The FDA has released an action plan for leafy greens to help prevent and respond to foodborne illness outbreaks linked to the commodity. According to a March 5 statement from Commissioner of Food and Drugs Stephen Hahn and Deputy Commissioner for Food Policy and Response Frank Yiannas, leafy greens have been implicated too often in such outbreaks, especially E. coli O157:H7 in romaine lettuce.
The FDA and the Centers for Disease Control and Prevention identified 40 foodborne outbreaks of Shiga toxin-producing (STEC) E. coli infections in the U.S. between 2009 and 2018 with a confirmed or suspected link to leafy greens, the plan noted. STEC strains of E. coli can cause serious health issues and even death. The FDA said the agency and stakeholders in the leafy greens sector can do more to address the problem.
The action plan includes several steps the FDA will take this year regarding prevention, response and education. Among them are: Increasing water safety through rules, education and purification methods; prioritizing inspections and assistance; strengthening food safety specifications for buyers; and creating a voluntary public-private data trust to assist with analytical research to help with prevention.
The FDA's action plan follows a number of high-profile and widespread E. coli contamination episodes involving romaine lettuce and other leafy greens. These outbreaks have given the sector a black eye, caused financial losses from sales declines and wasted crops, and prompted concerns from consumers over the health romaine lettuce and other leafy greens.
After a 2018 E. coli outbreak was probably caused by pathogens in Arizona canal irrigation water, the FDA action plan is advocating an increased focus on adjacent and nearby land uses, particularly those involving livestock production since they could be pathogen sources. The agency said more work is needed to get a fuller understanding about how to evaluate and mitigate potential hazards.
"Expediting the improved safety of leafy greens will require collaboration between FDA and stakeholders in the public and private sectors, including industry and our regulatory partners," the agency said. "This plan is designed to help foster a more urgent, collaborative, and action-oriented approach."
The plan also includes additional steps to put the Food Safety Modernization Act's Produce Safety Rule into action. Compliance dates for very small businesses kicked in during January, and 2020 will see another year of routine inspections under the rule for operations already covered, the FDA said. The agency said last fall it would start sampling romaine for E. coli and salmonella in California and Arizona, so more checking and testing are likely to continue.
Leafy greens producers have taken several steps to improve production processes. They have tightened up grower requirements and recently embarked on a multi-year food safety initiative involving government, academia and industry to better understand the impact of pathogens on leafy greens in areas including Yuma County in Arizona and the Imperial Valley of California.
The FDA acknowledged faster and more thorough and helpful responses to outbreaks are needed, and it recommended specific ways to share lessons already learned in order to enhance future prevention activities. Communicating information to industry and the consuming public will be an area of attention, and the FDA said it will collaborate with government partners to find ways of improving the information sharing.
The agency plans to publish its outbreak investigation report from last year's collaborative traceback and sampling work in the Salinas Valley following three outbreaks involving three different strains of E. coli. The FDA and its partners also will do follow-up surveillance in that area during this fall's growing and harvest season on farms that may have supplied contaminated produce.
The action plan seems aimed at tightening up the FDA's overall regulatory approach and adding more consistent oversight activities to make sure efforts under FSMA and those implemented by industry are more effective.
The agency's new plan looks like a step in the right direction, but efforts to improve oversight of leafy greens have been painstakingly slow despite multiple outbreaks in recent years and the realization by growers, industry, regulators and others that something more needs to be done. Working with retailers on point-of-purchase recordkeeping, such as shopper cards, is one example of the looming challenges.
While this information can improve the speed and accuracy of traceback investigations by helping retailers determine what specific products were purchased and may have been consumed, the agency said "more work is needed to streamline the process for gathering these data." The FDA pledged in 2020 to "work with retailers and government partners to improve the timely collection and transmission of purchase information during an open traceback investigation," but it didn't offer more specific details.
Some personal comments in the statement from the two FDA officials illustrated the gravity of the situation. They said as public health officials, they're concerned about the recurring outbreaks and believe all involved in producing and selling fresh leafy greens can do better. And, since they have children of their own, they said they were "heartbroken about the families whose lives have been forever changed by these illnesses."
Such statements aren't commonly heard from government officials, so it may signal the agency is more serious than usual about getting a handle on what's been causing pathogen contamination on U.S. produce and putting a stop to it. However, the plan's success won't become clear unless there's a declining number of outbreaks in the future linked to the consumption of leafy greens.