Pesticide Monitoring

FDA's Automated Import Information System Is Incomplete Gao ID: RCED-92-42 December 31, 1991

Imports of fruits and vegetables into the United States have risen substantially during the past decade. In response to public concerns about the safety of imported food, the Food and Drug Administration (FDA) has reformed its program for monitoring pesticides in imported food during the last 5 years. Among these reforms is the development of the Import Support and Information System (ISIS) to automate nearly all of FDA's import-monitoring operations, including pesticide residue monitoring. Repeated difficulties have plagued ISIS development, and FDA has failed to meet system commitments made to Congress. While FDA officials say that they have resolved these problems, FDA still has not developed detailed plans specifying milestones and tasks required for establishing the interface nationwide. Additionally, FDA has not yet prepared any detailed plans for developing and implementing the screening and profiling modules. GAO believes that the ISIS core system will improve FDA's import program by creating the agency's first nationally integrated and standardized automated information system for import monitoring. But these improvements will be limited until FDA adds its planned completion modules to the core. These completion modules are meant to automate data entry, supply comprehensive import information, and provide automated support for making monitoring decisions.

GAO found that: (1) ISIS development has taken FDA significantly longer than it originally estimated; (2) FDA did not meet system development and implementation milestones due to unrealistic projections and unexpected technical difficulties and procurement problems; (3) the ISIS core will provide FDA with a limited database for reviewing and evaluating its import monitoring operations and ISIS data entry requirements will prevent the system from attaining the expected efficiency gains; (4) to fully achieve ISIS objectives, FDA is planning to implement an interface with the Customs Service's Automated Commercial System (ACS) to electronically link the two systems; (5) the ISIS-ACS interface will provide FDA with up-to-date information on the volume of imported products coming from various nations, allow ISIS to collect import data on most shipments of FDA-regulated products, and improve FDA program efficiency by substantially reducing the amount of time needed for FDA personnel to manually enter such data; (6) disagreements between FDA and Customs regarding system design have delayed the ISIS-ACS interface; and (7) although FDA plans to add screening and profiling modules to provide field personnel with additional data and guidance to improve their ability to identify violations, it has not prepared detailed plans for developing and integrating them in the ISIS core.


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