FEATURE STORY
New Traceability Regulation: Is Two Years Plenty of Time? By Sonia Salas, Associate Vice President, Science
I n September 2020, the Food and Drug Administration (FDA) published “Requirements for Additional Traceability Records for Certain Foods” (the Traceability Rule or FSMA Rule 204), proposing regulations mandating the establishment and sharing of food production-related records to shorten the FDA’s investigations of outbreaks when they occur. After extending the original comment period until February 2021, the agency took several months to review stakeholder feedback, and the rule was finalized in November 2022. By January 20, 2026, all companies that are subject to the rule will be required to have a traceability plan in place, assign traceability lot codes and maintain records of various critical tracking events as defined in the rule. The rule comes with its own terminology that, as defined by the FDA, may or may not currently be used by or familiar to the fresh produce sector. Planning and Preparing Do not wait until the Traceability Rule
Traceability Rule Timeline and suggests a path to compliance, which includes four elements: Learn, Plan, Do and Review. Learn means reading and understanding the Traceability Rule as well as conducting a gap analysis to see what information is missing within the supply chain. Plan means the development of a food traceability plan and developing a budget for its implementation. Do refers to having
executing or implementing the traceability plan, and Review refers to assessing results, a gap analysis and periodic reviews to determine the level of compliance. Companies that have implemented the Produce Traceability Initiative (PTI) requirements, as many on the supply side have done, are already on the path to compliance with Rule 204. Although not all Rule 204 requirements align with
enforcement date; prepare now. As we start 2024, two years may seem like a long time, but if companies are judiciously planning and preparing to be compliant, this time will be used to: 1. Determine the information customers are going to need and the systems they use to accept that information. 2. Determine the information needed from suppliers and the systems they use to log that information. 3. Assess the records currently kept and the existing recording-keeping systems. 4. Analyze the information shared within the supply chain and identify missing data. During a recent Western Growers webinar, Andrew Kennedy, Principal Traceability Advisor with New Era Partners, and Minos Athanassiadis, Vice President at iFoodDS, reviewed common challenges and questions around implementing the Traceability Rule. Kennedy, who as a former FDA employee helped to write the proposed rule, outlined steps companies can take to prepare for rule compliance. An important recommendation was to follow a methodical and systematic approach to making decisions that assess the adequacy of existing recordkeeping systems as well as suppliers and customers’ information requirements and systems. Both speakers encouraged companies to do their homework and talk with their suppliers and customers first before buying new systems and/or services. As a reference, New Era Partners/iFoods created an infographic that depicts a Food
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JANUARY | FEBRUARY 2024
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