FDA Releases Draft Guidance on FSMA Voluntary Qualified Importer Program

On June 4, 2015, the Food and Drug Administration (FDA) released a new draft document to provide guidance on the agency’s planned implementation of the Voluntary Qualified Importer Program (VQIP), as required by the Food Safety Modernization Act (FSMA).  FSMA’s VQIP provisions instruct FDA to establish a program for the expedited review and importation of food from importers who achieve and maintain a high level of control over the safety and security of their supply chains.  In addition, FSMA authorized FDA to create a process for the issuance of a facility certification, which would accompany food offered by VQIP-participating importers.  This VQIP-focused draft guidance provides specific information on the benefits of participation and instructions for the application, and describes the eligibility criteria for participation, including the conditions that may result in revocation of participation in the VQIP.

Benefits of VQIP Participation

FDA expects that the benefits of participation in the VQIP will include:

• Expedited entry

FDA anticipates that expedited entry will incentivize importers to adopt a robust system of supply chain management that will allow FDA to focus its resources on food entries that pose a higher risk to public health.

• Limited examination and/or sampling of VQIP food entries to “for cause” situations, such as when the food is or may be associated with a risk to the public health, or when FDA needs to obtain statistically necessary risk-based microbiological samples or audit the VQIP

A risk to public health would be, for example, an investigation of an outbreak or illness associated with the type of food or with a foreign supplier covered by an approved VQIP application.  In the case of microbiological sampling, this would be related to specific risk-based surveillance assignments and would occur after the food is released from import status.

• Any examination of entries and sample collection will take place at the VQIP food destination or other location preferred by the VQIP importer
• Any samples will receive expedited laboratory analysis 
• FDA will maintain a VQIP Importers Help Desk
• FDA will post a publicly available list of approved VQIP importers

VQIP Participation Eligibility

Only food importers can participate in the VQIP; this may include the manufacturer, owner, consignee, or importer of record of the food.  In addition, the importer must meet stringent eligibility criteria, as follows:

1. Have at least a 3-year history of importing food into the United States (for all food, not just the food intended for inclusion in the VQIP).
2. Have a Data Universal Numbering System (DUNS) number.
3. Use paperless filers/brokers who received a passing rating during their last FDA Filer Evaluation.
4. Must not have any imported food (including food not subject to VQIP) subject to an import alert or Class 1 recall.
5. Must not be subject to an ongoing FDA administrative or judicial action (e.g., Import Alert, injunction, and debarment), or have a history of significant noncompliances relating to food safety (e.g., an “Official Action Indicated” (OAI) FDA inspection classification with no documentation of appropriate corrective actions; one or more voluntary Class 1 recalls relating to food safety).  Not only is the importer subject to this criterion, but also “Non-applicant entities,” which are those entities associated with a VQIP food that conduct activities throughout the supply chain necessary for ensuring that the eligibility requirements of VQIP are met, such as the foreign supplier or filer/broker.
6. Importers who are also subject to the importer requirements in FDA’s Foreign Supplier Verification Program (FSVP) regulations (yet to be finalized) or the juice or seafood hazard analysis and critical control point (HACCP) regulations must be in compliance with these regulations.  Alternatively, importers must identify the FSVP or HACCP importer for the food and ensure compliance with the applicable regulations.
7. Have a current facility certification for each foreign supplier of food imported under VQIP.  This certification would be issued following a regulatory audit conducted by a third-party auditor/certification body accredited under FDA’s third-party accreditation regulations (yet to be finalized).
8. Must develop and implement a VQIP Quality Assurance Program (QAP), and submit documentation of the QAP with the VQIP application.
   The QAP is a compilation of the written policies and procedures used to ensure adequate control over the safety and security of imported foods.  It should include the following substantive information:
   
• The corporate quality policy statement
• The organization structure and functional responsibilities
• Food safety policies and procedures
• Food defense policies and procedures
• A description of the experience and training for employees responsible for implementing the QAP
• Procedures for implementing and updating the QAP
• Written procedures for establishing and maintaining required records
 
9. Must not, within the past three years, have been the subject of any Customs and Border Patrol (CBP) penalties, forfeitures, or sanctions that are related to the safety and security of any FDA-regulated product that was imported or offered for import.
10. Must pay the annual VQIP user fee before October 1 of the year of intended participation.

How to Participate

Participation in the VQIP is for the US fiscal year, which begins on October 1 each year.  Importers who wish to join must submit a notice of intent to participate between January 1 and May 31 of the prior fiscal year.  FDA has indicated that due to resource constraints, it will limit the number of participants in the first year to 200 at the most, although it may be less depending on FDA’s ability to review applications.  Participation must be renewed annually, and participants will be subject to FDA inspection.  The guidance also describes when a participant must amend their VQIP application to maintain eligibility.

Participation can be revoked if an importer no longer meets the eligibility criteria (although reinstatement during that fiscal year may be possible), or if the importer participates in smuggling or other fraudulent activities.  In the latter case, reinstatement in the VQIP is not possible.  To ensure continued participation, participants are advised to report any deviations from the QAP to FDA, including a plan for correction of the deviations.

Comments

FDA has established a docket to submit comments, FDA-2011-N-0144, and requests receipt by August 19, 2015.  Please contact us if you would like more information or assistance with submitting comments to FDA.