Does the FDA Food Traceability Rule
Apply to You?
Answer 5 quick questions to find out whether your business is likely subject to FSMA 204 — and what that means for your operation.
No account required. Results shown instantly.
Do you handle any of these higher-risk foods?
FDA's Food Traceability List (FTL) identifies foods that pose higher outbreak risk. Select the answer that best describes your operation.
What best describes your business?
This helps us identify which Critical Tracking Events (CTEs) apply to your operation.
What are your approximate annual food sales?
Include all food sales across your operation — not just the products listed above. Based on a 3-year rolling average.
Tell us about your specific activities
These questions help identify which Critical Tracking Events (CTEs) apply to your business.
Your Business Is Likely Not Subject to the FDA Food Traceability Rule
Based on your responses, your business does not appear to handle foods on FDA's Food Traceability List — meaning the FSMA 204 record-keeping requirements likely do not apply to your operation at this time.
This tool provides general guidance based on FDA's Food Traceability Rule (21 CFR Part 1 Subpart S). It is not legal advice.
Your Business May Qualify for a Small Business Exemption
Based on your reported annual food sales, your business may qualify for the small business exemption under the FDA Food Traceability Rule. Businesses with average annual food sales under $250,000 (over a 3-year rolling period) are generally exempt.
This tool provides general guidance based on FDA's Food Traceability Rule (21 CFR Part 1 Subpart S). It is not legal advice.
Your Business Is Likely Subject to the FDA Food Traceability Rule
Based on your responses, your business handles foods on the Food Traceability List and exceeds the small business exemption threshold. You will likely need to maintain traceability records and provide sortable electronic records within 24 hours during a recall investigation.
You Will Likely Need to Maintain Records For:
Records must be maintained for 2 years and be sortable/searchable in electronic format.
This tool provides general guidance based on FDA's Food Traceability Rule (21 CFR Part 1 Subpart S). It is not legal advice.
Your Business Has Limited Traceability Record Requirements
Based on your responses, certain FSMA 204 requirements apply to your operation, but the full scope may be more limited than for other business types.
Likely Applicable Requirements:
This tool provides general guidance based on FDA's Food Traceability Rule (21 CFR Part 1 Subpart S). It is not legal advice.
Your Situation May Require Further Review
Based on your responses — including several uncertain answers — we're unable to make a clear determination of your FSMA 204 applicability. This is common for businesses in transition or with complex operations.
This tool provides general guidance based on FDA's Food Traceability Rule (21 CFR Part 1 Subpart S). It is not legal advice.