The Government Accountability Office (GAO) has frequently reported on the under-resourcing of FDA, including both staff and funding. This was most recently detailed in a February report in which GAO stated, “Over the last decade, we have reported that FDA has faced staffing shortages and increased oversight responsibilities, making it harder to effectively carry out its responsibilities”; and even more specifically, “FDA has struggled to recruit, retain, and train its staff, which has reduced its capacity to conduct inspections.”
It is for just such reasons that FDA initiated the BRIDGE Project (Better Regulatory Inspections for Dynamic Government Efficiency) earlier this year, through which it is passing more of the domestic food manufacturing facility inspections to the states. While this will help to ease the pressure on FDA, it does not come without challenges.
Building on the principles of Domestic Mutual Reliance (DMR) – that enable the FDA and state, local, tribal, and territory regulatory agencies with comparable regulatory public health systems, to work together to meet the public health goal of a safe national food supply – the BRIDGE Project is intended to optimize FDA/state collaboration and establish a sustainable, long-term partnership. Slated for national implementation by the end of 2030, the initiative is to result in most routine domestic inspections being completed by state programs, enabling FDA to focus on for cause and highly technical and foreign inspections.
Although the BRIDGE Project is new, state inspections for FDA are not. In fact, as AFDO Executive Director Steven Mandernach stated in the recent Congressional Committee Hearing, the FDA faces real capacity issues, with only about 430 investigators responsible for conducting both domestic and foreign food inspections. Because of that, the states are currently conducting nearly 90% of the food processing inspections in the U.S., along with all Grade A milk and shellfish inspections, and over 93% of produce safety inspections. Thus, many federal food safety programs already rely on state capacity to succeed, and that reliance is growing.
However, there are gaps that need to be improved. A primary one is that of information sharing. Due to provisions of the FD&C Act, the information FDA is able to share with the states is limited, with state authorities often asked to conduct investigations or take regulatory action, but receiving information that’s been redacted in ways that hinder the state’s ability to act under its own legal authority. The passage of H.R.8430, which was included in the Committee Hearing, would help to alleviate this through its amending of the FD&C Act to authorize the Secretary of Health and Human Services to share food safety information with state, local, tribal, and territorial authorities.
Another challenge inherent in the passing of inspections from the federal to the state level is achieving the trust that the officials of all 50 states would meet inspection standards equivalent to those of the FDA. Although AFDO has advanced state adoption of the Manufactured Food Standards (ISO-like standards audited by FDA) and liaised between the states and FDA, significant variability remains. An example in the retail and food service space is that each state can choose whether to adopt the FDA Food Code, in part or whole, and which version to apply. Additionally, the states also have various funding and staffing levels and training standards, with many not having programs that would enable them to conduct adequate Preventive Controls inspections.
Given these parameters, will the FDA take the states’ observations as accurate? Or will the inspections be seen more as surveillance tools requiring FDA follow up? In either case, the states will certainly need federal investment in training, staffing and program support, without which effective and equitable implementation across the states is unlikely.
FDA is currently in Phase 2 of the BRIDGE Project, focused on testing and refining new approaches through live operations with selected states to validate what works, identify gaps, and refine approaches based on the evidence. This phase is expected to go through 2027, with the final phase being national implementation, planned for January 2028-December 2030.
The BRIDGE Project is an excellent initiative, but the concept of closer reliance on the states for food safety regulatory oversight is not new. It has not worked well in the past largely due to lack of funding, lack of leadership, and lack of trust between FDA and the state inspectors. Will this initiative be different? We can hope it will; but without stability and better morale at FDA it will unfortunately struggle even though the concept is exactly where we need to go.
