This publication is the third 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 series provides essential guidance to help food industry stakeholders navigate the Food and Drug Administration's (FDA) Food Traceability Rule, 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 2017), 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 2025). When the FDA wants to add or modify a rule, the proposed rule must undergo a formal rule-making process. This includes publishing the proposed rule in the Federal Register, where the public can submit comments about the proposed regulation (FDA 2023). For the duration of the comment period, comments can be submitted through mail, in person, electronically, or by other methods as described on regulations.gov (FDA 2023). Comments submitted for these proposed rules are public records, and tips about submission can be found on regulations.gov. Once the comment period has ended, the FDA will review the comments, and one of three actions will occur: the rulemaking process will end, a new proposed rule will be released, or a final rule will be published (FDA 2024).
The first publication in this series introduces the foundational elements of the Food Traceability Rule, including its goals, scope, and key requirements. The second publication explains key acronyms and definitions. (See EDIS publications FSHN23-5 and FSHN26-6, respectively.) In this publication, we explain traceability plans and clarify which food businesses are required to have them under this rule. This fact sheet will also include a discussion of exemptions and expectations for partially exempt entities. This publication will be useful for food businesses looking to better understand what is required by this portion of the Food Traceability Rule and what information is needed to achieve compliance.
Who Is Required to Have a Traceability Plan?
One requirement of the Food Traceability Rule is all food operations that manufacture, process, hold, or pack foods listed on the Food Traceability List (FTL) must have a set of procedures describing their recordkeeping process, known as a traceability plan. The plan's purpose is to enable more accurate tracing of food through the supply chain, thereby providing a quicker and more efficient response in the case of foodborne disease outbreaks. The traceability plan outlines how a food operation’s traceability program functions and how traceability data and records are maintained. Records can be kept on original paper, as an electronic copy, or as true copies, and they must be made available to the FDA within 24 hours of a request (FDA 2022). If there is a potential public health threat, the records must be provided to the FDA as an electronic sortable spreadsheet (FDA 2022). The second publication in this series explains more information on required record.
What Must Be Included in Your Traceability Plan?
Table 1 provides the requirements of a traceability plan under 21 CFR § 1.1315 (Dec. 31, 2024) of the Food Traceability Rule (FDA 2022). A traceability plan needs four sets of information. These include (i) procedures used to maintain required records, (ii) procedures used to identify foods on the Food Traceability List (FTL), (iii) a method for assigning the Traceability Lot Code (TLC), and (iv) contact information for the person responsible for answering traceability questions. The procedures used to maintain records should include how the food operation stores and organizes records. The format (e.g., digital or paper) and the location of these records should also be included. Some food operations may work with multiple commodities, including those that are and are not on the FTL. Therefore, it is important in a traceability plan to describe how the food operation identifies and handles those foods that are on the FTL. Assignment of the Traceability Lot Code (TLC) that follows the FTL food throughout the supply chain is an important aspect of the rule. The food operation or some other entity can assign the TLC. In a traceability plan, the food operation also needs to specify whether it uses a date-based system, line numbers, a specific identification standard, or a combination of inputs. Even if the food operation does not assign the TLC, it is important to communicate in the plan how it is assigned to food product(s). The traceability plan must also include specific contact information for at least one individual who can answer questions related to the traceability plan and records. This is the person who the FDA will contact in the event of an outbreak to get access to product records in the form of an electronic sortable spreadsheet. The point of contact must be willing to provide their name and/or job title, as well as phone number, on the traceability plan.
Table 1. Traceability plan components.
Table 2 provides additional traceability plan information that must be included if an operation grows or raises food on the FTL. These requirements do not apply to eggs. Providing a farm map is required when growing or raising foods on the FTL. These maps must show the location and name of each field (or other growing area) in which food on the FTL is grown. This must also include the geographic coordinates and any other information needed to identify the location of each field or growing area. Farm maps can be as simple as a hand-drawn map with geographic coordinates. See the Farm Traceability Plan Examples section for hand-drawn map examples created by the FDA.
For aquaculture farm maps, these producers must show the location and name of the container used for rearing each animal (e.g., pond, pool, tank, cage) named on the FTL. The map should include geographic coordinates and any other information needed to identify the location of each container. Additionally, the Florida Department of Agriculture and Consumer Services (FDACS) requires the geographic coordinates of aquaculture operations in Florida as part of the permitting process (FDACS, n.d.). These coordinates are maintained by the operation and are available upon request (FDACS, n.d.).
Table 2. Traceability plan information for an operation processing food on the FTL.
Recordkeeping Requirements
The traceability plan should be updated as needed to ensure the information reflects current practices and maintains compliance with the requirements of the rule. The previous version of the traceability plan must be retained for two years after the plan is updated (FDA 2022).
What if You Are Fully or Partially Exempt from the Rule?
A partial exemption means that certain recordkeeping requirements are modified or removed for some entities. Since partially exempt entities still have some requirements, they must have a traceability plan as explained in Table 1. If a food operation is fully exempt according to the criteria listed in 21 CFR §1.1305 (Dec. 31, 2024), having a traceability plan is not required. However, even when a traceability plan is not required, fully exempt food operations (such as aquaculture farms) may still need to share relevant production information, such as a farm map or harvesting details, with downstream processors, subject to the rule. This information sharing helps the downstream processors meet their traceability requirements and ensures traceability throughout the supply chain.
Food Traceability Plan Examples
The FDA has created several examples of traceability plans. As of July 2025, there are English versions of plans for the following locations: farms, restaurants, and sprout growers.
These plans can also be found on the FDA website for the FSMA Final Rule on Requirements for Additional Traceability Records for Certain Foods by clicking on the traceability plan tile. There, you can find these example plans translated into additional languages.
References
Florida Department of Agriculture and Consumer Services (FDACS). (n.d.). “Division of Aquaculture.” Accessed June 30, 2025. https://www.fdacs.gov/Divisions-Offices/Aquaculture
U.S. Food and Drug Administration (FDA). 2017. “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). 2022. “Requirements for Additional Traceability Records for Certain Foods (Final Rule).” Federal Register 87 (223): 70910–70941. U.S. Department of Health and Human Services. https://www.govinfo.gov/content/pkg/FR-2022-11-21/pdf/2022-24417.pdf
U.S. Food and Drug Administration (FDA). 2023. “Comment on Proposed Regulations and Submit Petitions.” Last updated March 22, 2023. https://web.archive.org/web/20230330183637/https://www.fda.gov/regulatory-information/dockets-management/comment-proposed-regulations-and-submit-petitions
U.S. Food and Drug Administration (FDA). 2024. “FDA Rules and Regulations.” Last updated April 9, 2024. https://www.fda.gov/regulatory-information/fda-rules-and-regulations
U.S. Food and Drug Administration (FDA). 2025. “FDA intends to extend compliance date for Food Traceability Rule.” Last updated March 20, 2025. https://www.fda.gov/food/hfp-constituent-updates/fda-intends-extend-compliance-date-food-traceability-rule