FDA consumer safety officers Doriliz De Leon, left, and Amelia Tetterton
A Conversation with Doriliz De Leon and Amelia Tetterton
The Voluntary Qualified Importer Program, or 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.
The FDA Food Safety Modernization Act (FSMA) required FDA to establish VQIP, and the agency expects to begin accepting applications from importers in early 2018.
Why should importers enroll in VQIP? How does the program benefit them, the FDA, and the public health? Doriliz De Leon, a Consumer Safety Officer in the Food Adulteration Assessment Branch in FDA’s Center for Food Safety and Applied Nutrition, and Amelia Tetterton, a Consumer Safety Officer in the Import Program Development and Implementation Branch in FDA’s Office of Regulatory Affairs, explain the role of this program in helping to ensure the safety and security of imported foods.
Q: How does VQIP fit into the FDA’s mission to protect public health?
De Leon: To be accepted into VQIP, importers will need to meet rigorous criteria to help ensure that the food they’re importing into the United States is safe for consumers. Expedited shipment entry gives importers an incentive to adopt robust management of the safety and security of their supply chain. This is a benefit to industry, as well as to U.S. consumers.
Tetterton: At the same time, there is also a benefit for the FDA because it will enable us to better focus our resources on non-VQIP importers. While we will continue to use our existing risk-based tools to screen and target import shipments, because VQIP foods will have an established level of safety, we can direct agency resources toward imported food that presents a greater potential risk to public health.
Q: What are the benefits for participating importers?
Tetterton: The FDA will expedite import entry into the U.S. for all foods included in an approved VQIP application. We use an import screening tool called PREDICT (Predictive Risk- based Evaluation for Dynamic Import Compliance Targeting) to electronically assess whether incoming shipments of food products should be subjected to examination and/or sampling. We will be setting up PREDICT to recognize shipments of food that are part of the VQIP program and, in most cases, immediately release the shipment without further examination and sampling. This will reduce delays at the border for the approved VQIP importers.
De Leon: We will generally limit our examination and sampling of approved VQIP food to “for cause” situations in which we suspect a potential risk to public health, such as possible contamination or misbranding. Remember, we are a public health agency and we will immediately step in if there is a problem. However, if the FDA does intend to examine or sample 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. And if the FDA samples a VQIP food, laboratory processing of such samples would be expedited.
Q: What products can be included in this program?
Tetterton: The VQIP application can include any FDA-regulated human and/or animal food, including but not limited to seafood, processed foods, produce, dietary supplements, and pet food. Foods covered by the VQIP application must be produced in a foreign facility or farm that is certified by an auditor accredited through the FDA’s Accredited Third-Party Certification Program. That certification program, also mandated by FSMA, provides the means through which third-party auditors are accredited to conduct food safety audits and issue certifications of foreign entities and the foods for humans and animals they produce. These audits attest that the facility or farm has met the applicable food safety requirements. Importers will be able to find information to help them identify accredited third-party auditors on the FDA’s website.
Q: What criteria will importers need to meet in order to participate?
De Leon: Importers should have at least a three-year history of importing food into the U.S. and be in compliance with supplier verification and other responsibilities under the Foreign Supplier Verification Program (FSVP), juice Hazard Analysis and Critical Control Points (HACCP) and/or seafood HACCP regulations, if required. And the key to participation is the development and implementation of a Quality Assurance Program (QAP), which includes written policies and procedures regarding safety and security.
So you can see that the necessary steps to participate in VQIP are significant. In order to assist importers interested in VQIP, we have issued a guidance document that explains the program’s benefits and eligibility criteria, and provides instructions for completing an application.
Q: If an importer has met the requirements of the FSMA-mandated FSVP rule, will the importer have met most of the requirements for VQIP?
Tetterton: Importers required to comply with FSVP must verify that the food they’re importing has been produced in a manner that meets applicable U.S. safety standards. But that’s not everything. VQIP, a voluntary program, recognizes when importers go above and beyond the mandatory requirements of FSVP or HACCP to establish additional controls over their supply chains. For example, VQIP importers must have facility certifications of their suppliers from auditors certified under the Accredited Third-Party Certification rule. In addition, their QAP should show compliance with other criteria related to transportation and food defense.
Q: How do importers apply for VQIP and how much does it cost?
De Leon: Starting in early 2018, importers can apply online at the FDA Industry Systems website. They will need establish an account and submit a Notice of Intent to Participate in VQIP before submitting an application. This notice will need to be resubmitted every year. The VQIP year 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.
Q: The FDA originally said that importers could apply online starting in January 2018. Why has that date been pushed back?
Tetterton: Getting VQIP started is tied to implementation of the Accredited Third-Party Certification rule. The process by which auditors are accredited in that voluntary program is well under way, but more time is needed for facility certifications. Since the certifications supplied by these auditors are required for participation in VQIP, this meant a delay in the start of our program.
Q: Does the importer submit one application for all the different food it imports?
De Leon: Yes, the importer submits one application to cover all the different food 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.
Q: Will applicants get any help filling out the application?
Tetterton: Absolutely. Applicants will be able to contact the VQIP Importers Help Desk at the FDA to receive support and assistance throughout the entire application process. The goal of the VQIP Importers Help Desk will be to provide a direct line to a real person who can answer questions about VQIP.
Q: There is a lot of information needed to apply. Will applicants need to submit the information in a particular format?
De Leon: The application will be available online. There will be 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.
We created a lot of flexibility in how applicants fulfill the requirements of the QAP. Applicants don’t have to reinvent the way they are doing business. An applicant can use and submit existing documents as much as possible.
Q: How will the FDA evaluate an application?
Tetterton: The FDA will review the application, with all the relevant documents, to determine if an importer meets the VQIP eligibility criteria. If the importer is accepted into the program, the FDA will conduct an inspection to verify that the importer has met the eligibility criteria and has fully implemented the food safety and food defense provisions established in the QAP. (It’s worth noting that the food defense provisions do not apply to animal food.) The inspection will include a review of the written procedures and records demonstrating compliance with VQIP directives.
After the first year, the FDA will review the importer’s eligibility each year and will conduct a VQIP inspection at least once every three years that the importer participates in the program. If there is an outbreak, recall, new hazard, or any reason to doubt the safety of the food, the inspection may be conducted more frequently than once every three years.
Q: How many importers are you accepting into this program?
De Leon: We will initially try to assess up to 200 applications in the first year. However, depending on the amount of resources needed in initiating the program, we may review fewer or more applications. We’ll review them on a first-come, first-served basis.
Q: What do you want importers to know about VQIP?
De Leon: Whether or not to participate in VQIP is really a business decision. It takes resources to meet the criteria, but having the speed and predictability at import entry will be a real benefit. This will be particularly helpful for those importing perishable products or using “just in time” processing, in which ingredients must be at a food facility at a certain time in the manufacturing process.
Tetterton: We recognize that many companies out there are already doing much of what is required to participate in VQIP. We look forward to having a program that will provide industry with the benefit of expedited import entry while supporting the FDA’s mission to protect public health.