FDA Announces Food Traceability Rule Exemption for Certain Small Businesses, Considers Additional Flexibilities

The U.S. Food and Drug Administration (FDA) has issued a draft guidance that, if finalized, will provide enforcement discretion from the requirements of the Food Traceability Rule, also known as Section 204(d) of the Food Safety Modernization Act (FSMA 204), for certain smaller retail food establishments (RFEs) and restaurants that were not previously captured as part of the full exemption for small RFEs and restaurants offered as part of the rule.
FDA said it believes “this additional flexibility will maintain the intended public health benefits of the rule, as it would only impact a small percentage of total food sales, while also providing relief to numerous smaller RFEs and restaurants.”
Under the draft policy, FDA would not enforce Food Traceability Rule requirements for RFEs and restaurants whose average monetary value of food sold or provided during the previous three-year period is greater than $250,000 but not more than $1 million, adjusted for inflation using 2020 as the baseline year for calculating the adjustment.
FDA to Hold Public Meeting on Potential Additional Compliance Flexibilities
Moreover, FDA intends to offer additional flexibilities for Food Traceability Rule compliance and will hold a public meeting on November 6 as part of a series of planned engagements. During the public meeting, FDA hopes to discuss:
- Reasonable range of Traceability Lot Codes (TLCs) for distributors shipping to retailers: FDA cited regulated industry’s concerns about challenges with lot-level tracking as an FTL food moves through a distribution center and is shipped to a retail location, considering complications created by mixed-lot pallets and pick slots
- Inferred TLCs, with flexibility, for distributors shipping to retailers: FDA cited regulated industry’s concerns that distribution centers’ method for calculating which TLCs are being shipped to a retailer (instead of confirming at the time of shipment by scanning) may result in data errors
- Maintaining Key Data Elements (KDEs) for Eaches, which are Food Traceability List (FTL) food items that are no longer part of a case
- Returns and reclamations: FDA cited regulated industry’s concerns about challenges with maintaining KDEs as required by the rule for individual items that are sent back to the supplier as a return or reclamation.
- Food waste recovery: In the 2026 Continuing Appropriations Act, Congress directed FDA to provide assistance to industry on how to handle food waste recovery
- Intracompany shipments: FDA cited regulated industry’s concerns about inefficiencies with the requirement to maintain KDEs for intracompany shipments when no transformation is occurring
- Shipments for retailers transforming food and sending to other retailers: FDA cited regulated industry’s concerns that it is impractical to maintain transformation KDEs for food that is manufactured in retail kitchens, even when some of that food is being sent offsite
- Data standardization: Although FDA is not authorized to prescribe specific technologies for maintenance of records for the Food Traceability Rule, the agency is open to hearing industry’s thoughts on whether there is a specific data standard for industry to adopt.
Topics to be discussed during the November 6 meeting reflect feedback received during previous industry engagements, such as a series of tabletop readiness exercises held earlier in 2026.
Registration for the public meeting is required. A discussion paper for the meeting is available here.
Congressional Directives to Provide Flexibilities, Keep to Delayed Compliance Date
The additional flexibilities and industry engagements align with a Congressional directive under the Continuing Appropriations Act, which is the appropriations bill for Fiscal Year 2026 that ended the historic government shutdown in November 2025. Under this act, Congress also prohibited FDA from using any federal funds to enforce the Food Traceability Rule ahead of the delayed July 2028 compliance date.
The 30-month delay to the Food Traceability Rule compliance date, which was originally planned for January 2026, has been criticized by food safety-focused consumer protection groups as hindering foodborne illness outbreak investigations and response—especially in light of the largest-ever cyclosporiasis outbreak experienced by the U.S. this summer. For example, in August, the Safe Food Coalition wrote a letter to House and Senate leadership asserting that, if the Food Traceability Rule had been in effect, it could have minimized the scale and public health impact of the Cyclospora outbreak linked to lettuce, which is a commodity included on the FTL.
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