In the years ahead, the FDA’s goal is to become a risk-based global organization with the mission of preventing contaminated food stuffs from ever reaching the United States, rather than reactively intercepting them at U.S. ports of entry. To achieve its safety objectives, FSMA places most of the regulatory burden on U.S. food importers—from the large corporate food companies down to the mom-and-pop shops—because the exporters are beyond the reach of U.S. law.
The FDA reports that, over the past seven years, food import shipments, which are known as “lines,” have grown by an average of 10 percent per year, from 5.6 million in 2002 to 10.7 million in 2009. The inspection force, however, has not kept pace with this growth. “The growing challenges of globalization have far outstripped the FDA’s resources for inspection and quality monitoring,” the agency said in a recent strategic planning document.
Fewer than 2,000 FDA inspectors are employed to examine imports for signs of unsafe food stuffs passing through America’s 300-plus ports of entry. As a result, according to the FDA, just 2.1 percent of U.S. food imports in fiscal year 2010 were physically inspected. That meant that the FDA only got a “snapshot” of the quality of food coming across the border, says Dr. David Acheson, former associate commissioner for foods at the FDA and now managing director of food and import safety at the consulting firm Leavitt Partners.
FSMA’s intent is to change the model so that these inspectors become the last line of defense. “The border must be viewed as a final checkpoint for preventative controls, rather than the primary line of defense against unsafe imports,” the FDA’s five-year plan states.
Like the U.S. military did long ago, the FDA is going beyond U.S. territorial boundaries in search of security. “Over the next decade, FDA will transform itself from a domestic agency operating in a globalized world to a truly global agency fully prepared for a regulatory environment in which product safety and quality know no borders,” the FDA planning document states.
A big part of this effort will be ramping up inspections of high-risk foreign food facilities, establishing more FDA offices overseas, and requiring high-risk facilities to certify that their food is safe to import.