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On November 7, 2022, the Food and Drug Administration (FDA) submitted the Food Safety Modernization Act (FSMA) Final Rule: Requirements for Additional Traceability Records for Certain Foods (Food Traceability Rule) to be published in the Federal Register. The Rule is scheduled to be published November 21, 2022, and will become effective 60 days after. The compliance date for all entities subject to the updated recordkeeping requirements is two years later—January 21, 2025.
Food traceability is the ability to track any food through all stages of the supply chain—production, processing, distribution—to ensure food safety and operational efficiency. Improving food traceability is a key objective for the FDA. The Administration has taken a number of actions over the past few years to put food traceability in the forefront, including establishing Tech-Enabled Traceability as a core element in the FDA’s New Era of Smarter Food Safety Blueprint and now, publishing the final Food Traceability Rule.
Summary of Key Elements
While FDA has had food traceability requirements, the new rule under FSMA Section 204(d) is intended to enhance traceability recordkeeping for certain identified foods beyond a limited “one-up, one-back” traceback approach. The objective of the rule is to “help the FDA rapidly and effectively identify recipients of those foods to prevent or mitigate foodborne illness outbreaks and address credible threats of serious adverse health consequences or death.”
Key elements of the proposed Food Traceability Rule include the following:
- Food Traceability List (FTL): The FTL designates categories of high-risk foods that require additional recordkeeping to protect public health. The Agency created a risk-ranking model to identify the following high-risk foods for inclusion on the FTL: cheeses, shell eggs, nut butter, cucumbers, fresh herbs, leafy greens, melons, peppers, sprouts, tomatoes, tropical tree fruits, fruits and vegetables (fresh cut), finfish, crustaceans, mollusks/bivalves, and ready-to-eat (RTE) deli salads. The rule establishes a process for FDA to update the FTL, as appropriate. Additions become effective one year after publication in the Federal Register; deletions would become effective immediately.
- Critical Tracking Events (CTEs) and Key Data Elements (KDEs): The rule requires tracking KDEs for five defined CTEs: growing, receiving, creating, transforming, and shipping. At each CTE, the responsible entity needs to record the traceability lot code and relevant KDEs specific to that activity. The traceability lot code is to be established by entities that originate, transform, or create food on the FTL. This identifier remains the same as the product moves through the supply chain unless a transformation of the food occurs. The objective is to create linkages throughout the supply chain to help the FDA address key points in the supply chain more quickly in the event of an outbreak.
- Traceability Program Records: Any entity that engages in production of a food on the FTL must create and maintain traceability program records, including a description of relevant reference records, list of foods on the FTL that are shipped, description of how traceability lot codes are assigned, and any other information needed to understand data. Records must be maintained as either original paper records, electronic records, or true copies. An electronic sortable spreadsheet must be provided to FDA within 24 hours during an outbreak, recall, or other threat to public health.
The final rule maintains several exemptions and partial exemptions included in the proposed rule. Some of these include excluding produce that is rarely consumed raw (RCR), certain farms and small originators, farms that sell directly to consumers, certain food produced and packaged on farms, small retail food establishments (RFEs), and others.
Meeting the Needs: Document Management
Over the next two years, those who manufacture, process, pack, or hold foods on the FTL will need to develop and implement the management systems required to fulfill the Food Traceability Rule’s recordkeeping requirements. And while these requirements only apply to foods on the FTL, FDA states that “they were designed to be suitable for FDA food products” and encourages the voluntary adoption of these practices industry-wide.
Having a good document/records management system is essential for maintaining the vast number of documents required by regulations and standards such as the Food Traceability Rule. Companies have been keeping records and documents in binders and file cabinets for years. While that system can work, many dynamic tools are available to alleviate some of these challenges and support organizational decision-making. A document management system can help create:
- Process and document standardization
- Central and secure storage, organization, and access to documents and records locally or remotely
- Improved document searchability and accessibility
- Enhanced workflows for approving and completing tasks involving documents
- Easy access to documents for audits and clear audit trail, particularly for remote audits
- Version control and history
- Reduced paperwork
- Higher quality data due to reduced human error
- Improved collaboration
- Improved security of sensitive documents
All of which lead to consistent, efficient, and reliable compliance performance which, in the case of food traceability, will help to:
- Create standardization and harmonization across industry approaches.
- Reduce response time in a foodborne illness outbreak and, subsequently, the number of people impacted.
- Limit the overall scope of recalls.
- Improve communication and create stronger linkages through greater transparency throughout the supply chain.
- Eventually create end-to-end traceability.