FSMA 204 for Retailers: What You Should Consider When Implementing the FDA’s Food Traceability Final Rule Regulations

Implementing FSMA 204 regulations requires careful consideration of several key factors. Yes, retailers must ensure that their facilities are in compliance with the regulations, and they must document critical tracking events and key data elements. But, they also must also consider how the regulations impact supply chain operations, including traceability and risk assessment.

A compliance management system that promotes a strong food safety culture with third-party audits can help retailers stay on top of FSMA 204 requirements.


FSMA 204 Retail Supply Chain Operation Considerations


1. FTL Foods


Retailers sell a wide variety of foods but only the foods designated on the Food Traceability List (FTL) have the requirement for additional record keeping.


2. Traceability Plan


Retailers will need to have a ‘Traceability Plan’ detailing explanatory information about their traceability practices in order to help the FDA interpret their records in the event of an investigation.


3. Employee Training


Employees must be trained on the traceability plan and understand the importance of following them. Retailers must develop training programs that are tailored to their specific operations and ensure that all employees receive regular training. For example, implementing a recall plan and conducting regular drills to ensure that all stakeholders are prepared to respond in the event of a food safety incident.


4. Monitoring and Verification


Retailers who document new standard operating procedures for FSMA 204 and train their employees will be off to a good start. But success requires routine monitoring and verification to ensure employees are following the procedures without disruption to your business.


5. Record-keeping


The crux of FSMA 204 is enhanced record-keeping requirements for businesses along the food supply chain. Retailers that are prepared will have robust record-keeping practices.


6. Implementing Technology Solutions


The final rule was written so it would not require the use of technology, however meeting the needs of customers in today’s grocery environment often require solutions beyond manual entries. Traceability systems can track and monitor the movement of food products through the supply chain, minimizing the additional labor needed to maintain compliance.


7. Lot Number Assignment


FSMA 204 requires companies to record the lot number assigned to the food after initial packing, transformation, or first land-based receiving instead of generating a new one.


8. Receiving Lot Numbers


If retailers have been generating new lot numbers, they may not have been receiving them from their suppliers to begin with. FSMA 204 sets new expectations for retailers to routinely receive and store the lot numbers of foods, as well as where each lot number was assigned. This data was not commonly shared before.


9. In-house Transformation


Retailers are no longer in the business of only shipping, receiving, and selling goods. The modern grocery retailer also prepares specialty fresh foods that are sold in their stores. This may mean that retailers need to maintain records like their suppliers.


Ensuring the safety of food products is a top priority for retailers. With the FDA’s Food Traceability Final Rule (FSMA 204), it’s important to understand the significant implications these requirements have for retailers.

In our new ebook, The ULTIMATE GUIDE to FSMA 204 for Retailers: Everything you need to know for compliance, we discuss how FSMA 204 requirements will affect retailers, the risks associated with non-compliance, and what retailers need to consider when implementing the regulations in their facilities. We also explore the role of technology in complying with FSMA 204 and what other strategies retailers can implement to ensure compliance across their entire supply chain.


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