Are you covered by FSMA 204?

Two questions. Pick the foods you handle and your role in the chain, then flag any possible exemption. You will see whether the FDA Food Traceability Rule covers you, the exemption that fits if one does, and the tracking events and data elements your role must record.

Scope check · 21 CFR Part 1 Subpart S1.1305

1 · Do you handle a food on the Food Traceability List?

Select every one that applies. Coverage follows these foods.

Fresh soft cheeses Soft ripened / semi-soft cheeses Shell eggs Nut butters Cucumbers Fresh herbs Leafy greens Melons Peppers Sprouts Tomatoes Tropical tree fruits Fresh-cut fruits / vegetables Finfish (incl. smoked) Crustaceans Bivalve mollusks Ready-to-eat deli salads Contains a listed food as an ingredient None of these

2 · What is your role in the supply chain?

Grower / harvester Cooler Initial packer Seafood first land-based receiver Manufacturer / processor Distributor / warehouse (holder) Importer Retailer / restaurant Transporter only

3 · Any of these describe you? (self-reported)

Optional. These are your own figures. We name the exemption and cite the subsection; we do not verify the numbers.

Produce sales at or below $25,000 / yr Fewer than 3,000 laying hens Sell only direct to consumers from the farm Retail / restaurant food sales at or below $250,000 Food gets a kill step or is no longer an FTL food

FSMA 204

Personalized FDA Food Traceability Rule reports: coverage, tracking events, and the records you must keep, cited to the CFR.

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FSMA 204 Traceability Report is an independent educational tool. It is not affiliated with, endorsed by, or acting on behalf of the U.S. Food and Drug Administration or any government agency. 21 CFR Part 1 Subpart S is cited as a public source. Reports are educational screening briefings, not legal advice or an official compliance determination. Copyright FSMA 204 Traceability Report.