DHHS study finds food facility registry flawed

WASHINGTON—The Food and Drug Administration has a lot of work to do to improve the accuracy of the information in its food facility registry, according to a Dec. 11 report from the U.S. Department of Health and Human Services (D.H.S.S.) inspector general’s office.

The study, based on a sample of 130 selected domestic food facilities, compared information about the selected facilities in the registry with information obtained during structured interviews with the facility managers.

According to DHHS, 5% of the selected facilities failed to register with the FDA, as required, while an additional 2% failed to cancel their registration. In addition 48% of selected facilities failed to provide accurate contact information, and in more than half (52%), management was unaware of the FDA’s registry requirements. The DHHS said the shortcomings may leave the FDA without critical information in case of an emergency or may hinder the agency’s ability to accurately identify food facilities linked to an outbreak of foodborne illness.

To help address the flaws, DHHS offered several recommendations for FDA, including:
• Improve the accuracy of the information in the registry.
• Consider seeking statutory authority to impose civil penalties through administrative proceedings against facilities that do not comply with the registry requirements.
• Consider making some of the optional fields within the registry mandatory.
• Work with the food industry to increase facilities’ awareness of the registry requirements.

Since December 2003, The FDA has required food facilities — both foreign and domestic — that manufacture, process, pack or hold food for consumption in the United States to register with the FDA. As of January 2009, the registry contained approximately 150,000 domestic food facility registrations and 216,000 foreign food facility registrations.

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