Putting Humpty Dumpty Together Again: Consolidating Regulatory Authority Over Food Safety

By Diana R. H. Winters

[Cross-posted from the Health Affairs Blog]

The fragmented nature of regulatory authority over food in the United States is well known. More than a dozen federal agencies are responsible for the safety of the nation’s food supply. The Food and Drug Administration (FDA) and the Department of Agriculture (USDA) have the lion’s share of responsibility, together overseeing over 80 percent of the nation’s food safety.

Generally, the USDA regulates meat, and the FDA regulates everything else, but overlaps, exceptions, gaps, and therefore examples of resulting absurdities abound: the FDA regulates frozen pizza, unless it has pepperoni. The FDA regulates seafood, unless it’s catfish. The USDA has jurisdiction over packaged open-face meat sandwiches, but if the sandwiches are closed, authority shifts to the FDA.

This division in regulatory authority is neither planned nor rational. It is instead a historical accident, originating in the early twentieth century. When the Pure Food and Drug Act and Meat Inspection Act were passed on the same day in 1906, both targeting the adulteration of the food supply, their oversight was assigned to different departments within the USDA. The fissure widened when the FDA was moved out of the USDA in 1940. This divided regulatory framework is not the only reason for the fragmentation of regulatory authority over food in the US, but it is a main driver.

The President’s Proposal for a Single Food-Safety Agency

The President’s 2016 Budget, released last week, attempts to put the pieces back together and consolidate control over food safety. It proposes a new agency within the Department of Health and Human Services (HHS) that will incorporate the food safety functions of the FDA and the Food Safety and Inspection Service (FSIS) of the USDA.

This agency “would be charged with pursuing a modern, science-based food safety regulatory regime,” and would provide “centralized leadership … and clear lines of responsibility and accountability.” The amount of money that would be needed to implement this reorganization is not clear. Although the budget designates a total of $1.6 billion to food safety, the budget schedules for HHS and the USDA reflect food-safety functions “in their current alignment.”

The budget proposal bears certain similarities to a bill introduced earlier this year by Congresswoman Rosa DeLauro from Connecticut and Senator Richard Durbin from Illinois, which would create a single food safety agency. The Safe Food Act of 2015 (SFA) is much more detailed than the President’s proposal, but there are several apparent differences.

The DeLauro-Durbin Bill would create an independent agency, whereas the President’s agency would lie within HHS; the legislators’ SFA explicitly includes labeling functions and includes the Center for Veterinary Medicine in its consolidation, which we do not see in the President’s version. The SFA also includes a citizen-suit provision which would allow private citizens to sue for violations of food safety standards, an option that is currently unavailable under the Food, Drug, and Cosmetic Act.

The President’s proposal for a single food safety agency is also similar to numerous other proposals that have been introduced over the last seventy years. In a 2000 article about the feasibility and wisdom of consolidating food-safety functions, Richard A. Merrill and Jeffrey K. Francer identified sixteen proposals since 1949. These run the gamut. Some propose moving the FDA’s duties into the USDA, others advocate the opposite, and still others would create an independent agency. The one element all have in common is that they recognize the dysfunction of the current system.

Is this the moment, then? We have two strong proposals for a single food safety agency in a little over a month. Is the time finally right?

A Broader Vision of Food Safety

The answer is no. A single food safety agency will not be created—because of money, politics, and inertia—and moreover it is not at all clear that a single food safety agency should be created. The dysfunction resulting from the division of regulatory authority is obvious, but behind it are broader problems with our nation’s food systems and the regulatory regime, that simply consolidating authority or creating a new agency will not fix.

Why is the actual creation of such an agency a long shot? Because, not so long ago in 2010 Congress passed the Food Safety Modernization Act (FSMA). The sweeping food safety bill marked the biggest expansion of the FDA’s food-safety regulatory authority since the passage of the Food Drug and Cosmetic Act in 1938. FSMA shifted the FDA’s approach to food safety from a reactive to a preventative stance, while bringing the FDA’s food safety oversight more in line with that of the USDA.

At this point, the FDA, and the affected food industry, is focused on implementing this Act. Indeed, the President’s new budget includes $301 million for implementation of FSMA. Indeed, commodity leaders, such as the Northwest Horticultural Council and Western Growers (which represents half of the U.S. produce industry), have come out strongly in opposition to the President’s proposal, citing the ongoing implementation of—and their members’ investment in—FSMA controls. The beef industry also opposes the reorganization, noting the likelihood of disruption and an increased burden on industry. The resistance of these commodity leaders will make the creation of a single agency unpalatable for Congress.

Even if the reorganization could happen, it probably should not — for two reasons. First, the costs of such a massive bureaucratic consolidation will outweigh the potential benefits. Second, a single food safety agency would not address some of the more fundamental dysfunctions of the regulation of our nation’s food system.

The main criticisms of the fragmented food safety regulatory regime are inefficiency (regulatory overlaps), ineffectiveness (regulatory gaps), diffuse political accountability, and a failure of communication that leads to a misallocation of resources. While some of these problems may be fixed by a unified agency, others may remain. Here, as New York University’s Marion Nestle puts it, the devil is in the details. Will a new agency administer a new and unified statute? Will the combined agency’s separate divisions be integrated, or exist alongside one another?

Merrill and Francer point to the creation of the Environmental Protection Agency (EPA) as a unified agency that has failed to integrate control over the various spheres it oversees. Similarly, an importation of the USDA’s FSIS and the FDA’s Center for Food Safety and Applied Nutrition (CFSAN) into a single department, with no change in statutory authority and no new mechanism for melding the divisions, may result in a superficial shift. The current fissures could remain.

To be sure, communication may improve between divisions if food-safety functions were brought together, and as Secretary of Agriculture Tom Vilsack pointed out, this is a much more real possibility than it would have been before FSMA. With the implementation of FSMA’s safety controls, the FDA and the USDA are beginning to speak the same food-safety language.

Going forward, however, communication may be improved more simply and cheaply by just doing it — improving communication. A robust executive mechanism for coordination and communication, building on a body like the Food Safety Working Group, established in 2009 by President Obama, may be as effective as full reorganization.

Moreover, and more significantly, a reorganization of food-safety authority maintains the narrow view of “safety” that entrenches some of the deeper problems with our nation’s food systems. The prevention of foodborne pathogens and foodborne illness is only one facet of food safety (albeit an important one).

Other critical issues include meat production practices that lead to an increase in pathogens, the growth of antibiotic resistance linked to the use of antibiotics in animal feed, the contamination of our water and air by certain agricultural practices, which are often exempt from environmental laws, and governmental subsidies that support crops conducive to the production of processed foods. As Georgetown Law’s Lisa Heinzerling writes, “one of the great problems of the food system in the United States is its failure to understand and embody the unity of the health of the environment in which food is grown and the wholesomeness of the food itself.”

Advocating for a holistic approach to food safety does not mean abandoning attempts to improve the discrete pieces of the regulatory apparatus. We shouldn’t let the perfect be the enemy of the good. It is not, however, clear that the President’s proposal for a single food-safety agency meets even that lower standard.

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