FDA May Begin Rollout of New Import Screening System by Late September

July 20, 2009

Officials from the Food and Drug Administration (FDA) recently discussed two new import screening systems that could be ready for nationwide deployment by the end of September. The first system, the Predictive Risk-based Evaluation for Dynamic Import Compliance Targeting (PREDICT) system, will replace the FDA’s current OASIS import screaming system with a rule-based system that assesses information from multiple sources and determine which shipments carry the highest risk. The second system, the Import Trade Auxiliary Communications System (TRAC), is an internet portal for entry filers to check the FDA status of individual entries/lines, submit documents and link them to specific entries.

The PREDICT system will score each line entry and is expected to increase the number of automated “may proceed” decisions while increasing the “hit rate” of violations found during field inspections by targeting high risk shipments. In making these risk score determinations, the PREDICT system is expected to evaluate the following data elements:

• Admissibility history with respect to the manufacturer, exporter, importer, and consignee for the current product.
• Accuracy of product and facility coding by entry filers.
• Data anomalies within the current entry.
• Results of field exams and sample analyses of previous entries.
• Results of facility inspections, foreign and domestic.
• Ratings of inherent product risks.
• Open source intelligence pertaining to the manufacturer, foreign locale, product, etc.

When PREDICT comes online, the quality of entry data will be a key factor in determining an entries risk score. Higher risk scores increase the likelihood of examination and sampling by the FDA, both which can result in border release delays.

The FDA noted that during a trial period at the port of Los Angeles, inconsistent Manufacturer Identification Numbers (MIDs) for the same foreign facility frequently causes PREDICT to view foreign facilities as new and as a result, increase the attached entry’s risk score. According to the FDA, on average there are six MIDs per facility. The long term solution is to replace MID with a unique reproducible identifier such as Dunn and Bradstreet Universal Numbering System (DUNS) number.

Barring any major complications during the upcoming simulation and user acceptance testing, both the PREDICT and ITACS systems are expected to be rolled out simultaneously in late September.