Food Traceability Rule: Part 2—Definitions and Acronyms

This publication is the second in a series that provides information to the food industry on the Food Safety Modernization Act’s Food Traceability Rule and its key components.

Introduction

This publication is the second in a series of fact sheets designed to support the food industry’s compliance with the Food and Drug Administration’s (FDA) Food Traceability Rule (FTR), officially titled FSMA Final Rule on Requirements for Additional Traceability Records for Certain Foods. This rule, part of the FDA’s Food Safety Modernization Act (FSMA) (FDA 2011), is designed to enhance food safety by ensuring traceability across specific high-risk food categories. The compliance date for this rule was originally published as January 2026. However, on March 20, 2025, the FDA extended the original compliance date by 30 months to July 20, 2028 (FDA 2026).

The first publication in this series introduces the foundational elements of the Food Traceability Rule, including its goals, scope, and key requirements. Additionally, the first publication provides a table that includes all the available links and resources released by the FDA at the time of publication (Chuah and Farzad 2024). The goal of this publication is to foster a clear understanding of key terms related to traceability requirements, thereby supporting compliance efforts for high-risk foods as mandated by the new FSMA rule. This resource also provides information to support the accurate documentation of critical tracking events (CTEs) and key data elements (KDEs) across the food supply chain, helping industry members effectively implement and maintain traceability plans. The intended audience of this publication is food processors, manufacturers, packers, and others who will be required to comply with the Food Traceability Rule.

Definitions

1. Food Traceability List (FTL): The list of foods designated as having a higher risk for foodborne illnesses and contamination. These foods are subject to the Food Traceability Rule’s requirements. Current examples of foods on the FTL include leafy greens, finfish, shell eggs, and tomatoes (FDA 2022b). This list will be updated every five years.
2. Critical Tracking Event (CTE): Essential steps in the supply chain where collecting information (data) is required to track the movement of foods and any changes made to foods (FDA 2022a, 2022b). The CTEs that require data collection include harvest, cooling (before initial packing), initial packing, first land-based receiver, shipping, receiving, and transformation.
3. Key Data Element (KDE): Specific data points that are required to be recorded at each CTE in the supply chain. Examples include details about product identification, lot number, dates, and locations to enable traceability (FDA 2022a, 2022b). Table 1 shows the common KDEs required to be collected across CTEs.
4. Traceability Lot Code (TLC): A unique identifier assigned to a batch or lot of food products that enables the linking of product data across the supply chain and supports rapid identification in case of recalls or food safety concerns. A TLC must be assigned by food operations when they (1) initially pack a raw agricultural commodity (excluding food from fishing vessels), (2) receive food from a fishing vessel at a land-based location for the first time, or (3) conduct any transformation of a food product. Figure 1 shows TLC examples provided by the FDA (FDA 2024).

   

5. Traceability Lot Code (TLC) Source: The location where the TLC was assigned. The required KDEs for the TLC source include business name; phone number; physical location address (or geographic coordinates); city, state, and zip code for domestic locations; and comparable information for foreign locations, including the country (FDA 2024).
6. Traceability Lot Code (TLC) Source Reference: An alternative method that allows the FDA to access the TLC source while protecting the food operation’s confidential business relationships. Food operations typically collaborate with their supply chain partners to develop these methods. Examples include providing the FDA Food Facility Registration Number or a web address accessible only by the FDA (FDA 2024).
7. Traceability Plan: A written document that outlines how the food operation maintains and manages traceability records in compliance with the FDA’s Food Traceability Rule. Based on 21 CFR § 1.1315 the plan must include (1) a description of the procedures used to assign, maintain, and link KDEs to CTEs; (2) an explanation of how TLCs are created and assigned (if applicable); (3) a list of all foods on the FTL that the food operation handles; and (4) the name and contact information of the person responsible for traceability records. If growing or raising foods on the FTL, farms are required to keep maps showing where these activities occur. The plan must also describe where traceability records are maintained and ensure they can be made available to the FDA within 24 hours upon request. Traceability plans and accompanying records must be maintained for two years after creating, receiving, and updating documents.
8. Transformation: Any process that changes the form of a food product, such as cooking, cutting, combining with other ingredients, comingling, and repacking. Under the FTR, certain transformations can remove a product from some traceability rule requirements (e.g., pickling cucumbers to make pickles or freezing peppers).
9. Initial Packer: The first person (or food operation) that packs any raw agricultural commodities (RAC) or aquacultured seafood. This does not include seafood obtained from a fishing vessel. The initial packer is the entity that puts the food into packaging, such as boxes, bins, or bags, for the first time after harvest or receipt. This initial packer is responsible for creating the TLC and traceability records that link the harvested product to the initial packing event.
10. Kill Step: A processing step that significantly reduces or eliminates pathogens in food. Common kill steps include cooking, pasteurization, irradiation, or other validated food safety treatments. Under the traceability rule, foods that undergo a validated kill step may be exempt from some traceability requirements.
11. Shipping: Food is prepared for transport from one location to another (excluding direct-to consumer sales shipments or for donation purposes). This can include an intracompany shipment moved from one location at a particular street address to another location at a different street address.
12. Receiving: Food is received at another location after transportation. This can include receiving an intracompany shipment from one location at a particular street address to another location at a different street address.
13. Electronic Sortable Spreadsheet: A digital file format (e.g., Excel, CSV) used to record traceability data, including KDEs, CTEs, and TLCs, in a structured and searchable way. Each data element is entered into a separate field or column, allowing the information to be easily organized, filtered, and analyzed. Food operations must be able to provide these traceability records electronically in a sortable spreadsheet within 24 hours upon request to facilitate FDA traceback investigations (FDA 2022a, 2022b).
14. Reference Document: Any document used to support or link traceability information, such as purchase orders, bills of lading, invoices, or internal logs. These documents can serve as supporting evidence for KDEs and CTEs and may be requested during audits or traceback investigations to verify traceability records (FDA 2022a, 2022b).

Commodity-Specific Definitions

1. Harvest (Fishing) Vessels: Boats or ships involved in the harvesting of seafood or aquatic products. In many cases, these vessels are exempt from direct traceability requirements, although records may be required once products reach the first land-based receiver (FDA 2022a, 2022b).
2. First Land-Based Receiver: The first facility or entity that takes possession of food after it has been harvested and landed. This entity is often responsible for initial traceability records under the FTR (FDA 2022a, 2022b).
3. Commingled Raw Agricultural Commodities (RACs): Foods in their raw or natural state that are mixed after harvest but before processing (FDA 2026).

1. Seafood: Mixing step includes foods from different landing vessels and occurs once the vessels have landed.
2. Produce: This definition does not include produce covered under the Produce Safety Rule. This definition only applies to foods mixed from different farms when completed by a different company’s management.

Acronyms

References

Chuah, S., and R. Farzad. 2024. “Food Traceability Rule Overview: A Guide for Florida Food Industry: FSHN23-5/FS455, 01/2024.” EDIS 2024 (1). https://doi.org/10.32473/edis-fs455-2024

U.S. Food and Drug Administration (FDA). 2011. “Full Text of the Food Safety Modernization Act (FSMA).” Last updated December 13, 2017. https://www.fda.gov/food/food-safety-modernization-act-fsma/full-text-food-safety-modernization-act-fsma

U. S. Food and Drug Administration (FDA). 2022a. “FSMA Final Rule on Requirements for Additional Traceability Records for Certain Foods.” https://www.fda.gov/food/food-safety-modernization-act-fsma/fsma-final-rule-requirements-additional-traceability-records-certain-foods

U.S. Food and Drug Administration (FDA). 2022b. “Requirements for Additional Traceability Records for Certain Foods (Final Rule).” Federal Register 87 (223): 70910–70941. https://www.govinfo.gov/content/pkg/FR-2022-11-21/pdf/2022-24417.pdf

U.S. Food and Drug Administration (FDA). 2024. “Traceability Lot Code.” Last updated August 6, 2024. https://www.fda.gov/food/food-safety-modernization-act-fsma/traceability-lot-code

U. S. Food and Drug Administration (FDA). 2026. “Frequently Asked Questions: FSMA Food Traceability Rule.” Last updated March 10, 2026. https://www.fda.gov/food/food-safety-modernization-act-fsma/frequently-asked-questions-fsma-food-traceability-rule