The FDA’s Food Safety Modernization Act (FSMA) Section 204 establishes enhanced traceability requirements for high-risk foods. This regulation focuses on preventing foodborne illnesses by ensuring swift and accurate tracking of food products throughout the supply chain.

Key Objectives of FSMA 204:

1.Enhanced Traceability: Mandates the collection and sharing of traceability data for certain foods designated as high-risk.

2.Risk Reduction: Minimizes contamination risks by enabling quick identification of affected products during recalls.

3.Transparency: Builds consumer trust by ensuring greater accountability across the food supply chain.

Who is Impacted by FSMA 204?

FSMA 204 applies to:

• Growers and Farmers handling high-risk produce.
• Packagers and Processors responsible for storing and preparing food for distribution.
• Distributors and Retailers managing the movement of food to end consumers.

What Foods are Covered?

The FDA has released the Food Traceability List (FTL), which highlights foods requiring enhanced tracking. Examples include:

• Fresh Produce: Strawberries, leafy greens, and tomatoes.
• Dairy: Soft cheeses.
• Seafood: Raw fish and shellfish.

What is Required for Compliance?

FSMA 204 requires businesses to maintain specific traceability records and adopt technology to ensure data accuracy. Key requirements include:

• Critical Tracking Events (CTEs): Documenting growing, harvesting, packing, and shipping processes.
• Key Data Elements (KDEs): Capturing detailed information such as lot codes, harvest times, and locations.
• Record Accessibility: Making traceability records available to the FDA within 24 hours upon request.

Why FSMA 204 is Important

Foodborne illnesses affect millions each year. By improving traceability, FSMA 204 enables faster containment of contamination, protecting public health and reducing financial losses associated with recalls.

Preparing for FSMA 204

Compliance is not just about meeting regulations—it’s about building a safer, more transparent food system. Explore tools and technology, like IOMIST, to simplify compliance and future-proof your operations.