Organizations have begun auditing food traceability systems to prepare for FSMA 204. Learn how Foods Connected can help with compliance for FSMA 204.

The Food Safety Modernization Act (FSMA) 204 is a pivotal regulation established by the Food & Drug Administration (FDA) in the US, consisting of new rules on traceability record-keeping for those who manage foods listed on the Food Traceability List (FTL). This comprehensive list encompasses various categories, including non-pasteurized cheeses, nut butters, an extensive range of fresh produce (such as fruits, vegetables, and seafood), and pre-packaged ready-to-eat salads. These regulations ensure the safety and quality of our food supply chain by enhancing data-driven transparency and accountability.

What is the aim of implementing FSMA 204?

FSMA 204 legislation has been meticulously designed to streamline recalls and expedite product tracebacks. This has been prompted by an increased focus on foodborne illnesses like the recent salmonella outbreak in Chicago and the need for visibility within intricate supply chains. By implementing FSMA 204, food businesses can consolidate safety and security measures, thereby reducing avoidable costs and penalties associated with recalls. Moreover, this proactive approach allows them to stay ahead of the curve, as the legislation is regularly updated every five years to address evolving industry demands and emerging food safety challenges.

What are the key requirements of FSMA 204?

FSMA 204 specifies the need for a series of Critical Tracking Events (CTEs) that reflect crucial junctures for safety in the supply chain. By tracking the following events, it is possible to identify the source of any contamination, food safety or quality issues that may arise during:

  • The harvesting and cooling of ingredients and produce

  • The initial packing to make food products suitable for transportation

  • The shipping and receiving of products by retailers and manufacturers

  • The stage at which food products are transformed into consumer-ready goods

The tracking of CTEs requires the maintenance of records containing what are described as Key Data Elements (KDEs) such as the product’s name, lot code and date of manufacture. Lot codes are particularly vital for tracing food products in the event of a safety risk or recall. Data needs to be collected by the food business at each CTE, shared with supply chain partners and retained for two years following the sale or distribution of the food item.

Finally, those designated as responsible for FSMA 204 compliance must maintain proper record-keeping through the creation of a traceability plan. This plan should be accessible to the FDA within 24 hours of being requested, along with an electronic spreadsheet containing traceability information to address any risks to wider public health.

What is the timeline for compliance for FSMA 204?

FSMA 204 officially came into effect on January 23, 2023. To ensure compliance, relevant organizations are given a three-year window to meet the requirements, with the deadline set for January 23, 2026. This extended timeline allows for thorough preparation and implementation of relevant food safety solutions across the supply chain.

How can companies prepare for the FSMA 204 compliance date?

Companies can take concrete steps so that their traceability record-keeping adheres to FSMA 204 guidelines by the compliance date. These include capturing KDEs as part of wider standardization and digitization efforts. This can be facilitated by implementing robust data management systems and utilizing technologies like cryptographic ledger technology for enhanced data integrity and transparency.

By identifying and addressing gaps in capturing and preserving data across the supply chain, companies can establish a comprehensive and reliable traceability system. Furthermore, promoting compliance across their network of vendors, suppliers, and customers through training programs and regular audits can further strengthen traceability practices and mitigate potential risks. By prioritizing traceability, companies can enhance food safety, improve risk management, and build trust with consumers and regulatory authorities.

How Foods Connected can help companies prepare for FSMA 204  

Foods Connected is an award-winning suite of software solutions specializing in traceability and supply chain management. Our platform includes digital record-keeping solutions that can be easily used to fulfil FSMA 204 requirements regarding KDEs and CTEs.

By digitizing vital data, Foods Connected can help companies fulfil one of the main requirements of a compliant food traceability system. End-to-end traceability insights can be shared across the supply chain in real-time - giving companies confidence that they are ‘data ready’ for the FSMA 204 deadline.

A unique differentiator of the Foods Connected platform is that we are data agnostic. We are able to take data that has been collected across the various stages of the supply chain and transform it into a standardised format - allowing for clear farm to fork traceability. Companies can therefore connect a variety of data points into a standardized, end-to-end traceability solution.

Our traceability system has adapted blockchain concepts for the high-volume, low-margin business models that are utilized across the food industry, while complying with GS1 standards for data standardization and transformation. Here is a glimpse of how it works:

  • Clients specify their trace events and their associated data points across the supply chain. This trace is then modelled using a unique configuration language Trace ML, that can be customized to a range of business requirements.

  • We utilize unique cryptographic ledger technology, which consists of linked data blocks containing trace data (and a signature to confirm each block’s position in the wider chain).

  • Clients then use private identification keys in the event that new data blocks are linked to the existing chain, mitigating any risks associated with tampering or fraud. 

You can read more about managing transparency and compliance in the supply chain in the whitepaper below. Alternatively, if you think that Foods Connected can help you prepare for FSMA 204, request a demo of our food traceability software today.

Supply Chain Mapping for the Food Industry Brochure