21 U.S.C. § 2242 — Foreign offices of the Food and Drug Administration

(a) The Secretary must open Food and Drug Administration offices in foreign countries. The Secretary chooses which countries get an office. These offices help that country's government make its food and other FDA-regulated exports to the United States safer. They can do this directly, by conducting risk-based inspections themselves. They can also do this indirectly, by supporting inspections the foreign government carries out. (b) Before opening these foreign offices, the Secretary must consult three other officials. They are the Secretary of State, the Secretary of Homeland Security, and the United States Trade Representative. (c) By October 1, 2011, the Secretary had to send Congress a report. The report explains why the Secretary picked those specific countries for offices. It also describes the progress those offices made in helping foreign governments keep their exported food and products safe. Finally, the report covers the Secretary's plans for opening more foreign FDA offices, as appropriate.

The record establishes that this section was enacted by Public Law 111-353, title III, section 308, approved January 4, 2011, and published at 124 Stat. 3966. The source credit reflects a single enactment with no subsequent amendment listed beyond the original provision, indicating the text has remained largely as originally passed. Public Law 111-353 is commonly known as the FDA Food Safety Modernization Act (FSMA). The Act is generally understood to have been a significant overhaul of the federal food safety regulatory framework, shifting the Food and Drug Administration's approach from responding to contamination after it occurred toward preventing food safety problems before they arise. A major impetus for the legislation, as widely reported at the time, was a series of high-profile foodborne illness outbreaks and contamination incidents in the preceding years, coupled with the growing share of the U.S. food supply sourced from imports. Within that broader context, provisions such as this one establishing foreign FDA offices are generally understood to reflect Congress's recognition that ensuring the safety of imported food and regulated products required the agency to have a direct presence and cooperative relationships with authorities in exporting countries, rather than relying solely on inspection at the U.S. border. Beyond this general understanding of FSMA's purpose, the record here does not establish the specific legislative deliberations or reasoning behind this particular section's drafting.