	Background

Industry observers have raised concerns about perceived gaps in food import safety over the past few years. One particular area of concern focuses on imported goods that are released into the United States market after the Food and Drug Administration (FDA) detains them under an import alert. Generally, these goods may be released into the market after an importer "provides evidence that the entry is in compliance with federal laws and regulations." Currently, the FDA does not have express statutory authority to regulate the private laboratories that sample or test these imported goods, although the FDA regulates the importer and imported products. This report focuses on proposals for FDA regulation of the private laboratories that analyze imported, FDA-regulated goods. It provides background on the relationship between the FDA and the private laboratories, as well as information about agency and Bush Administration proposals and legislative responses in the 110 th Congress (particularly the Dingell Draft, S. 2418 , H.R. 5904 , and H.R. 5827 ) to the current lack of regulation.
Industry observers have raised concerns about perceived gaps in food import safety over the past few years. One particular area of concern focuses on imported goods that are released into the United States market after the Food and Drug Administration (FDA) detains them under an import alert. Generally, these goods may be released into the market after an importer "provides evidence that the entry is in compliance with federal laws and regulations." Currently, the FDA does not have express statutory authority to regulate the private labs that test these imported goods for compliance, although the FDA has authority over the importer and imported products. This report focuses on obstacles to and legislative proposals for FDA regulation of the private laboratories that analyze imported FDA-regulated goods. It provides background to that relationship, as well as information about agency and Bush Administration proposals and legislative responses from the 110th Congress (particularly the Dingell Draft, S. 2418, H.R. 5904, and H.R. 5827) to the lack of regulation.