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FSMA – Voluntary Qualified Importer Program (VQIP)

What is VQIP and who can benefit?

VQIP is a US FDA voluntary and fee-based program that allows eligible food importers to expedite the review and entry of food into the US. Eligibility is limited to importers who demonstrate, through accredited third-party certification, a commitment to food safety and security. The final but non-binding guidance for VQIP was published on November 2016.1 This said document answers some stakeholders’ concerns and questions, specifically concerns from small businesses, as reported in the FDA FSMA Regional Outreach Meetings Report published early this year.2

Who can participate?

Foreign farms and foreign food facilities subject to HACCP or FSMA requirements may participate in the program by undergoing annual unannounced certification audits conducted by qualified auditors (Refer to the Accredited Third-party Certification Rule). VQIP importers are defined as an eligible person or organization “who brings food, or causes food to be brought, from a foreign country into the United States. Unlike the Foreign Supplier Verification Program (FSVP) importer, the VQIP importer can be located outside the United States.” Qualified food importers may be manufacturers, owners, consignees, or importers of record.

Overview of import process

Food included in a VQIP application will be granted expedited access into the US through FDA’s PREDICT, a risk-based food safety screening system for imports. In the event of a food safety situation (i.e., a “for cause” situation), FDA reserves the right to hold product and expedite the sampling and testing of VQIP imports. FDA will also publicly post a list of VQIP importers on the VQIP web portal and provide a help desk to answer participants’ questions and concerns.

Eligibility criteria

FDA communicated verbally during an outreach webinar that prospective importers who are not meeting specific criteria are still “encouraged” to apply and discuss specifics with the agency. Food importers must meet the following requirements:

  1. 3-year history of importing food into the US (import history based on importation of all foods, including the import of non-VQIP food).
  2. 9-digit unique entity identifier (DUNS number).
  3. Filers’/brokers’ satisfactory compliance status (FDA Filer Evaluation Outcomes).
  4. No imported food, including a food not included under VQIP, is subject to detention without physical examination under an Import Alert or a Class 1 recall at the time of application.
  5. No VQIP food is subject to an ongoing FDA administrative or judicial action (e.g., Import Alert, injunction, debarment), no history of significant non-compliance relating to food safety.
  6. If a VQIP importer is the FSVP or HACCP importer, compliance with the FSVP, juice HACCP, or seafood HACCP regulations. If the VQIP importer is not the FSVP or HACCP importer, the VQIP importer must identify the FSVP or HACCP importer compliance with applicable FSVP or HACCP regulations.
  7. Valid facility certification issued in accordance with FDA’s third party certification program for each foreign supplier of food listed under a VQIP application.
  8. Quality Assurance Program (QAP)
  9. Within the past 3 years, no CBP penalties, forfeitures, or sanctions related to the safety or security of any FDA regulated imported product
  10. Annual VQIP user fee payment

VQIP’s Quality Assurance Program (QAP)

VQIP importers are required to develop a comprehensive food safety and security system. The policy and procedure manual must include the following elements:

  • Table of contents
  • Corporate Quality Policy Statement
  • Organizational structure and management responsibilities
  • Policies and procedures meeting the FSMA or HACCP regulatory requirements
  • Policies and procedures to ensure continuing foreign supplier certification
  • Written procedures for communicating information about potential health hazards to FDA and other stakeholders.
  • Written procedures for corrective actions to address food and foreign supplier non-compliance issues that pose a food safety risk.
  • A written description of the importer’s food defense system to protect food against intentional adulteration
  • Experience and training requirements for employees responsible for implementing the Quality Assurance Program
  • Written procedures for establishing and maintaining records relating to the structure, processes, procedures and implementation of the VQIP QAP.

Fees and Application Timeline

FDA anticipates that applications will be accepted starting January 2018. Annual VQIP benefits will start on October 1 following acceptance into the program and will last through September 30. The proposed flat fee has been set at $16,400, to be paid yearly before October 1St and after the application is approved.  FDA will publish VQIP fees for small businesses in a separate rule making.

How to Apply?

Importers must establish an online account by visiting the FDA Industry Systems web site and must submit a “Notice of Intent to Participate” from January 1 to May 31 each year. Information on how to complete and submit a VQIP application can be found here.

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References

1- Guidance for Industry: FDA’s Voluntary Qualified Importer Program

2- Report on Regional FSMA Import Safety Meetings

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