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FDA Issues Annual Food Safety Report to Congress

The U.S. Food and Drug Administration’s annual report to Congress, released this week, offers an overview of what the agency has been up to over the past year.

In FDA’s latest report, which is required by the 2011 Food Safety Modernization Act, one thing is immediately clear: FDA has an enormous food safety mandate. The agency regulates $417 billion worth of domestic food and $49 billion worth of imported food. In all, the agency oversees more than 421,121 registered domestic and foreign food facilities.

It’s been about a year and a half since President Obama signed FSMA into law. Though FDA is waiting on drafts of key food safety rules to be released by the White House Office of Management and Budget — where they have now been under review for eight months — the agency has moved forward in a number of other key areas.

In fiscal year 2011, FDA said it used around $190 million for FSMA implementation, $131 million of which was used to inspect domestic food facilities and $33 million for foreign facilities. The agency also gave $25 million to states for food inspections. In its report, FDA noted that the numbers do not include the cost of inspections at the U.S. border, nor did it include the cost of lab analyses or criminal investigations.

Out of 167,033 registered domestic facilities, FDA and states under contract inspected 19,073. Out of 254,088 registered foreign facilities, FDA and states under contract inspected 995. Of the 22,325 domestic food companies FDA has deemed “high-risk,” the agency inspected 11,007, or nearly half of them.

Exactly how much does it cost for FDA to inspect a food maker? For a “high-risk” facility, the average cost is $21,000. For a “non-high-risk” facility, the average is $14,200. Foreign high-risk food facilities cost taxpayers around $24,800 per inspection.

FDA said it is still working on its framework for establishing which food facilities fall into different risk categories.

When it comes to food imported into the United States, through multiple ports of entry, FDA still inspects a small percentage. The agency said it physically examined around 2.3 percent, or 243,400 import lines out of 10,439,236. Field exams cost around $170 each, but if samples are analyzed they cost around $2,800 each.

The agency has also “devoted significant time and resources” to building a more integrated national food safety system. FDA said in the last year they established several working groups to help state, local and tribal stakeholders work to help with the integration. Part of the plan is to integrate response efforts between multiple levels of jurisdiction so that the public health response is “coordinated, faster, and more effective.”

One of the key priorities is creating uniform national standards for program standards, facility inspections, lab testing and outbreak response. In its report, FDA said that achieving more uniformity would “enable greater ability to utilize analyses and observations across jurisdictions to protect public health.”

Sandy Eskin, the director of the Pew Charitable Trusts Food Safety Campaign, said that while the annual report offers a “useful snapshot” of how FDA is implementing FSMA, she remains concerned about “the type of oversight FDA will be giving state contractors as well as the substantial costs associated with traditional ‘pre-FSMA’ inspections.”

“Of course,” she added, “FSMA’s vision for inspection and food import safety will be incomplete as long as the proposed rules regarding the prevention-based requirements for facilities and importers remain bottled up at OMB.”

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