Applicability is determined food by food
The rule applies to persons who manufacture, process, pack or hold foods appearing on the FDA Food Traceability List. It does not apply to everything a covered business handles. Many companies find that only a subset of their portfolio is in scope, and building a program across the whole assortment wastes effort.
There is also a substantial set of exemptions and partial exemptions covering, among others, certain small producers, certain farm-to-retail arrangements, food that receives specified processing that eliminates the relevant hazard, and certain retail food establishment situations. Applicability should therefore be assessed against both the food and your role in handling it.
Compliance timing has been the subject of FDA rulemaking activity since the rule was published. Anyone planning a program should confirm the current compliance date position directly from FDA rather than relying on a secondary summary.
Critical tracking events and key data elements
The rule is structured around events. At defined points in the supply chain — critical tracking events — a covered entity must maintain specified key data elements and link them by a traceability lot code.
The events broadly cover harvesting, cooling before initial packing, initial packing, shipping, receiving and transformation. Which events apply depends on what you do. A distributor typically holds shipping and receiving records; a manufacturer that combines listed foods into a new product is performing a transformation and holds those records.
The unifying mechanism is the traceability lot code, assigned at defined points and carried forward so that records can be linked across entities. A program that captures the data elements but does not maintain the lot code linkage does not deliver the intended outcome.
The traceability plan
Covered entities are required to establish and maintain a traceability plan. In practical terms it documents how the system works so that someone outside your business can follow it.
- A description of the procedures used to maintain the required records, including their format and location
- A description of how traceability lot codes are assigned
- The point of contact for questions about the plan and its records
- For those who grow or raise listed foods other than eggs, a farm map of the relevant growing areas
Practical build advice
Two things determine whether a traceability program works: whether lot identity survives your internal handling, and how fast you can produce the records.
Lot identity is commonly lost at repacking, at case-breaking, at bulk commingling, and during rework. Each of those points needs a deliberate decision about how lot identity is preserved or how a new lot code is assigned and linked to its inputs.
Speed matters because the rule contemplates providing records to FDA within a defined timeframe on request, in an electronic sortable spreadsheet where requested. A system that requires manual assembly across several disconnected records is unlikely to meet that expectation under pressure.
Separately from the regulation, customers increasingly impose their own traceability data requirements. Where your customers demand data beyond what the rule requires of you, that is a commercial obligation to plan for alongside the regulatory one.
Primary sources
Go to the source rather than relying on this summary. Regulation text and agency guidance are the authority; this page is an interpretation of them.
- 21 CFR Part 1 Subpart S — Requirements for Additional Traceability Records for Certain Foods
- FDA Food Traceability List
- FDA Food Traceability Rule compliance and implementation resources