Blockchain and the FDA’s Blueprint for a New Era of Smarter Food Safety

Dr. Mason Marks is an Assistant Professor at Gonzaga University School of Law, and a RegTrax Contributor for the United States. He is the Edmond J. Safra/Petrie-Flom Center Joint Fellow-in-Residence at Harvard University and an Affiliated Fellow at the Information Society Project at Yale Law School.

Distributed ledger technology could update U.S. food tracking system to stop foodborne illness.

According to the Food and Drug Administration (FDA) and the Centers for Disease Control and Prevention (CDC), there are about 48 million cases of foodborne illness annually in the United States. Roughly 1 in 6 Americans are affected, 128,000 are hospitalized, and 3,000 die each year. There are several potential causes including Norovirus and bacteria such as E. coli, Salmonella, and Campylobacter. According to the U.S. Department of Agriculture, foodborne illness costs the country more than $15.6 billion annually.

To reduce the risk of foodborne illness, Congress introduced the Food Safety Modernization Act (FSMA) in 2011. It was designed to shift the focus of the U.S. food safety system from responding to foodborne illness to preventing it. Since 2011, the FDA has implemented seven major rules to achieve that mandate. Examples include rules to implement testing by accredited food laboratories, improve the cleanliness of food transport, and mitigate the impact of intentional food adulteration. However, effective prevention of foodborne illness requires robust systems for rapidly tracing the source of an outbreak.

The FSMA was passed ten years ago, before technologies like blockchain, artificial intelligence, and the internet of things had matured. Accordingly, on July 13, 2020 the FDA published its blueprint for a New Era of Smarter Food Safety, which utilizes these emerging technologies to build on its ongoing efforts to implement the FSMA. The blueprint aims to harness Information Age technologies to reduce food waste, prevent foodborne illness, and track contaminated food to its source.

The FDA had planned to unveil the blueprint in March 2020, but COVID-19 delayed its release. According to Commissioner Stephen Hahn: “In the months that have followed, it has become even clearer . . . just how essential the actions outlined in this blueprint are and, if anything, that they are more important now, than ever.”

The pandemic highlighted weak points in existing food infrastructure that contributed to retail shortages and regional surpluses resulting in wide-scale spoilage and crop destruction. Meanwhile, the country’s increased reliance on direct-to-consumer food delivery raised concerns over food preservation and contamination during transit. A smarter food supply chain could address these issues. According to Frank Yiannas, Deputy FDA Commissioner for Food Policy and Response, blockchain “has enabled food system stakeholders to imagine being able to have full end-to-end traceability. An ability to deliver accurate, real-time information about food, how it’s produced, and how it flows from farm to table is a game-changer for food safety.”

The FDA identifies a lack of traceability as the Achilles heel of the U.S. food system. Currently, tracking data remains largely paper-based. With an eye toward updating the system, the blueprint draws inspiration from real-time tracking of aircraft, ride sharing vehicles, and delivery trucks used by companies like FedEx, Uber, and Amazon.

According to the FDA, while the food system remains paper-based, there is “insufficient data identifying the product along the supply chain,” making it impossible to rapidly track and trace. Following an outbreak of foodborne illness, it could take hours or days to identify the source. The agency believes blockchain can help reduce that time to minutes or seconds. However, despite the ambitious tone of its blueprint, the FDA has engaged in no formal rulemaking regarding blockchain and food traceability.

In September, it published a proposed rule for improving the traceability of high risk foods on its Food Traceability List, which include eggs, leafy greens, certain fruits, and seafood. Though the proposed rule does not mention blockchain, it will impose additional record keeping requirements onto those who manufacture, process, pack, or store high-risk foods.

Meanwhile, many tech companies have already adopted blockchain to track products in the food supply. In 2018, IBM launched its blockchain-based Food Trust platform. Early adopters included Nestle, Dole, Tyson Foods, Unilever, Kroger, and French retailer Carrefour. IBM’s network is built on the Hyperledger Fabric, a “permissioned” distributed ledger platform that is part of a larger set of open source tools created by the Linux Foundation with help from IBM and Intel. It is compatible with GS1, a global standard for business communication, which includes the barcodes commonly used to identify products. Given how advanced commercial logistics have become, and the number of companies that have partnered with IBM, it is surprising that the national food tracing system remains relatively primitive.

According to Angela Fernandez, vice president of community engagement for GS1 US, blockchain may be helpful for food traceability. “Trading partners involved in the purchasing, receiving, and invoicing of products are writing to a distributed ledger. Anyone who’s a part of that transaction can go and see the real-time data. It streamlines visibility from end to end,” said Fernandez in an interview with Supply Chain Brain, a publication for supply chain professionals. However, Fernandez also said blockchain is only one tool in the food traceability toolbox. “The best traceability processes have a combination of technologies at play.” Other important tools include radio frequency identification (RFID) and internet of things sensors that track products as they move throughout supply chains.

On October 26, the FDA published a one-hour webinar on the first 100 days of its New Era of Smarter Food Safety. Blockchain was conspicuously absent from the discussion. However, FDA officials said they are “working to build a platform to rapidly receive electronic traceability data.” It is unclear whether this platform will utilize blockchain, the Hyperledger Fabric that underlies IBM’s Food Trust platform, or similar open-source tools. However, the FDA’s blueprint identifies compatibility with GS1 and other international standards as priorities. Interoperability is important because the supply chain is now global, and when food is imported or shipped overseas, it can harbor contaminants that must be traced if they trigger an outbreak.

While U.S. food tracking remains paper based, it subjects millions of Americans to foodborne illness. The FDA says its New Era of Smarter Food Safety is coming. But with thousands of lives and nearly $16 billion on the line each year, it can’t arrive soon enough.


Dr. Mason Marks is an Assistant Professor at Gonzaga University School of Law, and a RegTrax Contributor for the United States. He is the Edmond J. Safra/Petrie-Flom Center Joint Fellow-in-Residence at Harvard University and an Affiliated Fellow at the Information Society Project at Yale Law School.

Follow Mason on Twitter: @masonmarksmd