FDA Finalizes Plans for 'VQIP' Food Importer Trusted Trader Program, Open to 200 Importers in 2018
The Food and Drug Administration issued a final guidance document (here) detailing its upcoming Voluntary Qualified Importer Program, a trusted trader program for food importers that will provide benefits including fewer examinations and expedited laboratory analysis. Under the program, importers will receive benefits at the border, including reduced sampling, in return for meeting certain requirements including importing the food from food exporters certified annually under the program by third-party auditors. FDA will begin accepting VQIP applications on Jan. 1, 2018, for participation in the program for the fiscal year beginning October 2018 and ending September 2019, it said (here). The agency will limit participation to 200 applicants for the first year, it said.
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Program for importers with history of compliance. VQIP will be open to food importers in good standing with FDA and CBP that import from foreign food facilities that have been registered with FDA and certified by third-party auditors as compliant with FDA regulations. The importer must have a history of compliance stretching back at least three years. In a change from its draft guidance, FDA will allow that history to include "shared importation history of previous or parent companies." The importer must also use filers/brokers who have passed their most recent FDA filer evaluation, and cannot import food that is the subject of an import alert or other FDA administrative or judicial action.
For the purposes of VQIP, "importer" is defined as the person that brings food, or causes food to be brought, from a foreign country into the customs territory of the United States. The VQIP importer definition is not the same as FDA’s definition of importer for the purposes of the Foreign Supplier Verification Program or CBP’s definition of importer of record. The VQIP importer may be located outside the United States, FDA said.
VQIP status designated at entry. In order to obtain VQIP benefits, additional data elements will have to be submitted at entry. A VQIP Affirmation of Compliance (AofC) code and the importer’s VQIP application number will be required. Products and foreign suppliers must be listed on the importer’s approved VQIP application on file with FDA in order to be eligible for VQIP benefits. The importer may import both VQIP and non-VQIP food, with FDA expediting only the entry lines associated with the VQIP food. In such cases, the importer should make sure the VQIP foods are easily segregated from the non-VQIP foods so they can be moved into commerce, FDA said.
Benefits include immediate release, limited sampling, expedited lab analysis. For food designated as VQIP at entry and listed on an importer’s approved VQIP application, FDA will expedite entry by setting screening in its PREDICT import targeting system to recognize and immediately release VQIP entries “unless examination and sampling are necessary for public health reasons,” FDA said. Examination or sampling will be limited to “for cause” situations, such as when there is an outbreak or illness associated with the type of food or one of the importer’s foreign suppliers, as well as risk-based microbiological sampling, FDA said. The agency also will periodically conduct audit examinations to verify compliance with VQIP, with samples collected post-release.
When sampling and analysis is required, FDA will schedule laboratory analyses to ensure VQIP samples receive priority over non-VQIP samples, it said. FDA will also work with CBP in cases in which “exportation is warranted” to ensure the food is exported from the port preferred by the importer, it said.
VQIP participants will also get the benefit of a “VQIP Importers Help Desk" dedicated to "responding to questions and resolving issues raised by VQIP importers about VQIP food,” and importers will be able to contact the help desk if their VQIP entries are delayed to enlist FDA’s assistance to resolve issues with CBP. The agency will post a publicly available list of approved VQIP importers on its website. Importers will be able to opt out of the list.
Applications and fees due every year. Approval of VQIP applications will only run for one fiscal year, from Oct. 1 through Sept. 30. Each year, between Jan. 1 and May 31, importers must submit a new application for the fiscal year beginning Oct. 1, with the ability to repopulate new applications using data submitted on the importer’s previous application on file. Information required includes applicant and firm application, including a DUNS number, the company’s FSVP contact, details of the importer’s VQIP Quality Assurance Program, filer/broker information, foreign supplier facility information and products subject to VQIP. First-time applicants must also develop and submit a written "Quality Assurance Program," but must only submit their written plans afterward if they are updated. FDA will inspect the importer after the first application and at least every three years thereafter.
Once the application is approved, a user fee will be due by Oct. 1. The importer will be able to revise its application after approval and throughout the fiscal year to reflect changes to foods covered by the program and changes to the importer’s brokers and foreign suppliers. FDA said importers should immediately amend their VQIP applications if a food or foreign supplier becomes subject to an import alert or other FDA administrative or judicial action.
Revocation of VQIP participation. FDA says it will revoke an importer’s VQIP approval if the importer does not meet one or more of the VQIP eligibility requirements, or if there is evidence that the importer participated in smuggling or fraud, it said. Reinstatement into VQIP will be possible for importers that correct deficiencies or submit corrective action plans, except in cases where participation was revoked based on evidence of smuggling or fraud, FDA said.