FDA Regulations: Agency Sets Path to Modernize Approach to Food Safety

In early 2020, the FDA will unveil a “blueprint” outlining plans to modernize its approach to regulating food safety under the Food Safety Modernization Act (FSMA). These plans will include use of technology-enabled traceability tools such as blockchain, new predictive analytical measures to assess risk, and data analytics to improve root cause analyses and respond to contamination.

To help refine its analytical approach, the agency has solicited feedback through a federal docket and convened a public meeting. Representatives from the food and technology industries, consumer groups, academia, and officials from government agencies in the U.S. and UK attended a full-capacity meeting on Oct. 21.

“Smarter food safety is people-led, FSMA-based, and technology-enabled,” Frank Yiannas, deputy FDA commissioner for food policy and response, told attendees in opening remarks. While much progress has been made to improve safety and efficiency, “today’s food system has one major Achilles heel, and that’s a lack of traceability and transparency,” he said.

Prior to the meeting, the FDA had asked more than 100 agency staffers to brainstorm ideas for turning the smarter food safety vision into reality. The four broad areas were tech-enabled traceability, smarter tools and approaches for prevention, new business models, and food safety culture. These then served as focal points for discussion during the meeting, with the FDA and industry experts giving short presentations prior to simultaneous breakout sessions during which attendees offered comments and suggestions.

Tech-Enabled Traceability

Traceability and foodborne outbreak response involve technologies, data streams and processes to reduce the time needed to track and trace the origin of a contaminated food and respond to public health risks. Much of the discussion at the FDA meeting involved the need for clear data standards, challenges to implementing blockchain technology, ensuring protection of proprietary data, and enhancing outbreak response activities.

Currently, most food companies keep records of one step back to identify the source and one step forward to where the food has gone, as required by federal law. And many companies keep these records on paper, not electronically. Federal and state investigators found this especially frustrating in 2018 as they sought to determine the source of E. coli-tainted romaine lettuce from the Yuma growing region. Had growers and shippers used electronic records and blockchain technology, tracing the origin might have taken minutes or even seconds, instead of weeks and months.

Blockchain uses a decentralized, secure ledger that’s shared by all parties in the supply chain to provide transparency on a product’s origins. It can greatly assist in warning consumers about risks with specific foods and in implementing more targeted and efficient recalls. While the FDA does not intend to create a government-run blockchain platform, it will encourage industry to adopt this and other digital technologies to facilitate rapid traceability through the food distribution chain, Yiannas said.

Prior to joining the FDA in December 2018, Yiannas had been responsible for implementing blockchain technology for tracing produce sold at Walmart. In speeches to industry groups, he often tells how he was able to reduce the time needed to trace a package of sliced mangoes from farm to store from nearly seven days using traditional methods to a mere 2.2 seconds using blockchain. “An ability to deliver accurate, real-time information about food, how it’s produced, and it flows from farm to table is a game-changer for food safety,” Yiannas said in a recent FDA publication.

But there are serious hurdles to overcome if blockchain is to be widely adopted by the food industry, said Alex Manders, head of blockchain services at Information Services Group, a Stamford, CT-based consultancy. These include incomplete knowledge of blockchain vendors, the available technology solutions, collaboration models, and a lack of industry and governance frameworks, he said at the FDA meeting.