Designation of High-Risk Foods for Tracing; Request for Comments and for Scientific Data and Information

The American Frozen Food Institute (AFFI) appreciates the opportunity to comment on the U.S. Food and Drug Administration's (FDA) proposed rule to extend the compliance date for the final rule "Requirements for Additional Traceability Records for Certain Foods" (the "Traceability Rule") by 30 months to July 20, 2028. From manufacturers to distributors to suppliers to packagers, AFFI is proud to represent publicly traded and family-owned companies who help produce frozen foods and beverages for today's food service and retail marketplace and serve as economic pillars within their communities. Throughout the U.S., frozen food sales reached $85 billion in the last year, and the industry accounts for 670,000 U.S. jobs. In addition to our members' strong role in economic growth, AFFI members share a commitment to food safety and supply chain transparency. AFFI recognizes and appreciates FDA's efforts to facilitate the effective implementation of the Traceability Rule. Our members have a deep commitment to food safety and fully support FDA's efforts to develop a system that allows for fast and efficient traceback investigations and is protective of public health. Although the Traceability Rule largely excludes frozen foods, our members handle a number of foods on the Food Traceability List (FTL) in the manufacturing of their products and as a result have been directly impacted by the rule. As we have communicated in previous comments related to the Traceability Rule, our members have been working diligently to implement the rule's requirements but given the complexity of coordinating traceability systems across the supply chain and the current timeline of industry data standardization efforts, meeting the January 20, 2026 compliance date will be challenging. While technical compliance by this date may be achievable, AFFI and our members are concerned that rushing the implementation process in order to achieve technical compliance will result in an inefficient and ineffective system that does not meet FDA's public health and deregulatory objectives. For these reasons, AFFI strongly supports the agency's proposed rule to extend the compliance date for the Traceability Rule by 30 months until July 20, 2028. Additional comments attached.

The American Frozen Foods Institute (AFFI) appreciates the opportunity to comment on the Food and Drug Administration's (FDA) Proposed Rule Requirements for Additional Traceability Records for Certain Foods to implement Section 204 of the FDA Food Safety Modernization Act (FSMA). As the voice of the U.S. frozen food industry, AFFI is the national trade association that represents the interests of all segments of the frozen food industry. AFFI members manufacture and distribute frozen foods throughout the United States and globally. AFFI represents a broad group of companies throughout the food distribution chain, including food producers, distributors, and retailers. AFFI has long supported FDA's implementation of FSMA and supports FDA's implementation of Section 204 of FSMA by establishing recordkeeping requirements to improve traceability during foodborne illness outbreaks or recalls. AFFI appreciates the public health benefits that can be achieved through faster product tracing during recalls or foodborne illness outbreaks. Our members have significant experience conducting traceability exercises, implementing recalls, and complying with the "one-up, one-back" recordkeeping requirements under the Bioterrorism Act. Although AFFI supports efforts to facilitate enhance traceability, we believe that the Proposed Rule would impose a recordkeeping system that is overly burdensome, is not capable of being implemented across the food supply chain and is more complicated than necessary to achieve this goal. Moreover, the Proposed Rule would apply to low-risk foods such as frozen pizza containing cheese, even though enhanced traceability recordkeeping for these commodities would not result in any meaningful public health benefits. To that end, AFFI encourages FDA consider an approach that focuses on foods for which the maintenance of detailed traceability records would provide a public health benefit. Additionally, the rule should be simpler, less burdensome, and account for the practical realities of the food industry supply chain. A rule that is simpler to implement has a greater opportunity for adoption. We encourage FDA to adopt an outcome-focused standard requiring covered entities to be able to connect their outgoing product with incoming ingredients and respond to FDA within the timeframe requested, rather than focusing on specific records that must be retained and the information that must be included. Provided this outcome can be achieved, FDA should allow entities greater flexibility in how they develop their records to satisfy this basic requirement. A simplified approach would enable faster adoption among industry, would accommodate the wide range of industry practices and supply chains, would substantially reduce the burden on smaller entities, and would protect public health. AFFI believes that the current proposal is not feasible, and that a more outcome-based, flexible system is required. We are therefore offering our comments below on the ways in which FDA can narrow the scope and simplify the framework of the Proposed Rule to reduce its burden on covered entities and provide the greatest public health benefit. Overview Our comments generally focus on the following themes: •AFFI support's FDA's Proposed Rule and is committed to achieving the goal of faster traceback investigations. However, coming into compliance with new recordkeeping requirements will be a significant undertaking for all entities. FDA should provide industry the time, guidance, education, and information necessary to support a smooth implementation process. •FDA should have a scientific basis for any food included within the scope of the Proposed Rule. As drafted, the Proposed Rule will be much broader in scope than authorized by Section 204 of FSMA. •FDA should simplify the rule significantly to reduce the burden on covered entities and ensure there is a framework that can be implemented throughout industry. Both the C…