FDA Announces Web-Based Tool For Import Risk Assessment

The agency said PREDICT will allow inspectors to focus on the most likely threats to public health, as the volume of import entries has grown exponentially over the past decade.

 

“Globalization has fundamentally altered the markets for food and medicinal products and FDA needs to change in order to keep up,” FDA commissioner Margaret Hamburg said in announcing the solution.

 

The system will expedite clearance of low risk cargo but only if accurate and complete data are provided by importers and entry filers.

 

PREDICT replaces a process of picking shipments for testing at random based on educated guesses, the agency said.

 

Unloaded products are checked for a specific product code, which is transmitted to FDA headquarters. FDA inspectors running PREDICT will access hundreds of data bases to obtain information such as a product’s manufacturer and country of origin, and if the product is susceptible to being a security risk.

 

The system finds patterns that may not be obvious to entry receivers looking at individual entries. In minutes, receivers are sent a score for the product, with problem products red flagged.

 

PREDICT is integrated into FDA’s MARCs (Mission Accomplishments and Regulatory Compliance Services) import entry review software that is being rolled out one district at a time. The rollout started in Sept. 2009 in the Los Angeles district and will be completed nationwide by the end of summer.

 

The software includes the ability to view documents and shipment examination availability information transmitted to FDA via The Import Trade Auxiliary Communications System (ITACS), for which the agency launched a beta test last month.