Updated November 26, 2018
FDA and CDC lift consumer advisory, romaine to return to the marketplace
We know many of you have been monitoring the E. coli O157:H7 outbreak associated with romaine lettuce. Over the Thanksgiving holiday, PMA and United Fresh along with our regional partners: Western Growers, CA LGMA, AZ LGMA and Salinas Valley Grower Shipper Association have been working with two main objectives: (1) find ways to help FDA and CDC in their traceback investigation and (2) expedite re-introduction of romaine products back into the marketplace.
Summary of key points
- FDA and CDC are lifting the consumer advisory not to eat romaine lettuce.
- A new, voluntary labeling agreement reached with industry was integral to the FDA, CDC decision as that will communicate to consumers that product is safe to consume.
- PMA along with United Fresh and other association partners continue to offer support to the FDA and CDC to speed their traceback investigation.
- PMA is providing resources and support to our industry to help them implement voluntary labeling.
- The outbreak is not over, investigations continue to seek to identify the source.
The FDA and CDC announced that they are lifting their consumer advisory not to eat romaine lettuce based on a new voluntary labeling agreement reached with industry. The FDA’s objective of this labeling agreement is to provide consumers with clear information as to where their romaine is grown and when it was harvested. The labeling agreement was negotiated by several romaine grower-shipper-processors, who have each pledged to label their romaine products with the region where grown and approximate harvest date. Given the onset dates of this outbreak, we know that romaine scheduled for harvest this week would not have been at the proper maturity to have been in the market at the time of the outbreak. Additionally, the industry has physically moved to winter production locations subsequent to the earliest reported illnesses. The labelling program will permit FDA to communicate to consumers that product being re-introduced into retail and foodservice markets is safe to consume.
PMA has agreed to support this initiative and are recommending that all industry members throughout the supply chain follow this labeling program. We recognize that voluntary source labeling is not true traceability, but it is a mechanism to ensure consumers have access to romaine that was not implicated in the outbreak. In anticipation of many “how to” questions, PMA and United Fresh have created the linked Question & Answer (Q&A) document. A standardized approach to source labeling is new to the industry and we expect situation-specific questions that were not anticipated. All involved, including FDA, recognize that we will need to gain real-world experience as companies develop the most workable approach in different situations.
Importantly, the industry and FDA have also agreed to work together to continue improvement in the tracking and tracing of romaine lettuce through the supply chain. We recognize that the greatest challenge we face in true product traceability is product identification by end customers at point of sale, thus enhancing our ability to quickly trace produce from point of sale to the grower. This year we have repeatedly heard FDA say that they lose the trail in the “last mile.” Case labeling today often provides this vital information, but too often that information is not captured and retained at point of sale, thus complicating traceback. Improved data capture at all supply chain points is a prerequisite to leveraging technology that can quickly illuminate supply chain pathways.
PMA, United Fresh and our regional association partners are committed to working with FDA in a new effort with experts from within and outside the industry, together with government, to implement improved procedures that enhance the speed and accuracy of investigations. Moving forward, our efforts to enhance strong traceability systems will be most beneficial for consumers only if coupled with expert epidemiological methodology, accelerated traceback investigations and government-industry expert collaboration that allow us all to pinpoint the source of contaminated product resulting in more targeted recalls.
We hope many of your questions will be answered with the linked Q&A document.
It is important that we remember that this outbreak has not been declared over. There is an ongoing investigation by FDA and CDC. FDA and CDC will post the updated numbers later today on their websites, it is important to note that the onset dates remain the same, October 8 – October 31.
We have met several times with industry partner associations and members to discern what data the industry might have to help FDA move forward and we are also looking at the distribution pattern of this outbreak to gain insight as to where the product may have shipped from. It is striking that this same strain of E. coli has been involved in an outbreak for three straight years, previously in 2016 and 2017 thought to be associated with leafy greens and now in 2018 associated with romaine. It is also important to note that the areas of the US and Canada where illnesses have arisen are nearly identical over the course of the three years, and the outbreaks occurred within the same 30-day timeframe each year. While the investigation continues, FDA Commissioner Gottlieb has indicated in tweets over the weekend that their focus is in California and they have inspectors on the ground there. As always, PMA will continue to work with partner associations, members and the regulatory agencies to help determine the cause of the outbreak. It is an imperative for us to find the root cause to prevent this from happening again.
Today, the CDC and FDA, as well as the Canadian Public Health Agency, are investigating a multistate E. coli O157:H7 outbreak linked to romaine lettuce. The CDC and FDA have issued an advisory recommending that people should not consume romaine lettuce until more is known about the source of this contamination. CDC is also recommending that restaurants and retailers not serve or sell any romaine lettuce in any form, including mixes.
In light of today's announcement, PMA and our allied produce industry associations urge that industry members voluntarily and proactively ready traceback/trace forward data in the event investigators contact them.
Food safety is our top priority. We must take swift action to protect consumers by stopping shipment of romaine lettuce, withdrawing any product that has been shipped to retail stores or restaurants and aiding the outbreak investigation.
We believe a withdrawal of romaine lettuce is the fastest way to clear up the supply chain of any romaine that could be responsible for illnesses. Additionally, we are calling on handlers to clean and sanitize any harvest or packing equipment that may have been used in recent weeks to prevent cross-contamination of produce during future harvest and processing activities.
We will also convene a group of food safety experts from the produce industry this week to closely examine information that may help pinpoint the specific source of the outbreak utilizing the extensive traceback information maintained by leafy greens producers. The goal of this effort is to learn any information about the geographic region or specific farms that may be tied to this outbreak.
No one wants to get to the bottom of how these outbreaks are occurring faster than the producers of leafy greens. We absolutely must do everything possible to stop these recurring outbreaks.
Arizona Leafy Greens Marketing Agreement
California Leafy Greens Marketing Agreement
Produce Marketing Association
United Fresh Produce Association