The following article by Frank Yiannas and Mindy Brashears first appeared in Food Safety News on September 11, 2023, and is repost here with permission.
About the authors: Mindy Brashears served as Undersecretary for Food Safety at USDA from 2019 to 2020 and Frank Yiannas served as Deputy Commissioner for Food Policy and Response at the FDA from 2018 to 2022.
OPINION
Both of us have dedicated our careers to advancing food safety and protecting the public. We’ve both done so at the height of federal service, in academic settings, as well as within the private sector. That’s why we believe we’re well qualified to provide a perspective on this issue.
There aren’t too many topics more important for a nation than its ability to provide its citizens access to safe, nutritious, and available food. And to do that efficiently and effectively, while being good stewards of taxpayers’ dollars, things must change. It’s time for our nation to have a unified, future-looking, single food safety strategy.
We both have led teams and worked within large organizations with thousands and even millions of employees, so we understand strategy should precede organizational structure. Therefore, if you agree that a unified, single food safety strategy is in the best interest of everyone in nation, then by default, one must support the idea of a unified, single food safety agency. In other words, the right structure is needed to effectuate a unified strategy and vision.
The sad truth is that this isn’t a novel or unique idea. And let’s be clear, it’s not a political or partisan issue either.
In 2017, the Trump administration proposed re-organizing the oversight of food safety regulatory activities into one agency, the Federal Food Safety Agency, to be housed within USDA. Similarly, the Obama administration also proposed a single food safety agency, but it suggested that it reside within FDA. In fact, efforts have been made to consolidate food safety activities into one agency since 1949. Over the past decade, Congresswoman Rosa DeLauro and Senator Richard Durbin have repeatedly introduced similar legislation, the call for a single food safety agency, without success. The U.S. Government Accountability as also made similar recommendations. The GAO stated “that creating a single food safety agency to administer a uniform, the risk-based inspection system is the most effective way for the federal government to resolve long-standing problems, address emerging food safety issues, and better ensure the safety of the nation’s food supply.”
Recently, we (Mindy Brashears and Frank Yiannas) participated in a podcast hosted by the Federalist Society, along with Stephen Ostroff, former Acting Commissioner of FDA.
The goal of the podcast was to discuss a re-organization within FDA, as a result of the findings of a report titled, “Operational Evaluation of the FDA Human Foods Program” conducted by the Reagan-Udall Foundation. This report was written at the direction of current FDA commissioner, Dr. Robert Califf. Commissioner Califf asked for the independent evaluation after a barrage of stakeholder complaints ranging from the infant formula crisis, the agency receiving 3 separate lawsuits for failing to issue food safety rules within required timeframes Congress stipulated when they passed the Food Safety Modernization Act in 2011 (over a decade ago), as well as the agency failing to address toxic heavy metals in baby foods, among other issues.
The Reagan-Udall report discussed several problems with the current FDA Human Foods Program. First and foremost, there was concern that this program had no defined leader in the organizational structure. Office leaders each individually reported to the FDA commissioner without a designated leader responsible for oversight of the food programs. This resulted in a lack of clear vision or mission for the human foods program apart from the overall FDA. It was also noted in the report that the focus at FDA was on “consensus building” rather than decision-making thus pulling the organization down to the “lowest common denominator” to get buy in from everyone. The consensus model is needed in some situations, but this process slows decision-making and leads to a lack of ability to implement the latest scientific advancements. A lack of allocation of funds from congress and limitations in the ability to compete with industry for employees because of low salaries were also concerns.
To summarize, on the Podcast, while there was agreement that changes needed to be made at FDA, there was also consensus that a single food safety agency – with a broader view beyond just FDA – is needed in order to further strengthen the safety of our food supply and to have the greatest impact on public health.
While we didn’t have enough time to warrant a discussion on where a new, single food safety agency would be housed (USDA, FDA, or HHS as new, independent agency), it was apparent that we all believe, based on our experiences, that current system is fragmented and, in some cases, duplicative and ineffective.
To illustrate this point, think about this. A frozen pizza that contains cheese and pepperoni is subjected to continuous inspection under USDA, but frozen pizza with cheese only (no meat) is inspected by FDA, as a non-high risk, once every 5 years. These differences are not based on science, nor risk.
But it’s more than just about who inspects what foods. More importantly, it’s about how do we take a more modern, risk based, and data-driven approach to how we regulate the safety of our food supply. Why is a pepperoni pizza subjected to continuous inspection, yet something as critical as powdered infant formula, at best, inspected only once per year.
For those who do not know, FDA operates their inspection system different from USDA. USDA operates on a continuous system with each animal being inspected before and after harvest with DVM oversight. In processing facilities, an inspector is on sight at least once/day. FDA’s food inspection oversight model requires that high risk food facilities be inspected once every 3 years and non-high-risk facilities once every 5 years. Moreover, most of FDA’s food inspections are done by State officials on behalf of FDA under contract with the Agency.
Modern times require more modern approaches. It’s time we moved to a more risk based, data-drive compliance approach, putting more oversight on products that pose the greatest risk to the consumers.
While we were leaders at FSIS and FDA overseeing food safety at a very trying time in our nation, we worked together very closely, usually on a weekly and sometimes daily basis, on high level and impactful decisions due to long-time professional relationships – not because we were required to work together for decision-making, but because we knew that’s what the American people expected of us. However, there was no standard or defined “requirement” for these interactions. In many instances, we both found ourselves experiencing the biases, turf battles, and silos that existed between the two organizations, although we made strides to break them down. In our minds, it was critical, whether it was addressing the effects of the pandemic on food supply chains or in times of investigating foodborne outbreaks, the nation would be better served if we worked together. This often also included collaborating with another critical partner, the CDC. There was indeed a joint committee among the 3 agencies to explore outbreak investigations. However, in certain instances and in particular times of crisis, distance, structures, and unclear roles and responsibilities, resulted in difficulties in coordination of activities and communications.
As we all know, changes within the government take time and a move towards a single food safety agency would be difficult and require an “act of congress”, but it isn’t impossible. Sometimes, we need political leaders to have strength and courage to do the hard things.
By no means are we suggesting that the staff at FDA and USDA are not doing a good job. In fact, we commend the staff in both agencies for their service to the nation. It’s just that we both believe we can strengthen the system to help them be even more effective at what they do.
Lastly, for those who might think this would lead to bigger government, we are not advocating for that at all. We believe, if executed and implemented well, it leads to more effective government by establishing clear roles, responsibilities, and lines of authority; reducing inefficiencies and duplication of efforts by allowing for a more integrated approach to the nation’s work on food safety, and leading to a more data-driven, risk-based approach to inspectional oversight which would be good for consumers and food producers. No other developed country operates in such a divided system. It’s time for the U.S. to make the hard decision, put aside turf or political differences, and prioritize public health by setting a plan in motion to migrate towards a single food safety agency. Consumers nationwide, taxpayers, and the regulated industry deserve this.
Supplementary note from Phyllis Entis, publisher of eFoodAlert
The concept of a single food agency has been around for many decades, and has been put into practice in many countries around the world, including Canada, the United Kingdom, member countries of the European Union, Australia and New Zealand, to name a few.
It works.
I have been advocating the consolidation of all food regulatory activities into a single, independent food agency in the United States on multiple occasions since at least 2007 and I made the case again, most recently, in April of this year.
I am heartened to see Frank Yiannis and Mindy Brashears, both of whom have experienced the current, fractured system from the inside, take up the torch for a unified, independent food safety agency.
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