FSMA

What is FSMA?

The Food Safety Modernization Act (FSMA) is a law passed in 2011 that focuses on preventing food contamination rather than just responding to it after it happens. It’s one of the biggest updates to U.S. food safety regulations in decades and affects everything from how food is grown and processed to how it’s distributed.

Key Parts of

FSMA

Preventive measures

Food facilities must put plans in place to prevent contamination before it occurs and keep records of those measures.

Food defense

Companies are also required to protect food from intentional contamination.

Imported foods

FSMA requires that imported food meet the same safety standards as food produced in the U.S., giving the FDA more oversight of foreign suppliers.

Inspections

The FDA has increased power to inspect facilities and ensure proper food safety practices are being followed.

Mandatory recalls

The FDA now has the authority to order recalls if unsafe food is found, rather than waiting for companies to voluntarily recall products.

FSMA applies to many parts of the food supply chain, including farmers, processors, distributors, and importers. The goal is simple: to make the U.S. food supply safer and reduce the risk of foodborne illnesses.

What is FSMA 204?

FSMA 204 refers to a specific section of the Food Safety Modernization Act (FSMA) that focuses on enhanced traceability for certain high-risk foods. Officially known as Section 204 of FSMA, it aims to improve the ability to trace foods through the supply chain, making it easier to identify the source of contamination in the event of a foodborne illness outbreak.

Key elements of FSMA 204 include:

  • Traceability Requirements: The FDA mandates that companies handling certain high-risk foods (like leafy greens, dairy, seafood, etc.) maintain detailed records of where these foods come from, where they go, and how they are processed.
  • Food Traceability List (FTL): FSMA 204 requires that high-risk foods on the FDA’s Food Traceability List (FTL) follow enhanced traceability protocols, with additional record-keeping requirements for entities that grow, process, pack, or ship these foods.
  • Traceability Lot Codes (TLCs): A unique identifier, often alphanumeric, must be assigned to all foods on the FTL at key points, such as initial packing or first land-based receiving. This code links each lot to critical tracking events, ensuring accurate traceability throughout the supply chain.
  • Traceability Plan: Companies subject to FSMA 204 must maintain a detailed Traceability Plan, outlining how records are kept, how traceability lot codes are assigned, and providing a point of contact for inquiries. For producers, the plan includes a map showing the location of fields or containers for high-risk foods.
  • Key Data Elements (KDEs): Businesses must record and share specific data points (KDEs) like the food’s origin, batch or lot numbers, and shipment details at every step in the supply chain.
  • Critical Tracking Events (CTEs): Companies must track significant points (CTEs) in the food’s lifecycle, such as creation, transformation, or shipment, to ensure complete traceability of high-risk foods.

The primary goal of FSMA 204 is to improve the traceability of high-risk foods, enabling faster identification and removal of contaminated products from the supply chain. This reduces the risk of foodborne illnesses and creates a more transparent and responsive food traceability system.

How can you prepare for 204?

Assess Your Current Systems and Processes: Start with a comprehensive evaluation of your existing systems and workflows. Identify your strengths and pinpoint gaps by examining your approach to traceability, data capture, and record management. Determine what’s functioning well and where there’s room for improvement to optimize your operations.

Review Your Data Standards: Assess how your data is structured to ensure it supports effective traceability. Are you utilizing globally recognized standards such as GS1? If not, consider implementing standardized formats to improve consistency, accuracy, and shareability throughout your supply chain.

Perform a Gap Analysis: After evaluating your current systems and capabilities, conduct a thorough gap analysis to uncover deficiencies in meeting FSMA 204 requirements. This process will reveal exactly where your operations fall short, allowing you to identify specific areas that require enhancements or upgrades.

Engage Suppliers on FSMA 204 Compliance: Open a dialogue with your suppliers about supporting your FSMA 204 traceability efforts. Communicate the need for them to provide all Key Data Elements (KDEs) for relevant foods and ensure they understand the importance of complying with FSMA 204 requirements to maintain seamless traceability across the supply chain.

Align Data with Suppliers: Ensure your data is consistently up-to-date across all suppliers. Verify that product information is accurate and standardized throughout your network, from manufacturers to distributors. This alignment helps identify items requiring Key Data Elements (KDEs) and ensures you have the necessary compliance documentation to meet regulatory requirements.

Identify High-Risk Foods in Your Inventory: Determine which products in your inventory include high-risk foods listed on the Food Traceability List (FTL). By recognizing items that require enhanced traceability, you can prioritize collecting the necessary data and compliance documentation for those products.

Food Safety Compliance & FSMA

Ensure your business meets the latest food safety regulations, including the Food Safety Modernization Act (FSMA). SMRTR’s solution helps you streamline compliance by automating key processes and managing the critical data needed to stay in line with FSMA requirements. By reducing manual errors and enhancing operational efficiency, SMRTR enables your organization to confidently meet regulatory demands and maintain high standards in food safety.

Food safety and quality management. Food safety and quality inspector filling out quality control form in a laboratory, salmon in background

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