Initial Nationwide Rollout for Food Products Expected in Late September
Officials from the U.S. Food and Drug Administration (FDA) have announced their intention to begin a nationwide rollout in September 2009 of new risk-based screening procedures for imported products under FDA jurisdiction that could, in some cases, result in increased detentions of imports. A pilot of the new program, which was limited to seafood imported through a small number of ports in southern California, was conducted during the summer of 2007. The FDA’s plan is to begin full rollout of the system in September, starting with food products and eventually expanding to all imported products regulated by the FDA.
This new program, the Predictive Risk-Based Evaluation for Dynamic Import Compliance Targeting (PREDICT) system, is intended to replace the FDA’s OASIS legacy electronic system for processing import entries which has been operational since 1998. The current OASIS system provides the FDA with ability to electronically exchange admissibility data with U.S. Customs and Border Protection (CBP) on a real time basis by providing electronic screening of Customs entry lines. The new PREDICT system would replace OASIS with a system that uses more sophisticated automated data mining and pattern discovery capabilities, open source intelligence, and automated queries of key databases (such as registration and listing, marketing approval status, low-acid canned food scheduled processes, etc.).
Poor Quality or Missing Entry Data Will Create Problems
Of particular importance to importers, the new PREDICT system is intended to “improve” the “hit” rate for exams and samples by scoring each Customs entry line on the basis of risk factors and surveillance criteria. The FDA predicts that the system, by employing more sophisticated screening criteria, will increase the number of automated “may proceed” notices (thereby facilitating imports), but also acknowledges that the new scoring system will be particularly sensitive to “poor data,” including data that is missing or is otherwise of poor quality. The FDA concedes that inadequate data will increase risk scores and the likelihood of examination and/or sampling by the FDA.
The FDA has indicated that data used for risk scoring will include:
- Admissibility history with respect to the manufacturer, exporter, importer, and consignee for the current product (at industry and more specific levels)
- 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.
Accordingly, importers of food products will need to be more vigilant than ever under the PREDICT system to ensure the quality of entry information provided to CBP. For example, the FDA has singled out the fact that importers very often report multiple identification numbers (MIDs) for individual facilities. Such practices will lead to higher risk scores under the PREDICT system.
Import Trade Auxiliary Communications System (ITACS)
At the same time it unrolls the PREDICT system, the FDA also intends to rollout a new data exchange system for the private sector. The so-called Import Trade Auxiliary Communications System (ITACS) will establish an internet portal for Customs entry files to confirm the FDA status of individual entries/lines, to submit documents and link them to individual entries/lines, and to provide availability information for targeted shipments.
The ITACS system should further facilitate and streamline information exchange between the importing public and the FDA and, presumably, enhance the flow of food imports.