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The legal requirements for food traceability are changing with the U.S. Food and Drug Administration’s (FDA) final rule on food traceability taking effect on January 20, 2023.

“Regulated entities will have a three-year compliance period, with a current compliance date of January 20, 2026,” explained The National Law Review.

New Rules Part of Era of Smarter Food Safety Blueprint

The FDA's final rule on Requirements for Additional Traceability Records for Certain Foods (Food Traceability Final Rule) establishes traceability recordkeeping requirements, beyond those in existing regulations, for 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,” says the FDA.

The final rule is a key component of the FDA’s New Era of Smarter Food Safety Blueprint and implements Section 204(d) of the FDA Food Safety Modernization Act (FSMA).

“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,” says the FDA.

The A-B-C’s of Food Traceability Legal Requirements

Navigating the A-B-C’s of the new food traceability legal requirements will require those who manufacture, process, pack, or hold foods on the FTL to know their CTEs from their KDEs.

“The central provision of the rule is that regulated entities will be required to maintain, and be able to provide, records of Key Data Elements (KDE) related to Critical Tracking Events (CTE) for foods on the list,” says The National Law Review which says there is a lot to unpack with the new rules.

Some of the key features of the new food traceability legal requirements include:

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

CTEs in the final rule are:

o   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.

o   Cooling: Means active temperature reduction of a RAC using hydro-cooling, icing (except icing of seafood), forced air cooling, vacuum cooling, or a similar process.

o   Initial Packing: Means packing a RAC, other than a food obtained from a fishing vessel, for the first time.

o   First Land-Based Receiver: The person taking possession of food for the first time on land directly from a fishing vessel.

o   Shipping: 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 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.

o   Receiving: 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.     

o   Transformation: 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 FTL. Transformation does not include the initial packing of a food or activities preceding that event (e.g., harvesting, cooling).

• KDEs for Each of the CTEs: KDEs are the information required to be maintained under the rule. The type of KDE that must be maintained depends on what CTE a regulated entity performs.  Some examples of KDEs required along the supply chain include (but are not limited to -- companies should consult the FDA final rule for complete details):
  
  
  • Harvesting
    • Commodity and, if applicable, variety of the food
    • Quantity and unit of measure of the food.
    • Location description for the farm where the food was harvested.
    • Date of harvesting.
    • For produce the name of the field or other growing area from which the food was harvested.
    • Location description for the immediate subsequent recipient of the food (other than a transporter).
    • Business Name and phone number
      
      
  • Cooling
    • Location description for where you cooled the food.
    • Date of cooling.
    • Location description for the farm where the food was harvested.
      
      
  • Initial Packaging
    • Date you received the food.
    • Harvesting and Cooling KDEs.
    • Traceability lot code you assigned.
    • Product description of packed food.
    • Location description for where you initially packed the food (i.e., traceability lot code source).
      
      
  • First Land-Based Receiver (food obtained from a fishing vessel)
    
    • Traceability lot code you assigned.
    • Species and/or acceptable market name for unpackaged food, or the product description for packaged food.
    • Quantity and unit of measure of the food.
    • Harvest date and locations for the trip during which the food was caught.
    • Location description for the first land-based receiver.
    • Date the food was landed.
      
      
  • Shipping
    • Traceability lot code for the food.
    • Quantity and unit measure of the food.
    • Product description for the food.
    • Location description for the immediate subsequent recipient (other than a transporter) for the food.
    • Location description for the location from which you shipped the food.
    • Date you shipped the food.
      
      
  • Receiving
    • Traceability lot code for the food.
    • Quantity and unit of measure of the food.
    • Product description for the food.
    • Location description for the immediate previous source (other than a transporter) for the food.
    • Location description for where the food was received.
    • Date you received the food.
      
      
  • Transformation
    • For foods used as ingredients: traceability lot code for the food and product description for the food to which the traceability lot code applies.
    • For new food produced: new traceability lot code for the food; location description for where you transformed the food; date transformation was completed; product description for the food; and quantity and unit measurement of the food.

Traceability Plans are Also a Key Concept of the New Rules

Traceability plans are required for all persons covered by the rule including the following:

• Description of the procedures you use to maintain the required records, including the format and location of the records.
  
  
• Description of the procedures you use to identify foods on the FTL that you manufacture, process, pack or hold.
  
  
• Description of how you assign traceability lot codes to foods on the FTL, if applicable.
  
  
• Statement identifying a point of contact for questions regarding your traceability plan and records.
  
  
• If you grow or raise food on the FTL (other than eggs), a farm map showing the areas in which you grow or raise such foods.
  
  
• The farm map must show the location and name of each field (or other growing area) in which you grow food on the FTL, including geographic coordinates and any other information needed to identify the location of each field or growing area.
  
  
• For aquaculture farms, the farm map must show the location and name of each container (e.g., pond, pool, tank, cage) in which you raise seafood on the FTL, including the geographic coordinates and any other information needed to identify the location of each container
• You must update your traceability plan as needed to ensure that the information reflects your current practices and to ensure you are in compliance with the rule.

• You must retain your previous traceability plan for 2 years after you update the plan.

“While the rule is limited in scope by statute it is still far-reaching in a number of different ways.  Unlike other FSMA rules, the Food Traceability Rule applies to entities across the supply chain, from growers to retailers and restaurants, both foreign and domestic. And, while the agency cannot require end-to-end traceability, FDA intends to use the harmonized standards and common terminology established by the rule to achieve voluntary, end-to-end traceability to bring greater transparency to the supply chain,” wrote Sharon Lindan Mayl, former senior FDA official with more than 25 years of experience at the agency, in Food Safety News. “The bottom line is that industry should begin preparing for compliance now. The road ahead is a long one, even for those that have a head start. And, as you move toward compliance, it is important to keep an eye toward the FDA’s longer-term goal of end-to-end traceability, bearing in mind that expanded transparency in the supply chain can reap additional benefits for industry and consumers.“