Chris Koger

September 18, 2018

Food and Drug Administration officials looking into the source of the Cyclospora parasites in McDonald’s salads found two samples of U.S.-grown romaine with the parasites, although they weren’t connected to the outbreak attributed to the fast food salads.

The FDA released the information Sept. 18 in a statement from Commissioner Scott Gottlieb on the prevalence of Cyclosporiasis cases in the U.S. this year. The Centers for Disease Control and Prevention reported there have been 2,173 cases this spring and summer as of Sept. 12.

The rise in cases, in part, can be attributed to new FDA testing methods applied in routine tests on “appropriate commodities.” That includes cilantro, which along with basil, parsley, and processed avocado and guacamole is part of a current FDA sampling program. In July, the program found Cyclospora on U.S.-grown cilantro, and when FDA officials checked the farm where it grew, they found Cyclospora there.

That was the first time Cyclospora had been found in U.S.-grown produce; the romaine is the second.

In his statement, Gottlieb did not say where the romaine was grown.

“The discovery of Cyclospora in both domestic and imported produce raise both old and new concerns,” he said in the statement. “They underscore the importance of the FDA’s surveillance activities to better define risks, like investigating why different product types like vegetable trays are being linked to Cyclospora outbreaks, and how widespread Cyclospora may be in the U.S.”

In the past, FDA responses to Cyclospora outbreaks have focused on protecting consumers from imported produce, but the agency needs to “include actions that are more appropriate for addressing domestic contamination events,” according to the statement.

The romaine investigation was triggered by Cyclospora illnesses traced to McDonald’s salads sold in 14 states that were supplied by Fresh Express, Salinas, Calif. When the outbreak was declared over by the FDA and CDC on Sept. 12, 511 illnesses had been linked to the salads.

However, the investigation did not trace the Cyclospora to a grower or farm.

Another notable cyclospora outbreak, of 250 illnesses linked to Del Monte vegetable trays, was declared over on Sept. 6. The source could have been domestic or foreign — the broccoli was from Mexico — but “the findings were not conclusive regarding the source,” according to Gottlieb.

Ongoing investigations into illnesses linked to basil and cilantro from “Mexican-style restaurants” account for other Cyclospora illness clusters, according to Gottlieb’s statement.

“I want to reinforce to consumers that it’s our goal to figure out how these outbreaks happened,” Gottlieb said in the statement. “We take this obligation very seriously.

“That’s, in part, why we are intervening early. And it’s why we’ll be communicating regularly with the public to provide information and updates on all of the outbreaks we work on,” he said in the statement.

Gottlieb underscored the importance of the Food Safety Modernization Act and the Produce Safety Rule, and said the system needs to be “rigorous, nimble, and proactive in order to confront new challenges.”

Related Topics: Romaine Outbreak Food safety FDA