Food Safety: Additional Actions Needed to Help FDA's Foreign Offices Ensure Safety of Imported Food
Published: 2015-01-30T00:00:00

Fast Facts:

Highlights:
section_title: Why GAO Did This Study
paragraphs: FDA has responsibility for ensuring the safety and proper labeling of more than 80 percent of the U.S. food supply, including an increased volume of imported food. Beginning in 2008, FDA established foreign offices to help prevent unsafe products from reaching U.S. borders. In 2010, GAO examined FDA's foreign offices and found that they engaged in a variety of activities relating to food safety but faced challenges due to an increasing workload and other factors. GAO was asked to follow up that report.
This study examines (1) the activities 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. GAO reviewed documentation of foreign office activities and plans, visited offices in China and Mexico, and interviewed agency officials, foreign regulators, and other stakeholders.
section_title: What GAO Found
paragraphs: The Food and Drug Administration's (FDA) foreign offices have engaged in a variety of activities since 2010 to help ensure that imported food is safe. Foreign offices reported that building relationships with foreign counterparts and gathering and assessing information were among their top priorities. As directed by the FDA Food Safety Modernization Act (FSMA), foreign offices also inspected foreign food facilities. Under FSMA, FDA is to inspect at least 600 foreign food facilities in 2011 and, for each of the next 5 years, inspect at least twice the number of facilities inspected during the previous year. As shown in the figure below, FDA is not currently keeping pace with the FSMA mandate. FDA officials told GAO that they do not plan to meet the FSMA mandate because of funding, and they question the usefulness of conducting that many inspections. However, FDA has not conducted an analysis to determine whether the 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.
FDA foreign offices cite their contributions to the safety of imported food, but the agency's performance measures do not fully capture these contributions. GAO recommended in 2010 that FDA develop performance measures that can be used to demonstrate the offices' contributions to imported food safety. This recommendation remains valid. FDA has initiated a review to determine how to better reflect the value of the foreign offices in the agency-wide performance systems. Until the offices' contributions are captured, FDA will have less information to effectively measure their progress toward meeting agency goals.
FDA has taken some steps to address recruitment challenges since GAO last reported, but it still does not have a strategic workforce plan. In 2010, GAO recommended that FDA develop such a plan for the foreign offices to help ensure that it recruits and retains staff with the necessary experience and skills. GAO continues to believe that such a plan for the foreign offices is critical to FDA's ability to address staffing challenges, especially since 44 percent of foreign office positions were vacant as of October 2014.
section_title: What GAO Recommends
paragraphs: GAO recommends that FDA complete an analysis to determine the annual number of foreign food inspections that is sufficient to ensure comparable safety of imported and domestic food. FDA agreed with GAO's recommendation.

section_title: Letter
paragraphs: Globalization has increased the volume of food imported into the United  States and introduced a higher level of complexity for ensuring the safety  of food. For example, melamine- and cyanuric acid-contaminated pet food  imported from China sickened and killed U.S. cats and dogs in 2007 and  raised concerns about the safety of imported human and animal food.  Melamine, an industrial chemical that is not approved for use in food in  the United States, was used by a Chinese manufacturer to mimic  increased protein levels in food ingredients. The U.S. reliance on  imported food as a percentage of all food consumed has grown from  about 9 percent in 2000 to more than 16 percent in 2011. Some food  categories are now more likely to come from foreign sources than  domestic ones. For example, about 91 percent of seafood consumed in  the United States was imported in 2011, according to the National Marine  Fisheries Service. The United States also imported $4.6 billion in fresh  vegetables and $3.1 billion in fresh fruit (excluding bananas) from Mexico  in 2013, according to the Office of the U.S. Trade Representative. GAO’s  2013 High Risk List included the need to revamp federal oversight of food  safety and cited, as a major food safety challenge, the substantial and  increasing portion of the U.S. food supply that is imported.
The Food and Drug Administration (FDA) has responsibility for helping to  ensure the safety and proper labeling of more than 80 percent of the U.S.  food supply, including the increased volume of food imports. In response  to the challenge of globalization, beginning in 2008, FDA established a  total of seven foreign offices, each with responsibility for a different area  of the world. According to FDA, the mission of the foreign offices is to  engage with stakeholders in strategic areas abroad to help prevent  unsafe products, such as food, drugs, and medical devices, from reaching  U.S. borders and to help FDA make informed decisions about product  entry into the United States. In 2010, we examined the activities of FDA’s  foreign offices and found that they engaged in a variety of activities to  help ensure the safety of imported products, but FDA faced challenges  due to an increasing workload and other factors. You asked us to follow  up on that report and review issues related to FDA’s foreign offices and  the safety of imported food. This report examines (1) the activities 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,  “food” refers to food and dietary supplements for humans and food for  animals, unless otherwise specified.
To address all three objectives, we conducted an in-depth review of  foreign office 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, among other factors. Our review  included site visits to FDA’s locations in Beijing and Guangzhou, China,  and Mexico City, Mexico, to interview key FDA and U.S. embassy  officials, as well as foreign food safety regulatory authorities. We selected  those locations because they conduct food inspections, among other  reasons. We also accompanied foreign office staff on site visits to food  facilities to learn how inspections are conducted in other countries. To  examine the activities FDA’s foreign offices have engaged in since our  2010 report, we evaluated answers the foreign offices submitted to  questions about their activities, conducted structured interviews with  officials from the foreign offices, and compared the numbers of food  inspections completed by FDA investigators with targets mandated in the  FDA Food Safety Modernization Act (FSMA). To examine the extent of  the foreign offices’ contributions to the safety of imported food, we  analyzed documents describing outcomes of the foreign offices’  activities—including inspection reports and import alerts—and interviewed  officials. We analyzed performance planning and management  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. To examine the extent to which FDA has engaged in  workforce planning for its foreign offices, we evaluated staffing numbers,  interviewed officials, and reviewed workforce planning documents. We  also reviewed leading practices for workforce planning that we have  previously identified. Through interviews with FDA officials  knowledgeable about inspection, performance, and staffing data, we  determined that the data were sufficiently reliable for use in our review.  Appendix I provides details about our objectives, scope, and  methodology.
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.
subsections: section_title: Background
paragraphs: 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.
section_title: FDA Foreign Offices Have Engaged in a Variety of Activities Since 2010 to Help Ensure the Safety of Imported Food
paragraphs: 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.
subsections: section_title: Foreign Offices Vary in Their Focus on Different Activities; Building Relationships with Foreign Counterparts Has Been a Top Priority
paragraphs: 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.
section_title: Foreign Offices Have Conducted Food Inspections, but FDA Is Not Keeping Pace with Mandated Targets
paragraphs: 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.
section_title: FDA Foreign Offices Cited Contributions to the Safety of Imported Food, but the Extent of These Contributions Has Not Been Fully Measured
paragraphs: 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.
subsections: section_title: FDA Foreign Office Officials Cited Contributions to the Safety of Imported Food
paragraphs: 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.
section_title: FDA Performance Measures Do Not Fully Capture the Contributions of Foreign Offices
paragraphs: 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.
section_title: FDA Has Not Completed a Strategic Workforce Plan for Its Foreign Offices
paragraphs: 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.
subsections: section_title: FDA Continues to Experience Recruitment Challenges in the Foreign Offices
paragraphs: 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.
section_title: FDA Has Taken Some Steps to Address Workforce Challenges in Its Foreign Offices
paragraphs: 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.
section_title: Conclusions
paragraphs: 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.
section_title: Recommendation for Executive Action
paragraphs: 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.
section_title: Agency Comments and Our Evaluation
paragraphs: 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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If you or your staff members have any questions about this report, please  contact me at (202) 512-3841 or gomezj@gao.gov. Contact points for our  Offices of Congressional Relations and Public Affairs may be found on  the last page of this report. GAO staff who made key contributions to this  report are listed in appendix IV.
section_title: Appendix I: Objectives, Scope, and Methodology
paragraphs: 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.
section_title: Appendix II: Additional Information about Staffing of Foreign Offices
paragraphs: 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.
section_title: Appendix III: Comments from the Department of Health and Human Services
section_title: Appendix IV: GAO Contact and Staff Acknowledgments
subsections: section_title: GAO Contact
section_title: Staff Acknowledgments
paragraphs: 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.