U.S – In a joint effort, the U.S. Government Accountability Office (GAO) and the U.S. Department of Health and Human Services (HHS) are sounding the alarm for the U.S. Food and Drug Administration (FDA) to expedite the development and documentation of an implementation plan for Section 204 of the Food Safety Modernization Act (FDMA 204), commonly known as the Food Traceability Final Rule.

With the issuance of the Food Traceability Final Rule in November 2022, the clock is ticking for industry compliance, with a deadline set for January 20, 2026, to adhere to the rule’s recordkeeping requirements.

GAO’s recent report delves into the perspectives of FDA and selected stakeholders on the rule’s requirements, shedding light on the challenges both parties may encounter in achieving compliance.

At the heart of the rule is the Food Traceability List (FTL), determining which foods fall under its jurisdiction.

FDA employed a methodology incorporating mandated criteria, including the history and severity of previous outbreaks.

While some stakeholders endorsed FDA’s approach, others contested it, arguing that the resulting list was overly inclusive. FDA defended its stance, emphasizing the shared risk characteristics and associated hazards within categorized foods.

Despite taking initial steps to assist the industry in preparing for compliance, FDA’s planning process for implementing the rule remains incomplete and undocumented.

GAO reveals that the agency commenced an iterative planning process in late 2022 but has yet to finalize and document it.

The GAO stresses that an implementation plan is essential to tackle compliance challenges head-on.

Such a plan could provide clarity on the roles of nonfederal regulators in the inspection process, outline FDA’s enforcement strategy, and delineate necessary resources.

Additionally, it could offer guidance, training, and tools for stakeholders navigating the complex landscape of the Food Traceability Final Rule.

By finalizing and documenting an implementation plan, the FDA can bolster its commitment to regulatory goals and effectively address the multifaceted challenges identified by stakeholders.

The move is seen as crucial in ensuring progress towards compliance and navigating the intricacies of the approaching deadline.

The FDA recently took steps to further assist the industry in understanding the FSMA Food Traceability Final Rule by sharing frequently asked questions (FAQs) and additional tools.

The newly released FAQs address common inquiries to provide greater clarity on how the rule specifically applies to different scenarios.

The FDA developed these responses based on industry interactions and questions submitted via the Technical Assistance Network—an invaluable resource for FSMA-related inquiries. By addressing industry concerns, the FDA aims to facilitate smoother implementation of the Food Traceability Final Rule.

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