FDA 'Very Close' to Recognizing Canada Equivalency, Largely Exempting Canadian Food Imports From FSVP

The Food and Drug Administration is “very close” to recognizing Canada as having an equivalent food safety system, with a determination possible in the next few months, said Dominic Veneziano, director of FDA’s import division, at a seminar hosted by the American Bar Association Dec. 7 in Washington. The move would largely exempt food imports from Canada from the requirements of FDA’s Foreign Supplier Verification Program.

FDA’s Nov. 27 final rule on FSVP includes an exemption from hazard analysis and supplier verification requirements for food imported from countries recognized by FDA as equivalent. To qualify, the food must be within the scope of the equivalency determination; the importer must determine that the supplier of the food is in compliance with the relevant food safety authority; and the food must not be intended for further processing in the United States. New Zealand is currently the only country recognized by FDA as having an equivalent food safety system (see 12121326), and a review of Australia is pending.

FDA is still grappling with how to implement some other provisions of FSVP, according to Veneziano. One issue the agency faces is how to apply FSVP’s exemption for foods exported from and returned to the U.S. without manufacturing or processing in a foreign country. The exemption would apply in large part to “gray market” imports of U.S. food intended by its manufacturer for foreign markets but subsequently re-imported by another party looking to profit. The problem for FDA is, once the food is exported and control of the product is lost, it’s difficult for the agency to determine what has happened and whether the food has in fact been manipulated, said Veneziano. FDA intends to issue a guidance document on the subject, he said.

A second issue is how FDA can enforce provisions of FSVP allowing importers to rely on steps taken by downstream customers to address food safety hazards. Under those provisions, the importer can have its U.S. customers conduct required hazard analysis, supplier evaluation and verification activities, as long as the importer obtains written assurances that the hazards are being controlled. As a result, FDA may have to inspect not only the importer to ensure FSVP compliance, but also to the importer’s customer and the end user. FDA is considering two types of audits for FSVP compliance, added Veneziano: “desk audits” based on an importer’s records, and “on-site” audits, especially if issues are found during the desk audit.

FSVP’s staggered compliance dates and various exemptions complicate implementation of FSVP in the Automated Commercial Environment, said Veneziano. Unable at first glance to determine whether or not an importer is required to comply with FSVP, FDA has been forced to keep FSVP data elements optional in ACE. The agency can’t make the data elements mandatory until FSVP takes full effect after 2020, he said.