University of Minnesota study guides FDA's updated foodborne illness strategy

Federal food safety regulators are promising a faster and more transparent approach to foodborne illness outbreaks following a University of Minnesota review.

The Food and Drug Administration contracted with the U for an independent look at its outbreak response strategy and last week issued a plan to adopt more technology, share findings faster and work more closely with other agencies to tackle large, multi-state outbreaks.

"There's a great need for more interaction at a personal level among partners in the investigations," said report author Craig Hedberg, a public health professor at the U and co-director of the Minnesota Integrated Food Safety Center of Excellence. "Technology alone is not going to get us there."

The FDA has been criticized for moving slowly during outbreaks and withholding data early in investigations. Hedberg found "there is a perception that a culture of withholding information goes beyond actual legal restraints on sharing information."

"The default setting should be to disclose information whenever it can advance the progress of the investigation," Hedberg wrote.

The review also said staffing levels "are not adequate to respond to the growing number of outbreaks" associated with persistent food safety issues.

"There is a great opportunity for Congress to address the needs of our public health system," Hedberg said in an interview. "There are data that suggest that levels of federal support for public health actually lead to better performance."

The FDA said it "will continue to do everything we can to protect consumers from unsafe food" and increase staffing, "resources permitting," as it implements its "New Era of Smarter Food Safety" initiative first launched in 2019.

"Our investigations must be faster, more streamlined and more effective to identify, pinpoint and remove contaminated food from the market and identify root-cause factors in the food system to prevent similar outbreaks in the future," the agency said in a statement.

But it could be years before those efforts pay off.

"It's a massive agency changing the culture to be more activist, to be more aggressive during these outbreaks," said Brendan Flaherty, a founding partner at OFT Food Safety & Injury Lawyers in Minneapolis. "It's changing the direction of a giant ship — that takes a long time."

Foodborne illnesses kill about 3,000 Americans per year and send more than 125,000 to the hospital, according to the FDA. The agency estimates millions are sickened by foodborne pathogens annually.

This fall a widespread salmonella outbreak linked to onions imported from Mexico sickened 892 Americans, including 25 people in Minnesota and 30 in Wisconsin, according to the Centers for Disease Control and Prevention.

Those are just the confirmed salmonella infections; many infected people recover without hospitalization or a salmonella test.

Outbreak investigations typically start at the local or state level and begin to involve the FDA when potential sources of the contaminated food are identified. As the FDA increases its "traceback" efforts through digital tools, the agency says it will "increase transparency of outbreak investigations to increase widespread public confidence in results and help facilitate improved collaboration on investigation activities."

"We want to know what the FDA knows when they know it. And that would help the public health investigators, epidemiologists, working at the state level to trace things back," Flaherty said. "People do want transparency about their food — that's a consumer-driven thing."

Consumers also have a role to play in keeping food safe, but the responsibility ultimately lies with the producer.

"They're the ones making the food and making sure that it's safe," said Lorrene Occhino, senior scientist at the Agricultural Utilization Research Institute. Her colleague at the Minnesota nonprofit, Jason Robinson, added that food safety needs to be part of a product's design and manufacturing process.

"You've seen a lot of food safety issues break out not because you don't have oversight from the FDA or USDA or because consumers aren't washing their lettuce appropriately — issues have stemmed from producer delinquencies in their food safety system," said Robinson, the business development director for food at the institute.

Hedberg said despite the updates, the FDA remains limited in how far investigations can go, especially when contamination may stem from neighboring farms or livestock operations, for example. That has been the case with E. coli outbreaks tied to leafy greens in recent years.

"Regulatory agencies don't always have all the authorities they need to look at the whole production environment," he said. "On the whole, we have an abundant and safe food supply, but there are problems we have to continue to address."