Imported Food Safety Subject of GAO Study

Imported food makes up a substantial and growing portion of the U.S. food supply. To ensure imported food safety, federal agencies must focus their resources on high risk foods and coordinate efforts. In this context, the Government Accountability Office (GAO) was asked to (1) assess how Customs and Border Protection (CBP), FDA, and USDA FSIS are addressing challenges in overseeing the safety of imported food; (2) assess how FDA leverages resources by working with other entities, such as state and foreign governments; and (3) determine how FDA is using its Predictive Risk-Based Evaluation for Dynamic Import Compliance Targeting (PREDICT) system to oversee imported food safety. GAO analyzed CBP, FDA, and FSIS procedures, reports, and regulations and interviewed agency officials and key stakeholders.

The Study found that CBP, FDA, and FSIS have taken steps to address challenges in ensuring the safety of the increasing volume of imported food. For example, CBP maintains the system that importers use to provide information to FDA on food shipments; FDA electronically reviews food imports and inspects some foreign food production facilities to prevent violative food from reaching U.S. shores; and FSIS employs an equivalency system that requires countries to demonstrate that their food safety systems provide the same level of protection as the U.S. system.

However, gaps in enforcement and collaboration undermine these efforts. First, CBP’s computer system does not currently notify FDA or FSIS when imported food shipments arrive at U.S. ports, although efforts are underway to provide this information to FDA for air and truck shipments. This lack of communication may potentially increase the risk that unsafe food could enter U.S. commerce without FDA review, particularly at truck ports. Second, FDA has limited authority to ensure importers’ compliance with its regulations. Third, CBP and FDA do not identify importers with a unique number; as a result, FDA cannot always target food shipments originating from high risk importers. Finally, CBP faces challenges in managing in-bond shipments—those that move within the United States without formally entering U.S. commerce—and such shipments possibly could be diverted into commerce.
FDA generally collaborates with select states and foreign governments on imported food safety. FDA has entered into a contract, several cooperative agreements, and informal partnerships for imported food with certain states, and some state officials told GAO that they would like to collaborate further with FDA on food imports. However, citing legal restrictions, FDA does not fully share certain information, such as product distribution lists, with states during a recall. This impedes states’ efforts to quickly remove contaminated products from grocery stores and warehouses. FSIS has begun to make available to the public a list of retail establishments that have likely received food products that are subject to a serious recall. FDA is also expanding efforts to coordinate with other countries. In particular, through its Beyond Our Borders initiative, FDA intends to station investigators and technical experts in China Europe, and India, to provide technical assistance and gather information about food manufacturing practices to improve risk-based screening at U.S. ports.

According to FDA, PREDICT will analyze food shipments using criteria that include a product’s inherent food safety risk and the importer’s violative history, among other things, to estimate each shipment’s risk. A 2007 pilot test of PREDICT indicated that the system improved FDA’s ability to identify products it considers to be high risk while allowing a greater percentage of products it considers low risk to enter U.S. commerce without a manual review. However, FDA has not yet developed a plan to measure the system’s performance, and GAO previously identified shortcomings in FDA’s information technology modernization efforts. FDA began deploying PREDICT in September. 

As a result of the study, GAO recommends, among other things, that FDA seek authority from the Congress to assess civil penalties on firms and persons who violate FDA laws, and that the FDA Commissioner explore ways to improve the agency’s ability to identify foreign firms with a unique identifier. CBP and FDA generally agreed with our recommendations. FSIS provided technical comments only.