Questions and Answers About Requirements for Additional Traceability Records for Certain Foods: Guidance for Industry - Draft Guidance

The International Foodservice Distributors Association (IFDA) supports the draft guidance but requests specific revisions to provide greater flexibility for distributors. They argue for clearer provisions regarding inaccurate supplier records, multi-case pallet tracking, and the responsibilities of third parties to ensure the rule is manageable and does not impose undue burdens.

The National Grocers Association (NGA) supports the FDA's efforts to clarify the Food Traceability Rule but requests additional flexibility and specific exemptions for routine retail activities. They argue that certain inventory movements, quality control measures (like trimming produce), and internal labeling should not be classified as "transformations" or "distributor-style" shipments to avoid placing an undue burden on independent grocers.

Western Growers, an organization representing producers and handlers of specialty crops, supports the draft guidance but recommends expanding its scope to include more specific details on data standardization, lot definitions, and compliance for foreign entities. They argue for a single standardized approach to data sharing to reduce operational burdens and ensure a more effective, consistent traceability system across the supply chain.

The Consumer Brands Association supports the FDA's efforts to provide clarity on the Food Traceability Rule but requests additional flexibilities to reduce regulatory burdens. Specifically, they advocate for principle-based frameworks to avoid case-level tracking, exemptions for intracompany shipments, and clear "best practice" recommendations for location descriptions.

The National Restaurant Association supports the draft guidance but requests specific clarifications to ensure the traceability requirements are operationally feasible for restaurants. They specifically advocate for clearer definitions regarding minimum data requirements in limited circumstances, the classification of emergency "ad hoc" food transfers, and the definitions of "parent company" and "same company" for independent and franchise operators.

The Main Street Foundation's Center for Regulatory Analysis and Engagement (CRAE) supports the FDA's efforts to improve food traceability but argues for a risk-based, proportional approach that accounts for the differences between industrial and localized food systems. They emphasize the need to protect smaller producers from disproportionate compliance costs and advocate for clear, expanded exemptions to maintain food affordability and regional diversity.

The Food Industry Association (FMI) supports the Draft Guidance but argues that it lacks sufficient flexibility to address significant operational burdens. They request specific modifications, including allowing for a range of lot codes at the distribution level, using GTINs as source references, exempting intracompany shipments, and establishing a safe harbor for entities receiving incomplete data from suppliers.

The International Fresh Produce Association (IFPA) supports the traceability goals of FSMA 204 but argues that the draft guidance contains ambiguities and fails to account for the operational realities of the produce supply chain. They request clearer definitions on relabeling, distribution center implementation, and initial packer determination, while advocating for standardized data exchange and more feasible methods for tracking lot codes in high-velocity environments.

The Florida Fruit & Vegetable Association (FFVA) supports the FDA's public health objectives regarding the FSMA Section 204 Traceability Rule but urges the agency to provide more clarity and flexibility for small-scale and low-technology operations. They advocate for specific guidance on lot data transmission, KDE responsibilities, and the inclusion of retail and foodservice sectors to ensure a comprehensive and economically feasible traceback system.

Wholechain, Inc., a traceability software company, supports the draft guidance and requests specific clarifications to improve industry compliance. They advocate for allowing manufacturers to aggregate multiple production codes into a single traceability lot code (TLC) at the time of packing and seek clarification on how to document shipping events when a buyer picks up products directly from a seller's location.