How End-to-End Transportation Visibility Helps Shippers Meet FDA Perishable Traceability Requirements & Rules

February 10, 2023

July 2, 2024


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In January 2011, the Food Safety Modernization Act (FSMA) became law—the most sweeping reform of U.S. food safety laws in more than 70 years. Yet a mere eight months later, a listeria outbreak linked to cantaloupe caused 33 deaths and more than 140 illnesses. And while it’s hard to imagine anything good coming out of that, the regulatory fallout from that catastrophic event—namely, more stringent Food and Drug Administration (FDA) traceability requirements—continues to strengthen and safeguard food supply chains in the United States and abroad.

This article explores the FDA’s efforts to bring comprehensive, science- and technology-based preventive controls across the food supply chain, the evolution of the FDA’s traceability requirements, and how the right supply chain visibility solution can help perishable food shippers—and their logistics partners—comply with the rules.  

What is FDA traceability?

FDA traceability is the ability to trace a product from the point of origin to its destination through the supply chain. This involves keeping records of all transactions and activities related to each lot number, as well as providing the FDA with on-demand access to records and documents.

The FDA’s push for improved traceability began with the FMSA and continued with the agency’s issuance of a Final Rule on Traceability Records, which took effect in 2017. This rule requires food manufacturers, processors, and distributors to create and maintain records that enable them to quickly and accurately trace products in a timely manner—should a food safety issue arise. This helps the FDA to more quickly identify and recall contaminated food, reduce the risk of foodborne illness, and protect public health. The rule also creates a framework for companies to share information about recalled products, and helps to ensure that food products are safe and meet quality standards.

The FMSA and the Final Rule on Traceability Records were a good starting point, but the FDA advanced things even further as we entered a new decade.

The Push for Additional Traceability Records for Certain Foods 

The FSMA Final Rule on Requirements for Additional Traceability Records for Certain Foods took effect on May 20, 2020. This rule requires food manufacturers, processors, and distributors to develop and maintain records related to certain foods that are at higher risk for contamination—items such as fruits and vegetables, seafood, dairy products, juices, and baby formula. And yes, according to the American Academy of Pediatrics the Great Baby Formula Shortage of 2022 happened, in part, due to difficulty in tracing baby formula shipments.

 To meet this latest FDA traceability rule, food shippers must develop and maintain records that include the following information:

  • Product description
  • Lot or code number
  • Production and expiration dates
  • The name and address of the facility where the food was produced
  • The name and address of the facility where the food was shipped

They must also be able to track and trace the food back to the source within a reasonable amount of time. Additionally, food shippers are required to maintain the records for a period of two years from the date of shipment.

Regulations Around Perishable Shipping & Logistics Processes

In addition to the FDA’s stringent traceability requirements, shippers must navigate through more rules and regulations from other regulatory agencies. Here are two examples:

  • The U.S. Department of Agriculture (USDA) Perishable Agricultural Commodities Act: Outlines requirements for the safe transport of perishable agricultural commodities
  • The International Chamber of Shipping (ICS) Code of Practice for the Safe Loading and Unloading of Bulk Cargoes: Establishes requirements for the safe loading and unloading of bulk cargoes, including perishable products

Challenges to Tracking & Tracing Food Shipments

Moving perishable foods—whether across town, to another state, or coast to coast—is never an easy task. Shippers face a gauntlet of challenges, including:

  1. Keeping up with changing regulations and industry standards
  2. Ensuring the accuracy of collected and stored data 
  3. Implementing systems that are compliant with traceability requirements
  4. Ensuring accurate tracking of shipments throughout the supply chain
  5. Identifying and responding to transit delays and product spoilage
  6. Ensuring safe handling and storage of perishables during transit
  7. Integrating traceability systems with existing business systems
  8. Managing the cost associated with implementing traceability systems

To solve these challenges and more, shippers need a robust visibility solution based on modern sensors and an accessible and open cloud-based platform.

How End-to-End Visibility Solutions Aid in FDA Traceability

Tive’s portfolio of products includes robust products, hardware, cloud-based software, and services that deliver unparalleled monitoring and visibility for shippers and logistics professionals alike.

Tive Tag is a reusable, paper-thin temperature logger in the form of a flexible shipping label. Tive Tag captures and stores temperature data for each perishable food shipment from the moment it’s applied to a shipment, and is quickly activated using a smartphone (iOS or Android). Temperature data is available in the cloud, and can be downloaded to support a shipper’s compliance needs—including FDA traceability requirements. Tive Tag has no radiated emissions, and minimal electronic waste to support sustainability. The tag is reusable for over a year.

Alternatively, Tive Solo, Solo 5G, and Solo 5G non-lithium trackers capture and transmit hyper-accurate location and condition data—including temperature, humidity, shock, and light) in real time. Real-time data can be easily accessed from the cloud-based platform at any time, and shippers can prepare detailed reports–and easily create excursion alerts and notifications–showing they maintained cold chain custody throughout the supply chain journey.

All Tive Solutions Support FMSA Compliance

Whether it’s the easy-to-use Tive Tag temperature logger or the Solo 5G trackers, which provide real-time visibility into a shipment’s location and condition, perishable food shippers can rest assured that they will have the data to support their FDA traceability needs. To learn more about which solution would be best suited for you, contact Tive today.

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