Food Traceability Final Rule

Key Terminology

A major aspect of FSMA is setting a common language for the supply chain stakeholders. Here are some of the terms and acronyms used:

FSMA 204: Food Safety Modernization Act; Section 204
CTE: Critical Tracking Events, which can include harvesting, cooling, initial packing, receiving (by land-based vessel or other methods), shipping, and transforming items on the FTL.
KDE: Key Data Elements, which will depend on the CTE being performed and will require KDE records for each CTE linked to a traceability lot.
FTL: Food Traceability List
RAC: Raw Agricultural Commodity, most commonly referring to fresh fruits or vegetables
RFE: Retail Food Establishment
TLC: Traceability Lot Code

Overview

The FSMA Final Rule is just the beginning of a comprehensive initiative for the FDA to achieve complete end-to-end traceability along the food supply chain, setting the stage for the food industry to adopt more digital traceability systems.

Although the rule does not require electronic recordkeeping, the FDA noted that they hope many companies will adopt digital systems, speeding up the process and ultimately bending the curve of foodborne illness.

Any business (both foreign and domestic) that packs, processes, or holds foods on the FTL that will be sold to American consumers will need to track certain activities and data elements along the way. These activities, known as CTEs will help the FDA in the event of a foodborne illness outbreak or food recall.

The primary focus of FSMA is to protect public health. However, the FDA is also anticipating this regulation will diminish food waste, improve supply chain and inventory management, expedite recall processes, and save both businesses and the FDA time and money.

Updates

PREVENTION

For the first time, the FDA will be granted a legislative mandate to enforce comprehensive, science-based preventive measures throughout the food supply chain. This mandate encompasses:

Mandatory preventive controls for food facilities: Food facilities are obligated to develop a written preventive controls plan. This plan must include (1) an assessment of potential hazards that could compromise food safety, (2) a description of the preventive measures or controls that will be implemented to significantly reduce or eliminate these hazards, (3) a detailed monitoring strategy to ensure the effectiveness of these controls, (4) the maintenance of regular records documenting the monitoring process, and (5) a clear outline of corrective actions to be taken in response to any identified issues. (Final rule expected 18 months post-enactment)
Mandatory produce safety standards: The FDA is required to establish science-based minimum standards for the safe production and harvesting of fruits and vegetables. These standards must take into account naturally occurring hazards as well as those that may be introduced, either accidentally or deliberately, and must cover aspects such as soil amendments (materials like compost added to the soil), hygiene practices, packaging, temperature control, the presence of animals in growing areas, and water quality. (Final regulation anticipated approximately 2 years after enactment)
Authority to prevent intentional contamination: The FDA is tasked with issuing regulations aimed at safeguarding against the intentional adulteration of food. This includes the development of science-based mitigation strategies designed to prepare for and protect the food supply chain at particularly vulnerable points. (Final rule expected 18 months post-enactment)

INSPECTION & COMPLIANCE

The FSMA acknowledges that the effectiveness of preventive control standards in enhancing food safety is contingent upon the adherence of producers and processors to these standards. Consequently, the FDA must exercise oversight, ensure compliance with established requirements, and respond promptly to any emerging issues. The FSMA equips the FDA with significant new resources for inspection and compliance, which include:

Mandatory inspection frequency: The FSMA stipulates a mandatory inspection schedule based on risk assessment for food facilities, necessitating an immediate increase in inspection frequency. All high-risk domestic facilities are required to undergo inspection within five years of the law's enactment, with subsequent inspections occurring at least every three years. Additionally, within one year of enactment, the law mandates the FDA to inspect a minimum of 600 foreign facilities, with a commitment to double these inspections annually for the following five years.
Access to records: The FDA will be granted access to essential records, including industry food safety plans and documentation that firms must maintain to demonstrate the implementation of these plans.
Testing by accredited laboratories: The FSMA mandates that specific food testing be conducted by accredited laboratories and instructs the FDA to develop a laboratory accreditation program to ensure that U.S. food testing facilities adhere to high-quality standards. This accreditation program is to be established within two years of the law's enactment.

Response

The FSMA acknowledges the necessity for the FDA to possess adequate tools to address issues that may arise despite existing preventive measures. The new authorities granted include:

Mandatory recall: The FSMA empowers the FDA to enforce a mandatory recall if a company does not voluntarily withdraw unsafe food after being requested to do so by the FDA.
Expanded administrative detention: The FSMA allows the FDA to apply a more adaptable standard for the administrative detention of products that may violate legal regulations. This process is utilized by the FDA to prevent the movement of potentially harmful food items.
Suspension of registration: The FDA has the authority to suspend the registration of a facility if it concludes that the food presents a significant risk of serious health consequences or death. Facilities under suspension are barred from distributing food products. (This provision takes effect six months after enactment.)
Enhanced product tracing capabilities: The FDA is tasked with creating a system to improve its ability to track and trace both domestic and imported food products. Additionally, the FDA is instructed to initiate pilot projects aimed at exploring and assessing methods for quickly and effectively identifying food recipients to mitigate or manage foodborne illness outbreaks. (Pilot implementation is due nine months after enactment.)
Additional recordkeeping for high-risk foods: The FDA is mandated to propose regulations that establish recordkeeping requirements for facilities involved in the manufacturing, processing, packing, or storage of foods classified as high-risk by the Secretary. (Implementation is expected within two years of enactment.)

IMPORTS

The FSMA grants the FDA significant new powers to ensure that imported products adhere to U.S. standards and are safe for American consumers. Key new authorities include:

Importer accountability: For the first time, importers are explicitly required to confirm that their foreign suppliers implement sufficient preventive controls to guarantee the safety of the food they produce. (Final regulations and guidance are expected one year after enactment)
Third-Party Certification: The FSMA introduces a program allowing qualified third parties to certify that foreign food facilities meet U.S. food safety standards. This certification can facilitate the import process. (A system for the FDA to recognize accreditation bodies is to be established two years post-enactment)
Certification for high-risk foods: The FDA is empowered to mandate that high-risk imported foods be accompanied by credible third-party certification or other compliance assurances as a prerequisite for entry into the U.S.
Voluntary qualified importer program: The FDA is required to create a voluntary program for importers that allows for expedited review and entry of foods from participating importers. Eligibility is restricted to importers sourcing food from certified facilities, among other criteria. (Implementation is due 18 months after enactment)
Authority to deny entry: The FDA has the authority to refuse entry of food from a foreign facility if access is denied by that facility or the country in which it is located.

ENHANCED COLLABORATION

The FSMA establishes a structured framework for cooperation among various government entities, both at the national and international levels. This legislation acknowledges the necessity for all food safety organizations to collaborate cohesively to fulfill public health objectives.

Building state and local capacities: The FDA is tasked with creating and executing strategies aimed at enhancing the food safety and defense capabilities of state and local agencies. The FSMA introduces a new multi-year grant program to support investments in state capacities, enabling more effective achievement of national food safety objectives.
Enhancing foreign capacities: The legislation mandates the FDA to formulate a comprehensive strategy to bolster the capabilities of foreign governments and their industries. A key aspect of this strategy involves training foreign officials and food producers on U.S. food safety standards.
Utilizing inspections from other agencies: The FDA is granted explicit authority to depend on inspections conducted by other federal, state, and local agencies to fulfill its expanded inspection responsibilities for domestic facilities. Additionally, the FSMA permits the FDA to establish interagency agreements to optimize resources for inspecting seafood facilities, both domestically and internationally, as well as for seafood imports.

Further partnerships are essential for the development and execution of a national agriculture and food defense strategy, the creation of an integrated consortium of laboratory networks, and the enhancement of foodborne illness surveillance.

FSMA 204: Key Details

The FDA's final rule regarding Requirements for Additional Traceability Records for Certain Foods (Food Traceability Final Rule) introduces enhanced recordkeeping obligations for individuals and entities involved in the manufacturing, processing, packing, or storage of foods listed on the FTL. This regulation is a significant element of the FDA’s New Era of Smarter Food Safety Blueprint and is under Section 204(d) of the FDA FSMA.

The newly established requirements aim to facilitate quicker identification and removal of potentially contaminated food products from the market, thereby reducing the incidence of foodborne illnesses and fatalities. Central to this regulation is the mandate for those who manufacture, process, pack, or store FTL foods to maintain records that include KDEs linked to specific CTEs. Additionally, they must provide relevant information to the FDA within 24 hours or within a mutually agreed-upon timeframe. This final rule is designed to be in harmony with prevailing industry best practices and applies to both domestic and international companies that produce food for consumption in the United States, encompassing the entire food supply chain from farm to table.

Enhanced Traceability Requirements: FSMA 204 requires key participants in the food supply chain to maintain records of critical tracking events and key data elements. This means that companies must provide detailed documentation of the journey food items take from production to distribution.
Additional Recordkeeping For High-Risk Foods: The rule identifies certain foods as high-risk based on factors such as contamination frequency and severity. These foods require enhanced recordkeeping and traceability to prevent and quickly respond to any outbreaks.
Rapid Tracking & Tracing: The aim is to improve the speed and accuracy with which food items can be tracked and traced, thus minimizing the impact of contamination incidents.

Food Traceability List

Section 204 of the FDA's FSMA mandates that the FDA identify specific foods that necessitate enhanced recordkeeping to safeguard public health. The additional recordkeeping protocols are detailed in the Food Traceability Final Rule, which aims to facilitate the swift identification and removal of potentially contaminated food products from the marketplace, thereby reducing the incidence of foodborne illnesses and fatalities. The FTL specifies the foods that require these enhanced traceability records. These recordkeeping requirements pertain to the items explicitly mentioned on the FTL, as well as to any foods that incorporate listed items as ingredients, provided that the listed ingredient retains its original form (e.g., fresh) as indicated on the list.

For further details regarding the FTL, please refer to the Food Traceability List.

KDE & CTE

The Food Traceability Final Rule requires manufacturers, processors, packers, and holders of foods on the FTL to maintain records of KDEs for certain CTEs. KDEs include information like lot codes, product names, and packaging material information. The CTEs in the final rule are harvesting; cooling (before initial packing); initial packing of a raw agricultural commodity other than food obtained from a fishing vessel; first land-based receiving of food obtained from a fishing vessel; shipping; receiving; and transformation of the food.

Harvesting: This applies to farms and farm mixed-type facilities and means activities that are traditionally performed on farms to remove RACs from the place they are grown or raised and prepare them for use as food.

Cooling: This means active temperature reduction of a RAC using hydrocooling, icing (except icing of seafood), forced air cooling, vacuum cooling, or a similar process.

Initial Packing: This means packing a raw RAC, other than food obtained from a fishing vessel, for the first time.

First Land-Based Receiver: This means the person taking possession of food for the first time on land directly from a fishing vessel.

Shipping: This is an event in a food supply chain in which food is arranged for transport (e.g., by truck or ship) from one location to another location. Shipping does not include the sale or shipment of food directly to a consumer or the donation of surplus food. Shipping does include sending an intracompany shipment of food from one location at a particular street address of a firm to another location at a different street address of the firm.

Receiving: This is an event in a food supply chain in which food is received by someone other than a consumer after being transported (e.g., by truck or ship) from another location. Receiving includes receipt of an intracompany shipment of food from one location at a particular street address of a firm to another location of the firm at a different street address.

Transformation: This is an event in a food supply chain that involves manufacturing/processing or changing a food (e.g., by commingling, repacking, or relabeling) or its packaging or packing when the output is food on the FTL. Transformation does not include the initial packing of food or activities preceding that event (e.g., harvesting, cooling).

For a detailed description of the KDEs that would be required for each CTE, see Critical Tracking Events and Key Data Elements.

Traceability Lot Code

The goal of the Food Traceability rule is to ensure KDEs can be maintained across the supply chain for more efficient and effective tracing while providing firms flexibility within their existing tracing systems.

The TLC is an integral component of the rule’s requirements. It links to the other KDEs required, including the TLC Source, which provides the physical location where the traceability lot code for an FTL food was assigned. Requiring documentation of traceability lot codes and traceability lot code sources enables the FDA to identify the source of the food faster, link food to the firms that have handled it, and ultimately lead the FDA back to the source of the food during an outbreak investigation.

A traceability lot code means a descriptor, often alphanumeric, used to uniquely identify a traceability lot within the records of the traceability lot code source. This is similar to what the industry currently refers to as a "lot code".

Unless the relevant entity is exempt from the rule, the traceability lot code is assigned when the food is initially packed (for raw agricultural commodities not obtained from a fishing vessel), received by the first land-based receiver (for food obtained from a fishing vessel), or transformed. Once a TLC is assigned, it must stay the same as the food moves through the supply chain; it can only be changed if the food is transformed.

How to Code the TLC?

Numerous best practices and standards supported by the food industry exist for the unique identification of food lots. These practices typically involve a combination of a globally unique product identifier, an internal lot code assigned by the firm, and a standard date code. Additional examples may include a Julian date, a lot code, a batch code, or other production codes. When combined, this information can serve as a traceability lot code, as long as it aligns with the definition of "traceability lot code" outlined in the final rule. Below are some examples of traceability lot codes.

TLC Source

A TLC source refers to the physical location where food was assigned a traceability lot code. In certain situations, the Food Traceability Rule requires documentation of either the location description for the traceability lot code source or the traceability lot code source reference.

Location description means key contact information for the location where food is handled, specifically the business name, phone number, physical location address (or geographic coordinates), city, State, and zip code for domestic locations, and comparable information for foreign locations, including country. Therefore, the location description for a traceability lot code source would be this key contact information for the place where the food was assigned a traceability lot code.

Example:

Food, Inc.
123 Main Street
Anytown, PA 19123
(313) 123-4567

TLC Source Reference

A TLC source reference means an alternative method for providing the FDA with access to the location description for the traceability lot code source. Examples of a TLC reference include but are not limited to, the FDA Food Facility Registration Number for the TLC source or a web address that provides the FDA with the location description for the TLC source.

If a firm chooses to use a traceability lot code source reference, it can set it up in a way that will maintain the confidentiality of business information concerning suppliers. For example, if the firm uses a web address as the traceability lot code source reference, the associated website may employ reasonable security measures, such as only being accessible to a government email address, provided that FDA has access to the information at no cost and without delay. Two examples are below:

Example:

FDA Food Facility Registration Number:
#12345678911

Example:

Web address:
www.foodinc.com/rQyp67dz3

Traceability lot codes (TLC) help ensure accurate identification of the food as it moves through the supply chain, and the TLC Source provides the physical location where the traceability lot code for an FTL food was assigned. Both of these KDEs will improve our ability to identify the specific food and location involved in a contamination event and determine the appropriate scope of a recall event.

FIRMS SHOULD ESTABLISH CLEAR CRITERIA FOR DEFINING A TRACEABILITY LOT

The Food Traceability Rule does not prescribe a specific way firms must define a traceability lot; rather the rule provides firms with flexibility in how they determine what constitutes a traceability lot. We note that smaller traceability lots might lead to less food being affected in the event of a recall.

The rule does require that a TLC and the other required KDEs must be linked to each traceability lot. Linkages can be achieved by having the TLC appear on the reference documents the firm keeps to document the required KDEs. For example, the TLC could appear on a bill of lading or invoice, which also contains other KDEs. For firms that maintain records electronically, linkage could be achieved by including the TLC in the same row of a spreadsheet or database that documents the required KDEs for a tracking event.

Within the Traceability Plan, a firm must describe the process used to assign a TLC (e.g., Julian date plus product code, randomized generated code, etc.) to foods on the FTL, if applicable.

Firms must assign a TLC when they:

Initially pack an RAC other than food obtained from a fishing vessel
Perform the first land-based receiving of food obtained from a fishing vessel
Transform a food

Firms must not establish a new TLC when they conduct any other activities (e.g., shipping). However, if food is received from a person who is exempt from the rule, the firm must assign a TLC (unless the firm is a retail food establishment or restaurant) - 21 CFR 1.1345(b).

The final rule does not require that the TLC be included in food labeling or food packaging. The TLC could be sent to the next recipient of the food in a variety of ways, such as via a bill of lading, an advance shipment notice (ASN), in a separate email, or by embedding the information in a quick response (QR) code that appears on the packaging of the food or a related document. The information would not have to physically accompany the food sent to the recipient but must be provided in a way that permits the receiver of the food to keep the records it is required to maintain under the rule.

21 CFR 1.1455(g) states that the firm does not have to keep all of the information required by the rule in a single set of records. However, the traceability plan must indicate the format and location of the records the firm is required to keep under the rule, under § 1.1315(a)(1), For examples check this link.

Traceability Plan

If you fall under the stipulations of the final rule, it is essential to create and uphold a traceability plan that includes the following elements:

An outline of the methods you employ to manage the records mandated by this rule, detailing the format and storage of these records.
An explanation of the processes you utilize to identify foods listed on the Food Traceability List that you manufacture, process, pack, or store.
A description of how you allocate traceability lot codes to the foods on the Food Traceability List, if relevant.
A declaration of a designated contact person for inquiries related to your traceability plan and associated records.
If you cultivate or raise any food item on the Food Traceability List (excluding eggs), you must provide a farm map that illustrates the areas where these foods are grown or raised:
- The farm map should indicate the location and name of each field (or other cultivation area) where you grow food on the Food Traceability List, including geographic coordinates and any additional information necessary to pinpoint the location of each field or growing area.
- For aquaculture operations, the farm map must instead depict the location and name of each container (such as a pond, pool, tank, or cage) where you cultivate seafood on the Food Traceability List, along with geographic coordinates and any other pertinent information required to identify the location of each container.

The final rule also requires that:

Records must be maintained as original paper or electronic records, or true copies; they all must be legible and stored to prevent deterioration or loss. Electronic records may include valid, working electronic links to the information required to be maintained under the rule.
All records required under this rule, along with any information required to understand the records, must be made available to the FDA within 24 hours after a request is made (or within a reasonable time to which the FDA has agreed)
Unless exempt from this requirement, an electronic sortable spreadsheet containing relevant traceability information must be provided to the FDA within 24 hours of a request (or within some reasonable time to which the FDA has agreed) when necessary to assist the FDA during an outbreak, recall, or other threat to public health.

Compliance Date

Because the Food Traceability Final Rule requires entities to share information with other entities in their supply chain, the most effective and efficient way to implement the rule is to have all persons subject to the requirements come into compliance by the same date. The compliance date for all persons subject to the recordkeeping requirements is Tuesday, January 20, 2026.

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