The FDA has updated its materials about a proposed food traceability rule — “Requirements for Additional Traceability Records for Certain Foods” (Food Traceability Proposed Rule).

Traceability in the food supply chain is crucial during outbreaks and recalls, according to food safety experts in the public and private sectors. Outbreaks during the past two years, particularly involving romaine lettuce, demonstrated how the maze of shipping and receiving information stalled investigation efforts, allowing time for more people to become infected.

Traceability begins on the farm and ends when the consumer buys the product. During the romaine outbreaks in 2018 and 2019 it was well documented that many entities in the supply chain use paper records; much software in use is not compatible with that of trading partners; and that there is virtually no consistency in what information is gathered by trading partners along the way.

Frank Yiannas, FDA’s deputy commissioner for food policy and response, has kept the spotlight on traceability practices and regulations, working to encourage industry to make changes. In early 2020 he announced the FDA’s “New Era of Food Safety,” which focuses attention on traceability.

Changes to proposed rule
There are two main areas of change in the proposed traceability rule, which is in the public comment phase until Feb. 22, according to a statement from the FDA.

First, the agency has made edits to remove vague terms in the Food Traceability List (FTL), which shows the foods for which the additional traceability recordkeeping requirements in the proposed rule would apply. 

Specifically, the edits to certain commodity descriptions were made for clarity and do not reflect a change in which foods are on the FTL. For instance, the word “fresh” was added to certain fruit and vegetable commodities to clarify the scope of those commodities. Also, the description for “cheeses, other than hard cheeses” was revised to clarify what specific cheeses are part of this designation, and to include examples of such cheeses. 

All of the specific edits are described in a memo titled “Food Traceability List for ‘Requirements for Additional Traceability Records for Certain Foods’ Proposed Rule- Clarified Language.

The second area of change in the proposed regulation involves the agency’s publication of a Frequently Asked Questions document to address queries it has received about the proposed rule. 

The FDA gathered those questions during public meetings, through the FSMA Technical Assistance Network, and during other outreach engagements, according to a statement from the FDA. Those efforts were undertaken to assist stakeholders, including the general public, who are considering providing feedback during the comment period, which has been extended until Feb. 22. 

Comments can be submitted at, Docket ID: FDA-2014-N-0053.

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