FDA Proposes New Rule for Food Traceability

The agency seeks to establish additional traceability recordkeeping requirements for certain produce.

September 29, 2020

WASHINGTON—The U.S. Food and Drug Administration (FDA) proposed a new rule to establish additional traceability recordkeeping requirements for certain foods, based on Section 204 of the Food Safety Modernization Act (FSMA), as part of the New Era of Smarter Food Safety initiative.

“When we say traceability, what we are really talking about is the ability to track a food at every step of the supply chain,” said Frank Yiannas, FDA deputy commissioner for food policy and response. “While limited to certain foods, this proposed rule would create a first-of-its-kind standardized approach to traceability recordkeeping, paving the way for industry to adopt and leverage more digital, tech-enabled traceability systems both in the near term and the future.”

As part of the proposed rule, FDA released a draft Food Traceability List that identifies foods to which the additional recordkeeping requirements would apply. Those in the supply chain—including manufacturers, processors, and retail food establishments like convenience stores—will be required to comply with the recordkeeping requirements.

Yiannas says that more comprehensive traceability through access to records of key data elements associated with key tracking events in food production and distribution has the potential to help pinpoint the exact sources of foods involved in outbreaks.

“Not only does this help us to remove potentially unsafe products from the market more quickly, preventing additional illness or death, but it also helps us to conduct root cause investigations to figure out what went wrong leading to the outbreak,” Yiannas said, noting that this initiative would help industries develop and implement strategies to prevent future outbreaks tied to fresh produce like leafy greens.

Greater availability to traceability records would help limit the scope of recalls and in some instances, help the FDA avoid blanket alerts on whole commodity sectors,” said Yiannas, noting how FDA had to call for the removal of all romaine lettuce from the marketplace in November 2018 because the available supply chain information could not pinpoint a specific entity that produced the lettuce linked to the multistate outbreak of E. coli O157:H7. “With this proposed rule, we’re hoping to avoid situations like this in the future,” he said.

The proposed rule was published in the Federal Register. NACS plans to comment on the proposal before the January 21, 2021, deadline.