FDA Announces FSMA Food Traceability Proposed Rule

On September 21, 2020, the U.S. Food and Drug Administration (FDA) announced a proposed rule to establish additional traceability recordkeeping requirements for certain foods. The FDA also published a draft “Food Traceability List,” which describes the foods that would be subject to the proposed requirements. The list includes leafy greens, fresh cut fruits and vegetables, some types of fish, shell eggs, nut butters, and more.  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. 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 more digital traceability systems in the future.

The proposed rule requires those who manufacture, process, pack, or hold a food on the Food Traceability List (FTL) to establish and maintain records associated with specific Critical Tracking Events (CTEs): growing, receiving, transforming, creating, and shipping. In addition, those subject to the rule would also be required to create and maintain records related to their internal traceability program, which would help regulators better understand a firm’s recordkeeping practices and traceability operations.  The proposed rule would require records to be maintained as either electronic, original paper records, or true copies. Also, 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.  The requirements of the proposed rule would only apply to foods that are on the FTL, which includes foods that have listed foods as ingredients. The proposed rule includes several exemptions.

The proposed rule and draft Food Traceability List are available for public comment until January 23, 2021.

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