How to Write Your FSMA 204 Traceability Plan

FSMA 204 requires every operation that handles Food Traceability List items to maintain a written traceability plan. This isn’t a suggestion — it’s a regulatory requirement. If the FDA inspects your facility, this plan is one of the first things they’ll ask for.

The good news: it doesn’t need to be a 50-page document. It needs to be clear, accurate, and describe what you actually do.

Here’s what goes in it.

What the FDA requires

Under 21 CFR 1.1315, your traceability plan must contain:

1. A description of the procedures you use to maintain records — including the format and location of these records
2. A description of how you identify foods that you manufacture, process, pack, or hold
3. A description of how you assign traceability lot codes
4. A point of contact for questions about your plan and records
5. If you grow or raise FTL foods: a farm map showing the areas where you grow them

That’s it. Five elements. Let’s walk through each one.

1. How you maintain records

This section tells the FDA: where are your traceability records, and how do you keep them?

What to include:

• What system you use (e.g., “We use FieldToFile, a cloud-based traceability platform, to generate and store all traceability records”)
• Where records are stored (e.g., “Records are stored in FieldToFile’s cloud database and are accessible via web browser from any location”)
• How long you keep them (must be at least 2 years)
• How you’d produce records if the FDA requests them (e.g., “Records can be exported as CSV or PDF within minutes of a request”)

If you’re still on paper or spreadsheets, describe that honestly — but know that the 24-hour record availability requirement makes paper-based systems extremely difficult to maintain at scale.

2. How you identify foods

This section describes how you distinguish one product from another in your records.

What to include:

• How you identify the commodity (e.g., “by commodity name and variety as defined in our product setup”)
• What identifiers you use (e.g., GTIN, product codes, commodity descriptions)
• How you differentiate between, say, cantaloupe and honeydew if you pack both

Example language:

“Each commodity is identified in our system by commodity name, variety, and GTIN. Products are set up in FieldToFile with their GS1 Company Prefix-derived GTIN, and each lot is associated with the specific commodity and variety at the time of packing.”

3. How you assign traceability lot codes

This is the most important section. The FDA wants to know your system for creating lot codes that can trace produce back to its origin.

What to include:

• What your lot code format looks like
• When lot codes are assigned (at initial packing)
• What a lot code links to (growing area, harvest date, commodity, variety)
• How lot codes are applied to product (on pallet tags, case labels)

Example language:

“Traceability Lot Codes are assigned at the time of initial packing in FieldToFile. Each TLC is system-generated and linked to: the commodity and variety, the growing area (identified by field name and GPS coordinates), the harvest date, and the packer’s GS1 Company Prefix. TLCs are encoded in GS1-128 barcodes on PTI-compliant pallet tags printed via Zebra label printers.”

Key principle: Your lot code system should allow you to answer the question “Where did this specific pallet come from?” with a single lookup.

4. Point of contact

Simple: name, title, phone number, and email of the person the FDA should contact with questions about your traceability plan and records.

This should be someone who understands your system and can access records. It doesn’t have to be the owner — it can be your operations manager, quality lead, or whoever manages your traceability day-to-day.

5. Farm map (growers only)

If you grow any food on the Food Traceability List, you need a farm map that shows the areas where you grow those foods.

What to include:

• A map (hand-drawn is fine) showing your growing areas
• Field names or identifiers that match what you use in your records
• Enough detail that someone could look at the map and understand which field your records refer to

Tips:

• Label each field with the same name you use in your traceability system
• If you use GPS coordinates in your records, include them on the map
• Update the map when you add or change growing areas
• If you grow multiple FTL commodities, indicate which fields grow what

Common mistakes to avoid

Making it too complicated. Your plan should reflect what you actually do. If your process is simple, your plan should be simple. A 3-page plan that accurately describes a straightforward operation is better than a 30-page plan that doesn’t match reality.

Not updating it. If you change your lot code system, add a new facility, or switch from spreadsheets to software, update the plan. The FDA expects the plan to reflect your current operation.

Forgetting the farm map. This is the most commonly overlooked element for growers. It’s also the easiest to create — it can literally be a hand-drawn sketch of your fields with labels.

Making it aspirational instead of descriptive. Don’t describe the system you plan to have someday. Describe what you do now. You can update the plan when your process changes.

How FieldToFile makes this easier

If you use FieldToFile, most of your traceability plan writes itself:

• Record maintenance: “Cloud-based, accessible via browser, records retained indefinitely, exportable in seconds”
• Food identification: “Commodity and variety identified by GTIN in the FieldToFile product catalog”
• Lot code assignment: “System-generated TLCs assigned at initial packing, linked to growing area, harvest date, commodity, and GS1 data”
• Contact: Your operations lead

The farm map is the one thing you’ll need to create separately — but it’s a one-time effort.

Start now, even if enforcement is in 2028

The enforcement date is July 2028, but:

• Your buyers may be requiring traceability data now (check your retailer)
• Writing the plan forces you to think through your process before peak season
• Having a plan demonstrates compliance readiness to auditors and buyers
• It takes an afternoon to write — not a reason to defer

The bottom line

Your FSMA 204 traceability plan is a description of how you track produce from field to shipment. It has five required elements, and none of them require a lawyer or a consultant. Describe what you do, keep it current, and make sure you can actually do what you describe.

The plan is the easy part. Having the system to back it up is what matters.

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FieldToFile gives you the traceability system your plan describes — lot codes, KDEs, compliant labels, and 30-second record export. Pack a load on us — your first truckload is free.