FDA's New Traceability Rule:  Short Guide For Food Industry

Food Traceability Proposed Rule

On March 4, 2011, the Food Safety and Modernization Act (FSMA) was signed into law. Section 204 of the FSMA requires the FDA to designate foods for which additional recordkeeping requirements are appropriate to protect public health. As per this requirement, FDA developed a list for certain foods for additional recordkeeping requirements and established traceability regulations. This list is now known as the Food Traceability List (FTL).

View Food Traceability List (FTL)

The new regulations set forth by the FDA in their final rule implementing Section 204(d) of the Food Safety Modernization Act (FSMA) aim to improve consumer safety and public health. The proposed rule is called "Requirements for Additional Traceability Records for Certain Foods," commonly referred to as Food Traceability Proposed Rule. This rule is one of the last remaining elements of the FDA's Food Safety Modernization Act (FSMA) and lays the foundation for end-to-end food traceability across the food industry. The new regulation will push the food industry sector into an era of smarter traceability, heavily influenced by the New Era of Smart Food Safety Initiative, where technology-enabled traceability is considered a key element.

To comply with the law, certain food manufacturers must keep records containing key data elements (KDEs) for each critical tracking event (CTE), and they must report these KDEs to the Food and Drug Administration (FDA) within 24 hours or within a reasonable period to which the FDA agrees. The final regulation aligns with current industry standards and addresses domestic and foreign companies producing food for U.S. consumers at every stage of the food supply chain.

Critical Tracking Events and Key Data Elements

The rule establishes requirements for maintaining and providing key data elements (KDEs) for specific critical track­ing event (CTEs) records in the traceable product's supply chain. These KDEs form the basis for effective and efficient tracing by FDA.

Under the new proposed rule, companies must retain records of their shipments of FTL products and link them to other records identifying the product as it moves through the supply chains.

According to the FDA, these new rules would help the FDA quickly and effectively help prevent the spread of foodborne illnesses or address threats of severe health consequences or deaths.

The key requirements are

1. Records must be maintained as original paper, electronic, or true copies; they must all be legible and stored to prevent deterioration or loss.

2. Records related to this rule must be provided to the FDA within 24 hours of a written inquiry from the agency.

3. An electronic sortable spreadsheet containing traceability info must be submitted to the FDA within 24 hours if needed.

Also, note that the final rule lists some exemptions to its requirements. These exemptions are listed in section 1.1305 of that rule.

When Does the Traceability Rule Go Into Effect?

To comply with the Food Traceability Final Rules, all entities subject to the rules must come into full compli­ance by the same deadline. The deadline for all entities subject to these rules is January 20, 2026.

What Can I Do to Prepare for FDA's Food Traceability Rule?

Here are five steps to help ensure compliance with Food Traceability Rule (FSMA Rule 204).

1. Review Food Traceability List and determine if your product is listed on the FTL.

2. Understand Critical Tracking Events and relevant Key Data Elements you're required to capture and store based on your role in the supply chain.

3. Make sure these Key Data Elements are captured accurately and stored in a way that is easy to retrieve

4. Talk to your supply chain partners about their preparation.

5. Implement best practices such as product label standardization, electronic records across all of your supply chains

Commonly Used Terms

Traceback

Traceback refers to the ability to track a product back in the supply chains from the point of purchase or consumption to a common source. 

Traceability Lot Code (TLCs)

The rule defines Traceability Lot Code as an alphanumeric descriptor used to identify a traceability lot.

Key Data Elements (KDEs)

KDEs is the specific information provided by persons who manufacture, process, pack, or hold foods to their supply chain partners.

Examples of Shipping KDEs include:

• Traceability lot code for the food

• Quantity and unit of measure of the food

• Product description for the food

• Location description for the immediate subsequent recipient

• Location description for the location from which you shipped the food

• Date you shipped the food

• Location description for the traceability lot code source

• Reference document type and reference document number

Critical Tracking Events (CTEs)

CTEs are the critical events for tracking foods from farm to table

Examples of Critical Tracking Events (CTEs) include harvesting, cooling, packing, shipping, receiving etc.

What foods are included on the FDA's Food Traceability List?

The FDA's Food Traceability List (FTL) includes foods identified as high-risk for foodborne illnesses, requiring additional traceability recordkeeping. The foods on the FTL are:

• Cheeses (other than hard cheeses): Includes soft unripened/fresh soft cheeses like cottage, chevre, cream cheese, mascarpone, ricotta, queso blanco, queso fresco, queso de crema, and queso de puna, as well as soft ripened/semi-soft cheeses like brie, camembert, feta, mozzarella, taleggio, blue, brick, fontina, monterey jack, and muenster. It also includes all cheeses made with unpasteurized milk, other than hard cheeses.

• Shell eggs: Specifically refers to the eggs of domesticated chickens.

• Nut butters: Includes all types of tree nut and peanut butters, such as almond, cashew, chestnut, coconut, hazelnut, peanut, pistachio, and walnut butters.

• Cucumbers (fresh): Includes all varieties of fresh cucumbers.

• Herbs (fresh): Includes all types of fresh herbs like parsley, cilantro, and basil.

• Leafy greens: Includes fresh-cut leafy greens.

• Melons (fresh): Includes all types of fresh melons, such as cantaloupe and honeydew.

• Peppers: Includes all varieties of peppers.

• Sprouts: Includes all types of fresh sprouts.

• Tomatoes: Includes all varieties of fresh tomatoes.

• Tropical tree fruits: Includes various tropical tree fruits.

• Fruits and vegetables (fresh-cut): Includes all types of fresh-cut fruits and vegetables.

• Finfish: Includes all types of finfish, including smoked finfish.

• Crustaceans: Includes all types of crustaceans.

• Mollusks (bivalves): Includes all types of bivalve mollusks.

• Ready-to-eat deli salads: Includes all types of ready-to-eat deli salads.

These foods are subject to the FDA's stringent traceability requirements to ensure faster identification and removal of potentially contaminated products from the market, thereby enhancing food safety.

Are there any exemptions to the Food Traceability List?

Yes, there are several exemptions to the FDA's Food Traceability Rule for foods on the Food Traceability List (FTL). Here are some of the key exemptions:

• Produce that is Rarely Consumed Raw: Certain produce items that are not commonly eaten raw are exempt from the traceability requirements.

• Foods Subjected to a Kill Step: Foods that will be subjected to a kill step (a process that significantly reduces or eliminates pathogens) by an entity other than a farm, retail food establishment, restaurant, or consumer are exempt, provided there are written agreements in place confirming this process.

• Small Originators: Certain types of small originators, such as small farms and small food producers, may be exempt.

• Direct-to-Consumer Sales: Farms that sell food directly to consumers are exempt from the rule.

• Commingled Raw Agricultural Commodities (RACs): There is a partial exemption for commingled RACs.

• Retail Food Establishments: There is a partial exemption for small retail food establishments.

• Farm-to-School and Farm-to-Institution Programs: These programs may have partial exemptions.

• Fishing Vessels: Food from fishing vessels has partial exemptions.

• Transporters: Entities that only transport food are exempt.

• Nonprofit Food Establishments: Nonprofit food establishments are exempt.

• Personal Consumption: Food held for individual personal consumption is exempt.

• Persons Holding Food for Individual Consumers: Persons who hold food for individual consumers are exempt.

Additionally, specific herbs listed in 21 CFR 112.2(a)(1), such as dill, and certain leafy greens like collards are exempt from the requirements of the rule under 21 CFR 1.1305(e)

What are the Key Data Elements (KDEs) required by the Food Traceability Rule?

The FDA's Food Traceability Rule requires the recording and maintenance of Key Data Elements (KDEs) for specific Critical Tracking Events (CTEs) in the food supply chain. These KDEs must be linked to the traceability lot code for the food. Here are the example KDEs required for each CTE:

Harvesting

• Location description for the immediate subsequent recipient (other than a transporter) of the food

• Commodity and, if applicable, variety of the food

• Quantity and unit of measure of the food

• Location description for the farm where the food was harvested

For produce:

• Name of the field or other growing area from which the food was harvested

• Other information identifying the harvest location at least as precisely as the field or growing area name

For aqua-cultured food:

• Name of the container (e.g., pond, pool, tank, cage) from which the food was harvested

• Other information identifying the harvest location at least as precisely as the container name

• Date of harvesting

• Reference document type and reference document number.

Cooling (before Initial Packing)

• Location description for the immediate subsequent recipient (other than a transporter) of the food

• Commodity and, if applicable, variety of the food

• Quantity and unit of measure of the food

• Location description for the location where the food was cooled

• Date of cooling

• Reference document type and reference document number.

Initial Packing

• Location description for the grower of seeds for sprouting (for sprouts)

• All KDEs required for cooling, if applicable

• Date of initial packing

• Reference document type and reference document number.

First Land-Based Receiver

• Traceability lot code you assigned

• Species and/or acceptable market name for unpackaged food, or the product description for packaged food

• Quantity and unit of measure of the food

• Harvest date range and locations for the trip during which the food was caught (for food obtained from a fishing vessel)

• Location description for the first land-based receiver

• Date the food was landed

• Reference document type and reference document number.

Shipping

• Traceability lot code for the food

• Quantity and unit of measure of the food

• Product description for the food

• Location description for the immediate subsequent recipient (other than a transporter) of the food

• Location description for the location from which you shipped the food

• Date you shipped the food

• Location description for the traceability lot code source or the traceability lot code source reference

• Reference document type and reference document number (maintain only).

Receiving

• Traceability lot code for the food

• Quantity and unit of measure of the food

• Product description for the food

• Location description for the immediate previous source of the food

• Date you received the food

• Reference document type and reference document number.

Transformation

• Traceability lot code for the food

• Product description for the food to which the traceability lot code applies

• Quantity and unit of measure of the food

• Location description for the immediate subsequent recipient (other than a transporter) of the food

• Date of transformation

• Reference document type and reference document number.

These KDEs are essential for ensuring that the FDA can efficiently trace foods through the supply chain, thereby enhancing food safety and the ability to respond to foodborne illness outbreaks.

What are the specific requirements for maintaining traceability records for imported foods?

Here are the key requirements for maintaining traceability records for imported foods under the FDA's Food Traceability Rule:

• The recordkeeping requirements apply to imported foods on the Food Traceability List (FTL) both before and after importation into the United States.

• The requirements cover Critical Tracking Events (CTEs) that occur before an FTL food is imported (e.g. initial packing, shipping) as well as those that occur after the food has entered the U.S. (e.g. receiving, transformation, shipping).

• Importers are responsible for complying with the portions of the rule that apply to them, based on the CTEs they perform.

• Foreign entities covered by the rule (e.g. foreign farmers, packers, manufacturers, exporters) are responsible for complying with the applicable portions of the rule based on the CTEs they perform.

• There is no requirement to record or send the FDA entry number assigned to an imported FTL food.

• Records must be provided to the FDA within 24 hours upon request, unless an alternative timeframe is agreed upon.

• Electronic records, if used, need to be provided in a single file and in a format easily opened and used in standard commercial software.

• Key data elements that must be recorded include:

1) Identification of the food

2) Tracing one step back to the supplier

3) Tracing one step forward to whom the product was sold

4) If applicable, identification and tracing of ingredients used

• The rule applies to both FTL foods and certain multi-ingredient foods containing FTL ingredients.

• Entities can maintain a single traceability plan for all FTL foods they handle, rather than separate plans for each food.

The key is to maintain records of CTEs and associated KDEs throughout the supply chain, regardless of whether the activities occur before or after importation.

What steps should companies take to ensure their supply chain partners comply with the Food Traceability Rule?

To ensure supply chain partners comply with the FDA's Food Traceability Rule, companies should take the following steps:

1. Educate partners about the rule: Provide clear information on the requirements, deadlines, and implications of the Food Traceability Rule to all supply chain partners.

2. Assess current traceability practices: Evaluate existing traceability systems and processes of partners to identify gaps in compliance.

3. Develop a compliance roadmap: Create a detailed plan outlining the steps needed to achieve full compliance, including timelines and responsibilities.

4. Implement compatible traceability systems: Ensure all partners use traceability systems that can communicate and share data effectively across the supply chain.

5. Standardize data collection: Establish uniform methods for collecting and recording Key Data Elements (KDEs) for Critical Tracking Events (CTEs).

6. Conduct training sessions: Offer comprehensive training to partners on new traceability procedures, technologies, and record-keeping requirements.

7. Perform regular audits: Conduct periodic audits of partners' traceability practices to ensure ongoing compliance.

8. Establish clear communication channels: Create efficient ways to share traceability information quickly in case of recalls or FDA requests.

9. Update supplier agreements: Modify contracts to include specific language about Food Traceability Rule compliance requirements.

10. Collaborate on technology solutions: Work together to implement or upgrade to electronic quality management systems (EQMS) that facilitate traceability.

11. Develop contingency plans: Create protocols for addressing non-compliance issues or gaps in traceability data.

12. Monitor regulatory updates: Stay informed about any changes or updates to the Food Traceability Rule and communicate these to partners promptly.

13. Encourage a culture of transparency: Foster open communication about traceability challenges and solutions throughout the supply chain.

14. Provide incentives for compliance: Consider offering benefits or preferred status to partners who consistently meet or exceed traceability requirements.

15. Conduct mock traceability exercises: Regularly test the system with simulated scenarios to identify and address any weaknesses.

By taking these steps, companies can work collaboratively with their supply chain partners to ensure comprehensive compliance with the Food Traceability Rule, ultimately enhancing food safety and traceability throughout the supply chain.

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