Beltway Beat
Produce Traceability: Uncovering the Gaps in Your Program

The produce industry handles an estimated six billion cases of produce in the U.S. each year. [i] Because a significant portion of this produce travels through the supply chain to reach customers, many produce companies already have traceability program in place. With the finalization of the Food and Drug Administration’s (FDA) Food Safety Modernization Act (FSMA) Final Rule: Requirements for Additional Traceability Records for Certain Foods [ii] (Food Traceability Rule), the question is whether these existing traceability programs, systems, and procedures meet new FDA requirements.

A gap assessment can do just that—determine what requirements your existing programs already meet and identify where improvements are needed to comply with the final Food Traceability Rule by the January 2026 deadline.

Steps for Conducting a Gap Assessment

Not surprisingly, many produce companies already have elements of a traceability program that fulfill some of the Final Rule’s requirements. A gap assessment serves as the starting point for:

Performing a gap assessment will help you compare what you have to what you need. The following steps will get you started:

  1. Find the most current copy of the standard you will compare against your programs. You will likely want to use the Code of Federal Regulation (CFR) Title 21, Chapter 1, Subchapter A, Part 1, Subpart S [iii], as it outlines specific expectations for general provisions, Traceability Plan, records of Critical Tracking Events (CTEs), and more.
  2. After you are familiar with the rule, review the most current version of your own program. A systematic review over time may make conducting a gap analysis more manageable. Start by identifying which of your products are on the Food Traceability List (FTL) [iv], what CTEs you perform, and which Key Data Elements (KDEs) you are already collecting. Have you overlooked a CTE? Have you forgotten a KDE? Refer to the questions below as you conduct this gap assessment. Document all missing elements.
  3. Compare your Traceability Plan to what is required by the new rule. Document the items you have identified as missing from your Traceability Plan.
  4. Develop and document your strategy to address each gap identified in steps 2 and 3 above. There may be some items that can be addressed immediately, while others may require additional time and support. You may need to create new logs, enlist the help of other departments, or acquire approval from your supervisors to make the necessary changes. Set realistic goals to implement the required updates by the compliance date.
  5. Train or retrain employees. Tell them why the changes are happening, acknowledge the importance of compliance with the new rule, and empower them to make the necessary changes.
  6. Notify management, customers, and suppliers of changes to your program to ensure everyone involved is on the same page.

Turning Gaps into Opportunities: Key Questions to Ask

Asking the right questions is key to ensure your gap assessment identifies required missing elements in your programs compared to the rule. The following questions can help guide your food traceability gap assessment:

The answers to these questions will identify elements that you need to implement to help ensure compliance. Getting started on your gap assessment now affords time for produce companies to identify compliance program gaps, test protocols and verify their effectiveness, implement corrective actions, and ensure adequate traceability processes are in place before the January 2026 deadline.

[i] The Produce Traceability Initiative. https://producetraceability.org/.

[ii] U.S. Food and Drug Administration. FSMA Final Rule on Requirements for Additional Traceability Records for Certain Foods. June 27, 2024. https://www.fda.gov/food/food-safety-modernization-act-fsma/fsma-final-rule-requirements-additional-traceability-records-certain-foods.

[iii] Code of Federal Regulation. Title 21, Chapter 1, Subchapter A, Part 1, Subpart S. July 3, 2024. https://www.ecfr.gov/current/title-21/chapter-I/subchapter-A/part-1/subpart-S?toc=1.

[iv] U.S. Food and Drug Administration. Food Traceability List. March 30, 2024. https://www.fda.gov/food/food-safety-modernization-act-fsma/food-traceability-list.

[v] U.S. Food and Drug Administration. Food Traceability Rule: Critical Tracking Events (CTEs) and Key Data Elements (KDEs). https://www.fda.gov/media/163132/download?attachment.

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