earthOn January 2, 2018, FDA announced that it expects to begin accepting applications in early 2018 for its Voluntary Qualified Importer Program (VQIP), which we first advised you of back in 2015. VQIP is a voluntary, fee-based program for importers that will allow expedited review and importation of human and animal foods into the United States for approved applicants who achieve and maintain a high level of control over the safety and security of their supply chains. Below are the most important VQIP questions and answers from the FDA.

The FDA originally said that importers could apply online starting in January 2018. Why has that date been pushed back?

Getting VQIP started is tied to implementation of the Accredited Third-Party Certification program. In order to participate in VQIP auditors have to certify the foreign facilities from which the food is supplied. Although the process by which auditors are accredited is well under way, more time is needed for facility certifications.chart

 Who is Eligible to Participate?

Importers (defined as the person who brings food, or causes food to be brought, from a foreign country into the United States) should meet several eligibility criteria to participate in the program. These criteria include:

  • Developing and implementing aQuality Assurance Program (QAP) that demonstrates a high level of control over the safety and security of supply chains.
  • Assurance of compliance with the supplier verification and other importer responsibilities under the applicable Foreign Supplier Verification Program (FSVP), juice Hazard Analysis and Critical Control Points (HACCP), or seafood HACCP regulations.
  • A current facility certification issued under FDA’s Accredited Third-Party Certification regulations for each foreign supplier of food intended for importation under VQIP.  In the case of raw produce, there must be a certification for the farm.
  • At least a three-year history of importing food to the United States. If applicants have imported food for more than three years, the FDA may review additional years as necessary to adequately evaluate compliance history.
  • No ongoing FDA administrative or judicial action (e.g., import alert, injunction, recall), or other history of significant non-compliance with food safety regulations by the importer, other entities in the supply chain (e.g., foreign suppliers, filers/brokers, and FSVP and HACCP importers), or food.
  • Having a Dun & Bradstreet (D&B) Data Universal Numbering System (DUNS) number.

What is my VQIP Quality Assurance Program (QAP)?

A QAP is a compilation of the written policies and procedures you will use to ensure adequate control over the safety and security of the foods you import.  Your QAP, submitted with your VQIP application, should include:

  • A Table of Contents
  • A Corporate Quality Policy Statement related to food safety and security throughout the supply chain and an explanation of how this policy is communicated internally.
  • A description of the organizational structure and individual responsibilities.
  • Established Food Safety Policies and Procedures that include:
    • Compliance with supplier verification procedures in the FSVP or HACCP regulations, if applicable.
    • Written procedures for maintaining current foreign supplier certifications under FDA’s Accredited Third-Party Certification Program,
    • Procedures for controlling the safety of each VQIP food throughout the transportation supply chain, including compliance with FDA’s sanitary transport rule, if applicable.
    • Written procedures for communicating information about potential health hazards to FDA and others.
    • Written procedures for corrective actions to address food and foreign supplier non-compliances that pose a risk to public health.
    • A written description of your food defense system to protect against intentional adulteration, if applicable.
  • Knowledge and qualification requirements for employees responsible for implementing the VQIP QAP.
  • Written procedures for establishing and maintaining records relating to the structure, processes, procedures, and implementation of your VQIP QAP.

How does VQIP fit into the FDA’s mission to protect public health?

Expedited shipment entry gives importers an incentive to meet rigorous criteria to help ensure that the food they’re importing into the United States is safe for consumers. Ultimately, this is a benefit to industry, as well as to U.S. consumers. Furthermore, VQIP enables FDA to better focus its resources on non-VQIP importers.

What are the benefits for participating importers?

  • The FDA will expedite entry into the U.S. for all foods included in an approved VQIP application.
  • This means that the FDA will set up its import screening system, Predictive Risk- based Evaluation for Dynamic Import Compliance Targeting (PREDICT), to recognize shipments of food that are the subject of an approved VQIP application and, in most cases, immediately release the shipment after the receipt of entry information.
  • The FDA will limit examination and/or sampling of VQIP food entries to “for cause” situations in which there is a potential threat to public health, to obtain statistically necessary risk-based microbiological samples, and to audit VQIP.
  • In the event that FDA examines or samples a VQIP food, the location of such sampling or examination would, to the extent possible, be at the VQIP food’s destination or another location chosen by the importer.
  • In the event that FDA samples a VQIP food, laboratory analysis of such samples would be expedited.
  • The FDA will establish a VQIP Importers Help Desk dedicated to responding to questions and concerns from VQIP importers. The help desk will be available for assistance with completing the VQIP application, facilitating a review of VQIP food that does not receive an immediate release, and answering other questions from VQIP importers related to the program.
  • The FDA will post on its VQIP web page a list of approved VQIP importers; however, VQIP importers may choose not to be listed.

What products can be included in this program?

  • Foods from a foreign facility (or farm) certified under FDA’s Accredited Third-Party Certification regulations as following appropriate food safety practices.
  • No food that an applicant imports, including those not intended for inclusion in VQIP, should be subject to an import alert or Class 1 recall.

Will FDA expedite entry of a VQIP food that is part of a mixed entry (i.e., the entry includes VQIP food and food that is not covered by my VQIP)?

No. Combining VQIP and non-VQIP foods into a single entry may slow the entry of the VQIP food because the non-VQIP food is subject to normal FDA review procedures, including routine examination and sampling, when applicable.

What would necessitate a ‘For Cause’ examination of a VQIP food?

A shipment from a VQIP-qualified importer may be subject to a “for cause” examination if the food is or may be associated with a risk to public health.

How do importers apply for VQIP and how much does it cost?

  • Importers can apply online at theFDA Industry Systems website.
  • They will need establish an account and, from January 1 to May 31 each year, submit a “Notice of Intent to Participate” in VQIP before submitting an application.
  • This notice will need to be resubmitted every year, which begins October 1 after acceptance into the program and lasts until September 30 of the following year.
  • There will be an annual user fee to participate in the program, which will cover all foods covered by the VQIP application.  The annual user fee for this first year needs to be paid by Oct. 1, 2018, the start of the VQIP year, for the benefit period through Sept. 30, 2019.
  • The fee covers the FDA’s cost of administering the program and the amount will be published in the Federal Register around Aug. 1, 2018. To give you an idea of the approximate amount, the draft VQIP guidance in 2015 estimated the annual fee at $16,400.

FDA has not yet finalized the fee for applications in January 2018, but will publish the fee amount in the Federal Register on or before August 1, 2017, and each year thereafter.

Does the importer submit one application for all the different food it imports?

Yes, the importer submits one application to cover all the different foods it would like to import under the program. The application may cover multiple foreign supplier facilities or farms and the food(s) that the VQIP importer would like to have covered. All of the supply chain information covering the food(s), foreign suppliers, FSVP or HACCP importers, and filer/brokers will be covered by one single application. If the importer also imports food from facilities or farms that haven’t been covered by their approved VQIP application, those food items would not receive the program benefits, including expedited entry.

How soon will I receive benefits?

VQIP benefits will begin October 1 following your acceptance into the program and will last through September 30 of the following year (VQIP year).

There is a lot of information needed to apply. Will applicants need to submit the information in a particular format?

No. The online application process will provide opportunities to upload documents and provide additional comments throughout the application. Each section of the application will focus on specific information, such as a Foreign Supplier(s), Filer/Broker, or the QAP.

How will the FDA evaluate an application?

  • FDA will review the application, with all the relevant documents, to determine if you meet the VQIP eligibility criteria.
  • If you are accepted into the program, FDA will conduct a VQIP inspection to verify that you meet the VQIP eligibility criteria and have fully implemented the food safety and any food defense systems established in your QAP.
  • The inspection will typically include a review of the written procedures and records demonstrating compliance with VQIP.  If you are both the VQIP and FSVP/Juice or Seafood HACCP importer for one or more foods you import under this program, FDA may also conduct an FSVP or HACCP importer inspection to assess your compliance with the applicable regulations.
  • FDA may also request a copy of food labels for the foods you include in your application, to determine if there are labeling violations relating to the risk of the food (e.g., failure to disclose an allergen).  You will be asked to address any label deficiencies.  (Food labels do not have to be included in the VQIP application.)
  • FDA ordinarily will conduct a VQIP inspection after your application is approved and prior to October 1 of the first year that you participate in VQIP.

How often will FDA evaluate me for VQIP eligibility?

  • The first year that you submit a VQIP application, FDA will review all aspects of your application and conduct an inspection to verify your eligibility.  Thereafter, we will reevaluate your eligibility at least once every three years that you participate in VQIP.
  • An event such as an outbreak or recall linked to a food included in your VQIP application (or a similar food), a new hazard associated with a VQIP food, or intelligence data related to violations associated with one or more entities (e.g., foreign supplier, filer/broker) listed on your VQIP application may prompt FDA to reevaluate your eligibility, including conducting an inspection, more frequently than once every three years.

Can amendments be made to the VQIP application for business purposes during the VQIP fiscal year?

As necessary for your business purposes, you can amend your VQIP application to:

  • Add a food from a foreign supplier already in your VQIP;
  • Remove a food, the foreign supplier of a food, or the FSVP or Juice or Seafood HACCP importer for a food;
  • Replace a foreign supplier or FSVP or Juice or Seafood HACCP importer for a food that is already listed in your VQIP application as long as the foreign supplier has a current facility certification; and
  • Add or remove a filer/broker.

Can the FDA revoke my participation in VQIP and how will I be notified?

Yes.  The FDA may:

  • Revoke your participation in VQIP based on evidence that you do not meet one or more of the VQIP eligibility requirements or
  • Immediately revoke your participation in VQIP based on evidence that you participated in smuggling or other fraudulent activities.
  • Revocation of your participation in VQIP will apply to all foods you import under VQIP.
  • If the FDA has credible evidence that you do not meet one or more of the VQIP eligibility requirements, FDA will send a “Notice of Intent to Revoke” your participation in VQIP by email to the contact person identified in your VQIP application.
  • The notice will explain the basis for the proposed revocation and indicate that, within 30 days, you would need to make corrections and provide the FDA with evidence of the corrections to avoid revocation.
  • Benefits will continue for those 30 days unless the FDA believes there is a risk to public health.

Can I obtain reinstatement of my participation in VQIP after a revocation?

When revocation is based upon evidence that you do not meet one or more of the VQIP eligibility requirements, you may ask the FDA to reinstate your VQIP participation and benefits at any time after you have corrected the issues associated with your revocation.  Your request should include documentation of actions you have taken to correct or resolve all of the identified issues.

How many importers are you accepting into this program?

FDA will initially try to assess up to 200 applications in the first year. Depending on the amount of resources needed in initiating the program, FDA may review fewer or more applications. Applications will be reviewed on a first-come, first-served basis.

For more information on applying for the VQIP, or assistance in developing your QAP program contact us today at info@diaztradelaw.com or 305-456-3830.