What Can We Expect with FSMA 204?

Guest blogger Julie McGill, Vice President of Supply Chain Strategy and Insights, shares insights leading up to the release of the Final Rule for FSMA 204. 

What do you need to know about the FDA’s Food Traceability Rule? Probably more than you realize. Learn how this legislation applies to food safety and traceability programs.

Editor's note December 2022: The FDA has released the final rule for FSMA Section 204, published in November 2022. Read our blog The Roadmap to Enhanced Traceability Recordkeeping to learn the latest.

The Food Safety Modernization Act (FSMA) requires transparency from the entire supply chain and fundamentally changes the way food is regulated in the United States, and abroad. Section 204 will require even greater recordkeeping for certain high-risk foods. In order for food companies to manage all of these regulatory recordkeeping requirements, proactive measures are essential.

FSMA is the Foundation

Supplier verification and traceability data gathering require a thorough understanding of every trading partner, every location, every ingredient, and every product in your supply chain. Having a solid FSMA supplier compliance program in place provides the foundation needed to create a robust FSMA 204-compliant traceability program.

Enhanced Recordkeeping

FSMA 204's data-intensive traceability recordkeeping requirements are more stringent than the programs of the past. Real-time food traceability data must be saved, stored for 24 months, and if the FDA requests data from your company, that information must be provided to them within 24 hours. Also, if you are shipping products to another party in the supply chain, you will need to share certain Key Data Elements (KDEs) for the foods on the Food Traceability List (FTL). Critical Tracking Events (CTEs), designated activities in your supply chain, must be thoroughly detailed, including lot-level information for all FTL items. 

Companies need to determine how they will collect CTEs for each of the steps that they own in their supply chains, and figure out how they will receive lot-level information for the shipments that they receive. 

One Version of the Truth

Although the proposed rule does not prescribe any particular formats for data capture or data exchange, they do “encourage firms to maintain required traceability information in a single electronic system”. For those companies who do not have product tracing systems, they propose to require firms to describe the particular types of reference records in which they keep the required tracing information. For most, the manual management of these reference records will prove to be costly, resource intensive, and inefficient. 

Proactive vs. Reactive

A reactive stance often proves costly both in terms of lost profits and damaged reputation. On top of that, with labor shortages at an all-time high, it’s more important than ever to have the right tools and partners in place in order to avoid manual data gathering and labor-intensive traceability record retrieval. 

A supplier management solution can automate essential tasks and alert you to approaching document expirations, which better prepares you for FDA audits. You also want the ability to successfully complete internal and third-party audits of your suppliers and then save them in a centralized location, accessible to stakeholders across your company.  Companies will now need to collect, store and share enhanced traceability data, which is part of a robust supply chain system. To ensure both food safety and FSMA compliance, particularly with high-risk foods, visualization of events across your supply chain is important.

Make Sure You Have a Plan in Place Now

You should have a plan in place including the ability to easily collect enhanced traceability data, track compliance, procedures to identify and address suppliers that have repeated corrective actions, and the ability to supply requested documents and data within 24 hours. 

Make sure your plan answers the following questions:

• Can you provide records quickly and efficiently?  Under FSMA regulation, your food safety documentation is critical to demonstrate how you managed recalls and other issues effectively - and these records must be compiled within 24 hours of an FDA request and maintained for a minimum of two years.
• Can you verify foreign suppliers in your supply chain? Supplier verification is a critical component of FSMA compliance - and looks quite different from voluntary requirements. FSMA regulation requires food companies to verify and document the “hazards” that you are relying on your foreign suppliers to control — and then making sure they are taking the necessary steps to control those hazards adequately.  
• Are you collecting lot-level data for traceability? Go beyond “one-up and one-back” with your product traceability. With increasingly complex supply chains, traceability across your entire supply chain is critical for effective recall management and managing the quality of your products. For high-risk foods within your supply chain, it is especially critical to have visibility into the “last mile” of that product’s journey to the consumer.
• Are you prepared for an FDA Audit? For the first time, the FDA has mandatory recall authority for all food products along with more flexible standards for detaining products that are potentially in violation of the law - including the ability to halt operations of a facility that is under suspension.  

Protect Your Brand

In the post-FSMA universe, a compliant supply chain is essential to protect your brand. A recall costs a food company an average of $10 million. Be proactive about compliance and make consumer safety a top priority. By effectively managing your supplier relationships you can deliver your brand promise and give your customers exactly what they’re asking for.

FoodLogiQ is a robust supplier management solution that advances the quest for FSMA compliance. Streamline supplier documentation and template workflows to implement corrective actions, support supplier verification, and centralize required traceability record keeping.

 If your organization is looking for a platform to streamline your workflow, implement corrective actions, or centralize required recordkeeping, reach out to our experts at FoodLogiQ today.