Status of FDA's Efforts to Improve Import Monitoring and Enforcement

T-RCED-93-55: Published: Jun 16, 1993. Publicly Released: Jun 16, 1993.

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GAO discussed the Food and Drug Administration's (FDA) improvements to its pesticide monitoring program. GAO noted that: (1) FDA plans to implement its Automated Import Support and Information System (ISIS) in its Seattle district by September 1993; (2) FDA plans to have full ISIS implementation in its Pacific region by December 1994, but has no specific plans for expanding ISIS nationally; (3) FDA has extensively revised plans for two system modules, but it has not established development and implementation plans for these modules as recommended; (4) FDA has made significant progress in interfacing ISIS with the Customs Service's Automated Commercial System (ACS), which has increased efficiency, reduced paperwork, and increased the flow of imports through ports; (5) FDA considers the ISIS-ACS interface an integral part of its baseline system, since it reduces the data entry burden on ISIS users; (6) deterrents against improper distributions of adulterated food imports are not effective because some importers choose to pay the relatively low damages rather than destroy or export their shipments; (7) FDA believes that basing civil damages on potential public health risks would be scientifically questionable and extremely costly, since the risk is very small; (8) importers' disregard for FDA instructions to destroy or export adulterated food undermines the FDA pesticide monitoring program and is a long-term problem; and (9) improvements in the FDA monitoring program would detect more adulterated shipments with existing resources.

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