New FDA Screening System for Food Imports

Articles
February 18, 2010

New FDA Screening System for Food Imports

The Food and Drug Administration, FDA, is launching a new electronic screening tool for food imports called Predictive Risk-Based Evaluation for Dynamic Import Compliance Targeting or PREDICT reports the most recent edition of The Food Institute Report.

The Food and Drug Administration, FDA, is launching a new electronic screening tool for food imports called Predictive Risk-Based Evaluation for Dynamic Import Compliance Targeting or PREDICT reports the most recent edition of The Food Institute Report. 
Dr. Margaret Hamburg, Commissioner of Food And Drugs calls it “a new FDA program that should bring us a step closer to assuring the safety and quality of imported goods.”

She noted that this year, nearly 20 million shipments of food, devices, drugs, and cosmetics will arrive at U.S. ports of entry. Just a decade ago, that number was closer to 6 million, and a decade before only a fraction of that. About 15 to 20 percent of all food now consumed in the U.S. originates outside our borders. For some items imports account for a significantly larger share. For example 70 percent of seafood and about 35 percent of fresh produce consumed in the U.S. originates elsewhere.

PREDICT is a new risk-based screening system that automatically scans hundreds of databases for information that may affect FDA’s admissibility determination. For example, PREDICT will check:

  • A product’s inherent risk rating of a product. That includes information such as raw seafood having a higher inherent risk than other foods.
  • Whether a foreign company that produces a food product or the product itself is the subject of an FDA Import Alert.
  • PREDICT will also look at the compliance history of the relevant companies such as foreign manufacturers, shippers, and U.S. importers, and the products themselves. This will include looking at both the product and company’s recalls and inspection results
  • And what FDA calls open source intelligence about the product, producer, and foreign locale from which the product originated. This could include things like  extreme weather conditions such as floods or extreme heat\ that could impact the quality and safety of those products

The system also looks for patterns and associations in the data that FDA previously was previously doing manually.

All of this information will result in a risk score for each food item category entering the United States. Based on the score, the system will either issue a “may proceed” notice so the product can move into the U.S. supply chain or flag the entry as potentially risky and send it to an FDA reviewer for manual processing and possible examination and sampling.

PREDICT will replace the admissibility screening function of OASIS, FDA’s legacy system. Under OASIS, checking of other databases for information about a manufacturer, importer, or product had to be done manually and often relied on the memory of the reviewer.

PREDICT was pilot tested in Los Angeles, is currently being implemented in New York, and will be deployed in the rest of the country over the next several months with complete installation expected by the end of summer. It is anticipated that PREDICT will significantly increase the number of automated “may proceed” decisions issued for food imports. In pilot testing in Los Angeles, the percentage of “may proceed” decisions jumped to about 60%.

That is considerable considering that FDA-regulated products are currently imported from more than 150 countries, with more than 130,000 importers of record, and from more than 300,000 foreign facilities.

The Food Institute will be following the progress of this new program as it moves into the mainstream as a collaborative effort between the government and private industry to further ensure the safety of the food supply in a timely and more efficient manner than in the past.