September 09, 2009

New FDA Database on Food Safety Has Good Potential. The Proof Will be in the Pudding

Yesterday, the Food and Drug Administration implemented a 2007 food safety statute by promulgating a rule requiring food manufacturers to report instances of foodborne diseases to an electronic database that the agency has just established (the Reportable Food Registry). This long-awaited database will help epidemiologists at the Centers for Disease Control, state health agencies and academia identify "clusters" of illnesses that should contribute to a better assessment of the extent and magnitude of the foodborne disease problem in this country.

More important, the new database may assist epidemiologists in pinpointing the food items that have caused particular outbreaks much more quickly. This is critical to the government's ability to take action to prevent the spread of foodborne diseases before they become full-fledged catastrophes like the recent spinach and peanut butter outbreaks.

In a food distribution system in which ground beef from a single cow can wind up in hamburgers in several states and a single hamburger can be composed of meat from dozens of cows, we need all the information we can get on the nature and extent of the disease outbreaks that occur all too frequently these days. The new system that FDA has just created has the potential to contribute greatly to the available information.

The proof, however, will be in the pudding when the system is fully up and running. It will be awfully easy for a company that receives a complaint from an angry customer who got sick from eating one of its products to conclude that the disease must have had some other cause or was otherwise "idiopathic" and ignore it. The key question as FDA begins to implement the regulations will be the how well the thresholds that the regulations establish for reporting instances of disease work. And, of course, another critical issue will be the seriousness with which the agency goes about enforcing the new regulation. It is much harder to police violations of an affirmative reporting requirement than it is to enforce a prohibition.

FDA is off to a good start. Now it needs to follow through.

For more on the compliance issue, see also Food Poison Journal.


Thomas McGarity, CPR Member Scholar; Endowed Chair in Admin. Law, University of Texas School of Law. Bio.

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