Yesterday, the Office of Inspector General (OIG) within the Department of Health and Human Services (DHHS), issued a report which analyzed the vulnerabilities in Food and Drug Administration’s (FDA) oversight of state food inspections. The report identified in no uncertain terms “significant weaknesses in FDA’s oversight of food facility inspections conducted by States. ”
The December Report is a follow-up to OIG’s 2000 Report in which it found that FDA had “significant barriers in overseeing State inspections, including limited training provided by FDA to State inspectors and limited agency expertise…” And that’s not the only time that FDA has been on the OIG’s radar for its less-than-effective food inspection programs.
In a 2010 report evaluating FDA’s inspections of domestic food facilities, OIG found that more than half of all food facilities have gone 5 or more years without an FDA inspection and that FDA does not always take swift and effective action to remedy violations found during inspections. In a 2009 report on food traceability, OIG found that only 5 of 40 selected food products could be traced through each stage of the food supply chain. It also found that 59 percent of selected food facilities did not comply with FDA’s recordkeeping requirements and that these requirements were not sufficient to ensure the traceability of the food supply. OIG also issued a report that found that 5 percent of selected facilities failed to register with FDA as required and that almost half of the selected facilities failed to provide FDA with accurate information about their facilities.
The problems with the nation’s food inspection program is evident even without the OIG’s report. The statistics speak loudly to those faults as each year approximately 128,000 Americans are hospitalized and 3,000 die after consuming contaminated foods and beverages.
The OIG’s December Report found that FDA increasingly relies on States to conduct their own inspection of food facilities by contracting with State agencies responsible for ensuring food safety. In 2009, for example, FDA held contracts with 41 States to conduct FDA’s inspections.
Those States conducting FDA’s inspections are required to be monitored by FDA through its Contract Inspection Audit Program. What that means is that the agency requires that a minimum of 7% of a State’s contract inspections be audited each year.
The OIG’s finding reveal significant weakness in the agency’s oversight role.
For example, in eight States–Nevada, California, West Virginia, Oklahoma, Connecticut, Texas, Maine, and Virginia–FDA failed to ensure that the required number of inspections was completed. The agency also paid for many inspections that were incomplete. Additionally, in four other States, FDA paid for inspection visits, even though FDA’s responsibility for payment for such visits was not specified in the States’ contracts.
The OIG also found that even though uniform classification of State inspections is critical to the success of FDA’s food safety program, FDA did not ensure that all State inspections were properly classified. Likewise, the OIG found that FDA did not ensure that all violations were remedied.
Classifications are the scores a facility receives following an inspection. FDA guidance classifies inspections as follows: an official action indicated (OAI), voluntary action indicated (VAI), or no action indicated (NAI). An OAI classification is the most serious as it signifies that the inspector found objectionable conditions in the food facility and that these violations potentially “warrant regulatory action.” A VAI classification signifies that the inspector found violations that are serious enough to record but do not cross “the threshold for regulatory action.” An NAI classification signifies that the inspector found either no violations of law and regulations or violations that were so insignificant that no action is warranted. FDA may also classify an inspection as “referred to State” (RTS). According to FDA guidance, an RTS classification means either there is no Federal jurisdiction over the violation or that State action is the most efficient method of obtaining compliance.
As a result of FDA’s failure to ensure proper classification for all contract inspections, FDA was unable to assess the relative risk of facilities. Astonishingly, the OIG found that when FDA performs an inspection, a facility is five times more likely to receive an OAI classification, the most serious score, when compared to State contract inspections.
Among other holes in FDA’s oversight was the agency’s lack of knowledge as to whether all inspection violations were remedied. The OIG also found that FDA failed to complete the required number of audits for one-third of the States and did not always follow up on systemic problems identified.