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U.S. Department of Health and Human Services

About FDA

AQSIQ Regulatory Assessment

Description: Upon completion of training of China's General Administration of Quality Supervision, Inspection and Quarantine (AQSIQ), and confirmation of proficiency by FDA based on an audit, develop a mutually agreed operational process to accept information from AQSIQ laboratories to confirm the absence of melamine and cyanuric acid in dairy-containing products. Full implementation of this project, in which Chinese food regulators will, for the first time, provide laboratory data directly to FDA, will mark significant progress in FDA’s efforts to build confidence in the Chinese regulatory system and enhance U.S. consumer protection.

The audit and training phases of this project have been completed. AQSIQ's laboratories substantially passed FDA's audit regarding their capacity to test accurately and consistently for melamine and cyanuric acid. In 2010, however, several factors changed AQSIQ's thinking regarding their willingness to bring this project to completion:

a) AQSIQ came to a fuller understanding of the significant, new, long-term responsibilities its staff would need to shoulder to implement this project; and

b) AQSIQ reviewed and reassessed the volume of dairy-containing products exported from China.

When AQSIQ juxtaposed the low volume of Chinese dairy-containing products to the U.S. with the significant burden this effort would place on their staff, they ultimately decided to withdraw from the project.

Milestone DescriptionMilestone DateMilestone StatusMilestone Completion Date

A. Completion of ORA/DFI audit, resolution of outstanding issues with AQSIQ

4/15/2010

Completed 4/15/2010

B. Complete training of AQSIQ regarding linkage of laboratory packages to specific shipments

5/11/2010

Completed 5/11/2010

C. Begin pilot project to accept data from selected AQSIQ laboratories

7/2/2010

Delayed

D. Full implementation - accept information from half of the identified (13) AQSIQ laboratories

9/30/2010

Delayed

Key Projects Legend

Milestone StatusDefinition
Not Yet StartedWork for specific milestone has not yet been started.
CompletedMilestone and/or overall project is completed.
On TrackMilestone - On track for completion by milestone deadline. Quarter status - Project is on track for completion based on overall milestone status.
On HoldMilestone - On hold, but deadline for completion has not passed. Quarter status - Project is on hold, based on overall milestone status.
DelayedMilestone - Delayed as it has not been completed and deadline has passed. Quarter status - Project is delayed based on overall milestone status.

Glossary

Note: The data provided on this website is produced on an ongoing basis for performance management purposes and is subject to change due to updates of preliminary estimates, corrections, or other reasons. In addition, FDA may change the type or amount of data provided on this website at any time. Information marked as "Completed" may include measures and/or key projects for which activities are ongoing but no longer tracked as part of FDA-TRACK.