of food safety, Food Marketing Institute
Thesmar said while the group and its 33,000 retail store members supported the removal of romaine lettuce in the interest of public health, the decision by federal regulators to request the voluntary removal of the item created uncertainty, such as what happens to the product next or how stores work with their suppliers — questions that are clearer during a recall.
In addition, she said, grocers were faced with the decision of what to do with products in inventory and whether they should discard them or hold them in the hopes that the FDA and Centers for Disease Control and Prevention would quickly narrow the scope of the outbreak so they could sell products that weren't affected. (Most complied with the government's request and proactively tossed it.) FMI also faced inquiries from retailers over what to do with romaine supplied from local greenhouses or grown using hydroponics; both were included in the initial advisory.
Produce remains a major contributor to foodborne illness, according to a report from the Interagency Food Safety Analytics Collaboration — a collaboration between the CDC, the FDA and the U.S. Agriculture Department.
The report, released last December, found that in 2013, produce accounted for 59% of listeria cases, 51% of E. coli O157 cases, 46% of salmonella cases, and 33% of campylobacter cases. A prominent source of the outbreaks for E. coli came from vegetable row crops, including leafy greens — more than any other food category, IFSAC found.
The Food Safety Modernization Act, signed into law in 2011, called for growers to test their irrigation water and take steps to prevent contaminated sources from being used on produce. But the FDA announced in September 2017 that implementation would be delayed until at least 2022, beginning with the largest farms, in order to allow the agency to “consider how we might further reduce the regulatory burden or increase flexibility.”
An economic analysis by the FDA estimated the delay would save the industry $12 million annually, but lower the annual benefit to consumers by $108 million each year. The Center for Science in the Public Interest and Center for Food Safety said the postponement could lead to more than 730,000 additional cases of foodborne illness and "countless deaths."
Food safety groups have pointed to the recent outbreaks as an impetus to fully implement the 2011 reforms rather than further reducing or delaying the regulatory requirements.
Scott Faber, vice president of governmental affairs at the Environmental Working Group, was hopeful that following the latest outbreak, FDA's Gottlieb would accelerate the implementation timeline for the water testing requirements or Congress would require more stringent testing by big growers — potentially as part of the upcoming spending bill on Capitol Hill.
"That's the tragedy of this. It was almost certain that in the absence of testing the irrigation water that people would get sick," Faber told Food Dive. "We've taken no steps to address the risk. It's not rocket science, it's food science."
'We have to do better'
The produce industries in California and Arizona, where 95% of all lettuce is grown, have their own nearly identical food safety frameworks. Each state formed its own Leafy Green Marketing Agreement following a 2006 spinach outbreak that infected 200 people and cost growers millions of dollars. Earthbound Farm launched a test-and-hold program less than two weeks after the September recall, where it started checking all greens for pathogens when they are received and before they are shipped.
"We have to do everything in our power to keep pathogens, which exist in the environment, out of the food supply," Maserang said.
Today, leafy green growers and shippers who are members of the LGMA must have a traceback program showing where every product came from and where it went. They also are audited on average five times each year to make sure they are complying with all required food safety practices, including monthly water testing.
Scott Horsfall, CEO of the California Leafy Green Marketing Association, told Food Dive the water testing requirements in the Food Safety Modernization Act would test for contaminants using the same methodology and microbial standards as the LGMA standards, but conduct the tests less frequently. As a result, they likely wouldn't have made any difference in preventing the latest outbreaks. Still, he acknowledged that "there clearly is something there that we have to do better."
"That's the tragedy of this. It was almost certain that in the absence of testing the irrigation water that people would get sick. We've taken no steps to address the risk. It's not rocket science, it's food science."
Vice president of governmental affairs, Environmental Working Group
As FDA investigators and researchers look to uncover the cause of the latest outbreak, and determine whether there is something about the romaine plant or the way it grows that makes it more susceptible to contamination, Horsfall remains hopeful the industry will learn more about what happened — and whether there are any changes producers can make to their operations to avoid a future outbreak.
"Obviously, it hurts the reputation, the trust in the industry when you have episodes like this," Horsfall said. "I'm confident we'll rebound. It may take some time, but we'll get there."
Acheson said the food supply chain and the process used by regulators to investigate an outbreak, while generally effective on their own, are not properly linked. This creates problems and inefficiencies that can make it difficult for a foodborne illness outbreak to be stopped or minimized before it gets worse.
He cited the lack of communication between local and state officials and delays on involving CDC that can hinder the ability to quickly link outbreaks over a wider area.
In addition, he said, regulators should be more open with industry when they discover a possible lead during an investigation. This way, growers and shippers can check when and where the batch of lettuce in question was shipped. And growers, processors, distributors, retailers and restaurants generally are hesitant to spend more money beyond what they are required if it doesn't generate an immediate payoff, Acheson noted, even if doing so may prevent a bigger problem like the recent voluntary lettuce withdrawal.
Acheson said while a practice like testing water for contaminants is effective, it's going to take more from everyone with a stake in produce to reduce the likelihood of another outbreak.
"We will never get a leafy green that we can guarantee is 100% free of pathogens 100% of the time," Acheson said. "It will never happen because of the nature of the product, so we need to put in control systems that are as good as we can afford ... and to continue to push the likelihood down."