FSMA Final Rule on Requirements for Additional Traceability Records for Certain Foods

1. Critical Tracking Events (CTE) (§ 1.1325 through 1.1350)  

The final rule identifies Critical Tracking Events (CTEs) for which records containing Key Data Elements (KDEs) will be required. The KDEs required will vary depending on the CTE that is being performed. 

The Critical Tracking Events in the final rule are harvesting; cooling (before initial packing); initial packing of a raw agricultural commodity other than a food obtained from a fishing vessel; first land-based receiving of a food obtained from a fishing vessel; shipping; receiving; and transformation of the food.

Below is a brief description of each CTE. For a detailed description of the KDEs that would be required for each CTE, see Critical Tracking Events and Key Data Elements. You can also see how the final rule applies in three different supply chain examples below, including the KDEs and CTEs that would be associated with each commodity. 

Harvesting

Harvesting applies to farms and farm mixed-type facilities and means activities that are traditionally performed on farms for the purpose of removing raw agriculture commodities (RACs) from the place they are grown or raised and preparing them for use as food. 

Cooling

Cooling means active temperature reduction of a raw agricultural commodity (RAC) using hydrocooling, icing (except icing of seafood), forced air cooling, vacuum cooling, or a similar process.

Initial Packing

Initial Packing means packing a raw agricultural commodity (RAC), other than a food obtained from a fishing vessel, for the first time. 

First Land-Based Receiver

First Land-based Receiver is the person taking possession of a food for the first time on land directly from a fishing vessel. 

Shipping

Shipping is 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 does include 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.

Receiving

Receiving is an event in a food’s supply chain in which a food is received by someone other than a consumer after being transported (e.g., by truck or ship) from another location. Receiving includes receipt of an intracompany shipment of food from one location at a particular street address of a firm to another location of the firm at a different street address.      

Transformation

Transformation is an event in a food’s supply chain that involves manufacturing/processing or changing a food (e.g., by commingling, repacking, or relabeling) or its packaging or packing, when the output is a food on the Food Traceability List (FTL). Transformation does not include the initial packing of a food or activities preceding that event (e.g., harvesting, cooling).

2. Traceability Lot Code

Traceability lot code (TLC) means a descriptor, often alphanumeric, used to uniquely identify a traceability lot within the records of the firm that assigned the traceability lot code.  

You must assign a traceability lot code to a food on the Food Traceability List (FTL) when you do any of the following: initially pack a raw agricultural commodity (RAC) other than a food obtained from a fishing vessel; perform the first land-based receiving of a food obtained from a fishing vessel; or transform a food. If you receive an FTL food from an entity that is exempt from the final rule, you must assign a TLC if one has not already been assigned (unless you are a retail food establishment or restaurant). Otherwise, you must not establish a new TLC when you conduct other activities (e.g., shipping) for a food on the Food Traceability List. 

Once a food has been assigned a TLC, the records required at each Critical Tracking Event (CTE) must include that TLC. All of the Key Data Elements (KDEs), including the TLC, must be linked to the relevant traceability lot.

3. Traceability Plan (§ 1.1315) 

If you are subject to the requirements of the final rule, you must establish and maintain a traceability plan containing the following information: 

1. A description of the procedures you use to maintain the records you are required to keep under this rule, including the format and location of these records.
2. A description of the procedures you use to identify foods on the Food Traceability List that you manufacture, process, pack, or hold;
3. A description of how you assign traceability lot codes to foods on the Food Traceability List, if applicable;
4. A statement identifying a point of contact for questions regarding your traceability plan and records; and
5. If you grow or raise a food on the Food Traceability List (other than eggs), a farm map showing the areas in which you grow or raise such foods.
   1. The farm map must show the location and name of each field (or other growing area) in which you grow a food on the Food Traceability List, including geographic coordinates and any other information needed to identify the location of each field or growing area.
   2. For aquaculture farms, the farm map instead must show the location and name of each container (e.g., pond, pool, tank, cage) in which you raise seafood on the Food Traceability List, including geographic coordinates and any other information needed to identify the location of each container.

4. Additional Requirements (§ 1.1455)

The final rule also requires that:

• Records must be maintained as original paper or electronic records, or true copies; they all must be legible and stored to prevent deterioration or loss. Electronic records may include valid, working electronic links to the information required to be maintained under the rule.
• All records required under this rule, along with any information required to understand the records, must be made available to the FDA within 24 hours after a request is made (or within a reasonable time to which the FDA has agreed). 
• Unless exempt from this requirement, an electronic sortable spreadsheet containing relevant traceability information must be provided to the FDA within 24 hours of a request (or within some reasonable time to which the FDA has agreed) when necessary to assist the FDA during an outbreak, recall, or other threat to public health.