Keeping the food system safe is a tough job - someone's got to do it. The question is who? Photo: Getty Images.
Food safety regulation in the United States is a patchwork of overlapping authority across fifteen federal agencies and various government departments. Since 2007, the Government Accountability Office has identified the federal oversight of food safety as a high risk issue. This summer, the Administration proposed consolidating food safety regulation into a single agency under the U.S. Department of Agriculture (USDA).
Currently, the Food & Drug Administration (FDA) regulates approximately 80% of the nation’s food supply. The USDA has oversight over meat, poultry, certain egg products, and catfish.
The new policy would transition virtually all of the nation’s food supply under the USDA’s regulatory authority. The proposal would strip authority over food from the FDA, and change the name of the agency to the “Federal Drug Administration.” As noted elsewhere, the new proposal to house food safety at the USDA faces considerable challenges, stemming in large part from the choice of department to house the newly-consolidated agency.
The new proposal has some historical antecedents. Indeed, the FDA grew out of the USDA’s Bureau of Chemistry and later became a wing of the USDA itself. Famously, Harvey Washington Wiley and his “Poison Squad” - a group of young men monitored for their reactions to borax and other chemicals added to food - demonstrated the need for federal oversight of food safety in the early 20th Century. In 1940, the FDA moved out of the USDA and later became an agency of the federal department governing health. The FDA has been located outside of the USDA for over 70 years, and there are logical reasons why food safety should continue to reside within the Department of Health & Human Services alongside other agencies responsible for public health, such as the Centers for Disease Control. More recently, the Obama Administration proposed a single agency under the FDA to oversee America’s food in 2015. Other countries, including Ireland, have a single Food Safety Authority to ensure the safety of food produced, distributed, or marketed in their jurisdictions.
The proposal to move food safety oversight to the USDA poses some issues on its own terms. For example, the USDA currently regulates 20% of the nation’s food supply, compared to the FDA’s 80%. That would mean that the USDA and its food safety regulators would absorb an additional 80% of the food supply within its regulatory sphere. The proposal does not indicate whether the USDA has the bandwidth to do so, or why the comparably smaller lift regarding the FDA’s expansion would pose an issue.
Relatedly, the proposal notes “the different legislative authorities that govern the two agencies have resulted in two distinct regulatory regimes, cultures, and approaches to addressing food safety.” The proposal highlights the USDA’s highly-involved inspection approach for the products it currently regulates, but it does not indicate whether that approach is appropriate for the foods under the FDA’s current regulatory ambit. This highly-involved inspection approach might exacerbate capacity issues if the USDA were to absorb the additional food supply oversight.
In addition, removing food from the FDA’s regulatory sphere would leave dietary supplements under the FDA’s control. That could pose substantial issues given the rise of “functional foods” and “nutraceuticals” that blur the line between dietary supplements and conventional foods. The FDA has noted that these terms are “widely used in the marketplace.” According to the FDA, dietary supplements are “a special category of products” that come under “the general umbrella of foods.”
In marking out territory for the USDA and FDA, the federal government would have to distinguish between what is a “food” and what is a “dietary supplement.” Unfortunately, the legal definitions of these product categories do not offer much assistance. Under 21 U.S.C. § 321, “foods” are “articles used for food or drink for man or other animals;” whereas a “dietary supplement” is, in relevant part, “a dietary substance for use by man to supplement the diet by increasing the total dietary intake.” These circular definitions could pose headaches for regulators in attempting to discern between conventional foods under one regulator and dietary supplements under another agency.
The new proposal is a promising step forward to address the fragmented federal oversight of the nation’s food supply, especially in the wake of several high-profile food safety issues. This proposal faces considerable challenges that could hamper its feasibility and effectiveness. These concerns might be addressed in part by moving USDA’s food safety oversight under the FDA’s umbrella, rather than the other way around.