Pros, Cons of Becoming Certified in FDA’s Voluntary Qualified Importer Program

Food industry representatives appear to be largely supportive of FDA’s Voluntary Qualified Importer Program (VQIP), a provision of the Food Safety Modernization Act (FSMA) designed to expedite the review and importation of foods from certified facilities. This voluntary, fee-based program will reward importers that have demonstrated a “high level of control over the safety and security of their supply chains,” according to FDA.

In June 2015, FDA published draft guidance for and requested comment from industry about the proposed VQIP standards, which will become a key complement to the Foreign Supplier Verification Program (FSVP), the final rules for which are to be published by Oct. 31, 2015. The 28-page VQIP document outlines expected benefits, eligibility requirements, procedures, and user fees associated with the program, which is slated to begin in fiscal year 2018. The comment period closed in late August.

Among other benefits, VQIP-identified food products will be immediately released at the port of entry with FDA limiting its examination or sampling of such imports only in “for cause” situations, such as when a food may be associated with a public health risk. When sampling is required, the agency will do so at the final destination point or at a location preferred by the VQIP importer and will expedite any necessary laboratory analysis. “Expedited entry incentivizes importers to adopt a robust system of supply chain management and further benefits public health by allowing FDA to focus its resources on food entries that pose a higher risk to public health,” the draft guidance document says.

Most of the comments submitted by 51 trade associations, organizations, and individuals generally supported VQIP, but also identified areas of potential concern. Many of these revolved around overly restrictive qualifications, prohibitive fees for small- to medium-sized businesses, duplication of efforts, and excessive recordkeeping.

“We have great expectations that preventive control assurances brought about by the FSVP rule and VQIP will speed border crossings, reduce border bottlenecks, and facilitate international trade,” wrote James R. Gorny, PhD, vice president at Produce Marketing Association, in his comments. But he said it was unclear whether the estimated $16,400 VQIP annual user fee would be refunded if FDA rejected a firm’s application. He also criticized FDA’s plan to limit participation to only 200 firms during the program’s first year. That number “will be infinitesimally small compared to the overall food import volume” of 12 million line-entries to 88,000 consignees annually, Dr. Gorny wrote.

The Fresh Produce Association of the Americas (FPAA), whose membership includes more than 100 companies involved in growing, shipping, and distributing fresh fruit and vegetables from Mexico to rest of North America, also expressed concerns over the proposed user fee. Lance Jungmeyer, FPAA president, urged there be some flexibility in the requirement that firms have a three-year history of importing food into the U.S. because companies often merge or form new entities. Jungmeyer also objected to strict requirements that the imported food not be subject to an import alert or a Class 1 recall and that all firms involved not be subject to an ongoing FDA administrative or judicial action. In both cases, he said, these actions could occur at no fault of the importer’s. “It would be punitive, for example, for a grape importer to lose VQIP eligibility because it works with a non-applicant entity that is under Import Alert for cilantro,” he wrote.

A ‘Heavy Lift’ for Business

James Acheson, a business analyst at The Acheson Group, predicts the process of becoming VQIP certified will be a “heavy lift” for many businesses. “But if you are an importer of food, and if you have VQIP, I think you will look very attractive to any U.S. domestic customer who only wants to purchase from those that are best-in-class,” Acheson says. “So my view is that the economic upside of this may not rest with fast implementation of food, but more with the ability to leverage your programs to your customers.”