FDA Extends Routine Seafood Safety Paperwork
Published Date: 6/11/2026
Notice
Summary
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.
Analyzed Economic Effects
3 provisions identified: 1 benefits, 2 costs, 0 mixed.
Estimated Annual Recordkeeping Burden: 1.93M Hours
FDA estimates the total annual recordkeeping burden for seafood HACCP activities is 1,930,264 hours. Examples from the estimate include 1,260,000 hours for documenting monitoring of critical control points (Sec. 123.6(c)(7)) and 65,600 hours for import verification activities (Sec. 123.12).
Seafood Processors Must Keep HACCP Records
If you process or import fish or fishery products, you must continue to collect and keep Hazard Analysis and Critical Control Point (HACCP) records under 21 CFR part 123. These records (for example, processing times, temperatures, acidity, monitoring logs) must be reviewed by trained employees and made available for FDA review as provided in Sec. 123.12(c).
No New Monetary Costs for Recordkeeping
FDA states there are no capital costs or operating and maintenance costs associated with this information collection; the submission is a reinstatement of current paperwork. The collection is described as a continuation of existing HACCP recordkeeping rather than adding new monetary costs.
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
2026-11740 — 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.
2026-11760 — Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Establishment, Maintenance, and Availability of Records; Additional Traceability Records for Certain Foods
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.
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.
2026-11578 — 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: 2026-11760 — Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Establishment, Maintenance, and Availability of Records; Additional Traceability Records for Certain Foods
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.
Next: 2026-11763 — Cancellation of Previously Scheduled Open Meeting
The Equal Employment Opportunity Commission (EEOC) canceled its June 4, 2026 open meeting because the important decisions were already made by a vote on paper. This means no one needs to attend the meeting, but the new National Enforcement Plan for 2025-2029 and updated reporting instructions are still in effect. No extra costs or delays are expected from this change.