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

HRD-84-65: Published: Aug 30, 1984. Publicly Released: Sep 4, 1984.

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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 for Executive Action

  1. Status: Closed - Implemented

    Comments: FDA reviewed the 85 etablishments in GAO's nationwide sample to justify the basis for continued inspection. It stated that 69 establishments must be included in its inspection inventory. FDA did not contact state inspection agencies to determine their inspection frequency and responsibilities for the 69 establishments. FDA believes an entire inventory review is not needed.

    Recommendation: The Secretary of Health and Human Services should direct the Commissioner of FDA to continue to review the current food manufacturing establishment inventory and remove those establishments with little or no interstate shipment of foods unless FDA finds a compelling need for continued inspection of such establishments.

    Agency Affected: Department of Health and Human Services

  2. Status: Closed - Not Implemented

    Comments: FDA stated that, based on an analysis of the 85 establishments, it planned no steps to delete establishments with less than 10 percent interstate sales. FDA will review its inventory adding or removing establishments and adjusting resources as necessary. GAO believes that resources need to be adjusted for FDA-inspected establishments with little or no interstate commerce.

    Recommendation: The Secretary of Health and Human Services should direct the Commissioner of FDA to consider the sufficiency of the current level and allocation of inspection resources devoted to the food sanitation and quality control programs and make appropriate adjustments recognizing the reduced inventory and extent of inspection coverage needed to adequately monitor food manufacturing establishments.

    Agency Affected: Department of Health and Human Services


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