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.
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.
Manders urged the FDA to commission research to help industry facilitate blockchain implementation. But he cautioned against over-regulation. “New requirements … could slow the adoption of real-world blockchain track-and-trace solutions,” he said.
Perspectives on the FDA’s role
While most panelists and attendees applauded the FDA’s initiative to formulate the new era smarter food safety, some noted that the agency should do more with the tools it already has.
“I think ‘smarter’ means more effective, that we’re doing a better job, all of us, in reducing contamination and reducing the burden of food-borne illness,” said Sandra Eskin, director of food safety at the Pew Charitable Trusts. “That may involve some shiny new technologies and it may involve some lower-tech but no less important tools,” she told the conference.
“I don’t think [the] FDA has to wait,” Eskin added. “[The] FDA has to do something now. And that something is guidance to industry. What are those key data elements? What are best practices? A guidance document on traceability would be hugely helpful,” she said.
Sarah Sorscher, deputy director for regulatory affairs at the Center for Science in the Public Interest, noted that the FDA needs to use its existing authority as well as potential new regulatory tools to promote progress. “The FDA has yet to deploy additional authorities [granted] under FSMA, key among these long-delayed water testing requirements of the produce safety rule,” she said.
Focus on Blockchain
In announcing the smarter food safety initiative earlier this year, the FDA said government and industry should cooperate to leverage advances in digital technologies. These include blockchain to enhance product traceability, artificial intelligence and machine learning to facilitate food import inspections and new packaging and transportation approaches to help modernize the food industry and meet the growing demands of e-commerce.
The FDA will launch a pilot project using artificial intelligence to enhance its ability to review imports at ports of entry to ensure they meet U.S. food safety requirements. The agency will also tap into its programs related to tracking the drug supply chain to see whether similar approaches might be adapted to tracking the nation’s food supply.
“When you look at how other industries digitally track the movement of planes, ride sharing, and delivery of packaged goods, it becomes clear that we must explore how these types of technologies could improve tracking when it comes to food,” acting FDA Commissioner Norman “Ned” Sharpless, MD, and Yiannas said in a joint statement at the time.
Tracing is only one area where technology can enhance food safety. “We’ll also be looking at how to leverage emerging technologies and other approaches that are being used in society and business sectors all around us, such as distributed ledgers, sensors, the Internet of Things, and artificial intelligence,” the two officials explained.
According to Natalie Dyenson, vice president for Food Safety & Quality at Dole Food Co., Inc., “blockchain is a journey. There is no one single provider that will be the silver bullet for the industry. But there is a lot of potential in the system already,” she told the FDA conference.
Major industry players have been eager to gain a foothold in this burgeoning field. Walmart and other retailers are partnering with IBM Food Trust for blockchain services. Nestle is also partnering with IBM in a pilot traceability program in Europe for packaged instant mashed potatoes.
Financial services powerhouse MasterCard is looking to extend its blockchain-based Provenance Solution system, designed to combat money laundering, into food safety. Toward this end, MasterCard is partnering with Envisible LLC, a food supply chain system vendor, to pilot a seafood blockchain traceability program with Topco Associates LLC, a leading U.S. food cooperative.
“The identity of things is becoming even more important as consumers raise demands for transparency,” said Deborah Barta, senior vice president for innovation and startup engagement at MasterCard, in a statement.
The FDA has taken a leaf from its own book. In late September 2019, the agency launched its Food Safety Dashboard, designed to monitor and track the agency’s and industry’s progress in implementing FSMA implementation. Initial metrics are available for the preventive control of human and animal foods rules and for the Foreign Supplier Verification Program. Data for additional FSMA rules will be added over time, the agency said.
“We know that we can’t stop every outbreak of foodborne illness,” Dr. Sharpless and Yiannas said in a statement. “However, reducing the incidence of illness and death attributed to contaminated food is a shared goal of growers, manufacturers, packers, suppliers, importers and regulators alike.”