Inspections. FSMA mandates that the FDA increase the number of its foreign food facility inspections from 357 in fiscal year (FY) 2010 to 600 in 2011, doubling that total each year until 2016. By then, Congress expects the FDA to inspect 19,200 foreign facilities—an increase of almost 3,200 percent over 2011.
Because this is still only a fraction of the number of actual facilities, the FDA must prioritize by targeting high-risk facilities. The determination of whether a foreign facility is high risk will depend on the types of foods produced or handled there, how prone those foods are to contamination and pathogens, and whether the facility is located in an area known for poor safety standards, among other factors. “So if I’m looking at bringing in black pepper that’s going to be irradiated versus bringing in farmed shrimp that has a history of antibiotic residues, I’ll inspect the shrimp farm,” says Shaun Kennedy, the director of the National Center for Food Protection and Defense, a Homeland Security Center of Excellence.
These facilities are, by definition, located in other countries, where U.S. laws do not apply. But the FDA is not without leverage. To help drive up inspection compliance among high-risk facilities and their home governments, FSMA gives the FDA a big stick. If the facility or home government refuses to give FDA inspectors access within 24 hours of a request, the agency can impose a ban on imports from that facility. This translates into a “motivation in developing countries to develop an infrastructure that will ensure safe products because it’s better for business,” Kennedy says.
The FDA already started foreign inspections and is currently on pace to meet this year’s inspection goal of 600 foreign food facilities, says Ann Marie Montemurro, director of the FDA’s Division of Foreign Field Investigations. The inspections concentrate on facilities in high-volume, high-risk regions. For instance, the FDA has inspected 54 Chinese food firms and 48 Indian food firms this year. While this may seem like a small number, just two years ago, the agency only inspected four Chinese firms and nine Indian firms.
But the open secret here is that there’s no way the FDA will meet Congress’s future inspection goals unless Congress gets serious about authorizing and appropriating sufficient funding. Captain Domenic Veneziano, director of import operations at the FDA, admitted as much, telling Security Management that the agency would fail to meet Congress’s 2013 inspection goal and beyond without a substantial increase in staffing and other resources. In this budgetary environment, that’s simply not going to happen, and the FDA knows it.