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.
Your PRIA Score
Personalized for You
How does this regulation affect your finances?
Sign up for a PRIA Policy Scan to see your personalized alignment score for this federal register document and every other regulation we track. We analyze your financial profile against policy provisions to show you exactly what matters to your wallet.
Key Dates
Department and Agencies
Related Federal Register Documents
2026-11739 — Medical Devices; Immunology and Microbiology Devices; Classification of the Simple Point-of-Care Device to Directly Detect SARS-CoV-2 Viral Targets From Clinical Specimens in Near-Patient Settings
The FDA is officially putting simple COVID-19 rapid test devices into a safer, easier-to-manage category called Class II. This change means these tests can get to patients faster and with fewer hoops to jump through, while still making sure they work well and stay safe. Starting June 11, 2026, companies making these tests will follow new rules that help speed up innovation without extra costs.
2026-11740 — Medical Devices; Immunology and Microbiology Devices; Classification of the Spinal Muscular Atrophy Newborn Screening Test System
The FDA is officially putting the Spinal Muscular Atrophy (SMA) newborn screening test into class II, meaning it has special safety rules but fewer hurdles than the strictest category. This change helps make the test safer and easier to get to babies who need it, starting June 11, 2026, with the classification effective since November 2022. Labs and device makers will benefit from clearer rules and faster access, helping catch SMA early without extra costs or delays.
2026-11762 — Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Procedures for the Safe Processing and Importing of Fish and Fishery Products
The FDA is asking for approval to keep collecting info from seafood processors and importers to make sure fish products are safe using a system called HACCP. This affects anyone who processes or imports fish and requires them to keep records showing they’re following safety rules. Comments on this plan are open until July 13, 2026, and there’s no new cost, just a continuation of current paperwork.
2026-11578 — Amending Over-the-Counter Monograph M020: Sunscreen Drug Products for Over-the-Counter Human Use, and Related Information
The FDA just gave a thumbs-up to adding bemotrizinol as a new active ingredient in sunscreens, letting it be used up to 6% concentration. This means sunscreen makers can now include this ingredient, which is safe and effective, in their products. The change is official as of June 10, 2026, and could lead to better sun protection options without extra costs for consumers.
2026-11589 — Medical Devices; Ear, Nose, and Throat Devices; Classification of the Combined Acoustic and Electrical External Stimulation Device for the Relief of Tinnitus
The FDA has officially placed the combined acoustic and electrical external stimulation device for tinnitus relief into class II, meaning it now has special safety rules but fewer regulatory hurdles. This change helps patients get access to this innovative device faster and ensures it’s safe and effective. The new classification is effective June 10, 2026, with the rules applying retroactively from March 6, 2023.
2026-11429 — Determination That Protamine Sulfate (Protamine Sulfate) Intravenous; Solution, 50 Milligrams/5 Milliliters, and Other Drug Products Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness
The FDA has decided that Protamine Sulfate and some other drugs weren’t taken off the market because they’re unsafe or don’t work. This means generic drug makers can keep getting approval to sell their versions, as long as they follow the rules. Patients and pharmacies can keep counting on these medicines without any interruptions or extra costs.
Previous / Next Documents
Previous: 2026-11759 — Request for Comments on the Renewal of a Previously Approved Information Collection: Capital Construction Fund and Exhibits
The Maritime Administration wants to keep collecting info from U.S. ship owners who use the Capital Construction Fund, a special savings plan that helps them build or upgrade vessels by delaying some taxes. Fewer people are responding now, but the rules and forms won’t change. If you’re involved, you’ve got 30 days to share your thoughts—no extra costs or new paperwork coming your way!
Next: 2026-11762 — Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Procedures for the Safe Processing and Importing of Fish and Fishery Products
The FDA is asking for approval to keep collecting info from seafood processors and importers to make sure fish products are safe using a system called HACCP. This affects anyone who processes or imports fish and requires them to keep records showing they’re following safety rules. Comments on this plan are open until July 13, 2026, and there’s no new cost, just a continuation of current paperwork.