The Food and Drug Administration is using a combination of old and new tools to improve the safety of imports and a quick look at the numbers explains why.
We’ve seen the familiar statistics: Almost 50 percent of fresh fruit, 20 percent of fresh vegetables, and 80 percent of seafood is imported. The U.S. imports from more than 200 countries and from about 125,000 firms, so a risk-based approach to inspection is really the only kind of oversight that makes sense.
FDA’s Don Prater, in his new role as acting assistant commissioner for food safety – which makes him the agency’s new point person for FSMA – discussed this in an FDA Constituent Alert last month.
FDA activities related to imported foods are undergoing big changes, largely due to FSMA, he said.
Overseas inspections are very resource intensive because of the need for coordination with national and local authorities, visa requirements, logistical arrangements, language (need for interpreters), and other challenges, he said. So the agency will keep focusing on facilities that pose the highest risk.
The agency currently uses the Predictive Risk-based Evaluation for Dynamic Import Compliance Targeting (PREDICT) system to electronically screen all regulated shipments imported or offered for import into the U.S. In addition, it is now using data analytics to get a deeper understanding of the global inventory of regulated entities, he said. This will help the agency target its resources.
Traditional inspection will continue, Prater said, so facility inspections and examination at the port of entry will continue to be important tools. The challenge is integrating the old and new tools. The agency currently has several FSMA implementation groups working on this issue.
One challenge involves using information from third parties for oversight activities. A big question is how the agency can use this information in planning its work, he said.
Integrating open source material, such as new reports and social media, has great potential, but is challenging to evaluate and confirm. FDA historically has been very conservative in using unofficial and unconfirmed information to direct its focus. Data analytics may offer some degree of confidence as FDA gains experience.
The agency has recognized just three countries as providing the same level of public health protection – New Zealand, Canada and, just last month, Australia. It is still too early to know when and what will be a recognizable difference in FDA surveillance activities compared to those prior to recognition.