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Business Alert – US







6 Nov 2009
GAO Recommends Improvements to U.S. Safety Regime for Imported Food

The Government Accountability Office has released a report identifying a number of improvements federal agencies should make to further ensure the safety of imported food. This report assesses how U.S. Customs and Border Protection, the Food and Drug Administration and the Department of Agriculture’s Food Safety and Inspection Service are addressing challenges in overseeing the safety of imported food; assesses how FDA leverages resources by working with other entities, such as state and foreign governments; and determines how FDA is using its Predictive Risk-Based Evaluation for Dynamic Import Compliance Targeting system to oversee imported food safety.

GAO acknowledges 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 and issues civil penalties against importers that fail to comply with food safety regulations. FDA electronically reviews all formal entries of food products and inspects some foreign food production facilities to prevent violative food from reaching U.S. shores. FSIS employs an equivalency system that requires countries exporting meat and poultry and processed egg products to the U.S. to demonstrate that their food safety systems provide the same level of protection as the U.S. system. FSIS is also developing a new Web-based application, the Public Health Information System, that is expected to allow the agency to receive foreign health certificates electronically and provide secure and timely advance notice of a foreign shipment certified by a foreign government.

Despite these actions, the report identifies the following four gaps in enforcement and collaboration that could allow high-risk foods to enter domestic commerce without assurance that they have been examined.

  • CBP’s import screening system does not currently notify FDA or FSIS when imported food shipments arrive at U.S. ports. Without access to time-of-arrival information, FDA and FSIS may not know when shipments that require examinations or re-inspections arrive at the port, which could potentially increase the risk that unsafe food may enter U.S. commerce. Efforts are underway to provide this information to FDA for air and lorry shipments, but no such work is underway with FSIS. CBP is also upgrading its import screening system in part to improve data-sharing with other government agencies, but CBP officials said the development of key system components has been delayed because of budget shortfalls and unforeseen difficulties in programming the system to meet agency requirements. In addition, it is unknown whether this new system will address CBP’s inability to routinely communicate time-of-arrival information.
  • FDA has limited authority to ensure importers’ compliance with its regulations. FDA relies on a bond between CBP and the importer to discourage the premature release of FDA-regulated shipments, but the maximum bond value is often not sufficient to deter the sale of imported goods that FDA has not yet released.
  • CBP and FDA do not identify importers with a unique number. This occurs because FDA relies on entry filer-generated identification numbers to create FDA’s own identifiers for firms at the time of importation, a process that, over time, often results in multiple identifiers for a single firm. As a result, FDA cannot always target food shipments originating from high-risk importers.
  • CBP faces challenges in managing in-bond shipments; i.e., those that move within the U.S. without formally entering domestic commerce. Food is one of the most common types of products to be shipped in-bond, and until CBP finalises amendments to its in-bond regulations concerns will remain that imports of violative food could be shipped in-bond and enter U.S. commerce undetected.

GAO also notes that FDA does not always share certain information, such as product distribution lists, during a recall. As a result, state officials are unable to quickly remove contaminated products from grocery stores and warehouses. FSIS discloses certain information to the public during a recall, specifically the names and locations of retail consignees of meat and poultry products that have been recalled by a federally inspected meat or poultry establishment if the product has been recalled at the retail level.

The report also provides a brief overview of the FDA’s  PREDICT system, which will analyse food shipments using criteria that include a product’s inherent food safety risk and the importer’s violative history 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. FDA planned to begin deploying PREDICT at all ports and for all FDA-regulated products in September 2009 but at that time had not yet developed a plan to measure the system’s performance. In addition, the report observes that FDA may ultimately not be able to adequately meet its mission without a comprehensive information technology strategic plan for PREDICT and other modernisation efforts.

In light of this, GAO has advised the FDA to seek authority from Congress to assess civil penalties on firms and persons who violate FDA’s food safety laws and determine what violations should be subject to this new authority as well as the appropriate nature and magnitude of the penalties. GAO is also recommending that CBP ensure that the Automated Commercial Environment is able to accept a unique identification number for foreign firms that export FDA-regulated foods, and that FDA explore ways to improve its ability to identify foreign firms with a unique identifier. Finally, to enhance agency co-ordination and streamline FDA’s refusal process with CBP’s redelivery process, GAO believes the two agencies should study ports where a joint initiative would be feasible.