What Is a Traceability Plan?

Every business covered by FSMA 204 must establish and maintain a written traceability plan describing how it creates and maintains the required traceability records. The plan is not a one-time filing with the FDA -- it is an internal document that must be available for FDA review within 24 hours of a request (Source: 21 CFR 1.1315).

The plan does not need to be complex. For restaurants, it can be as short as 2-3 pages.

What are the 5 required contents?

Every traceability plan must include these five elements:

1. Record maintenance procedures

Describe how you maintain traceability records:

• What format records are kept in (paper, electronic, or both)
• Where records are stored (onsite, offsite, cloud-based)
• How records are organized and indexed for retrieval
• How long records are retained (2 years minimum)

2. FTL food identification procedures

Describe how you identify which foods you handle are on the Food Traceability List:

• How staff determine whether a received food is an FTL food
• Training procedures for identifying FTL foods
• Reference lists or product categorization systems used
• How you account for foods that contain FTL ingredients (for example, a pre-made salad containing romaine lettuce)

3. TLC assignment procedures

Describe how you assign Traceability Lot Codes -- if applicable.

This section only applies to entities that perform Initial Packing, First Land-Based Receiving, or Transformation. If your business only receives and serves food (like most restaurants), state that you do not assign TLCs and record the TLCs provided by your suppliers.

For entities that do assign TLCs:

• What format your TLCs use
• How you ensure uniqueness
• How TLCs are applied to products or documentation

4. Point of contact

Designate a specific individual who can answer FDA questions about your traceability system:

• Name of the designated individual
• Job title
• Phone number

This person must have knowledge of your traceability procedures and be reachable when the FDA calls. Keep this information current -- update the plan when the designated contact changes.

5. Farm map (farms only)

This requirement applies only to farms growing or raising FTL foods (excluding shell egg producers):

• Map showing the location of fields and growing areas
• Names of each field or growing area
• Geographic coordinates (latitude/longitude) for each field or growing area
• For aquaculture: map of containers (ponds, pools, tanks, cages) with geographic coordinates

Restaurants, distributors, processors, and retailers do not need farm maps.

How often must the plan be updated?

The traceability plan must be updated as needed to reflect current practices. Common triggers for updates:

• Changing your record-keeping system (paper to digital, or switching software)
• Adding or removing FTL foods from your menu or product line
• Changing your designated point of contact
• Modifying TLC assignment procedures
• Changing storage locations for records

Previous versions of the plan must be retained for 2 years after each update.

What is the electronic sortable spreadsheet requirement?

During a foodborne illness outbreak, recall, or other public health threat, covered entities must provide traceability information in an electronic sortable spreadsheet format (Source: 21 CFR 1.1455).

Key requirements:

• Must be electronic -- not paper
• Must be sortable -- column-based data that can be filtered and sorted
• Must include explanatory information needed to understand the data (coding systems, abbreviations)
• The FDA provides a downloadable Excel template with tabs for each CTE

Who is exempt from the electronic spreadsheet requirement?

| Entity Type | Exempt If Annual Food Sales Below | |------------|-----------------------------------| | Farms | $250,000 (3-year rolling average) | | Retail food establishments | $1,000,000 (3-year rolling average) | | All other entities | $1,000,000 (3-year rolling average) |

These entities must still maintain records -- they are just not required to provide them in electronic sortable spreadsheet format. They can provide paper records instead.

What is the 24-hour response requirement?

When the FDA requests traceability records, covered entities must provide them within 24 hours -- or within a reasonable time agreed upon with the FDA.

During an active outbreak investigation, the timeline is stricter:

1. The FDA contacts you because it believes you handled an FTL food implicated in an outbreak
2. You must provide requested CTE/KDE information within 24 hours
3. If above the revenue threshold, you must provide it in electronic sortable spreadsheet format
4. You must include information needed to understand the records (coding keys, abbreviations)

The 24-hour requirement is the strongest practical argument for digital record-keeping. Locating specific records across thousands of receiving events, compiling them into a sortable spreadsheet, and delivering them within 24 hours is extremely difficult with paper-based systems.

Does the FDA provide example traceability plans?

Yes. The FDA has published example traceability plans for multiple entity types:

• Farms
• Restaurants
• Sprouters
• Food processors
• Distribution centers
• Seafood processing facilities
• Aquaculture farms

These examples are available on the FDA FSMA 204 page and have been translated into multiple languages. They are fictional examples, but they provide a clear template for what the FDA expects.

What does a restaurant traceability plan look like?

A restaurant traceability plan is one of the simplest versions. It typically includes:

• Record maintenance: "We retain all delivery invoices and receiving logs for FTL foods for 24 months in [paper filing cabinet / digital folder / POS system]."
• FTL identification: "We maintain a reference list of FTL foods and train receiving staff to identify them on deliveries. Our FTL reference list is reviewed quarterly."
• TLC assignment: "We do not assign TLCs. We record TLCs from supplier delivery documents."
• Point of contact: Name, title, and phone number of the designated manager.

No farm map is required. No complex TLC procedures are needed. The plan documents what you already do -- and demonstrates to the FDA that you have a system in place.