– Opinion –

Editor’s note: Frank Yiannas, FDA Deputy Commissioner for Food Policy and Response

Foodborne outbreaks can affect all of us, and the U.S. Food and Drug Administration is at the forefront of helping to protect consumers from foodborne illnesses. Every day, the agency takes steps to help protect the nation’s food supply. Our ability to do so successfully relies on continuously improving our surveillance system and providing timely and transparent updates to consumers about outbreaks when they occur. 

To achieve these goals, we recently released a Foodborne Outbreak Response Improvement Plan, an important step to enhance the speed, effectiveness, coordination, and communication of foodborne outbreak investigations conducted by the agency. The Improvement Plan builds on years of work by the FDA to protect consumers from outbreaks of foodborne illness, working in close collaboration with state, federal and international partners in the public and private sectors.

There’s a lot at stake here. Each year, about 48 million people in the U.S. (1 in 6) get sick, 128,000 are hospitalized, and 3,000 die from foodborne diseases, according to the Centers for Disease Control and Prevention. But trust me, statistics don’t tell the whole story. We realize that behind every number is a real person with a real story of the painful consequences of foodborne illness. 

That’s why FDA is laser-focused on prevention. We recognize that to advance food safety, we must be faster, more streamlined and more effective at identifying and locating food associated with illnesses and identifying root-cause factors to help prevent similar outbreaks in the future. We also recognize that sometimes advancing food safety means removing contaminated food from the market.  

Public health advancements, such as whole genome sequencing (WGS), have improved our ability to detect foodborne outbreaks and allowed us to recognize that some of the outbreaks identified today may have previously gone undetected in the past. WGS has also allowed the agency to detect some outbreaks sooner compared to previously used laboratory methods and allows us to detect new and novel food vehicles of foodborne disease. These advancements are a good thing for public health. That said, in a large, distributed, and global food system, outbreak investigations remain challenging. As our ability to detect outbreaks improves, we must also strive to make improvements to our investigative processes, to ensure that we are able to quickly and effectively investigate outbreaks, prevent additional illnesses, understand the factors that allowed them to occur, and help prevent them from happening again.  

Since the FDA Food Safety Modernization Act (FSMA) was signed into law in 2011, we have made great strides in modernizing and further safeguarding the U.S. food supply. This includes the recent release of a proposed rule to enhance the safety of pre-harvest agricultural water for produce (other than sprouts) covered by the Produce Safety Rule. Contamination of water used in farming operations has been a factor in certain outbreaks, and the proposed rule, if finalized, is designed to provide practical, effective ways to protect both water sources and public health. 

In 2011, the FDA also created a permanent group, the Coordinated Outbreak Response and Evaluation (CORE) Network, dedicated to identifying, responding to, and assisting in the prevention of multi-state illness outbreaks linked to FDA-regulated food dietary supplements, and cosmetic products. In October 2020, as part of our further commitment to transparency, we began publishing the CORE Investigation Table, a weekly update that includes information on all foodborne outbreaks to which the FDA is responding and provides updates at each stage of an investigation. We aim to share information quickly and accurately during an outbreak investigation when significant details, such as the food that may be causing illnesses, may still be unknown. 

The Improvement Plan released this month focuses on four priority areas in which improvements will have the most impact: 1) product traceback, 2) root-cause investigations, 3) outbreak data, and 4) operational improvements.

We collaborated with experts in both the public and private sectors during the development of this plan for input on how to strengthen the agency’s outbreak response. As part of this process, the agency contracted with the University of Minnesota’s School of Public Health to assess the FDA’s capacity to support, join, or lead multistate outbreak investigations as well as to provide recommendations for improvement, which were provided to the agency in a recently released report. The new Improvement Plan reflects our commitment to bend the curve of foodborne illness in the U.S., an overarching goal embodied in the FDA’s New Era of Smarter Food Safety.

In 2019, we announced the New Era of Smarter Food Safety initiative and in July 2020 published a blueprint outlining our goals over the next decade. The New Era initiatives build on what we have achieved in our implementation of FSMA by leveraging the use of new and emerging technologies, tools, and approaches. An example of work underway includes the proposed Food Traceability Rule. The proposed requirements in the rule would help the FDA rapidly and effectively identify recipients of certain foods to prevent or mitigate foodborne illness outbreaks.  We believe this rule is a bridge to this New Era of a safer and more digital, traceable food system.

Conducting timely and effective foodborne outbreak investigations is a team effort that involves collaboration at the federal, state, and local levels. At the FDA, we understand we have an important role to play. We have a devoted team of public health professionals who work tirelessly, day and night, to accomplish this. But there are challenges in getting to the root cause of an outbreak given, among other things, the complexities of our food supply and the lack of transparency in the supply chain. 

FDA is committed to strengthening food safety and we believe American consumers deserve to have confidence in the safety of the foods they eat themselves and serve their families. As we implement the goals outlined in the Foodborne Outbreak Response Improvement Plan, the New Era of Smarter Food Safety, and as we continue to implement FSMA, we will be transparent every step of the way. The American consumer deserves no less.