Evaluation of Selected Aspects of FDA's Food Manufacturing Sanitation Inspection Efforts

In response to a congressional request, GAO developed information on the status of sanitation conditions in the food manufacturing industry and the Food and Drug Administration's (FDA) management of its inspection activities. In addition, GAO reviewed the ability of FDA to enforce regulations which ensure that foods are manufactured under sanitary conditions.

GAO found that 93 percent of the food manufacturers sampled nationwide have sanitary conditions that would likely prevent products from becoming contaminated. In response to a GAO request, FDA inspected 97 randomly selected food manufacturing plants and 69 percent of the plants had insanitary conditions in both large and small establishments covering a variety of products. FDA took action to deal with 11 of these establishments. GAO found that the FDA food establishment inventory is inaccurate and contains establishments that are out of business or misclassified. Furthermore, over half of the manufacturers included in the sample which GAO reviewed have interstate sales of 10 percent or less and, therefore, are more appropriately subject to routine inspections by state or local governments. Although FDA has been adjusting its food establishment inventory, GAO has found that opportunities exist for FDA to further reduce the inventory. Finally, GAO found that regulations, aimed at ensuring that establishments operate under sanitary conditions, are valid and substantive and are enforceable when a departure from the regulations represent insanitary conditions sufficient to meet the definition of adulterated food as defined in the Federal Food, Drug and Cosmetic Act. However, the act does not impose any sanctions for departures from the regulations.

Recommendations

Our recommendations from this work are listed below with a Contact for more information. Status will change from "In process" to "Open," "Closed - implemented," or "Closed - not implemented" based on our follow up work.

Director: David P. Baine Team: General Accounting Office: Human Resources Division Phone: (202) 512-7101