The Food and Drug Administration on Nov. 10 issued a guidance for industry describing a voluntary, fee-based program for the expedited review and importation of foods by importers who achieve and maintain a high level of control over the safety and security of their supply chains. The Voluntary Qualified Importer Program (VQIP) is being established under the FDA's Food Safety Modernization Act with the aim of incentivizing “importers to adopt a robust system of supply chain management.” The FDA said the program, which will begin in fiscal year 2019, also will benefit consumers by allowing the agency to concentrate its resources on food entries that pose a higher risk to public health.
The FDA said it will expedite entry into the United States for all foods included in an approved VQIP application. Such foods will be termed VQIP foods.
“This means that the FDA will set up its import screening system 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 said.
The agency said it 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 For example, if there is an outbreak of foodborne illness that has been linked to the type of food or to a foreign supplier covered in the VQIP application, the FDA may examine and sample the food. In the event that the FDA samples a VQIP food, laboratory analysis of such samples would be expedited.
Foods allowed under the V.Q.I.P. include foods from facilities or farms certified under the FDA’s Accredited Third-Party Certification regulations as following appropriate food safety practices. The FDA cautioned no food that an applicant imports, including those not intended for inclusion in VQIP, should be subject to an import alert or Class I recall.
The FDA . noted it will only expedite the importation of VQIP food.
“A non-participating food will be subject to normal FDA review procedures, including routine examination and sampling, where applicable,” the FDA said. “Therefore, combining VQIP and non-VQIP foods in a single entry may slow the entry of the VQIP food.”
Food importers who wish to participate in the program must meet several eligibility criteria outlined in the guidance. The applicant must develop and implement a quality assurance program that demonstrates a high level of control over the safety and security of supply chains. It must provide assurance it will be in compliance with the supplier verification and other importer responsibilities under the applicable Foreign Supplier Verification Program, juice HACCP (Hazard Analysis and Critical Control Points), or seafood HACCP regulations.
A VQIP applicant also must have a current facility certification issued under the 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 supplying farm.
The applying importer must have at least a three-year history of importing food into the United States. The import history may be based on the shared importation history of previous or parent companies, such as those that have been involved in a merger. If applicants have imported food for more than three years, the FDA may review additional years as necessary to adequately evaluate compliance history.
To be accepted into VQIP, the applying importer must not be a subject of an ongoing FDA administrative or judicial action, or have a history of significant non-compliance with food safety regulations. The same must be true of other entities in the supply chain of the food to be imported by the applying importer.
Each participant must pay a fee to cover the FDA’s costs of administering the program. In 2015, the FDA estimated the flat annual fee would be about $16,400, but it will publish the actual fee in the Federal Register or before Aug. 1, 2017, for those importers who plan to apply for participation when enrollment for fiscal year 2019 is opened on Jan. 1, 2018.
The F.D.A. will be able to revoke a company’s participation in the program if it has credible evidence that the company does not meet all VQIP requirements or that it is involved in fraudulent activity (such as smuggling). Revocation will apply to all foods the company imports under VQIP The company may apply for reinstatement by submitting documentation of actions it has taken to correct or resolve all of the deviations. However, the FDA will not reinstate participation if revocation was based on evidence of fraudulent activity.
“Time will tell if the VQIP system will be of benefit to the food industry,” commented David Acheson, president and chief executive officer, The Acheson Group. “In principle, it is a great program that has the potential to signal to your customers in the United States that you have hit a high bar with regard to FDA standards. But will the costs and hassles outweigh the challenges? Will having VQIP really be attractive to your customers? Will it materially impact the speed and ease of importation of foods?
“Currently, the amount of food that is held at the border for routine inspection is very small, so a key question is whether VQIP will make a material difference. At this point, it is not clear. So, lots of questions remain, including the actual cost of signing up for the program, but at least we now have a good vision of FDA expectations around VQIP .”