GAO Faults FDA Third-Party Certification Plans for VQIP, says FDA Should Assess Foreign Food Sectors

As one of its new food safety mandates, FSMA requires the FDA to establish a system for accrediting third parties that may certify foreign facilities or imported foods under FDA jurisdiction. Accreditation bodies would be responsible for approving the third-party auditors. The third-party auditors would then certify that a foreign food product or facility complies with U.S. requirements, including planned FSMA preventative control requirements. The third-party certifications would be used to establish a Voluntary Qualified Importer Program (VQIP) that will allow FDA to offer expedited review and entry to participating importers who are importing foods from foreign facilities certified by accredited third parties. FDA also has the authority to require third-party certifications as a condition of granting entry to imported foods based on a food safety risk.

FDA faces several challenges in implementing the third-party certification scheme, the report said. For example, before third-party certification begins, FDA must develop minimum standards for implementing preventative controls and supporting guidance. FDA was required to issue proposed produce safety standards by January 2012, and was required to issue a rule on preventative controls for facilities that manufacture, process, pack, or hold food by July 2012. FDA officials say they have developed both proposed rules, GAO said, which are currently under review by the Office and Management and Budget. Seafood and juice must already comply with Hazard Analysis and Critical Control Points standards, which include preventative controls, and so are exempt from the new preventative control requirements.

Developing preventative controls with the necessary level of detail for each FDA-regulated food product will be difficult, GAO said, and preventative controls that are sufficiently flexible to consider the diversity of regulated products also poses a challenge for FDA. Training and guidance on implementing the preventative controls will also be difficult, particularly for foreign food producers and processors, GAO said. It may take a considerable amount of time before desired compliance levels are achieved.

But even once the preventative controls are developed, FDA will face further challenges in setting up third-party certification. VQIP will require fees from importer participants in order to cover administrative costs related to the accreditation system for third-party auditors. It may be difficult for FDA to make the case that the fees will be a worthwhile cost for expedited entries, particularly when entry delays are mostly related to detention time during FDA examinations, GAO said. Only a small portion of all food entry lines -- 2.2 percent -- were examined by FDA at ports of entry in fiscal year 2011. And if FDA chooses to mandate third-party certifications based on a food safety risk, foreign companies may choose to ship their goods elsewhere rather than pay certification fees, GAO said.

The report said other challenges FDA faces in implementing its third-party certification scheme include: (1) foreign governments who wish to serve as auditors may disdain dealing with private accreditation firms instead of the U.S. government; (2) identifying the correct level of specialized knowledge required for third-party auditors; (3) conflicts of interest, particularly when foreign governments must accredit third-party auditors; and (4) deciding on a level of oversight that ensures food safety but doesn’t use up too many FDA resources.

In light of these challenges, FDA should instead rely more heavily on its country comparability assessments to reduce the need for third-party certifications, the report said. The FDA comparability assessments, which are currently in the pilot stage, examine the entire food safety system of a foreign country to determine whether it is up to U.S. standards. Few countries have systems that would comply, GAO said. But if FDA followed the approach of the Department of Agriculture’s Food Safety and Inspection Service and the European Union by limiting the comparability assessments to specific products and allowing those products entry, it could place the onus on the foreign government to ensure food products meet U.S. safety requirements, and conserve scarce agency resources, it said.

FDA disagreed with GAO’s conclusions in its response to the report. System-wide comparability assessments are a more efficient and appropriate tool for assessing whether a country’s entire food safety system provides for comparable public health outcomes to those in the U.S., while third-party certifications are better for looking at particular segments of a country’s food safety system, FDA said. Therefore, it said, countries with more mature food safety systems would use the system-wide comparability assessment approach, while those with food safety systems not comparable to the U.S. would pursue third-party accreditation.

FDA said it will develop a plan for the use of comparability assessments once it concludes its pilot project with Canada in 2013, GAO said. The FDA will ask for public comments on its current system-wide comparability approach before finalizing the assessment process, it said.