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.
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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.
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Recommendation for Executive Action
Comments: In January 2015, we recommended that the Commissioner of 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. Additionally, if the inspection numbers from that analysis are different from the inspection targets mandated in the FDA Food Safety Modernization Act (FSMA), FDA should report the results to Congress and recommend appropriate legislative changes. At the time of our report, FDA was not keeping pace with FSMA's mandate to increase inspections each year from 2011 through 2016. In April 2017, FDA indicated that 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 FSMA. However, FDA has not conducted an analysis to determine whether the increased number of inspections mandated by FSMA or the lower number of inspections it is currently conducting is sufficient to ensure comparable safety of imported and domestic food. FDA noted that, in January 2017, it began an analysis to define and describe the global inventory of human and animal food firms and examine the application of regulatory oversight tools across the inventory. According to FDA, the analysis will help it assess the annual number of foreign food facility inspections as part of an overall risk-based allocation of resources for ensuring that imported foods are produced in a manner the meets applicable U.S. safety standards. We continue to believe that FDA should complete such an analysis and report the results to Congress. In August 2018, agency officials indicated that FDA is undertaking a larger review of its approach to overseeing the safety of imported food and will be drafting a new strategy. As part of this effort, they will determine the annual number of foreign food inspections that is sufficient to ensure comparable safety of imported and domestic food. They were not able to provide a date as to when they expect to complete the analysis, but they indicated that it may take more than a year to finalize their study. As of August 2019, FDA is making progress toward achieving the recommendation. Specifically, FDA has conducted an analysis of the global inventory of foreign and domestic facilities. They stated that the correct number of inspections is related to the amount of "cumulative oversight" applied to foreign facilities. Cumulative oversight includes new authorities given to them under FSMA, including inspections of importers, audits conducted under the accredited third party certification program, FDA's voluntary qualified import program, and systems recognition (oversight of food facilities by foreign authorities that have been comprehensively assessed to deliver FDA-comparable food safety outcomes). According to FDA, the information they get through this cumulative oversight will inform the annual number of inspections needed. FDA also indicated that they are investigating the potential to develop an integrated modeling framework to support risk-based allocation decisions related to strategic global oversight of human and animal food facilities and firms. This part of the effort is still in process. For GAO to close the recommendation, FDA will still need to determine (using the methods they described) a target number of foreign facilities to inspect.
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