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The US Food and Drug Administration (FDA) on 15 November issued a more than 600-page final rule establishing additional recordkeeping requirements for persons who manufacture, process, pack or hold foods that the FDA has designated for inclusion on the Food Traceability List (FTL).
Prior to the adoption of this final rule, the existing regulations were designed to enable the FDA to identify the immediate previous sources and immediate subsequent recipients of foods to address credible threats of serious adverse health consequences or death to humans or animals. This final rule adopts additional recordkeeping requirements for foods designated as high-risk foods in accordance with factors specified by Congress in the Food Safety Modernization Act (FSMA). The final rule is also a key component of the FDA’s New Era of Smarter Food Safety blueprint. The food traceability final rule establishes a standardised approach to traceability recordkeeping, paving the way for industry to adopt, harmonise and leverage more digital traceability systems in the future.
The final rule adopts provisions requiring these entities to maintain records containing key data elements (KDEs) on critical tracking events (CTEs) in the supply chain for these designated foods on the FTL. The FDA has identified KDEs required for each CTE performed and has published an infographic that summarises the KDEs required for each CTE along with examples of how the rule would apply in the produce, seafood and cheese supply chains. CTEs include harvesting, cooling before initial packing, initial packing of raw agricultural commodities, first land-based receiver, shipping, receiving, transformation, and traceability plan. The information and KDEs that firms must keep and send forward under the rule varies depending on the type of supply chain activities they perform with respect to an FTL food, from harvesting or production of the food through processing, distribution and receipt at retail or other point of service.
Central to the requirements is the assignment, recording and sharing of traceability lot codes (TLCs) for FTL foods, as well as linking these TLCs to other information identifying the foods as they move through the supply chain so that a food can be tracked from farm to retail. This standardised data-driven approach to recordkeeping for traceability helps to create a universal language for food traceability so that industry can leverage a more digital, tech-enabled approach in interoperable food traceability systems.
The FTL established by the FDA through use of a risk ranking model for food tracing (RRM-FT) is included as a reference to the final rule. The model is a semi-quantitative, multi-criteria decision analysis tool. It considers FDA-regulated human foods, identifies commodities available for purchase at retail, and for each commodity identifies associated known or reasonably foreseeable hazards. The FDA relied on the expertise of SMEs both within and outside of the agency to develop the RRM-FT. The FTL designates the foods that are subject to the additional traceability recordkeeping requirements and foods that contain listed foods as ingredients, provided that the listed food that is used as an ingredient remains in the same form (e.g. fresh) in which it appears on the list.
Before final adoption of this rule, the FDA received comments expressing concern or requesting changes to simplify and reduce the burden of this rule throughout the supply chain. In response to these comments, the FDA made several changes to the proposed rule to make it easier for supply chain entities to understand and comply with the final rule. The final rule more closely aligns the FTL recordkeeping requirements with industry best practices and effectively addresses stakeholder concerns about the complexity of the requirements and the need to protect the confidentiality of commercial information regarding suppliers. To address additional concerns regarding specific foods or entities, the FDA has listed numerous exemptions to this rule that would be best reviewed on their website. A few of these exemptions address: products destined for a kill-step or use in non-FTL form, small retail food establishments, foods subject to regulation by the US Department of Agriculture (USDA), certain ad hoc purchases by retail food establishments and restaurants from other retail food establishments and restaurants, and other new exemptions introduced by the FDA. The FDA has provided an on-line exemption tool to help companies determine if any of the exemptions apply to their products.
Entities will also need to maintain a single traceability plan for all FTL foods they handle and must update the plans as needed to remain current. This is one of the major rules that the FDA was required to issue under the FSMA. Traceability plans must contain the following elements:
- A description of the procedures the entity uses to maintain the records the entity is required to keep under the rule, including the format and location of these records.
- A description of the procedures the entity uses to identify foods on the FTL that it manufactures, processes, packs or holds.
- A description of how the entity assigns traceability lot codes to foods on the FTL, if applicable.
- A statement identifying a point of contact for questions regarding the entity’s traceability plan and records. If the entity grows or raises food on the FTL (other than eggs), a farm map showing the areas in which the entity grows or raises such foods is required.
Entities may maintain records required under the rule in paper, electronic or true copy form. Records must be provided to the FDA within 24 hours or a reasonable amount of time agreed upon by the FDA. In some cases, the FDA will request information to be provided in a sortable spreadsheet but will not prescribe a specific format. However, it will provide sample spreadsheets to assist with compliance.
The requirements established in the final rule turn this common language into a tool that will help the agency rapidly and effectively identify recipients of potentially contaminated foods and quickly remove these products from the market. This will speed up outbreak investigations and recalls to prevent or mitigate foodborne illness outbreaks and address credible threats of serious adverse health consequences or death resulting from foods being adulterated or misbranded. These records will enhance the ability of the involved agencies such as the FDA and the Centers for Disease Control and Prevention (CDC) to conduct root-cause analysis and provide data about the CTE to prevent future occurrence. They will also help in narrowing the scope of a recall to avoid overly broad recalls that implicate unaffected products.
The final rule is effective 20 January 2023, with a compliance date of 20 January 2026, for all persons subject to the record keeping requirements. Facilities that are exclusively regulated by the USDA Food Safety Inspection Services (USDA FSIS) are not covered by this rule. The FDA intends to focus on education, rather than enforcement, during the early implementation stages of the rule. The FDA has published educational and training materials on its Food Traceability Rule website. Companies should begin assessing the steps they will need to take to ensure compliance by the enforcement date of 20 January 2026.
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