Proposed FDA Rule Seeks To Make Tracing Food, and Food Poisoning Outbreaks, Easier

A new rule proposed by federal regulators would allow investigators to more easily trace certain products often found at the center of food poisoning outbreaks, helping contain new cases once problems are identified.

In a press release issued on September 21, the FDA announced a proposed rule to advance traceability of foods (PDF), which establishes additional traceability record keeping requirements for companies that manufacture, process pack, or hold foods the agency has designated as part of the Food Traceability List.

A draft list of foods on the list includes leafy greens, fresh-cut fruits and vegetables, some types of fish, eggs and nut butters, among others.

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The FDA claims the rule would offer the agency the ability to track food at every step of the supply chain. It calls on manufacturers to establish records to track events occurring within the supply chain, as well as allows the food industry to move to a more digital, tech-enabled traceability system.

The proposed rule is a part of the “New Era of Smarter Food Safety initiative” which is in accordance with the FDA’s Food Safety Modernization Act (FSMA).

Record keeping systems are largely paper-based, which can make it difficult to trace a food product throughout the food system and to determine the source of an outbreak. The new rule would help create an electronic record keeping system to streamline the food process and improve traceability during contamination and outbreaks.

The rule would require companies to submit electronic sortable spreadsheets regarding relevant traceable food information within 24 hours of an illness outbreak.

For example, during past outbreaks the FDA had to call for all leafy green vegetables to be recalled because a source of the contamination could not be pinpointed. This rule would allow the agency to identify the source quickly and reduce the length of outbreaks, the number and scope of recalls, and prevent additional illnesses and deaths.

“The availability of the traceability records that are set out in the proposed rule would also help limit the scope of recalls and in some instances, allow the FDA to better target consumer advice, avoiding blanket alerts on whole commodity sectors,” wrote FDA officials.

The proposed rule and draft Food Traceability List will be available for public comment for 120 days on the FDA website before a final rule is issued. Electronic comments can be submitted at, or by mail to Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.


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