FDA Issues “Transformational” Food Traceability Rule

FDA Issues “Transformational” Food Traceability Rule

November 17, 2022, Covington Alert

On November 15, 2022, FDA released its Food Traceability Final Rule, which will impose traceability recordkeeping requirements on persons who manufacture, process, pack, or hold foods that appear on FDA’s Food Traceability List (FTL). The final rule retains the core requirements of FDA’s Food Traceability Proposed Rule, subject to some key differences discussed below. In short, the rule will require entities to maintain records containing specific “key data elements” (KDEs) when they engage in “critical tracking events” (CTEs) regarding FTL foods, and will require entities to link these records to a food’s “traceability lot code” (TLC). Entities will also need to maintain “traceability plans” outlining how they will comply with the rule.

This is one of the major rules FDA was required to issue under the Food Safety Modernization Act (FSMA). Frank Yiannas, FDA’s Deputy Commissioner for Food Policy and Response, has described the rule as a “game changer” for food safety that will “transform” how FDA and industry work together to conduct traceability activities. The compliance date is January 20, 2026.

The rule applies to all entities who manufacture, process, pack, or hold foods that appear on the FTL (FTL foods).[1] FDA updated the FTL upon release of the final rule to clarify the scope of certain items on the list, but FDA did not add or remove any foods from the FTL that was in the proposed rule. FDA plans to update the FTL every 5 years, in accordance with procedures outlined in the rule.

The rule applies to both FTL foods and certain multi-ingredient foods containing FTL ingredients. In response to significant stakeholder concerns, FDA clarified that multi-ingredient foods with FTL ingredients are only covered if the FTL ingredients remain in the same form specified in the FTL (e.g., “fresh,” “fresh-cut,” or “fresh and frozen”). For example, a sandwich with fresh tomato would be subject to the rule, since the FTL lists “tomatoes (fresh).” A frozen pizza topped with tomato slices would not be subject to the rule, since the FTL does not list “frozen” tomatoes.

The final rule retains the exemptions included in the proposed rule, subject to some modifications, and adds multiple new exemptions. Key modifications and additions include:

• Exemption for Products Destined for a Kill Step or Use in Non-FTL Form: The final rule retains the proposed rule’s partial exemption for foods subject to a kill step (requiring that entities maintain only records of the application of the kill step) and the proposed rule’s full exemption for entities that receive foods previously subjected to a kill step. Notably, however, FDA has expanded this exemption to also cover foods destined for a kill step. Such foods are exempt from the rule as long as the shipper and receiver of the food enter into a written agreement stating that either the receiver or a subsequent entity in the supply chain (other than a retail food establishment or restaurant) will apply a kill step. FDA also expanded this exemption to apply to FTL foods that are destined to undergo changes (not limited to kill steps) that will change them to a non-FTL form. This would apply, for example, to fresh tomatoes that are destined to be frozen.
• Exemption for Small Retail Food Establishments (RFEs): The rule includes a full exemption for small RFEs and restaurants (i.e., those with an annual monetary value of food sold or provided during the previous 3-year period of not more than $250,000 (on a rolling basis), adjusted for inflation using 2020 as a baseline year). The rule also introduces a new partial exemption for larger, but still relatively small, RFEs and restaurants. These entities will be subject to the rule, but will not need to comply with the requirement to provide FDA with an electronic sortable spreadsheet to assist the agency in responding to outbreaks, recalls, or other public health threats.
• Exemption for Foods Subject to Regulation by USDA: The rule introduces a new exemption for meat, poultry, and egg products subject to USDA oversight. These foods will be fully exempt from the rule upon arrival at USDA-regulated facilities, and will remain exempt after leaving such facilities.
• Additional New Exemptions: The rule also introduces new exemptions for raw bivalve molluscan shellfish, food intended for research or evaluation use, and certain ad hoc purchases by RFEs and restaurants from other RFEs and restaurants.

FDA has released an interactive tool to help stakeholders evaluate whether they qualify for the rule’s exemptions. The rule also establishes procedures for requesting new exemptions, modified requirements, or waivers for specific foods or entities. These provisions are largely unchanged from the proposed rule.

What are the rule’s key recordkeeping requirements?

The rule requires covered entities to develop, maintain, and pass forward various records associated with the FTL foods they manufacture, process, pack, or hold. Key recordkeeping requirements include:

• Critical Tracking Events and Key Data Elements: When covered entities engage in certain CTEs for FTL foods, they will be required to develop, maintain, and pass forward traceability records containing specific KDEs. The CTEs covered by the final rule include:
  • Harvesting (i.e., activities that are traditionally performed on farms for the purpose of removing raw agriculture commodities (RACs) from the place they are grown or raised and preparing them for use as food);
  • Cooling before initial packing (i.e., active temperature reduction of a RAC using hydrocooling, icing (except icing of seafood), forced air cooling, vacuum cooling, or a similar process);
  • Initial packing of a RAC (i.e., packing a RAC, other than a food obtained from a fishing vessel, for the first time);
  • First land-based receiving of a food obtained from a fishing vessel (i.e., taking possession of a food for the first time on land directly from a fishing vessel);
  • Shipping (i.e., arranging a food for transport from one location to another location, including intracompany shipments but excluding the sale or shipment of a food directly to a consumer or the donation of surplus food);
  • Receiving (i.e., receiving of food by someone other than a consumer after the food has been transported from another location, including intracompany shipments between locations); and
  • Transformation (i.e., manufacturing/processing or changing a food—including by commingling, repacking, or relabeling—or its packaging or packing, when the output is a food on the FTL).

Different KDEs are required for each CTE, and entities that engage in multiple KDEs must maintain KDEs for each CTE. FDA has published an infographic that summarizes the KDEs required for each CTE along with examples of how the rule would apply in the produce, seafood, and cheese supply chains.

These requirements reflect certain key changes from FDA’s proposed rule. FDA eliminated the proposed CTEs for “growing” and “first receiving” and replaced them with the CTEs for harvesting, cooling, initial packing, and first land-based receiving. FDA also merged the proposed “creation” and “transformation” CTEs into a single “transformation” CTE. The agency also modified and eliminated various KDE requirements. For example, the required shipping KDEs no longer include the entry number assigned to imported food, product and location identifiers, or the time of shipment. FDA also eliminated provisions that would have required entities to pass forward KDEs identifying the upstream generator of a product’s traceability lot code.

• Traceability Lot Codes: Entities are required to assign “traceability lot codes” (TLCs) to FTL foods when they engage in (1) initial packing of a RAC; (2) first land-based receiving of a food obtained from a fishing vessel; or (3) transformation. Entities may not assign new TLCs when they engage in other CTEs. KDEs developed at each CTE must be linked to a food’s TLC.
  
  Unlike the proposed rule, the final rule recognizes that there may be circumstances where entities receive FTL foods from suppliers who are exempt from the rule. In such cases, receivers will not be given the information they need to establish receiving KDE records. The rule addresses this challenge by requiring entities that receive FTL foods from exempt suppliers to (1) assign new TLCs to those foods and (2) maintain records linking certain basic information to those TLCs (e.g., the quantity and unit of measure of food, a description of the food, and other information regarding where, when, and from whom the food was received).
• Traceability Plans: Covered entities will be required to maintain “traceability plans” that contain the following elements:
  • A description of the procedures the entity uses to maintain the records the entity is required to keep under the rule, including the format and location of these records;
  • A description of the procedures the entity uses to identify foods on the FTL that it manufactures, processes, packs, or holds;
  • A description of how the entity assigns traceability lot codes to foods on the FTL, if applicable;
  • A statement identifying a point of contact for questions regarding the entity’s traceability plan and records; and
  • If the entity grows or raises a food on the FTL (other than eggs), a farm map showing the areas in which the entity grows or raises such foods.

Entities can maintain a single traceability plan for all FTL foods they handle, rather than separate plans for each FTL food, and must update these plans “as needed” to ensure their plans remain current. These requirements replace the “traceability program records” requirements outlined in FDA’s proposed rule and, of particular note, eliminate the proposed requirement that entities maintain a list of all FTL foods they manufacture, process, pack, or hold.

Entities may maintain records required under the rule in paper, electronic, or true copy form. All required records must be made available to FDA within 24 hours upon request, unless FDA agrees to an alternative timeframe. While entities can contract with third-parties to maintain records on their behalf, they must be able retrieve any requested records within 24 hours.

The rule retains the proposed requirement that entities provide FDA with an electronic sortable spreadsheet containing relevant traceability information when necessary to assist FDA during an outbreak, recall, or other threat to public health. Entities are required to provide these spreadsheets within 24 hours, unless FDA agrees to an alternative timeframe. This requirement does not apply to certain smaller entities, including RFEs, restaurants, and farms. FDA will not prescribe a specific format for these spreadsheets, but it does plan to publish sample spreadsheets to assist stakeholders in complying with this requirement.

Stakeholders have until January 20, 2026, to comply with the rule. Consistent with its approach to implementing other FSMA rules, FDA intends to focus on education, rather than enforcement, during the early implementation stages of the rule. For example, FDA anticipates that initial routine inspections conducted after January 20, 2026, will primarily focus on helping entities identify compliance gaps and implement voluntary corrective actions. In the interim, FDA plans publish additional educational and training materials on its Food Traceability Rule website.

We recommend that companies promptly begin assessing the steps they will need to take to ensure timely compliance with the rule. Stakeholders should engage with FDA as necessary to obtain clarity on the rule’s requirements.

If you have any questions concerning the material discussed in this client alert, please contact the members of our Food, Beverage, and Dietary Supplements practice: