FDA Announces FSMA Food Traceability Proposed Rule – Comment Period Opens

Yesterday, the U.S. Food and Drug Administration (FDA) announced a proposed rule to establish additional traceability recordkeeping requirements for certain foods. FDA also published a draft Food Traceability List (FTL), which describes the foods that would be subject to the proposed requirements. The proposed  FTL consist of several foods including leafy greens, cucumbers, herbs (fresh), melons, peppers, sprouts, tomatoes and fresh cut fruits and vegetables.

Click here to access the “Requirements for Additional Traceability Records for Certain Foods” proposed rule.

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. 

What is in the Proposed Rule?

• Those who manufacture, process, pack, or hold a food on the FTL would be required to establish and maintain records associated with specific Critical Tracking Events (CTEs), including growing, receiving, transforming, creating, and shipping.
• For each CTE, entities would be required to establish and maintain records containing Key Data Elements (KDEs), such as the traceability lot code, the date the product was received, the date the product was shipped, and a product description. 
• In addition, those subject to the rule would also be required to create and maintain records related to their internal traceability program.
• 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 Food Traceability Proposed Rule is a key component of FDA’s New Era of Smarter Food Safety Blueprint and would implement Section 204(d) of the Food Safety Modernization Act (FSMA).

The proposed rule and draft FTL are available for public comment for 120 days from the date of publication. FDA will also be holding three public meetings during the public comment period. More information about the public meetings will be provided in a forthcoming announcement.

Western Growers will assess the impact of the proposed rule and develop comments for submission to FDA. We will be conducting member outreach , gathering feedback and highlighting potential changes as we develop our comments.

Please contact Sonia Salas at ssalas@wga.com for more information.