FSMA 204

The FDA Food Traceability Rule

The Impact of FSMA 204 on Foreign Producers and Handlers of Food Destined for the U.S.

The FDA’s Food Safety Modernization Act (FSMA) is a watershed in U.S. food safety law. The act was signed into law by President Barack Obama in January 2011 and has since significantly reshaped food safety regulations in the U.S. With its international implications, one of the most consequential components is Section 204, focusing on the “Enhanced Tracking and Tracing of Food and Recordkeeping”. This provision has a significant impact on foreign producers and handlers of food destined for the U.S.

What is FSMA 204?

The FSMA 204 regulation mandates improvements in the tracking and tracing of food to enhance the FDA’s capabilities in preventing foodborne illness outbreaks. This means food businesses, including foreign producers, need to maintain more comprehensive records and provide these records to the FDA when required. Essentially, the regulation increases transparency and traceability across the food supply chain.

Impact on Foreign Food Producers and Handlers

FSMA 204 affects all sectors of the food industry that supply the U.S. market, including foreign producers and handlers. These entities have to adjust their operations in several key ways.

1. Enhanced Record Keeping

The first significant impact is the requirement for enhanced record-keeping. Foreign producers and handlers must now maintain records regarding the source from where they obtained the food and the subsequent recipient, referred to as “one step up and one step down” in the food supply chain. This includes information about the type of food, quantity, how it was processed and transported, who supplied it, and to whom it was sold. It is an obligation that demands robust systems for data collection and storage.

2. Access to Records

FSMA 204 provides the FDA with improved access to these records in certain circumstances, such as a foodborne illness outbreak. This requirement means foreign producers and handlers must not only keep detailed records but also ensure they can retrieve and present them quickly and efficiently when required by the FDA.

3. Increased Transparency

Foreign producers and handlers must also provide the FDA with information about their full supply chain. This transparency allows the FDA to identify potential hazards quickly and take necessary action to prevent outbreaks or quickly mitigate their impact.

4. Adoption of New Technologies

To satisfy these new record-keeping requirements, many foreign producers and handlers are turning to new technologies like blockchain and digital ledger technology. These tools allow for real-time recording and tracking of food items through every stage of the supply chain, thus providing the required traceability FSMA 204 demands.

5. More Rigorous Inspections

Given the increased visibility and traceability of the supply chain, foreign food facilities should expect more rigorous inspections by the FDA. These inspections will focus on ensuring compliance with FSMA 204, meaning the food facilities must demonstrate robust record-keeping and traceability practices.

Costs and Benefits for Foreign Producers and Handlers

Like any regulatory change, FSMA 204 imposes costs and offers benefits. On the cost side, foreign food producers and handlers have had to invest in their record-keeping systems, employee training, and technology upgrades. This requirement is particularly challenging for smaller businesses with limited resources. The potential for increased inspections also adds to the cost.

On the benefit side, enhanced traceability can improve supply chain management and efficiency. It can lead to reduced waste, as products can be tracked more accurately, and improve the reputation of the business as it demonstrates compliance with stringent food safety regulations. In the long run, these benefits can outweigh the initial investment costs.

Compliance Strategies for Foreign Producers and Handlers

To ensure compliance with FSMA 204, foreign producers and handlers can adopt several strategies:

  1. Adopting Traceability Systems:Implementing a traceability system, such as blockchain, can help meet the “one step up and one step down” requirement of FSMA 204.
  2. Training Staff:Staff should be trained to understand the new requirements and how to maintain the necessary records.
  3. Working with a U.S. Agent:Hiring a U.S. agent can help navigate the complexities of FSMA 204. An agent can liaise with the FDA and ensure all documentation is properly prepared and submitted.
  4. Preparing for Inspections:Foreign facilities should prepare for potential inspections by having their record-keeping systems ready to present to FDA inspectors.

The Way Forward

Although the FSMA 204 presents challenges for foreign food producers and handlers, it is an opportunity to improve the global food supply chain. The enhanced traceability the regulation demands can improve food safety, operational efficiency, and consumer trust. By adopting robust traceability systems, foreign producers and handlers can not only comply with the regulations but also improve their overall operations.

In conclusion, FSMA 204 is a significant step towards enhanced food safety and traceability. Foreign food producers and handlers supplying to the U.S. market should view this as an opportunity for operational improvement and take the necessary steps to ensure compliance.

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).