On January 20, 2023, the US Food and Drug Administration’s (FDA) final rule on food traceability will take effect. Regulated entities will have a three-year compliance period, with a current compliance date of January 20, 2026. But what exactly will companies have to do to comply with the new rule? Read on to find out more about what the traceability rule is, who is regulated, and what compliance will look like.

Tracing Back: Background to the Traceability Rule

The Traceability Rule is the first core element of FDA’s New Era of Smarter Food Safety Blueprint, which is FDA’s modernized framework for “a safer and more digital, traceable food system.” 

The Food Traceability Rule is designed to foster a faster and more targeted approach to combatting foodborne illnesses and will make remedial actions, like recalls, easier to conduct. The rule centers on traceability recordkeeping for foods that are included on the Food Traceability List. The list comprises “high-risk foods” identified by FDA using a risk-ranking model that weighs seven factors — such as the frequency of outbreaks, severity of illness, and probability of contamination during the manufacturing process — to evaluate whether a food should be included on the List.

Currently, the list includes certain cheeses; shell eggs; nut butters; a variety of fresh and fresh-cut fruits and vegetables; fresh, frozen, and smoked finfish; fresh and frozen crustaceans, molluscan shellfish, and bivalves; and ready-to-eat deli salads. The list is updated every five years but may be updated more frequently based on public health needs. 

What Are the Key Provisions?

The central provision of the rule is that regulated entities will be required to maintain, and be able to provide, records of Key Data Elements related to Critical Tracking Events for foods on the list. There’s a lot to unpack here, so let’s walk through each part.

a. Regulated Entities

The rule applies to manufacturers, processors, packers,^[1] and holders^[2] of foods on the list. The rule will also apply to manufacturers, processors, packers, and holders of foods that contain foods on the list. For example, a maker of premade sandwiches that contains listed items such as leafy greens or sliced tomatoes must comply with the rule.

The rule sets out a number of exemptions for different types of entities. For example, the Rule exempts certain small producers and farms, certain shell egg producers, certain producers of other raw agricultural commodities, certain entities that are regulated by the US Department of Agriculture, certain small retail food establishments (ex., grocery stores) and restaurants, transporters, and nonprofit food establishments. There are also exemptions for certain foods that come from farms, foods that are subject to certain types of processing, produce that is rarely consumed raw, raw bivalve molluscan shellfish, and commingled raw agricultural commodities.

FDA has created an online tool to determine if an entity falls within an exemption.

b. Critical Tracking Events

Regulated entities are required to maintain information related to Critical Tracking Events (CTEs). FDA has identified seven CTEs relevant to the rule: (1) harvesting, (2) cooling (before initial packing), (3) initial packing, (4) first land-based receiver, (5) shipping, (6) receiving, and (7) transformation. Definitions for each of the CTEs are in § 1.1310.       

c. Key Data Elements

Key Data Elements (KDE) are the information required to be maintained under the rule. The type of KDE that must be maintained depends on what CTE a regulated entity performed. In general, the information required will tell a viewer what food is involved, where it came from, and what happened to it (i.e., what CTE was involved).

For example, according to FDA’s guide, at the harvesting stage, entities must record a location description for the subsequent recipient (besides a transporter), commodity/variety of the food, quantity/unit of measurement, harvest information (ex. name of the field from which produce was harvested or name of the container from which aquacultured food was harvested), date of harvesting, and a reference document type/number. At the cooling stage, the same information is required except that instead of harvest location and date of harvesting, the entity must provide the location where the food was cooled and date of cooling. The cooler must also provide a location description for the harvester, since cooling is the step after harvesting.

The rule not only requires that KDE be maintained, but that it can also be provided to FDA within 24 hours. While the records may be paper or electronic, a regulated entity must also be able to provide an electronic sortable spreadsheet with relevant traceability information at FDA’s request. 

d. Traceability Plan

In addition to maintaining required records, the rule also requires that regulated entities establish and maintain a traceability plan. The plan must describe the entity’s procedures for maintaining records, procedures used to identify foods on the list that bring the entity under the purview of the rule, how traceability lot codes are assigned, and identify a point of contact. For growers and raisers (other than eggs), the plan must also include a farm map showing where the regulated foods are grown or raised.

FOOTNOTES

^_[1] Packing includes re-packing and related activities (such as sorting, culling, grading, and weighing).

^_[2] FDA has given examples of holding facilities such as “warehouses, cold storage facilities, storage silos, grain elevators, and liquid storage tanks.”