FSMA 204 questions, answered plainly

As at July 12, 2026, FDA will not enforce the Food Traceability Rule before July 20, 2028. The date rests on a proposed 30-month extension (published August 7, 2025) and a congressional directive in the FY2026 appropriations act that FDA not enforce before then. The substantive requirements did not change, so building your plan now is the right move.

Certain cheeses (fresh soft, soft ripened, semi-soft), shell eggs, nut butters, cucumbers, fresh herbs, leafy greens (including fresh-cut), melons, peppers, sprouts, tomatoes, tropical tree fruits, fresh-cut fruits and vegetables, finfish (including smoked), crustaceans, bivalve mollusks, and ready-to-eat deli salads.

Yes, where the listed food used as an ingredient stays in the same form it takes on the list, for example a fresh soft cheese used in a finished product. If the ingredient is changed so it is no longer an FTL food, that can be a different situation.

A small produce farm with average annual produce sales of no more than $25,000 (rolling, inflation-adjusted from a 2020 baseline) is exempt. Keep this separate from the $250,000 retail and restaurant threshold, which is a different test.

A retail food establishment or restaurant with average annual food sales of no more than $250,000 over the previous 3-year period (rolling, inflation-adjusted) is exempt.

A point in the supply chain where the rule requires you to keep records: harvesting, cooling, initial packing, first land-based receiving (for a food from a fishing vessel), shipping, receiving, and transformation.

A specific field you must record at a tracking event, such as the traceability lot code, product description, quantity and unit of measure, location descriptions, dates, and the reference document type and number. Which elements apply depends on the event.

It is the identifier that links a food to its records. It is assigned when you initially pack a raw agricultural commodity, do first land-based receiving of a fishing-vessel food, or transform a food. It then travels with the food, and each later event matches back to it.

Five parts: how you keep the required records and where they live, how you identify FTL foods, how you assign lot codes, a point of contact for questions, and, for farms that grow or raise an FTL food other than eggs, a farm map. Keep it up to date and retain prior versions for 2 years.

You must make required records available to an authorized FDA representative within 24 hours of a request (or another reasonable time FDA agrees to). During an outbreak, recall, or other public-health threat, FDA can request the information as an electronic sortable spreadsheet within 24 hours. Smaller entities that meet the criteria may provide it in another form.