iFoodDS’ Perspective on the Final Version of FSMA Rule 204

On November 15, 2022, the FDA announced the final version of FSMA Rule 204. This new traceability regulation mandates additional recordkeeping across the entire supply chain for certain food categories. While the overall purpose and theory remains the same, the final Rule differs from the proposed Rule in several key areas:

Revised Critical Tracking Events

The Critical Tracking Events (CTEs) have been updated and the role of first receiver and grower have been eliminated, while the roles of harvester, cooler, initial packer, and first land-based receiver have been added. Creation has been combined with transformation and is now only referred to as the transformation CTE.

Clarification on Last-Mile Delivery

Of note to grocery retailers and foodservice operators, the FDA has clarified that retail and foodservice businesses are responsible for shipping and receiving KDEs during last-mile delivery from the DC to the store or restaurant. According to the FDA’s new definitions of shipping and receiving (see “Key Features”):

• “Shipping does include sending an intracompany shipment of food from one location at a particular street address of a firm to another location at a different street address of the firm.”
• “Receiving includes receipt of an intracompany shipment of food from one location at a particular street address of a firm to another location of the firm at a different street address.”

New Traceability Plan Requirement

The FDA has added a new requirement to create a traceability plan that describes a business’s procedures for maintaining their traceability records, identifying foods on the Food Traceability List that they handle, and assigning traceability lot codes.

New Exemptions

There are new exemptions in the final Rule for smaller retail food establishments (RFEs) and foodservice operators. There are also exemptions that apply to other supply chain segments. See the FDA’s free tool for more information.

iFoodDS’ Perspective on the Rule

A More Transparent Supply Chain Will Empower the Food Industry

iFoodDS supports FSMA Rule 204 and applauds the FDA’s efforts to prioritize food safety by increasing transparency throughout the supply chain. While we recognize these new requirements are complex, they are not unmanageable. Furthermore, these additional records are vital for assisting the FDA in the event of a foodborne illness outbreak. Ultimately, a transparent supply chain will empower the food industry to proactively manage food safety risks and consistently provide wholesome, high-quality food to consumers.

Gain Greater Insights With Traceability Data

As a leader in traceability, quality management, and food safety solutions, iFoodDS has been working to help our customers gain greater insights into their supply chain data. We’ve also been actively involved in GS1 workgroups and discussions about Rule 204, and we will continue to participate in the industry conversation about traceability. We understand the complexities of the final Rule – particularly for retailers, foodservice operators, distributors, and processors – and recognize that it places new recordkeeping requirements on the industry.

Nuances to Navigate

The final Rule also introduced some nuanced scenarios that can be difficult to navigate. Take, for example, retailers or restaurants (download) who prepare food on the FTL in a central kitchen and ship it out to individual stores or restaurants. In this situation, they will need to record transformation KDEs. However, if they prepare the food onsite at the store or restaurant and sell directly to the consumer, they don’t need to record transformation KDEs.

Although FSMA Rule 204 is undoubtedly complex and places additional traceability requirements on retailers and foodservice operators, it is not an unbearable burden. The exemptions for smaller retailers and foodservice businesses demonstrate that the FDA is striving to minimize disruptions to business operations while ensuring greater transparency in the movement of food through the supply chain.

The right tools make Rule 204 compliance more manageable

Compliance with the Rule will require implementing new workflows, and potentially new tools, to capture, store, and share Key Data Elements with supply chain partners, as well as create an electronic sortable spreadsheet within 24 hours of an FDA request. Digital traceability solutions can help ease the burden of compliance. By gathering all the data into one digital platform, you’ll be able to access it instantly and easily see where there are gaps in information.

Enterprise-level organizations will find it nearly impossible to meet the new requirements without a digital solution. A trusted solution partner can help you navigate the new Rule effectively and verify compliance across vast supplier networks.

Companies should start preparing now

Due to the complexity of the Rule, companies need to start preparing now rather than waiting for the enforcement date of January 20, 2026. Compliance requires alignment across supply chain partners and adapting internal workflows, which will take a considerable amount of planning. If businesses wait until just before January 2026 to start thinking about compliance, they will not be able to meet the deadline.

Traceability can be leveraged as a competitive advantage

Companies should start thinking beyond Rule 204 compliance now to establish a foundation that will provide a competitive advantage in the future. By laying the groundwork today and gaining greater visibility into your supply chain, you can associate food safety and quality data tomorrow, resulting in better sourcing decisions.

What Can Businesses Do Today to Prepare for Enforcement of Rule 204?

1. Start by auditing your supply chain, particularly your suppliers’ labeling practices and the way they share information with you. Shipping data should be shared in electronic format to be easily accessible for storage, recall, and sharing. For example, ASN is a common method for sharing electronic shipping data. You could also use a cloud-based storage platform. This will ensure you can access key information when the FDA requests it.
2. Evaluate the information your suppliers currently provide and the information you send to the retail store or restaurant. How can you incorporate all the Key Data Elements you’re required to capture into your regular receiving/shipping workflows? If your suppliers are not sending you the information you need, what’s your plan for getting them onboard?
3. Understand the KDEs you’re responsible for under the Rule. Most retailers, foodservice businesses, and distributors will be required to capture shipping and/or receiving KDEs. However, retailers or restaurants who prepare and ship foods on the Food Traceability List from a central kitchen will also be required to capture transformation KDEs.
4. Verify that you can quickly access this information, see which suppliers are in compliance, traceback and traceforward, and export all the data in an electronic sortable spreadsheet within 24 hours.

Check out this Timeline to FSMA 204 Compliance from New Era Partners to learn more about starting your organization’s path to compliance. iFoodDS also has a number of resources that will help you better understand the new requirements. Visit our Rule 204 Hub to learn more.

This material is for informational purposes only and not for the purpose of providing legal advice. You should contact your attorney to obtain advice with respect to any particular issue or problem.