The U.S. Food and Drug Administration (FDA) reviews more than 45 million shipments being offered for import each year. FDA aims to ensure that it possesses complete information about every shipment to determine whether the product complies with U.S. laws and regulations before it is marketed in the U.S. This information can determine how likely the shipment is to pass through the U.S. port of entry without complications or delays.

FDA can not stop and examine every shipment, so the agency employs an electronic system called PREDICT to forecast which shipments to examine or sample at the U.S. port of entry.

What factors does PREDICT tell FDA about a shipment that might affect the importing process? Keep reading for more insights.

PREDICT Scores

PREDICT helps FDA prioritize higher risk shipments, considering:

• Inherent product risk
• The shipper’s FDA compliance history
• Randomization for additional security – even if you are shipping a no-risk product with no compliance issues, your product may still be stopped

Other factors that can alter the PREDICT score include having an invalid registration number, attempting to ship a product with labeling errors, having a failed FDA facility inspection on your record, or having consumer complaints on your record.

FDA reviews the PREDICT score of each shipment entering the U.S. to help determine whether or not to stop the shipment. A higher PREDICT score means that you may have a poor compliance history or be shipping a higher-risk product, and you may encounter more issues with getting your product to pass through the port of entry.

Product Risk

Several factors can contribute to a product’s inherent risk level. Some products have a higher risk of causing an illness outbreak, such as a product contaminated with salmonella. Alternatively, your product could have a higher risk of contamination, because it was grown under the regulations of a country that allows use of a pesticide that is prohibited to use when growing that product in the U.S. In that case, the product would not be allowed to be sold in the U.S. Higher risk is also associated with products more likely to experience pathogen growth, including agricultural products such as fresh herbs and cucumbers, shelled eggs products and seafood products. The higher the product’s risk level, the more likely the product will be stopped for additional inspection upon entry to the U.S.

Under FSVP, U.S. Importers must analyze reasonably foreseeable hazards associated with foods they import and document controls for these hazards. Importers may conduct more thorough and frequent verification activities when buying higher risk products. Importers must be familiar with their supplier’s manufacturing process, understand the risks and hazards associated with the product, and possess documentation that confirms the supplier has the correct controls in place for those hazards. When importing a higher risk product, the Importer may need to conduct more verification activities such as requesting a certificate of analysis or requiring a third-party inspection of the supplier’s facility.

FDA has also proposed a Traceability Rule that would require persons who manufacture, process, pack, or hold foods on an FDA “Traceability List” to maintain records of key data elements throughout the supply-chain. This would be another rule intended to ensure adherence to processing requirements and controls for risky products.

Compliance History

FDA is more likely to inspect, detain or delay shipments if a facility has a history of compliance issues, which lead to a higher PREDICT score. Factors that impact a facility’s compliance history include:

• FDA inspection classifications
• Import Alerts
• Warning Letters
• Import Refusals
• Recalls

All of these actions are public information and appear on a company’s record, but FDA may not always inform the exporter when they occur. FDA sends Warning Letters to companies to explain compliance issues with their products and companies are notified if FDA is requiring a product recall. However, FDA will not inform a manufacturer that their product has been refused entry into the U.S. Additionally, FDA will not notify the manufacturer that their product is subject to an Import Alert. Often, manufacturers will only learn of the Import Alert when their products are detained at the U.S. port under the alert.

U.S. Importers are required to monitor their suppliers for these data points under FSMA and may use this information to inform purchases. FSVP regulations require Importers to monitor their non-U.S. suppliers’ compliance history, so Importers may be more likely to purchase from suppliers with few or no compliance issues to reduce the need for increased verification activities.