Food Inspections:

FDA Should Rely More on State Agencies

HRD-86-2: Published: Feb 18, 1986. Publicly Released: Mar 10, 1986.

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Pursuant to a congressional request, GAO reviewed whether the Food and Drug Administration (FDA) could rely more on state agencies to inspect the sanitation conditions of the food manufacturing establishments in its current inventory.

GAO noted that FDA does not specify the frequency with which food sanitation inspections should be conducted, but selects establishments for inspection based on products produced, the potential health risk involved, and the industry's inspection history. GAO found that: (1) 57 out of 69 food establishments in the FDA active inventory were routinely inspected by state agencies on an average of every 7 months; (2) over half of the establishments had 10 percent or less interstate sales; and (3) of the 57 firms sampled, 23 had one or more routine inspections where serious sanitation problems were noted. GAO also found that: (1) FDA justified keeping 69 establishments in its inventory because they had a large volume of business, produced products that had the potential for sanitation problems, or were subject to consumer complaints and labelling problems involving food and color additives; (2) where seriously unsanitary conditions are noted, state agencies inspect such establishments twice as frequently as other establishments; (3) consumer complaints could be forwarded to state agencies for follow-up procedures; and (4) in view of the states' significant roles in regulating the condition of food manufacturers, FDA inspections of most of the establishments are not warranted.

Recommendations for Executive Action

  1. Status: Closed - Implemented

    Comments: FDA adopted criteria for allocating resources for food sanitation inspections. A forthcoming report will assess this criteria.

    Recommendation: The Secretary of Health and Human Services should direct the Commissioner, FDA, to review the current inventory and determine the establishments that should be removed, considering state inspection frequency, policies, results, interstate commerce, and sales volume.

    Agency Affected: Department of Health and Human Services

  2. Status: Closed - Implemented

    Comments: In 1987, FDA was directed to focus attention on problem firms. However, a forthcoming report will show that little has changed and that FDA needs to take additional action.

    Recommendation: The Secretary of Health and Human Services should direct the Commissioner, FDA, in conjunction with state inspection agencies, to begin developing a strategy for future inspection of establishments with a history of serious or very serious sanitation problems to help ensure that these establishments are in compliance with applicable food laws and regulations.

    Agency Affected: Department of Health and Human Services

  3. Status: Closed - Implemented

    Comments: FDA indicated that it has reduced its inspections of food establishments. However, based on recent work, GAO noted that some establishments are still being inspected although they appear to be the states' responsibility. A forthcoming GAO report will recommend that establishments not be inspected routinely and FDA should stop inspecting establishments being inspected by states.

    Recommendation: The Secretary of Health and Human Services should direct the Commissioner, FDA, to consider the current level and allocation of inspection resources devoted to the food sanitation 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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