The FDA is accepting comments until August 19 about its Voluntary Qualified Importer Program (VQIP), a fee-based program that would allow for expedited review and importation of foods from importers that have a proven food safety track record. The program is expected to begin in fiscal year 2018.
The new program is an outgrowth of the Food Safety Modernization Act that authorized FDA to ensure that imported foods meet the same safety standards as those that are domestically produced in the U.S. VQIP, according to information available on the Federal Register, “incentivizes importers to adopt a robust system of supply chain management.” Also, according to the FDA, the program, with its focus on food safety, should increase consumer protection by “enabling the FDA to focus its resources on food imports that are more likely to present a potential risk to public health.”
Benefits of participation in the program, beyond expedited review, will include limited examination and/or sampling of VQIP food entries to “for cause” situations, an expedited laboratory analysis of “for cause” samples, and access to a VQIP Importers Help Desk dedicated to resolving issues raised by VQIP importers.
An extensive application process is outlined in the draft guidance; the agency estimates that the process will require between 80 and 100 person-hours per applicant the first year and about 20 person-hours to renew each year. To participate in the program, importers must meet all of the eligibility criteria, which include having a 3-year history as a food importer, with none of the imported foods subject to an import alert or Class 1 recall. Neither the business nor the nonapplicant entities associated with a VQIP food should have a history of noncompliance related to food safety. The foreign supplier’s facility must have a facility certification, issued after an auditor or certification body accreditation under FDA’s regulations.
An importer will need to submit the written policies and procedures it will use to ensure adequate control over the safety and security of foods it imports and an explanation of how those policies are communicated to employees and to its nonapplicant entities, according to the draft document.
The actual fee schedule for the program will be published at least 60 days prior to the start of the program. The current estimated annual fee for each participant is $16,400, an amount based on the assumption that about 200 importers will participate. The agency is requesting comments about whether the fee will be a burden on small businesses and, if so, recommendations about how a reduction in fee should be structured, i.e. size of business, annual gross sales, value of import entry, number of facilities included in the application, etc.
The industry can submit electronic comments or write its comments to Division of Dockets Management (HFA-305), FDA, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.