On November 15, 2022, the US Food and Drug Administration (FDA) issued a final rule on food traceability. The rule, which implements Section 204(d) of the FDA Food Safety Modernization Act (FSMA), outlines requirements for certain entities involved in the manufacturing, processing, packing and holding of food that will enable the identification and removal of potentially contaminated food from the market faster. The intended result is fewer illnesses or deaths due to the consumption of these potentially contaminated foods. The date by which all entities subject to the rule must be compliant is January 20, 2026. Our goal is to summarize components of the FSMA, detail specifics of the rule pursuant to Section 204(d) of the FSMA and discuss what food and beverage entities can do to ensure compliance with the rule.
The FDA Food Safety Modernization Act, signed into law by President Obama on January 4, 2018, is designed to strengthen the food safety system and provide a more proactive approach to protecting public health. Additionally, the FSMA provides the FDA greater authority in ensuring food and beverage industry compliance. Some of the broad categories of authorities granted by the FSMA are prevention, inspection and compliance, response, imports, and enhanced partnerships. These categories are broken out into more detailed components, one of which being the rule on food traceability.
The food traceability rule is the FDA’s response to Section 204(d) of the FSMA, which discusses the additional record keeping requirements related to high-risk foods. The intent of this section is “to rapidly and effectively identify recipients of a food to prevent or mitigate a foodborne illness outbreak and to address credible threats of serious adverse health consequences or death to humans or animals.” The food traceability rule details what falls under the term “high-risk.” These include:
- Cheeses (other than hard cheeses)
- Shell eggs
- Nut butters
- Leafy greens (fresh and fresh-cut)
- Fresh-cut fruits and vegetables
- Smoked and unsmoked finfish (fresh, frozen and previously frozen)
- Crustaceans and molluscan shellfish (fresh, frozen and previously frozen)
- Ready-to-eat deli salads
The rule discusses various Critical Tracking Events (CTEs), which are analogous to the various steps in the supply chain. Each CTE contains Key Data Elements (KDEs) that are required to be tracked and recorded, and then shared with the entity’s supply chain partners. A major part of these KDEs is the assignment, recording and sharing of traceability lot codes (TLCs). These will enable the FDA to identify the source of potentially contaminated food faster. The CTEs that the food traceability rule is concerned with include harvesting, cooling (before initial packing), initial packing, first land-based receiver, shipping, receiving and transformation. The FDA published a document that details the KDEs that are required to be tracked and recorded and is available on their website.
There are various exemptions (full and partial) and waivers available for entities that meet certain criteria or sell food identified by the FDA as exempt foods. The FDA provides a flowchart tool to help determine whether an entity is exempt from the rules.
Food and beverage companies will need to understand what CTEs they represent in the supply chain, begin tracking the related KDEs to provide to their supply chain partners, and assign traceability lot codes. These companies should implement procedures to identify the KDEs they need to track and start having conversations with their supply chain partners to ensure this flow of information is being communicated effectively. A traceability plan must also be created by companies subject to these rules. This plan must be updated as needed to ensure it reflects companies’ current practices and that the requirements of the rules are being met. The plan must include the following information:
- Descriptions of the procedures used to meet the record keeping requirements under the rules
- Descriptions of the procedures used to identify foods on the Food Traceability List
- Descriptions of the procedures used to assign traceability lot codes to foods on the FTL
- Identification of a point of contact for questions on the plan and records
- A farm map showing the areas where food is grown or raised (other than eggs), if applicable
The rules surrounding food traceability are complex, and compliance is a major undertaking for entities subject to the rules. To discuss the rules and what you can do to ensure compliance, contact a Manufacturing Solutions team member at manufacturing@hbkcpa.com.
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