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The Proposed Traceability Rule: Recordkeeping and Exemptions


There’s a lot to absorb in FDA’s newly published Food Traceability Proposed Rule (Requirements for Additional Traceability Records for Certain Foods)! So the TAG team is continuing to closely review and study the 55-page document to bring our readers and clients up to speed and help ensure you have a complete understanding. While FDA recognizes that many companies and organizations have developed strong traceability practices, there have also been instances in which insufficient data, delayed access to data, and incompatible traceability programs have hindered FDA’s ability to effectively investigate and respond to food safety outbreaks. This proposed rule is intended to harmonize traceability information across the entire food supply chain, which should help to better establish linkages for traceability activities since we know that the supply chain is only as strong as its weakest link.

We began last week with an overview of the Food Traceability List (essentially a high-risk foods list, though FDA is declining to call it that), and the proposed requirements for identification of critical track and trace data (i.e., Key Data Elements [KDEs]) at critical points in the supply chain that involves growing, receiving, transforming, creating, or shipping food included in the Food Traceability List (i.e., Critical Tracking Events [CTEs]).

This week, we continue with the overview to focus on FDA’s proposed recordkeeping requirements and exemptions. And tune in October 30th for TAG’s FSMA Friday webinar in which TAG Director, Food Safety Eric Edmunds, JD, will discuss the rule and its implications for the industry.

Recordkeeping. In addition to the required KDE records, the proposed rule would require traceability program records to include:

  • Relevant reference records. Because KDE's might be kept on various reference records (e.g., bills of lading, purchase orders, production logs), traceability program records must include a description of these explaining where traceability information is on the reference record and how reference records for different tracing events for food are linked.

  • A list of FTL foods shipped. Anyone who ships an FTL food is to keep a list of these, including the traceability product identifier and traceability product description for each. This list would be part of a firm’s traceability program records.

  • Traceability lot codes assignment. Traceability lot codes, that would uniquely identify the food throughout the supply chain, are to be established when an FTL food is originated, transformed, or created. This would include a description of how the lot codes are established and assigned, so regulators can understand the scope of the records they are reviewing.

  • Definitions. Any other information needed to understand the data within their traceability records is to be included (e.g., internal/external coding systems or classification schemes, glossaries, abbreviations, etc.) to help regulators understand the terminology, methods, and systems a firm uses in its traceability operations.

  • Sortable Spreadsheet. An electronic sortable spreadsheet containing relevant traceability information must be able to be provided to the FDA within 24 hours of a request when needed to assist in an outbreak, recall, or other public health threat. An FDA request for this information will specify the foods and date ranges that must be provided.

  • Record maintenance. Traceability records must be kept as legible, original paper records, electronic records, or true copies that are stored to prevent deterioration or loss, retained for two years, and are to be provided to FDA within 24 hours after a request.

Exemptions. The proposed rule includes exemptions for certain types of foods and certain persons who manufacture, process, pack, or hold foods on the Food Traceability List. Some of these exemptions were provided by Congress, while others reflect the FDA’s current thinking about the application of this rule to certain foods and persons.

Exemptions are proposed for: certain types of small originators, farms that sell directly to consumers, foods that receive certain types of processing, produce that is rarely consumed raw, small retail food establishments (full and partial proposed), transporters, nonprofit food establishments, personal consumption, persons who hold food for individual consumption, foods subject to a kill step. Partial exemptions are proposed for: commingled fruit/vegetable RACs subject to the produce safety rule, retail food establishments, farm-to-school and farm-to-institution programs, food from fishing vessels, and transporters. (For complete information on the exemptions see Exemptions and Modified Requirements At-A-Glance)

Compliance date. Because an effective traceability system requires all entities in a supply chain to maintain traceability records, FDA has proposed that the compliance date for all persons and establishments subject to the recordkeeping requirements be two years after the effective date of the final regulation.

Virtual Public Meetings. FDA will be holding three virtual public meetings on the proposed rule “to facilitate and support the public's evaluation and commenting process on the proposed rule.”

Comment Period. The proposed rule is available for public comment by January 21, 2021, at docket FDA-2014-N-0053 on regulations.gov.

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