Lack of Equivalency Authority Diminishes FDA’s Ability to Protect U.S. Consumers

To ensure the safety of meat and poultry imports, FSIS has a statutory mandate to require that each country wishing to export meat and poultry products to the United States demonstrate that it has an equivalent food safety system. As a result, FDA must rely primarily on selecting and testing import samples at ports of entry to ensure that foods are safe. Given the ineffectiveness of port-of-entry inspections, FDA cannot realistically ensure that unsafe foods are kept out of U.S. commerce. Even if FDA could inspect more shipments at ports of entry than it currently does, such an approach would still provide little assurance that imported foods are picked, processed, and packed under sanitary conditions because inspectors have no assurance that the exporting country has an effective food safety system. An equivalency requirement would allow FDA to share the burden of ensuring safety with the exporting country and allow it to make better use of limited resources. Agencies Could More Effectively Target Resources to Inspect Unsafe Foods

FSIS and FDA use computer systems to review information on each import shipment and to help identify the import shipments requiring inspector action. However, neither agency’s system takes maximum advantage of available data to target those imported foods posing the greater health risks. As a result, importers aware of FDA’s inaction could evade FDA’s inspections by incorrectly describing the contents of a shipment. Weaknesses in Import Controls Allow the Entry of Unsafe Products

In addition to the problems associated with FDA’s system for selecting food shipments for inspection, several weaknesses in its controls over imported products enable some importers or their representatives to sell unsafe foods in the United States. According to Customs inspectors, some importers, to ensure their products appear to meet U.S. requirements, share shipments that have already been tested and proven to be in compliance—a practice referred to as “banking.” FDA says it lacks the explicit authority to place restrictions on which laboratories importers can use to test products. Importers of FDA-regulated foods generally retain possession of import shipments until FDA releases them and must make the shipments available for FDA’s inspection if requested. The results of this investigation are consistent with the findings in our 1992 report on pesticides, which found that 60 percent of the perishable foods and 38 percent of the nonperishable foods that FDA found to be adulterated with illegal pesticides were released into U.S. markets, or not returned to Customs for destruction or reexport as required.
Why GAO Did This Study

Pursuant to a congressional request, GAO discussed: (1) findings from its recent report in which it pointed out how limitations in the Food and Drug Administration's (FDA) authority and approach for regulating imported foods adversely affect its ability to ensure food safety; (2) how FDA and the Food Safety and Inspection Service's (FSIS) procedures for selecting shipments to review result in the ineffective targeting of inspection resources; and (3) how weaknesses in FDA's and Customs Service's controls allows unscrupulous importers to market unsafe products.

What GAO Found

GAO noted that: (1) FDA lacks the legal authority to require that countries exporting foods to the United States have food safety systems equivalent to U.S. systems, an authority that FSIS has and uses to share the burden of ensuring safe foods with the exporting countries; (2) without such authority, FDA must rely primarily on its port-of-entry inspections, which covered less than 2 percent of shipments in 1997, to detect and bar unsafe foods; (3) such an approach has been widely discredited as an effective protective measure; (4) both FDA and FSIS could make better use of their inspection resources by using available health risk information to target shipments for inspection that pose the highest food safety risk; (5) FDA could further improve the use of resources by clarifying its communications to inspectors about which shipments to select and by taking enforcement action when importers are found to inaccurately describe the contents of shipments; (6) with such improvements, FDA could better ensure that it is using its scarce resources to identify the foods posing greater risks; (7) FDA's procedures for ensuring that unsafe imported foods do not reach U.S. consumers are vulnerable to abuse by unscrupulous importers; (8) under current procedures, FDA generally allows importers to retain control over shipments until the agency grants their release; (9) if importers move shipments into domestic commerce without a FDA release, FDA has no effective means of compelling importers to return the shipments for inspection, destruction, or reexport; (10) when FDA requires an importer to provide evidence that a suspect shipment is safe, the agency allows the importer to select the laboratory that picks the samples to be tested and that conducts the tests; and (11) FDA's and Custom's principal deterrent for ensuring that importers comply with U.S. requirements is uneven and uncertain.