What Is FSMA 204?
FSMA 204 is the FDA Food Traceability Rule, made under section 204 of the Food Safety Modernization Act. It requires businesses that handle foods on the Food Traceability ListFood Traceability List: FDA's list of foods that the extra FSMA 204 record keeping applies to, including certain fresh produce, shell eggs, nut butters, soft cheeses, finfish and shellfish. to keep additional traceability records, recording key data elements (KDEsKDE (Key Data Element): Under FSMA 204, a specific piece of information that must be recorded at a critical tracking event, such as the traceability lot code, quantity and location description.) at critical tracking events (CTEsCTE (Critical Tracking Event): Under FSMA 204, a point in the supply chain where records must be kept. The rule names seven: harvesting, cooling, initial packing, first land based receiving, shipping, receiving and transformation.), and to maintain a written traceability plan.
The rule sits in 21 CFR Part 1, Subpart S. FDA says it "covers domestic, as well as foreign firms producing food for U.S. consumption".
Who It Applies To (Including Non US Exporters)
The rule applies to people who manufacture, process, pack or hold foods on the Food Traceability List. It also covers "foods that contain listed foods as ingredients, provided that the listed food that is used as an ingredient remains in the same form (e.g., fresh)".
It applies to foreign firms supplying the US, so a UK or EU manufacturer exporting listed foods is in scope in the same way as a US site. Your US customers will also ask you for these records, so it pays to be ready.
Some businesses are fully or partly exempt. FDA provides a free exemptions tool, which is the best place to check your position. We do not give exemption advice here.
The Food Traceability List
The Food Traceability List (FTL) is FDA's list of foods that the extra record keeping applies to. The categories are:
- Cheeses (several types; see FDA's list for which)
- Shell eggs
- Nut butters
- Fresh cucumbers
- Fresh herbs
- Fresh leafy greens and fresh-cut leafy greens
- Fresh melons
- Fresh peppers
- Fresh sprouts
- Fresh tomatoes
- Fresh tropical tree fruits
- Fresh-cut fruits and vegetables
- Finfish, including smoked finfish
- Crustaceans
- Molluscan shellfish
- Refrigerated ready-to-eat deli salads
Each category has its own scope and exclusions, so always check [FDA's Food Traceability List](https://www.fda.gov/food/food-safety-modernization-act-fsma/food-traceability-list) for the exact wording.
Critical Tracking Events and Key Data Elements
Critical tracking events (CTEs) are the points in the supply chain where records must be kept. The rule names seven:
- Harvesting
- Cooling (before initial packing)
- Initial packing of a raw agricultural commodity other than a food obtained from a fishing vessel
- First land-based receiving of a food obtained from a fishing vessel
- Shipping
- Receiving
- Transformation
At each CTE you must record specific key data elements (KDEs). Manufacturers mainly need the shipping, receiving and transformation records below. The first four events apply to farms, packers, coolers and the first receivers of seafood; they are summarized in the downloadable checklist.
A "location descriptionLocation description: Under FSMA 204: the business name, phone number and physical address (or geographic coordinates) of a site where food is handled, with city, state and ZIP code for US sites, or the local equivalent plus country for sites outside the US." means the business name, phone number, physical address (or geographic coordinates) and city, state and zip code, or the equivalent for foreign locations, including country (§ 1.1310). A "reference documentReference document: Under FSMA 204, a business transaction document, record or message, on paper or electronic, that may contain some or all of the key data elements for a critical tracking event. Examples include a bill of lading, purchase order, advance shipping notice or invoice. For each event, you record the reference document type and number." is a business transaction document, record or message, such as a bill of lading, purchase order or advance shipping notice (§ 1.1310). Each record notes its type and number.
Shipping (§ 1.1340)
| # | Key data element | Pass to next party? (Yes/No) | Recorded? (Y/N) |
|---|---|---|---|
| 1 | Traceability lot code | Yes | |
| 2 | Quantity and unit of measure | Yes | |
| 3 | Product description | Yes | |
| 4 | Location descriptionLocation description: Under FSMA 204: the business name, phone number and physical address (or geographic coordinates) of a site where food is handled, with city, state and ZIP code for US sites, or the local equivalent plus country for sites outside the US. of the immediate subsequent recipient (other than a transporter) | Yes | |
| 5 | Location descriptionLocation description: Under FSMA 204: the business name, phone number and physical address (or geographic coordinates) of a site where food is handled, with city, state and ZIP code for US sites, or the local equivalent plus country for sites outside the US. of where shipped from | Yes | |
| 6 | Date shipped | Yes | |
| 7 | Location descriptionLocation description: Under FSMA 204: the business name, phone number and physical address (or geographic coordinates) of a site where food is handled, with city, state and ZIP code for US sites, or the local equivalent plus country for sites outside the US. of the traceability lot code source, or the source reference | Yes | |
| 8 | Reference documentReference document: Under FSMA 204, a business transaction document, record or message, on paper or electronic, that may contain some or all of the key data elements for a critical tracking event. Examples include a bill of lading, purchase order, advance shipping notice or invoice. For each event, you record the reference document type and number. type and number | No |
These shipping records do not apply to shipping a raw agricultural commodity before it is initially packed.
Receiving (§ 1.1345)
| # | Key data element | Recorded? (Y/N) |
|---|---|---|
| 1 | Traceability lot code | |
| 2 | Quantity and unit of measure | |
| 3 | Product description | |
| 4 | Location descriptionLocation description: Under FSMA 204: the business name, phone number and physical address (or geographic coordinates) of a site where food is handled, with city, state and ZIP code for US sites, or the local equivalent plus country for sites outside the US. of the immediate previous source (other than a transporter) | |
| 5 | Location descriptionLocation description: Under FSMA 204: the business name, phone number and physical address (or geographic coordinates) of a site where food is handled, with city, state and ZIP code for US sites, or the local equivalent plus country for sites outside the US. of where received | |
| 6 | Date received | |
| 7 | Location descriptionLocation description: Under FSMA 204: the business name, phone number and physical address (or geographic coordinates) of a site where food is handled, with city, state and ZIP code for US sites, or the local equivalent plus country for sites outside the US. of the traceability lot code source, or the source reference | |
| 8 | Reference documentReference document: Under FSMA 204, a business transaction document, record or message, on paper or electronic, that may contain some or all of the key data elements for a critical tracking event. Examples include a bill of lading, purchase order, advance shipping notice or invoice. For each event, you record the reference document type and number. type and number |
[1] If the food comes from a supplier the rule does not apply to, you must assign a traceability lot code if none has been assigned. (21 CFR 1.1345(b)).
Transformation (§ 1.1350)
Transformation covers manufacturing or processing, commingling, repacking or relabeling, where the output is a listed food.
Inputs (listed food used)
| # | Key data element | Recorded? (Y/N) |
|---|---|---|
| 1(i) | Traceability lot code | |
| 1(ii) | Product description | |
| 1(iii) | Quantity and unit of measure used from each lot |
Outputs (new food produced)
| # | Key data element | Recorded? (Y/N) |
|---|---|---|
| 2(i) | New traceability lot code | |
| 2(ii) | Location descriptionLocation description: Under FSMA 204: the business name, phone number and physical address (or geographic coordinates) of a site where food is handled, with city, state and ZIP code for US sites, or the local equivalent plus country for sites outside the US. of where transformed (the traceability lot code source), and the source reference if applicable | |
| 2(iii) | Date transformation completed | |
| 2(iv) | Product description | |
| 2(v) | Quantity and unit of measure | |
| 2(vi) | Reference documentReference document: Under FSMA 204, a business transaction document, record or message, on paper or electronic, that may contain some or all of the key data elements for a critical tracking event. Examples include a bill of lading, purchase order, advance shipping notice or invoice. For each event, you record the reference document type and number. type and number |
For transformation of a raw agricultural commodity not initially packed, keep the applicable initial packing records, including sprouts records where applicable (21 CFR 1.1350(b)). These requirements do not apply to retail food establishments and restaurants for foods they do not ship (21 CFR 1.1350(c)).
Farm, Packing and Seafood Events
These events apply to farms, packers, coolers and the first land-based receivers of seafood. They are included because FTL foods reach manufacturers through these steps.
Harvesting (21 CFR 1.1325(a))
Applies to farms harvesting an FTL RAC, other than one from a fishing vessel.
| # | Key data element | Pass to next party? (Yes/No) | Recorded? (Y/N) |
|---|---|---|---|
| i | Location descriptionLocation description: Under FSMA 204: the business name, phone number and physical address (or geographic coordinates) of a site where food is handled, with city, state and ZIP code for US sites, or the local equivalent plus country for sites outside the US. of the immediate subsequent recipient (other than a transporter) | Yes | |
| ii | Commodity and, if applicable, variety | Yes | |
| iii | Quantity and unit of measure | Yes | |
| iv | Location descriptionLocation description: Under FSMA 204: the business name, phone number and physical address (or geographic coordinates) of a site where food is handled, with city, state and ZIP code for US sites, or the local equivalent plus country for sites outside the US. of the farm where harvested | Yes | |
| v | For produce: field or growing area name (or equally precise location) | Yes | |
| vi | For aquaculture: container name, for example pond or tank (or equally precise location) | Yes | |
| vii | Date of harvesting | Yes | |
| viii | Reference documentReference document: Under FSMA 204, a business transaction document, record or message, on paper or electronic, that may contain some or all of the key data elements for a critical tracking event. Examples include a bill of lading, purchase order, advance shipping notice or invoice. For each event, you record the reference document type and number. type and number | No |
The harvester must also give the initial packer its business name and phone number (21 CFR 1.1325(a)(2)).
Cooling Before Initial Packing (21 CFR 1.1325(b))
Applies to anyone cooling an FTL RAC before it is initially packed.
| # | Key data element | Pass to next party? (Yes/No) | Recorded? (Y/N) |
|---|---|---|---|
| i | Location descriptionLocation description: Under FSMA 204: the business name, phone number and physical address (or geographic coordinates) of a site where food is handled, with city, state and ZIP code for US sites, or the local equivalent plus country for sites outside the US. of the immediate subsequent recipient (other than a transporter) | Yes | |
| ii | Commodity and, if applicable, variety | Yes | |
| iii | Quantity and unit of measure | Yes | |
| iv | Location descriptionLocation description: Under FSMA 204: the business name, phone number and physical address (or geographic coordinates) of a site where food is handled, with city, state and ZIP code for US sites, or the local equivalent plus country for sites outside the US. of where cooled | Yes | |
| v | Date of cooling | Yes | |
| vi | Location descriptionLocation description: Under FSMA 204: the business name, phone number and physical address (or geographic coordinates) of a site where food is handled, with city, state and ZIP code for US sites, or the local equivalent plus country for sites outside the US. of the farm where harvested | Yes | |
| vii | Reference documentReference document: Under FSMA 204, a business transaction document, record or message, on paper or electronic, that may contain some or all of the key data elements for a critical tracking event. Examples include a bill of lading, purchase order, advance shipping notice or invoice. For each event, you record the reference document type and number. type and number | No |
Initial Packing of a RAC (21 CFR 1.1330(a)) [2] [3]
Applies to the first packer of an FTL RAC (not from a fishing vessel). This is where the TLCTLC (Traceability Lot Code): Under FSMA 204, a descriptor, often alphanumeric, used to uniquely identify a traceability lot. The TLC source is where it was assigned. is assigned.
| # | Key data element | Recorded? (Y/N) |
|---|---|---|
| 1 | Commodity and, if applicable, variety received | |
| 2 | Date received | |
| 3 | Quantity and unit of measure received | |
| 4 | Location descriptionLocation description: Under FSMA 204: the business name, phone number and physical address (or geographic coordinates) of a site where food is handled, with city, state and ZIP code for US sites, or the local equivalent plus country for sites outside the US. of the farm where harvested | |
| 5 | For produce: field or growing area name | |
| 6 | For aquaculture: container name | |
| 7 | Harvester's business name and phone number | |
| 8 | Date of harvesting | |
| 9 | Location descriptionLocation description: Under FSMA 204: the business name, phone number and physical address (or geographic coordinates) of a site where food is handled, with city, state and ZIP code for US sites, or the local equivalent plus country for sites outside the US. of where cooled (if applicable) | |
| 10 | Date of cooling (if applicable) | |
| 11 | Traceability lot code assigned | |
| 12 | Product description of the packed food | |
| 13 | Quantity and unit of measure of the packed food | |
| 14 | Location descriptionLocation description: Under FSMA 204: the business name, phone number and physical address (or geographic coordinates) of a site where food is handled, with city, state and ZIP code for US sites, or the local equivalent plus country for sites outside the US. of where initially packed (the TLC sourceTLC Source: Under FSMA 204, the place where a traceability lot code was assigned, recorded by its location description or a TLC source reference.), or the TLC source reference | |
| 15 | Date of initial packing | |
| 16 | Reference documentReference document: Under FSMA 204, a business transaction document, record or message, on paper or electronic, that may contain some or all of the key data elements for a critical tracking event. Examples include a bill of lading, purchase order, advance shipping notice or invoice. For each event, you record the reference document type and number. type and number |
[2] Sprouts (21 CFR 1.1330(b)) add 7 seed elements: seed grower, conditioner, packinghouse and supplier details with their lot codes, a seed description, the date seeds were received, and the reference documentReference document: Under FSMA 204, a business transaction document, record or message, on paper or electronic, that may contain some or all of the key data elements for a critical tracking event. Examples include a bill of lading, purchase order, advance shipping notice or invoice. For each event, you record the reference document type and number..
[3] RAC received from an exempt supplier (21 CFR 1.1330(c)) has a shorter 10 item list. Check the rule text.
First Land Based Receiving of Seafood (21 CFR 1.1335)
Applies to the first person on land to take a food from a fishing vessel. A TLC is assigned here.
| # | Key data element | Recorded? (Y/N) |
|---|---|---|
| a | Traceability lot code assigned | |
| b | Species and/or acceptable market name (unpackaged), or product description (packaged) | |
| c | Quantity and unit of measure | |
| d | Harvest date range and locations for the trip (NMFS Ocean Geographic Code, FAO Major Fishing Area or another widely recognized standard) | |
| e | Location descriptionLocation description: Under FSMA 204: the business name, phone number and physical address (or geographic coordinates) of a site where food is handled, with city, state and ZIP code for US sites, or the local equivalent plus country for sites outside the US. of the first land-based receiver (the TLC source), or the TLC source reference | |
| f | Date landed | |
| g | Reference documentReference document: Under FSMA 204, a business transaction document, record or message, on paper or electronic, that may contain some or all of the key data elements for a critical tracking event. Examples include a bill of lading, purchase order, advance shipping notice or invoice. For each event, you record the reference document type and number. type and number |
These tables are a planning aid, not a complete compliance checklist. Exemptions (§ 1.1305) and the traceability plan (§ 1.1315) also apply.
The Traceability Plan
Under § 1.1315, your written traceability plan must include:
- Procedures for keeping the required records, including format and location
- How you identify listed foods
- How you assign traceability lot codes
- A point of contact
- A farm map, for growers of listed foods other than eggs
Providing Records to FDA
Records must reach FDA within 24 hours of a request, or within a reasonable time FDA agrees to (§ 1.1455). When FDA needs them for an outbreak, recall or other threat, you must supply an electronic sortable spreadsheet unless you are exempt. FDA offers a free sortable spreadsheet template.
Exemptions
Exemptions depend on the type of business, the food and how it is handled. FDA has also published a draft Q&A guidance and an exemption for cottage cheese.
FDA has published draft guidance offering enforcement discretion for certain smaller retail food establishments and restaurants. It does not apply to manufacturers.
Use FDA's free exemptions tool to check your own position. You may also find our guide to HARPC vs HACCP useful for the other FSMA rules that apply to US facilities.
Compliance Date: What FDA Currently Says
The rule was originally due 20 January 2026; FDA will not enforce it before 20 July 2028 (Pub. L. 119-37). FDA proposed extending the compliance date by 30 months to 20 July 2028, and Congress then directed FDA not to enforce the rule before that date. FDA has said it "intends to comply with this Congressional directive".
As of 21 October 2026 there is no final rule formally amending the compliance date, so watch the FDA rule page for updates. Some older text on FDA's site still shows the original date, so rely on the current notices.
FDA Public Meeting: Register by 5 Nov
- Event: "Challenges and Solutions in Lot-Level Food Traceability", a virtual public meeting
- Date: 6 Nov 2026, 12:00 to 15:30 ET (17:00 to 20:30 UK time), per the Federal Register notice. The FDA event page currently lists a 15:00 ET finish, so check before the day.
- General registration: closes 5 Nov 2026
- Speakers: register by 26 Oct 2026
- Comments: due 6 Dec 2026
This is FDA's second meeting on the topic; the first was on 15 June 2026.
KDE and CTE Checklist (Download)
Use our checklist to work through each CTE that applies to your site, confirm the KDEs you record and check your traceability plan covers every required element. It covers all seven events and is designed to sit alongside FDA's free sortable spreadsheet template and exemptions tool, not replace them.
Your traceability records depend on reliable suppliers. See our Supplier Audit Checklist, and our guide to traceability exercises and mock recalls for testing your system.
