Additional Actions Needed to Help FDA's Foreign Offices Ensure Safety of Imported Food
GAO-15-183: Published: Jan 30, 2015. Publicly Released: Feb 27, 2015.
What GAO Found
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 Inspections of Foreign Food Facilities Compared with FSMA 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.
Why GAO Did This Study
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.
What GAO Recommends
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.
For more information, contact J. Alfredo Gómez at (202) 512-3841 or email@example.com.
Recommendation for Executive Action
Comments: As of April 2017, FDA has not completed the recommended analysis to determine the annual number of foreign food inspections needed to help ensure comparable safety of imported and domestic food. According to FDA's fiscal year 2017 budget request, the agency completed 1,347 inspections of foreign food facilities in fiscal year 2015, and it requested funding for 1,200 inspections during fiscal year 2017. As of April 2017, FDA had not released its fiscal year 2018 budget request, which contains actual inspection counts for fiscal year 2016--the final year of the FSMA mandate to double foreign food inspections each year from 2011 through 2016. In April 2017 FDA officials stated that it does not anticipate going significantly beyond 1,200 foreign food facilities inspections per year, based on the amount of additional funding needed to meet the foreign inspection requirement of the FDA Food Safety Modernization Act (FSMA). FDA maintains that additional resources would be better spent on implementing the tools in the FSMA import safety toolkit. FDA agreed with the recommendation and we continue to believe that the agency should complete an analysis to determine the annual number of foreign food inspections that is sufficient to ensure comparable safety of imported and domestic food. In addition, if FDA's analysis is different from the FSMA inspection targets mandated in FSMA, FDA should report the results to Congress.
Recommendation: To help ensure the safety of food imported into the United States, the Commissioner of Food and Drugs should 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 Affected: Department of Health and Human Services: Food and Drug Administration