The FDA on Sept 21 announced a proposed rule to establish additional traceability recordkeeping requirements for certain foods, including leafy greens, fresh cut fruits and vegetables, some types of fish, shell eggs and nut butters.

The rule follows a number of recent foodborne illness outbreaks that involved produce, and they proved to be some of the most difficult to trace back to the source.

The proposed rule, “Requirements for Additional Traceability Records for Certain Foods” (Food Traceability Proposed Rule) is a key component of the FDA’s New Era of Smarter Food Safety Blueprint and would implement Section 204(d) of the FDA Food Safety Modernization Act (FSMA).

"If finalized, the proposal would standardize the data elements and information firms must establish and maintain and the information they would need to send to the next entity in the supply chain to facilitate rapid and accurate traceability," the announcement read.

"While limited to only certain foods, this proposal lays the foundation for a standardized approach to traceability recordkeeping, paving the way for industry to adopt, harmonize, and leverage more digital traceability systems in the future."

The agency noted existing regulations require the food industry to maintain records to identify the immediate previous sources and the immediate subsequent recipients of foods (commonly referred to as “one-up, one-back” recordkeeping). But those rules increasingly are being called inadequate.

"These [current] requirements form a baseline for traceability recordkeeping, but they provide limited information to effectively and rapidly link shipments of food through each point in the supply chain," the agency said. "This -- and the fact that recordkeeping systems can be largely paper-based and lack a universal lexicon throughout industry-- can make it difficult to trace a product to its original source when necessary."

At the heart of the proposal is a requirement for effected companies to maintain records associated with specific Critical Tracking Events (CTEs): growing, receiving, transforming, creating and shipping. For each CTE, entities would be required to maintain records containing Key Data Elements, such as traceability lot code, date the product was received, date the product was shipped and a product description.

The traceability lot code is an especially key factor throughout the supply chain -- intended to establish critical linkages that will help to facilitate rapid traceback and traceforward investigations during foodborne illness outbreaks and recall events.

The proposed rule would require records to be maintained as either electronic, original paper records or true copies. In addition, the proposal states that in the event of a foodborne illness outbreak, a product recall or other threat to public health, the FDA could require that firms submit, within 24 hours, 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 identification of traceability information when needed to address threats to public health.

The proposed rule and draft Food Traceability List are available for public comment till about Jan. 19, 2021. The FDA also will hold three public meetings, details of which will come shortly.