SEATTLE — In a Dec. 11 webinar hosted by iFoodDS, food safety experts from the US Food and Drug Administration (FDA) discussed the role of FSMA 204’s data-sharing requirements in outbreak investigations.

The speakers used the 2020 Salmonella outbreak involving onions as a reference and explained how better reporting can reduce the amount of product companies have to recall in the event of an outbreak.

At the beginning of the webinar, Frank Yiannas, MPH, former deputy commissioner, food policy and response, US FDA, pointed out the ways some company leaders try to give outbreaks a positive spin by saying the increase in food recalls means the food safety system is working. Yiannas said he respectfully disagrees and that the large number of outbreaks the industry saw in 2024 means there are major food safety problems that need to be addressed.

“To me, every single recall that happens, whatever class, is a sign that the processing system is broken and needs to be fixed,” Yiannas said. “Five recalls a day is far too many.”

Yiannas also said some people have an inaccurate view of traceability and see it as reactive, not preventative. However, Yiannas said that better food traceability allows the FDA to trace suspected food safety issues back and address the problem at the source to prevent it from occurring again. It is called secondary prevention, he said.

Yiannas said the industry does not see a lot of investigative reports finding out why the problem occurred and what happened. When companies say actions have been taken and the food is safe to the public again, it is an empty statement if they still do not know what happened.

“We’re getting good at finding the needles in the haystacks, but we’re not finding the haystacks,” he said.

Yiannas said that during the largest Salmonella outbreak involving onions in 2020, the CDC and FDA came razor-thin close to advising Americans to stop eating onions entirely because of how large the problem became. However, they managed to stop the outbreak in its tracks and avoid that.

Angela Fields, senior consumer safety officer, CORE at FDA, followed what Yiannas shared with an explanation of how the FDA conducts outbreak investigations.

Fields said when there is an initial report, it takes time to investigate when an individual started having symptoms and what they ate during the time period leading up to the symptoms, along with conducting tests in hospitals.

Once the food is identified, those products from local stores are tested before the FDA traces it farther back to where the product came from. This is where FSMA 204 requirements are important.

In the 2020 onion case, the Salmonella outbreak was associated with Thomson International red onions, Fields said.

Because the FDA was lacking traceability information, the company had to also recall yellow and white onions to make sure the contamination was taken off the market. 

Fields said a lack of traceability affects sales more than necessary when outbreaks occur. Consumers will fully stop buying all onions if they do not know which ones are safe, she said.

Fields also said an outbreak involving a product like onions is difficult to investigate because not everyone will remember they ate onions if they are cooked into other foods. There can be some inaccurate reporting from people who were infected. The FDA has to pay close attention to what items are being reported and identify common ingredients they share to piece it together.

Once again highlighting the importance of FSMA 204 requirements, Fields said the investigation process takes a long time because the notes the FDA receives have to be reviewed by individual people, not a computer program.

“People don’t realize the quality of records we receive and the amount of time it takes to go through those kinds of records scribbled on a piece of paper,” Fields said. “We’ve finally started seeing more PDFs. It used to just be printed documents to go through.”

Fields said even with PDFs, individual people still have to translate the information into a spreadsheet before they can begin to analyze the data.

When companies submit information already formatted in a spreadsheet, the problem can be narrowed down sooner, and companies can avoid losing money recalling products that are not actually contaminated.

Andrew Kennedy, chief traceability officer at iFoodDS, added that a product with a long shelf life like onions means the amount of time the contaminated product was shipped can go back pretty far.

Ideally, the traceability lot code would allow you to skip over the supply chain and find the source of the outbreak even faster, he said.

Kennedy also said that food companies should be working on updating their traceability processes all through 2025 to get ready for the FSMA 204 mandate in January 2026.