Food Safety: Additional Actions Needed to Help FDA's Foreign Offices Ensure Safety of Imported Food
Released: 2015-02-27T00:00:00

Letter

Background

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 Foreign Offices Have Engaged in a Variety of Activities Since 2010 to Help Ensure the Safety of Imported Food

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.

Foreign Offices Vary in Their Focus on Different Activities; Building Relationships with Foreign Counterparts Has Been a Top Priority

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.

Foreign Offices Have Conducted Food Inspections, but FDA Is Not Keeping Pace with Mandated Targets

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. The second scenario, as FDA has reported to Congress, would yield a target of 19,200 foreign inspections in 2016.

FDA is not currently keeping pace with the FSMA mandate for increased foreign food inspections under either scenario’s targets. As the figure shows, FDA completed 1,002 foreign food inspections in 2011, 167 percent of the FSMA mandate. In 2012, FDA completed 1,343 such inspections, a 34 percent increase from, but not twice, the previous year’s number. During 2013, FDA completed 1,403 such inspections, a 4 percent increase from the previous year but also less than twice the previous year’s number. Thus far, the agency has completed 1,323 inspections in 2014, which is more than planned but an overall decrease compared with the previous 2 years. FDA officials told us that the agency has not met—and is not planning to meet—the FSMA mandate. They questioned the usefulness of conducting the number of inspections mandated by FSMA.

According to FDA officials, the cost of inspections is the main reason that the agency is not keeping pace with the FSMA mandate for foreign food facility inspections. In its most recent report to Congress on food imports and foreign offices, FDA estimated that the average cost of a foreign inspection was $23,600, compared with $15,500 for a comparable domestic one. By that estimate, FDA would have needed at least $113 million to complete the 4,800 foreign inspections that it has reported were required in fiscal year 2014 to meet the FSMA mandate. For 2014 and 2015, FDA requested funding for 1,200 foreign food inspections for each year. For fiscal year 2014, FDA received a total of about $138 million to implement all provisions of FSMA, including training, rulemaking, and foreign inspections. FDA officials told us that, given limited funding, the agency determined that additional foreign inspections were not the best use of FSMA-related funds. FDA officials said they were focusing resources instead on technical assistance to the domestic and foreign food industry to help manufacturers comply with new FSMA rules, as well as training for FDA investigators and other agency staff to modernize FDA’s food inspection program. However, FDA has not conducted an analysis to determine whether either the required number of inspections in the FSMA mandate or the lower number of inspections it is conducting is sufficient to ensure comparable safety of imported and domestic food. Without such an analysis, FDA is not in a position to know what is a sufficient number of foreign inspections and, if appropriate, request a change in the mandate regarding the number of foreign inspections to be conducted.

FDA Foreign Offices Cited Contributions to the Safety of Imported Food, but the Extent of These Contributions Has Not Been Fully Measured

FDA foreign office officials cited a variety of contributions to improving the safety of food imported from other countries to the United States. However, the extent of the contributions is unknown because FDA’s performance measures have not fully captured these contributions.

FDA Foreign Office Officials Cited Contributions to the Safety of Imported Food

Officials from the foreign offices cited instances when they had made significant contributions to determining the cause of outbreaks that led to illnesses and deaths in the United States. Among them:

The Europe Office credited new relationships with their Italian counterparts for providing information that helped link a 2012 outbreak of listeriosis, which sickened 22 people and resulted in four deaths in the United States, to ricotta cheese imported from Italy. According to FDA officials, the office staff worked with Italian food safety authorities to investigate firms that could have caused the outbreak. The result of these efforts was a recall of some ricotta cheese, ending instances of illness and death in the United States.

In 2012, the India Office’s in-country investigators were able to rapidly conduct inspections of tuna processing facilities that were identified as potential sources of an outbreak of Salmonella in tuna products, which sickened 425 people in the United States. FDA and other agencies were then able to quickly take action on the inspection findings, including FDA issuing an import alert for the tuna products.

Listeriosis. The Centers for Disease Control and Prevention (CDC) estimated that approximately 1,600 illnesses and 260 deaths due to listeriosis occur annually in the United States. Listeriosis is a serious infection with symptoms that can include headache, stiff neck, confusion, loss of balance, and convulsions in addition to fever and muscle aches. Infection during pregnancy can lead to miscarriage, stillbirth, premature delivery, or life-threatening infection of the newborn. relationship with the Mexican government’s food regulatory authorities to narrow down the source of a Cyclospora outbreak in 2013 that sickened 631 people in the United States. This office coordinated investigations at the facilities that handled the leafy greens identified as the potential source of the outbreak and certified the facilities as free of Cyclospora so the shipment of the products could resume.

Salmonellosis. According to the CDC, Salmonella is estimated to cause more than 1 million illnesses annually in the United States, with 19,000 hospitalizations and 380 deaths. Most persons infected with Salmonella develop diarrhea, fever, and abdominal cramps 12 to 72 hours after infection.

Cyclosporiasis. Cyclosporiasis is an intestinal infection that can be caused by people ingesting food or water contaminated with feces. In the United States, outbreaks since the mid-1990s have been linked to various types of imported fresh produce such as raspberries, basil, and mesclun lettuce.

The foreign office officials also provided examples of additional actions that stopped the importation of food products that were potentially harmful to humans. For example, in 2012, the Latin America Office in Mexico City helped stop the importation of a fraudulent dietary supplement into the United States because the officials discovered that the supplement did not contain the ingredients it claimed to include. Also, in 2012, this office helped test shipments of orange juice products from all foreign sources for a pesticide residue, carbendazim, and found that 31 of 166 shipments had carbendazim. EPA has not registered carbendazim for use as a fungicide on oranges or established a tolerance or an exemption from a tolerance for carbendazim in orange juice. As a result of the testing, several facilities were stopped from exporting orange juice containing carbendazim residues to the United States, and the occurrence of carbendazim in imported orange juice declined.

FDA also provided an example of a foreign office’s contribution to the safety of imported animal food. Specifically, in 2012, in-country investigators in the China Office conducted inspections of five facilities that made jerky pet treats to determine if they were the cause of ongoing illnesses and deaths in pets in the United States. As of May 2014, FDA had received reports of illness involving more than 5,600 dogs and 24 cats, and the deaths of more than 1,000 dogs, which may be related to consumption of jerky pet treats. In addition, FDA received three reports of human illness after exposure to jerky pet treats. The China Office has assisted with the ongoing investigation into the illnesses; however, as of October 2014, the cause has not been found. FDA investigators were not permitted to take samples of the pet treats or their ingredients inside the facilities and have them tested in an FDA laboratory in the United States. Foreign office officials told us that FDA investigators do not typically take samples during foreign inspections, but they have taken samples in Mexico and sent them to an FDA laboratory in the United States to assist in a food outbreak investigation. FDA’s Center for Veterinary Medicine continues to work on finding the cause for illnesses and deaths linked to jerky pet treats.

FDA Performance Measures Do Not Fully Capture the Contributions of Foreign Offices

The extent of the foreign offices’ contributions to food safety is unknown because FDA does not fully capture the foreign offices’ contributions through performance measures that are either agency-wide or specifically developed by OIP for the foreign offices. In our 2010 report, we recommended that, as the agency completed its strategic planning process for the foreign offices, it develop performance goals and measures that can be used to demonstrate the offices’ contributions to long-term outcomes related to imported FDA-regulated products.

FDA’s agency-wide performance measures for the foreign offices provide counts from each foreign office on how many inspections were conducted within each country and the number of completed country profiles— reports and papers on the food safety conditions in a given country. These measures do provide important output information, but they do not provide outcome-oriented information on how a specific action by a foreign office contributed to food safety. For example, an output measure, such as a number count of inspections, does not show how the inspections and reports contribute to broader food safety goals. OIP does have one measure that is outcome oriented—a measure of collaborative actions by each foreign office that led to improved public health outcomes. However, neither FDA’s agency-wide performance measures nor OIP’s measure fully captures the foreign offices’ activities to help improve food safety. See table 2 for a list of FDA agency-wide and OIP performance measures for the foreign offices in fiscal year 2014.

In our 2010 report, we acknowledged that some measures are difficult to develop because results for some activities are not easy to quantify and that it can be difficult to attribute results to programs that involve multiple organizations within FDA. However, performance measures are important management tools for agencies. The agency has initiated a review to determine how to better reflect the value of the foreign offices in the agency-wide performance system. The initial phase of this review has been completed, and FDA could not provide a date when the full review would be completed or when new performance measures would be implemented. OIP has developed a strategic map that aligns the activities of the foreign offices with strategic outcomes. OIP is also collecting information from its foreign offices by means of annual operational plans that track each office’s progress toward completing a specific project, such as organizing a conference to help foreign regulatory counterparts and industry officials better understand FSMA. These are potentially useful performance planning and management tools; however, they are not performance measures. Leading practices indicate that results- oriented performance measures focus on expected results to show progress toward, or contributions to, intended results. We believe our previous recommendation that FDA develop performance goals and measures for the foreign offices that are outcome-oriented is still valid. Without performance measures that can be used to demonstrate the offices’ contributions to long-term outcomes related to imported FDA- regulated products, FDA has less information available to effectively measure the foreign offices’ progress toward meeting the agency’s goals.

FDA Has Not Completed a Strategic Workforce Plan for Its Foreign Offices

Since we last reported, FDA has continued to experience recruitment challenges in the foreign offices. FDA has taken some steps to address those challenges, but it has not completed a strategic workforce plan.

FDA Continues to Experience Recruitment Challenges in the Foreign Offices

In 2010, we found that FDA had experienced challenges in staffing some of the foreign offices. For example, at that time, FDA had 2 vacant staff positions in the Latin America Office out of a total of 14 positions, and 4 vacancies in the India Office out of a total of 15 positions. In subsequent years, the number of vacancies in the foreign offices has increased as these offices have expanded. There are fewer staff members in the foreign offices now than in 2010, and the percentage of vacant positions has increased because the number of approved staff positions is larger. As shown in figure 5, 44 percent of FDA’s approved foreign office positions were vacant as of October 2014, and most of these vacancies were in the China Office.

These vacancies shown in the figure above include both U.S. government and locally employed staff positions. Locally employed staff account for 17 out of the 50, or 34 percent of the total staff working in FDA’s foreign offices, as of October 2014. Appendix II provides additional information about the staffing composition of the foreign offices and the contributions of locally employed staff.

A number of factors have contributed to vacancies in the foreign offices, including delays in obtaining visas from the Chinese government. According to FDA officials, the last visa for a new FDA staff member to be posted in the China Office was issued in October 2012; there are nine U.S. government staff who have been hired by FDA for the China Office, but they cannot deploy because of the Chinese government’s delay in issuing new visas for FDA employees. OIP officials told us that they began discussions with Chinese government officials in February 2012 about increasing the number of investigators in the China Office. As of October 2014, FDA’s discussions with the Chinese government were ongoing. Figure 6 shows a timeline of developments, including White House involvement, related to FDA’s efforts to obtain visas for new staff in the China Office.

In an effort to facilitate the granting of visas for new staff, FDA agreed to close its locations in Guangzhou and Shanghai and consolidate all China Office staff in Beijing. However, officials in the China Office expressed concern that they will lose a valuable resource because one of the two locally employed staff members in Guangzhou will not be able to relocate to Beijing. The language skills of the locally employed staff are especially important in China, where the investigators do not typically speak the local language. OIP officials told us that, in the absence of locally employed staff available to translate, investigators in China rely on translators provided by the firms that are being inspected. Consolidating all China Office staff in Beijing also poses challenges in providing enough office space within the embassy. OIP officials told us that when adding investigators to the China Office was first proposed in February 2012, they knew that they might face space constraints regardless of whether staff were placed in the China Office’s locations in Shanghai, Guangzhou, or Beijing. There is not enough space in the U.S. embassy in Beijing to house additional FDA staff, so FDA will be one of the occupants in a new annex building that the Department of State is currently constructing. FDA anticipates moving into that space in October 2015.

Other factors that have affected the recruitment of staff for the foreign offices include issues that are directly affected by FDA personnel policies, such as reintegration of staff who have returned from assignments at a foreign office location. In the past, FDA handled reintegration on a case- by-case basis. Foreign office officials told us that not having a reintegration policy for staff members who have completed foreign assignments had hampered their ability to recruit staff to work in the foreign offices. Foreign office officials said U.S.-based ORA investigators have been hesitant to transfer to foreign offices because they were concerned about whether they would be able to return to their previous geographic location once they completed their posting abroad. They have also been concerned about whether FDA would value the experiences they gained while abroad. To address the uncertainty surrounding reintegration, FDA adopted a set of standard operating procedures, which were finalized in November 2014. OIP officials said they, in conjunction with the Office of Human Resources, have been engaging in outreach efforts to help managers understand the reintegration process.

Foreign office officials told us that lengthy hiring processes also have affected FDA’s ability to staff its foreign offices. According to information published by the Office of Management and Budget, in 2009 it took federal agencies an average of 122 days to fill an open position. According to the most recent data available, that time dropped to an average of 93 days for fiscal year 2011 and 87 days for fiscal year 2012. For FDA, during fiscal years 2013 and 2014, it took an average of 121 days to fill staff positions in the Asia-Pacific Office, 140 days in the China Office, 172 days in the Europe Office, 200 days in the India Office, and 104 days in the Latin America Office. FDA has recently implemented an agency-wide initiative known as FDA’s Accelerated Staffing Track to reduce the time it takes to hire a candidate to 80 calendar days.

FDA Has Taken Some Steps to Address Workforce Challenges in Its Foreign Offices

OIP has undertaken initiatives to help recruit and develop staff. According to OIP officials, one successful initiative was to implement temporary duty assignments of investigators for 60, 90, or 120 days to meet immediate resource needs of the foreign offices. Officials in the foreign offices told us that the investigators assigned on temporary duty were a staffing resource that helped the offices conduct inspections. Temporary duty assignments also served as an important recruiting tool since investigators returning from a temporary overseas assignment can provide a firsthand account of their foreign office experiences to their U.S. colleagues. In addition, OIP officials told us that they were able to use information from a draft workforce gap analysis to implement some learning and development initiatives to help ensure that the foreign office staff had the necessary skills to perform their job duties. OIP identified “diplomacy” and “global awareness” as training topics for foreign office staff. OIP also sought to strengthen staff members’ foreign language skills by offering language training.

However, OIP does not have a formalized staffing mechanism through which it can decide on strategic resource allocations based on a targeted analysis of the specific staffing needs of its various foreign offices. Such a staffing mechanism would be included in a strategic workforce plan. Currently, the foreign offices provide input into staffing decisions through office-level staffing proposals, but some of the needs identified in their proposals have not been met. For example, officials from one foreign office expressed a need to have a staff member located in headquarters to represent them in real time during face-to-face discussions of policy matters. That office also identified a need for additional information technology support because of the challenges created by operating in a time zone when headquarters staff are not typically working and the security requirements for accessing FDA computer systems in an embassy setting.

OIP officials told us that they are developing a strategic workforce plan that requires an FDA-wide perspective and approach that recognizes the broad role of FDA’s centers and ORA in its international activities. To that end, OIP has developed a strategic workforce planning framework, and officials told us that, over the next year, they will develop the first phase of a forward-looking strategic workforce plan for the foreign offices. However, OIP has yet to define what the workforce plan will entail, and there are no time frames for completion. Strategic workforce planning is an essential tool to help agencies align their workforces with their current and emerging missions and develop long-term strategies for acquiring, developing, and retaining staff. In our 2010 report on FDA’s foreign offices, we recommended that FDA develop a strategic workforce plan for the foreign offices to help ensure that the agency is able to recruit and retain staff with the necessary experience and skills. We continue to believe that completing a strategic workforce plan for the foreign offices is critical to FDA’s ability to address staffing challenges.

Conclusions

FDA established foreign offices to help prevent unsafe products from entering the United States. Through their activities, FDA’s foreign offices have helped the agency to increase the total number of foreign food inspections conducted annually. Nonetheless, FDA has not kept pace with FSMA’s inspection mandate since 2011. FDA is planning to conduct 1,200 foreign food inspections through the end of the mandate—well below either scenario that might satisfy the FSMA mandate to increase inspections each year through 2016. FDA officials cited limited resources as the primary reason they are not conducting more foreign food inspections. FDA officials also questioned the usefulness of conducting the number of inspections mandated by FSMA. However, FDA has not conducted an analysis to determine whether the number of inspections mandated by FSMA or the number of inspections it is now conducting is sufficient to ensure comparable safety of imported and domestic food. Without such an analysis, FDA is not in a position to know what is a sufficient number of foreign inspections and, if appropriate, request a change in the mandate regarding the number of foreign inspections to be conducted.

In addition, in 2010, we recommended that FDA develop performance goals and measures that can be used to demonstrate the foreign offices’ contributions to long-term outcomes related to improving the safety of imported food products. According to FDA officials, the agency has initiated a review to determine how to better reflect the value of the foreign offices in the agency-wide performance system. However, FDA has not yet implemented new performance measures or determined when its review would be completed. We continue to believe that performance measures that demonstrate the foreign offices’ contributions to long-term outcomes for the safety of imported food are important to provide information to help the agency track progress toward meeting its goals and to provide managers with crucial information on which to base funding decisions. We also recommended that FDA develop a strategic workforce plan for the foreign offices to help ensure that the agency is able to recruit and retain staff with the necessary experience and skills. FDA has taken some steps to address recruitment challenges, but the agency has not yet completed a strategic workforce plan. We continue to believe that a strategic workforce plan for the foreign offices is critical to FDA’s ability to address staffing challenges, especially given the number of vacancies abroad. There are other challenges affecting the foreign offices, such as problems obtaining visas for the China Office staff. However, a strategic workforce plan would provide FDA some assurance that it has placed the right people in the right positions at the right time and can carry out its mission to protect public health in an increasingly complex and globalized world.

Recommendation for Executive Action

To help ensure the safety of food imported into the United States, we recommend that the Commissioner of Food and Drugs complete an analysis to determine the annual number of foreign food inspections that is sufficient to ensure comparable safety of imported and domestic food. If the inspection numbers from that evaluation are different from the inspection targets mandated in FSMA, FDA should report the results to Congress and recommend appropriate legislative changes.

Agency Comments and Our Evaluation

We provided a draft of this report to FDA for comment. In its written comments, which are reprinted in appendix III, FDA concurred with the recommendation, pending the necessary resources to conduct the analysis, as part of a larger FSMA-implementation strategy to improve the safety of imported food that will, among other things, reconsider the number of inspections conducted in other countries. FDA said that foreign inspections are an important part of FSMA, providing accountability for inspected foreign firms, incentives for them to comply with U.S. import requirements, and intelligence about foreign food safety practices. FDA added that foreign inspections will not, in themselves, ensure comparable safety of imported and domestic food, and the agency is expanding its collaborations with foreign governments to assist in ensuring the safety of imported food. As noted in its comments, FDA is optimistic that additional visas will be approved to expand its presence in China, which would help reduce the number of vacant staff positions that we cite in this report. FDA also provided technical comments that were incorporated, as appropriate.

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Appendix I: Objectives, Scope, and Methodology

This report responds to your request that we examine the progress of Food and Drug Administration (FDA) foreign offices since we last reported in 2010 for helping to ensure the safety of imported food. Our objectives of this report were to examine (1) the activities the FDA foreign offices have engaged in since 2010 to help ensure the safety of imported food, (2) the extent of the foreign offices’ contributions to the safety of imported food, and (3) the extent to which FDA has engaged in workforce planning for its foreign offices. For the purposes of this report, imported food refers to food for human or animal consumption, unless otherwise specified.

To examine the activities of FDA’s foreign offices, we reviewed and analyzed documents including FDA reports to Congress that were mandated by the FDA Food Safety Modernization Act (FSMA) that describe the activities of all foreign offices, evaluated written answers to questions about their activities since the 2010 report, and conducted structured interviews with FDA officials in the foreign offices, and analyzed counts of foreign food facility inspections for each year of the FSMA mandate. We questioned all FDA offices that reported conducting food safety activities at the time of our review. The Sub-Saharan Africa post was vacant and, therefore, was not included in the structured interview. Based on conversations with officials from the China Office and Latin America Office, the Chile post and Shanghai post were not included in the structured interview because the posts did not focus on food. As part of our questions, we asked the officials to identify their three top priority activities. In addition, we analyzed food inspections conducted by the foreign offices compared with targets mandated in FSMA between 2011 and 2016. We cross-checked FDA’s foreign inspection numbers, as provided by the Office of Regulatory Affairs through its FACTS database, with information in FDA reports to Congress and additional information obtained during our site visits to locations in Beijing and Guangzhou, China, and Mexico City, Mexico. We selected those offices, in part, because they conducted food inspections. Through this examination of the data and interviews with FDA officials who were knowledgeable about foreign food inspections, we determined that the inspection counts provided by the agency were sufficiently reliable for use in our review.

To examine how FDA foreign offices have contributed to imported food safety, we reviewed and analyzed documents and data that described the outcomes of the foreign offices’ activities, including inspection reports and import alerts. We conducted structured interviews with FDA officials from the foreign offices, including the Asia-Pacific Office, China Office, Europe Office, India Office, and Latin America Office to determine the outcomes of the foreign offices’ activities. We also discussed the outcomes of the foreign offices with FDA’s Center for Food Safety and Applied Nutrition and Center for Veterinary Medicine. We analyzed performance planning and management planning documentation to determine the extent that FDA had performance measures that were outcome oriented and captured the activities of the foreign offices, based on leading practices that we have previously identified. We interviewed FDA officials in the Office of International Programs (OIP) and the Office of Strategic Planning and Analytics to understand how FDA is measuring the performance of the foreign offices. Through interviews with FDA officials knowledgeable about performance measures for the foreign offices, we determined that the performance measure data were sufficiently reliable for use in our review.

To examine the extent to which FDA has engaged in workforce planning for its foreign offices, we reviewed workforce planning documents, including descriptions of recruitment and retention and learning and development initiatives, FDA’s 80-day hiring model and draft reintegration policy, and draft analyses from a contractor hired to develop a workforce plan for the foreign offices. We also reviewed leading practices for workforce planning that we have previously identified. We also analyzed staffing data from the foreign offices, and we interviewed officials from the OIP, the Office of Operations, the Office of Planning, and the Office of Human Resources. We cross-checked the staffing counts provided by the OIP with information we obtained during our site visits to locations in Beijing and Guangzhou, China, and Mexico City, Mexico. Through this examination of the data and interviews with FDA officials knowledgeable about staffing for the foreign offices, we determined that the data were sufficiently reliable for use in our review.

In addition, to address all three objectives, we conducted an in-depth review of FDA operations in Canada, China, and Mexico. We selected these locations based on an analysis of the volume of food imports, the percentage of food imports refused at the border, and the number of food facility inspections for fiscal year 2013. We also considered the number of active import alerts (i.e., warnings about particular products, manufacturers, and countries based on FDA experience or information that triggers a more intensive inspection at the U.S. border). We visited FDA’s offices in Beijing and Guangzhou, China, and Mexico City, Mexico. We interviewed all FDA staff at those locations, as well as the regional director for the Latin America Office who was present in Mexico City during our visit. We also met with officials from U.S. government agencies in those locations, including the United States Department of Agriculture’s (USDA) Foreign Agricultural Service and USDA’s Animal and Plant Health Inspection Service, the Centers for Disease Control and Prevention, the Department of Commerce’s Foreign Commercial Service and the Department of State’s Environment, Science, Technology, and Health Officers. We also accompanied FDA foreign office staff on site visits to food facilities. During our visit to Mexico City, we visited the world’s largest greenhouse, which grows and packs hydroponic tomatoes and peppers for export to the United States. During our visit to Guangzhou, we visited a large facility that produces farm-raised seafood for export to the U.S. market. Additionally, we spoke with food safety regulatory authorities in Canada, China, and Mexico, including the Canadian Food Inspection Agency; the China Food and Drug Administration; the China Center for Food Safety Risk Assessment; the General Administration of Quality Supervision, Inspection, and Quarantine of the People’s Republic of China; the Guangdong Entry-Exit Inspection and Quarantine Bureau of the People’s Republic of China; the Mexico Federal Commission for the Protection against Sanitary Risk; and the Mexico National Service of Agro Alimentary Health, Safety and Quality.

We conducted this performance audit from November 2013 to January 2015 in accordance with generally accepted government auditing standards. Those standards require that we plan and perform the audit to obtain sufficient, appropriate evidence to provide a reasonable basis for our findings and conclusions based on our audit objectives. We believe that the evidence obtained provides a reasonable basis for our findings and conclusions based on our audit objectives.

Appendix II: Additional Information about Staffing of Foreign Offices

The Food and Drug Administration’s (FDA) foreign offices comprise both U.S. government staff and locally employed staff who are non-U.S. citizens employed at U.S. missions abroad. Figure 7 below shows staff numbers for each foreign office position, as of October 2014.

Figure 8 shows the approved and filled staff positions by foreign office, as of October 2014.

Foreign office officials told us that locally employed staff provide valuable contributions toward the activities of the foreign offices. Locally employed staff speak the local language and help foreign office staff better understand local regulations. Foreign office officials said that the locally employed staff also are knowledgeable about FDA standards and inspection protocols and are helpful to FDA investigators.

Table 3 shows the number of staff in each foreign office by location and position as of October 2014.

Appendix III: Comments from the Department of Health and Human Services

Appendix IV: GAO Contact and Staff Acknowledgments

GAO Contact

Staff Acknowledgments

In addition to the individual named above, Mary Denigan-Macauley (Assistant Director), Darnita Akers, Cheryl Arvidson, Kevin Bray, Michele Fejfar, Jennifer Gould, and Terrance Horner Jr. made key contributions to this report. Other contributors included Adam Cowles, Marcia Crosse, Elizabeth Curda, Joyce Evans, Kimberly Gianopoulos, Armetha Liles, Cynthia Norris, Ifunanya Nwokedi, and Geri Redican-Bigott.