Romaine Outbreak Update: Call for Voluntary Labeling

Last week, The U.S. Food and Drug Administration, the Centers for Disease Control and Prevention (CDC), along with state and local partners, began investigating a multistate outbreak of E. coli O157:H7 likely linked to romaine lettuce and advised retailers, restaurants and other food service operators to not serve romaine lettuce until more was known. While the investigation continues FDA is announcing new steps to help consumers better identify where their romaine is grown through voluntary labeling. At this point, the investigation suggests romaine lettuce associated with the outbreak comes from areas of California that grow romaine lettuce over the summer months, and that the outbreak appears to be related to “end of season” romaine lettuce harvested from these areas. The involved areas include the Central Coast growing regions of central and northern California.

By encouraging place-of-origin labeling for romaine lettuce, the FDA is moving the entire produce industry toward labeling that will make outbreak response more effective and safety warnings to consumers more targeted.

This is the first time, the FDA is pushing place-of-origin labeling for produce and it's an important step in tracing the source of outbreaks and limiting the scope of recalls,  said Creighton Magid, a partner at the international law firm Dorsey & Whitney and head of its Washington DC office. He also serves as the co-Chair of the firm-wide Products Liability practice and works with clients to reduce their liability risks and to help them navigate the federal regulatory system, particularly in connection with the U.S. Consumer Product Safety Commission. 

"The need for such labeling is highlighted by the recent directive not to eat romaine lettuce," Magid said. "Unlike manufactured products, which can be traced through serial numbers, a consumer generally has no way to know where fresh produce was grown.  That makes tracing the source of an outbreak more difficult, and also prevents limiting recalls of produce to products of a particular farm or region.  By encouraging place-of-origin labeling for romaine lettuce, the FDA is moving the entire produce industry toward labeling that will make outbreak response more effective and safety warnings to consumers more targeted."

The FDA is continuing tracebacks of romaine lettuce from locations where impacted consumers purchased or consumed romaine lettuce before they became ill in order to identify specific locations that are the likely source of the outbreak and to determine the factors that resulted in contamination. Through laboratory studies they identified that the E. coli O157:H7 strain causing the outbreak is similar to one that produced an outbreak of E. coli O157:H7 in the fall of 2017 that also occurred in the U.S. and Canada, which was associated with consumption of leafy greens in the U.S. and specifically romaine lettuce in Canada.

"The FDA believes it was critically important to have a “clean break” in the romaine supply available to consumers in the U.S. in order to purge the market of potentially contaminated romaine lettuce related to the current outbreak," said FDA Commissioner Scott Gottlieb, M.D. "This appears to have been accomplished through the market withdrawal request of Nov. 20, 2018. Knowing the growing origin of produce will continue to play an important role in allowing consumers to avoid contaminated products and facilitating market withdrawals and tracebacks. That’s why we previously called on the romaine lettuce industry to provide unambiguous and clear information to consumers regarding where their lettuce was grown and when it was harvested."

 The FDA recently participated in discussions with the major producers and distributors of romaine lettuce in the U.S. and with the major trade associations representing the produce industry regarding product labeling and dating to assure consumers that any romaine lettuce that will come onto the market is not associated with the current outbreak of E. coli O157:H7. The labeling will identify the origin of the romaine based on harvest region, along with the date of harvest. This can improve the ability of the FDA to provide more targeted information to consumers in the event of a future outbreak of illness. The FDA also has commitments from the romaine lettuce industry that such labeling will continue into the future and become the standard for their products. 

In addition, the leafy greens industry has agreed to establish a task force to find solutions for long term labeling of romaine lettuce and other leafy greens for helping to identify products and to put in place standards for traceability of product. The task force will also examine information from this outbreak to identify measures that led to its occurrence and how to prevent ongoing safety problems with romaine lettuce. One outcome could be to extend the commitment for labeling for origin and date of harvest to other leafy greens.

The FDA currently advises:

• Romaine lettuce entering the market will now be labeled with a harvest location and a harvest date. Romaine lettuce entering the market can also be labeled as being hydroponically or greenhouse grown. If it does not have this information, you should not eat or use it.
• If consumers, retailers, and food service facilities are unable to identify that romaine lettuce products are not affected – which means determining that the products were grown outside the California regions that appear to be implicated in the current outbreak investigation — we urge that these products not be purchased, or if purchased, be discarded or returned to the place of purchase. 
• Romaine lettuce that was harvested outside of the Central Coast growing regions of northern and central California does not appear to be related to the current outbreak. Hydroponically- and greenhouse-grown romaine also does not appear to be related to the current outbreak. There is no recommendation for consumers or retailers to avoid using romaine harvested from these sources.   

The FDA has urged growers, processors, distributors and retailers to:

• clearly and prominently label all individually packaged romaine products to identify growing region and harvest date for romaine; and
• clearly and prominently label at the point of sale the growing region when it is not possible for romaine lettuce suppliers to label the package (e.g. individual unwrapped whole heads of romaine lettuce available in retail stores).

As of November 26,, this outbreak has resulted in 43 people becoming ill in 12 states, with the last reported illness onset date being October 31. An additional 22 people in Canada have become ill, and the FDA and our partners are also coordinating the investigation with Canadian health and food safety authorities.