Press Office
Food and Drug Administration
U.S. Department of Health and Human Services

 
STATEMENT                       Print Media:         301-827-6242
May 11, 1998                    
                                Consumer Inquiries:  800-532-4440
 

STATEMENT FROM DR. MICHAEL FRIEDMAN, LEAD DEPUTY COMMISSIONER OF THE FDA, ON GAO FOOD SAFETY REPORT

GAO recommends legislation that gives FDA new authority that requires food-exporting countries to have in place essentially the same food safety system as the United States. The Department of Agriculture already has such legal authority over imported meats and poultry. In October 1997, President Clinton proposed legislation to give FDA similar authority and the Administration has expressed its support for the "Safety of Imported Food Act" currently languishing in Congress.

While most of GAO's recommendations mirror solutions FDA already is implementing, the Agency disagrees with GAO's criticism that the agency fails to use its resources appropriately. The agency has faced a steadily rising workload with the number of food imports more than doubling in the last five years, and FDA has warned that it was in danger of being overwhelmed by the volume of products reaching U.S. ports. The Agency is using its available resources and continues to recommend that additional resources are needed to ensure that the food Americans set on their table - both domestic and imported - is safe, wholesome and nutritious.

####

FDA Backgrounder on GAO Food Safety Report

Now, the General Accounting Office has released its evaluation of the safety of imported foods. In its report, "Food Safety: Federal Efforts to Ensure Safety of Imported Foods Are Inconsistent and Unreliable," GAO concludes that some of FDA's import control activities are inadequate. The agency agrees that more needs to be done to safeguard the quality of imported foods and already has undertaken many of the steps outlined in the GAO report. To make adequate progress, however, FDA will require additional legal authority and resources. The GAO itself has recommended legislation to give FDA additional authority.

The major concerns raised by GAO, and FDA's responses, include:

• Equivalency Authority. GAO proposes that FDA be given authority to require that food-exporting countries have in place a food safety system that is essentially equivalent to the United States' system. GAO notes that the Department of Agriculture's Food Safety and Inspection Service (FSIS) already has that authority and blocks the importation of meat and poultry from any country whose food safety system does not measure up to the U.S. standard. Under current law, FDA cannot prevent food from being shipped to this country. The agency must attempt to identify all unsafe food at the port of entry, an extremely difficult task given the enormous volume of imports. Thus, FDA and the Administration agree with GAO that it is imperative that Congress enact legislation giving FDA authority to require that, as a condition to exporting to the United States, foreign governments adopt adequate measures in their own countries to ensure that food exported to the U.S. is safe.

• Civil Money Penalties. When food importers or brokers bring in shipments, they are required to post a $1,250 bond. If the brokers do not hold the product on the docks while FDA conducts its tests, they may forfeit their bonds. GAO observed that many brokers and importers distribute their products even when ordered to wait and simply include the bond as the cost of doing business. Once the product enters U.S. distribution, U.S. Customs Service has a difficult time getting it back. There are cases where contaminated foods have been distributed. FDA lacks the legal authority to then penalize brokers who violate the law. GAO recommends -- and FDA agrees -- that it should have legal authority to seek sufficiently large civil money penalties (fines) to make it too costly for brokers to flout U.S. law. Legislation will be required to give FDA this authority.

• Private Laboratories. FDA automatically detains imported foods that, on the basis of prior violations, have a high probability of being contaminated. Importers have the option of hiring private laboratories to test their products and certify that they meet U.S. standards. If the lab report clears the product, it may enter distribution. FDA, however, does not control the choice of samples or laboratories, raising questions about the validity of these reports. FDA lacks the authority to restrict brokers to certain laboratories, but the agency is issuing a new guidance to the district offices, emphasizing that results must come from reliable labs and, in some cases, the results should be verified.

• OASIS Computer Update. Last year, in an effort to increase efficiency, OASIS, the Operational and Administrative System for Import Support, became fully operational in every U.S. port of entry where FDA-regulated products come into the country. This computerized system electronically links all FDA inspection offices with the brokers who import foreign products. Based on the information supplied by the broker, OASIS can give automated and immediate clearance for the imports or trigger an inspection by a FDA official. GAO noted that the current computer system requires inspectors to switch between OASIS and other related data bases, such as the FDA Import Alert Retrieval System and the low acid canned food database. Because it takes time to shift from one program to another, the efficiency of the inspector is lessened. FDA has recognized the problem and is already moving to link OASIS to all of the other relevant databases.

• Error Rates. FDA agrees with GAO that action should be taken against importers who continue to submit erroneous entry data to FDA. Most of the errors result from the complexity and the recent introduction of the OASIS system. FDA is auditing error-prone brokers and has begun implementing both electronic and paper copies of their import documents until they learn to use the electronic system correctly.

• Work Plans. FDA agrees with GAO that the work plans developed each year for the inspectors in regional offices do not always reflect how they actually spend their time, but as with any annual plan, the workplan sets targets and anticipates that unforseen activities or emergencies will supersede planned/routine tasks. Typically, about 80 percent of the tasks on the annual work plan are completed. FDA disagrees, however, with GAO's conclusion that the work plans have failed. Inspectors do not complete all the items on their annual list because they get reassigned as new problems and emergencies arise. It does not mean they are not working 100 percent of the time. FDA is re-evaluating how it constructs the annual work plans.

This is a mirror of the page at HTTP://www.fda.gov/bbs/topics/NEWS/NEW00639.html