Review Necessary to Ensure FDA’s Food Transport Rule Actually Drives Results

June 19, 2014

Philip J. Austin, MPA Candidate

On February 5, 2014, the Food and Drug Administration (FDA) published a proposed rule regarding the Sanitary Transportation of Human and Animal Food, which it hopes will help to ensure that food will not become contaminated during the transportation process. The regulation would establish criteria for sanitary transportation practices, such as washing trucks, training employees, and refrigerating foods to the correct temperature during transport, and would affect nearly 84,000 firms involved in food transportation. Although the rule will cost businesses hundreds of millions of dollars, FDA could not identify any tangible benefits that will result from the regulation.

According to FDA’s proposed rule, “Isolated incidents of insanitary transportation practices for human and animal food and outbreaks and illnesses caused by contamination of these foods during transport have resulted in concerns over the past decades about the potential that food can become contaminated during transportation.” Findings of an Interstate Food Transportation Project, released in 2007, and a 2009 report of a study conducted for FDA, further increased concerns about food transportation safety. The two studies examined baseline practices in the sectors involved with food transportation and found multiple areas where food was at risk for contamination. This proposed rule seeks to ensure that appropriate sanitary practices are followed during all stages of food transportation and, through increased record keeping, determine during which stage of the transportation process food has been adulterated.

However, given the uncertainty of the underlying data used to formulate the provisions of the rule, it is far from clear that the rule will have its intended effect.

In a comment filed with FDA on the proposal, I suggest that FDA commit to measuring the actual effects of the regulation. For example, if the costs that the regulation would impose on carriers are significantly different than those estimated by FDA, the agency should be open to revising the regulation.

FDA admits in its proposal that it lacks the necessary data to give reliable estimates for compliance and administrative costs, yet the agency puts forth cost estimates that are specific to the dollar. FDA should examine whether its estimated costs, such as the number of firms that would be affected by the regulation and the number of hours it would take for affected firms to review and assess the requirements of the rule, are close to accurate. Even a slight amount of inaccuracy in these estimates could shift the total costs of the proposal by millions of dollars.

Additionally, FDA should commit to using the data it collects during the implementation of the rule to annually review whether the standards are having their desired effect. If the rule is creating unnecessary costs without producing any tangible benefits, some or all of the regulations implemented by FDA could be rescinded.