Food facilities failing to register with FDA
The Bioterrorism Act of 2002 requires food facilities — exempting farms, retail facilities, and restaurants — to register with the FDA; the FDA had expected about 420,000 domestic and foreign food facilities to register because of the 2002 law; according to an FDA spokesman, as of 14 December, 392,217 facilities had registered — 157,395 in the United States and 234,822 foreign facilities that export to the United States
Nearly half of surveyed food facilities failed to give correct information to the Food and Drug Administration’s (FDA) food facility registry, according to a government review. The 30-page report from the Department of Health and Human Services’ Office of Inspector General found that 48 percent of firms surveyed (62 out of 130) either failed to provide accurate information when they first registered or failed to provide required updated information after changes at their facilities.
The Packer reports that the Bioterrorism Act of 2002 requires food facilities — exempting farms, retail facilities, and restaurants — to register with the FDA. The FDA had expected about 420,000 domestic and foreign food facilities to register because of the 2002 law. According to an FDA spokesman, as of 14 December, 392,217 facilities had registered — 157,395 in the United States and 234,822 foreign facilities that export to the United States.
The report said 7 percent of facilities either failed to register or failed to cancel their registration with FDA. “For each of these facilities, FDA was missing critical information that could be used to locate the facility in an emergency,” the report said.
Thirty facilities out of 130 surveyed did not provide accurate contact information to the FDA, the report said. Facility managers contacted by the Office of Inspector General said the main reason they failed to provide FDA with accurate contact information was because they did not update information as required. Another reason for noncompliance, the study found, was that the responsibility for maintaining the registration was transferred to another person who mistakenly reregistered the facility.
According to the report, FDA regulations do not make sure that the registry provides needed information in the case of an emergency. “Specifically, 23% of the facilities (30 of 130) did not provide a valid emergency contact name or a physical address for contacting the parent company or the owner or operator,” the report said.
The Office of Inspector General recommended that the FDA improve the accuracy of information on the registry and adopt strategies to make sure the information remains accurate. “FDA should seek statutory authority to require food facilities to reregister on a routine basis,” the report said. In addition, the report recommends a registration fee to deter facilities from submitting multiple registrations. What’s more, the report said the FDA should be able to impose civil penalties on facilities that don’t comply with the registry requirements.
The FDA generally agrees with the recommendations outlined in the report. “FDA further noted that it already has in progress several efforts that respond to our recommendations and that provisions in proposed legislation are intended to address many of the problems we identified,” the report said.
