FSMA 204 Resource Center

The finalization of the Food Safety Modernization Act (FSMA) Rule 204(d) is here. The goal of 204 is to create visibility within the supply chain to enable a better response to foodborne illnesses, contamination, and other public health and safety issues. 

​We support the FDA's Smarter Food Supply Chain Initiative  to create a fully transparent supply chain that ensures safer food for all. Our goal is standards-based interoperability that benefits all supply chain participants by lowering the technological and financial barriers to adoption. 

​Companies can’t afford to focus on their single link in the chain. The stakes are simply too high. This resource page is your guide to your traceability needs. 

Questions about traceability? We can help!

Photo courtesy of Avery Dennison

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Just Released
Food Traceability QuickStart Guide
 This paper is for companies wanting to learn more about enabling supply chain visibility, differences between product tracking versus product tracing and the benefits of traceability.

When Does FMSA 204 Go into Effect? 

FSMA Rule 204 will go into effect in January 2023, 60 days after the final rule is published in November 2022. The FDA will give companies a period of two years to comply, so you will have until the year 2025 to become fully compliant. However, it is imperative for companies to start preparing now since vetting and implementing a food traceability solution takes time and careful consideration. If you wait until after the rule is published to start preparing, you may find it difficult to meet the 2025 deadline.

What are the FDA Food Traceability Requirements? 

If you grow, ship, pack, process, manufacture, or sell any of the foods on the Food Traceability List, you are required to keep additional records on these items. The FDA has defined a set of metrics called Key Data Elements (KDEs) that correspond to different events in the supply chain known as Critical Tracking Events (CTEs). The CTEs are:

• Growing
• Receiving
• Transformation
• Creation
• Shipping

To determine what KDEs and CTEs relate to your company, consult the FDA’s resource guide, Which Key Data Elements Would Apply to Me? Depending on the details of your business operation, you may need to capture multiple sets of KDEs. For example, a processor could be considered a receiver and a transformer since they take physical possession of product from a grower or supplier and they also cut, repack, or otherwise transform the product.
It’s also important to note that the FDA has created a distinct role known as first receiver. A first receiver is defined as “the first person (other than a farm) who purchases and takes physical possession of a listed food.” The FDA clarifies that the first receiver role is designed to accommodate on-farm activities where product may be moved but not sold (e.g., sent to a cooler on the farm).
In addition to capturing these KDEs, the FDA has outlined these requirements:

• Maintain records as original paper records, electronic records, or true copies (must be legible and stored to prevent deterioration or loss).
• Provide traceability records to the FDA no later than 24 hours after a request is made.
• Provide an electronic sortable spreadsheet containing relevant traceability information to the FDA within 24 hours of a request when necessary to assist during an outbreak, recall, or other public health threat.

Expertise is a Click Away

ACSIS, Inc.
Auto Data Corporation
Avery Dennison
BarTender by Seagull Scientific
Digimarc Corporation
EM Microelectronic - US
FEIG Electronics, Inc.
FLEXcon
Golden State Foods
GS1 Global
GS1 US
Impinj, Inc.
Metalcraft Inc.
NOVEXX Solutions USA
Omron Microscan Systems
OpsSmart
PLM TrustLink
SATO America
SICK, Inc.
Socket Mobile
TEKLYNX
​Trustwell
Wiliot, Inc.
Zebra Technologies Corporation

Read our FDA Public Comments

Read our comments to the FDA Docket FDA-2014-N-0053 Requirements for Additional Traceability Records for Certain Foods
Read our comments to the FDA Docket FDA-1995-N-0062 Food Standards
Read our comments to the FDA Docket No. FDA-2019-N-4187 A New Era of Smarter Food Safety. 
Read our Position Statement on FSMA. ​

AIM NA board Jeannne Duckett and staff members Mary Lou Bosco and Mike Alen with Frank Yiannas, FDA Deputy Commissioner for Food Policy and Response

Watch our ​
Smarter Food Supply Chain Webinar Series