FDA rolls out Web-based risk assessment tool for food, drug imports

The Food and Drug Administration is deploying a new Web-based computer application to flag high-risk imports of food and medical products for additional monitoring and inspection.

FDA Commissioner Dr. Margaret Hamburg announced the Predictive Risk-based Evaluation for Dynamic Import Compliance Targeting (Predict) system Feb. 4 in a speech at the Center for Strategic and International Studies.

The Predict system, which has been tested in Los Angeles, will rank the hazards of imported food and drug shipments to enable inspectors to focus on the items with highest risk.

It is currently being implemented in New York and will be operating nationwide by early summer, Hamburg said.

The new system will replace the admissibility screening function of the Operational and Administrative System for Import Support, FDA's legacy risk-assessment system.

Predict uses a variety of assessments to rank and score shipments according to risk, including information on the product itself, such as raw seafood, as well as information on weather conditions during shipment, country of origin and manufacturer’s safety record.

Based on the risk score, inspectors will target higher-risk shipments for examination. The system also will expedite the clearance of lower-risk cargo, but only if importers and entry filers provide accurate and complete data, the FDA said.

The system will allow for greater accountability along the global supply chain for the 20 million imported shipments of food, medical devices, drugs and cosmetics regulated by the FDA. About 70 percent of seafood, 40 percent of drugs and 35 percent of fresh produce consumed in the U.S. is imported.