The food system is on the cusp of a dual revolution, said Frank Yiannas, deputy commissioner for food policy and response with the Food and Drug Administration.
One side of that revolution is the way that food is made, as plant-based, cell-based, gene-edited and newly sustainable processes are coming into play. The other side, he told participants in a Wednesday webinar put on by the Alliance for a Stronger FDA, is changing the way regulators and food companies use data to ensure food safety.
"We believe that we're living in a new day of data," Yiannas said. "And with better data, we can further modernize how we do exceptional compliance oversight. Let me be clear: This is not about doing less of things. ...But it is about using the right data insights, identifying the right attributes of the establishments that you regulate."
Yiannas, as well as Susan Mayne, director of the FDA's Center for Food Safety and Applied Nutrition, and Steven Solomon, director of the Center for Veterinary Medicine, spoke about their priorities — especially as they relate to the fiscal year 2022 budget proposal. The proposed departmental budget for all functions — including food, drugs, medical devices and public health initiatives — is $6.5 billion, an increase of $477 million over current fiscal year funding levels. Food programs would get $1.2 billion of this, with food safety making up $82.5 million.
A large chunk would go to funding the New Era of Smarter Food Safety program, which is a 10-year blueprint to use technology to build upon food safety methods. The budget would put $44.8 million toward this program, about half of which would come out of the data monetization and tech portion of FDA's budget. Technology-enabled traceability will help significantly increase food safety, though Yiannas said this initiative is not about any one sort of technology system, like blockchain. What is important is the goal of using interconnected digital systems to collect and analyze data to keep the food system safer and pinpoint any problems more quickly.
Digital traceability systems — blockchain and the like — would receive $6.1 million, Yiannas said. He believes a lack of better digital traceability is a key weakness in the food safety system right now. Many of the biggest recent outbreaks, including those from romaine lettuce and red onions, took time to pinpoint because traceability systems aren't stronger.
"Let me be clear: This is not about doing less of things. ...But it is about using the right data insights, identifying the right attributes of the establishments that you regulate, typically can do a better job of safety for those regulated by FDA."
Deputy commissioner for food policy and response, FDA
"Traceability to me is not a reactive tool simply trying to respond to outbreaks quicker," Yiannas said. "...But it is about providing a new level of transparency in the food system, [and it] can be a game changer in terms of influencing behaviors and understanding how changes need to be made to strengthen prevention."
Better digital traceability data also means there's more information that machine learning systems can use to make predictions about what may happen. Yiannas said FDA is not looking to do less regulating or be more hands-off, but an ideal system could show the department where and when specific problems might occur. He said the department built a pilot system, which is working well.
But the paradigm of how people get food is rapidly changing, Yiannas said, and so food safety inspections need to change with it. During the pandemic, millions of people ordered food, either from grocery pick-up and delivery services or from manufacturers themselves. Because of this shift, Yiannas said, "the world is becoming the grocery store," and there is a new set of food safety protocols that need to be designed and met. If there is more data collected and put into a central system, it's easier to adapt it to a framework.
The culture has already started to shift toward food safety, Yiannas said. It's been more than a decade since the Food Safety Modernization Act (FSMA) was signed into law, and the sweeping set of regulations set on preventing foodborne illness has made a big difference, he said. Now, farmers, importers and companies that transport food and ingredients are required to take food safety precautions, and issues of safety and avoiding outbreaks are talked about in boardrooms, he said.
If the culture about data collection and availability can shift, Yiannas can foresee a time maybe 50 years in the future when food safety compliance has shifted dramatically. Instead of the FDA focusing on writing rules and doing periodic inspections, food facilities will have real-time data monitoring that is interconnected, meaning regulators would always have an idea of how systems are operating and what needs attention.
Nutrition and safety priorities
But FDA's food safety functions go deeper than inspections and foodborne illness. The Center for Food Safety and Applied Nutrition plays a role in ensuring ingredients are safe and that beneficial nutritional guidelines are followed. Mayne said the new budget would provide $8.3 million to support work assessing the safety of food additives and chemicals — an important area of regulation that has not benefited from budgetary increases to facilitate FSMA implementation.
"We are already making progress in this area as evidenced by our work to remove certain PFAS used in food contact, but frankly, we need additional resources to conduct similar evaluations for many of the thousands of other chemicals present in the food supply," Mayne said, referring to chemicals that were commonly used in food packaging that have been found to contribute to long-term negative health effects. "As we have seen with PFAS, sometimes new data become available that require FDA to reconsider previous safety designations. Ensuring the continued safety of food requires that we prioritize our post-market efforts."
Mayne's division is also working on maternal and infant health and nutrition, and has requested funds to bring more reviewers to evaluate new infant formula applications as well as drive healthy eating campaigns. Other nutrition-related initiatives slated for this year include work on modernizing product standards of identity and further steps to address sodium content in products, she said.
"Sometimes new data become available that require FDA to reconsider previous safety designations. Ensuring the continued safety of food requires that we prioritize our postmarket efforts."
Director, Center for Food Safety and Applied Nutrition, FDA
Coming out of the pandemic, FDA leaders said the past 15 months have taught them a lot about how the system right now works, as well as where it could be improved. Yiannas said the food system has been subjected to its biggest test in a century. It passed, he said, but not with flying colors. At the beginning of the pandemic, as grocery store shelves became empty and certain products were in short supply, supply chain issues in the food system became evident.
Mayne added that many of these issues were logistical — as consumers abandoned foodservice options and turned to get all their food from grocery stores, it took time to redirect food for retail sale because of labeling and inspection laws governed by FDA. But Mayne said the department was nimble, offering flexibility for these labeling situations when needed, and working with the private sector to coordinate information and response.
Digital data also played an important role in pandemic response, Yiannas said. FDA developed a system called 21 Forward initially to track COVID-19 outbreaks at facilities important to the food supply chain, from manufacturers to distributors. As the U.S. moved into vaccination mode, 21 Forward was redeployed to help keep track of COVID-19 vaccine efforts nationwide.
Yiannas said the usefulness of 21 Forward, the exposed supply chain weaknesses and the value of information from private companies show the best way forward.
"I believe that we have to continue to digitize the food system, understanding interdependencies and connections," he said.