OIG Report Criticizes FDA’s Food Facility Registry, Tracking Capabilities
The U.S. Department of Health and Human Services’ Office of Inspector General (OIG) has issued a report criticizing the U.S. Food and Drug Administration’s (FDA’s) food facility registry and traceability standards. According to the report, “FDA requires each domestic food facility to provide information for the registry,” including contact information for the facility, the owner or operator, and the parent company, and an emergency contact. After sampling 130 selected domestic food facilities, OIG concluded that (i) “Seven percent . . . either failed to register or failed to cancel their registration with FDA, as required”; (ii) “Almost half . . . failed to provide accurate information for the registry”; (iii) “FDA regulations do not ensure that the registry contains certain information that may be needed to locate a facility in an emergency”; and (iv) “Over half of the managers . . . were unaware of FDA’s registry requirement.”
OIG has recommended that FDA improve the registry’s accuracy by developing “strategies to systematically verify” the information, in part by seeking “statutory authority to require food facilities to reregister on a routine basis.” The government watchdog has also urged FDA to “consider seeking statutory authority to impose civil penalties through administrative proceedings against facilities that do not comply with registry requirements.” In addition, FDA has been asked to make mandatory some optional parts of the registry and to “work with the food industry to increase facilities’ awareness” of these requirements.
Although FDA apparently agreed with OIG about problems with the registration process, the agency has indicated that “proposed legislation would create a strong incentive to ensure timely and proper registration.” As OIG remarked in its executive summary, however, “we still recommend that FDA consider seeking statutory authority to impose civil penalties, such as a daily fine, as an intermediate step before taking more severe actions.” See Law360.com, December 11, 2009.
