The FDA’s Food Safety Modernization Act (FSMA) helps prevent foodborne illnesses by creating requirements throughout certain points in the supply chains for human and animal foods. This structure creates a system that promotes public safety by improving traceability to prevent potential issues. The FDA is requiring compliance from many businesses in the human and animal food industries, and the deadline to comply with FSMA’s requirements affects food suppliers, trading partners, and suppliers alike. While the current compliance deadline was extended to July 20, 2028, businesses may need the additional time to make sure all requirements are met. Here is some of what businesses need to know in order to meet the FDA’s requirements. 

What is FSMA?

The Food Safety Modernization Act (FSMA) is an FDA program that allows for faster identification and rapid removal of potentially contaminated food from the market. FSMA is responsible for ensuring the shared responsibility of food safety among the many points in the global supply chain for both human and animal food. FSMA contains several foundational rules to create a modern, risk-based framework for food safety. These rules cover areas including the registration of food facilities, standard for produce safety, sanitary transportation of food, and new dietary ingredients. 

Why is this important?

The FDA finalized the FDA Food Traceability Final Rule (The FSMA 204 Rule), requiring companies to keep additional records for designated foods to protect public health and the food safety system. According to the Center for Disease Control and Prevention (CDC), each year in the United States about 1 in 6 people get sick, 128,000 are hospitalized, and 3,000 die from foodborne diseases. The CDC suggests these health outcomes are largely preventable with the appropriate measures in place. The FDA states that if a business manufactures, processes, packs, or holds any of the foods on the Food Traceability List they are required to keep additional records on the items in order to comply with new requirements.

What this means for your business

If you are a supplier and your customer requires compliance, are a buying organization that either supplies, manufactures, or handles any item on the Food Traceability List, or are a business involved in the supply chain for any item on the list, you must comply with The FSMA 204 Rule by the compliance deadline. Buying organizations and suppliers involved in any Critical Tracking Event (CTE) as defined by the FDA for any item on the Food Traceability List, including harvesting, initial packaging, shipping, and receiving, must provide the records to the FDA containing specific information or Key Data Elements (KDEs) within a predefined time period. 

How do I pass Key Data Elements (KDEs) that FSMA requires?

It is important for organizations to implement a system that captures, stores, and shares KDEs throughout the supply chain in case they must report information to the FDA due to a health or safety concern. Here are a few methods to keep in mind: 

• Partner with a third party provider - Providers will capture and store required KDEs via applications, secure file transfers, or other methods to help with KDE tracking.
• Electronic Data Interchange (EDI) - An EDI provider like Edict Systems can help automate the exchange of KDEs, making traceability easier. Some organizations use an Advance Ship Notice (EDI 856) to send or receive the required KDEs. EDI helps organizations eliminate the need for manual data entry and costly mistakes, successfully pass necessary KDEs, and adhere to FSMA requirements.
• Rely on a manual solution - Some organizations may find it easy to use manual solutions for recordkeeping like spreadsheets, however, these can lead to costly mistakes due to human error.

Where to find more information

• FSMA and the FDA’s requirements including application portal, code list, and fees
• FSMA Final Rule Requirements
• FSMA Final Rule Frequently Asked Questions
  

Edict Systems' EDI experts can help with FSMA compliance

FSMA was designed to help improve the food safety and traceability in the supply chains of human and animal food products in the United States. This act will create mandatory controls, oversight using tools for inspection and compliance for those producing items, and enhancements in the response to food and food related recalls. For buying organizations and suppliers needing to comply with FSMA before the deadline, Edict Systems can help you prepare to pass key information throughout the supply chain through the use of EDI. If you are a buying organization and want to discuss capturing this information via EDI, contact us to speak to one of our experts on how to get started. We do EDI so you don't have to.^®