Federal agencies won’t report what companies were involved in romaine outbreak despite promise of ‘radical transparency’

Both the FDA and the CDC know what romaine lettuce grower is responsible for a deadly outbreak of E. coli O157 infections in late 2024, but the agencies won’t release that grower’s name.

In February reports just obtained by Food Safety News, the Food and Drug Administration and the Centers for Disease Control and Prevention say the same grower behind the 2024 outbreak was also responsible for an outbreak in 2021.

There were at least 45 FDA staffers involved in the investigation into the 2024 outbreak. It is not known how many of them have been let go from the agency as a result of the “reduction in force” implemented by Health and Human Services Secretary Robert F. Kennedy Jr. The secretary has promised “radical transparency” as part of his plan.

The 2024 outbreak, which occurred in November and December, sickened 89 people across 15 states, killing one. Seven of the patients developed hemolytic uremic syndrome, which causes kidney failure sometimes resulting in the need for transplants.

In its report, the FDA says that the grower is not named because by the time the investigation was over the implicated lot of romaine lettuce was no longer available for sale. In the heavily redacted report, the FDA says seven subclusters of  E. Coli infections were part of the outbreak.

The subclusters involved catered events in Missouri, an Ohio school, an Indiana restaurant, an Illinois restaurant and an Illinois catered event. An investigation by the CDC showed that for 65 people who were part of the subclusters and for whom information was available, 95 percent reported eating a mix of leafy greens before becoming ill. Of those who could remember exactly what leafy greens they ate, 88 percent reported eating romaine lettuce.

The FDA’s traceback investigation revealed what firms handled and grew the implicated romaine, but the agency redacted all of the company names from its report.

This is an FDA diagram showing that the agency’s traceback investigation led to one grower. Click on image to enlarge.

“The three traceback legs identified 4 distribution centers, broker, processors, (redacted) grower, and (redacted) ranch. The traceback investigation determined that (redacted), the sole processor, sourced romaine lettuce from (redacted) grower, (redacted).” The FDA report states. 

“This romaine was available at all points of service (POS) during the specified timeframe of interest. Additionally, romaine lettuce supplied to (redacted) POS was traced back to a common ranch and lot. Through analysis of records, (redacted) lots of romaine lettuce were implicated, resulting in confirmation of romaine lettuce as the vehicle.”

The CDC also reported that romaine lettuce was the cause of the outbreak. The agency’s report did not indicate how many staffers were involved in the outbreak investigation. Staff cutbacks imposed by Kennedy include the firing of many CDC employees.

The FDA report stated that no “product or firm actions” were taken by the agency during its investigation. (Redacted) reported there was no additional product for consumption.

Two sentences of the FDA report discussed public communication — or lack of it — during the outbreak investigation.

“There were no public communications related to this outbreak. (Redacted) this outbreak because there was no product remaining in commerce,” the FDA report said.

The FDA report repeatedly said the agency knew what grower produced the lettuce.

“The traceback investigation determined that a sole processor sourced romaine lettuce from (redacted) grower that would have been available at all points of service during the timeframe of interest,” the FDA reported. “Additionally, romaine lettuce supplied to (redacted) POS was traced back to a common ranch and lot.”

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