A group of food industry organizations are coming together to establish the “Food Industry FSMA 204 Collaboration” to improve overall understanding and prepare for the US Food and Drug Administration’s (FDA) Food Traceability Rule.

The rule enforces Section 204(d) of the Food Safety Modernization Act (FSMA), which mandates a “comprehensive tracking and tracing system” for certain high-risk foods listed in the FDA’s Food Traceability List (FTL).

The FTL encompasses fresh produce and leafy greens, deli salads, cheeses (other than hard cheeses), nut butter, fresh herbs, vegetables other than leafy greens (fresh-cut), smoked finfish (refrigerated, frozen and previously frozen) and crustaceans (fresh, frozen and previously frozen).

The consortium includes the Association of Food and Drug Officials (AFDO), The Food Industry Association (FMI), GS1 US, Institute of Food Technologists (IFT), International Foodservice Distributors Association (IFDA), International Foodservice Manufacturers Association (IFMA), International Fresh Produce Association (IFPA) and National Association of State Departments of Agriculture (NASDA).

What is the FSMA Rule 204?

According to the FDA, the nclick="updateothersitehits('Articlepage','External','OtherSitelink','US food safety: F&B organizations join forces to get ahead of new track and trace rules','US food safety: F&B organizations join forces to get ahead of new track and trace rules','343204','https://www.fda.gov/food/food-safety-modernization-act-fsma/fsma-final-rule-requirements-additional-traceability-records-certain-foods', 'article','US food safety: F&B organizations join forces to get ahead of new track and trace rules');return no_reload();">final rule on Requirements for Additional Traceability Records for Certain Foods (Food Traceability Final Rule) establishes “traceability recordkeeping requirements, beyond those in existing regulations,” for persons who manufacture, process, pack or hold foods included on the FTL.

These individuals are required to maintain records containing key data elements associated with specific Critical Tracking Events (CTE) and provide information to the FDA “within 24 hours or within some reasonable time to which the FDA has agreed.”

The CTEs entail processes like harvesting, cooling, initial packing, shipping, receiving and transformation events along the food supply chain.

“The new requirements identified in the final rule will allow for faster identification and rapid removal of potentially contaminated food from the market, resulting in fewer foodborne illnesses and/or deaths.”

A “cross-industry challenge”

Food safety is the single most important issue that food retailers, wholesalers and suppliers focus on every day, according to Leslie G. Sarasin, president and CEO of FMI.

“FDA’s FSMA Rule 204 is the most significant regulation the food industry has ever faced and will demand tremendous investments for recordkeeping, data management and systems changes. This collaboration demonstrates our collective commitment to sharing information and working together to ensure the food supply chain has the resources and clarity it needs for compliance.”

Ed Treacy, VP of Supply Chain at IFPA, agrees that implementing the FSMA Rule 204 requirements is a “cross-industry challenge.”

“This collaboration will ensure that the resources created and education offered to our collective members are coordinated and aligned.”

The confederation’s objective is to convey clear, concise messaging and resources that enable the F&B industry to take action in preparing for FSMA Rule 204, which was published in November 2022.

Accelerating compliance

Manufacturers working with the specific foods on the FTL are required to comply with the rules of recordkeeping by January 20, 2026.

The collaboration aims to provide a forum for business and government officials to collaborate, educate the industry and help ease compliance practices through collaboration, traceability for enhanced food safety, standardized data collection and widespread training and education initiatives.

For the US, compliance with FSMA Rule 204 presents a “significant challenge,” and foreign agri-food interests, as it imposes unprecedented recordkeeping requirements and necessitates the adoption of advanced traceability technologies,” flags Angela Fernandez, Senior VP of Market Development, GS1 US.

“By convening food safety, supply chain logistics and data management experts across many food segments, the new collaboration aims to share best practices for meeting Food Traceability Rule requirements.”