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Collaboration Graphic

Proposed Collaborative for FSMA 204 Compliance Seeks Industry Support

By Food Safety Tech Staff
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Collaboration Graphic

On Tuesday, January 20, 2026, the food industry will need to be compliant with FDA’s FSMA 204: Requirements for Additional Traceability Records for Certain Foods (aka, Food Traceability Final Rule). Compliance with the final rule will require adoption of new technologies and streamlined communication and record-keeping throughout the supply chain. To help ensure compliance and success in meeting the intent of the rule, Leavitt Partners and Acheson Group are working with FDA to create a public-private governing body for food traceability, based on the medical industry’s Partnership for DSCSA Governance (PDG).

Eric Marshall, Leavitt Partners
Eric Marshall

Founded in 2019, the PDG is a collaborative of pharmacy industry members working together to help the industry implement the Drug Supply Chain Security Act (DSCSA) and develop a sustainable, effective and efficient model for interoperable tracing and verification of prescription pharmaceuticals in the U.S.

“DSCSA and FSMA do have significant differences. For example, there are unique requirements for bar codes, serialization and electronic interoperability in the medical industry,” said Eric Marshall, Principal at Leavitt Partners and Executive Director of PDG. “But at the core, they have a lot of similarities and they both have the same goal from the government’s viewpoint: modernizing industry’s data and recordkeeping practices to create supply chain traceability that helps industry and government together react faster and more effectively to risks in our food and drug supply chains.”

Last month, Erik Mettler of FDA joined Marshall and Laura Brown of Leavitt Partners and Ben Miller and Eric Edmunds of the Acheson Group for an informational webinar on the proposed project.

Eric Edmunds, Acheson Group
Eric Edmunds

The goal of the public-private partnership is to:

  • Help industry decide how to meet the core issues of FSMA 204, so stakeholders are not wasting money on different technologies that others are not using or accepting
  • Bring together divergent industry groups working on disparate plans for getting to compliance and bring this work together into one cohesive vision
  • Ensure all sectors of the industry have a voice in the process
  • Provide a decision-making mechanism for those key components of compliance that require a shared view throughout the industry
  • Develop a coordinated plan and timeline to get from today to the compliance date
  • Develop core requirements to which commercial solution/software providers can build
  • Hold collaborative interactions with FDA
  • Create a shared IP (i.e. industry lookup directory) needed to achieve compliance

The vision for the collaborative is to create “an independent, sector-neutral forum for the industry to come together to jointly define a shared vision for enhancement of traceability,” said Edmunds.

Recognizing that the deadline for compliance is fast approaching, Leavitt Partners and Acheson Group are currently seeking industry members to act as part of a working group to finalize the operating structure of the organization, which they envision as encompassing a general membership tier with elected officers and board members, and multiple committees. Their goal is to organize the working group and define key organizational aspects of the collaborative by end of June; secure 35 members, form the legal entity and hold Board elections by end of July; and by the end of 2024 begin awareness and education campaigns, committee work and blueprint development, and establish the 2025 budget.

Those interested in getting involved can contact Eric Edmunds at eric.edmunds@achesongroup.com or Ben Miller at ben.miller@achesongroup.com.