The U.S. Food and Drug Administration (FDA) has published a new Voluntary Qualified Importer Program (VQIP) resource to help importers understand eligibility criteria and answer questions prior to submitting an application. VQIP expedites the review and importation of foods into the U.S. for importers that can demonstrate a high level of control over the safety and security of their supply chains.
To participate in VQIP, importers of human and animal food must meet certain conditions, including having foreign suppliers audited and certified under FDA’s Accredited Third-Party Certification Program (TPP) by an accredited third-party certification body. The resource includes lists of considerations for preparing to apply for VQIP and for VQIP program maintenance.
When preparing to apply for VQIP, importers should consider the following for participation in the program and for audits conducted under TPP for importers and foreign suppliers:
- Review FDA’s VQIP Guidance eligibility requirements
- Ensure that each of the foreign suppliers of the food(s) intended for import under VQIP have been audited by an accredited certification body under TPP and issued a valid facility certification
- Develop and implement a VQIP Quality Assurance Program (QAP), which compiles the policies and procedures for the safety and security of imported foods, should be submitted with the VQIP application, and should include all components outlined in the VQIP Guidance
- Audits under TPP evaluate compliance to the applicable food safety requirements of FDA regulations and the Federal Food, Drug, and Cosmetic Act (FFDC Act), which facility certification(s) issued to a foreign supplier must meet
- The TPP certification bodies table includes information on firms that are accredited to conduct regulatory audits and issue facility certifications for the purpose of VQIP
- Foreign suppliers interested in an audit under TPP to establish VQIP eligibility should contact an accredited certification body under TPP to request an audit that meets the definition of a regulatory audit; only the results of a regulatory audit can determine eligibility for issuing a certification under TPP
- A facility certification is required to establish eligibility for VQIP participation; food or facility certifications may be issued by accredited certification bodies under TPP
- Before beginning an audit under TPP, an accredited certification body must require the foreign supplier seeking the audit to identify the scope and purpose of the audit, including the facility, process(es), or food to be audited, and the type of certification(s) being sought; accredited certification bodies must determine whether a requested audit is within its scope of accreditation
- Importers interested in VQIP should coordinate with foreign suppliers on which foods are to be included in a VQIP application, and the foreign supplier should coordinate with the accredited certification body under TPP to plan for their regulatory audit to ensure that the foods intended for the VQIP application would be included in the scope and purpose of the regulatory audit conducted under TPP and any resulting facility certification(s) that would be used to establish eligibility for VQIP.
- Once an accredited certification body issues a certification to a foreign supplier, the certification body must submit information electronically to FDA through FDA Industry Systems, at which point the certification body should select FDA product codes to describe the products covered under the certificate; FDA product codes in the facility certifications should correspond to the product codes for the foods in the importer’s VQIP application.
The resource also outlines considerations for VQIP program maintenance by importers of human and animal food:
- Report any changes to the VQIP QAP that may impact eligibility for the VQIP through the amendment process
- Foreign suppliers should maintain a valid facility certification under TPP to support an importer’s continued participation in VQIP throughout the VQIP year; FDA recommends foreign suppliers maintain contact with accredited certification bodies to plan for timely audits to maintain certification
- Renew participation yearly by submitting a renewal application and paying the VQIP user fee, payment for which is due after FDA approves the application
- VQIP user fee rates are calculated each fiscal year and published in August in the Federal Register
- The VQIP user fee is assessed per application and importers may apply to include any number of foods with valid facility certifications (issued under TPP) from the indicated foreign supplier(s); VQIP benefits funded by the user fee extend from October 1 to September 30 of each fiscal year.
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