A Realistic Approach to Food Safety Regulation

The U.S. system is, of course, quite similar, with frequent USDA inspections that generally reflect on-site working relationships, as well as FDA inspections that typically occur every five to seven years. Second, mandatory recall authority—the legal authority to remove, or require another party to remove, a product from the market—is rarely used in the countries studied. In the U.S., virtually all recalls are producer initiated: The only mandatory food recall authority is that of the FDA over infant formula and human tissue products, but the government can expand the scope of any voluntary company recall and can also encourage seizure of recalled products. State and local health authorities have broad, well-established powers as well.

The Real Issue

So, did the GAO conclude that the “fewer food regulators, the better” in the locations they examined? In fact, the study reports that not one of the selected countries had conducted a comprehensive evaluation of its reorganized food safety system. Most track certain indicators, such as the number of inspections conducted, the number of enforcement actions taken, and the number of foodborne illness outbreaks, but go no further than that. And there is little, if any, hard evidence that the unified food regulatory structures led to a decrease in illness.

That, of course, is the real bottom line: Will a single food regulatory agency make food-related illness outbreaks less likely? Reorganizing food safety agencies is less important than adopting policies that prevent tainted food from entering the food supply and making people sick. Currently, even the minimum basis for deciding whether food safety is increasing or decreasing is lacking: namely, a useful database of foodborne illness that can track trends easily. Cases of illness are tracked in one fashion, “outbreaks” of foodborne illness in another way.

When foodborne illness rates go up—or down—in a particular category, regulators cannot easily determine whether the trend is caused by, say, globalization of food stocks; trends in public consumption like the rising consumption of fresh salads; distribution methods; processing (such as the prevalence of bagged salads); storage and refrigeration, whether at grocers or homes; farming issues like fertilizer or run-off at farms; or food handling and preparation. Building a single database would not be easy, but it could be done without reorganizing more than a dozen federal agencies. And without an adequate database, we will not be able to tell whether any reorganization achieves much in the way of food safety, especially considering the past success the FDA, USDA, and other agencies have had in making massive food safety advances. The knowledge base for evaluating broad policy changes is not there.

At a minimum, reorganization under a single authority likely means potential distraction and infighting among the component groups merged into the new single agency, and such an environment would not encourage efficient policy adoption. Simply recall the ongoing communication and efficiency problems in the Department of Homeland Security nearly a decade after its creation to visualize what could happen to the public health as a single food safety authority tries to get itself functioning. Moreover, without an upgraded foodborne illness database, we could not even tell whether reorganization or any broad policy change has succeeded.

Rather than establishing a new regulatory structure with no proven likelihood of food safety improvement, working to create a usable foodborne illness database—and continuing and expanding collaboration among the existing food regulatory agencies and the food industry to identify and rectify quality and safety concerns—offer the best means of reducing foodborne illnesses in the United States. ■

Hargan formerly served as deputy secretary and regulatory policy officer for the U.S. Department of Health and Human Services. He is currently a partner with McDermott Will & Emery; reach him at [email protected] or (312) 984-0385.