Foreign offices. In an effort to help ensure that foreign facility inspections will be as effective as possible and to put the FDA in a better position to build relationships with foreign regulators, FSMA directs the agency to open more foreign offices.
Even before FSMA’s passage, the FDA had begun to expand its global reach, opening 13 foreign offices since late 2008. It focused much of its attention on China and India, whose food exports are expected to increase annually by 9 percent within the next decade, according to the FDA’s special report, Pathway to Global Product Safety and Quality.
These foreign offices provide a home base for FDA inspectors, who in the past were primarily stationed in the United States—a practice that the Government Accountability Office (GAO) noted can create logistical roadblocks to timely inspections. “For example, some [FDA] officials indicated that for domestic-based investigators, visa and other delays can result in an inspection being conducted several months after an establishment is notified of FDA’s intent to conduct an inspection,” wrote the GAO in a September 2010 report.
FSMA explicitly calls for foreign office personnel to conduct inspections as well as support the inspections and regulatory efforts of their host government, creating a train-the-trainer-type multiplier effect.
Certification requirements. FSMA also empowers the FDA to require facilities, particularly those that handle high-risk food or have performed poorly in the past, to receive third-party certification before exporting food to America. The certification can be carried out by either the foreign government of the country in which the facility resides or a third-party auditor but these entities, whether governments or private auditors, must first be accredited by FDA-designated bodies. Shipments from these companies must arrive at U.S. entry points with proof of the exporters certification; without that certification, the shipment will be flagged at the border and denied entry.