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

As part of FSVP and VQIP, in July 2015 FDA issued a proposed rule that would establish levels of industry user fees associated with third-party auditors/certification bodies (CBs) and accreditation bodies (ABs)—private companies or foreign governments that will be responsible for auditing and certifying relevant overseas facilities. FDA will recognize ABs to accredit CBs, which will perform the necessary audits and inspections and issue certifications under VQIP. The proposed user fees range from $18,853 for ABs to $35,850 for CBs, depending on the amount of work FDA expects to review an entity’s application.

Also in July, FDA issued draft guidance on model accreditation standards required for the third-party auditors and certification bodies. These include education levels, training, and competencies required for auditors and other personnel. As mandated by FSMA, when drafting the requirements FDA took into account existing international standards for certification bodies in order to avoid duplication of efforts and costs. As a result, the proposed standards are based on (but are not identical to) those established by the International Organization for Standardization and the International Electrotechnical Commission (ISO/IEC standard 17021:2011).

Obtaining FDA approval as an auditor, certifier, or accreditor under VQIP is likely to be challenging. Third-party auditor/certification bodies must demonstrate that they have the necessary authority to access records, conduct onsite audits, issue, and suspend or withdraw certifications; have adequate personnel and staff with the necessary knowledge, skills, and experience; protect against conflicts of interest; evaluate and monitor their agents through a documented process; demonstrate the capability to meet the quality assurance requirements including periodic self-assessment with a written report in English; and have the ability to quickly implement corrective actions.

According to the draft guidance, entry-level auditors should have at least a Bachelor’s degree in a food or relevant scientific discipline, 30 semester hours in the same, plus experience or additional education, or demonstrate successful knowledge and experience. Lead auditors should have at least five years of experience, at least two of which are in quality assurance or food safety, or an advanced degree with at least two years of experience. “This is quite a lift if you want to become an FDA-certified auditor,” says David Acheson, MD, founder and CEO of The Acheson Group and a former FDA associate commissioner for foods. “How many certification bodies and auditors will want to go through with this? My take is that it will be entirely driven by market demand, which for VQIP may not be all that great, at least initially. But if FDA begins to classify a lot of imported food as high risk, and as such the imported food will require a certificate from an accredited auditor to be allowed into the U.S., this will really drive the program far and fast,” Dr. Acheson says.

Objections from Europe

VQIP’s requirements are raising numerous concerns in the European Union (EU). For example, the requirement that participating facilities be certified by a third-party auditor or certification body accredited by FDA “is an unnecessary complex approach in that it appears to be independent from, and unrelated to, all the internationally recognized certification and audit systems,” complained Bernard Van Goethem, the European Commission’s director for health and food safety, in written comments. The requirement also doesn’t recognize the authority of existing government agencies because it makes them subject to the same rules and procedures as private organizations, he added.

Van Goethem also noted that VQIP’s high cost and complexity would benefit larger importers to the detriment of small operators “who represent a large proportion of the EU exporters.” Importantly, he added, importers are likely to pass the additional costs onto their suppliers. The net result “could potentially result in a comparative advantage for domestic [U.S.] sources,” he warned. That statement carries ominous international trade overtones in light of the recent World Trade Organization ruling on country of origin labeling against the U.S. and in favor of Canada and Mexico.