The FDA released the proposed rules for the Foreign Supplier Verification Program and third-party auditor accreditation on July 26, and comments will be accepted on the proposals until Nov. 26. The FDA also has indicated that the comment period for the draft Preventive Controls and Produce Safety rules will be extended to mid-November, two months past the current Sept. 16 deadline.
There are no surprises in FDA’s proposals on imported foods and third-party auditor accreditation, said David Gombas, senior vice president for food safety and technology for the United Fresh Produce Association.
“It’s very consistent with what FDA has used in the past for seafood and juice (food safety rules), when you hold the importer of record responsible for taking affirmative steps to verify compliance,” he said.
Gombas said he appreciated that FDA gives importers a number of alternatives on what they can do to verify produce safety compliance.
Gombas said there were several key elements of the proposed rule:
- A requirement for all foreign suppliers to have a U.S. importer agent of record;
- A requirement for all importers to have a written Food Safety Verification Program;
- All Food Safety Verification Programs must be assessed every three years, or when there have been significant changes;
- Importers must verify foreign suppliers have assesssed potential hazards, and they comply with FDA regulations;
- Importers may use an FDA inspector or one authorized in the exporter’s country, if performed within the past 12 months; and
- Modified provisions for “very small importers” or “very small suppliers,” defined as $500,000 or less annual food sales.
Gombas predicts the FDA will use the foreign supplier verification regulation to target inspections of imports more precisely than they have been able to do in the past.
“Right now the FDA doesn’t have a way to pick and choose what imports to inspect,” he said. “This will give FDA a better way of focusing on certain higher-risk facilities,” he said.
Gombas said he’s concerned about how the “very small” exporters will be handled. The FDA says importers are required to demonstrate compliance with the rules, but according to the Food Safety Modernization Act, small operations are exempt.