Seeing benefits for both the agency and for importers, officials at the Food and Drug Administration expect to soon begin accepting applications for the Voluntary Qualified Importer Program (VQIP).

In a blog post on the FDA website, FDA officials Doriliz De Leon and Amelia Tetterton described the goals of the program for 2018.

Starting in “early 2018,” importers can apply at the FDA Industry Systems website, according to the agency.

The program is voluntary and fee-based, to allow for quicker reviews and importation of foods into the U.S. for approved applicants who achieve and maintain a high level of control over the safety and security of their supply chains.

Mutual benefits

Tetterton said the agency also will benefit from the Voluntary Qualified Importer Program.

“Expedited shipment entry gives importers an incentive to adopt robust management of the safety and security of their supply chain,” she said in the blog post. “There is a benefit for the FDA because it will enable us to better focus our resources on non-VQIP importers.”

She said the agency will direct resources to imported food “that presents a greater potential risk” to public health.

The FDA will use an import screening tool called PREDICT (Predictive Risk- based Evaluation for Dynamic Import Compliance Targeting) to determine whether incoming shipments of food should be subject 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,” Tetterton said.

That will reduce delays at the border for approved VQIP importers, she said. 

De Leon said the FDA will generally limit the agency’s examination and sampling of approved VQIP food to “for cause” situations which raise a potential risk to public health, such as possible contamination or misbranding. 

The VQIP application can include any FDA-regulated food, including produce, seafood, processed foods, dietary supplements and pet food.

The agency said foods covered by the VQIP application must be produced in a foreign facility or farm that’s part of the FDA’s Accredited Third-Party Certification Program. 

That program, also mandated by the Food Safety Modernization Act, 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. The FDA said importers will be able to find information to help them identify accredited third-party auditors on the FDA’s website. 

What to expect

De Leon said importers who apply for the VQIP 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.

“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,” she said. 

The program year begins Oct. 1 after acceptance into the program and lasts until Sept. 30 of the following year. 

Though the FDA won’t announce its official annual user fee for the program until later in the year, the agency’s earlier draft guidance on the program estimated the annual fee at $16,400.

Tetterton said the start of the VQIP is tied to implementation of the Accredited Third-Party Certification rule, which is underway but going somewhat slower than expected.

“Since the (facility) certifications supplied by these auditors are required for participation in VQIP, this meant a delay in the start of our program,” she said.

Still, De Leon said the FDA expects to process up to 200 importer applications for the VQIP program this year..

“We’ll review them on a first-come, first-served basis,” she said.