HHS auditor faults FDA food inspections, enforcement

Robert Roos

Apr 7, 2010 (CIDRAP News) – The US Food and Drug Administration (FDA) inspected only 24% of food facilities annually in a recent 5-year period, issued relatively few notices of potential safety violations, and didn't always follow up on the problems it did find, according to an audit report by the Department of Health and Human Services (HHS).

Reviewing FDA records for fiscal years 2004 through 2008, the HHS Office of the Inspector General (OIG) found that the proportion of regulated food facilities that were inspected dropped from 29% in 2004 to 22% in 2008, according to the report.

The number of facilities that received FDA notices of potential food safety violations dropped from 614 in 2004 to 283 in 2008, even as the number of facilities grew, the OIG found. For 54% of the facilities that received a notice, the FDA either lowered the classification of the original notice or took no action.

The FDA, in a response included at the end of the 38-page report, said it has already addressed or is addressing many of the concerns the report raises. The agency says it is hiring more inspectors and that legislation now in Congress would improve its enforcement powers, including the authority to access food safety records.

The report comes about 9 months after President Obama's Food Safety Working Group announced plans to pursue four broad steps for improving food safety, one of which is to improve federal food safety oversight in general. Establishment of the working group was prompted by a series of widespread foodborne disease outbreaks in recent years, involving foods such as peanut butter, pistachios, hot peppers, and ground beef.

The OIG, which reviewed the FDA's inspection program at the request of the Senate Committee on Agriculture, Nutrition, and Forestry, based its report on FDA inspection and enforcement records for 2004 through 2008 and on interviews with officials in many of the agency's district offices. The OIG focused particularly on enforcement efforts in 2007, since enough time had passed for resolution of issues raised that year.

Inspection staff dwindled
The OIG said the FDA's inspection staff dwindled through the middle 2000s, from 3,167 full-time equivalents in fiscal year 2003 to 2,569 in 2007. Last year Congress increased the FDA's food program funding enough to support 3,019 full-time inspectors, the report says.

In its response to the report, the FDA cited different figures, saying it will have 2,505 food inspectors this fiscal year, up from 1,806 in 2007.

The FDA listed 51,229 food facilities that were in business and subject to inspection from 2004 through 2008, the OIG found. On average, 24% of these were inspected annually. More than half of the facilities—56%—were never inspected during the 5 years, while 14% were inspected once and 30% were inspected two or more times.

Like inspections of food facilities overall, inspections of facilities classified as high-risk declined over the 5 years, from 77% in 2004 to 63% in 2008, the report says. In 2008 there were 8,667 facilities designated as high-risk.

Information was not immediately available from the FDA today on the number or percentage of facilities that were inspected in 2009, after the period covered by the report.

FDA notices of potential food safety violations are called "official action indicated," or OAI, the report notes. In 2004 the agency issued OAI notices to 614 of the 17,032 facilities inspected (3.6%). By 2008 the number was down to 283 of 14,966 facilities inspected (1.9%). Almost 75% of those facilities had a history of violations.

In examining the 2007 records, the OIG found that 446 facilities received OAI notices. The FDA took regulatory action against 46% of these. For the rest, the agency changed the OAI notice to call for only voluntary action or no action in 29% of cases, and it took no regulatory action for 25%.

Of the facilities on which the FDA took regulatory action in 2007, in most cases the agency sent a letter or met with the company to recommend corrective steps. Only 2% of the firms that received OAI notices became the targets of enforcement actions, which included injunctions against seven facilities and product seizures at three.

In 2007, 280 facilities received OAI notices that were not changed to a lower classification, the report says. For 36% of those, the agency did not reinspect the facility within a year or review evidence provided by the operator to make sure the problems were corrected. The agency said it reinspected 35% of the facilities and received evidence of correction action from another 30%.

In its response to the findings, the FDA said it has already addressed many of the concerns raised and that "considerable progress is being made on the other recommendations."

The agency said the proposed Food Safety Enhancement Act of 2009 (H.R. 2749)—supported by the Obama administration—would expand civil penalties for food safety violations and give the FDA access to all records that bear on whether food is adulterated or misbranded.

Also, in the wake of lessons from a Salmonella outbreak linked to peanut products, the agency said it is now conducting "intensive environmental sampling" when inspecting some facilities where there is an increased risk of contamination.

The response also mentions several enforcement initiatives announced by FDA Commissioner Margaret Hamburg in August 2009.