The Food and Drug Administration July 26 announced the Foreign Supplier Verification and Accredited Third Party Certification.

Part of the Food Safety Modernization Act, the proposed rules would make importers accountable for food safety and create standards for third-party audits of foreign food producers. About 15 percent of the U.S. food supply, including 50 percent of fresh fruit and 20 percent of fresh vegetables, is imported.

"We must work toward global solutions to food safety so that whether you serve your family food grown locally or imported you can be confident that it is safe," says Margaret A. Hamburg, FDA commissioner.

Brian Pendleton, a senior policy advisor at FDA, explains that the import rules build on the two FSMA rules proposed earlier. "It's a way to ensure that imports meet U.S. safety standards," he says. "It's all part of a multi-pronged effort to improve the safety of both domestic and imported foods."

Importers would have to establish that the food being exported to the United States was according to U.S. standards.

"We will continue to check food at our borders. However, rather than relying almost entirely on FDA's investigators at the ports to detect and respond to food safety problems, importers would—for the first time—be held accountable for verifying, in a manner transparent to FDA, that the food they import is safe," says Michael R. Taylor, deputy commissioner for foods and veterinary medicine.

U.S. fruit and vegetable industry approves

U.S. fruit and vegetable industry likes the rules.

“The rules for imported foods and third-party auditor accreditation will have a critically important role in the safety of fresh produce,” said Tom Stenzel, president and CEO of United Fresh. “United Fresh will immediately begin a comprehensive review of these new draft rules and work closely with FDA to ensure that they contribute to our mutual goal of continued food safety improvement.”

“Initially, we don’t see any surprises in FDA’s draft rules on imported foods and third-party auditor accreditation,” said David Gombas, senior vice president for food safety and technology. “However, it’s important that we thoughtfully review them in a line-by-line fashion, including analysis of their interaction with other FSMA draft rules, to ensure they advance food safety and are workable for the industry.”

Rules highlights:

  • All foreign suppliers must have a U.S. importer agent of record.
  • All importers must have a written Food Safety Verification Program.
  • All FSVPs must be reassessed within 3 years, or when there have been significant changes.
  • The importer must conduct verification activities to ensure the foreign supplier 1) has controlled each of the hazards identified in the importer’s hazard analysis and 2) is in compliance with relevant FDA regulations.
  • Instead of an onsite audit, an importer may use an FDA inspection or inspection of the foreign operation by an officially recognized food safety authority of the supplier’s country, if performed within the past 12 months.
  • There are modified provisions (no exemptions) for “very small importers” or importing from a “very small supplier”, defined as $500,000 or less annual food sales.