Domestic Food Safety:

FDA Could Improve Inspection Program to Make Better Use of Resources

HRD-89-125: Published: Sep 27, 1989. Publicly Released: Sep 27, 1989.

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Pursuant to a congressional request, GAO reviewed the Food and Drug Administration's (FDA) inspections of domestic food firms, focusing on the: (1) criteria FDA used to select firms for inspections; (2) frequency with which FDA inspected firms with low risks for product adulteration; and (3) results of those inspections.

GAO found that FDA: (1) issued October 1986 guidance instructing field offices to concentrate inspection resources on food firms with a history of violations; (2) lacked criteria for determining the frequency of inspections; (3) and its state contractors inspected about 11,500 domestic food firms during fiscal year (FY) 1987; (4) conducted 90 percent of those inspections for routine surveillance, not compliance purposes, and most of the surveillance inspections did not reveal any serious violations; (5) spent over half of its inspection resources on low-risk firms; (6) inspected less than half of firms with violation histories, including those firms that its state contractors had previously identified; (7) did not consider the extent to which state agencies independently inspected certain firms when scheduling its own inspections; and (8) believes that it needs to maintain its level of routine surveillance inspections.

Recommendations for Executive Action

  1. Status: Closed - Implemented

    Comments: FDA examined FY 1988 through 1990 data to improve inventory of firms inspected by FDA or through state contract inspections and refined inspectional targeting criteria.

    Recommendation: To more efficiently and effectively use the resources FDA devotes to domestic food sanitation inspections, the Secretary of Health and Human Services should direct the Commissioner, FDA, to review the FDA inventory of food firms and reduce its inspection of firms that the states routinely inspect as part of their own programs.

    Agency Affected: Department of Health and Human Services

  2. Status: Closed - Implemented

    Comments: While FDA does not believe that it can inspect a valid sample of food establishments with its present resources, it agreed to remind its district offices to use agency directives when meeting with state officials to discuss inspection coverage, including transfer of "high risk" firms for inspection under state contracts.

    Recommendation: To more efficiently and effectively use the resources FDA devotes to domestic food sanitation inspections, the Secretary of Health and Human Services should direct the Commissioner, FDA, to develop a policy on the frequency of food inspections that incorporates the use of statistical sampling to monitor low-risk, nonproblem firms.

    Agency Affected: Department of Health and Human Services

  3. Status: Closed - Not Implemented

    Comments: FDA believes that agency follow-up of violations in firms inspected by states is not necessary. However, FDA will stress to its personnel the need to follow-up on agency-identified inspections.

    Recommendation: To more efficiently and effectively use the resources FDA devotes to domestic food sanitation inspections, the Secretary of Health and Human Services should direct the Commissioner, FDA, to instruct FDA district offices to target all firms with histories of violations, including those identified by state contract inspections, in its plans for future inspections.

    Agency Affected: Department of Health and Human Services

 

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