The FDA announced last week the release of a draft guidance that outlines FDA’s plan to implement the Voluntary Qualified Importer Program (VQIP) mandated under the Food Safety Modernization Act (FSMA).  The draft guidance describes how FDA intends to determine eligibility to participate in the program, along with the benefits of participating, instructions for completing an application, and conditions under which a granted application can be revoked.

Under FSMA section 302, FDA must establish a program that provides for the expedited review and importation of food offered by importers who have voluntarily agreed to participate in the program, and establish a process for the issuance of a facility certification related to that food.  In explaining the benefits of program participation, the draft guidance describes FDA’s intention to “limit examination and/or sampling of VQIP food entries to ‘for cause’ situations (i.e., when the food is or may be associated with a risk to the public health), to obtain statistically necessary risk-based microbiological samples, and to audit VQIP.”  Additionally, participants in the VQIP will have access to the VQIP Importers Help Desk, which will be dedicated to responding to questions and concerns of VQIP importers.

The draft guidance also describes eligibility for participating in the program.  Requirements for participation include: (1) the importer must have a 3-year history of importing food into the United States; (2) the importer cannot have imported food subject to an import alert or Class 1 recall; (3) the importer must have a current facility certification for each foreign supplier of food intended to be imported under FDA’s Accredited Third-Party Certification regulations; (4) the importer must assure compliance with Foreign Supplier Verification Program requirements and applicable seafood and juice HACCP regulations.

FDA will accept comments on the draft guidance until August 4, 2015.  Thereafter, FDA will consider comments and finalize the guidance and expects to begin accepting applications for the program in January 2018.

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