The report is the second to be issued under FSMA requirements, and although the agency has come in for criticism in recent weeks for not moving forward on some requirements of the legislation, it outlines advances made in implementing the law.
The FDA regulates $417bn worth of domestic food and $49bn worth of imported foods, according to the report. Under FSMA regulations, the agency used about $189.5m to inspect facilities last year, of which $131.3m was used to inspect domestic facilities and $33.2m for foreign registered facilities.
FSMA categorized different food facilities as ‘high-risk’ or ‘non-high-risk’.
The report said that the agency is still working on how to categorize a facility as high-risk or not, and that the cost of inspections depended on a number of other variables as well as risk level, such as facility size and how many different products are produced there. Among the 22,325 domestic food firms designated as high-risk, the FDA inspected about half of them in 2011. It also inspected 995 foreign registered food facilities, of a total of 254,088, and physically examined 2.3 percent of food import lines, or 243,400 out of more than 10 million.
During 2011, the FDA said that average costs for inspecting a domestic high-risk facility were $21,100, while non-high-risk facility inspections cost $14,200 on average. Foreign high-risk facility inspections averaged $24,800 per inspection, the report said.
In addition, the report said that FDA worked on building an integrated national food safety system in collaboration with regulatory and public health partners.
“FSMA encourages and enables FDA to make further progress toward an integrated national food safety system,” it said. “In 2011, FDA established several working groups to begin the process of implementing the provisions of FSMA that directly impact partnerships with state, local, tribal and territorial partners.”