Prepare Now for U.S. Food Traceability Rule

Trade Update • August 13, 2024

the United States (U.S.) Food and Drug Administration (FDA) recommends that Canadian 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.

FSMA 204

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”.

What do Canadian Food Business Need to Do?

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.

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.

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.

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.

CFIA & SFCR

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.

Questions about ensuring compliance with this new rule on food exports into the USA? We are always here to help, contact us.