What is the “FSMA 204 Food Traceability Rule?”
Source: FDA FSMA Traceability Rule (fda.gov)
The Food Safety Modernization Act (FSMA) Final Rule on Requirements for Additional Traceability Records for Certain Foods establishes traceability recordkeeping requirements beyond those in existing regulations. It applies to persons who manufacture, process, pack, or hold foods included on the Food Traceability List (FTL). The new requirements identified in the final rule will allow for faster identification and rapid removal of potentially contaminated food from the market, resulting in fewer foodborne illnesses and/or deaths.
At the core of this rule is a requirement that persons subject to the rule who manufacture, process, pack, or hold foods on the FTL, maintain records containing Key Data Elements (KDEs) associated with specific Critical Tracking Events (CTEs); and provide information to the FDA within 24 hours or within some reasonable time to which the FDA has agreed.
Compliance Date
Because the Food Traceability Final Rule requires entities to share information with other entities in their supply chain, the most effective and efficient way to implement the rule is to have all persons subject to the requirements come into compliance by the same date. The compliance date for all persons subject to the recordkeeping requirements is Tuesday, January 20, 2026.
Getting Started with the Food Traceability Rule
If you are uncertain about whether the Food Traceability Rule applies to your business or food, or if you know the rule applies and you’re not sure what do to next, the Getting Started links below will help. You may already be fulfilling some of the rule’s requirements such as Critical Tracking Events (CTEs), maintaining Key Data Elements (KDEs), and a traceability plan.
- Do you manufacture, process, pack or hold a food on the Food Traceability List?
- Do any exemptions apply to your situation?
- What Critical Tracking Events (CTEs) do you conduct?
- What Key Data Elements (KDEs) do you already maintain? What additional KDEs do you need to maintain to comply with the final rule?
- Develop your traceability plan.
- Talk with your supply chain partners.
- How can you work together to meet the requirements of the rule? It is helpful to understand your recordkeeping systems and those of your partners in the supply chain so you can determine the best way to communicate traceability information and discuss potential solutions.
The compliance date is January 20, 2026. Start working on this today!
FSMA 204 Shipping Critical Tracking Event
Source: https://www.ecfr.gov/current/title-21/section-1.1340
§ 1.1340 What records must I keep and provide when I ship a food on the Food Traceability List?
- For each traceability lot of a food on the Food Traceability List you ship, you must maintain records containing the following information and linking this information to the traceability lot:
- The traceability lot code for the food;
- The quantity and unit of measure of the food (e.g., 6 cases, 25 reusable plastic containers, 100 tanks, 200 pounds);
- The product description for the food;
- The location description for the immediate subsequent recipient (other than a transporter) of the food;
- The location description for the location from which you shipped the food;
- The date you shipped the food;
- The location description for the traceability lot code source, or the traceability lot code source reference; and
- The reference document type and reference document number.
- You must provide (in electronic, paper, or other written form) the information in paragraphs (a)(1) through (7) of this section to the immediate subsequent recipient (other than a transporter) of each traceability lot that you ship.
Definitions
Source: https://www.ecfr.gov/current/title-21/chapter-I/subchapter-A/part-1/subpart-S#1.1310
Location description means key contact information for the location where a food is handled, specifically the business name, phone number, physical location address (or geographic coordinates), and city, State, and zip code for domestic locations and comparable information for foreign locations, including country.
Product description means a description of a food product and includes the product name (including, if applicable, the brand name, commodity, and variety), packaging size, and packaging style. For seafood, the product name may include the species and/or acceptable market name.
Reference document means a business transaction document, record, or message, in electronic or paper form, that may contain some or all of the key data elements for a critical tracking event in the supply chain of a food. A reference document may be established by you or obtained from another person. Reference document types may include, but are not limited to, bills of lading, purchase orders, advance shipping notices, work orders, invoices, database records, batch logs, production logs, field tags, catch certificates, and receipts.
Reference document means the identification number assigned to a specific reference document.
Shipping means an event in a food’s supply chain in which a food is arranged for transport (e.g., by truck or ship) from one location to another location. Shipping does not include the sale or shipment of a food directly to a consumer or the donation of surplus food. Shipping includes sending an intracompany shipment of food from one location at a particular street address of a firm to another location at a different street address of the firm.
Traceability lot means a batch or lot of food that has been initially packed (for raw agricultural commodities other than food obtained from a fishing vessel), received by the first land-based receiver (for food obtained from a fishing vessel), or transformed.
Traceability lot code means a descriptor, often alphanumeric, used to uniquely identify a traceability lot within the records of the traceability lot code source.
Traceability lot code source means the place where a food was assigned a traceability lot code.
Traceability lot code source reference means an alternative method for providing FDA with access to the location description for the traceability lot code source as required under this subpart. Examples of a traceability lot code source reference include, but are not limited to, the FDA Food Facility Registration Number for the traceability lot code source or a web address that provides FDA with the location description for the traceability lot code source.