221295 FDA'S food facility registry

Monday, November 8, 2010 : 10:45 AM - 11:00 AM

US Department of Health and Human Services Office of Inspector General , HHS Oig, Office of Evaluation and Inspections, New York, NY
Jodi Nudelman, HHS OIG Regional Inspector General , Office of Inspector General, US Department of Health and Human Services, New York, NY
Meridith Seife, Deputy Regional Inspector General , Office of Inspector General, US Department of Health and Human Services, New York, NY
Jonathan Bandel, Program Analyst , Office of Inspector General, US Department of Health and Human Services, New York, NY
Lucia Fort, Program Analyst , Office of Inspector General, US Department of Health and Human Services, New York, NY
Vincent Greiber, Program Analyst , Office of Inspector General, US Department of Health and Human Services, New York, NY
Iris Lin, Program Analyst , Office of Inspector General, US Department of Health and Human Services, New York, NY
Tiffany Moore, Program Analyst , Office of Inspector General, US Department of Health and Human Services, New York, NY
Bailey Orshan, Program Analyst , Office of Inspector General, US Department of Health and Human Services, New York, NY
As of December 2003, the Food and Drug Administration (FDA) began requiring food facilities that manufacture, process, pack, or hold food for consumption in the United States to register their facilities with FDA. The purpose of this registration is to provide FDA with reliable information about food facilities. This information allows FDA to locate facilities during an outbreak of foodborne illness or to locate facilities for inspection. This evaluation determined the extent to which selected domestic food facilities registered with FDA and provided complete and accurate information for FDA's food facility registry. For this evaluation, we identified a sample of 141 food facilities. We conducted structured telephone interviews with the managers of those 141 facilities. In these interviews, we verified the information in the registry, asked for explanations where discrepancies existed, and asked managers about their familiarity with the registry requirements. We found that 5 percent of selected facilities failed to register with FDA, as required. Additionally, we found that 48 percent of selected facilities either failed to provide accurate information when they first registered or after changes in the facility's information, as required. Finally, we found that 52 percent of the facility managers at the selected facilities reported that they were unaware of FDA's registry requirements. Our review raises serious questions about the accuracy and utility of the registry and its usefulness in identifying food facilities that may be linked to an outbreak of foodborne illness.

Learning Areas:
Public health or related laws, regulations, standards, or guidelines
Public health or related research

Learning Objectives:
Explain the extent to which selected domestic food facilities are registered with the Food and Drug Administration (FDA). Discuss the extent to which selected domestic food facilities provided complete and accurate information for FDAs food facility registry.

Presenting author's disclosure statement:

Qualified on the content I am responsible for because: I am qualified to present because I was a team member on this study.
Any relevant financial relationships? No

I agree to comply with the American Public Health Association Conflict of Interest and Commercial Support Guidelines, and to disclose to the participants any off-label or experimental uses of a commercial product or service discussed in my presentation.