FSMA 204

The FDA Food Traceability Rule

Six FSMA Facts to Know: The Food Traceability Rule

The Food Safety Modernization Act (FSMA) is a landmark piece of legislation that was signed into law in 2011. The goal of FSMA is to prevent foodborne illness by requiring food producers to implement preventive controls throughout their operations.

One of the key provisions of FSMA is Section 204, which requires food producers to maintain traceability records for certain foods. The final rule for Section 204 was issued in January 2023, and compliance is required by January 2026.

Here are six facts you should know about FSMA 204:

  1. The FDA has issued a new food safety regulation. The Food Safety Modernization Act (FSMA) Rule 204 was finalized in January 2023.
  2. FSMA 204 establishes traceability recordkeeping and reporting requirements for certain foods. The rule applies to foods that are:
    • High-risk foods, such as leafy greens, ground beef, and poultry;
    • Foods that are frequently eaten by young children; and
    • Foods that have been linked to foodborne illness outbreaks in the past.
  3. FSMA 204 applies to all persons who manufacture, process, pack or hold foods. This includes food producers, processors, distributors, retailers, and restaurants.
  4. FSMA 204 applies to foreign firms producing food for U.S. consumption. These firms must comply with the traceability requirements if they want to export their products to the United States.
  5. The compliance deadline for FSMA 204 is January 20, 2026. This means that food producers have three years to implement the new traceability requirements.
  6. The FDA is providing guidance and resources to help food producers comply with FSMA 204. These resources include a compliance guide, a webinar series, and a list of accredited third-party service providers.

Why is traceability important?

Traceability is the ability to track the movement of a food product through the food supply chain. This means being able to identify where the food came from, where it has been, and who has handled it.

Traceability is important for several reasons. First, it can help to identify the source of a foodborne illness outbreak. This can help to prevent further illness and protect public health.

Second, traceability can help to recall contaminated food products. This can help to prevent people from becoming sick from eating contaminated food.

Third, traceability can help to improve food safety management. By tracking the movement of food, food producers can identify potential risks and take steps to mitigate them.

What are the traceability requirements of FSMA 204?

The traceability requirements of FSMA 204 are complex. However, the basic requirements are as follows:

  • Food producers must maintain traceability records for certain foods.
  • The traceability records must include certain information, such as the product’s identity, lot code, and date of production.
  • The traceability records must be maintained for a specified period of time, such as five years.
  • Food producers must be able to provide the traceability records to the FDA upon request.

How can food producers comply with FSMA 204?

There are a number of ways for food producers to comply with FSMA 204. One way is to develop a traceability plan. A traceability plan is a document that describes how a food producer will track the movement of food products.

Another way to comply with FSMA 204 is to use a traceability software system. Traceability software systems can help food producers to track the movement of food products and to generate traceability records.

The FDA is also providing guidance and resources to help food producers comply with FSMA 204. These resources include a compliance guide, a webinar series, and a list of accredited third-party service providers.

Conclusion

FSMA 204 is a significant step forward in the fight against foodborne illness. By requiring food producers to maintain traceability records, the rule will help to ensure that contaminated food can be quickly and easily traced back to its source. This will make it easier to prevent foodborne illness outbreaks and protect public health.

If you are a food producer, you need to take steps to comply with FSMA 204 by January 2026. By following the tips in this blog post, you can make sure that your business is prepared to meet the requirements of the rule

About dFarm

The US FDA issued the Food Safety Modernization Act (FSMA) Rule 204 in January 2023 mandating recordkeeping and reporting for certain food producers and supply chain intermediaries, with regulatory compliance required by January 2026.  

dFarm advanced capabilities such as deep whole chain data collection and continuous real-time access deliver unparalleled transparency and visibility into supply chain dynamics.  This enhanced visibility enables food producers and intermediate services to surpass current FSMA 204 requirements and achieve food traceability at speeds and precision previously impossible, enabling consumers to realize superior food safety.

What is FSMA 204?

The FDA final rule on Requirements for Additional Traceability Records for Certain Foods (Food Traceability Final Rule) establishes traceability recordkeeping requirements, beyond those in existing regulations, for persons who manufacture, process, pack, or hold foods included on the Food Traceability List (FTL).