Expedited Entry of Imported Foods Remains a Gleam in Importers’ Eyes

By Ricardo Carvajal –

The Government Accountability Office ("GAO") published a report that examines FDA’s progress in implementing provisions of the Food Safety Modernization Act ("FSMA") that direct the agency to establish a third-party certification system for imported foods.  Among other things, that system is a prerequisite to implementation of the Voluntary Qualified Importer Program ("VQIP"), which would provide expedited entry for foods certified by third-party auditors as meeting applicable domestic requirements.  The report examines numerous significant challenges that FDA faces in developing a third-party certification system.  These include the development of model accreditation standards and conflict-of-interest regulations, for which there is as yet no time frame for issuance. 

Given these challenges and associated delays, GAO recommends that FDA be more flexible in its conduct of comparability assessments for food safety systems.  Under its current approach, which FDA has begun testing in pilot programs with select countries, FDA examines and demands comparability of a country’s entire food safety system.  If a country’s entire food safety system is deemed comparable, then that country’s exports could receive expedited entry.  The breadth of this approach is expected to disqualify all but a few countries.  Citing FSIS’s more targeted approach for imported meat and poultry products and FDA’s own work with assessment of foreign aquaculture programs, GAO recommends that FDA narrow the scope of its comparability assessments to address specific foods (e.g., seafood).

FDA’s comments on the report suggest that FDA intends to stick with its current approach pending the receipt of public comment:

FDA believes that comparability is a more efficient and appropriate tool for FDA to use in assessing whether a country’s entire food safety system provides adequate assurances of comparable public health outcomes, and third-party certification is a more appropriate approach for FDA to use when assessing a particular segment of the food safety system – e.g., export controls for one or more commodities.  FDA intends to seek public comment on FDA’s current approach to comparability, and in that context, stakeholders will have an opportunity to comment on GAO’s recommended approach.

In summary, it appears that viable mechanisms for gaining expedited entry of imported foods are not on the near horizon, given FDA’s acknowledgement that both the comparability and third-party certification programs “are still in the formative stages.”