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:
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.