FDA’s Food Traceability Rule

These are the regulations that the FDA created to go with the Food Safety Modernization Act (FSMA). The full Rule and associated guidance can be found here.

The FDA says that it will not begin routine traceability inspections until sometime in 2027. The FDA may conduct traceability inspections any time after January 20, 2026, and before 2027 if it has reason to do so, for instance, during a foodborne illness outbreak investigation. 

Before enforcement and routine inspections in 2027, the FDA may provide fact sheets and opportunities for businesses to ask questions about the Rule during other routine FDA inspections.

The Product Tracing System (PTS) is an internal technology system that is being created for the FDA to use to track all food in the United States or offered for import into the United States. The new PTS system will receive and analyze industry food traceability data.

The Product Tracing System (PTS) is an internal technology system that is being created for the FDA to use to track all food in the United States or offered for import into the United States. The new PTS system will receive and analyze industry food traceability data.

Once food traceability data is uploaded, the PTS will automatically process the information into a visibility data standard called EPCIS (Electronic Product Code Information Services). Note: It is not a requirement for the industry to send food traceability data to the FDA in EPCIS format. 

The PTS will have strict data security and network security protocols. Only government users with permission will be able to access the data. FDA will protect all confidential information from disclosure. 

When the FDA requests that the industry provide tracking data on an FTL food, there will be a couple of ways to provide the information:
 

1. Email it to the FDA, and the FDA will then upload the data into their new Product Tracing System (PTS). 
2. Industry can directly upload an electronic sortable spreadsheet or other traceability records into the FDA’s Safety Reporting Portal (SRP). Note: This portal is now being updated to add a traceability-specific landing page. The Association will add the link to this page once it is available.

The FDA will provide more information on how the industry can upload or provide traceability documents before the January 20, 2026, deadline.

An ASN is a notice sent by the shipper ahead of a shipment informing that delivery is about to arrive. ASNs are used in Electronic Data Interchanges (EDIs). The ASN can contain order information, product descriptions, packaging types, and carrier information.

A Critical Tracking Event (CTE) is the time something significant happens with a Food Traceability List (FTL) food. These “events” in the life of an FTL food include:

• Growing or raising
• Creation
• Harvesting 
• Cooling before initial packaging. This includes produce that has been harvested and then cooled. It does not include cooling at a restaurant.
• Initial packing of a raw agricultural commodity (RAC). An RAC is any food in its raw or natural state, including all fruit that is washed, colored, or otherwise treated in unpeeled natural form before marketing. This does not include an FTL food initially received from a fishing vessel.
• Receiving 
• Transforming the food 
• Shipping  

An EDI is an electronic data exchange of business information between two or more organizations electronically. This typically replaces using paper documents (ex., purchase orders or invoices).

These are the foods that the FDA put on a list because research indicates they are at a higher level of risk for causing foodborne illness.

This is the Food Traceability List (FTL): soft cheeses, fresh leafy greens, tomatoes, fresh-cut fruits, nut butters, fresh herbs, fresh cucumbers, fresh peppers, shell eggs, fresh melons, sprouts, fresh tropical tree fruits, finfish and smoked finfish, fresh-cut vegetables, ready-to-eat deli salads, crustaceans and molluscan shellfish, bivalves.  

If you have questions or need more clarity about what is on this list, please review the Food Traceability List- FDA version.

A Food Traceability Plan explains how your restaurant creates and maintains FTL Food required information. It is intended to help the FDA quickly review and understand the information you provide during a foodborne illness outbreak investigation related to food(s) on the Food Traceability List.

Transformation occurs when a Food Traceability List (FTL) food is mixed or blended with other foods, repacked/repackaged, and then shipped to another location, or is relabeled. 

Transformation does not include:

• The initial packing of an FTL food when it is first assigned a Traceability Lot Code (TLC). 
• Any activities that happen before the FTL food is packed and assigned a TLC (ex. Harvesting or Cooling - not cooling at a restaurant)
• When you break large cases of an FTL food into smaller units, as long as it is not repackaged into smaller units or ship them. 
• Taking a pallet that includes many individual packed cases and breaking the individual cases into separate shipments - as long as none of the individual cases are re-packaged, relabeled or mixed/blended in the process. If they are, then food transformation has occurred.

A Key Data Element (KDE) is information related to a FTL Food’s Critical Tracking Events(CTEs). KDEs include: the Traceability Lot Code, quantity & unit measure of the food, food description, previous food suppliers’ location, restaurant receiving location, date received, and reference documents with identification numbers.

All KDE information must be kept for a minimum of 2 years. 

Some KDEs must be provided to other food supply chain businesses and maintained on-site. In some situations, a restaurant might receive a FTL food record with KDEs from a supply chain partner (e.g., the shipper) and would not need to create their own new record.

A kill step means doing something that kills or damages organisms that cause disease in a food. 

Example of a kill step: Cooking chicken to an internal temperature of 165 degrees.

Example of what is not a kill step: Washing some fruit. A washing process reduces the number of organisms that cause disease but does not kill them.

A raw agricultural commodity (RAC) is any food in its raw or natural state, including all fruit that is washed, colored, or otherwise treated in unpeeled natural form before marketing. This does not include an FTL food initially received from a fishing vessel.

Reference documents are bills of lading, purchase orders, advance shipping notices (ASNs), work orders, invoices, database records, batch logs, production logs, field tags, catch certificates, and receipts. The reference document number is the number assigned to the reference document.

A traceability lot code is an alphanumeric code/barcode used to uniquely identify a specific batch (lot) of food from the business that was originally created, transformed, first received from a fishing vessel, or packaged the FTL food and assigned a code to the batch. Lot-based recordkeeping is not required when an FTL food is harvested or at any point before the initial packing or first land-based receiving.

Restaurants only need to assign a TLC if they are shipping food to another location. 

A lot code, batch code, or other production code for an FTL food can be used as a traceability lot code if it meets the definition stated above.

There are no limits on how much of an FTL food can be put into a lot or how many different sources (including different fishing vessels) the food can be from. 

Many businesses are still working on solutions for capturing and transmitting traceability lot code information.

Food Traceability List

• Soft cheeses
• Fresh leafy greens
• Tomatoes
• Fresh-cut fruits
• Nut butters
• Fresh herbs
• Fresh cucumbers
• Fresh peppers
• Shell eggs
• Fresh melons
• Sprouts
• Fresh tropical tree fruits
• Finfish and smoked finfish
• Fresh-cut vegetables
• Ready-to-eat deli salads
• Crustaceans
• Molluscan shellfish, bivalves

If you have questions or need more clarity about what is on this list, please review the Food Traceability List- FDA version.

These are the foods that the FDA put on a list because their research indicates they are at a higher level of risk for causing foodborne illness.

Restaurants selling less than $250,000 of food yearly may not need to follow the FDA’s Food Traceability Rule. 

Please download the Restaurant Traceability Evaluation (located in the upper right corner of this page) to determine if your restaurant is required to follow the rule as there are some exemptions. It is your responsibility to identify if any exemptions apply to your restaurant.

This exemption must be calculated on all the food the restaurant sells yearly, not just the FTL foods.

The rule applies to each individual restaurant’s annual average food sales, not all the restaurants owned totaled together. It is possible that some restaurants of a franchise owner will need to follow the FDA’s Food Traceability Rule, and others will not.

Unless the restaurant is exempt from the FDA’s Food Traceability Rule (download the Restaurant Traceability Evaluation (located in the upper right corner of this page) to determine if your restaurant is exempt), each individual restaurant location is responsible for following the requirements of the FDAs Food Traceability Rule. It is ok for a restaurant location to have their corporate headquarters establish and maintain the required records on their behalf. However, the restaurant location is still responsible for ensuring that the records can be provided to the FDA within 24 hours of a request for review. 

Yes, the rule applies to commissaries and central kitchens that prepare food and then ship the food to a restaurant or store. KDEs must be maintained for any FTL foods received, shipped, or transformed (blended, mixed, repackaged or relabeled). 

Yes, restaurants that use a central kitchen model transform (mix, blend, repackage, relabel) and ship menu items before they are sold to consumers. The FDA views this model as operating as a manufacturer/processor/distributor. As a result, the central kitchen must keep the Key Data Element records for two years.

Restaurants that get all their food directly from a farm may not need to follow the FDA’s Food Traceability Rule. However, restaurants that get all their food directly from a farm do need to: 

1. Document the name and address of the farm(s) you purchase from.
2. Document type(s) of food you purchased from the farm(s).
3. Maintain the records for 180 calendar days. Time/Date Calculator Online Tool can help.

Sample spreadsheet

Restaurants do not need to keep records on the FTL foods they transform (in other words: mix, blend, repackage, or relabel) UNLESS the restaurant acts as a central kitchen/commissary or manufacturer/processor. If the restaurant or central kitchen/commissary is shipping/sending FTL foods or transformed foods that include FTL foods, then they will need to keep records. The FDA considers this to be a manufacturing/distributor activity. 

No, the kill step exemption does not apply to restaurants that give food directly to consumers. However, the restaurant must keep records of all FTL foods they receive.

The compliance deadline is January 20, 2026. It is important for restaurant operators to understand how the rule may impact current business practices long before the January 2026 deadline, as most restaurants will need time to develop solutions to meet the new requirements and implement them.  

Download and complete the Restaurant Traceability Evaluation (located in the upper right corner of this page) to determine if your restaurant may need to follow the FDA’s Food Traceability Rule.

A food traceability plan explains how your restaurant creates and maintains required information related to FTL Foods. It is intended to help the FDA quickly review and understand the information you provide during a foodborne illness outbreak investigation related to food(s) on the Food Traceability List. 

The Food Traceability Plan must:

• Explain the process used to maintain the required food tracking records. 
• Describe how you identify foods on the Food Traceability List that are on your menu at any time. 
• Provide the name and contact information of the person that can answer questions regarding your traceability plan and records.
• Be kept for a minimum of 2 years.
• Be updated as needed to reflect your current practices. When you create an updated plan, you must save your previous Food Traceability Plan for at least 2 years.

See an example of a Food Traceability Plan.

The Traceability Plan must:

• Explain the process used to maintain the required food tracking records. 
• Describe how you identify foods on the Food Traceability List that are on your menu at any time. 
• Show how you assign traceability lot codes (TLC) to foods on the Food Traceability List (FTL).
• Provide the name and contact information of the person that can answer questions regarding your traceability plan and records.
• Be kept for a minimum of 2 years.
• Be updated as needed to reflect your current practices. When you create an updated plan, you must save your previous Food Traceability Plan for at least 2 years.

Your plan must include a map showing the location areas where you grow or raise these foods.

1. The map must show the location and name of each field (or other growing area) where you grow food on the Food Traceability List, including geographic coordinates and any other information needed to identify the location of each field or growing area.
2. For aquaculture, the map must show the location and name of each container (e.g., pond, pool, tank, cage) in which you raise seafood on the Food Traceability List, including geographic coordinates and any other information needed to identify the location of each container.

In addition, your plan must meet these other Food Traceability Plan requirements:

• Explain the process used to maintain the required food tracking records. 
• Describe how you identify foods on the Food Traceability List that are on your menu at any time. 
• Show how you assign traceability lot codes (TLC) to foods on the Food Traceability List (FTL).
• Provide the name and contact information of the person that can answer questions regarding your traceability plan and records.
• Be kept for a minimum of 2 years.
• Be updated as needed to reflect your current practices. When you create an updated plan, you must save your previous Food Traceability Plan for at least 2 years.

In most cases, records containing the Key Data Elements information must be kept for two years from the date you created or obtained the records. One exception is for records maintained by a restaurant for food bought directly from a farm. Those records must be maintained for 180 days.

Restaurants do not need to attach KDEs and TLCs to specific recipes and meals. However, restaurants do need to keep records on any FTL food that they receive from a supplier or for any food they grow or ship to another business.

These are the Key Data Elements must be linked, recorded, and maintained for a FTL food:

• Traceability Lot Code
• Food quantity and unit measurement 
• Food description 
• Previous supplier and location 
• Restaurant Receiving Location (ex., Load dock, receiving area of the restaurant)
• Date you received the food
• The name of and the location description for the initial supplier that assigned the traceability lot code. Examples of traceability lot code sources include, but are not limited to: 
• The FDA Food Facility Registration Number for the traceability lot code source 
• A web address that provides FDA with the location description/address for the traceability lot code source.
• Reference document and reference document number. 

Reference documents are bills of lading, purchase orders, advance shipping notices (ASNs), work orders, invoices, database records, batch logs, production logs, field tags, catch certificates, and receipts. The reference document number is the number assigned to the reference document.

Please see Sample KDE record below: 

Yes, the FDA encourages restaurants to work with their suppliers to decide the best way to store and access required KDE information. 

Restaurants are required to keep receiving records. Most of these records will be sent to the restaurant by the business shipping the food.  Restaurants may have another business create and maintain the required KDE records on your restaurant’s behalf. Your restaurant will still be responsible for ensuring the KDE records can be provided onsite to the FDA within 24 hours of their official review request.

it is important you talk with your suppliers as soon as possible to understand how they intend to share the required KDE information with your restaurant as it is your responsibility to make sure you maintain all the KDEs required under the rule.

The FDA does not require a specific format or technology for maintaining and sharing records with restaurants. You may receive records from your suppliers via any of the methods currently used by the food industry or any new methods created to comply with the FDAs Traceability Rule. This may include bills of lading, invoices, Advanced Ship Notices (ASNs), Electronic Data Interchanges (EDIs), packing lists, case labels, 2-D barcodes, etc.

No. The FDAs Food Traceability Rule does not require any specific technology to be used to keep the required records. 

Restaurants with an average annual food sale of over $250,000 but less than 1 million are exempt from the requirement to provide FDA with an electronic, sortable spreadsheet upon request. However, these restaurants must still maintain the records required by the rule. These records must be kept as original paper or electronic or true copies (such as photocopies, pictures, scanned copies, or other accurate reproductions of the original records). Records must be legible and stored to prevent deterioration or loss. Electronic records may include working electronic links to the information required to be maintained under the final rule.

If your average annual food sales are over 1 Million you must keep the FTL Food records in an electronic, sortable spreadsheet. Spreadsheet requirements include:

• Recording and tracking all required key data element (KDE) information for foods on the Food Traceability List*. Electronic records may include links to the information required to be maintained under the rule.
• Keeping all required data for a minimum of two years.
• Providing FDA access to the spreadsheet within 24 hours of their request. 

*Please see the information for Key Data Elements and Traceability Lot Codes to see what information must be collected/kept and what information your food shipper must provide. 

This is an example of what the spreadsheet might look like:

Additional record-keeping requirements:

• You may have other organization(s) create and maintain records on your behalf, but you are still responsible for ensuring that those records can be accessed and provided onsite within 24 hours of FDA request. 
• Offsite records storage is permitted if the records can be accessed and provided onsite within 24 hours of FDA request. Electronic records are onsite if they are accessible from an onsite location.
• Records must be maintained as original paper or electronic records or true copies.
• Records must be legible and stored to prevent deterioration or loss. 

If a restaurant receives food from a person or business that does not need to follow the rule, you must create, maintain, and link to the traceability lot code of the food, the following KDEs:

• Traceability Lot Code
• Food quantity and unit measurement 
• FTL Food and description 
• Previous supplier and location 
• Restaurant Receiving Location
• Date you received the food
• Reference document and reference document ID number

Please see Sample KDE record below: 

In most situations, the food shipper will send you most of the above KDEs. You may be required to keep other records if you perform other CTEs. Your supplier may be able to keep and store KDE information for you, however you are still responsible for providing  access to that information within 24 hours of FDA official request.