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The IA Rule Basics - TAG

Nearly a decade after the passage of the Food Safety Modernization Act (FSMA), FDA is fulfilling the mandate to propose a rule for traceability requirements for a “high-risk foods” list. In this, and subsequent newsletters we will review the proposed rule and its application to FDA-regulated facilities – from farm to distribution. This week, we provide a very general overview and some points TAG found to be of interest.

The basic statutory authorities granted to FDA were to allow the agency to require more complete product tracking records for what FDA considers to be “high-risk foods.” As we have noted before, the first challenge is to define that list and figure out how to update and amend the list.

The Food Traceability List (FTL). TAG’s review of the “Requirements for Additional Traceability Records for Certain Foods” (Food Traceability Proposed Rule) is finding a number of interesting aspects of the proposed rule. The most obvious is that, once FDA introduces its designation of high-risk foods as being on its newly defined “Food Traceability List” (FTL), it rarely uses the wording “high risk” except in reference to the FSMA requirement for the designation. This seems to be a ruse to get away from the emotive issue of whether certain foods are considered “high risk” and then question whether other foods not on this list are by default “low risk.”

The FTL foods were determined through FDA’s development of a draft risk-ranking model. Data was collected to populate the model for chemical and microbiological hazards associated with specific foods, and the draft risk-ranking model and data, were reviewed by independent external experts. From this, FDA proposed 16 FTL foods, with the rule mandating additional traceability requirements for both the listed food and any food that contains a listed food as an ingredient. Those foods include:

  • Cheeses, other than hard cheeses (made with milk)
  • Sprouts
  • Shell eggs (of domesticated chicken)
  • Tomatoes
  • Nut butter (excludes soy and seed butters)
  • Tropical tree fruits
  • Cucumbers
  • Fruits and Vegetables (fresh-cut)
  • Herbs (fresh)
  • Finfish, including smoked finfish
  • Leafy greens, including fresh-cut leafy greens
  • Crustaceans
  • Melons
  • Mollusks, bivalves
  • Peppers
  • Ready-to-eat deli salads

The proposed rule also includes a process for FDA to update the list when appropriate.

CTEs and KDEs. It also is interesting to note that the foundational elements of the rule are firmly rooted in the recommendations of the 2011-12 pilot tracing projects, which were executed by the Institute of Food Technologists (IFT) and an oversight panel – on which a number of current and former TAG team members participated. Included in those recommendations was the capture and communication of critical track and trace data (i.e., Key Data Elements [KDEs]) at critical points of product transfer and transformation (i.e., Critical Tracking Events [CTEs). As such, as a part of the group’s recommendations for a uniform set of recordkeeping requirements (which it advocated for all FDA-regulated foods, not just those considered high risk) were that FDA:

  • Require firms to identify and maintain records of CTEs and KDEs as determined by FDA.
  • Develop standardized electronic mechanisms for the reporting and acquiring of CTEs and KDEs during product tracing investigations.
  • Accept summarized CTE and KDE data submitted through standardized reporting mechanisms and initiate investigations based on such data.

FDA apparently saw the KDEs and CTEs as valuable traceability concepts, as the core components of the rule “are the requirements to establish and maintain records containing key data elements (KDEs) associated with different critical tracking events (CTEs) in a listed food’s supply chain, including the growing, receiving, transforming, creating, and shipping of listed foods.” Additionally, the proposed recordkeeping requirements “emphasize the importance of documenting the applicable traceability lot codes and linking these codes to other KDEs at critical points in the supply chain of a food to aid product tracing during an investigation of a foodborne illness outbreak or during a recall.”

Thus, the proposed rule is based on the recordkeeping of KDEs and CDEs (for which it also has developed interactive slides with supply chain examples):

  • KDEs vary based on the CTE but must include the traceability lot code for CTEs
  • CTEs are specified for the growing, receiving, creating, transforming, and shipping of foods include:
    • Growing. FDA specifies general KDEs for growing, with sprout growers required to establish and maintain additional sprout-specific KDEs.
    • Receiving. The rule establishes a new supply-chain category, “first receivers” for which additional KDEs are required. The first receiver is the first person (other than a farm) who purchases and takes physical possession of a listed food. Only foods that are originated (i.e., grown, raised, caught, or, in the case of a non-produce commodity such as eggs, harvested) can have a first receiver. Listed foods that are created (such as a ready-to-eat deli salad that is not made from any listed ingredients) do not have a first receiver. First receivers are required to maintain different KDEs depending on whether the food was obtained from a fishing vessel or not. (FDA examples).
    • Creating. This is the producing, (e.g., manufacturing or processing) of an FTL food using only ingredient(s) that are not on the FTL. Creating does not include originating or transforming a food. (Examples)
    • Transforming. Transformation involves changing an FTL food, its package, and/or label (traceability lot code/product identifier), such as by combining ingredients or processing a food (e.g., by cutting, cooking, commingling, repacking, or repackaging). It does not include the initial packing of a single-ingredient food or creating a food. (Examples)
    • Shipping. The food is arranged for transport (e.g., by truck or ship) from one defined location to another at a different farm, first receiver, or subsequent receiver.

At 55 pages, the proposed rule is quite in-depth, so TAG is conducting an in-depth analysis, which we will be bringing to you over the next weeks. Because of the substantial involvement of TAG team members in the development of key elements of the rule, we can be of significant assistance to the food industry as you begin determining its application to your business and seeking to comply or creating comments for FDA’s consideration.

Give us a call for assistance!


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