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:

• Understanding your regulatory obligations compared to your current compliance status.
• Determining if existing programs, procedures, and systems are good as is, need improvement, or are missing and need to be developed.

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:

• Do you manufacture, pack, process, or hold any of the foods found on the FTL? The FDA developed the FTL considering a few specific food safety factors, including frequency of outbreaks, occurrences of illness, severity of illness, likelihood of contamination, potential for pathogen growth, process contamination, consumption rate, and cost of illness. Comparing your products to the FTL may indicate the likelihood of your produce being implicated in a recall or outbreak event and will underscore the importance of your organization’s compliance with the Traceability Rule.
• Are you performing CTEs? These include harvesting, cooling, initial packing, first land-based receiving (food obtained from a fishing vessel), shipping, receiving, or transforming any of the foods on the FTL. If so, specific data must be collected. Do you understand and are you meeting these data collection requirements?
• Does your organization capture data that is considered a KDE? For example, do you apply lot codes to your products? Do you collect detailed location information about where your product is harvested (e.g., farm site A, field 7)? Determine if there is any specific information, data points, or additional KDEs you must capture and maintain to meet FDA requirements (e.g., date, harvest crew, common name of the commodity and variety, etc.). The data required is dependent on which of the CTEs you are performing. This guide from the FDA[v] can help determine whether you are collecting all the required data. Once you know what data you are missing, as identified by your gap assessment, you can determine how to best record it (e.g., developing new processes and procedures, implementing a new lot code sticker program).
• Do you have a sufficient Traceability Plan? Does your Plan cover all the elements required in the Food Traceability Rule? The Traceability Plan must include the following, at a minimum:
  • Description of the procedures used to maintain required records, as well as how to format and where to store those records.
  • Description of how lot codes are assigned.
  • Assignment of and contact information for a point person who can answer questions about the Traceability Plan and/or traceability records.
  • Map identifying the farms where FTL produce is grown.
  • Updates to reflect updated or new practices.
• What recordkeeping system are you using? Are there upgrades you need to make to your recordkeeping system to solve your data collection pain points? Can your system handle new requirements? Is required information readily retrievable? While hard copies in binders and Excel spreadsheets can work, an electronic document management system can create efficiencies and standardization, reduce human error, and improve accessibility when managing vast amounts of data. Your gap assessment can help you identify and better understand your needs and requirements prior to investing in an IT solution that helps streamline your traceability process and improve overall compliance efficiency.
• How are you sharing data? What collaborative activities can you and your suppliers/buyers perform to ensure efficient data sharing? How do you communicate and with what frequency? What systems are your partners using? What is the best way to connect them to enable data sharing? It is important to ensure you have established processes, systems, and methods of communication throughout the supply chain to facilitate the required documentation, information sharing, and collaboration.

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.