FDA announced the final traceability rule earlier this week. The Final Rule, which is largely similar to the Proposed Rule, will require certain members of the food industry to develop a traceability program and maintain records of traceability data.
As in the Proposed Rule, only foods determined to be high-risk by the FDA will be subject to the additional traceability requirements. FDA evaluated different commodity and product types, and established the Food Traceability List. This list, which FDA will reevaluate periodically, reflects those foods subject to the additional requirements.
These additional traceability requirements go beyond the standard “one up, one down” tracking that currently occurs. Companies subject to the additional requirements must develop a traceability plan that applies to each food on the Food Traceability List that is manufactured, processed, packed, or held by the company. The traceability plan must include procedures for maintaining the required records, procedures used to identify which foods are subject to the requirements, procedures to assign traceability lot codes, when applicable, and a statement identifying a point of contact for questions about the traceability plan. In addition, for farms or aquaculture operations, a farm map must be included showing the location and name of each separate growing area or container, including geographic coordinates and other information necessary to identify the specific growing location.
Traceability lot codes are assigned only at three points of operations: the initial packing of a raw agricultural commodity (other than food obtained from a fishing vessel); the first land-based receiving of a food obtained from a fishing vessel; and every time the food is transformed. Transformation is any point in a food’s supply chain that involves changing a food through manufacturing, processing, packing, or labeling, for example, where the output food is also on the Food Traceability List.
Records required under the Final Rule depend on the stage of the supply chain. Generally, however, records must include the location information for the immediate subsequent recipient, immediate previous recipient, and for any processing that occurred. In addition, quantity and product descriptors are required. Finally, for each transfer throughout the supply chain, a specific reference document must be associated with the transfer. Reference documents are business transaction documents that reflect the transaction or process, and may include purchase orders, invoices, bath logs, or production logs.
Generally, all companies that handle a food type on the Food Traceability List are subject to the Final Rule. However, FDA has provided certain exceptions based on company size or company type. In addition, certain products that may otherwise be subject to the requirements of the Final Rule are exempt from the requirements in certain circumstances. When an exemption is available and applicable, however, modified record requirements are typically triggered to demonstrate that the exemption is applicable and to ensure that the traceability chain is intact until the exemption applies. Product-based exemptions include produce that is rarely consumed raw, food that has been subjected to a kill step, and food that has been transformed such that the final product is no longer listed on the Food Traceability List. Here, FDA has provided an example of canned spinach as a product that would be exempt from the requirements. Prior to treatment, leafy greens are listed on the Food Traceability List and, as such, spinach would be subject to the traceability requirements. However, canning acts both as a kill step and transforms the product, a fresh leafy green, into a cooked, non-fresh leafy green, which is not listed on the Food Traceability List. The canning processing step would, regardless, be subject to recordkeeping to demonstrate why the exemption applies, and the canner would still need to comply with record requirements applicable to receivers of foods on the Food Traceability List, as the food was received while not eligible for an exemption.
The Final Rule becomes effective sixty days after publication, on January 20, 2023. FDA has indicated the Compliance Date will be three years from the effective date, or January 2026. Unlike other Final Rules issued recently by FDA through FSMA, FDA has not indicated a staggered compliance period based on company size. Rather, FDA has indicated that all companies subject to the traceability requirements will be required to comply by the same Compliance Date. This, the agency has said, is due to the complexity of the food supply chain and the challenges that would present if portions of the supply chain were subject to later compliance dates.
If you have any questions or would like to discuss further how the Final Rule on traceability applies to your business, please know that the Food Industry Counsel team is here to assist.
Liz Presnell is a food industry consultant and lawyer, and has worked in the food industry for nearly a decade. She can be reached at presnell@foodindustrycounsel.com.