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'Constant Turmoil' at FDA Makes Our Food Less Safe

— Reflections on a new report about the agency's Human Foods Program

MedpageToday
 A photo of the headquarters of US Food and Drug Administration in Silver Spring Maryland

Americans take the safety of our food for granted. But it's not safe by accident. Our food is safe because of laws that ensure food companies and farmers take steps to keep pathogens out of our food. And the enforcement of these laws depends on the people charged with making sure our food won't harm us.

A task force created as a result of the infant formula shortage -- stemming from a contamination crisis and supply chain disruptions -- has critical structural, cultural, and financial challenges at the FDA, which is responsible for the safety of of our food supply. The task force, facilitated by the Reagan-Udall Foundation at the request of FDA Commissioner Robert Califf, MD, found that the FDA's fragmented leadership structure has contributed to "competing priorities" and a "culture of indecisiveness and inaction" that has created "disincentives for collaboration."

During the infant formula contamination crisis, there was, in the words of the task force, "little motivation, and apparently no requirement, to share information and interact across the Agency" to make decisions to protect babies. In the understated fashion of a government report, the task force called this "problematic."

One overarching problem the report identified is that the Agency's food safety risk assessor, (located at the Center for Food Safety and Applied Nutrition) and its food safety inspectors (located in the separate Office of Regulatory Affairs) are, well, separate. Placing the staff who assess food safety risks and the staff who inspect food companies under the same leader was a component in five reform options the task force identified. This closer collaboration is also a of consumer organizations and food companies that have asked the FDA to create a single deputy commissioner for food safety.

The FDA's problems are not simply structural, though the lack of a single food safety leader has created what the task force called "constant turmoil." The structural problems have contributed to cultural challenges, too. The lack of leadership has hindered the transition to the "prevention mindset" Congress envisioned when legislators passed the , more than a decade ago. That law sought to make the prevention of foodborne illness the focus of our food safety efforts by requiring food companies to develop food safety plans and by requiring farmers to test their irrigation water for pathogens. So far, this mindset has not taken hold.

Another challenge facing the FDA is financial. Although food safety challenges have grown dramatically in the past 40 years, the number of people employed by the FDA to keep our food safe has not. The reason is simple: Whereas other FDA programs, which review drugs and medical devices, have received industry funding to complete needed safety reviews, FDA programs designed to keep our food safe have not.

Food is not safe by accident. It becomes safe when people -- especially those at the nation's top food safety agency -- have a common vision and leader who will ensure they are working collaboratively to keep our food safe.

is senior vice president for government affairs at Environmental Working Group.