IFT's GFTC Submits Comments to FDA Regarding Proposed Traceability Rule

On behalf of the science of food community, IFT’s Global Food Traceability Center (GFTC) recently submitted comments to the U.S. Food and Drug Administration (FDA) regarding the proposed “Requirements for Additional Traceability Records for Certain Foods” (Food Traceability Proposed Rule). The proposed rule is a key component of the FDA’s New Era of Smarter Food Safety Blueprint and would implement Section 204(d) of the FDA Food Safety Modernization Act (FSMA).

The proposed rule aims to improve recordkeeping standards for manufacturers, processors, packers, and those who hold foods identified on the draft Food Traceability List. It identifies critical tracking events (CTEs) in the supply chain, such as growing, shipping, receiving, creating, and transforming the foods, that would require records to be captured containing key data elements (KDEs).

Despite the availability of best practices for food tracing which have been well defined for nearly a decade, outbreaks of foodborne illnesses continue to occur with a frequency that is undermining consumer confidence in important foods for health and nutrition, including several types of produce, nut butters, and seafood. The safety of these foods is critical from a public health perspective, both in terms of preventing outbreaks of acute illness and all the related costs to people and businesses and preventing underconsumption of these foods driven by safety concerns.

In its comments, IFT commended the FDA on the steps the rule takes to enhance record keeping and traceability for foods that have been known to cause foodborne illness outbreaks and recalls. IFT is fully supportive of the FDA’s stated objectives to reduce the time and scope of recalls through requirement of a first receiver to end of supply chain lot-level traceability record within 24 hours (Proposed § 1.1455(b)(1)).

The comments also included feedback and recommendations for FDA to consider to further enhance the rule prior to finalization. Highlights include:

• Advocating that FDA describe methods for ensuring global uniqueness in identifiers to support flexible, accessible traceability systems that meet the needs of impacted industries and objectives of the proposed rule.
• Further defining CTE-KDE matrices to support necessary new levels of data sharing among supply chain partners.
• Introducing the traceability lot code definition but changing the concept to a simple yet unambiguous term (i.e., “traceability code”), and removing the definition of “lot” to reduce potential confusion with other business practices.
• Clearly defining what is meant by “establish and maintain” in this rule’s context and explicitly address and acknowledge the evolving realities of digital record keeping.
• Releasing digital spreadsheet templates modeling acceptable data submissions for review and comment.
• Redefining small retailers based on existing SBA criteria (<$7.5M receipts per year) regardless of the number of sites and including them as full participants to provide them with the necessary regulatory backup to encourage traceability in their supplier networks.
• Explicitly requiring actors downstream of a kill step to maintain lot-based traceability capable of linking back to the CTE where the kill step occurred to alleviate potential confusion and liability for downstream supply chain actors.
• Supporting convening of public-private partnerships to develop interoperability in impacted sectors, particularly those on the draft Food Traceability List (FTL) with less well-developed baseline traceability.
• Organizing convenings of state and federal authorities as well as between the USDA and FDA to identify and develop additional codes to clarify inter-agency handoff for maximum efficiency.
• Collaborating with non-governmental partners, industry associations, and neutral, nonprofit, technical organizations to assess industry educational needs and develop educational content to support rule implementation.
• Maintaining the implementation timeline but continuing to work toward larger goals articulated in the New Era of Smarter Food Safety around developing low-cost solutions appropriate for digitized supply chains.

Since its inception, IFT’s GFTC has actively worked with the FDA, partner organizations, and the private sector to help address global food traceability challenges and opportunities across the supply chain, including completing task orders, conducting primary research, leading pre-competitive industry platforms, creating implementation tools, and delivering educational programming. The GFTC looks forward to partnering with stakeholders impacted by the proposed rule to realize the vision of accurate, rapid end-to-end traceability.

End-to-end traceability leveraging digital technologies is achievable and this rule, once finalized, will be a critical element. You can find the complete comments on our Policy Developments web page.