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

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.