Challenges and Solutions in Lot-Level Food Traceability; Public Meeting and Request for Comments

The commenter, representing Fresh Byte, opposes the proposed flexibilities for "reasonable range" and "inferred" traceability lot codes, arguing that these measures undermine the precise traceability goals of FSMA 204 and increase public health risks and civil liabilities. They advocate for scanning every case and utilizing existing software capabilities to maintain accurate lot-level data.

James Forshay, an owner-operator of a small fresh-cut produce business, supports maintaining strict lot-level traceability requirements as a means of protecting small businesses from broad, costly recalls. He argues that while flexibility is needed for practical implementation, it should not compromise data precision and suggests providing small operators with plain-language guidance and model records.

The commenter proposes the development and adoption of a mobile application to support food traceability for agricultural exports from Mexico to the United States. They have already developed a prototype and offer to enhance and scale it to meet the regulatory and operational needs of stakeholders.

The Minnesota Wholesale Marketers Association (MWMA), in conjunction with the Convenience Distribution Association (CDA), argues that the FDA should adopt a flexible option for FSMA Section 204(d) compliance by requiring manufacturers to imprint Traceability Lot Codes (TLC), TLC Sources, and expiration dates directly on case labels, inner packs, and individual packages. They contend that this "imprinting" model is a feasible, long-standing industry practice that avoids forcing distributors, retailers, and restaurants to overhaul their existing business operating systems or software to achieve effective lot-level traceability.

Dot Foods, a large food industry consolidator, supports the use of GS1 Standards to implement the Food Traceability Rule under FSMA Section 204. They argue that standardized data and exchange protocols are essential for ensuring consistency, interoperability, and efficient data sharing across the supply chain.

Altibbe Inc., an independent research organization, supports the FDA's exploration of pragmatic flexibilities in how lot-level records are formatted and transmitted. However, they urge the FDA to maintain strict requirements on the granularity of the data itself, arguing that any flexibility must allow for the reconstruction of the same lot-to-CTE linkage as full compliance.