Papaya outbreak highlights FDA’s food safety challenge

‘Inability to track and trace foods with speed or precision’ is agency’s ‘Achilles’ heel’

Salmonella infections caused by contaminated papayas highlight the challenges Food and Drug Administration officials face in fighting foodborne illness. (Al Drago/CQ Roll Call file photo)
Salmonella infections caused by contaminated papayas highlight the challenges Food and Drug Administration officials face in fighting foodborne illness. (Al Drago/CQ Roll Call file photo)
Posted July 15, 2019 at 7:00am

Salmonella infections caused by contaminated papayas highlight the challenges federal officials face in fighting foodborne illness, as a law from nearly a decade ago meant to modernize the food safety system is starting to show its age. 

The Food and Drug Administration is trying to bring its efforts to track and prevent outbreaks in line with the technology now at its disposal. But because spending for next year is uncertain, Congress could make it difficult for the agency.

Already this year, the government shutdown delayed most food safety inspections, and during the other four months when the agency was under a continuing resolution, trying to launch new programs was much harder. This fall, the FDA may get a modest funding increase for food safety in fiscal 2020 — or face prolonged flat funding if the budget impasse isn’t resolved. 

The papaya outbreak is the latest instance of the FDA issuing a blanket warning against an entire product because officials were unsure where the problem originated. A similar thing happened before Thanksgiving last year when the government warned against eating any romaine lettuce. In both cases, it took a week before consumers got more specific guidance on what brands or locations of origin to avoid. 

Frank Yiannas, the head of the FDA’s food safety programs, described “the inability to track and trace foods with speed or precision” as the agency’s “Achilles’ heel.” Part of the problem is that while genomic sequencing technologies make it easier than ever to identify that disparate sicknesses are tied to one outbreak, the infrastructure that would help trace the outbreak to its original source hasn’t been fully developed. 

The FDA in April announced a blueprint to modernize the food safety system by looking at ways to increase the use of digital technology in the supply chain. The agency also wants to learn how to better apply artificial intelligence to screenings of imported foods at ports and border crossings, and assess how to handle concerns about the rapidly expanding e-commerce food delivery system.

In short, the food and technology landscape looks different than when Congress wrote the Food Safety Modernization Act in 2010. 

“Things have changed a lot since FSMA passed,” Yiannas told CQ Roll Call in May. He said the FDA will continue to work with Congress “so that they understand that there’s a need for continued modernization of our food safety efforts as our food system and society changes.” 

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Flaws in the system

When the papaya outbreak was originally announced June 28, the FDA didn’t have enough information to pinpoint a source other than Mexico. Officials told consumers and retailers to avoid any papaya imported from the country. 

More details eventually came out July 5, when the Centers for Disease Control and Prevention identified the brand, Cavi, and the distributor that were the likely culprits in the illnesses of 71 people across eight states. The FDA then urged consumers nationwide to avoid the brand. 

Yiannas wants to update the food system so tracebacks can be done in seconds, rather than the days or weeks it currently takes. It can take so long because food producers are only required to know the immediate source of a product, and its next stop, not the whole route. Smaller producers may only keep paper records. So when it’s time to trace back a contaminated item, particularly produce or an ingredient in a processed food, it takes time to piece the steps together.

Helping producers shift to digital forms of tracking technologies, like blockchain, could help pinpoint outbreak sources more quickly and eliminate the need for blanket warnings, Yiannas said. The agency hopes lawmakers provide additional funding to back its goals. 

“While in today’s systems those broad consumer advisories are absolutely the right thing to do, with better track and trace they wouldn’t have to be so broad and overly prescriptive,” Yiannas said. 

Yiannas joined the FDA in November 2018 after running the food safety program for Walmart, the retail giant that is also the largest grocer in the U.S. There, Yiannas implemented digital tracking requirements for producers in the company’s supply chain to ensure that food could be traced back to its source rapidly.

He would like to help the nation’s food system gain the same capabilities, but acknowledges the challenges. The system is extremely fragmented and composed of many small companies that might have a harder time adopting digital tracking methods. 

Congress may also be feeling funding fatigue after boosting food safety resources from around $700 million in 2009 to nearly $1.1 billion today. Some lawmakers have concerns about how much progress the FDA has made on FSMA implementation. While most of the new rules that the FDA was supposed to implement after the law’s passage are in place, it wasn’t until this year that the FDA and states began sending inspectors to produce-growing farms. Rules about standards for agricultural water were delayed in 2017 and won’t be in effect for the largest farms until 2022. 

Fight for funding

For fiscal 2020, the House is proposing $1.1 billion for the FDA’s food programs, out of a total $5.9 billion budget. That would be around a $40 million increase for food programs compared to fiscal 2019.

Lawmakers are aware of the gaps in traceability. While extra money wasn’t specifically allocated in the report accompanying the House spending bill, appropriators directed the FDA “to work with stakeholders on a wide-scale traceability system that could help companies and government agencies more rapidly access data crucial to tracking foods.”

An increase could help the FDA pursue its goals. The agency’s fiscal 2020 budget request asked for a $52 million overall boost for foods, including $13.3 million to improve the response to outbreaks, which encompasses the traceability efforts.

But House and Senate leaders have yet to agree on topline spending levels for the next fiscal year. While the Senate hasn’t written its appropriations bills yet, it seems poised to start with lower amounts than the House. 

As the FDA prods Congress to provide more money and support its goals of using modernized technology, lawmakers have sometimes been frustrated with the agency. 

The FDA’s initial response to the papaya outbreak drew criticism from Democratic Connecticut Rep. Rosa DeLauro, a senior member of the Appropriations Agriculture Subcommittee, which funds the agency.

She noted the first sign of an outbreak didn’t come from the FDA or CDC but from a fruit and vegetable industry trade publication, which published a story about the outbreak on the morning of June 28. It wasn’t until 3:30 p.m. that the CDC sent its own alert, and the FDA’s came an hour later. 

“When it comes to announcing an ongoing outbreak, where consumers potentially have contaminated food in their homes, minutes matter,” DeLauro wrote in a letter to acting FDA Commissioner Ned Sharpless.