FSMA 204

The FDA Food Traceability Rule

Understanding FSMA Rule 204: Applicability and Penalties for U.S. Food Producers, Handlers, Packers, Processors, and Distributors

Navigating regulatory environments can be a challenge, especially when it comes to food safety laws. One such law, the Food Safety Modernization Act (FSMA), was signed into law in January 2011 to enhance U.S. food safety measures. One section of the FSMA that has drawn significant attention is Rule 204, known as “Enhanced Tracking and Tracing of Food and Recordkeeping”. Understanding if they fall under this rule and the penalties for non-compliance is crucial for U.S. food producers, handlers, packers, processors, and distributors.

Understanding FSMA Rule 204

Rule 204 enhances the FDA’s ability to track and trace food through the supply chain. It mandates that certain establishments maintain more comprehensive records about the food they handle, enabling faster and more accurate responses to foodborne illness outbreaks.

Who is Covered by FSMA Rule 204?

The rule applies to those who manufacture, process, pack or hold foods on the FDA’s Food Traceability List (FTL). The FTL includes a range of foods that the FDA has determined have “high risk” of being associated with foodborne illness outbreaks.

Businesses, small and large, are covered if they partake in activities such as growing, harvesting, packing, manufacturing, processing, or holding of the foods included on the FTL. The rule applies to both domestic and foreign food establishments that are required to register with the FDA under section 415 of the Federal Food, Drug, and Cosmetic (FD&C) Act.

However, there are exceptions. Farms, retail food establishments, non-profit food establishments, fishing vessels, and facilities regulated exclusively throughout the entire supply chain by the USDA (e.g., facilities handling only meat, poultry, and egg products) are not subject to Rule 204.

Compliance Requirements

Once you’ve determined that your business is covered by Rule 204, it’s essential to understand the specific compliance requirements. Key requirements include:

  1. Record Keeping:Establishments must keep detailed records of the food they receive and to whom they send it (one step up and one step down the supply chain). Records should contain details such as the type of food, quantity, and information about the supplier and recipient.
  2. Access to Records:These records must be readily available to the FDA upon request, especially during foodborne illness outbreak investigations.
  3. Traceability Program: Covered facilities are required to establish and maintain a traceability program, which should include a list of the types of foods it ships that are on the FTL, a description of reference records, and key data elements and critical tracking events.

Penalties for Non-Compliance

Non-compliance with FSMA Rule 204 can lead to serious penalties.

  1. Monetary Fines:Fines can vary depending on the severity of the violation, but in some cases, they can be up to $500,000 for a company.
  2. Criminal Penalties:In more extreme cases, non-compliance could lead to criminal charges, especially if non-compliance leads to severe illness or death.
  3. Suspension of Registration:The FDA can suspend a facility’s registration, effectively halting its operation.
  4. Seizure and Injunction:The FDA can seize the adulterated product or obtain a court order to prevent the distribution of the product.
  5. Import Alerts:For foreign facilities, non-compliance could lead to an import alert, effectively blocking the importation of the company’s products.
  6. Mandatory Recall: The FDA has the authority to mandate a recall of the food product.

Preparing for Compliance

To ensure you’re in line with FSMA 204, here are several steps to take:

  1. Understand the Law:Familiarize yourself with the provisions of FSMA 204 and other FSMA rules.
  2. Assess Your Business:Understand whether your business falls under Rule 204. Check the FDA’s Food Traceability List to see if the foods you handle are listed.
  3. Implement a Traceability Program:If covered, develop and implement a traceability program. This program should align with the recordkeeping requirements of FSMA 204.
  4. Train Your Team:Provide proper training to your team to ensure everyone is aware of the compliance requirements.
  5. Prepare for Inspections:Be prepared for potential FDA inspections and have a plan to present your record-keeping systems to inspectors.


FSMA Rule 204 brings new challenges for U.S. food producers, handlers, packers, processors, and distributors, but it’s essential to remember the ultimate goal: enhanced food safety. By understanding whether Rule 204 applies to your business and complying with its provisions, you’ll not only avoid potential penalties but also contribute to a safer and more transparent food supply chain.

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).