In November 2022, the United States Food & Drug Administration (FDA) finalized a new rule under the Food Safety Modernization Act called “Requirements for Additional Traceability Records for Certain Foods.” This rule is commonly referred to as FSMA 204.
Food traceability requirements have existed for years, but this rule expands those regulations by requiring more detailed recordkeeping for certain high-risk foods. The goal is to help the FDA identify the source and movement of contaminated foods faster and limit the spread of foodborne illness during outbreaks.
The mission of FSMA 204 is to improve traceability for foods that have historically been linked to food safety risks.
According to the FDA:
“The requirements will help the FDA rapidly and effectively identify recipients of foods to prevent or mitigate foodborne illness outbreaks and address credible threats of serious adverse health consequences or death.”
In simple terms, the FDA wants better visibility into where certain foods come from and where they go throughout the supply chain. If contamination occurs, regulators and suppliers will be able to trace affected products more quickly and notify the parties involved.
Ultimately, the goal is straightforward: identify food safety problems faster and reduce the number of people who become ill.
Here’s the basic idea behind the rule.
Businesses that manufacture, process, pack, or hold certain foods must keep records containing Key Data Elements (KDEs) associated with specific Critical Tracking Events (CTEs).
CTEs represent key points in the lifecycle of a food product where traceability information must be recorded. These include:
At each of these events, businesses must capture specific data elements that allow the product to be traced forward and backward through the supply chain.
The FDA provides a detailed breakdown of these events and the required data elements on its Food Traceability Final Rule page.
The rule applies to foods that the FDA considers higher risk for foodborne illness. These foods appear on the Food Traceability List (FTL).
The list includes both the foods themselves and products that contain them as ingredients.
Examples include:
For more detailed coverage, see FDA Food Traceability List (FTL): What Foods Are Covered Under FSMA 204?
It’s also worth noting that while the rule specifically applies to foods on the FTL, many suppliers are choosing to apply these traceability practices across their entire product catalog to simplify compliance.
As with most regulations, there are several exemptions.
For example, certain smaller operations may not fall under the rule. These include:
Additionally, the rule provides exemptions for some foods sold directly to consumers, including sales at:
These are only a few examples. The FDA outlines a broader set of exemptions and modified requirements in the official rule documentation.
The FDA finalized the Food Traceability Rule in November 2022.
The original compliance deadline was January 20, 2026, but the timeline has since been extended.
Companies that handle foods on the FTL are now expected to comply with the rule by July 20, 2028.
The extension was granted to allow food businesses and their supply chain partners additional time to implement the systems and processes required to capture traceability data across the entire supply chain.
FSMA 204 does not require a specific technology solution. However, many organizations are adopting digital systems to help manage the additional traceability requirements.
These systems may include:
For example, many retailers and distributors rely on EDI 856 Advance Ship Notices (ASNs) to receive shipment data electronically. These messages can include product identifiers, shipment details, and lot numbers that support traceability requirements.
Automating this type of data exchange can make it easier for companies to capture and retrieve the information required under FSMA 204.
The FDA’s food traceability rule represents a major step toward improving transparency and accountability in the food supply chain.
While the requirements may introduce additional recordkeeping responsibilities, they are designed to ensure that when food safety issues occur, the affected products can be identified and removed from the supply chain as quickly as possible.
For companies that handle foods on the Food Traceability List, now is the time to evaluate how traceability data is captured, stored, and shared with trading partners.
Many food companies are evaluating digital tools to help manage the additional traceability requirements introduced by FSMA 204. Cloud EDI platforms such as BOLD VAN allow suppliers to exchange shipment data electronically, helping capture traceability information while simplifying communication with retailers and distribution partners. Learn more in our guide: Do You Need EDI for FSMA 204 Compliance? How EDI 856 ASNs Enable Food Traceability.
Do You Need EDI for FSMA 204 Compliance? How EDI 856 ASNs Enable Food Traceability
FDA Food Traceability List (FTL): What Foods Are Covered Under FSMA 204?
Why do retailers require EDI 856 Advance Ship Notices? Learn how ASNs help food suppliers share shipment data and support FSMA 204 traceability.
What foods are on the FDA Food Traceability List (FTL)? Learn which foods fall under FSMA 204 and what traceability requirements apply to food companies.
Many food suppliers are adopting EDI to support FSMA 204 traceability requirements. Learn how EDI 856 ASNs help capture and share shipment data.
