FDA Issues Final Rule on Recordkeeping, Product Tracing Requirements for High-Risk Foods

FDA on Nov. 15 released its final rule setting new record-keeping requirements for foods it deems high-risk. Set for publication in the Nov. 21 Federal Register, the “traceability” rule requires entities at key points in the supply chain to keep records of certain high-risk foods as they move through the supply chain, and also to provide more general records of their traceability record-keeping program.

Compliance with the requirements set by the new regulations is required by three years after the Jan. 20 effective date of the final rule, i.e., Jan. 20, 2026. That’s an additional year from what was originally proposed by FDA (see 2009220041), and will give entities subject to the final rule additional time to understand the requirements of the rule, purchase or update tracing technology, train staff, coordinate with supply chain partners, and establish or update record-keeping systems, the agency said.

Required by the Food Safety Modernization Act over a decade ago, the final rule requires entities that “manufacture, process, pack, or hold FTL foods maintain and provide to their supply chain partners specific information (key data elements, or KDEs) for certain critical tracking events (CTEs) in the handling of the food, consistent with the developing industry consensus approach to food tracing,” FDA said.

“The information that firms must keep and send forward under the rule varies depending on the type of supply chain activities they perform with respect to” foods listed on the FDA’s new Food Traceability List, “from harvesting or production of the food through processing, distribution, and receipt at retail or other point of service,” FDA said. “Central to the proposed requirements is the assignment, recording, and sharing of traceability lot codes for” listed foods, “as well as linking these lot codes to other information identifying the foods as they move through the supply chain.”

Entities covered by the final rule also will have to “establish and maintain a traceability plan that, among other things, describes their procedures for maintenance of records under the new requirements, identification of [listed] foods handled, and assignment of traceability lot codes to” listed foods, FDA said.

FDA’s list of high-risk foods subject to the rule’s requirements -- unchanged from the list released alongside FDA’s proposed rule, but with additional detail added since -- covers cheeses (other than hard cheeses), shell eggs, nut butters, cucumbers (fresh), herbs (fresh), leafy greens (fresh and fresh-cut), melons (fresh), peppers (fresh), sprouts (fresh), tomatoes (fresh), tropical tree fruits (fresh), fruits (fresh-cut), vegetables (fresh-cut), finfish (fresh, frozen and smoked), crustaceans (fresh and frozen), molluscan shellfish and bivalves (fresh and frozen) and ready-to-eat deli salads (refrigerated).

As with FDA’s proposed rule, the agency’s final rule includes mechanisms for adding and removing foods from the Food Traceability List.

FDA made several changes in the final rule in response to comments received on its proposal “that will make the final rule easier for supply chain entities to understand and comply with, while still ensuring that the rule substantially improves FDA’s ability to respond quickly and effectively to foodborne illness outbreaks involving foods on the” Food Traceability List, FDA said.

The agency “streamlined” requirements for what must be included in a traceability plan, and deleted a proposed requirement to keep a list of listed foods shipped. Those who grow or raise a listed food must now keep a farm map containing geographic coordinates instead of proposed records documenting the growing area coordinates for individual traceability lots of the food. The final rule also changes some “critical triggering events” for which entities are required to maintain records. Some responsibilities for records on origination, harvesting, cooling and packing of food are transferred from the “first receiver” to the initial packer, FDA said.

Key data elements required for shipping and receiving listed foods “have been streamlined” and shipping record requirements no longer apply to shipments that occur before a raw agricultural commodity is initially packed, FDA said. FDA added a new critical triggering event specific to harvesting and cooling of raw agricultural commodities before they are initially packed, and events for “transformation” and “creation” of a listed food have been combined under a single transformation event.

The final rule also includes privacy-related changes, including now requiring only the title and phone number of an entity’s listed point of contact, rather than the name. Addressing concerns related to revealing information about an entity’s supplier, FDA now will allow alternative methods to pass forward information on a listed food, such as through websites that only allow access to a government email address.

FDA also made several changes to exemptions from the rule’s requirements, including a revised exemption for small producers, an expanded exemption for food sold by farms directly to consumers, an expanded exemption for foods subject to a kill step, and the addition of new partial or full exemptions from the regulations, including for raw bivalve molluscan shellfish, foods subject to regulation by USDA and food for research or evaluation.