FSMA 204 traceability plan: what it must say and a template to copy

A FSMA 204 traceability plan is a short written document that says how you keep your traceability records, how you spot Food Traceability List foods, how you assign lot codes and who to call with questions. Farms that grow listed foods add a farm map. FDA says no specific format is required, so a page or two is enough if it matches what you really do.

This guide covers the required parts, a fill-in template, how to keep the plan current and how it connects to the 24-hour records request.

What does the rule say a traceability plan must include?

21 CFR 1.1315 says that if you are covered by the Food Traceability Rule, you must establish and maintain a plan with these parts:

1. A description of the procedures you use to maintain the records the rule requires, including the format and location of those records.
2. A description of the procedures you use to identify foods on the Food Traceability List.
3. A description of how you assign traceability lot codes to listed foods, where that applies.
4. A statement naming a point of contact for questions about your plan and records.
5. If you grow or raise a listed food (other than eggs), a farm map.

The rule also says to update the plan as needed so it reflects your current practices, and to keep the previous version for 2 years after you update it.

Who needs one? Anyone covered by the rule’s recordkeeping requirements. That is not every food business, because the rule applies to listed foods and has exemptions. Start with the category-by-category list check and the exemptions guide. If you are only partly exempt, check with FDA or a food safety professional before you skip the plan.

What is a point of contact? The rule’s definitions in 21 CFR 1.1310 describe a point of contact as an individual who is familiar with your traceability procedures, given by name and/or job title and a phone number. A job title such as “Quality Manager” survives staff changes better than a personal name. Pick someone who can actually answer questions on a recall day.

What does a farm map need? The map must show the location and name of each field or other growing area, including geographic coordinates and any other information needed to find it. Aquaculture farms map each container, such as a pond, tank or cage, instead. FDA’s farm example notes that the rule requires only one farm map, if it applies to you.

What does FDA’s example plan look like?

FDA publishes example plans for several kinds of business, listed on its Food Traceability Rule page. Look for the one closest to your operation. The sample plan in the farm example (November 2023) is two pages. It describes, in plain sentences:

• where records are stored (commercial software) and how long they are kept
• how paper bills of lading and barcoded case labels carry the data
• that every product packed at the facility is on the Food Traceability List
• how lot codes are built, from a case GTIN plus a date and packing line
• who the point of contact is, by job title and phone number
• a review each year, with old versions kept in a folder for at least two years

FDA calls it “one example” of how a plan can be established. Yours should describe your own practice, not copy theirs.

What is a simple traceability plan template?

Copy this into a document and replace the bracketed parts. The wording is illustrative, not legal advice, and every answer must match what you do.

1. Records: how we keep them

• Records we keep: [receiving, shipping, transformation, and, if we grow or pack, harvesting, cooling and packing records].
• Format: [original paper, scans or photos, spreadsheet, software]. Paper copies are scanned within [number] days.
• Location: [folder path, system name or cabinet], at [site].
• Retention: at least 2 years from the date we created or obtained each record, per 21 CFR 1.1455.
• Who can retrieve them within 24 hours: [role].

2. How we identify Food Traceability List foods

• We compare each product and ingredient with the FDA Food Traceability List when we add or change it.
• Products on the list: [list]. Products not on the list, with the reason: [list].
• We review this list [yearly, and when we add a product].

3. How we assign traceability lot codes

• Events where we assign a code: [initial packing, transformation, first receiving from a fishing vessel], per 21 CFR 1.1320. We do not assign a new code at other times, such as shipping.
• Code format: [for example, product code + date + line].
• What a lot is: [one line, one shift, one day].
• Where the code appears: [case label, invoice, bill of lading].

4. Point of contact

• [Job title or name], [phone number].

5. Farm map (growers only)

• [Attach map showing each field or growing area, its name and coordinates.]

6. Plan updates

• Reviewed [yearly] and whenever a procedure changes.
• Previous versions kept in [location] for 2 years after each update.
• Current version dated [date], approved by [role].

How do you keep the plan from going stale?

The rule asks that the plan reflect your current practices. Three habits help:

• Update it when you add a product, a facility, a software system or a lot-code format.
• Date each version and keep the old ones. A folder named “retired plans” is enough.
• Test it. A mock recall drill shows quickly whether the plan matches reality.

How does the plan connect to the 24-hour request?

Under 21 CFR 1.1455, your plan must indicate the format and location of your records. That tells an FDA investigator where to look. You must give FDA your required records within 24 hours of a request, or within a reasonable time FDA agrees to. For outbreaks, recalls and other threats, FDA can ask for an electronic sortable spreadsheet, though some smaller businesses may send another form. See the 24-hour spreadsheet guide for how to prepare one. The compliance checklist places the plan among the other steps.

When do you need to have it done?

The original compliance date was January 20, 2026. FDA has proposed moving it to July 20, 2028, and Congress directed FDA not to enforce the rule before then. FDA says it intends to comply with that directive. Check FDA’s Food Traceability Rule page for the current wording. A plan costs little to write, and it forces you to decide how your records and lot codes will work.

Where Lotcrumb fits

Lotcrumb is being built to turn the paperwork you already handle into FSMA 204 records and to draft your traceability plan from how your records are actually kept. Join the waitlist for early access.

This guide is general information, not legal or regulatory advice. Your obligations depend on your products and operations, so confirm them with FDA guidance or a food safety professional.