Food Traceability and FSMA

Traceability in FDA Regulation

The FDA’s Food Safety Modernization Act (FSMA) is a piece of United States federal legislation ratified in 2011 by President Obama. FSMA has since served as the primary regulatory framework for food safety and consumer protections for the industry, articulating rules for more intelligent prevention and response throughout the food system.

Food traceability is covered under FSMA Section 204, titled “Enhancing Tracking and Tracing of Food and Recordkeeping.” Under FSMA Section 204, the FDA was required to conduct pilot programs, access global standards, and further develop recordkeeping requirements, particularly for food products deemed as high risk.

In September 2020, the FDA published a proposed rule for traceability under FSMA section 204. The recordkeeping requirements outlined within the rule will establish a broader foundation for food traceability, starting with recordkeeping requirements for designated foods from creation, transformation, processing, packing, shipping and more.

FDA Webinar: Requirements for Additional Traceability FSMA Section 204

In a recorded webinar by the FDA, Deputy Commissioner for Food Policy and Response Frank Yiannas discusses the value of the proposed traceability rule for the food industry, who may be affected, in addition to what the suggested requirements entail.

The FDA’s Approach to Traceability

Proposed Traceability Rule Overview

Proposed Traceability Rule Overview

Understanding Traceability Events CTEs and KDEs

Understanding Traceability Events: CTEs and KDEs

The Food Traceability List

The Food Traceability List

Traceability in the FDA’s New Era of Smarter Food Safety

Traceability in the FDA’s New Era of Smarter Food Safety

The FDA’s FSMA Traceability Glossary

In accordance with the FSMA section 204 rule proposal, the FDA has released the following glossary of terms, which can also be found quoted in the part below. See the full list of terms within the proposed rule document here

Category: A code or term used to classify a food product in accordance with a recognized industry or regulatory classification scheme, or a classification scheme a person develops for their own use. Examples of industry or regulatory classification schemes include the GS1 Global Product Classification standard, the United Nations Standard Products and Services Code, the Food and Agriculture Organization of the United Nations 3-Alpha Seafood Species Code, and the European Union Common Procurement Vocabulary.

Cooling: Active temperature reduction of a food using hydro cooling, icing, forced air cooling, vacuum cooling, or a similar process, either before or after packing.

Creating: Making or producing a food on the Food Traceability List (FTL) using only ingredient(s) that are not on the FTL. Creating does not include originating or transforming a food. Proposed recordkeeping requirements related to the creation of a listed food are discussed in sections V.D and V.E.4 of the proposed rule.

Critical Tracking Event (CTE): An event in the supply chain of a food involving the growing, receiving (including receipt by a first receiver), transforming, creating, or shipping of the food. Each CTE has specific recordkeeping requirements, discussed further in the proposal.

First Receiver: The first person (other than a farm) who purchases and takes physical possession of a food on the FTL that has been grown, raised, caught, or (in the case of a non-produce commodity) harvested. The first receiver of a food might be a manufacturer/processor, distributor, or other non-farm entity who receives a food that has been originated.

Food Traceability List: The list of foods for which additional traceability records would be required if the proposed rule is finalized. The term “Food Traceability List” includes both the foods specifically listed and foods that contain listed foods as ingredients.

Growing Area Coordinates: The geographical coordinates (under the global positioning system (GPS) or latitude/longitude) for the entry point of the physical location where the food was grown and harvested. 

Harvesting: Activities that are traditionally performed on farms for the purpose of removing raw agricultural commodities (RACs) from the place they were grown or raised and preparing them for use as food. Harvesting is limited to activities performed on RACs, or on processed foods created by drying/dehydrating a RAC without additional manufacturing/processing, on a farm. Harvesting does not include activities that transform a RAC into processed food. Examples of harvesting include cutting (or otherwise separating) the edible portion of the RAC from the crop plant and removing or trimming part of the RAC (e.g., foliage, husks, roots, or stems). 

Holding: The storage of food, including activities, performed incidental to the storage of a food (e.g., activities performed for the safe or effective storage of that food, such as fumigating food during storage, and drying/ dehydrating RACs when the drying/dehydrating does not create a distinct commodity (such as drying/ dehydrating hay or alfalfa). 

Key Data Element: Information associated with a CTE for which a record would have to be established and maintained. Proposed requirements for records containing KDEs associated with CTEs are discussed further in section V.E. of the proposed rule. 

Kill Step: Processing that significantly minimizes pathogens in a food. Examples of kill steps include cooking, pasteurization, heat treatment, high-pressure processing, and irradiation, as long as those processes are conducted in a manner that significantly minimizes pathogens in the food. We discuss proposed requirements for foods on the Food Traceability List that are subjected to a kill step in section V.F. of the proposed rule.

Location Description: A complete physical address and other key contact information, specifically the business name, physical location name, primary phone number, physical location street address (or geographical coordinates), city, state, and zip code for domestic facilities and comparable information for foreign facilities, including country; except that for fishing vessels, “location description” would mean the name of the fishing vessel that caught the seafood, the country in which the fishing vessel’s license (if any) was issued, and a point of contact for the fishing vessel.

Location Identifier: A unique identification code that an entity assigns to the physical location name identified in the corresponding location description; except that for fishing vessels, “location identifier” would mean the vessel identification number or license number (both if available) for the fishing vessel. 

Lot: The food produced during a period of time at a single physical location and identified by a specific code. A lot may also be referred to as a “batch” or “production run.” While each firm determines the size or quantity of a lot, we recommend that lots consist of products produced under uniform conditions, be as small as possible, and generally not exceed 24 hours of production. Limiting the size of a lot allows for more precise traceability of a product and helps narrow the scope of the potentially recalled products.

Manufacturing/processing: Making food from one or more ingredients, or synthesizing, preparing, treating, modifying, or manipulating food, including food crops or ingredients. Examples of manufacturing/processing activities include the following: baking, boiling, bottling, canning, cooking, cooling, cutting, distilling, drying/ dehydrating RACs to create a distinct commodity (such as drying/dehydrating grapes to produce raisins), evaporating, eviscerating, extracting juice, formulating, freezing, grinding, homogenizing, irradiating, labeling, milling, mixing, packaging (including modified atmosphere packaging), pasteurizing, peeling, rendering, treating to manipulate ripening, trimming, washing, or waxing. For farms and farm mixed-type facilities, manufacturing/ processing does not include activities that are part of harvesting, packing, or holding. 

Originating: An event in a food’s supply chain involving the growing, raising, or catching of a food (typically on a farm, a ranch, or at sea), or the harvesting of a non-produce commodity. 

Packing: Placing food into a container other than packaging the food. “Packing” would also include re-packing and activities performed incidental to packing or re-packing a food (e.g., activities performed for the safe or effective packing or re-packing of that food (such as sorting, culling, grading, and weighing or conveying incidental to packing or re-packing)), but would not include activities that transform a RAC into processed food. 

Point of Contact: An individual having familiarity with an entity’s procedures for traceability, including their name, telephone number, and, if available, their email address and fax number. 

Produce: The proposal would adopt the definition of “produce” in § 112.3 in the produce safety regulations, which defines “produce” to mean any fruit or vegetable (including mixes of intact fruits and vegetables) and includes mushrooms, sprouts (irrespective of seed source), peanuts, tree nuts, and herbs. 

Receiving: An event in a food’s supply chain in which a food is received by a customer (other than a consumer) at a defined location after being transported (e.g., by truck or ship) from another defined location. Receiving is a CTE for which KDEs are required to be kept. Further discussion regarding the proposed KDEs for receiving can be found in section V.E.3 of the proposed rule. 

Reference Record: A record used to identify an event in the supply chain of a food, such as a shipping, receiving, growing, creating, or transformation event. The proposed definition states that types of reference records include, but are not limited to, bills of lading (BOL), purchase orders, advance shipping notices (ASNs), work orders, invoices, batch logs, production logs, and receipts. We discuss the use of reference records in product tracing beginning in section V.D.1.

Shipping: An event in a food’s supply chain in which a food is arranged for transport (e.g., by truck or ship) from a defined location to another defined location at a different farm, a first receiver, or a subsequent receiver. This would mean that, for example, shipping would not include arranging for the transport of a food between different locations of a single farm. The definition in the proposed rule further specifies that shipping does not include the sale or shipment of a food directly to a consumer or the donation of surplus food. 

Traceability Lot: A lot of food that has been originated, transformed, or created. 

Traceability Lot Code: A descriptor, often alphanumeric, is used to identify a traceability lot. As with location descriptions and location identifiers, traceability lot codes are typically stored in business systems and printed in human-readable and machine-readable format on food product packaging. We discuss the generation and use of traceability lot codes in product tracing in section V.D.1.

Traceability Product Description: A description of a food product typically used commercially for purchasing, stocking, or selling, and includes the category code or term, category name, and trade description. 

Traceability Product Identifier: A unique identification code (such as an alphanumeric code) that an entity assigns to designate a specific type of food product. As with traceability lot codes and traceability product descriptions, traceability product identifiers are typically stored in business systems and printed in human and machine-readable format on food product packaging. We discuss the use of traceability product identifiers in section V.E.3. 

Transformation: An event in a food’s supply chain that involves changing a food on the FTL, its package, and/or its label (regarding the traceability lot code or traceability product identifier), such as by combining ingredients or processing a food (e.g., by cutting, cooking, commingling, repacking, or repackaging). This would not include the initial packing of a single ingredient food or creating a food. The definition of “transformation” in the proposed rule might differ from the way the term is defined in other traceability systems and approaches; however, as discussed in the proposed rule, we believe this definition is appropriate for use with traceability records for foods on the FTL. We discuss the traceability records we propose to require for transformation events in section V.E.4 of the proposed rule. 

Transporter: A person who has possession, custody, or control of an article of food for the sole purpose of transporting the food, whether by road, rail, water, or air. We propose to exempt transporters from this rule if finalized.

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