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The Food and Drug Administration (FDA) released a guide in May to help small farms and businesses comply with the requirements of the new Food Safety Modernization Act (FSMA) Food Traceability Rule. You can download a copy of the guide here.
The guide provides a general overview of the traceability rule, the requirements for a traceability plan, and recordkeeping requirements. Specifically, the guide covers:
Who is subject to the traceability rule
Who is exempt from the rule (includes a link to the FDA’s software tool to help you determine whether you qualify for an exemption)
What records are required to be kept, and for how long
How to apply for a modification or exemption
How to petition the FDA for waivers of one or more of the requirements
Consequences of failing to comply with the traceability rule
The guide is not law. It is the agency’s recommendations for how small enterprises might comply with the traceability rule. Although the guide is written for the small-farms audiences, it is a useful reference for any size farm or business.
The traceability rule was first published in November 2022. It mandates traceability recordkeeping requirements for those who “manufacture, process, pack, or hold foods” on the Food Traceability List (FTL). Additionally, persons who manufacture, process, pack, or hold foods on the FTL must implement a traceability plan that outlines procedures for maintaining records, identifying, and assigning lot codes for FTL foods. This means that, if you ever handle an FTL food (and you’re not exempt from the rule), you will need to have a traceability plan in place. The compliance date for the rule’s recordkeeping requirements is January 20, 2026.
If you have questions about FSMA, the Produce Safety Rule, or the new traceability rule, you can contact Carol Allen, Agent Associate with the University of Maryland Plant Science Food Safety Group, at callen12@umd.edu, or contact an ALEI Legal Specialist by visiting umaglaw.org or emailing umaglaw@umd.edu.
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