The FDA’s Traceability Rule (21 CFR Part 1 Subpart S), popularly known as The Food Safety Modernization Act (FSMA) Rule 204, marks a groundbreaking stride in ensuring food safety across the United States. This rule, a foundation of the FSMA, is designed to enhance the FDA’s ability to rapidly and effectively track and trace foods, ensuring a safer food supply chain.
With its introduction, the FDA aims to minimize the impact of foodborne illness outbreaks by requiring companies to maintain detailed records of critical tracking events in the journey of food products, from farm to consumer.
This rule not only promises to protect public health but also to foster greater transparency and accountability in the food industry. By mandating a standardized approach to traceability, it paves the way for a more responsive and resilient food system, capable of quickly identifying and addressing potential hazards.
Embracing technology and data, the Traceability Rule is a testament to the FDA’s commitment to evolving with the times to safeguard the health of millions. The rule became in effect on January 20, 2023. However, implementation will not be evaluated by FDA inspectors until January 20, 2026.
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FoodReady is dedicated to ensuring our customers stay informed about any new developments and regulatory changes that could impact their operations. As part of this commitment, we are launching a series of blog articles designed to simplify and explain the essential details of the new Traceability Rule.
We will cover key definitions in this article to set the context of the rule.
A Commingled Raw Agricultural Commodity refers to any type of farm produce that is grouped or blended together after being harvested but before undergoing any processing. However, this does not include certain fruits and vegetables that are already covered under the Produce Rule’s standards for growing, harvesting, packing, and storing produce for human consumption.
In this context, Combined or Mixed means that the produce is mixed with food from different farms that are managed by separate companies. For seafood from fishing vessels, it only counts as “combined or mixed” if it involves seafood from different vessels and happens after the vessels have docked.
The term Processing here means any method that changes the basic state of the commodity, such as canning, cooking, freezing, drying, milling, grinding, pasteurizing, or homogenizing.
A Critical Tracking Event (CTE) is an event in the supply chain of a food involving the harvesting, cooling (before initial packing), initial packing of a raw agricultural commodity (RAC) other than a food obtained from a fishing vessel, first land-based receiving of a food obtained from a fishing vessel, shipping, receiving, or transformation of the food. Definitions for each CTE will be provided in subsequent articles.
A Fishing Vessel is any kind of boat or ship that is used, equipped, or typically used for fishing. It includes vessels that help other boats at sea with fishing-related activities.
These activities can be anything like getting ready to fish, supplying equipment, storing, cooling, moving, or processing the catch, as described in the Magnuson-Stevens Fishery Conservation and Management Act.
The Food Traceability List (FTL) is a list of specific foods that need extra record-keeping for traceability purposes, as required by section 204(d)(2) of the FDA Food Safety Modernization Act.
This list includes the foods named directly and any foods that use these listed items as ingredients, as long as the ingredient stays in the same form (like fresh) as it is listed. Find the foods contain in the FTL and their descriptions here.
Holding refers to the storage of food, along with activities that are part of or necessary for safely and effectively storing that food. Examples include fumigating food during storage and drying raw agricultural products, as long as the drying doesn’t turn the product into a different type of commodity (like drying hay or alfalfa).
Holding also covers tasks needed for distributing the food, such as mixing the same type of raw agricultural product and breaking down pallets. However, it doesn’t include processes that change a raw agricultural product into a processed food.
Places where holding happens can be warehouses, cold storage, silos for grains, elevators for grains, and tanks for storing liquids.
Key Data Elements (KDEs) are information associated with a Critical Tracking Event (CTE) for which a record must be maintained and/or provided in accordance with 21 CFR Part 1 Subpart S.
Product Description means explaining what a food product is, including its name (like the brand, type, and variety if applicable), how big the packaging is, and the style of packaging. For seafood, this description can also include the species of the fish or its common market name.
A Reference Document is any kind of business document, record, or message, whether in digital or paper format, that might have important details needed for tracking a food item at a key point in its supply chain.
You can either create this document yourself or receive it from someone else. Types of reference documents can include a variety of forms such as bills of lading, purchase orders, advance shipping notices, work orders, invoices, database records, batch logs, production logs, field tags, catch certificates, and receipts, among others.
A Reference Document Number is a unique number given to a specific reference document. This number is not only used as a key detail for certain critical tracking events but might also be used in an electronic spreadsheet requested by the FDA to show which particular reference documents have information included in that spreadsheet.
A Traceability Lot Code (TLC) is a unique code, usually consisting of letters and numbers, that is used to identify a specific batch of a product in the records of the place where the code was assigned to the food. The following CTEs are required to assign TLC to the food: First Packer of Raw Agricultural Commodities (RACs), First Land Receiver, and Transformation.
The Traceability Lot Code Source is the location where a food product is given its unique traceability lot code.
For most cases, this is where the food is first packed (except for raw agricultural commodities from a fishing vessel), where it’s first received on land (if it’s from a fishing vessel), or where it undergoes significant changes. This applies unless the entity involved is exempt from the rule.
In conclusion, the FDA’s Traceability Rule, a key component of The Food Safety Modernization Act (FSMA) Rule 204, represents a significant advancement in ensuring the safety of the food supply in the United States.
By mandating detailed record-keeping of critical tracking events from the farm to the consumer, it aims to reduce the impact of foodborne illnesses and enhance transparency in the food industry. This rule necessitates a standardized approach to traceability, contributing to a more efficient, responsive, and safer food system.
Do you need help with FSMA 204 compliance? Our FSMA 204 Consultants leverage their expert knowledge to simplify the path to compliance, ensuring a seamless transition for businesses regardless of size.
