Making Synapses · Bringing Knowledge to Mankind
CulinaryFood Traceability Rule (FSMA 204)
Twenty flashcards on the FDA rule that makes high-risk foods traceable from farm to table, record by record.
Free to startYour progress here is temporary and is lost when you close this page. Install Making Synapses free to keep it, with spaced repetition.
20 cards
- Which law section does the FDA Food Traceability Rule carry out?
- Section 204(d) of the FDA Food Safety Modernization Act (FSMA).
- What is the goal of the rule?
- Faster identification and rapid removal of possibly contaminated food, for fewer illnesses and deaths.
- Which foods does the rule cover?
- Foods on the Food Traceability List, and foods that contain them as ingredients in the same form.
- What is at the core of the required records?
- Key Data Elements (KDEs) tied to Critical Tracking Events (CTEs).
- Name the Critical Tracking Events.
- Harvesting, cooling, initial packing, first land-based receiving, shipping, receiving and transformation.
- How fast must the records reach the FDA after a request?
- Within 24 hours, or a reasonable time the FDA agrees to.
- What digital file can the FDA ask for during an outbreak or recall?
- An electronic sortable spreadsheet with the traceability information, within 24 hours.
- What is a traceability lot code?
- A descriptor, often alphanumeric, that uniquely identifies a lot in the records of the firm that assigned it.
- When must a traceability lot code be assigned?
- At initial packing of a raw agricultural commodity, first land-based receiving from a fishing vessel, or transformation.
- How long must the traceability records be kept?
- 2 years from the date they were created or obtained.
- What must a traceability plan include?
- Record procedures, how list foods are identified, how lot codes are assigned, and a point of contact.
- What extra must a farm growing list foods add to its plan?
- A farm map with each field's name, location and geographic coordinates.
- Which restaurants are exempt because of their size?
- Those with no more than $250,000 a year of food sold, averaged over the previous 3-year period.
- A restaurant buys straight from a farm: what record must it keep?
- The farm's name and address, kept for 180 days.
- When will the FDA start enforcing the rule?
- Not before July 20, 2028, as Congress directed; the original date was January 20, 2026.
- Name produce on the Food Traceability List.
- Fresh cucumbers, herbs, leafy greens, melons, peppers, sprouts and tomatoes, among others.
- Which seafood is on the list?
- Finfish, smoked finfish, crustaceans and bivalve molluscan shellfish.
- Which cheeses are on the list?
- Fresh soft, soft ripened and semi-soft cheeses, and unpasteurized-milk cheeses other than hard cheese.
- How many criteria does the FDA risk-ranking model score?
- Seven, including outbreak frequency, illness severity and cost of illness.
- When does a food added to the list take effect?
- 2 years after the FDA publishes the revised list; deletions take effect immediately.
Official sources
U.S. Food and Drug Administration
FSMA Final Rule on Requirements for Additional Traceability Records for Certain Foods
U.S. Food and Drug Administration
Food Traceability List
U.S. Food and Drug Administration, via eCFR
21 CFR Part 1 Subpart S: Additional Traceability Records for Certain Foods
Making Synapses is not affiliated with, sponsored by or endorsed by the FDA, the Massachusetts Department of Public Health or any certification provider. Agency names are named only to describe the content.