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  5. Microbiological Surveillance Sampling: FY20 to FY21 Romaine Lettuce (Raw Agricultural Commodity)
  1. Sampling to Protect the Food Supply

Microbiological Surveillance Sampling: FY20 to FY21 Romaine Lettuce (Raw Agricultural Commodity)


Romaine Lettuce Surveillance Sampling

The FDA is conducting a small, focused assignment to collect samples of raw agricultural commodity (RAC) romaine lettuce to test for pathogenic Escherichia coli (also known as Shiga Toxin-producing E. coli or STEC) and Salmonella spp., microbial hazards repeatedly linked to foodborne illnesses associated with romaine lettuce consumption. The assignment began November 2019. The agency subsequently paused the assignment in connection with the COVID-19 pandemic.  Intended to last one year, the assignment has been restarted and extended through to the end of 2020.

Precautions implemented given the COVID-19 pandemic

The FDA has equipped its staff with criteria and instructions for conducting sampling during the COVID-19 pandemic to help assure the safety of agency investigators and firm employees, providing the safest possible environment to accomplish regulatory activities.

The health, safety and wellbeing of our investigators, as well as the public, are of the utmost importance to the FDA. We are ensuring our investigators are outfitted with personal protective equipment (PPE) and otherwise equipped to carry out their work while adhering to state and local guidance as well as applicable CDC guidance.


Questions and Answers

The FDA is conducting this assignment following multiple outbreaks of foodborne illness associated with the consumption of romaine lettuce. In 2018, the United States experienced two large multistate outbreaks of E. coli 0157:H7 infections associated with the consumption of romaine lettuce: one in the spring; the other, in the fall. Both prompted nationwide public health advisories. In 2019, the FDA has to date investigated three additional outbreaks of E. coli 0157:H7 infections associated with romaine lettuce consumption (in October, November and December), the latter two having occurred shortly after this assignment was implemented. Salmonella spp. are commonly responsible for foodborne illness outbreaks associated with the consumption of fresh produce in the United States, and in 2012 the nation experienced a multistate outbreak of Salmonella Newport infections associated with the consumption of romaine lettuce.

Consistent with the FDA’s mission to protect consumers, if one of the target pathogens is detected as a result of this assignment, the agency will perform whole genome sequencing of the microorganism’s DNA to determine its virulence and whether it is genetically related to isolates causing human illness. Determining the genetic relatedness of pathogens isolated from food sources and clinical isolates helps the FDA, the Centers for Disease Control and Prevention, and state public health agencies develop targeted investigations into foodborne illness outbreaks. This assignment is intended to help the FDA, CDC and state public health agencies to identify sources of contamination and factors that may be contributing to them, so that they can be addressed.

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Follow-up and Enforcement

If the FDA detects Salmonella spp. or pathogenic E. coli in a sample, the agency will notify the firm of the findings and work with the firm to take appropriate action to protect the public health. The FDA encourages voluntary corrective action and, in all cases, seeks to employ an approach of “educate before and while we regulate.” 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 work with the state to coordinate any necessary follow-up at the farm. The agency may consider multiple compliance and enforcement actions based on the available evidence and the adequacy of the firm’s response to prevent future contamination. Enforcement activities include actions to correct and prevent violations and to remove violative food from the market, as appropriate.

Additional Information

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