One of the key aspects of Section 204 of the Food Safety Modernization Act (FSMA) is the establishment of records pertaining to the production, processing, packing, distribution, receipt, holding or importation of food. This broad scope reflects the comprehensive approach that FSMA adopts in addressing the entire lifecycle of food products. Businesses are required to maintain accurate and detailed records for a specified period, allowing for effective traceability and accountability.

The records mandated by Section 204 include information that is kept in the normal course of business and some items that are not captured and shared immediately. Records will be be required for each lot of product on the food traceability list, including lot codes, locations, quantity and units of measure, product information, company information and reference documents in addition to having a traceability plan in place. The goal is for FDA to be able to independently and quickly identify the source of outbreaks and to remove implicated products from commerce.

“[Supermarket operators] have to maintain records for every lot of product they’re receiving in each of those required categories. The quantity of items and volumes are staggering. Given that retailers receive and sell all product categories, the rule is a huge challenge and will come with changes in business practices,” said Hilary Thesmar, chief science officer and senior vice president of food and product safety at FMI - The Food Industry Association.

FSMA Section 204 imposes requirements on the accessibility and availability of records. Businesses must have systems in place to provide relevant records promptly to the FDA upon request. This emphasis on accessibility is designed to expedite the response to potential food safety issues, ensuring that regulatory authorities can swiftly assess the situation and take necessary action.

The implementation of FSMA Section 204 involves not only creating and maintaining records but also regularly reviewing and updating them. This proactive approach is integral to the prevention-centric philosophy of FSMA. By routinely evaluating and enhancing recordkeeping practices, businesses can identify potential vulnerabilities and address them before they escalate into safety concerns.

It is essential for businesses to recognize the collaborative nature of FSMA implementation. Section 204 emphasizes communication and cooperation within the food supply chain. Entities involved in the production, distribution, and importation of food must work together to share relevant information and ensure the effectiveness of traceability efforts. This collaborative approach strengthens the overall resilience of the food supply chain against potential threats.

“FSMA Section 204 will likely necessitate greater collaboration and transparency in the retailer-supplier relationship. Retailers and suppliers will need to establish more integrated systems for sharing traceability data and ensuring compliance throughout the supply chain. That said, the rule does not require ‘full pedigree’ traceability that would allow a retailer (or anyone more than one-step removed in the supply chain) to easily determine the full movement of an FTL food through the supply chain,” said Ben Miller, executive vice president of regulatory and scientific affairs at The Acheson Group LLC, a leading food safety advisory firm.

“The final version of the rule created a KDE called the ‘Traceability Lot Code Source Reference’ to provide an alternative method for providing FDA with access to the location description for the traceability lot code source. Examples of a traceability lot code source reference include, but are not limited to, the FDA Food Facility Registration Number for the traceability lot code source or a web address that provides FDA with the location description for the traceability lot code source. This allows suppliers upstream in the supply chain to protect commercially confidential information and relationships, while still maintaining compliance with the rule.”

Critical Tracking Events

The points in the food supply chain where Key Data Elements must be collected include:

  • Harvesting
  • Cooling (before initial packing)
  • Initial packing of a raw agricultural commodity other than a food obtained from a fishing vessel
  • First land-based receiving of a food obtained from a fishing vessel
  • Shipping
  • Receiving
  • Transformation of the food

Key Data Elements

The information required to be collected at the retailer’s location include:

  • Traceability lot code for the food
  • Quantity and unit of measure of the food
  • Product description for the food
  • Transformation of the food
  • Location description for the immediate previous source (other than a transporter) for the food
  • Location description for where the food was received
  • Date you received the food
  • Location description for the traceability lot code source or the traceability lot code source reference
  • Reference document type and reference document number

This article is an excerpt from the March 2024 issue of Supermarket Perimeter. You can read the entire Navigating Change Part 2 feature and more in the digital edition here.