FDA is responsible for helping to ensure that food products marketed in the United States meet the same statutory and regulatory requirements, whether they are produced in the United States or another country. FDA shares responsibility for the oversight of food safety with the United States Department of Agriculture’s (USDA) Food Safety and Inspection Service (FSIS). FSIS oversees the safety of domestic and imported meat, poultry, and processed egg products, while FDA is responsible for the safety of virtually all other foods, including milk, seafood, fruits, and vegetables. FDA’s responsibilities for overseeing the safety of imported products are divided among its product centers and program offices. FDA’s six centers are each responsible for the regulation of specific types of products, whether manufactured in the United States or another country. For example, the Center for Food Safety and Applied Nutrition is responsible for ensuring that the nation’s food supply is safe, sanitary, wholesome, and honestly labeled, and that cosmetic products are safe and properly labeled. FDA’s Office of International Programs (OIP) has responsibility for leading, managing, and coordinating all of the agency’s international activities, including its foreign offices. OIP, which is part of FDA’s Office of Global Regulatory Operations and Policy, collaborates with the international affairs staff in FDA’s centers and the Office of Regulatory Affairs (ORA). ORA—also part of the Office of Global Regulatory Operations and Policy—performs fieldwork to promote compliance with FDA requirements and the applicable laws, such as inspecting foreign facilities and examining products at the U.S. border. FDA’s foreign offices function within the embassy or consulate for the country or region under the auspices of the Department of State, along with other federal agencies that operate abroad, such as the USDA’s Foreign Agricultural Service, USDA’s Animal and Plant Health Inspection Service, and the Department of Commerce’s U.S. Commercial Service. FDA also works on related issues with other U.S. agencies, including USDA’s Food Safety Inspection Service to share food safety information, the Centers for Disease Control and Prevention (CDC) during foodborne outbreaks, and the Environmental Protection Agency (EPA) to enforce pesticide residue tolerances in foods that are established by EPA. FDA’s foreign offices have a director or deputy director to whom staff members report. The offices also may have food investigators that conduct inspections, as well as senior regional specialists, technical experts, and program support specialists who are responsible for engaging with foreign stakeholders and gathering information. Some offices also may have investigators responsible for inspecting other FDA- regulated products, such as drugs and medical devices, and locally employed staff, also known as Foreign Service Nationals, who are non- U.S. citizens employed at U.S. missions abroad. In 2011, FSMA expanded and modified FDA’s authorities and responsibilities, enhancing the agency’s oversight of imported food by, among other things, including provisions that might better ensure the comparable safety of imported and domestic food. For example, FSMA gave FDA express authority to hold imported foods to the same standards as domestic foods. FSMA directed the establishment of offices in foreign countries and specified that the offices (1) assist governments in those countries in ensuring the safety of food and other FDA-regulated products and (2) conduct risk-based inspections of food and other products and support such inspections by foreign governments. With respect to foreign facilities that are sources of food imported to the United States, the law directs FDA to inspect at least 600 foreign facilities within 1 year of enactment of FSMA and, in each of the 5 years following that period, to inspect at least twice the number it inspected during the previous year. In addition, FDA can refuse entry into the United States of food from a foreign facility if FDA is denied access for inspections by the foreign facility or the country in which the facility is located. FDA’s foreign offices have engaged in a variety of activities intended to help ensure the safety of imported food; building relationships with foreign counterparts has been a top-priority activity. Foreign offices have conducted inspections of foreign food facilities, but FDA is not keeping pace with FSMA’s mandate for increasing the number of these inspections. FDA reported to Congress in 2012 that the primary purpose of posting staff in other countries is to engage more proactively and consistently with various stakeholders to help prevent unsafe products from reaching U.S. borders. To accomplish that purpose, the foreign offices have engaged in various types of activities, including (1) building collaborative and cooperative working relationships with foreign regulatory authorities and U.S. federal agencies located in other countries, (2) gathering and assessing information to increase FDA’s knowledge of the regulatory landscape, such as conditions in other countries that could affect the safety of food, and (3) conducting inspections to help identify high-risk facilities and determine the risks from imported products. Table 1 explains these and other types of activities conducted by FDA’s foreign offices. These activities are carried out by FDA’s foreign offices—some of which have multiple locations—that divide up responsibilities for different parts of the world. As shown in figure 1, all offices are located in other countries except the Asia-Pacific Office, which is located at FDA headquarters in the United States. As illustrated in the figure, FDA has closed, or plans to close, some of its foreign office locations. FDA has closed these offices for a variety of reasons. For example, the location in Parma, Italy—where the European Food Safety Authority (EFSA) is headquartered—was closed, and FDA staff relocated to the United States Mission to the European Union in Brussels, Belgium, as a more efficient use of resources to ensure coverage for FDA-related activities within the European Union while maintaining the liaison with EFSA through temporary duty assignments. As part of these closures, the Asia-Pacific Office—which covers Canada, Australia, New Zealand, and countries in Asia other than China and India—has absorbed responsibilities for countries previously covered by the Middle East and North Africa Office and the Sub-Saharan Africa Office. We questioned the foreign offices to determine the extent to which they performed these activities and which three activities were a top priority in 2014. The foreign offices reported similarities and differences in the types of activities they conducted. For example, all offices similarly reported conducting activities related to (1) gathering and assessing information, (2) providing information on FDA standards, and (3) building relationships. As shown in figure 2, we found differences in top-priority activities across the foreign offices. As noted earlier, FSMA directed, among other things, the establishment of foreign offices to conduct risk-based inspections of food and other products. The foreign offices that conduct inspections of food facilities use investigators that are either assigned to a foreign office for at least a 2- year rotation (in-house) or assigned to a foreign office on temporary duty for 60, 90, or 120 days from ORA. FDA’s China Office, India Office, and Latin America Office are the only foreign offices that conducted inspections of food facilities in 2014. Our analysis showed that the number of inspections performed by the foreign offices has increased since we reported in 2010 but remains a small part of FDA’s total number of foreign food inspections. In 2010, FDA’s China Office completed 13 food inspections, and the India Office completed none. By 2013, the China Office completed 45 of FDA’s total 59 food inspections in China (about 76 percent), and the India Office completed all 20 FDA food inspections in India—about 5 percent of FDA’s total 1,415 inspections of foreign food facilities. In 2014, FDA added food investigators to its Latin America Office to conduct inspections, and the agency anticipates conducting more inspections of foreign food facilities in the future. During 2014, the foreign offices completed 140 of FDA’s total 1,323 inspections of foreign food facilities—66 in China, 67 in India, and 7 in Latin America—a 10-fold increase in the 4 years since 2010. The foreign offices also have begun providing in-country information to U.S.-based ORA investigators to help them complete their assigned foreign food inspections. Figure 3 shows the locations where FDA investigators conducted inspections of foreign food facilities in fiscal year 2014. These numbers include food inspections performed by FDA investigators, whether they were assigned to a specific foreign office, on temporary duty from ORA, or based with ORA in the United States and assigned to travel for a few weeks at a time to inspect foreign facilities. The increase in inspections completed by the foreign offices notwithstanding, FDA is not keeping pace with the targets for foreign food inspections set by Congress in FSMA. The act mandated that FDA inspect at least 600 foreign food facilities in the 1-year period following the enactment of FSMA. For each of the 5 following years, FSMA mandated that FDA inspect at least twice the number of facilities inspected during the previous year. Figure 4 shows the number of inspections FDA actually completed (or has planned to complete), along with two possible scenarios in response to FSMA. The first scenario has FDA inspecting twice the actual (or planned) number of foreign food facilities compared with the previous year, starting with the 1,002 inspections FDA completed in 2011 (see shaded bars labeled “FSMA mandate”). For example, as highlighted in the figure data, the FSMA mandate set a target of at least twice as many inspections—2,004—in 2012 as FDA actually inspected in 2011. The second scenario shows FDA inspecting 600 facilities—the FSMA minimum—in 2011, then doubling that number each of the 5 following years (see white bars labeled “Doubling each year”). The first scenario would yield a target of at least 2,646 foreign inspections in 2015 and an estimated target of at least 2,400 foreign inspections in 2016, the final year of the mandate.