FDA’s Response to Romaine Outbreak

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Faced with an increasing number of produce recalls, in 2011 the FDA created rules requiring produce growers to test their irrigation waters for certain pathogens. Shortly before the new regulations were to take effect in January of 2018 and in response to both cost concerns and President Trump’s order to eliminate regulations, the FDA delayed the water testing requirements for at least four years. Under the proposed new plan by the current administration, large growers will not have to inspect water systems and test for pathogens until 2022 and will then have two years, until 2024, to ensure irrigation water that comes in contact with vegetables and fruit does not contain E. coli above a certain concentration.

Some  critics, such as Trevor Suslow, University of California, Davis, are taking the position that the recent recalls of romaine lettuce are due to contaminates in the water and soil and the outbreaks could have been prevented had the 2011 regulations taken effect. Suslow states, “If the risk factor associated with agricultural water use is that closely tied to contaminates and outbreaks, there needs to be something now…I can’t think of a reason to justify waiting four to six to eight years to get started.” Generally, scientists from Rutgers and the FDA have both concluded that contaminants in irrigation water “has been regarded as one of the major sources for fresh produce contamination…” In spite of speculation by many, the FDA has indicated that they have not yet confirmed how the romaine lettuce sickened so many, but that irrigation water is a “viable explanation.” 

Despite the finger-pointing, the FDA has indicated there is no change in their current plans to postpone implementation and enforcement of the water testing rules. While enforcement of the regulations regarding water testing are postponed, the FDA is considering major changes to the rule, including allowing produce growers to test less often or seek alternatives to testing. The FDA has indicated that the standards need to be “the right standards, ones that both meet our public health mission and are feasible for growers to meet.”  

On November 26, 2018, in response to the most recent recall of romaine lettuce, the FDA released a recommendation that all romaine lettuce entering the market be labeled with a harvest location and harvest date, or labeled as being greenhouse grown. As its investigation allows, the FDA is identifying harvest locations and dates of known contaminations. Consumers are advised not to eat the lettuce without this label.

As the FDA balances the cost of compliance by growers with keeping the public safe, we can expect to see additional proposals and recommendations in the coming months and years. Polsinelli continues to monitor produce labeling recommendations and requirements by the FDA as well as legislation regarding the testing of water by growers of produce.

DISCLAIMER: Because of the generality of this update, the information provided herein may not be applicable in all situations and should not be acted upon without specific legal advice based on particular situations.

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