FDA shoots one across the bow of papaya industry; puts entire food industry on notice

foodsafetynews 2019-08-28

Tag: FDA papaya salmonella

Papayas got the most ink from the FDA, but an announcement about stepped up food safety measures for the fruit is actually an example of how the agency is pressing ahead on enforcement and prevention activities for all foods.

Citing the papaya industry’s responsibility to stop recurring Salmonella outbreaks that have plagued U.S. consumers in recent years, a joint statement Monday from FDA Acting Commissioner Norman E. “Ned” Sharpless and the agency’s Deputy Commissioner for Food Policy and Response Frank Yiannas said “this trend has to stop.”

Since 2011, there have been eight U.S. Salmonella outbreaks traced to papayas imported from Mexico. One outbreak is ongoing with more than 70 people in eight states infected.

Overall, two people have died, with a total victim count of almost 500. More than 100 people have been hospitalized, according to the Centers for Disease Control and Prevention.

“The pattern of recurrent outbreaks we have observed since 2011, including the 2019 illnesses, have involved Salmonella infections traced back to, or are suspected of being associated with, papaya grown in Mexico,” according to the statement from Sharpless and Yiannas.

“The recurring nature of these outbreaks is a clear indication that more must be done within all sectors of the papaya industry to protect its customers and to meet its legal obligations. This includes growers, importers and even retailers that can and must do more. This is why today we have issued a letter calling on all sectors of the papaya industry to take actions to prevent these outbreaks in the future.”

A case illustrating the FDA’s enforcement of food safety laws for the papaya industry is a warning letter sent Monday to an importer. The letter cites problems including breaches of the Foreign Supplier Verification Program (FSVP), which makes importers responsible for verifying that the foods they bring into the U.S. have been produced in a manner that meets applicable U.S. safety standards.

The warning letter to Agroson’s LLC follows an FDA investigation at the facility in conjunction with the current Salmonella outbreak associated with papayas from Mexico. The investigation uncovered “significant violations” of the U.S. Food, Drug, and Cosmetic Act. As of Monday evening the warning letter was not yet available on the FDA website.

Broad warning given to entire food industry
In their Monday announcement, the Food and Drug Administration leaders said all of the food the agency regulates is in the crosshairs.

“Although today’s actions focus on the papaya industry, recurring outbreaks taking place with any commodity are unacceptable from a public health perspective,” the FDA leaders wrote.

“We know that more must be done by industry as repeated illness outbreaks are a threat to public health. In such situations, it is incumbent upon all sectors of the industry to work together to investigate the cause, review food safety procedures and practices, and take action to prevent further outbreaks.”

Sharpless and Yiannas emphasized the importance of the agency’s enforcement efforts. They said consumer demand and global supply chains are driving increases in imported food such as papayas. People want year round access to fresh fruits and vegetables and industry is responding.

“To keep up with this trend, we have doubled down on our efforts to ensure the safety of imported food. This includes issuing a new Strategy for the Safety of imported Food and requesting new funding from Congress to support our efforts,” the FDA leaders wrote.

All FDA regulated foods are subject to safety laws, but the agency gives a lot of attention to foods that are consumed raw or without a so-called kill step.

“The Produce Safety Rule under (the Food Safety Modernization Act) sets science- and risk-based minimum standards for domestic and foreign farms for the safe growing, harvesting, packing and holding of covered produce, which includes papayas,” Yiannas and Sharpless said.

The papaya situation is one example of how preventive standards can be enforced, according to FDA officials.

In what could become a sort of template for other commodities, FDA leaders set clear expectations for those in the papaya supply chain.

Letter to papaya industry
Referring to it as a “call to action” for the papaya industry, Yiannas and FDA Associate Commissioner for Regulatory Affairs Melinda K. Plaisier sent the papaya industry a list of safety points to address.

To meet food safety requirements and follow best practices to provide the public with safe foods, Yiannas and Plaisier wrote, we are asking the papaya industry to:

assess the factors that make crops vulnerable to contamination. If a foodborne pathogen is identified in the crop or growing environment, a root cause analysis should be performed to determine the likely source of contamination. Procedures and practices that minimize that risk must be implemented.
examine the use and monitoring of water used to grow, spray (pesticides, fungicides), move, rinse or wax crops to identify and minimize risks from potential hazards.
adopt tools and practices needed to enhance traceability. Papayas are a perishable commodity, and traceability information should facilitate the rapid tracking of involved product to expedite its removal from commerce, prevent additional consumer exposures, and properly focus any recall actions.
fund and actively engage in food safety research to identify the potential sources and routes of microbial pathogens and develop data-driven and risk-based preventive controls.

In addition to posting the letter publically, Yiannas and Plaisier sent it directly to: