United Fresh Produce Association welcomes the release of two proposed food safety rules under the Food Safety Modernization Act (FSMA) of 2011. The proposed regulations, the Foreign Supplier Verification Programs for Importers of Food for Humans and Animals, and Accreditation of Third-party Auditors, join two previously released draft rules under FSMA, which address produce safety at the farm level and food processing and storage facilities. “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.” Since January of this year, United Fresh has conducted a full review of FDA’s proposed Produce Safety and Preventive Controls rules, bringing together member company experts from each segment of the produce supply chain. United will use that same process in the review of FDA’s draft rules on imports and third-party auditors to provide comments to FDA. “Initially, we don’t see any surprises in FDA’s draft rules on imported foods and third-party auditor accreditation,” said Dr. 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.” Some key elements of the proposed rules announced today:
  • Requirement for all foreign suppliers to have a U.S. importer agent of record
  • Requirement for all importers to have a written Food Safety Verification Program (FSVP)
  • 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