The Food Safety Modernization Act (FSMA) was enacted in 2011 with the purpose of preventing foodborne illnesses. Finalized on November 15th 2022, the 204 Traceability Rule outlines the requirements for food facilities to implement effective systems for tracking and tracing food. The rule applies to all facilities that are required to register with the FDA, including domestic and foreign facilities that manufacture, process, pack, or hold food for human or animal consumption in the United States.
One of the key components of FSMA 204 is the Food Traceability List (FTL). The FTL was decided upon using a risk ranking model, where each food product in the market has been scored on hazard potential, based on factors such as outbreak frequency and criticality. The information required within this list includes details about the food, such as the type, brand, and any lot codes, as well as information about the immediate previous sources and immediate subsequent recipients of the food.
What Are the FDA Food Traceability Requirements?
Key Data Elements (KDEs) that are associated with certain Critical Tracking Events (CTEs) include:
1. Information about the food: Type of food, brand name, and any lot codes or other identifying information.
2. Information about the immediate previous source of the food: The name, address, and phone number of the source, as well as any other relevant information about the source.
3. Information about the immediate subsequent recipient of the food: The name, address, and phone number of the recipient, as well as any other relevant information about the recipient.
4. Information about the movement of the food: The date the food was received and the date it was shipped to the next recipient.
The FDA is actively encouraging businesses within the Food & Beverage industry to take the same approach toward all food products, voluntarily, anticipating that additional items may be added to the list in due course. Rule 204 became effective on 20th January this year, 60 days after the rule was published in the Federal Register. However, revisions have confirmed an additional three year period, 20th January 2026, for organizations to come into full compliance with Section 204. The FDA believes a period of 3 years is an adequate amount of time for Food & Beverage organizations to implement the necessary compliance processes.
Overall, traceability plays a critical role in protecting public health, ensuring food safety, and building consumer trust. However, to effectively track the movement of your food products from its origin to the consumer (through all stages of production, processing, distribution and delivery) you require a digital FSQA solution that can assist in:
1. Food Safety: Enabling the rapid identification and recall of potentially hazardous food products, helping to minimize the risk of foodborne illness.
2. Compliance: Helping comply with legal and regulatory requirements, such as the Global Food Safety Initiative (GFSI) and the Food Safety Modernization Act (FSMA).
3. Quality Assurance: Helping ensure the quality of your products by tracking and monitoring key aspects of production and distribution, such as temperature control and product handling.
4. Supply Chain Management: Enabling effective management of your supply chain, reducing the risk of product waste/recall, improving efficiency, and increasing transparency.
Preparing for FSMA 204 With AuditComply
To ensure compliance with the FSMA 204 Traceability Rule, food facilities should consider the next steps:
1. Maintaining accurate records: Facilities must keep records of the sources and recipients of their food, including the name, address, and phone number of the previous and subsequent sources and recipients.
2. Establishing traceability procedures: Facilities must have written procedures for tracing food, including the steps for identifying and locating the source and recipients of food in the event of a foodborne illness outbreak.
3. Training employees: Facilities must train their employees on their traceability procedures and the importance of maintaining accurate records.
4. Implementing technology: Facilities may use technology, such as barcode scanning or digital recordkeeping, to help them comply with the rule.
Following on from step 4, although the FDA permits paper records, many Food Organizations will start turning to technology to help meet FSMA 204 requirements. Imagine if you keep paper records and you are required to provide the FDA a digital sortable spreadsheet within 24 hours? Would your team be able to meet this deadline?
Manual tracking methods are often time-consuming, error-prone, and inadequate for meeting the demands of a rapidly growing and highly regulated industry. To address these challenges, companies in the food and beverage industry are turning to AuditComply to manage their traceability and recordkeeping needs. Here are some of the key benefits of using a software platform like AuditComply for enhanced traceability:
1. Improved Food Safety: Quickly and easily identify and recall potentially hazardous food products, reducing the risk of foodborne illness. The platform can also help companies monitor and control key aspects of production and distribution, such as temperature control and product handling, to ensure food safety.
2. Compliance: Comply with a range of legal and regulatory requirements, such as the Global Food Safety Initiative (GFSI), Safe Quality Food (SQF), the Food Safety Modernization Act (FSMA) and more. A software platform can help meet these requirements by providing a centralized repository of information, automating reporting and documentation, and enabling real-time monitoring of production and distribution processes.
3. Quality Assurance: Identify potential quality issues early, reducing the risk of product waste and improving the overall quality of their products.
4. Supply Chain Management: Increase transparency and reduce the risk of product waste. Stitch together the digitized Key Data Elements (KDEs) and Critical Tracking Events (CTEs) of your products’ movement across the supply chain to get comprehensive visibility and transparency. Enabling companies to make informed decisions and respond quickly to changes in demand.
AuditCompy is a critical tool for companies in the food and beverage industry who need to manage their traceability needs. By providing a centralized repository of information, automating reporting and documentation, and enabling real-time monitoring of production and distribution processes, we can help companies ensure the safety and quality of their products, comply with legal and regulatory requirements, and manage their supply chains more effectively.
If you need help understanding how to best approach FSMA 204, reach out to our FSMA 204 experts today.