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 proposed one food safety agency, but suggested it be located within FDA. Efforts have been made to consolidate food safety activities into one agency since 1949, and those efforts continue.

Last week, I participated in a podcast hosted by the Federalist Society with former FDA Acting Commissioner, Stephen Ostroff, and former FDA Deputy Commissioner of Food Policy and Response, Frank Yiannis, to discuss re-organization of the FDA as a result of the findings of a report, “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. Dr. Califf asked for the independent evaluation after the infant formula outbreak of 2022. The full webinar can be viewed here.

To summarize the overall view of the panel members, there was consensus that a single food safety agency is needed in order to protect the safety of our food supply and to have the greatest impact on public health. While there wasn’t an overall opinion on where this should be housed (USDA vs FDA vs a new, independent agency), it is apparent that the current system is fragmented and in some cases duplicative. Dr. Ostroff gave a great example using the fact that frozen pepperoni pizza is subjected to continuous inspection under USDA but bagged salad and infant formula had sporadic inspection. There has to be a risk-based approach putting more oversight on products that pose the greatest risk to the consumer.

The Reagan-Udall report discussed several problems with the current FDA Human Foods Program. First and foremost, there is concern that this program has no defined leader in the organizational structure. Office leaders each individually report to the FDA commissioner without a designated leader responsible for oversight of food programs. This results 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.

For those who do not know, FDA operates their inspection system differently from USDA. As mentioned by Dr. Ostroff, 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 is different, with more sporadic visits for inspection or “for cause” visits. It is possible that an inspector may be onsite only once per year or less. While I was at FSIS, I worked closely with FDA due to a long-time professional relationship with Frank Yiannis. However, there was no requirement for this interaction. It was critical in times of investigation of outbreaks to work together and also to engage CDC. The physical distance among USDA, FDA and CDC (DC, Maryland and Atlanta), resulted in difficulties in coordination of activities. While my counterparts at USDA who sat in the other Under Secretary seats (ie APHIS, Trade, NIFA, ARS) worked with all commodities, FSIS was limited to meat, poultry and processed eggs and the oversight of food safety for all foods was split. While Frank and I worked well together, there wasn’t a culture of working cooperatively at all levels in the agencies. The lack of communication and coordination can lead to public health risks.

As we all know, changes within the government take time and a move towards one food safety agency would require an “act of Congress,” but it isn’t impossible. No other developed country operates in a divided system. It is time for the US to coordinate efforts and work cooperatively, putting aside politics and prioritizing public health to move towards a coordinated approach in their regulatory structure for the food industry.

One Food Safety Agency

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