One requirement of the Food Safety Modernization Act (FSMA) is for the Food and Drug Administration (FDA) to develop a program to expedite food imports to the U.S. from importers with a proven food safety track record. On Thursday, FDA published draft guidance for industry explaining how the new fee-based Voluntary Qualified Importer Program (VQIP) will work. The document lays out the benefits of participating in the VQIP program, eligibility criteria, instructions for obtaining facility certifications for foreign suppliers, instructions for completing a VQIP application, VQIP user fees, reasons why benefits might be revoked, and, using a question-and-answer format, how to be reinstated in the program. Some of the criteria for eligibility include a three-year history of importing to the U.S., none of the importer’s food being subject to an import alert or Class 1 recall, and a current facility certification for each foreign supplier. The importer must also ensure that VQIP food is in compliance with FSMA’s Foreign Supplier Verification Program, juice Hazard Analysis & Critical Control Points (HACCP), or seafood HACCP regulations. The thinking is that the fee-based system will make VQIP self-sufficient, freeing up other resources to focus on higher-risk products. It’s unclear how many importers will be interested in the participating, but FDA estimates that “up to 200 qualified importers” will be accepted in the first year. There will be a public comment period of 75 days on the draft guidance. FDA is asking for comments on whether and how the estimated annual fee of $16,400 might be a burden on small businesses and possible alternatives if it is. After comments are considered and the guidance finalized, it’s expected that applications for the program will be accepted from January 2018 to allow enough time for a facility to be certified under FDA’s Accredited Third Party Certification program.
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