As part of its overarching policy initiative, the “New Era of Smarter Food Safety,” which expands upon the platform put in place by the Food Safety Modernization Act, the U.S. Food and Drug Administration (FDA) recently proposed a new rule which would establish additional traceability recordkeeping requirements for certain foods, called “Requirements for Additional Traceability Records for Certain Foods.” It is one of the first measures introduced under the new policy initiative since a blueprint was introduced by the administration in July. 
 
If finalized, the proposal would standardize data elements and information which firms must establish and maintain, and would outline the information that a supplier would need to send to the next entity in a supply chain to establish faster traceability. While it’s only limited to certain foods (examples include leafy greens, all types of herbs (fresh), fresh cut fruits and vegetables, some types of fish, shell eggs, nut butters, and more) the FDA reports that the new rule would be “paving the way for industry to adopt, harmonize, and leverage more digital traceability systems in the future.”
 
A full list of the foods that would be subject to the tentative rule, which were selected due to their foodborne illness risk factors, can be viewed here.
 
In terms of traceability, existing FDA regulations require much of the industry to establish and maintain records to identify the immediate previous sources and the immediate subsequent recipients of foods, which can provide a baseline for traceability recordkeeping. However, FDA believes this is too limited to effectively and rapidly link shipments of food through each point in the supply chain as a whole. Additionally, the fact that recordkeeping systems are paper-based and lack an industry-wide “universal lexicon,” it is difficult to trace a product back to its original source when necessary, the agency said.
 
“As a result, many foodborne illness outbreak investigations have been slowed, resulting in more illnesses and economic loss,” the agency said in its announcement. “Improved traceability, as envisioned by the proposed rule, would allow the FDA to more quickly identify the source of a contaminated product, reduce the scope of product recalls, and conduct more timely root-cause investigations to learn more about how contamination occurred in order to prevent future outbreaks.”
 
The rule calls for companies that manufacture foods which the FDA listed to establish and maintain records associated with specific critical tracking events: growing, receiving, transforming, creating, and shipping. For each of these events, entities would be required to establish and maintain records containing standard key data elements, which include the traceability lot code, the date the product was received, the date the product was shipped, and a product description.
 
Those subject the rule would also be required to create and maintain records related to their internal traceability program, which would better help regulators understand a firm’s recordkeeping practices and traceability operations.

The proposed rule would require the aforementioned records to be maintained as either electronic, original paper records, or true copies. In the event of a foodborne illness outbreak, a product recall, or other threat to public health, the FDA could require that firms submit an electronic sortable spreadsheet containing relevant traceability information for specific foods and date ranges. More generally, the FDA encourages all food businesses to maintain their traceability records electronically whenever possible to expedite the sharing of information when needed.
 
The proposed food traceability rule and its draft are available for public comment for 120 days following publication, and the FDA will be holding three public meetings during the public comment period. Information about the public meetings will be provided at a future time.