Specialty Food Magazine

An Outcry from the Industry FDA held virtual public hearings in October, November, and December 2020, in the Eastern, Central, and Pacific time zones. FDA and state officials, trade associations, and consumer interest groups presented, followed by public comments. The complexity of the regulations and the cost to comply was addressed by many trade associations, including the Specialty Food Association. SFA expressed concern about the general categories of foods for exclusion on the FTL. SFA also requested an extended and phased timeline for implementation based on business size and type and questioned a lack of training programs regarding the rule. The deadline for written comments was February 22, 2021. More than 5,000 comments were submitted, from food trade associations, grower organizations, and consumer interest groups. Industry Questions and Concerns FDA clarified some of the ambiguities about products on the FTL in January. For instance, cheeses subject to the FTL were those with more than 39 percent moisture content. The word fresh was added to fruits and vegetables on the list. For instance, dried mangoes would not be considered high-risk whereas fresh mangoes would be. In a 7,500-plus word statement, SFA expressed the concerns of the specialty food industry. SFA requested that FDA: 1. Revisit the determination of listed foods to list particular foods—not broad categories of food. 2. Establish requirements for labeling of foods exempt or no longer subject to the rule to reduce the burden on receiving entities. 3. Consider complexities presented for implementing this rule under common commercial arrangements in the specialty food industry. 4. Eliminate the collection of burdensome, often duplicative information that is not necessary to trace back. 5. Respect data privacy and confidentiality concerns of firms and limit the collection of information to better safeguard sensitive commercial information. 6. Follow the statutory mandate not to prescribe particular technologies. 7. Establish education requirements and dedicate resources for education. 8. Increase and establish a phased timeline for compliance. 9. Clarify mechanisms for enforcement by FDA with different entities in the supply chain. Identify Particular Foods, Not Food Categories SFA believes that the FTL is overly inclusive because it is based on a category approach rather than specifying particular foods. For instance, bananas are a tropical tree fruit and would thus be on the FTL, even though they are rarely implicated in foodborne illness. FDA examples of ready-to-eat deli salads include egg salad, potato salad, seafood salad, and others made with mayonnaise. But delis today offer hundreds of combinations, such as olives, meat, and cheese or tofu and beans. Would all of these be subject to the traceability rule? SFA also believes that the collection of redundant and duplicative information will increase the cost of compliance, adversely affecting small and very small businesses. The comments state, "FDA has proposed a duplicative, burdensome system which undermines the key statutory purpose of creating an efficient and effective end-to-end traceback." The American Cheese Society, which represents 2,100 cheese makers, distributors, and retailers, stresses that its small and very small members would not have the technology to supply FDA with a sortable digital spreadsheet within 24 hours. SFA agrees that many small businesses are not able to afford these technologies and that they may stop handling food on the traceability list. This is contrary to the Congressional intent that the traceability system "be scale- appropriate and practicable to facilities of varying sizes and capabilities." FDA has stated that companies will have two years to comply after the publishing of the final rule in November 2022. SFA has requested that the timeline mirror that of the Preventive Controls for Human Food regulation, with a one-year extension for small businesses, defined as companies with fewer than 500 employees. Although compliance with the "Requirements for Additional Traceability Records for Certain Foods" seems distant, it will become an enforced regulation before many in the industry have time to understand and comply with it. These records must be provided to FDA no later than 24 hours after a request. If the request is due to an outbreak, recall, or other threat to public health, the records must be provided in a digital sortable spreadsheet. SUMMER 2021 53 Ron Tanner is president of Tanner Food Group and former vice president of education, content & advocacy for the Specialty Food Association.

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