Traceability in the Food Supply Chain: Preparing for FSMA Section 204

Food Safety Modernization Act (FSMA) Section 204 introduces a range of stringent requirements for entities involved in the supply chain of certain high-risk foods. These requirements are designed to ensure comprehensive tracking and documentation of food products, from their origin to their final destination, enhancing food safety and accountability throughout the supply chain.

For food companies that are not yet compliant, the looming July 20, 2028 deadline can be a source of significant concern. The pressure to meet these strict requirements can be overwhelming, but it is essential to take proactive steps now to avoid these risks.

This article provides a brief overview of FSMA Section 204 and implementation considerations to help you understand what is needed for compliance. By familiarizing yourself with these key points, you can begin to take the necessary actions to ensure your company is ready for the upcoming changes.

What Foods Are Affected?

The Food Traceability List (FTL) documents the high-risk foods that are subject to FSMA Section 204. Some examples include:

• Soft cheeses
• Shell eggs
• Nut butters
• Fresh-cut fruits and vegetables
• Finfish and crustaceans
• Ready-to-eat deli salads

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Who Must Comply?

Generally, if a business is involved in the supply chain of FTL foods, it is required to comply with FSMA Section 204. Such businesses include:

• Farms
• Food manufacturers and packers
• Warehouses and distributors
• Retailers and food service operators

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Traceability and Recordkeeping Requirements

Companies must meticulously record key data elements during critical supply chain events, such as the harvesting, processing, and distribution of FTL foods. The documentation of the movement and transformation of each food product at the lot level ensures swift and effective traceability in the event of a recall or safety issue. Additionally, traceability records must be maintained for 2 years and provided to the FDA within 24 hours upon request.

How Can I Prepare for FSMA Section 204 Compliance?

When preparing for FSMA Section 204 compliance, food companies should take the following steps:

1. Develop a traceability plan
   
   1. Create a comprehensive traceability plan that outlines how your business will track and trace food products at the lot level through the supply chain
   2. This plan should include procedures for identifying and documenting the origins, handling, and distribution of food products
   3. Existing processes that obfuscate lot traceability must be updated to ensure compliance
      
      1. For example, a warehouse that currently only labels at the pallet level should consider also labeling lots at the case level within a pallet
2. Implement technology solutions
   
   1. Leverage technology to automate and streamline processes
   2. For example, consider using software systems for recordkeeping, barcode scanning, and RFID tracking to ensure accurate data collection
3. Standardize and digitize records
   
   1. Data should be stored in a central repository, as opposed to scattered across multiple sources
   2. Digitizing records not only helps standardize records, but also facilitates the storage and sharing of records
   3. While FSMA Section 204 does not stipulate the use of any specific digital technologies, managing the extensive data necessary for detailed traceability will be difficult without digital records
4. Train employees
   1. Ensure that all employees are well-trained in the new requirements and understand the importance of traceability
   2. Provide training sessions and educational materials to help staff comply with FSMA Section 204
5. Collaborate with supply chain partners
   
   1. Work closely with all relevant supply chain partners to ensure they are also compliant with FSMA Section 204
   2. Establish clear communication channels and protocols for sharing traceability information
6. Consult with experts
   
   1. Seek advice from food safety consultants or legal experts who can help you navigate the complexities of the regulations
7. Monitor and Review
   
   1. Regularly monitor and review your traceability processes to maintain ongoing compliance
   2. Conduct audits and assessments to identify any areas for improvement and make necessary adjustments

Conclusion

Understanding and adhering to the requirements outlined in FSMA Section 204 is crucial for entities involved in the food supply chain. By taking proactive steps, businesses can navigate the complexity of food safety regulations and contribute to a safer food supply for all. Compliance is not just a legal requirement; it is a commitment to ensuring the health and safety of consumers.

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