Fresh Produce Traceability

Fresh Produce Traceability

When there is an outbreak of foodborne illness, it is critical that the contaminated food be rapidly traced through the supply chain to identify the source and remove the contaminated product from the market before more people get sick.  Identifying the source of contamination also allows us to better understand the cause of contamination so that we can prevent it from occurring again.

The FDA final rule on Requirements for Additional Traceability Records for Certain Foods (Food Traceability Final Rule) establishes traceability recordkeeping requirements, beyond those in existing regulations, for persons who manufacture, process, pack, or hold foods.  In this new rule, stages in production are called Critical Tracking Events (CTE) and required records or data points are referred to as Key Data Elements (KDE).  The Food Traceability List (FTL) identifies high risk foods for which the additional traceability records are required.  The following covered fresh fruits and vegetables are on the food traceability list:

  • Cucumbers
  • Herbs
  • Leafy greens (fresh and fresh-cut)
  • Melons
  • Peppers
  • Sprouts
  • Tomatoes
  • Fruits (fresh-cut)
  • Vegetables (fresh-cut)

The FDA hosted a webinar to cover the new requirements of the Food Traceability Rule.  Key requirements for any fruit and vegetable on the food traceability list are as follows:

  • Traceability planA traceability plan [timepoint 1:49:18 in webinar] is required and must be updated as needed to reflect current practices.  Following any updates to the plan the previous plan must be maintained for two years. A farm map must be maintained in the traceability plan.
  • Growers must initiate a traceability lot code for the food grown but the code does not have to be on the package if it is recorded in another way (i.e. email, bill of lading).
  • Record key data elements in an electronic sortable file [timepoint 1:56:08 in webinar].Traceability records
  • Establish and maintain required records [timepoint 2:12:15 in webinar].

The FSMA Food Traceability Rule (FSMA 204) was finalized and published in November 2022.  The compliance date for the changes to FSMA 204 is set for January 20, 2026. To determine if you might be exempt from this rule, use the food traceability exemption rule tool (English or Spanish).