Summary
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, GAO was asked to (1) assess how Customs and Border Protection (CBP), the Food and Drug Administration (FDA), and the U.S. Department of Agriculture's (USDA's) Food Safety and Inspection Service (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.
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 plans to begin deploying PREDICT at all ports and for all FDA-regulated products in September 2009.
Recommendations
Our recommendations from this work are listed below with a Contact for more information. Status will change from "In process" to "Open," "Closed - implemented," or "Closed - not implemented" based on our follow up work.
Director:
Team:
Phone:
Lisa R. Shames
Government Accountability Office: Natural Resources and Environment
(202) 512-2649
Recommendations for Executive Action
Recommendation: To ensure that FDA and FSIS receive the information they need to adequately oversee imported food safety, the CBP Commissioner should ensure that CBP's new screening system communicates time-of-arrival information to FDA's and FSIS's screening systems.
Agency Affected: Department of Homeland Security: Directorate of Border and Transportation Security: Bureau of Customs and Border Protection
Status: In process
Comments: When we confirm what actions the agency has taken in response to this recommendation, we will provide updated information.
Recommendation: To enhance FDA's authority to oversee the safety of imported food, the FDA Commissioner should seek authority from the Congress to assess civil penalties on firms and persons who violate FDA's food safety laws.
Agency Affected: Department of Health and Human Services: Public Health Service: Food and Drug Administration
Status: In process
Comments: When we confirm what actions the agency has taken in response to this recommendation, we will provide updated information.
Recommendation: To improve CBP's ability to identify foreign firms with violative histories, the CBP Commissioner should ensure that the Automated Commercial Environment (ACE) is able to accept a unique identification number for foreign firms that export FDA-regulated foods.
Agency Affected: Department of Homeland Security: Directorate of Border and Transportation Security: Bureau of Customs and Border Protection
Status: In process
Comments: When we confirm what actions the agency has taken in response to this recommendation, we will provide updated information.
Recommendation: To improve FDA's ability to identify foreign firms with violative histories, the FDA Commissioner should explore ways to improve the agency's ability to identify foreign firms with a unique identifier.
Agency Affected: Department of Health and Human Services: Public Health Service: Food and Drug Administration
Status: In process
Comments: When we confirm what actions the agency has taken in response to this recommendation, we will provide updated information.
Recommendation: To enhance agency coordination and to streamline FDA's refusal process with CBP's redelivery process, the FDA Commissioner and the CBP Commissioner should jointly study, with input from agency field officials, ports where a joint initiative would be feasible.
Agency Affected: Department of Homeland Security: Directorate of Border and Transportation Security: Bureau of Customs and Border Protection
Status: In process
Comments: When we confirm what actions the agency has taken in response to this recommendation, we will provide updated information.
Agency Affected: Department of Health and Human Services: Public Health Service: Food and Drug Administration
Status: In process
Comments: When we confirm what actions the agency has taken in response to this recommendation, we will provide updated information.
Recommendation: To better leverage state resources for protecting the safety of imported food, the FDA Commissioner should reach out to states to find opportunities for additional collaboration through contracts, cooperative agreements, and informal partnerships.
Agency Affected: Department of Health and Human Services: Public Health Service: Food and Drug Administration
Status: In process
Comments: When we confirm what actions the agency has taken in response to this recommendation, we will provide updated information.
Recommendation: To enhance public safety, the FDA Commissioner should find ways to share with states product distribution lists, to the extent permitted by law, while also protecting confidential commercial information, and if necessary, consider what regulatory or legislative changes may be needed to allow FDA to share otherwise protected information with states while preventing public disclosure.
Agency Affected: Department of Health and Human Services: Public Health Service: Food and Drug Administration
Status: In process
Comments: When we confirm what actions the agency has taken in response to this recommendation, we will provide updated information.
Recommendation: To ensure that FDA and FSIS receive the information they need to adequately oversee imported food safety, until this new system is capable of communicating this information, CBP should implement its interagency agreement with FDA to provide time-of-arrival information and explore opportunities to implement a similar agreement with FSIS.
Agency Affected: Department of Homeland Security: Directorate of Border and Transportation Security: Bureau of Customs and Border Protection
Status: In process
Comments: When we confirm what actions the agency has taken in response to this recommendation, we will provide updated information.
Recommendation: To help ensure that PREDICT is effectively targeting high risk imported food shipments for field and laboratory examinations, the FDA Commissioner should develop a performance measurement plan prior to deploying the system at additional U.S. ports.
Agency Affected: Department of Health and Human Services: Public Health Service: Food and Drug Administration
Status: In process
Comments: When we confirm what actions the agency has taken in response to this recommendation, we will provide updated information.
Recommendation: To enhance FDA's authority to oversee the safety of imported food, the Commissioner should determine what violations should be subject to this new FDA civil penalties authority, as well as the appropriate nature and magnitude of the penalties.
Agency Affected: Department of Homeland Security: Directorate of Border and Transportation Security: Bureau of Customs and Border Protection
Status: In process
Comments: When we confirm what actions the agency has taken in response to this recommendation, we will provide updated information.
