The Food and Drug Administration has made available a final guidance for industry on the fee-based Voluntary Qualified Importer Program, which will provide for expedited review and importation of human and animal food by participating importers with a proven track record of food safety and security. The FDA believes that expedited entry under the VQIP will incentivize importers to adopt a robust system of supply chain management and allow the FDA to focus its resources on examining and sampling food imports that are more likely to present a potential risk to public health.

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The guidance describes the eligibility criteria for, and benefits of, participation in the VQIP. It also provides information on submitting an application for VQIP participation, obtaining a facility certification for the foreign supplier of a food imported under the VQIP, the VQIP user fee, conditions that might result in the revocation of VQIP eligibility, and criteria for reinstatement of eligibility.

According to the FDA, changes from the draft guidance include the following.

- clarifies that during the VQIP fiscal year a VQIP importer may add additional food from a foreign supplier from which the importer already imports food under the VQIP

- clarifies that VQIP applicants will not be required to upload food labels for foods included in the VQIP application but that the FDA may request a copy of such labels to determine if there are labeling violations relating to the risk of the food during a VQIP inspection or audit examinations

- provides examples of how to ensure that the Foreign Supplier Verification Program or the Hazard Analysis and Critical Control Point importer of the food (when it is not the VQIP applicant) is in compliance with the applicable FSVP or HACCP regulations

- revises the “three-year import history” eligibility criteria to provide for use of shared importation history of previous or parent companies

The FDA plans to begin accepting applications for the VQIP on Jan. 1, 2018, for participation starting in fiscal year 2019, which begins Oct. 1, 2018. The FDA anticipates approving about 200 applications in the first year.

The annual fee to be paid by all VQIP participants has been estimated at $16,400 but has not yet been finalized. The FDA states that it will publish the fee amount in the Federal Register on or before Aug. 1, 2017, and each year thereafter.

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