Trade Compliance

GHY discusses changes to international trade regulations and explores cutting-edge compliance strategies.

FDA’s Expedited Food Import Program Now Accepting Applications

Posted March 26, 2018


Called for by a mandate of the previous administration’s Food Safety Modernization Act (FSMA), 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.

Benefits

The U.S. Food and Drug Administration (FDA) states that participating importers will be able to import their products to the U.S. with greater speed and predictability, avoiding unexpected delays at the point of import entry. Consumers will also benefit, the agency says, from the importers’ robust management of the safety and security of their supply chains.

To facilitate this process, the agency has established its PREDICT (Predictive Risk-based Evaluation for Dynamic Import Compliance Targeting) import screening tool to recognize food shipments that are part of the VQIP program and, in most cases, immediately release such cargo without further examination and sampling.

The FDA notes that it will generally limit its examination and sampling of approved VQIP food to “for cause” situations in which it suspects a potential risk to public health, such as possible contamination or mislabelling. In such cases the sampling or examination location would be the VQIP food’s destination or another location chosen by the importer, to the extent possible, and any laboratory processing of samples would be expedited.

Eligibility & Application

To participate, importers must meet eligibility criteria and pay a user fee that covers costs associated with the FDA’s administration of the program. That cost and the applicable fees are expected to be published in the Federal Register around the beginning of August. In the meantime, to provide an idea of the approximate amount involved, the draft VQIP guidance in 2015 estimated the annual fee at $16,400.

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 the FDA or an accredited third-party auditor confirming that the facility or farm has met the applicable food safety requirements.

Importers looking to qualify for the program 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. Above all, key to participation is the development and implementation of a Quality Assurance Program (QAP), which includes written policies and procedures regarding safety and security.

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 should be noted 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.

In order to assist importers interested in VQIP, the FDA has issued a guidance document that explains the program’s benefits and eligibility criteria, and provides instructions for completing an application. A slide-show version of the Final Guidance is available here. Importers can submit their application online at the FDA Industry Systems website.

Compliance Verification

Importers required to comply with FSVP must verify that the food they are importing has been produced in a manner that meets applicable U.S. safety standards. However, it be also noted that because VQIP is a voluntary program, importers are acknowledged for exceeding 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.

After the first year, the FDA will review the importer’s eligibility on an annual basis 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.

Looking Ahead

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 FDA says it intends to initially assess up to 200 applications in the first year, although that number could be higher or lower depending on the amount of resources needed to get the program initiated.