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FDA food safety inspections and enforcement declining, auditors say

By Caroline Scott-Thomas , 08-Apr-2010

Federal inspections of food manufacturing facilities have declined over time, as have regulatory actions triggered by inspections, a government auditor reported on Wednesday.

The Department of Health and Human Services’ inspector general said that the Food and Drug Administration (FDA) had inspected fewer than half of the 51,229 domestic food facilities subject to inspection from 2004 to 2008. Less than a quarter were inspected each year, and the number of inspections declined during the period, even as the number of food facilities increased.

In addition, the number of facilities receiving an official action indicated (OAI) classification fell sharply, from 614 in fiscal 2004, to 283 in fiscal 2008. The OAI classification is given to food manufacturers found to have the most serious safety violations, and its issuance means the FDA can move to ensure a company takes action. But the FDA took no regulatory action against 25 percent of food facilities that received an OAI in 2007, the report said.

The FDA blamed a lack of resources, including a decline in staffing levels, for the falling frequency of inspections.

In response to the report, the FDA said it was already addressing many of the issues and recommendations mentioned, specifically by looking to Congress for better enforcement tools and more statutory authority, and by increasing appropriations to allow it to increase inspections.

Senator Tom Harkin, chairman of the Health, Education, Labor and Pensions (HELP) committee, said: “This new report shows what we have feared for too long: that that our domestic food facilities are not being adequately inspected and FDA needs additional authorities to keep the food on our tables safe. This is unacceptable in our modern society and an important reminder that we must provide FDA with the needed tools to properly inspect food facilities and effectively react to problems in order to ensure the safety of the food American families eat.”

The HELP committee unanimously signed off on the Food Safety Modernization Act in November, which is currently awaiting a full hearing in the Senate. If passed, the bill would increase the frequency of facility inspections, give the FDA the authority to order a product recall if a company fails to act voluntarily, and require that manufacturers keep more thorough records.

The Centers for Disease Control (CDC) estimates there are a total of 76m foodborne illness cases across the US each year, leading to about 300,000 hospitalizations and 5,000 deaths.

The full report from the inspector general’s office is available here .

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