What You Need to Know About FSMA 204: The Food Traceability Final Rule

What is the Food Safety Modernization Act (FSMA)?

The FDA Food Safety Modernization Act (FSMA), enacted in 2011, empowers the FDA to bolster public health by strengthening the food safety system through new regulatory actions.

FSMA’s primary objective is to establish a more comprehensive and preventative approach to food safety regulation, aiming to improve the safety of the U.S. food supply by shifting the focus from reacting to contamination to proactively preventing it.

Key elements of FSMA encompass stringent rules for food production, enhanced inspection and compliance measures, increased accountability throughout the food supply chain, and a heightened emphasis on science-based risk assessment and prevention.

What is FSMA 204 (The Food Traceability Rule)?

Section 204 of FSMA, known as the Food Traceability Rule, directs the FDA to identify high-risk foods requiring additional records and to establish the corresponding recordkeeping requirements. The objective of FSMA 204 is to expedite the identification and removal of potentially contaminated food from the market, reducing the incidence of foodborne illnesses and deaths.

The FDA published the final rule, titled “Requirements for Additional Traceability Records for Certain Foods,” on November 21, 2022. The remainder of this resource is dedicated to exploring the intricacies of FSMA 204.

FSMA 204 Requirements

The Food Traceability Rule mandates that businesses involved in manufacturing, processing, packing, or holding foods on the Food Traceability List (FTL) maintain records with key data elements (KDEs) for specific supply chain activities, which the FDA has defined as critical tracking events (CTEs). This information must be captured, stored and maintained for 24 months, and event data must made available to the FDA within 24 hours upon request. Additionally, shipping events must be shared with supply chain partners.

CTES ARE EVENTS ALONG THE SUPPLY CHAIN THAT REQUIRE ENHANCED TRACEABILITY RECORDKEEPING AND KDES ARE THE PIECES OF INFORMATION THAT SHOULD BE INCLUDED IN EACH RECORD.

The Traceability Rule also requires that businesses establish and uphold a traceability plan, outlining procedures for record maintenance under the new requirements, identification of FTL foods handled, and the assignment of traceability lot codes to FTL foods.

When is the Compliance Date?

The FSMA 204 Final Rule took effect in January 2023, and companies have been granted a three-year compliance period. The compliance date is January 20, 2026, for all companies covered by the rule.

Who Must Comply?

Business who manufacture, process, pack, or hold foods on the Food Traceability List (FTL).

What is The Food Traceability List (FTL)?

The Food Traceability List (FTL) identifies the foods for which the additional traceability records are required. The additional recordkeeping requirements apply not only to foods specifically listed on the FTL, but also to foods that contain foods on the list as ingredients.

What Foods are on the FTL?

The following foods have been identified by the FDA as “high-risk” and are subject to the Food Traceability rule. For the full list check out the FDA’s Food Traceability List.

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Cheeses, other than hard cheeses
Crustaceans (fresh and frozen)
Cucumbers (fresh)
Finfish (fresh and frozen)
Fruit (fresh-cut)
Herbs (fresh)
Leafy greens (fresh)

Leafy greens (fresh cut)
Melons (fresh)
Molluscan shellfish, bivalves (fresh and frozen)
Nut butters
Peppers (fresh)
Ready-to-eat deli salads (refrigerated)

Shell eggs
Smoked Finfish (refrigerated and frozen)
Sprouts (fresh)
Tomatoes (fresh)
Tropical tree fruits (fresh)
Vegetables other than leafy greens (fresh-cut)

What are Critical Tracking Events (CTEs)?

Critical Tracking Events (CTEs) are the crucial points along the product journey of foods listed on the Food Traceability List (FTL) where FSMA 204 will require enhanced traceability recordkeeping. For each type of event, the rule specifies what information (KDE) must be recorded.

These events represent key stages in the lifecycle of food products, and the accompanying records must contain the requisite KDEs as defined by the Food Traceability Rule. Understanding and meticulously documenting these events are crucial for compliance with FSMA 204 regulations.

Harvesting

Cooling (before initial packing)

Initial Packing

First Land-Based Receiver

Shipping

Receiving

Transformation

What are Key Data Elements (KDEs)?

Key Data Elements refer to the data related to each CTE that companies are required to retain and share with supply chain partners and/or the FDA. The information that must be tracked varies depending on the type of supply chain activities they perform. Some examples of KDEs are location, dates(s), as well as quantity and unit of measure of the food.

Location Name & Description

Date of Activities & Events

Quantity & Unit of Measure

Reference Document Type & Number

Business Name & Phone Number

Traceability Lot Code

What is a Traceability Lot Code?

A Traceability Lot Code (TLC) is a descriptor, often alphanumeric, used to uniquely identify a traceability lot within the records of the firm that assigned the traceability lot code. Food industry workgroups recommend the use of a Global Trade Item Number (GTIN), plus the product lot code to create a unique and traceable TLC.

When is a Traceability Lot Code Needed?

Entities are obligated to assign traceability lot codes under specific circumstances. These include the initial packing of raw agricultural commodities (excluding those from fishing vessels), the first reception of a food from a fishing vessel on land, or when transforming a food product. However, activities like shipping do not require the creation of a new traceability lot code, unless otherwise specified.

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Record-Keeping Requirements

Traceability records must be maintained, legible, and stored for 24 months, with a requirement to provide them to the FDA within 24 hours. The key aspects of these record-keeping requirements include:

Maintenance of records as original paper or electronic records, or as true copies.
Timely provision of requested records to the FDA within 24 hours of a request (or within a reasonable time agreed upon with the FDA).
Providing records in an electronic sortable spreadsheet when necessary to aid the FDA during an outbreak, recall, or other threats to public health.
Mandatory maintenance of records for 24 months (2 years).

Ensuring compliance with these record-keeping requirements is essential for meeting the standards set forth by FSMA 204 and contributing to the overarching goal of enhancing food safety and traceability.

What Goes Into a Traceability Plan?

If you are subject to the requirements of the final rule, you must establish and maintain a traceability plan. This plan should include details such as record-keeping procedures, methods for identifying FTL items, the assignment of traceability lot codes (if applicable), a designated point of contact for inquiries about the plan, and, for those growing or raising listed foods, a farm map displaying growing areas. The farm map must include specific details like location, field names, and geographic coordinates. Aquaculture farms must provide container details instead of field information. Entities are required to update the traceability plan as needed to reflect current practices and remain compliant, retaining the previous version for two years after updates.

Close up of warehouse worker scanning barcodes on paper working in a large warehouse, sitting at table

Why Trustwell as Your FSMA 204 Compliance Partner?

With regulations such as FSMA 204, for enhanced traceability and recordkeeping requirements, you need a trusted partner with industry expertise and extensive knowledge in traceability solutions to help ensure you’re meeting FSMA 204 compliance, customer requirements, and consumer expectations. No other solution provider has decades of food industry expertise and experience that we do.

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