As part of the US Food Safety Modernization Act (FSMA), the US Food and Drug Administration (FDA) has issued several rules, published guidelines and created tools to help companies understand and comply with the updated regulations. The Voluntary Qualified Importer Program (VQIP) is a fee-based program designed to help streamline the importation process for those who qualify.
Eligibility of Companies:
Importers must maintain a high level of control over the safety and security of their supply chain by implementing a Quality Assurance Program (QAP) (see below). They must also:
• Ensure that supplier verification and other applicable importer responsibilities, as outlined in the Foreign Supplier Verification Program (FSVP), juice HACCP (Hazard Analysis and Critical Control Points), or seafood HACCP regulations, are met
• Hold a current third-party certification, issued by an FDA-accredited certification body, for each foreign food supplier, or, for raw produce, for each farm
• Have a minimum three-year history of importing to the US
• Be subject to no ongoing judicial or administrative actions by the FDA, or any history of non-compliance within the supply chain
• A Dun & Bradstreet (D&B) Data Universal Numbering System (DUNS) number
Eligibility of Foods:
• The food must come from a facility (or farm) that is certified under the FDA’s Accredited Third-Party Certification regulations.
• No food that an applicant imports may be subject to an import alert or Class 1 recall.
Benefits of Participating:
The FDA will expedite the entry into the US of any food covered by VQIP. This means that their import screening system will recognize and release shipments covered by VQIP as soon as the entry information is received. In addition, examination and sampling will only occur for necessary statistical analysis or to audit VQIP, where the food is or may be associated with a public health risk.
VQIP Quality Assurance Program (QAP)
The QAP must be submitted with the VQIP application and should include:
• A Corporate Quality Policy Statement that applies to the whole supply chain, as well as an explanation of how this is communicated internally
• A description of the organization’s structure and responsibilities
• Policies and procedures that ensure food safety from source to entry, including a range of compliance and procedural information
• Knowledge and qualifications requirements for all relevant employees
• Written procedures for establishing and maintaining records.
Applying for VQIP
Applications must be renewed each year and online accounts can be created by visiting the FDA Industry Systems website. If the application is approved, the VQIP benefits will apply from October 1st to September 30th. There is a fee which must be paid by October 1st. The amount of the fee will be published each year in the Federal Register on or before August 1st.
The FDA will first review your application to determine if you meet the criteria. If you are accepted, the FDA will conduct an inspection to verify you have implemented your QAP procedures. If your facility is covered under other regulations, the inspection will cover these, and your labels may be reviewed to ensure there are no labelling violations.
Should there be an outbreak, recall or newly identified hazard linked to a food included in your VQIP, or violations associated with one or more entities associated with your company, the FDA may conduct more frequent inspections.
During the VQIP year, you can amend your application to:
• Add a food from a foreign supplier already included in your VQIP
• Remove a food, supplier or importer
• Replace a foreign supplier or importer for a food that is in your VQIP as long as they have a current facility certification
• Add or remove a filer/broker.
The FDA may revoke your participation if they receive evidence that you no longer meet one or more of the eligibility requirements, or that you participated in smuggling or other fraudulent activities. This revocation will apply to all foods you import under VQIP.