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Draft guidance on importer program published by FDA

By Joe Whitworth, 


Related topics: Audit and Certification, Regulation and safety, Fresh produce, FSMA 

The US Food and Drug Administration (FDA) has published draft guidance for importers of human or animal food. 

The Voluntary Qualified Importer Program (VQIP) is a fee­based program for expedited review and importation of foods into the country from importers with a proven food safety track record. 

The draft guidance describes eligibility criteria for participating in VQIP, the user fee, conditions that might result in withdrawal of eligibility and criteria for reinstatement. Electronic or written comments on the draft guidance can be made until August 19 . 

The Food Safety Modernization Act (FSMA) requires FDA to establish such a program for importers who achieve and maintain a high level of control over the safety and security of supply chains. 

The agency said it will be able to focus its resources on food imports that are more likely to present a potential risk to public health. 

Estimated fee FDA said for the purpose of calculating the fee, it estimated it would receive 200 notices of intent to participate and be able to review 200 applications in the first year. 

After considering the burden of the fee on small businesses, via proposed guidelines and public comment, the agency will publish information on the fee schedule.

 It estimated the costs of administering the program will be $3.4m in FY 2018. FDA also predicted the annual fee would be $16,400 to cover the application review process, inspection of importers, determining eligibility and annual IT maintenance costs. 

The agency said this figure is intended to provide small business with a program cost so they can comment on any burden the fee might impose. 

Program benefits FDA said it would encourage importers to apply when the program begins.

“We believe that the benefits of VQIP participation, including expedited entry and reduced sampling by FDA, will be of substantial value to importers. “We also anticipate that VQIP will benefit the public health by incentivizing the adoption of robust supplier verification programs and by allowing FDA to focus its resources on food shipments that pose a higher risk to public health and will facilitate risk­based admissibility practices.” 

The draft guidance document said each VQIP participant will submit to FDA a notice of intent to maintain its participation and update information on its original application on an annual basis. 

After guidance is finalized, the program is expected to be open for applications in January 2018 to allow enough time for a facility to be certified under FDA’s Accredited Third Party Certification program. 

The VQIP is not limited to importers located inside the country. 

Manufacturers, owners, consignees, and importers of record can all be VQIP importers if they meet the criteria for participation. 

These include have three years of experience importing food into the US, develop, implement, and document a VQIP Quality Assurance Program (QAP) and not be subject of an ongoing FDA administrative or judicial action or have a history of significant noncompliance related to food safety.

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