Pesticide Monitoring:

FDA's Automated Import Information System Is Incomplete

RCED-92-42: Published: Dec 31, 1991. Publicly Released: Jan 30, 1992.

Additional Materials:

Contact:

Peter F. Guerrero
(202) 512-4907
contact@gao.gov

 

Office of Public Affairs
(202) 512-4800
youngc1@gao.gov

Pursuant to a congressional request, GAO reviewed the status of the Food and Drug Administration's (FDA) efforts to implement the Import Support and Information System (ISIS) to automate its import monitoring operations.

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.

Recommendations for Executive Action

  1. Status: Closed - Implemented

    Comments: FDA, in conjunction with Customs, has developed implementation plans and milestones for only one region of the nation. This is insufficient to ensure effective and timely implementation of the ISIS-ACS interface in all FDA districts nationwide and therefore jeopardizes FDA's efforts to improve its import monitoring operations. GAO is currently reviewing the program.

    Recommendation: The Secretary of Health and Human Services should ensure that FDA develops, in coordination with Customs, detailed plans and milestones for implementing an electronic interface between ISIS and ACS nationwide.

    Agency Affected: Department of Health and Human Services

  2. Status: Closed - Implemented

    Comments: FDA has established a basic screening module and has developed a basis for creating a profiling module, but the agency has not developed the detailed plans and milestones required for nationwide implementation of these modules. At this point, FDA plans no further development of these modules until an unknown future date. Failure to implement these modules would greatly detract from the usefulness and effectiveness of ISIS. GAO is currently reviewing the program's progress.

    Recommendation: The Secretary of Health and Human Services should ensure that FDA develops detailed plans and milestones for implementing ISIS screening and profiling modules.

    Agency Affected: Department of Health and Human Services

  3. Status: Closed - Not Implemented

    Comments: Last year, Congress transferred the responsibility and funds for developing the interface plans to the U.S. Customs Service. As a result, the recommendation to HHS is no longer applicable.

    Recommendation: The Secretary of Health and Human Services should ensure that FDA informs Congress of its established target dates for implementing the interface and the screening and profiling modules and periodically updates Congress on its progress, including any deviations from those dates.

    Agency Affected: Department of Health and Human Services

 

Explore the full database of GAO's Open Recommendations »

Sep 28, 2016

Sep 26, 2016

Aug 15, 2016

Jul 26, 2016

Jul 21, 2016

Jul 14, 2016

Jul 7, 2016

Looking for more? Browse all our products here