FDA Seeks Renewal of Food Traceability Records
Published Date: 6/11/2026
Notice
Summary
The FDA is asking for approval to collect extra records from food businesses that handle certain high-risk foods. This helps track food sources quickly to keep everyone safe. Food companies should get ready to keep and share these new records, and comments on this plan are due by July 13, 2026.
Analyzed Economic Effects
7 provisions identified: 3 benefits, 4 costs, 0 mixed.
Mandatory Food Traceability Recordkeeping
If you are a food business that manufactures, processes, packs, holds, receives, distributes, transports, or imports food in the United States, you must establish and maintain records identifying the immediate previous sources and immediate subsequent recipients of food under 21 CFR part 1, subpart J and subpart S (OMB control number 0910-0560).
Extra Records for High‑Risk Foods (FTL)
If your business handles foods FDA has listed on the Food Traceability List (FTL), you must keep additional records linking traceability lot codes and data for critical tracking events (harvest, packing, receiving, shipping, transforming) as specified in 21 CFR part 1, subpart S.
Large Estimated Compliance Burden Hours
FDA estimates the annual recordkeeping burden at 23,071,935 hours and total annual records at 2,981,605,187 across activities covered by 21 CFR part 1, subparts J and S; the agency reports no capital or operating and maintenance costs for this collection.
Public‑Health Benefit from Faster Tracebacks
These traceability record requirements help FDA more rapidly identify sources and recipients of contaminated foods, enabling faster removals from the market and reducing harm from foodborne illness or credible threats of serious adverse health consequences or death.
Record Retention Requirement: 2 Years
Records required under 21 CFR part 1, subpart S must be maintained for 2 years from the date they were created or obtained.
Small‑Business Relief, Exemptions, and Waivers
Although there is no statutory exception for small businesses, the regulations provide exemptions and partial exemptions (Secs. 1.327 and 1.1305), and businesses may request modified requirements or exemptions via citizen petition (Sec. 1.1370) or request waivers for economic hardship under Secs. 1.1415 and 1.1425; FDA also offers Regional Small Business Representatives and online assistance.
Existing Records May Satisfy Requirements
FDA states that existing records may be used to meet the requirements if they contain all required information and are retained for the required time period.
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Key Dates
Department and Agencies
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