FDA, papaya company discuss recall, disagree on evidence

FDA, papaya company discuss recall, disagree on evidence

(CORRECTED July 22) Despite requests from the Food and Drug Administration, the distributor of Mexican papayas named by the agency in an outbreak of salmonella has declined so far to issue a recall.

The FDA’s New York division first contacted Agroson's LLC, Bronx, N.Y., on July 3 about results of an investigation of Salmonella Uganda, which had sickened 71 people in eight states, according to the Centers for Disease Control and Prevention’s most recent update on July 5.

On that day, the CDC and FDA named Cavi papayas distributed by Agroson’s as the likely source of the salmonella. Although there have been no positive salmonella findings from the fruit itself, “the epidemiological and traceback information” points only to Agroson’s, according to the FDA’s July 5 notice.

Scott Davidson, of Davidson Law Group, Miami, is a trade consultant for Agroson’s. He disputes the validity of the traceback information presented by the FDA. 

Davidson named multiple concerns with the findings, including the lack of a positive salmonella sample on the fruit and the fact that FDA inspectors at a port of entry had tested and released Cavi papayas after the agency named the brand in the outbreak.

“The FDA is barking up the wrong tree for reasons I can only explain by speculation,” Davidson said in a July 10 e-mail.

Peter Cassell, the FDA’s lead press officer for food emergencies and safety, said outbreak investigations often lead to naming a food item, brand or distributor, without a sample testing positive. 

For example, the FDA issued a public advisory in November 2018 for consumers to avoid all U.S. romaine after traceback led investigators to pinpoint the lettuce in an E. coli outbreak.

Product and environmental sampling is just one of three types of evidence in an outbreak, Cassell said.

Epidemiological evidence (samples from ill people) and traceback, starting with interviews of those who ate the tainted food, are the other two.

“The FDA and regulatory officials in several states collected records from grocery stores where ill people reported buying papayas,” according to the CDC’s July 5 notice. 

“These records showed that Cavi brand papayas were sold at multiple grocery stores where ill people bought papayas. Cavi brand papayas distributed by Agroson’s LLC of Bronx, New York, would have been available for purchase by cases in the time prior to illness at these stores.”
Cassell said samples from the grower (identified by Davidson as Carica de Campeche) had been collected as of July 8, but results were pending.

The Food Safety Modernization Act gives the FDA the authority the power to recall food it believes is involved in an outbreak. 

The process involves a hearing before a judge where the FDA/CDC argue their case, and the company linked to the outbreak presents its evidence.

“If you have a clear convergence and data (pointing to a particular company) we can take action, and that’s all outlined in our guidance documents,” Cassell said. 

Note on correction: Scott Davidson's title in the original article was incorrect.

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