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 the D.H.H.S., 5% of the selected facilities failed to register with the F.D.A., as required, while an additional 2% failed to cancel their registration. The D.H.H.S. said the shortcomings may leave the F.D.A. 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.
Another area of concern identified by the D.H.H.S. was the fact 48% of selected facilities either failed to provide accurate information when they first registered or failed to provide accurate information after changes in the facility’s information. Specifically, 30 facilities did not provide accurate contact information, 26 did not provide an accurate emergency contact phone number, 20 did not provide accurate contact information for the owner or operator, and 14 did not provide accurate contact information for their parent company.
In more than half (52%) of the facilities, management was unaware of the F.D.A.’s registry requirements, the study found. This included five managers who said they were unaware of any requirements to register, as well as 62 managers who were unaware of the requirement to update the information within 60 days of a change in the facility’s information.
To help address the flaws in the food registry, the D.H.H.S. offered several recommendations for the F.D.A., 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 F.D.A. 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 F.D.A.
As of January 2009, the registry contained approximately 150,000 domestic food facility registrations and 216,000 foreign food facility registrations.