As food safety policy wonks reflect on the past 6 months they will either say that change is possible in Washington DC, or that it’s not. This is because The U.S. Food and Drug Administration (FDA) will either take seriously the criticisms of a wide cast of characters, or they won’t. Either way, the present state of the Foods programs at FDA doesn’t embrace the culture of food safety that Agency officials talk so much about.
It’s notable that the charge to the Reagan-Udall Foundation, tasked with conducting an independent review of the human foods programs at FDA, includes an evaluation of resources, authority leadership / structure, and culture. The FDA surely has a culture. A diversity of stakeholders, including industry associations, consumer groups, Congress and former and current FDA officials - the latter via anonymous comments through an anonymous portal - paint a bleak picture. They describe an FDA whose knee-jerk reaction is to say “no,” find ways to stall, punt to others, or blame other parts of the Agency.
The foods programs must be elevated within FDA, and the scientific, policy, and inspectional activities that encompass the programs must be held to a high standard. Compared to the amount of drugs or medical devices used by Americans each day, the quantity of food consumed is orders of magnitude higher. Yet, there is no barrier to entry for food: premarket approval is not required, and any visit to a local farmers market shows that anyone can proclaim themselves a maker of food.
At the same time, nearly half the food consumed in the U.S. is imported- from hundreds of thousands of foreign facilities that are registered with FDA, routed through numerous exporters to numerous importers. Expecting FDA to effectively wield the stick of compliance at this complex supply chain is unrealistic. When Congress passed the Food Safety Modernization Act in 2010, a different approach was needed to move away from the reactive verification of compliance to a proactive focus on preventing food safety issues.
FDA advocates for a food safety culture within food companies so that everyone involved in the production of food realizes their role in producing safe food and protecting the public. However, it seems that FDA has not made this culture shift themselves. As Congresswoman Nanette Barragan (D-CA) emphasized during a line of questioning this summer, there’s no one in charge of the foods programs at FDA to push for the cultural change and accountability that is so desperately needed.
There have been repeated calls for an empowered Deputy Commissioner for Foods with line authority over CFSAN, the foods components of ORA, and the Center for Veterinary Medicine (CVM). It’s easy to write a job description that describes the food-related expertise needed, ability to manage people, etc. It’s not as easy to describe or find someone bold and brave that is able to transform a deeply embedded culture.
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If the FDA Commissioner acts on the consensus recommendation from stakeholders, but organizes the foods programs under someone who is unwilling or unable to change the culture of FDA and the way the Agency engages with stakeholders, the status quo will be maintained. And that would be a shame for FDA, for the Administration, and for our collective health and nutrition.
The Commissioner has an opportunity to rise to the occasion and implement a leadership structure and team that will help propel FDA towards the goals laid out by FSMA. To do this, he should continue to dig into the issues raised by stakeholders to understand why the approach to manage foods programs can’t simply borrow from the way other parts of FDA are organized. Addressing issues of culture won’t come easy, and won’t automatically derive from a reorganization. But embracing food safety culture needs to start at the top.
Dr. Jennifer McEntire is the Chief Food Safety and Regulatory Officer for the International Fresh Produce Association, the successor to the United Fresh Produce Association. A food microbiologist by background, she has worked in the Washington, DC area for over 20 years, bringing the scientific perspective to food safety regulatory issues. She has held previous food safety leadership positions with the Grocery Manufacturers Association, The Acheson Group and the Institute of Food Technologists. McEntire earned a PhD from Rutgers University as a USDA National Needs Fellow in Food Safety and received a Bachelor of Science with Distinction, magna cum laude, in food science from the University of Delaware. She serves as an advisory board member of the Global Food Traceability Center, is on the technical committee of the Center for Produce Safety, and was the 2020 recipient of the NSF International Food Safety Leadership Award.
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