Blockchain for Compliance with Proposed FDA Rule for Food Traceability

Author photo: Ralph Rio

Overview

The FDA defines food traceability as the ability to follow the movement of a food product and its ingredients through all steps in the supply chain, both backward and forward. Though manual systems are not banned, it is impractical to comply using paper. Reporting involves tracing through dozens of critical tracking events within one day.

Immutable digital processes across the supply chain become necessary, which initiates the consideration of blockchain. The decision flowchart in this report makes the case for deploying blockchain for track and trace in the complex and dynamic mesh of the food supply chain.

This report builds on the Insight “New FDA Food Safety Regulation Drives Digital Transformation of Food Supply Chain” published on Oct 22, 2020 that reviewed the purpose and scope of the proposed rule. This Insight delves into why blockchain should be considered for compliance.

FDA’s Proposed Traceability Rule

The Food Safety Modernization Act (FSMA) became law in 2011. It instructs the FDA to develop record keeping requirements for clear tracing of a food product’s source for faster recalls when identified as unsafe. On September 21, 2020, FDA formally released for comment the proposed traceability rule.

Food Consumed Raw

Since cooking kills bacteria like salmonella, the proposed rule focuses on food that is often consumed raw. The specific foods include cheeses, eggs, nut butter, cucumbers, herbs (fresh), leafy greens, melons, peppers, sprouts, tomatoes, fruits, vegetables, finfish, crustaceans, mollusks, bivalves, and ready-to-eat deli salads. A complete list is available here.

Food Supply Chain Complexity

Rather than a neat, limited linear chain as often depicted, the food supply chain is a complex dynamic mesh with many thousands of nodes. The recently proposed traceability rule requires capturing critical tracking events (CTE) and providing real-time visibility across the product's supply chain.

Blockchain for Compliance

Food Industry Has Adopted Blockchain

The overlapping, mesh-like supply chain makes it impractical for each company to create and deploy its own custom solution for traceability – there would be thousands of applications with extensive duplication. With an immutable distributed ledger available to all participants, blockchain has become the preferred infrastructure for traceability in the food supply chain. Currently, the food industry is the leading industry for applying blockchain.[1] 

Decision Path for Selecting Blockchain

Blockchain technology offers a means to share immutable data among independent entities. It involves multiple layers of encryption and automated voting processes to resolve inconsistencies when they occur[2]. Blockchain offers a unique set of capabilities that are suitable for a limited set of applications. The decision flowchart provides a structured means to determine if blockchain fits an application.

 

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Keywords: Blockchain, Food Safety, FDA, Track and Trace, Supply Chain, ARC Advisory Group.

 


[1] Rio, Industrial Blockchain in the Food Supply Chain, ARC Insight, March 12, 2020

[2] Voting occurs often. Each node has a copy of the blockchain database and accumulates transactions as they occur during a set period of time into a block. Bitcoin uses 10 minutes. At the moment the period closes, some nodes may put a transaction into the current block while others may put it in the next. Blockchain has a voting mechanism that determines the most common block.

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