The FDA’s Food Traceability Rule is a big move towards safer food. This rule helps us trace certain high-risk foods, giving consumers greater peace of mind about what’s on their plates.
The FDA’s enactment of the new Food Traceability Rule responds to a critical need for enhanced safety and transparency in the food supply chain. This initiative stems from a history of significant foodborne illness outbreaks in the US, which have highlighted vulnerabilities in tracking and tracing food products. Traditional methods of tracing food origins and distribution paths proved insufficient during these crises, often leading to delayed responses, widespread consumer panic, and substantial economic losses for the food industry.
The rule is part of the broader FDA Food Safety Modernization Act (FSMA), which represents a paradigm shift from reacting to food safety incidents to preventing them.
The rule’s idea is to have more detailed record-keeping and traceability for certain high-risk foods to rapidly identify and isolate the source of contamination during an outbreak, minimize public health risks, and ensure quicker, more targeted recalls. This approach bolsters consumer confidence in the food supply.
Here’s what you need to know:
FSMA Rule 204 Overview
FDA’s Food Traceability Final Rule known as FSMA Rule 204 or FSMA 204 introduces additional recordkeeping requirements for businesses that manufacture, process, pack, or hold foods listed on the FDA’s Food Traceability List (FTL).
These requirements are designed to trace critical tracking events (CTEs) in the supply chain of designated foods, including their packing, shipping, receiving, and transformation.
FSMA 204 Food Traceability List (FTL)
The Food Traceability List (FTL) identifies high-risk foods that require enhanced recordkeeping under FSMA 204. These products are prioritized due to their susceptibility to contamination, ensuring a faster and more accurate food traceability process.
Check out the FSMA 204 food traceability list:
- Cheeses (soft & semi-soft): Includes cheeses like cottage, ricotta, brie, feta, mozzarella, and blue cheese. Excludes frozen or shelf-stable varieties.
- Shell Eggs: Applies to chicken eggs in shell form.
- Nut Butters: Includes all tree nut and peanut butters, such as almond, cashew, and peanut. Excludes soy or seed butters.
- Cucumbers (fresh): Covers all fresh cucumber varieties.
- Herbs (fresh): Includes fresh herbs like parsley, cilantro, and basil.
- Leafy Greens (fresh): Includes varieties like arugula, kale, romaine, and spinach. Excludes whole head cabbages and tree leaves.
- Leafy Greens (fresh-cut): Covers single and mixed fresh-cut leafy greens.
- Melons (fresh): Includes all melons like cantaloupe and watermelon.
- Peppers (fresh): Applies to all fresh pepper varieties.
- Sprouts (fresh): Covers all fresh sprouts, including alfalfa and bean sprouts.
- Tomatoes (fresh): Includes all fresh tomatoes.
- Tropical Tree Fruits (fresh): Includes fruits like mango, guava, and lychee. Excludes bananas and citrus.
- Fresh-Cut Fruits: Applies to all fresh-cut fruit varieties.
- Fresh-Cut Vegetables (excluding leafy greens): Includes all fresh-cut veggies, except leafy greens.
- Finfish: Covers fresh, frozen, and smoked species like tuna, cod, and salmon. Excludes catfish.
- Crustaceans: Includes shrimp, crab, and lobster.
- Bivalve Mollusks: Covers oysters, clams, and mussels. Excludes scallop muscle.
- Ready-to-Eat Deli Salads: Includes refrigerated salads like potato, egg, and seafood salads.
Critical Tracking Events (CTEs)
Under this rule, specific events in the food supply chain, known as Critical Tracking Events (CTEs), require maintaining records with Key Data Elements (KDEs). The CTEs include:
- Harvesting: Activities on farms or farm mixed-type facilities for removing and preparing raw agricultural commodities (RACs) for food use.
- Cooling: Active temperature reduction processes like hydro cooling or vacuum cooling for RACs.
- Initial Packing: First-time packing of an RAC, excluding foods from fishing vessels.
- First Land-Based Receiver: The first entity taking possession of food from a fishing vessel on land.
- Shipping: Arranging the transport of food from one location to another, excluding direct consumer sales or food donations.
- Receiving: Taking possession of food after transport, including intracompany shipments.
- Transformation: Manufacturing or processing that changes a food or its packaging when the output is on the Food Traceability List (FTL).
This infographic shows a clear example of how CTEs are tracked for romaine lettuce across the supply chain.
Traceability Lot Code (TLC)
Businesses must assign a unique Traceability Lot Code (TLC) to FTL foods during initial packing, first land-based receiving, or transformation. This code, often alphanumeric, ensures traceability throughout the supply chain.
Traceability Plan
Entities subject to this rule must establish and maintain a traceability plan detailing:
- Recordkeeping procedures, including format and location of records.
- Methods to identify FTL foods and assign TLCs.
- A point of contact for traceability-related queries.
- For farms, a detailed farm map indicating the growing or raising areas.
Additional Requirements
- Records must be original, legible, and well-preserved, with electronic records having valid links.
- Upon FDA’s request, records and an electronic sortable spreadsheet with traceability information must be provided within 24 hours or a reasonable agreed time.
Purpose and Benefits of the FDA Traceability Rule
I will highlight 3 key benefits of the traceability rule our clients often highlight. Those are:
- Rapid Response: The FDA can swiftly pinpoint food recipients involved in illness outbreaks using detailed reports.
- Preventive Measure: The rule is a proactive approach to prevent or mitigate the spread of foodborne diseases.
- Consumer Safety: Enhanced traceability ensures greater consumer protection against health threats from adulterated or misbranded foods.
When Did FSMA Go Into Effect?
The rule officially took effect on January 20, 2023. However, the FDA will not be enforcing compliance until January 20, 2026, at which point all persons subject to the Food Traceability Rule must be compliant.
How Does the FSMA Traceability Rule Affect Businesses?
FSMA rule 204 increases compliance demands but enhances food safety, protecting public health and reducing outbreak-related costs. We have a couple of guides highlighting the effect of the FSMA 204 on different types of businesses and food operators to get detailed insights:
Impact on Small Businesses
Recognizing the diverse landscape of the food industry, the FDA has also released a Small Entity Compliance Guide. This guide offers a comprehensive breakdown of the rule, providing clarity and guidance to small businesses on how to navigate these new requirements.
Action Steps for FSMA 204 Compliance
I invite you to explore our detailed guide on complying with the food traceability rule. The guide is packed with practical insights to help you navigate each step with confidence
Here, I will summarize the process into three key steps as listed below:
- Review the Food Traceability List: Familiarize yourself with the foods on the FTL to determine if your business is impacted.
- Understand Recordkeeping Requirements: Ascertain the specifics of the recordkeeping process for the critical tracking events associated with your products.
- Implement Changes: Adjust your current tracking and recordkeeping systems to comply with the new regulations.
Leveraging Technology for FSMA 204 Compliance
Achieving FSMA 204 compliance requires effective, streamlined FSMA 204 software, and that’s where FoodReady excels. This cloud-based platform integrates advanced traceability, reporting, and inventory management tools, helping businesses align with FDA requirements efficiently.
FoodReady’s technology enables companies to track Critical Tracking Events (CTEs) and Key Data Elements (KDEs) across the supply chain, from supplier management to product recall processes. With features like mock recall exercises, automated supplier documentation, and customizable HACCP and SOP checklists, food traceability software simplifies compliance tasks while enhancing operational control.
Last Words on FSMA 204
The FDA’s Food Traceability Rule marks a significant stride in food safety. It underscores the importance of transparency and accountability in the food supply chain. As the industry adapts to these changes, we can expect to see more robust and resilient food system, ultimately benefiting both businesses and consumers.
If you operate in the food industry, FSMA rule 204 is an opportunity to enhance food safety and consumer trust. Let’s embrace these changes for a healthier future!
FoodReady has FSMA 204 Consultants, which can make compliance with FSMA 204 an easy task.
FAQs
There are certain small farms and certain produce growers that are not subject to FSMA 204, however it is complicated and best to read this document.
Begin by reviewing the FDA’s Food Traceability List to identify if your products are covered under the new rule. Next, understand the requirements for recording Critical Tracking Events and Key Data Elements associated with your products. Finally, assess your current traceability system to identify necessary adjustments to meet the new regulations.
A Traceability Lot Code (TLC) is assigned to identify foods on the Food Traceability List during critical handling stages, such as initial packing or transformation. This unique identifier enables precise tracking of food products through the supply chain, facilitating quick identification and action in the event of a food safety concern.
FSMA Rule 204 defines a hostile act as intentional food contamination causing widespread harm to people, animals, or the environment. This includes acts like terrorism, sabotage, arson, and other intentional contaminations.
Businesses must comply with the FDA’s Food Traceability Rule by January 20, 2026.
Violating FSMA 204’s recordkeeping requirements (excluding farms) is a prohibited act under section 301(e) of the FD&C Act. FDA typically seeks voluntary compliance first, issuing advisory or warning letters. If noncompliance persists, federal civil or criminal actions may be pursued. FDA lacks authority to impose fines.
