Food Safety:

Agencies Need to Address Gaps in Enforcement and Collaboration to Enhance Safety of Imported Food

GAO-09-873: Published: Sep 15, 2009. Publicly Released: Oct 14, 2009.

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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.

Status Legend:

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  • Review Pending-GAO has not yet assessed implementation status.
  • Open-Actions to satisfy the intent of the recommendation have not been taken or are being planned, or actions that partially satisfy the intent of the recommendation have been taken.
  • Closed-implemented-Actions that satisfy the intent of the recommendation have been taken.
  • Closed-not implemented-While the intent of the recommendation has not been satisfied, time or circumstances have rendered the recommendation invalid.
    • Review Pending
    • Open
    • Closed - implemented
    • Closed - not implemented

    Recommendations for Executive Action

    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: Closed - Implemented

    Comments: To further the advancements already in progress regarding information technology (IT) projects, FDA told us that it has initiated a project through the Partnership for Food Protection to further enhance IT integration through the augmentation of the functionality of eLEXNET, an internet-based data exchange system that allows Federal, State and local laboratories to electronically share food safety sample and test data for various foodborne pathogens. While this project is in the earliest stages of development, it initiates the process of providing a global repository of test data for FDA. The 2011 enhancements to eSAF include the ability to collect recall audit check data from state partners and the collection of data to support Field Management Directive (FMD) 76 and Manufactured Food Regulatory Program Standards (MFRPS) inspection auditing requirements. FDA has also implemented a process to utilize state analytical data to support the issuance of import alerts. If a state collects an imported sample as part of routine inspection or surveillance work and determines that the sample is violative, FDA can use those data to support import alerts. In addition, FDA stated that five state agencies, through the food contract, currently participate in a program to review and/or sample imported commodities during the course of routine contract work.

    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: United States Customs and Border Protection

    Status: Open

    Comments: FSIS does not yet receive time-of-arrival information from CBP.

    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: United States Customs and Border Protection

    Status: Closed - Implemented

    Comments: CBP reported that it has tested and implemented time-of-arrival information in its existing screening system, the Automated Commercial System. (CBP's new system, called the Automated Commercial Environment, will not be operational until October 15, 2011). Furthermore, CBP has explored the possibility of implementing a similar agreement with FSIS, and FSIS has a plan for pulling time-of-arrival information from ACE into the FSIS's import screening system.

    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: Closed - Implemented

    Comments: FDA has worked with Congress to include civil penalty authority in food safety legislation, and the House of Representatives passed this bill. Section 135 of H.R. 2749, the Food Safety Enhancement Act, which was passed by the House of Representatives on July 30, 2009, would establish civil monetary penalties that FDA would be able to impose for violations relating to food. The Administration has issued a Statement of Administration Position in support of H.R. 2749.

    Recommendation: 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 Health and Human Services: Public Health Service: Food and Drug Administration

    Status: Closed - Implemented

    Comments: Section 135 of H.R. 2749, the Food Safety Enhancement Act, which was passed by the House of Representatives on July 30, 2009, would establish civil monetary penalties that FDA would be able to impose for violations relating to food.

    Recommendation: To improve CBP's and FDA's ability to identify foreign firms with violative histories, the CBP Commissioner should ensure that 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: United States Customs and Border Protection

    Status: Closed - Implemented

    Comments: On March 7, 2012, CBP sent documentation indicating that a Participating Government Agency (PGA) Message Set had been developed for ACE that will allow for the capture of unique identifiers required by participating government agencies. (CBP further indicated that while FDA has not yet selected the specific unique identifier for foreign firms, the message set is flexible enough to adapt to their decision when it is made.)

    Recommendation: To improve CBP's and 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: Closed - Implemented

    Comments: In March 2012, CBP sent documentation indicating that a program had been developed for ACE that will allow for the capture of unique identifiers required by participating government agencies. (Although FDA has not yet selected the specific unique identifier for foreign firms, the message set is flexible enough to adapt to their decision.) Moreover, the FDA Food Safety Modernization Act included a provision stating that, not later than 1 year after the date of enactment of the Act, the Secretary, acting through the Commissioner of Food and Drugs, shall conduct a study regarding the need for, and challenges associated with, development and implementation of a program that requires a unique identification number for each food facility registered with the Secretary and, as appropriate, each broker that imports food into the United States. Because FDA worked with Congress to include this authority in the legislation, this recommendation is closed.

    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 Health and Human Services: Public Health Service: Food and Drug Administration

    Status: Closed - Implemented

    Comments: FDA said it believes that continuing to engage with CBP to develop a joint refusal/redelivery process is important. CBP and FDA have begun discussions of the joint form, as a prerequisite to consider this joint notice as a national procedure. Additional discussions are needed to complete this evaluation, after which it may be that national procedures can be drafted, cleared, and implemented. According to CBP, moreover, FDA determined that it would conduct an internal survey of the procedures currently being used when issuing refusals. CBP received the results of the FDA survey on 6/28/10.

    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: United States Customs and Border Protection

    Status: Closed - Implemented

    Comments: CBP and FDA conducted the recommended study to determine the current refusal/re-delivery process. CBP conducted an internal survey requesting copies of the local Standard Operating Procedures being utilized to develop a national policy. Based on the findings from that internal survey, CBP drafted national procedures to implement a joint refusal/re-delivery process.

    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: Health and Human Services: Public Health Service: Food and Drug Administration

    Status: Open

    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: Closed - Implemented

    Comments: In FY10, FDA began distributing its weekly operational report as well as Reportable Food Registry (RFR) submissions with commissioned state officials to improve federal-state response to food and feed safety incidents. FDA also maintains support for changes to existing law to strengthen the ability of the agency to share information with states.

    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: Closed - Implemented

    Comments: In August 2013, FDA sent its PREDICT Process Evaluation Plan, which evaluates performance in four key areas: (1) Rules Management, (2) Entry Review, (3) Examination and Sampling, and (4) Communication. FDA began the evaluation of PREDICT based on the written evaluation plan in late FY 2012 and expects to complete it in FY 2013.

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