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.
“There (are) a lot of those small suppliers importing to the U.S. and if the importer of record says they are in compliance because they are exempt, now what do you do?” Gombas said.
Gombas said the proposed third-party auditor regulation mandates that certifiers have no conflict of interest with the audited party. In addition, the produce safety standards in the audit are established by FDA, Gombas said. Third-party auditor accreditation is also operated independently of auditors, he said.
“This enables companies outside the U.S. to use their third-party audit as a regulatory audit,” he said. “Now (the proposal) actually establishes requirements for those auditors to do a regulatory audit and for the first time ever allows the private sector to do those regulatory audits.”
That will free up FDA personnel to concentrate on higher-risk operations, Gombas said.
Bret Erickson, president of the Mission-based Texas International Produce Association, welcomed the proposed rules.
“We’re eager to get into the weeds on them and see what all they require,” he said July 31. “What I anticipate is a lot of our folks are already doing these things that are going to be required under this set of proposed rules.”
Lance Jungmeyer, president of Fresh Produce Association of the Americas, Nogales, Ariz., said the FDA regulations must treat domestic food and imported food in the same way or foreign governments will object.
“I think one of the things that held up the release of the rule and still may cause for changes in the rule is that generally under World Trade Organization obligations you cannot hold imported foods to a higher standard than domestic food,” he said.
Jungmeyer said one aspect of the FDA’s new rules that warrants more attention is the stipulation any audits done by an accredited third party have to be submitted to FDA. “You could end up where, due to an FDA backlog, you could find yourself blacklisted from FDA for a minor problem that was already fixed,” he said.
Jungmeyer said he was pleased that the comment period for all food safety rules will extend into November. “It is very important to be able to look at these two new rules in the same context as the two rules on produce safety and preventive controls for food facilities,” he said.