FDA Begins Surveillance Efforts on Romaine Lettuce in 2020

David Fiske

Senior Vice President

Lori Hunter

Executive Vice President

January 7, 2020

David Fiske, Senior Vice President
Lori Hunter, Executive Vice President

In November of 2019, the Food and Drug Administration announced it would begin collecting 270 romaine lettuce samples in 2020. This sampling process is in direct response to the number of illness outbreaks that were linked to romaine lettuce in 2019, as well as ongoing consumer concern regarding lettuce consumption.

This effort is designed to assist the FDA, the Centers for Disease Control and Prevention and state public health agencies in identifying sources of contamination and help with the targeting of investigations into foodborne illness outbreaks. For wholesalers, food service distribution centers and commercial cooling and cold storage facilities, including on-farm holding facilities, it’s important to understand what the FDA Surveillance Sampling Assignment is and its potential impact on operations. Here are the basics.

What is the FDA Assignment?

In January of 2020, the FDA will begin collecting and testing 270 romaine lettuce samples for E. coli and salmonella bacteria in the California and Arizona growing regions. According to the Nov. 11, 2019, FY20 FDA Surveillance Sampling Assignment report, samples will be taken from wholesalers, food service distribution centers and commercial facilities.

Sample Collection, Testing and Results

Samples to be collected include raw agricultural commodity romaine lettuce, including trimmed or washed lettuce in its natural form prior to processing. Currently, the FDA has no plans to collect samples from fresh-cut processed products. By sampling RAC romaine lettuce before it is commingled with other produce, the FDA can quickly trace the lettuce to its point of origin when samples test positive for the presence of a human pathogen.

The FDA will prioritize sampling efforts to registered domestic facilities and farms identified by traceback from 2017 to present foodborne illness outbreaks for which romaine lettuce was confirmed or suspected in the food chain. Samples will be collected with more frequency during production transition periods in March/April and October/November and will only be collected after harvest and not from farm fields. The FDA will provide test results generally within three to four days of the completed testing.

Enforcement Efforts

If Salmonella spp. or pathogenic E. coli is detected in a sample, the FDA will notify the farm of the findings and assist in taking the appropriate action to protect consumers. In the FY20 report, the FDA states that it “fully encourages voluntary corrective action and, in all cases, seeks to employ an approach of educate before and while we regulate.” The report notes that for samples traced back to a farm in a state that holds a grant with the FDA under the State Produce Implementation Cooperative Agreement Program, the FDA will cooperate and coordinate with any necessary follow-up with the grower. In addition, the agency is considering multiple compliance and enforcement actions based on the available evidence and satisfactory response of an operation to prevent future contamination. Actions may also include efforts to correct and prevent violations and remove tainted food from the market, as appropriate.

Worldwide Facilities can help your clients mitigate the financial impact of a product recall event with market access to product recall insurance that includes the product refusal of coverage endorsement. To view real-life examples and read more about the refusal of coverage endorsement, see our informational product sheet Product Refusal of Coverage: Are Your Clients Covered?

For coverage questions, please contact David Fiske at 312-465-5305 or dfiske@wwfi.com, or Lori Hunter at 213-236-4585 or lhunter@wwfi.com.

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