Industry Responds to the U.S. Food & Drug Administration’s Food Traceability Proposed Rule

Created on Tuesday, 22 June 2021


The four core elements of the New Era blueprint
The four core elements of the New Era blueprint

The U.S. Food and Drug Administration (FDA) is tasked with effective tracking of food products, through tracebacks and recalls, in order to mitigate food-borne illnesses outbreaks. Over the next decade, the FDA will be implementing the New Era of Smarter Food Safety Blueprint, which is designed to support end-to-end, electronic traceability throughout the food safety system, harmonize tracing activities, and encourage interoperability across a variety of technology solutions. To begin addressing this vision, the FDA has proposed a new traceability rule for certain foods that will require the collection of key data elements (KDEs) at critical tracking events (CTEs) along supply chains. The goal of these proposed requirements is to improve traceback response time and address credible threats more efficiently. Although there is support for the overall goal and mission of the proposed rule, the seafood industry raised several noteworthy themes in their public comments around scope, clarifying language, and alignment with existing programs. 

Theme 1: Food Traceability List

The proposed Food Traceability List (FTL) includes finfish (catfish excluded), crustaceans, mollusks, bivalves, and other commodities such as leafy greens and soft cheeses deemed higher risk for food-borne illness. Because the FTL is organized by commodity, there are many seafood products subject to the rule, making the scope of the regulation quite extensive. Comments from the seafood industry suggest different levels of risks within each commodity, and the current FTL is oversimplified. Comments highlight that risks can differ based on species, production method, and region of origin. Regardless of how the risks are measured, 56% of the seafood industry recommends revisions to the FTL to narrow the scope of the rule.

Theme 2: Clarification Needed 

The proposed rule introduces CTEs and KDEs to be collected throughout supply chains. For seafood products subject to the rule, data collection begins at the “first receiver.” From the first receiver, data is collected and transferred between parties as the product is shipped, transformed, and received.  The “traceability lot code” is the KDE that links the product as it moves from one event to the next. Because this rule is not exclusively for seafood, there are nuances of seafood supply chains that are not captured in the proposed supply chain (see Figure 2), and some industry members provided exemption recommendations. Revised exemptions to the proposed rule would narrow the scope of the rule, minimize the burden of implementation, and address some of the missed considerations of seafood supply chains. Additionally, the language presented in this rule introduces new terminology and format, such as “first receiver” and “traceability lot code”, that are not typically used in seafood traceability practices. Industry responses (67%) suggested that the language presented in this proposed rule needs further clarification to be implemented effectively. FishWise notes that standardized, industry-wide terminology, such as those outlined by the Global Dialogue on Seafood Traceability, is encouraged to prevent confusion and harmonize existing procedures and protocols.

Figure 2 shows the example seafood supply chain CTEs subject to the proposed rule.

Theme 3: Alignment with Existing Regulations 

Ultimately, the seafood industry’s primary concern is the lack of alignment with existing regulations. Seafood products included in the FTL are also subject to the Seafood Hazard Analysis Critical Control Point (HACCP), the National Shellfish Sanitation Program (NSSP), and the Seafood Import Monitoring Program (SIMP).  For this reason, 89% of the industry comments urged the FDA to consider how this proposed rule would be duplicative and how the already existing regulations can provide the recommended clarification and revisions to the language and FTL. For example, the HACCP outlines high-risk seafood by species, not commodity. The species subject to the HACCP can inform the revision of the FDA’s FTL. A review of the information currently collected with existing programs against the information proposed in the FDA’s new traceability program might reveal that a good amount of data is already being collected. Where KDEs required under this proposed rule overlap with information collected under others (e.g., SIMP, NOAA 370), alignment will improve efficiency and cost-effectiveness of compliance. With standardization and alignment of KDE formats, companies can more readily adapt their existing data management systems that are already collating supply chain data, resulting in improved opportunities for data interoperability. 

Interestingly, the request to align with existing regulations was shared by the seafood industry, non-governmental organizations, technology providers, and organizations specializing in traceability, signaling broad agreement that this is a priority area that needs to be addressed.

It is important to remember that this is a proposed rule, and as a proposed rule, comments submitted to the FDA will shape how the final rule is structured and implemented. Public comment is a powerful way to engage with new federal regulations as they are proposed, and FishWise commends the seafood industry’s involvement in policies as they develop. 

For more information about the proposed rule (Docket # FDA-2014-N-0053) can be found here. Public comments can be viewed on the portal. 

Written by:


Nina Rosen, Project Manager