In 2022, under the authority of Section 204 of the Food Safety Modernization Act (FSMA), the United States (U.S.) Food and Drug Administration (FDA) published the Food Traceability Final Rule, also known as "FSMA 204". The compliance date for the Food Traceability Final Rule is January 20, 2026.
Outcome of the rule
FSMA 204 will enable faster identification and removal of potentially contaminated foods from the United States market, resulting in fewer foodborne illnesses and deaths. The rule requires additional traceability information (Key Data Elements - KDE) to be maintained for important activities (Critical Tracking Events - CTE) along the supply chain. The exact KDEs to be maintained will depend on the specific CTE.
Under the rule, both domestic and foreign food businesses must maintain specific supply chain traceability data for certain foods and be able to provide such data to FDA in an electronic sortable spreadsheet within 24 hours.
What products are on the U.S. Food Traceability List
The Food Traceability Final Rule applies to many food product types that the FDA has identified based on risk assessment and published on the Food Traceability List (FTL), including:
- many types of whole fresh fruits and vegetables (for example, cucumbers, peppers, tomatoes, melons, tropical tree fruits, leafy greens, herbs, and sprouts)
- fresh-cut fruits, vegetables and leafy greens (all kinds)
- soft and semi-soft cheeses
- finfish (fresh, frozen, previously frozen, and smoked)
- crustaceans and bivalve molluscan shellfish (fresh, frozen and previously frozen)
- ready-to-eat deli salads (refrigerated) (for example, egg salad, tuna salad, potato salad, and pasta salad)
- nut butters
- shell eggs
Note: The rule applies to foods on the FTL and any food containing FTL listed foods as an ingredient.
Note: The above list is provided as a courtesy and may not be complete. Food businesses should refer to FDA's Food Traceability List and related questions should be directed to FDA.
How the rule impacts Canada's food industry
FSMA 204 will impact many food sectors in Canada. Canadian food businesses will need to work together with their supply chain partners through 2024 and 2025 to ensure they are able to provide FDA with the additional traceability information in the requested spreadsheet format within 24 hours.
FDA recommends that food businesses producing or preparing FTL listed food products (or foods containing FTL listed ingredients) for export to the U.S. start preparing now for the compliance date of January 20, 2026.
Non-compliance with the rule will lead to enforcement by FDA and could result in loss of market access until compliance with the rule is demonstrated to FDA.
Role of foreign competent authorities such as CFIA
The FDA does not require foreign competent authorities such as the Canadian Food Inspection Agency (CFIA) to verify compliance with the rule. Industry bears the responsibility to comply with the rule and to seek clarification on requirements with FDA directly.
Note: Traceability requirements under the Safe Food for Canadians Regulations (SFCR) are not equivalent to the new requirements of FSMA 204; therefore, compliance with the SFCR does not equal compliance with this rule. Companies must complete their own analyses and implement changes to their business processes to ensure compliance.
Online resources
To learn more about FSMA 204, refer to FSMA Final Rule on Requirements for Additional Traceability Records for Certain Foods published by the FDA.
Industry is encouraged to visit the FDA website which includes many resources to help you better understand how to comply with the new rule:
- "Inquiry/Information" which allows you to submit questions to FDA's FSMA Technical Assistance Network (TAN)
- "Meeting Request" and "Meeting Request Form"
- "Speaker Request" and "Speaker Request Form"