FDA responds to GAO food safety report.

Earlier this year, the General Accounting Office (GAO) released a report tided "Food Safety: Federal Efforts to Ensure Safety of Imported Foods Are Inconsistent and Unreliable." The report concluded that the import control activities of the Food and Drug Administration (FDA) are inadequate. In May, FDA responded. According to Dr. Michael Friedman, FDA Lead Deputy Commissioner, the GAO study "is a wake-up call to Congress to pass legislation to help ensure the safety of imported foods." FDA and GAO are in agreement that FDA needs additional legal authority and resources.

The FDA response addressed several major concerns raised in the GAO report.

Equivalency Authority

The GAO report proposed that FDA be given authority to require that food-exporting countries have food safety systems equivalent to that of the United States. The U.S. Department of Agriculture already has authority to block importation of meat and poultry from any country whose food safety system does not meet U.S. standards. Under current law, however, FDA does not have such authority. The agency must identify all unsafe food at the port of entry. The volume of food imports makes this approach to food safety extremely impractical.

Fines

Food importers are required to post $1,250 bond when they bring food to this country. They may forfeit their bonds if they do not hold the food on the docks while FDA conducts its tests. Nevertheless, many importers distribute their products, even when they have been ordered to wait, and write off the bond as the cost of doing business. Under current law, FDA lacks the legal authority to penalize these importers. The GAO report proposed - and FDA agreed - that FDA should be able to impose fines that make it too expensive to flout U.S. law.

Private Laboratories

FDA automatically detains imported foods that, because of prior violations, are considered likely to be contaminated. Importers may then hire private laboratories to test their products and certify that the food meets U.S. safety standards. Because FDA does not control the choice of samples or laboratories, the validity of such reports is questionable. FDA is issuing a new guidance to district offices, emphasizing that results must come from reliable laboratories and that, in some cases, the results should be verified.

Computer System

The Operational and Administrative System for Import Support (OASIS) electronically links all FDA inspection offices with importers. On the basis of information' supplied by the importer, OASIS can give immediate clearance or can trigger an inspection by an FDA official. The GAO report noted that inspectors currently have to switch between OASIS and other databases (such as the FDA Import Alert Retrieval System and the Low-Acid Canned-Food Database). The time spent in switching from one program to another lessens the efficiency of the inspectors. The response to this criticism emphasized that FDA had already recognized the problem and was linking OASIS to the other databases.

Error Rates

FDA agreed with GAO that action should be taken against importers who repeatedly submit erroneous entry data. (The complexity of the recently introduced OASIS has caused most of the errors.) Error-prone importers are being audited and must submit both electronic and paper copies of their documents until they learn to use the system correctly.

Work Plans

FDA agreed with GAO that the work plans developed each year for inspectors in regional offices do not always reflect actual use of time. As with any plan, however, the work plan sets targets and anticipates that unforeseen activities or emergencies will supersede routine tasks. Typically, about 80 percent of the tasks on an annual work plan are completed. GAO's conclusion that the plans have failed is not correct, according to the FDA response. Nevertheless, FDA is reevaluating the work plans.