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

In addition to objecting to the requirement for a three-year history of importing food to the U.S. and to the user fee, the Juice Products Association (JPA) raised concerns about parts of VQIP’s quality assurance program that may duplicate requirements under Hazard Analysis and Critical Control Points (HACCP) and the U.S. Customs and Border Protection’s Custom-Trade Partnership Against Terrorism program. Companies covered under HACCP, for example, are exempt from FSVP requirements. “The FDA should take steps to prevent importers from having to duplicate their efforts in order to comply with two similar programs,” wrote Patricia Faison, JPA’s technical director.

But having a valid HACCP plan and abiding by it are not the same. In the seafood industry, for instance, having a HACCP plan is only part of the food safety solution. “There also needs to be some level of verification that the HACCP plan is actually being effectively and successfully used in the facility,” wrote Tom Chestnut, vice president, NSF International, an auditor and certifier of food safety standards under the Global Food Safety Initiative (GFSI).

“The unfortunate reality is that there are likely less than 5 percent of the facilities exporting to the U.S. that possess this level of compliance,” Chestnut wrote. Verification of HACCP compliance could come by means of a comprehensive audit under GFSI or other internationally recognized standard. A simplified “stepped” process could involve remote desk audits that validate the HACCP plan and associated documents, combined with a low-cost consultative audit to evaluate HACCP implementation and provide training and coaching when needed.

The American Association of Exporters and Importers (AAEI), an international trade association, urged FDA to tailor FSVP requirements to the roles and responsibilities specific to participants in the supply chain. For example, risk-based controls for manufacturing food products will differ from those for distributors, which will differ still from those needed at farms. FDA should also “exercise caution in accrediting third-party auditors,” wrote Marianne Rowden, president and CEO, AAEI, noting that the international trade community “is currently being bombarded from third-party auditor requirements for many statutory requirements,” such as the conflict minerals prohibitions under Dodd-Frank and requirements of the Consumer Product Safety Improvement Act.

Agres is a freelance writer based in Laurel, Md. Reach him at [email protected].