Some food manufacturers will face additional scrutiny under new FDA regulations to identify and contain foodborne illness outbreaks faster. While this regulation is often discussed in terms of data and software, compliance ultimately depends on what happens on the plant floor.

That’s where packaging, labeling, and material handling processes determine whether this traceability information exists. Learn what the new regulations require and how you can accurately capture data at production speed.

FSMA 204 Explained

What It Is

The Food Safety Modernization Act Section 204 (FSMA 204) mandates enhanced recordkeeping for companies that manufacture, process, and pack foods at high risk of contamination.

These high-risk foods must have Key Data Elements (KDEs) recorded at Critical Tracking Events (CTEs).

CTEs

These track any time food is handled or changes hands during the growing, receiving, transforming, packaging, and shipping process.

KDEs

These must be recorded at each CTE and include the following:

• Traceability lot codes linking the product to its origin and processing history
• Product descriptions
• Quantity and unit of measure
• Location identifier
• CTE date
• Who performed the CTE

What It Does

If there’s an outbreak, having improved traceability means contaminated foods can be removed from the shelves much more quickly, ideally within 24 hours.

What Foods It Affects

Foods that can be contaminated early, have little or no “kill steps”, support pathogen growth and/or are handled extensively before people eat them.

This includes:

• Some fresh produce: herbs, leafy greens, melons, peppers, spouts, tomatoes, tropical tree fruits
• Some seafood: fish with fins, crustaceans, mollusks
• Some dairy: soft and non-pasteurized cheese
• Nut butters
• Eggs in the shell
• Ready-to-eat deli salads: potato salad, egg salad, seafood salad

What Foods It Doesn’t Affect

• Meat, poultry and egg products regulated by the USDA
• Foods that undergo a required “kill step” before consumption, such as pasteurization or cooking
• Certain forms of foods on the list, such as dried or frozen

When It Goes Into Effect

The original compliance date of Jan. 20, 2026, has been extended to July 20, 2028.

Understanding KDEs and CTEs in a Plant Setting

Complying with FSMA 204 doesn’t just involve software. It extends to your coding, labeling and material handling processes on the plant floor. That’s because CTEs often occur at:

• Packaging lines
• Case packing
• Palletizing
• Shipping lanes

If coding is:

• Smudged due to poor application
• Unreadable due to labels tearing during conveying or wrapping
• Missed in scans due to lines moving too fast

Then you have a problem because the KDE doesn’t exist. This is where coding, labeling, and material handling systems play a critical role in consistent application and readability.

Where KDEs and CTEs Happen and How Automation Supports Accurate Traceability

This table shows where FSMA 204 requirements happen on the plant floor—and how automation supports accurate traceability.

How Our Solutions Close the Traceability Gap

Traceability only works when coding is applied accurately, remains readable, and stays connected to products as they move throughout your operation.

RMH Systems specializes in turnkey solutions for the food industry, closing the gap with customized coding, labeling and material handling systems that meet the real-world demands of food production environments.

Here are just a few of the ways our engineering experts can assist you in becoming FSMA 204-compliant.

High-Speed CIJ Systems Built for Food Environments

Traceability begins when coding is applied to packaging or directly to the product. Continuous inkjet printers apply coding contact-free and provide a high level of reliability and consistency. They work in tandem with print verification systems, which ensure every print is perfect.

Labeling Solutions Ensuring Accurate Data Collection

Traceability next depends on accurate aggregation at the case and pallet level. RMH supports this process with product labeling solutions such as print-and-apply labelers that print directly to cases and pallet labelers that label full pallets. This ensures data can be captured, scanned and verified during receiving, storage and shipping.

Material Handling Systems Designed for Traceability

High-speed food production environments can undermine traceability if material flow is not controlled. RMH specializes in helping food companies maintain data integrity without sacrificing operational efficiency through conveyors and palletizing robots, to name just a few solutions.

Take the Next Step Toward FSMA 204 Readiness

Effective traceability depends on how products are coded, labeled, and moved through a facility. While there is still time until FSMA 204 regulations go into effect, now is the time to review how prepared your packaging and material handling processes are. RMH offers free consultations to assess your readiness and identify practical next steps, so request yours today!